WO2025207671A1 - Heart valve repair devices and methods - Google Patents

Heart valve repair devices and methods

Info

Publication number
WO2025207671A1
WO2025207671A1 PCT/US2025/021396 US2025021396W WO2025207671A1 WO 2025207671 A1 WO2025207671 A1 WO 2025207671A1 US 2025021396 W US2025021396 W US 2025021396W WO 2025207671 A1 WO2025207671 A1 WO 2025207671A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchors
central body
anchor
implementations
arm
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/021396
Other languages
French (fr)
Inventor
Noam NIR
Ofry Efraim YOSSEF
Carmel PELEG
Aviv GALON
Eva Adriana de la Cruz ROMITO
Yaron Herman
Bar EYTAN-VAISMAN
Zachary James ZIRA
Itay AVINATHAN
Gil HAMERMAN
Ido HALABI
Meir ABUCASIS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025207671A1 publication Critical patent/WO2025207671A1/en
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit

Definitions

  • a healthy heart has a generally conical shape that tapers to a lower apex.
  • the heart is four-chambered through which blood flows,
  • a native human heart includes four chambers: two atria (upper chambers) - the left atrium and the right atrium, and two ventricles (lower chambers) - the left ventricle and the right ventricle.
  • a wall, the septum separates the right and left sides of the heart (i.e., of each pair of chambers).
  • a respective native valve the mitral, tricuspid, aortic, and pulmonary valves, respectively
  • deoxygenated blood from the body is received in the right atrium and passes downstream (forward) through the tricuspid valve to the right ventricle. From the right ventricle it is pumped downstream through the pulmonary valve to the lungs by way of a blood vessel for blood with low oxygen levels, the pulmonary artery.
  • oxygenated blood from the lungs is received in the left atrium and passes downstream through the mitral valve to the left ventricle. From the left ventricle it is pumped downstream through the aortic valve to the remainder of the body by way of a blood vessel for oxygen rich blood, the aorta.
  • the systolic phase includes an atrial systole, when the atria contract to eject blood from within the atria downstream into their respective ventricles; and ventricular systole, when the ventricles contract to eject blood from within the ventricles downstream into their respective downstream blood vessels.
  • the tricuspid, aortic, and pulmonary heart valves have three leaflets, while the mitral valve has two leaflets (also known as cusps).
  • the leaflets operate as flaps that open and close to allow the downstream (forward) flow of blood when pressure urges the blood forward through the valve and obstructs the flow of blood through the valve when pressure urges the blood to flow upstream (backward) through the valve (as occurs for the mitral and tricuspid valves during ventricular systole).
  • the mitral valve which connects the left atrium to the left ventricle, includes an annulus portion, which is an annular portion of the valve’s tissue surrounding a mitral valve orifice, and a pair of leaflets extending downward from the annulus portion into the left ventricle.
  • the mitral valve annulus portion can form a "D" -shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes.
  • An anterior leaflet can be larger than a posterior leaflet, forming a generally "C "-shaped boundary between the abutting sides of the leaflets when they are closed together.
  • the anterior leaflet and the posterior leaflet of the mitral valve function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle.
  • atrial systole after the left atrium received oxygenated blood from the pulmonary veins during cardiac diastole, the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole” or “diastole"), and the oxygenated blood that is collected in the left atrium flows into the left ventricle.
  • the native heart valves serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system.
  • these heart valves may be dysfunctional (e.g., damaged, or otherwise malformed), and thus less effective, such as by congenital malformations, inflammatory processes, infectious conditions, disease, and the like.
  • dysfunctionality may result in serious cardiovascular compromise or death.
  • One form of dysfunctionality is valvular regurgitation.
  • Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the mitral valve fails to close properly and blood flows upstream into the left atrium from the left ventricle during ventricle systole. Likewise, tricuspid regurgitation occurs when the tricuspid valve fails to close properly and blood flows upstream into the right atrium from the right ventricle during ventricle systole.
  • FIG. 1 shows a device for repairing leaflets, e.g., an anterior leaflet 20 and a posterior leaflet 22, of a dysfunctional mitral valve MV.
  • a catheter or catheter device 11 is positioned in the left atrium LA above the left ventricle LV.
  • the catheter device is coupled to an implant 13.
  • the implant can be positioned to repair the dysfunctional mitral valve MV.
  • While devices like this provide significant potential for potentially lifesaving repairs, there are still challenges.
  • one challenge is that, when treating a beating heart, the leaflets are in motion (both in shape and location) with the continuing operation of the heart.
  • a repair device must navigate and operate relative to a moving target.
  • one or both leaflets of the dysfunctional valve may be deformed and/or damaged.
  • the leaflets might not regularly move into a position and configuration in which they can be readily treated by the repair device.
  • the two or three target leaflets might have unusually large gaps therebetween, and they might be tethered into an unnaturally open position, such as by changes in the underlying structure (e.g., a dilated ventricle).
  • the device includes an anchor portion.
  • one or more anchors of the anchor portion are moveable between an open position and a closed position.
  • the device can be positioned within a heart valve, using a delivery system comprising catheters.
  • the device can include leaflet anchors for attaching to valve leaflets, and one or more connectors forming decouplable or detachable connections between the anchors and the delivery system.
  • the one or more connectors are severable connectors forming severable connections between the anchors and the delivery system.
  • a set of tethers is actuatable to move the anchors closer and/or into contact after the connectors have decoupled or detached leaving the anchors separated from the delivery system.
  • the device can optionally include a spacer positioned to be compressed by opposing surfaces of the anchors when around the spacer.
  • a system can include a transvascular delivery system including a steering catheter system and/or an implant catheter system.
  • the system can also include a device (e.g., treatment device, repair device, valve repair device, implantable device, implant, valve treatment device, etc.) that is introduced via the implant catheter system.
  • the implant catheter system can optionally be guided by a steering catheter system.
  • the device includes a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to tissue (e.g., one or more leaflets, an annulus, etc.) of a valve.
  • anchors e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
  • slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
  • the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while one or more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors.
  • the anchor can comprise an actuator engagement extension.
  • the paddle of the anchor comprises an actuator engagement extension.
  • the paddle comprises a plurality of actuator engagement extensions.
  • a first actuator engagement extension of the plurality of actuator engagement extensions can be used to open the paddle, while a second actuator engagement extension can be used to close the paddle.
  • the actuator is configured to engage the anchor to move the anchor to a closed position. In some implementations, the actuator is configured to engage the anchor to move the anchor to an open position.
  • the anchor can comprise a plurality of actuator engagement extensions.
  • the actuator can be configured to engage a first one of the plurality of actuator engagement extensions to move the anchor to a closed position and can be further configured to engage a second one of the plurality of actuator engagement extensions to move the anchor to an open position.
  • the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body. For instance, by while a tether pulls an anchor toward the central body, the anchor can be permitted to tilt relative to the central body. In some implementations, the anchor can be configured to tilt away from the central body as it is pulled toward the central body.
  • each tether is connected to a closed end of each anchor.
  • a tether can be connected to a closed end of the corresponding anchor.
  • a valve repair system includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body, a plurality of anchors, a plurality of tethers attached to the plurality of anchors, and an actuator.
  • the plurality of anchors can be attached to the central body via the plurality of tethers.
  • the actuator can be coupled to the central body.
  • each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
  • slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
  • the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while one or more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors. [0041] In some implementations, the actuator is configured to open all anchors that are against the central body.
  • the actuator can simultaneously open the one or more anchors that are against the central body.
  • This disclosure includes methods of repairing a heart valve e.g. native heart valve and/or simulated heart valve).
  • methods of repairing a heart valve include opening a plurality of anchors that are against a central body.
  • the plurality of anchors can be simultaneously opened.
  • an implantable device includes an actuator that opens and/or simultaneously opens the plurality of anchors.
  • a first anchor of the plurality of anchors is positioned such that a first native heart valve leaflet is in the first anchor.
  • the implantable device can be moved toward the first native heart valve leaflet such that the open first anchor receives the first native heart valve leaflet.
  • the first anchor is closed to capture the first leaflet.
  • the plurality of anchors that are against the central body e.g. , including but not limited to the first anchor are closed to capture the first leaflet.
  • the central body and a remaining one or more anchors are moved away from the first anchor.
  • the plurality of anchors are coupled to the central body with a plurality of tethers.
  • each tether can couple a corresponding anchor to the central body.
  • the remaining one or more anchors that are against the central body are opened.
  • an actuator can be used to open the remaining one or more anchors that are against the central body.
  • the remaining one or more anchors that are against the central body are simultaneously opened.
  • an actuator can be used to simultaneously open the remaining one or more anchors that are against the central body.
  • a second anchor of the plurality of anchors is positioned such that a second native heart valve leaflet is in the second anchor.
  • the device can be moved toward the second native heart valve leaflet such that the open second anchor receives the second native heart valve leaflet.
  • the plurality of anchors that are against the central body are closed to capture the second leaflet.
  • an actuator can be used to close the plurality of anchors that are against the central body, including the second anchor.
  • the plurality of anchors that are against the central body are simultaneously closed to capture the second leaflet.
  • an actuator can be used to simultaneously close the plurality of anchors that are against the central body, including the second anchor.
  • the present disclosure further includes a vale repair device (e.g. , a heart valve repair device for use in the heart of a real and/or simulated subject).
  • a valve repair device e.g. , a heart valve repair device for use in the heart of a real and/or simulated subject.
  • a valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors.
  • each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body.
  • a connection between each tether and each anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body.
  • the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.
  • the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body.
  • the anchor can interact with the central body to move from the tilted position to the more upright position.
  • An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.
  • the retaining wall and the central post are configured to pivot the anchors to a more upright or vertical position.
  • the retaining wall can interact with the anchor to cause the anchor to pivot to the more upright position.
  • the anchors and the central body are configured such that pulling the anchors against the central body pivots the anchors to the more upright position.
  • the central body can interact with the anchor to cause the anchor to pivot to the more upright position.
  • each of the plurality of anchors includes a tilting flange.
  • the tilting flange can interact with a portion of the central body to cause the anchor to tilt.
  • the tilting flange of an anchor can engage the bottom wall to move the anchor to the more upright position.
  • the bottom wall can interact with the anchor to cause the anchor to move to the more upright position.
  • rotation of the central body relative to the anchors moves the anchors to the more upright position.
  • the central body includes a plurality of petals configured to engage the plurality of anchors upon rotation of the central body relative to the plurality of anchors.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
  • slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
  • a valve repair system includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors.
  • the plurality of anchors can be attached to the central body via the plurality of tethers.
  • each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body.
  • a connection between a tether and a corresponding anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body.
  • the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.
  • the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body.
  • the anchor can interact with the central body to move from the tilted position to the more upright position.
  • An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.
  • This disclosure provides methods for repairing a heart valve (e.g., a heart valve in a real or simulated subject).
  • the method for repairing a heart valve includes attaching an anchor is to a leaflet of the native heart valve.
  • the anchor is pulled toward a central body in a tilted orientation.
  • the anchor can be attached to the central body via a tether.
  • the anchor can be pulled toward the central body via the tether.
  • the anchor is engaged with the central body to move the anchor from the tilted position relative to the central body to a more upright position relative to the central body.
  • the central body is rotated relative to the anchor to move the anchor to the more upright position.
  • a valve repair device e.g. , a heart valve repair device for repairing a valve in a heart of a real or simulated subject.
  • a valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.
  • the plurality of tethers are attached to the plurality of anchors.
  • a tether can be attached to a corresponding anchor.
  • the plurality of tethers are wound around the plurality of spools.
  • a tether can attach the corresponding anchor to a corresponding spool.
  • rotation of the plurality of spools in a second direction slackens the tethers to allow the plurality of anchors to be spaced apart from the central body.
  • the device includes a plurality of springs bias the plurality of anchors away from the central body.
  • the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body.
  • Implementations of the present disclosure provide a valve repair system (e.g. , a heart valve repair system for repairing a valve in a heart of a real or simulated subject).
  • the valve repair system includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.
  • the plurality of tethers are attached to the plurality of anchors.
  • a tether can be attached to a corresponding anchor.
  • the plurality of tethers are wound around the plurality of spools.
  • a tether can attach the corresponding anchor to a corresponding spool.
  • a valve repair device includes a center clip and a plurality of anchors.
  • the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
  • the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
  • a plurality of tethers are attached to the plurality of anchors.
  • a tether can be attached to a corresponding anchor.
  • the corresponding anchor can be attached to the center clip via the tether.
  • the plurality of tethers are configured to pull the plurality of anchors toward the center clip.
  • tethers are configured to allow the anchors to tilt as the anchors are pulled toward the center clip.
  • each tether is connected to a closed end of each anchor.
  • a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a center clip and a plurality of anchors.
  • the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
  • the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
  • this disclosure provides a method of repairing a valve (e.g., a native heart valve of a real or simulated subject.
  • the method includes attaching a plurality of anchors to a plurality of leaflets of the native heart valve.
  • the plurality of anchors are captured with a center clip after the plurality of anchors have been attached to leaflets of the native heart valve.
  • the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
  • a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject
  • a valve repair device includes a central body and a plurality of anchors.
  • the central body has a plurality of expandable strips.
  • the valve repair device includes a plurality of anchors attached to the plurality of expandable strips.
  • an anchor can be attached to a corresponding expandable strip.
  • the plurality of anchors are attached directly to the plurality of expandable strips.
  • the expandable strips are configured to move the plurality of anchors inward and outward.
  • each anchor comprises a paddle and a gripping member attached to the paddle.
  • the paddle comprises a fixed arm and a movable arm.
  • the fixed arm of each paddle is fixed to one of the expandable strips.
  • the gripping member is attached to the movable arm of the paddle.
  • a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the expandable strips are configured to move the plurality of anchors inward and outward.
  • a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject
  • a valve repair device includes a central body and a plurality of anchors.
  • each anchor comprises a paddle and a gripping member.
  • the gripping members are movable toward and away from the central body by sliding the gripping members along the paddles.
  • the plurality of anchors comprises three paddles and three gripping members.
  • a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body and a plurality of anchors.
  • each anchor comprises a paddle and a gripping member.
  • the paddles are connected to the central body.
  • the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.
  • the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
  • the coupling member comprises one or more of an elastic material and a spring.
  • a valve repair system includes e.g. , a valve repair system for repairing a heart of a real or simulated subject) a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a first anchor, a second anchor, and a coupling member attached to the first anchor and the second anchor.
  • the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.
  • the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body.
  • the central body can include a bore.
  • the paddle can include a first arm that is hingeably attached to a second arm by a hinge portion.
  • the hinge portion comprises an actuation gear.
  • the first arm, second arm, and hinge portion can comprise a gripping member of the paddle.
  • the worm gear is attached to a distal end of the actuation element such that it extends from a bore of the central body.
  • the worm gear can engage one or more actuation gears of one or more anchors that are engaged with the central body.
  • rotating the actuation element and the worm gear in a first direction causes the second arm of the paddle to move and/or pivot in an opening direction via the actuation gear.
  • Moving and/or pivoting the second arm of the paddle in the opening direction can move the anchor, paddle, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • rotating the actuation element and the worm gear in a second direction causes the second arm of the paddle to move in a closing direction via the actuation gear.
  • Moving and/or pivoting the second arm of the paddle in the closing direction can move the anchor, paddle, and/or second arm toward a closed condition.
  • the closing direction can be a clockwise direction.
  • the valve repair device includes a plurality of tethers attached to the plurality of anchors.
  • one or more tethers can be associated with a corresponding anchor.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers. [00150] In some implementations, the paddles or the gripping members of the valve repair device include a locking mechanism that prohibits rotation of the second arm of the paddles when the locking mechanism is in a locked condition.
  • the paddles or the gripping members of the valve repair device include a biasing member arranged between the first arm and the second arm.
  • the biasing member can be configured to bias the second arm in the closing direction, e.g., toward a closed condition.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body and a plurality of anchors.
  • each of the anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
  • the valve repair device includes an actuation element that can extend through a bore of the central body.
  • the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
  • the actuation element can include an actuation arm connected to the gripping member.
  • the actuation arm can be connected to the first arm.
  • the actuation arm can be connected to the hinge portion.
  • movement of the actuation element in a proximal direction causes the second arm to pivot in an opening direction. Moving and/or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • movement of the actuation element in a distal direction causes the second arm to pivot in a closing direction.
  • Moving and/or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition.
  • the closing direction can be a clockwise direction.
  • the valve repair device includes a plurality of paddles.
  • the pivot arm can extend from a paddle of the plurality of paddles, through the second arm, and back to the one of the plurality of paddles.
  • the second arm can include a hinge barrel that the pivot arm passes through.
  • the second arm can include an opening on an outer surface of the gripping member that the pivot arm passes through.
  • the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition. In some implementations, the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition by the hinge portion of the gripping member.
  • the gripping member can be formed from a shape-set alloy.
  • one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy.
  • the shape-set alloy is shape-set in the closed condition.
  • the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
  • the valve repair device includes a plurality of tethers attached to the plurality of anchors.
  • one or more tethers can be associated with a corresponding anchor.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body and a plurality of anchors.
  • an anchor of the plurality of anchors includes a gripping member.
  • the gripping member can have a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
  • each anchor includes a gripping member.
  • the valve repair device includes an actuation element.
  • the actuation element extends through a bore of the central body.
  • the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
  • the actuation element includes an actuation arm.
  • the actuation arm can be connected to the second arm via a tether connected to an end portion of the actuation arm.
  • the tether can comprise one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
  • movement of the actuation element in a distal direction causes tension in the tether to cause the second arm to pivot in an opening direction.
  • Moving and/or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • movement of the actuation element in a proximal direction causes the end of the actuation arm to engage the second arm to pivot the second arm in a closing direction.
  • Moving and/or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition.
  • the closing direction can be a clockwise direction.
  • the actuation arm biases the gripping member in the closing direction, e.g., toward the closed condition.
  • the actuation arm can include a spring portion that biases the end of the actuation arm in the closing direction, e.g., biases the gripping member toward a closed condition.
  • the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.
  • the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.
  • the gripping member can be formed from a shape-set alloy.
  • one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy.
  • the shape-set alloy is shape-set in the closed condition.
  • the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
  • the valve repair device includes a plurality of tethers attached to the plurality of anchors.
  • one or more tethers can be associated with a corresponding anchor.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body and a plurality of anchors.
  • an anchor of the plurality of anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
  • each anchor includes a gripping member.
  • retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction.
  • the actuation element can be retracted in a retraction direction. Moving and/or pivoting the second arm in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • the first alignment feature is a locking eyelet extending from the mounting plate and the second alignment feature is an opening in the central body for receiving the locking eyelet.
  • the central body includes a central bore.
  • one or more tethers extend through the central bore and out of an opening in the central body.
  • the opening is arranged to one side of the second alignment feature.
  • the anchor include a second mounting plate attached to the second arm of the gripping member.
  • each of the plurality of anchors includes a respective second mounting plate attached to the second arm of the gripping member.
  • the mounting plate includes a bore and an actuation element extends through the bore of the mounting plate to engage the paddle.
  • extending the actuation element in a distal direction causes the paddle to open and retracting the actuation element in a proximal direction causes the paddle to close.
  • extending the actuation element in a distal direction causes the paddle to close and retracting the actuation element in a proximal direction causes the paddle to open.
  • rotating the actuation element in a first direction causes the paddle to open and rotating the actuation element in a second direction causes the paddle to close.
  • the actuation element is a tube that extends through the bore of the mounting plate to engage a distal end of the paddle.
  • the distal end of the paddle has a proximally extending pin that is received by the actuation element.
  • the actuation element is tube-shaped.
  • the actuation element threadably engages the distal end of the paddle.
  • the valve repair device also includes a locking pin extending through a central bore of the central body.
  • a locking eyelet is attached to a mounting plate of the anchor.
  • each mounting plate is attached to a corresponding locking eyelet.
  • openings are provided in the central body for receiving the locking eyelets of the anchor and/or anchors.
  • the locking pin threadably engages with a threaded proximal opening of the central bore.
  • the locking eyelet of one anchor is offset from the locking eyelets of the other anchors so that the locking eyelets of all of the plurality of anchors can be moved into alignment with the locking pin.
  • the locking eyelets can be axially offset or staggered axially relative to each other. In some implementations, the locking eyelets are configured to align with a central longitudinal axis of the valve repair device when moved into alignment with the locking pin.
  • the valve repair device also includes a sheath extending along the actuation element to the paddle so that when the sheath is in an extended condition the sheath engages the bore of the mounting plate so that the anchor is engaged with the central body. When the sheath is retracted to a retracted condition, the anchor is able to move away from the central body.
  • each paddle is associated with a corresponding sheath.
  • the actuation element is biased to move the anchor laterally away from the central body when the sheath is retracted to the retracted condition.
  • the anchors are moved to a distally staggered bailout position by extending the actuation element and sheath for each anchor to a different distance.
  • the valve repair device includes a gripping member attached to the paddle of each anchor.
  • the gripping member has a first arm, a second arm, a hinge portion hingeably attaching the first arm to the second arm, and a secondary actuation element connected to the second arm.
  • a valve repair system includes a delivery system with one or more catheters and a control handle and any of the valve repair devices described herein.
  • the delivery system includes a positioning arm extending from a catheter of the delivery system to engage an anchor of the valve repair device.
  • the positioning arm comprises the actuation element of the valve repair device, e.g., the actuation element associated with the anchor of the valve repair device.
  • extending the positioning arm from the catheter allows the positioning arm to flex laterally to allow the anchor to move away from the central body.
  • the positioning arm is biased to flex laterally outward and away from the central body. [00294] In some implementations, retracting the positioning arm into the catheter causes the positioning arm to straighten so that the anchor is moved into engagement with the central body.
  • the delivery system further includes a guide extending through the positioning arm to a distal cap.
  • the distal cap is connected to the central body of the valve repair device.
  • the distal cap includes a stop for engaging the anchors when the anchors are moved into engagement with the distal cap.
  • extending the positioning arm moves the anchor along the guide and into engagement with the distal cap.
  • applying a force to the positioning arm in the extending direction after the anchor has engaged the distal cap compresses the positioning arm.
  • the positioning arm can comprise and/or be formed from a hypotube with a central lumen and a plurality of segments.
  • the plurality of segments of the hypotube are cut from a single tube.
  • each segment extends from a first end to a second end.
  • the first end and/or the second end include a plurality of retaining slots and a plurality of corresponding keyed retaining tabs.
  • the retaining slots are rotationally symmetric.
  • the retaining slots of the first end of a segment are rotationally offset from the retaining slots of the second end of the segment.
  • FIG. 20 illustrates the treatment/repair device of FIG. 19, with the anchors moved into contact with the central body.
  • FIG. 25 illustrates the valve repair system of FIG. 24 with two leaflets and two anchors tethered to a remainder of the valve repair device.
  • FIG. 26 illustrates the valve repair system of FIG. 25 with the two anchors and attached leaflets pulled back to the remainder of the valve repair device by the tethers.
  • FIG. 28 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.
  • FIG. 29 illustrates the valve repair system of FIG. 28 with the anchors pulled to the central body by tethers.
  • FIG. 30 illustrates the valve repair system of FIG. 29 with the anchors pulled downward into the central body to move the anchors to a more upright position.
  • FIG. 31 illustrates the valve repair system of FIG. 30 where the delivery system has been separated from the device.
  • FIG. 32 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.
  • FIG. 33 illustrates the valve repair system of FIG. 32 with the anchors pulled toward the central body by tethers.
  • FIG. 34 illustrates the valve repair system of FIG. 33 with the anchors pulled against the central body to move the anchors to a more upright position.
  • FIG. 35 is a perspective view of a valve repair system.
  • FIGS. 36 and 37 are top views of a valve repair system.
  • FIGS. 38-42 are schematic illustrations of a valve repair system.
  • FIG. 43 is a perspective view of a delivery system for delivering anchors to native heart valve leaflets.
  • FIG. 44 is a side view of a portion of a valve repair system.
  • FIG. 45 is a perspective view of a portion of the valve repair system illustrated by FIG. 44.
  • FIG. 46 is the top view of the valve repair system illustrated by FIG. 44.
  • FIG. 47 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.
  • FIG. 48 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.
  • FIGS. 49-56 are cross-sectional views of a valve repair system.
  • FIG. 57 illustrates a perspective view of an expandable/expansion member in an expanded configuration
  • FIG. 58 illustrates a perspective view of the expandable/expansion member of FIG. 57 in a collapsed configuration
  • FIG. 59 illustrates an exploded perspective view of the expandable/expansion member and an example actuation mechanism for the expandable coaptation element
  • FIG. 60 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 61 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 62 illustrates a perspective view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 63 illustrates a front view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 64 illustrates a front view of an example expandable/expansion member and an example actuation mechanism for an expandable coaptation element;
  • FIG. 65 illustrates an exploded view of the actuation mechanism of FIG. 64
  • FIG. 66 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 64;
  • FIG. 67 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 64;
  • FIG. 68 illustrates a perspective view of the sectioned expandable/expansion member and the actuation mechanism of FIG. 67 ;
  • FIG. 69 illustrates an example expandable/expansion member and an example actuation mechanism for an expandable coaptation element
  • FIGS. 70-72 are schematic illustrations of a valve repair system.
  • FIGS. 73 and 74A-74E are schematic illustrations of a valve repair system.
  • FIGS. 75A-75D illustrate a consecutively inserted, center-coupled implementation of a treatment/repair system.
  • FIG. 76 is a cutaway view of a central body of the consecutively inserted, center- coupled implementation of a treatment/repair system of FIGS. 25A-75D, being connected to an implant catheter and tethered anchors.
  • FIG. 77 is a cutaway view of an example central body, including a spacer.
  • FIG. 89 is side view of the valve repair device of FIG. 88 with a paddle in an option condition
  • FIG. 97 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation arm of an actuation element includes a tether for connecting to a second arm of the gripping member;
  • FIG. 98 shows the gripping member of FIG. 97 in an open condition and positioned to capture a valve leaflet
  • FIG. 99 shows the gripping member of FIG. 97 in a closed condition with a valve leaflet captured by the gripping member
  • FIG. 100 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body that is disposed distally to a hinge portion of the gripping member;
  • FIG. 101 shows the gripping member of FIG. 100 in an open condition and positioned to capture a valve leaflet
  • FIG. 102 shows the gripping member of FIG. 100 in a closed condition with a valve leaflet captured by the gripping member
  • FIG. 104 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body and around a routing member before engaging the gripping member;
  • FIG. 105 shows the gripping member of FIG. 104 in an open condition and positioned to capture a valve leaflet
  • FIG. 108 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the extended position;
  • FIG. 109 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the retracted position;
  • FIG. 110 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a flexible portion and a head having a barbed end and a hook for engaging a catch member of a first arm of the gripping member;
  • FIG. 110A is a partial front view of the gripping member of FIG. 110;
  • FIG. 11 1 shows the gripping member of FIG. 110 in the closed condition with the head and barbed end of the second arm disengaged from the catch member of the first arm;
  • FIG. 112 shows the gripping member of FIG. 110 in an open condition and positioned to capture a valve leaflet
  • FIG. 115 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a folding barbed portion in an extended condition;
  • FIG. 120 shows a top perspective view of an example of a valve repair device and its aesthetic features
  • FIG. 121 shows a top perspective view of the valve repair device of FIG. 120 with an anchor in an open condition
  • FIG. 122 shows a cross-sectional view of the valve repair device of FIG. 120
  • FIG. 133 shows a top perspective view of the valve repair device of FIG. 132 with the gripping member in an open condition
  • FIG. 134 shows a side view of the valve repair device of FIG. 133;
  • FIG. 135 shows a top perspective view of the valve repair device of FIG. 131 with an anchor in a released condition
  • FIG. 136 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 135;
  • FIG. 137 shows a cross-sectional view of the valve repair device of FIG. 135
  • FIG. 138 shows a cross-sectional view of the valve repair device of FIG. 131 with the anchor in a retracted condition
  • FIG. 139 shows a cross-sectional view of the valve repair device of FIG. 131 with actuation elements locked
  • FIG. 140 shows a cross-sectional view of the valve repair device of FIG. 131 with a locking element retracted
  • FIG. 141 shows a cross-sectional view of the valve repair device of FIG. 131 with a handshake coupling decoupled
  • FIG. 142 shows a cross-sectional view of the valve repair device of FIG. 131 with a delivery mechanism retracted;
  • FIG. 143 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 131;
  • FIG. 144 shows a top perspective view of an example of a valve repair device and its aesthetic features
  • FIG. 145 shows a top perspective view of the valve repair device of FIG. 144 with an anchor having a paddle in an open condition and a gripping member in a closed condition;
  • FIG. 146 shows a top perspective view of the valve repair device of FIG. 145 with the gripping member in an open condition
  • FIG. 147 shows a side view of the valve repair device of FIG. 146;
  • FIG. 148 shows a top perspective view of the valve repair device of FIG. 144 with an anchor in a released condition
  • FIG. 149 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 148;
  • FIG. 150 shows a cross-sectional view of the valve repair device of FIG. 148
  • FIG. 151 shows a cross-sectional view of the valve repair device of FIG. 144 with the anchor in a retracted condition
  • FIG. 152 shows a cross-sectional view of the valve repair device of FIG. 144 with actuation elements locked
  • FIG. 153 shows a cross-sectional view of the valve repair device of FIG. 144 with a locking element retracted
  • FIG. 154 shows a cross-sectional view of the valve repair device of FIG. 144 with a handshake coupling decoupled
  • FIG. 155 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 144;
  • FIG. 156 shows the valve repair device of FIG. 144 with anchors moved to an elongated position;
  • FIG. 157 shows a top perspective view of an example of a valve repair device and its aesthetic features
  • FIG. 158 shows the valve repair device of FIG. 157 with an anchor in an open condition
  • FIG. 159 shows a bottom perspective view of an anchor of the valve repair device of FIG. 157 in a closed condition
  • FIG. 160 shows a bottom perspective view of an anchor of the valve repair device of FIG. 158;
  • FIG. 161 shows a side view of the valve repair device of FIG. 158 positioned for leaflet capture
  • FIG. 162 shows a partial cross-sectional view of the valve repair device of FIG. 157 with an anchor in the retracted condition
  • FIG. 163 shows a partial cross-sectional view of the valve repair device of FIG. 162 with the anchor in a released condition
  • FIG. 164 shows a top perspective view of the valve repair device of FIG. 163 ;
  • FIG. 165 shows a cross-sectional view of an anchor locking mechanism of the valve repair device of FIG. 157;
  • FIG. 166 shows a perspective view of the anchor locking mechanism of the valve repair device of FIG. 157 ;
  • FIG. 167 shows a cross-sectional view of the valve repair device of FIG. 157 with an actuation element retracted
  • FIG. 168 shows a cross-sectional view of the valve repair device of FIG. 157 with a delivery mechanism retracted;
  • FIG. 169 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 157;
  • FIG. 170 shows the valve repair device of FIG. 157 with anchors moved to a delivery configuration
  • FIG. 172 shows a side view of the valve repair device of FIG. 171 with the anchors in a retracted condition
  • FIG. 173 shows a side view of an example of a valve repair device with anchors in a released condition
  • FIG. 178 shows a top perspective view of a segment of the hypotube of FIG. 177;
  • FIG. 179 shows a top view of the hypotube of FIG. 177
  • FIG. 180 shows a side view of a hypotube and its aesthetic features usable and/or for use as an actuation element in a valve repair device
  • FIG. 181 shows a top perspective view of a segment of the hypotube of FIG. 180;
  • FIG. 182 shows a top view of the hypotube of FIG. 180;
  • FIG. 183 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a bent condition;
  • FIG. 184 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a straight condition.
  • Some implementations of the present disclosure are directed to systems, devices, methods, etc. for treating or repairing a defective heart valve.
  • various implementations of devices, valve repair devices, implantable devices, implants, and systems are disclosed herein, and any combination of these options can be made unless specifically excluded.
  • individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.
  • the mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from functioning properly, allowing for the regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA, as depicted in FIG. 4).
  • the regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable.
  • the systems, devices, procedures, and concepts disclosed herein are described in detail for treating/repairing the structure of a native valve, often using a mitral valve as an illustrative example.
  • the systems, devices, and procedures can be used between the anterior and posterior leaflets 20, 22 of the mitral valve MV to connect them and help prevent or inhibit regurgitation of blood from the left ventricle into the left atrium.
  • the devices, procedures and concepts disclosed herein can also be used to treat/repair a single leaflet of a native valve.
  • the other valves can be treated/repaired using the devices, procedures and concepts disclosed herein.
  • the devices, procedures and concepts can be used between any two of the three leaflets on the tricuspid valve (e.g., the anterior leaflet 30, the septal leaflet 32 and the posterior leaflet 34) to connect them and prevent or inhibit regurgitation of blood from the right ventricle into the right atrium.
  • the devices, procedures and concepts disclosed herein can be used between all three tricuspid valve leaflets 30, 32, 34 to connect all three of them and prevent or inhibit regurgitation of blood from the right ventricle to the right atrium.
  • the devices, procedures, systems, and concepts disclosed herein can also be used to treat/repair a single leaflet of a valve.
  • the described devices, procedures, systems, and concepts might be used to treat or repair any native valve, as well as any component of a native valve.
  • the systems herein can be configured as organ repair systems for repairing an organ, e.g., the heart, or a valve of a heart. In some implementations, the systems can be configured to treat/repair another part of the body. In some implementations, the systems herein are valve treatment/repair systems for repairing or treating a valve. In some implementations, the systems herein include a treatment and/or repair device (e.g., a valve repair device, a valve repair implant, a valve treatment device, a treatment device, an implant, a device, etc.).
  • a treatment and/or repair device e.g., a valve repair device, a valve repair implant, a valve treatment device, a treatment device, an implant, a device, etc.
  • the device can be delivered to the valve by the delivery system through the subject’s vascular system.
  • the delivery and/or implant catheter(s) can have a distal end for insertion into a proximal end of a steering catheter system, and a proximal end for manipulation by a user of the delivery system.
  • system is provided with a wide array of related parts and methods, such as may be described herein, either directly or indirectly.
  • An example transvascular technique that can be used with the systems, devices, methods, etc. herein for treating/repairing a native valve can comprise advancing a catheter or catheter device into an atrium (e.g., inserting the catheter device into the right femoral vein, up the inferior vena cava and into the right atrium).
  • the tricuspid valve is treated from the right atrium.
  • the septum can be punctured from the right atrium, and the catheter device passed into the left atrium.
  • the catheter device can be coupled to a device (e.g., treatment device, repair device, implant, etc.). The device can be positioned to repair a dysfunctional native valve.
  • the delivery systems herein can comprise one or more components forming a steering catheter system and/or an implant catheter system.
  • the delivery systems can have one or more components forming a steering catheter system and an implant catheter system.
  • the implant catheter system includes one or more implant catheters capable of placing and implanting, or otherwise deploying, a treatment or repair device.
  • the one or more implant catheters can be steerable catheters capable of navigating a subject’s vascular system, thereby also forming all or part of the steering catheter system rather than being a separate system.
  • the delivery system can further include additional devices for transvascular procedures, such as sheaths, control guidewire, external catheter control systems and controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbles, etc.), and the like.
  • the one or more steering catheters can be either individually or collectively configured to guide the one or more implant catheters through the subject’ s vascular system. In some implementations, this can involve positioning a distal end of the steering catheter system upstream of a defective valve (relative to a blood flow direction) and pointing the distal end of the implant catheter system downstream (in the blood flow direction) through the valve.
  • the implant catheter system starts off inserted within the steering catheter system prior to its insertion into the subject’s body or is inserted into a proximal end of the steering catheter system after the steering catheter system’s distal end is positioned upstream of the valve. With the steering catheter system in place and the implant catheter inserted, the implant catheter system is extended downstream from within steering catheter system, toward the valve.
  • the component parts of the treatment/repair device can be configured to traverse the subject’s vascular system through the delivery system in an operational configuration.
  • the treatment/repair device can be structurally configured with a first, small-form-factor (e.g., small diameter) delivery configuration structurally laid out for traversing the delivery system through the subject’s vascular system, and a second, operational configuration structurally appropriate for valve treatment or repair operations.
  • the implant catheter includes one or more actuators functional to actuate the treatment/repair device from the delivery configuration to the operational configuration while the device is located at its installation location within the subject’ s heart.
  • the component parts of the device can be configured for simultaneously traversing the subject’s vascular system through the delivery system as a single implantable unit.
  • the component parts of the device can be configured to transvascularly traverse the delivery system through the subject’s vascular system on a piece- by-piece basis.
  • the pieces are assembled into an implantable device within the body (e.g., within the heart during an implantation procedure).
  • a treatment/repair system includes and uses a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to tissue (e.g., tissue of an organ).
  • the system is in the form of and/or comprises a treatment or repair device that includes at least one of or a plurality of independently actuatable leaflet anchors (e.g., clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.) are also possible.
  • a leaflet anchor is an attachment device structured (once it is in an operational configuration) with a leaflet-attachment mechanism to affix itself to a leaflet, in any one or more of a variety of ways.
  • This attachment mechanism can be, for example, in the form of an attachment-body (e.g., a bar).
  • attachment-bodies there will be a plurality of attachment-bodies (a first attachment-body, a second attachment-body, a third attachment-body, etc.), each of which can have any of a variety of cross sections (e.g., a relatively flat, paddle-type cross), and longitudinally extending in any of a wide variety of shapes (e.g., a straight line or a circle) to form compressive structures (e.g., paddles or rings).
  • the attachment-bodies can be configured affix to the leaflet, such as by pressing against the leaflet and thereby constraining the movement of the leaflet with respect to the anchor.
  • two attachment-bodies in the form of paddles can be configured such that they are attached at one end with a hinge to form a jaw that can bite down and clamp or clasp on to a leaflet and thereby affix to the leaflet.
  • this clasp-type anchor attachment apparatus (or attachment mechanism) can be provided with two control apparatuses (or control mechanisms), one that actuates the attachment apparatus between an open configuration and an attached configuration (optionally using a spring to load the jaw towards an open or closed position), and one that locks the attachment apparatus onto a leaflet.
  • the control apparatuses can be controlled using control wires, such as sutures, wires, lines, tethers, etc.
  • any leaflet anchor herein can be provided with various other forms of tissue-attachment mechanisms such as friction devices, adhesion devices, tissue piercing mechanisms and/or various forms of grapnel.
  • the anchor(s) can take and/or comprise a variety of forms, e.g., clasps, clamps, clips, darts, staples, hooks, bars, rods, screws, knots, toggle anchors, etc.
  • each leaflet anchor can comprise or be in the form of a toggle anchor, having a bar with a centrally attached respective anchor tether (e.g., a tether or tether section associated with a specific anchor).
  • the bar can be made to longitudinally pierce, penetrate, and pass through a wall of a leaflet, pulling the anchor tether with it like a needle pulling a thread. To do this maneuver, the bar can be oriented parallel to the anchor tether, and then an end of the bar is pushed through a wall of a leaflet using a sharp point or edge (the point either being on an end of the bar or on a separate penetrator that contains or is attached to the toggle anchor).
  • a structural support member can be used to support leaflet structures during penetration.
  • the anchor tether after passing through the wall, the anchor tether is pulled and the bar thereby toggles, (rotates) to laterally press against the wall of tissue with a distal (anchor) end of the anchor tether pulled back against, and extending back through, the penetrated wall of tissue in a T-shaped configuration (where the bar forms the top of an uppercase T).
  • This T-shaped toggle anchor also known as a T-element anchor
  • each anchor connector structurally fastens, couples, attaches, etc. the anchor and catheter together rigidly.
  • Each such anchor connector provides for the user (via the delivery or implant catheter system) to first position the associated anchor for affixing it to a valve portion like a leaflet, and then, after the anchor is affixed to that leaflet, with user actuation, to decouple, detach, or sever the connection provided by the anchor connector, and thereby unfasten and release the anchor from the implant catheter.
  • the decoupling/detaching/severing of the anchor connector thereby removes that connector’s constraint on the anchor from becoming separated from the implant catheter.
  • the implant catheter can then move separately away from the anchor, to, for example, position one or more other anchors at other leaflets or leaflet locations.
  • the central body is configured with a gapfilling shape, structure and composition that obstructs gaps between leaflets to reduce regurgitation.
  • the central body structure is shaped and positioned with respect to the leaflets such that, upon coaptation, opposing surfaces of the anchors, and their respective leaflets, close around the central body during appropriate portions of the cardiac cycle.
  • the central body/spacer can be configured to seal against opposing surfaces of two or three anchors, and thereby against two or three nativevalve leaflets, depending in part upon the type of valve for which it is adapted.
  • the central body/spacer can be shaped in any of a variety of shapes, as might be appropriate for the intended use.
  • the delivery or implant catheter 111 mounts and carries some or all portions of a device 101 (e.g., treatment device, repair device, valve treatment device, valve repair device, implantable device, implant, etc.).
  • device 101 comprise two leaflet anchors, e.g., a first leaflet anchor 113 and a second leaflet anchor 115.
  • each anchor has a respective leaflet- attachment mechanism (e.g., a first leaflet- attachment mechanism, and a second leaflet- attachment mechanism) in the form of an actuatable clip with independent actuators and actuation controls such that each anchor can be separately and independently affixed to respective leaflet locations.
  • the device is further provided with an optional central body 131 (e.g., a spacer, a coaptation element, a plug, a gap filler, etc.) and a centerbody connector 133.
  • the center-body connector 133 is a structural fastener that forms a center-body decouplable connection (e.g., detachable connections, severable connection, releasable connection, etc.) that fastens the central body 131 to the delivery/implant catheter 111 when in a connected state or unsevered state (e.g., it restricts and/or constrains their relative movement to be in-sync).
  • the anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue herein can take a variety of different forms, e.g., clamping mechanisms, clasping mechanisms, suction mechanisms, adhering mechanisms, etc.
  • the anchoring systems, apparatuses, mechanism, etc. are separate and/or independent from systems, apparatuses, mechanisms, etc. for the controlled tether.
  • anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue can be comparable to other anchor actuation systems, such as those that use sutures, threaded members, cams, shafts, and/or springs, etc. for controlled opening and closing of a clamp, clasp, etc.
  • a clamping system, apparatus, or mechanism is used to clamp onto tissue, e.g., onto a leaflet, for anchoring.
  • the drive link 306 is pivotably coupled to the optional follower 304 at a pivot axis 308.
  • the follower 304 is omitted and line the drive link 306 is pivotally connected directly to the actuation element 302.
  • the drive link 306 is pivotally connected to the outer paddle 117 at a pivot axis 310.
  • movement of the actuation element 302 in the direction 320 moves the drive link 306, which in turn moves the outer paddle toward 117 an open condition.
  • movement of the actuation element 302 in the direction 322 moves the drive link 306, which in turn moves the outer paddle toward a closed condition.
  • An optional biasing element can bias the outer paddle 117 toward or away from the inner paddle 119. Once in the closed position, the relative positions of the outer paddle 117 and the inner paddle 119 can optionally be locked.
  • a leaflet anchor 413 includes a first arm 417 and a second arm 419.
  • the first arm 417 and the second arm 419 are formed from a single piece curved and/or bent material, such as a piece of metal or plastic that has spring-like properties.
  • the first arm 417 and the second arm 419 are connected together at a closed end 430.
  • the first arm 417 and/or the second arm 419 are shape set to snap to a closed configuration (FIG. 10C) and to snap to an open configuration (FIG. 10D).
  • moving the first arm 417 past a center or snap-over line 420 in the direction indicated by arrow 422 causes the leaflet anchor to snap to the closed condition illustrated by FIG. 10C.
  • moving the first arm 417 past the center or snap-over line 420 in the direction indicated by arrow 424 causes the leaflet anchor to snap to the open condition illustrated by FIG. 10D.
  • FIGS. 10E and 10F illustrate an example of a clamping mechanism 500 that uses the leaflet anchor 413 illustrated by FIGS. 10C and 10D.
  • the clamping mechanism 500 includes a base 502 (e.g., a frame, a coaptation element, and/or a tube, etc.) an actuation element 504 (e.g., a wire, a hypotube, a flexible shaft, etc.), and the leaflet anchor 413.
  • the closed end 430 of the leaflet anchor 413 can be fixed to or coupled to a distal end 432 of the base 502.
  • the actuation element 504 can extend through the base 502 and can be releasably coupled to the first arm 417.
  • the first leaflet anchor 1 13 can be a separable anchor.
  • the user actuates a control decoupling or detaching the first anchor connector 121 and thereby releasing the first leaflet anchor from its primary connection to the implant catheter (e.g., its connection by the first anchor connector). Therefore, the central body and the implant catheter are freed to translate and rotate together in six degrees of freedom relative to the first leaflet anchor.
  • the decoupling or detachment of the separably attached first leaflet anchor 113 leaves only the first controlled tether 141 loosely connecting the first leaflet anchor 113 to the delivery /implant catheter 111.
  • the first anchor connector 121 provides for the delivery or implant catheter 111 and central body 131 to position the first leaflet anchor 113 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet, to decouple/detach/sever/release/unfasten the first leaflet anchor from the implant catheter, central body and second leaflet anchor 115.
  • the delivery/implant catheter 111, central body 131 and second leaflet anchor 115 can then move separately from the first leaflet anchor 113, such as to position the second leaflet anchor 115 at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22).
  • the second leaflet anchor 1 15 can be a separable anchor.
  • the user then gives the first controlled tether 141 adequate slack to allow the implant catheter to freely move (with the second leaflet anchor 115 still attached) to a second location (such as at a location on a second leaflet 153 requiring constraint) without pulling the first leaflet anchor 113 and the first leaflet 151 along with it, and without being detrimentally pulled and tugged upon by the motion of the first leaflet due to the operation of the heart.
  • the user actuates the implant catheter to move the implant catheter and its attached portions of the device, positioning the second leaflet anchor at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22). This positioning occurs without pulling the first leaflet anchor and the first leaflet to the second leaflet.
  • the user can controllably release (lengthen) slack on the first controlled tether 141 to provide for this movement without detrimental resistance from the first leaflet. This can be done by the user releasing slack on an end of the controlled tether suture at the proximal end of the implant catheter, as for other transvascular mechanisms having wires, chords, lines, etc. for control.
  • the implant catheter can then be actuated to position the second leaflet anchor 115 at the second position.
  • the second leaflet anchor 115 can then be actuated to attach it to the first portion of the edge of the second leaflet (e.g., the second leaflet anchor is actuated to clamp down on the leaflet edge to affix it to the leaflet).
  • the device 201 can optionally be structurally configured with a first, small-form- factor delivery configuration and a second, operational configuration configured for valve treatment or repair operations.
  • a small-form-factor, side-by-side serial delivery configuration e.g., spaced at 120° angles
  • a more complex delivery configuration might be necessary.
  • the implant catheter With the implant catheter extended from within steering catheter system, pointing downstream toward the tricuspid valve TV, the implant catheter moves downstream into and partially or entirely through the tricuspid valve to the extent needed based upon the geometry of the device and the valve. If it is first delivered to the heart in a delivery configuration, either before or after passing through the tricuspid valve TV, the implant catheter can actuate the device 201 from a delivery configuration to an operational configuration.
  • the implant catheter can be actuated to move the implant catheter and the device, positioning the first leaflet anchor 213 at a first position within the heart, being located and oriented to grasp a first portion of the edge of a first leaflet 251 requiring constraint for improved operation.
  • the first leaflet anchor 213 can then be actuated to attach it to the first portion of the edge of a first leaflet.
  • the first anchor connector can be decoupled/detached/severed/unfastened to release the first leaflet anchor from the implant catheter.
  • the central body 231 and implant catheter can be freed to translate and rotate together relative to the first leaflet anchor 213.
  • the decoupling or detachment of the separably attached first leaflet anchor 213 leaves only the first controlled tether 241 loosely connecting the first leaflet anchor 213 to the implant catheter.
  • the first anchor connector provides for the implant catheter and central body 231 to position the first leaflet anchor 213 in a correct position for affixing to the first leaflet 251, and then after the first leaflet anchor is affixed to the first leaflet, to unfasten and release the first leaflet anchor from the implant catheter, central body, second leaflet anchor 215 and third leaflet anchor 217.
  • the implant catheter, central body 231, second leaflet anchor 215 and third leaflet anchor 217 can then move separately from the first leaflet anchor 213 to position the second leaflet anchor 215 at a second position within the heart to grasp a first portion of the edge of a second leaflet 253 requiring constraint for improved operation.
  • the second anchor connector can be decoupled/detached/severed/unfastened to release the second leaflet anchor from the implant catheter.
  • the decoupling or detachment of the separably attached second leaflet anchor 115 leaves only the second controlled tether 143 loosely connecting the second leaflet anchor to the implant catheter.
  • first controlled-tether slack and second controlled-tether slack are not already adequate, slack on the first controlled tether 241 and second controlled tether 243 can be controllably released to provide for this movement without substantial detrimental resistance from the second leaflet 253.
  • the implant catheter can be actuated to position the third leaflet anchor 217 at the third position.
  • the third leaflet anchor 217 can be actuated to attach it to the first portion of the edge of the third leaflet.
  • the central body 23 can be provided with one or more mechanical locks (e.g., clips, clamps, portions that structurally mate, interlocking portions, etc.) to lock each tethered anchor in position and/or relative to each other.
  • mechanical locks e.g., clips, clamps, portions that structurally mate, interlocking portions, etc.
  • these are locked into contact and/or stationary relative to each other (e.g., completely stationary, mostly stationary, with portions that are stationary (e.g., contact surfaces) and other portions (e.g., extensions) that can move somewhat, etc.)
  • the first, second and third controlled tethers 241, 243, 245 and the implant catheter are disconnected from the device 201 and removed from the subject’ s body (see, FIG. 14). More particularly, the second- end segment of each controlled tether is freed to advance into the implant catheter (to pass up through the anchor slidable restraints and then back down the implant catheter) while the first- end segment is continuously pulled from the implant catheter until the full length of the controlled tether comes out of the implant catheter.
  • anchors By making one or more inserted anchors separable from one another (and the rest of the implant) prior to leaflet attachment, anchors can be attached to leaflets without resistance from other previously attached anchors. The device was placed without suffering the difficulties caused by leaflets having excessive spacing and movement.
  • this can offer additional structural support to a damaged leaflet at risk of further structural failure, and/or better attachment to a leaflet having characteristics indicating poor anchor-attachment characteristics.
  • two anchors on one leaflet can be placed adjacent to each other on the leaflet (e.g., in contact, etc.) or can be placed spaced apart along the leaflet.
  • the second leaflet anchor 115 can be inseparably connected to the central body 131 (e.g., connected to the central body without the use of a controllable anchor connector such that the second leaflet anchor cannot be controllably separated from the central body while within the body of a subject).
  • this inseparably connected anchor is still separably connected to the delivery/implant catheter 111, in that the central body 131 is separably connected to the implant catheter.
  • the first leaflet anchor 113 is separably connected to the central body 131 by a first anchor connector 121.
  • the first anchor connector 121 still provides for the delivery or implant catheter 111 to position the first leaflet anchor 1 13 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet 151, to decouple/detach/sever/unfasten and thereby release the first leaflet anchor from the implant catheter, central body 131 and second leaflet anchor.
  • the delivery/implant catheter 111 and central body 131 can then separate and move away from the first leaflet anchor 1 13, such as to position the second leaflet anchor 115 at a second position within the heart, where it can be attached to the first portion of the edge of the second leaflet 153.
  • the location of the second leaflet 153 is used as a coaptation location (to the extent that the catheter remains rigidly in place).
  • the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual location where the resulting device 101 will end up once the anchors are locked into position with respect to the central body (and one another), and the delivery/implant catheter 111 is disconnected from the de vice 101.
  • one anchor When combined three or more anchors, one anchor might be inseparable while the others are separable. In some implementations, two or more anchors might be inseparable while at least one is separable. In some implementations, greater flexibility during use is emphasized, e.g., with two separable anchors. In some implementations, the cost and size of a less complicated structure can be emphasized, e.g., with non or only one anchor separable.
  • the system (e.g., controlled tether system, tether system, etc.) includes one or more multi-anchor controlled tethers that each have an anchor-tether section with a plurality of anchor-tether segments (e.g., a first anchor-tether segment, a second anchor-tether segment and a third anchor-tether segment), each anchor-tether segment extending from an anchor-tether segment connection point (or a plurality of anchor-tether segment connection points) on the anchor-tether section to a respective one of the anchors having anchor connectors (thereby joining the anchor-tether segments).
  • anchor-tether segment e.g., a first anchor-tether segment, a second anchor-tether segment and a third anchor-tether segment
  • each anchor-tether segment extending from an anchor-tether segment connection point (or a plurality of anchor-tether segment connection points) on the anchor-tether section to a respective one of the anchors having anchor connectors (thereby joining the anchor-tether segments).
  • the anchor-tether segments can be connected at the connection points with connection mechanisms, or they can be unitary (e.g., form a unitary tether that is unitary at their connection points in their original formation).
  • the connection points can be located at or within the central body prior to and/or after the anchor connectors are decoupled/detached/severed.
  • the tethers 2841 are pulled into the openings 2827 to pull the anchors 2821 into the central body 2831 (and/or pull the central body 2831 over the anchors 2821).
  • the anchors 2821 are engaged between the retaining wall 2814 and the central post 2810 to rotate or pivot the anchors to a more upright or vertical position.
  • the tethered anchors 3421 can be opened and closed in a variety of different ways.
  • the inner arm 3460 and the outer arm 3462 can be pulled relatively apart to open and close the tethered anchors 3421.
  • the tilting flange or projection 3463 is fixed to and extends from a closed end 3423 of the tethered anchors 3421.
  • the tethered anchors are coupled to the central body 3431 by one or more control tethers 3441.
  • the one or more control tethers 3441 are positioned on and/or coupled to the anchors 3421 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 3431.
  • the tethers are attached at or near a closed end 3423 of the anchors 3421.
  • the one or more control tethers 3441 can be used to selectively pull the anchors 3421 against and onto the central body 3431 and/or to be selectively slackened to allow the central body to move away from the anchors 3421.
  • the one or more control tethers 3441 and the central body 3431 are configured to pull the anchors toward the central body 3431 in a tilted orientation.
  • FIGS. 32-34 illustrate implantation of the device 3401 onto native heart valve leaflets 20, 22 or 30, 32, 34.
  • the tethered anchors 3421 have already been attached to two native valve leaflets 20, 22.
  • the tethered anchors 3421 could be attached to any number of native valve leaflets.
  • three tethered anchors 3421 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve.
  • the device can include any number of tethered anchors 3421 .
  • the tethers 3441 can be tied, locked or otherwise secured together to hold the anchors 3421 on (e.g., against) the central body 3431.
  • the anchors can be secured to the central body 3431 by something other than the tethers 3441.
  • the anchors and/or the central body 3431 can include a connection arrangement, fastener, or coupler that secures the anchors 3421 to the central body 3431.
  • the tethers 3441 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.
  • the device 3401 can be decoupled from the delivery system.
  • locks 3490 can be placed over the tethers 3441 to secure them in place relative to the central body 3431. This leaves the device 3401 secured to the native valve leaflets.
  • FIG. 35 illustrates an example of valve repair device 3401 that includes a base or bottom wall 3412 with a tapered upper surface 3510.
  • the tapered upper surface 3510 can be shaped to move the anchors 3421 more gradually to the more upright or vertical position and/or to control how upright the anchors 3421 become as the tilting flanges or projections 3463 are moved into engagement with the bottom wall 3412.
  • a shallow or less inclined tapered surface 3510 will move the anchors to a more upright position.
  • a steep or more inclined tapered surface 3510 will move the anchors to a less upright position.
  • the anchors 3421 of the FIG. 35 example can take a variety of different forms.
  • the plurality of tethered anchors can be any of the anchors disclosed by the present application.
  • the tethered anchors 3421 include an inner arm 3460 coupled to an inner mounting plate 3461, an outer arm 3462 mounted to an outer mounting plate 3465 that includes the tilting flange or projection 3463, and a hinge portion 3467 that connects the inner and outer arms 3460, 3462.
  • the outer arm 3462 can move between a closed position and an open position.
  • the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460.
  • the tethered anchors 3421 can be opened and closed in a variety of different ways.
  • the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463.
  • the outer arm 3462 can be biased by the hinge portion 3467 to the open position relative to the inner arm 3460 and the base or bottom wall 3412 can be moved distally or away from the tilting flange or projection 3463 to allow the outer arm 3462 to open.
  • the base or bottom wall 3412 can be moved back into engagement with the tilting flange or projection 3463 to close the outer arm 3462.
  • This configuration can be implanted in the same or a similar way as shown in the example of FIGS. 22-27.
  • FIGS. 36 and 37 are top views of an example of valve repair device 3401 that includes a base or bottom wall 3412 with extensions or petals 3610 and cutouts 3612.
  • the anchors 3421 can be moved to the more upright or vertical position in a variety of different ways.
  • the base or bottom wall 3412 is rotated to move the anchors 3421 between the tilted position and the upright position.
  • the anchors are free to assume the tilted position when the cutouts 3612 are aligned with the tilting flanges or projections 3463.
  • the tethered anchors 3421 can be opened and closed in a variety of different ways.
  • the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463 when the cut outs 3612 are aligned with the tilting flanges or projections 3463.
  • the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460. With the extensions or petals 3610 out of the way of the flanges or projections 3463, the outer arm 3462 and/or the tilting flanges or projections 3463 can be pushed or pulled by an actuator to open the anchors 3421.
  • a valve repair system 5200 includes a valve repair assembly 5201 with a plurality of anchors 5221 that are controlled by one or more catheters (not shown), such as any of the catheters disclosed herein.
  • the valve repair assembly can take a variety of different forms.
  • the valve repair assembly 5201 includes a center clip 5231, and the plurality of anchors 5221.
  • the center clip 5231 can take a variety of different forms.
  • the center clip 5231 can include a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the center clip 5231 includes a central base 5210 and a plurality of clipping arms 5214 or an annular or semi-annular clipping wall.
  • the central base 5210 can take a variety of different forms.
  • An outer surface of the central base 5210 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets.
  • the plurality of clipping arms 5214 or an annular or semi-annular clipping wall can take a variety of different forms.
  • the clipping arms 5214 are biased to a closed or clamping configuration (See FIG. 42).
  • the plurality of clipping arms 5214 or an annular or semi-annular clipping wall can be elongated and/or straightened when loaded into a catheter 5252 (See FIG. 38).
  • the clipping arms 5214 can be made from a metal, such as steel or ni tinol. Any number of clipping arms can be included. In some implementations, the clipping arms 5214 are evenly spaced around a perimeter of the center base 5210 when the clipping arms are in the closed position. The size, number, and/or spacing of the clipping arms 5214 can be selected to approximate an annular wall around the center base 5210 when the clipping arms are in the closed position.
  • the clipping arms 5214 can move between a closed position and an open position.
  • the clipping arms 5214 can be biased (e.g. by shape setting, etc.) to the closed position.
  • the clipping arms can be opened and closed in a variety of different ways.
  • the tethers 5241 can draw the anchors 2821 toward one another.
  • the catheter 5252 can be positioned for deployment with the clipping arms 5214 in the catheter in the elongated configuration (see FIG. 38.).
  • the second arm 3992 can be moved to the open position in a variety of different ways.
  • a line 3996 e.g., suture, wire, chord, hypotube, etc.
  • the line 3996 can be attached to the second arm 3992 and pulled to open the gripping member 3933.
  • the hinge portion 3994 is shape set and/or provides a spring bias to bias the gripping member 3933 to the closed position. Relieving tension or slackening the line 3996 allows the gripping member 3933 to move to the closed position.
  • the device 3901 can be implanted onto native heart valve leaflets 20, 22 or 30, 32, 34.
  • the actuator end 3951 is moved in the direction 3991 by the proximal shaft.
  • the lower actuation extension, plate, or disc 3984 engages the lower extension or link 3965 and the upper actuation extension, plate, or disc 3985 engages the upper actuation extension or link 3964 of each of the paddles that are against the central body 3931 when the actuator end 3951 is moved proximally as indicated by arrow 3991.
  • the line 4296 can be pulled while the catheter 4297 is advanced to engage the actuating arm 4292 and move the gripping arm 4290 of the gripping member 3933 toward the open position, away from the single paddle arm 3960.
  • the gripping member 3933 can be biased to the closed position in the FIG. 47 example.
  • one or more of the lines 3996 can be pulled to move the second arm 3992 of the gripping member 3933 toward to the open position, away from the first arm 3990.
  • the gripping member 3933 can be biased to the closed position in the FIG. 48 example.
  • the device 3901 can be implanted by being moved to position a leaflet 20 in the open paddle arm 3960 and/or the optional open gripping member 3933.
  • the catheter 4297 can be retracted (FIG. 47) or the line 3996 can be slackened (FIG. 48) to close the gripping member 3933 and attach the gripping member 3933 to the first leaflet 20.
  • the actuator end 3951 can optionally be moved distally to close the first arm 3960 of all of the paddles 3915, with the first leaflet secured in the first anchor 3921.
  • the catheter 4297 or the line 3996 can be removed from the gripping member 3933 any at any time after the first leaflet is secured in the first anchor.
  • the one or more tethers 3941 are slackened to allow the remainder of the device 3901 to be moved away from the first leaflet 20 and the attached first anchor 3921 by one or more catheters of the valve repair system. This process can be repeated to attach all the anchors 3921 to the leaflets.
  • the tethers 3941 can be tied, locked or otherwise secured together to hold the anchors 3921 against the central body 3931.
  • the anchors can be secured to the central body 3931 by something other than the tethers 3941.
  • the anchors and/or the central body 3931 can include a connection arrangement, fastener, or coupler that secures the anchors 3921 to the central body 3931 when the anchors 3921 are pulled back against the central body 3931.
  • the tethers 3941 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.
  • the actuator end 3951 is moved distally (opposite of arrow 3991). This movement causes the upper actuation extension, plate, or disc 3985 to engage the lower extensions or links 3965 of all of the paddle arms 3960 to close all of the paddle arms.
  • the actuator end 3951 can be secured in place to set the closed position of the paddle arms.
  • the delivery system components can be decoupled from the device 3901, leaving the device 3901 secured to the native valve leaflets.
  • FIGS. 49-56 illustrate an example of a valve repair system 4400 that includes a valve repair device 4401 and a delivery system 4403.
  • the valve repair device 4401 includes a plurality of tethered anchors 4421 that are controlled by a plurality of spools 4450.
  • the valve repair device can take a variety of different forms.
  • the valve repair device 4401 includes a central body 4431 , a plurality of tethered anchors 4421 , and the plurality of spools 4450.
  • the central body 4431 can take a variety of different forms.
  • the central body 4431 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the central body 4431 includes a bore 4435 that the spools 4450 are rotatably disposed in.
  • the central body 4431 can accept one or more shafts 4453 that are configured to rotate the spools 4450.
  • the plurality of tethered anchors 4421 can take a variety of different forms.
  • the plurality of tethered anchors can be any of the anchors disclosed by the present application.
  • the anchors 4421 each include a gripping member 4433, such as a clasp.
  • the tethered anchors 4421 can optionally be connected to the central body 4431 by an optional biasing member 4432, such as a spring, a shape set arm or wire, etc.
  • the biasing member can bias the tethered anchors to a selected position.
  • the optional biasing member 4432 can bias the anchors 4421 away from the central body 4431 (see the anchor 4421 on the right in FIG. 50).
  • the optional biasing member 4432 can bias the anchors 4421 toward from the central body 4431.
  • the central body 4431 can be moved away from the anchors 4421 due to attachment of the anchors to the leaflets and/or due to movement of the leaflets.
  • the gripping member 4433 can take a variety of different forms. In some implementations, the gripping member 4433 can be any of the gripping members or clasps disclosed herein. In some implementations, the gripping member 4433 includes a fixed arm 4490, a movable arm 4492, and a hinge portion 4494 that connects the fixed arm 4490 to the movable arm 4492. The gripping member can have optional barbs 4437.
  • the fixed arm 4490 is fixed to the biasing member 4432.
  • the movable arm 4492 can be moved relative to the fixed arm 4490 between an open position (left anchor in FIG. 50) and a closed position (right anchor in FIG. 50).
  • the movable arm 4492 can be moved relative to the fixed arm 4490 in a variety of different ways. In some implementations, further tensioning of tethers 4441 by the spools 4450 after the anchors 4421 are pulled up to the central body 4431 can cause the movable arm 4492 to open. The tethers 4441 can be attached to the movable arm 4492 and pulled to open the gripping member 4433.
  • the hinge portion 4494 is shape set and/or provides a spring bias to bias the gripping member 4433 to the closed position. Relieving tension or slackening the tether 4441 allows the gripping member 4433 to move to the closed position. Further slackening of the tether 4441 after the gripping member 4433 has moved to the closed position allows the anchor 4421 and the central body 4431 to be moved relatively apart.
  • the anchors 4421 are coupled to the central body 4431 by one or more control tethers 4441.
  • the one or more control tethers 4441 can extend from the movable arm 4492, into the central body 4431, and are wrapped around the spools 4450.
  • the one or more control tethers 4441 can be used to selectively pull the anchors 4421 against the central body 4431. In some implementations, once the anchors 4421 are against the central body 4431, the control tethers 4441 can be further pulled to move the anchors 4421 to the open position. The tethers 4441 can also be slackened to allow the anchors to close and allow the central body to move away from the anchors 4421.
  • the delivery system 4403 for implanting the device 4401 on a native heart valve can take a variety of different forms.
  • the delivery system includes a catheter 4480 and a plurality of shafts 4453 that are configured to rotate the spools 4450.
  • the catheter 4480 can be releasably coupled to the central body 4431 of the device 4401.
  • the plurality of shafts 4453 can be concentric shafts. A smallest of the shafts 4453 can be extended into the central body 4431 and to a distal one of the spools 4450, through any spools that are proximal to the distal spool. A middle sized one of the shafts 4453 can be extended into the central body 4431 and to a middle one of the spools, through any spools that are proximal to the middle spool.
  • the shaft when a shaft 4453 is engaged with its respective spool 4450, the shaft can rotate the spool in a first direction to selectively pull the anchors 4421 against the central body 4431 and then to pull the anchors 4421 to the open position.
  • the tethers 4441 can rotate the spool 4450 in a second direction to selectively slacken the tethers to allow the anchors to close and then allow the central body to move away from the anchors 4421.
  • the tether 4441 pulls on the movable arm 4492 to open the anchor 4421.
  • the device 4401 is moved by the delivery system 4403 to position a leaflet 20 in the open gripping member 4433 either before or after the anchor 4421 is opened.
  • a distal one of the spools 4450 is rotated by an inner or smallest one of the shafts 4453.
  • the spools can be used in any order. Rotation of the spool 4450 pulls on the corresponding tether 4441.
  • the tether 4441 pulls on the movable arm 4492 to open the anchor 4421.
  • the device 4401 is moved by the delivery system 4403 to position a leaflet 22 in the open gripping member 4433.
  • the tether 4441 can then be slackened to close the gripping member 4433 and attach the gripping member 4433 to the second leaflet 22.
  • the tether 4441 of the anchor connected to the leaflet 22 can be slackened to allow the remainder of the device 4401 to be moved away from the second leaflet 20 to allow the device to capture any additional leaflets. This process can be repeated for each spool, shaft and native valve leaflet.
  • shafts 4453 can be rotated, to rotate the spools 4450, and pull on the tethers 4441 to draw the anchors 4421 back against the central body 4431.
  • the spools are not rotated so far that the anchors start to reopen.
  • there can be a tactile indicator provided to an operator e.g., increased resistance in the tether
  • the tethers 4441 pull the native heart valve leaflets toward the central body.
  • the spools 4450 can be locked or otherwise secured to hold the anchors 4421 against the central body 4431.
  • the delivery system 4403 can be decoupled from the device 4401. This leaves the device 4401 secured to the native valve leaflets.
  • anchors are movable toward and away from on another by attaching the anchors to an expandable/expansion member 21018.
  • the expandable/expansion member 21018 can take a variety of different forms. Referring to FIG. 57A, an example of a valve repair device 5701 includes an expandable/expansion member 21018 and a plurality of anchors 5721.
  • the proximal end portion 21022 (FIGS. 57-63) of the expandable/expansion member 21018 includes a first pair of radially opposed openings 21036, and a second pair of radially opposed openings 21038 distal to the first pair of radially opposed openings 21036 and the distal end portion 21024 of the expandable/expansion member 21018 includes a third pair of radially opposed openings 21040.
  • the actuation mechanism 21020 is configured as a threaded connection.
  • the example actuation mechanism 21020 includes a distal member 21042 (e.g., tube, body, shaft, etc.) configured to threadably couple with a proximal member 21044 (e.g., tube, body, shaft, etc.).
  • the distal member 21042 and the proximal member 21044 can be configured in a variety of ways.
  • the distal member 21042 is formed as a cylindrical tube having a circular cross section. In some implementations, however, the distal member 21042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
  • the distal member 21042 includes a proximal end 21046, a distal end 21048 opposite the proximal end 21046, and an inner passage 21050 extending through the distal member 21042 from the proximal end 21046 to the distal end 21048.
  • the inner passage 21050 includes female threads 21052 (FIGS. 60-61) for threadably coupling with the proximal member 21044.
  • the distal member 21042 is sized to be received within the passage 21027 of the expandable/expansion member 21018.
  • the distal member 21042 includes structure for fixing the distal member 21042 in position within the passage 21027 relative to the expandable/expansion member 21018.
  • the distal end 21048 includes a pair of opposed projections 21054 configured to be received within the third pair of radially opposed openings 21040, as shown in FIGS. 60-63.
  • the proximal member 21044 is formed as a cylindrical tube having a circular cross section. In some implementations, the proximal member 21044 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
  • the proximal member 21044 includes a proximal end 21056, a distal end 21058 opposite the proximal end 21056, and an inner passage 21059 extending through the proximal member 21044 from the proximal end 21056 to the distal end 21058.
  • the proximal member 21044 can include male threads 21060 (FIGS. 60-61) extending along at least a portion of the exterior of the proximal member 21044.
  • the male threads 21060 are configured to mate with the female threads 21052 of the distal member 21042.
  • the proximal member 21044 is sized to be received within the passage 21027 of the expandable/expansion member 21018.
  • the actuation mechanism 21020 can include structure for restricting axial movement of the proximal member 21044 within the passage 21027 relative to the expandable/expansion member 21018.
  • the structure restricts axial movement of the proximal member 21044 within the passage 21027 relative to the expandable/expansion member 21018 while allowing rotational movement of the proximal member 21044 relative to the expandable/expansion member 21018.
  • the structure for restricting axial movement of the proximal member 21044 can be configured in a variety of ways.
  • the actuation mechanism 21020 includes a circumferential, radially extending ridge 21062 at the proximal end 21056.
  • the ridge 21062 is configured to engage with a stop 21064 and an end cap 21066 to restrict axial movement of the proximal member 21044 within the passage 21027.
  • the stop 21064 can be configured in a variety of ways. In some implementations, the stop 21064 is configured to inhibit movement of the proximal member 21044 distally within the passage 21027.
  • the stop 21064 is formed as a ring having a central passage 21068 sized to receive a portion of the proximal member 21044 therethrough. In some implementations, the stop 21064 is further sized to be received within the passage 21027.
  • the stop 21064 can include structure configured to fix the position of the stop 21064 relative to the expandable/expansion member 21018.
  • the stop 21064 includes a pair of opposed projections 21070 configured to be received within the second pair of radially opposed openings 21038 of the expandable/expansion member 21018, as shown in FIGS. 60-63.
  • the distal member 22042 and the proximal member 22044 can be configured in a variety of ways.
  • the distal member 22042 is formed as a cylindrical tube having a side wall 22045 with a circular cross section.
  • the distal member 22042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
  • a valve repair system 7000 includes the valve repair device 7001 with a plurality of anchors 7021 that are tiltable toward and away from one another by an actuator 7050.
  • the valve repair device can take a variety of different forms.
  • the valve repair device 7001 includes a central body 7031, a plurality of anchors 7021, and an actuator end 7051.
  • the central body 7031 can take a variety of different forms.
  • the central body 7031 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the central body 7031 includes a bore or passage 7035 that a shaft 7053 of the actuator end 7051 extends through and that inner tilting arms 7060 of paddles 7015 extend into.
  • the plurality of anchors 7021 can take a variety of different forms. In some implementations, the plurality of anchors can be any of the anchors disclosed by the present application.
  • the paddle 7015 can take a variety of different forms. In some implementations, the paddle 7015 can be any of the paddles disclosed by the present application. In some implementations, the paddle 7015 includes the inner tilting arm 7060 and an outer arm 7062. In some implementations, the outer arm 7062 can be pivotally and/or flexibly coupled to the inner arm 7060.
  • the outer arm 7062 can move between a closed position (FIG. 71) and an open position (FIG. 70).
  • the outer arm 7062 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position and is moved to the open position (e.g., in any of the ways disclosed herein) against the bias.
  • the outer arm 7062 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position and moved to the closed position against the bias.
  • the outer arm 7062 is not biased open or closed.
  • the inner tilting arm 7060 is tilted by moving the actuator end 7051.
  • the inner tilting arm 7060 can be tilted by the actuator end 7051 in a variety of different ways. Any arrangement that allows all paddles 7015 that have at least a portion of the inner tilting arm 7060 in the bore or passage 7035 of the central body 7031 to be tilted toward and away from one another by the actuator end 7051 can be used.
  • FIGS. 70-72 engagement of a portion of the inner tilting arm 7060 in the central body 7031 by the actuator end 7051 tilts the inner arms 7060 toward or away from one another.
  • upward or proximal movement of the actuator end 7051 causes the inner arm 7060 to tilt inward or move to a more upright position.
  • downward or distal movement of the actuator end 7051 causes the inner arm 7060 to tilt outward or move to a more tilted position.
  • the outer arm 7062 is opened and/or closed relative to the inner arm 7060 with an actuation element 7150, such as a line, wire, hypotube, suture, etc.
  • an actuation element 7150 such as a line, wire, hypotube, suture, etc.
  • the outer arm 7062 is opened by pulling with the actuation element 7150. Any arrangement that allows the paddles 7015 to be opened and/or closed can be used.
  • the inner tilting arm 7060 of each paddle 7015 is coupled to the central body 7031 by the actuator 7050.
  • the inner tilting arm 7060 is optionally coupled by one or more tethers or other coupling arrangements that prevent or inhibit the inner tilting arm 7060 from completely separating from the central body 7031.
  • the actuator end 7051 can take a variety of different forms. Any arrangement that tilts the inner tilting arm 7060 of the paddles 7015 by pulling the inner tilting arm into the central body 7031 and/or pushing the inner tilting arm out of the central body 7031 can be used.
  • the actuator end 7051 includes the shaft 7053 and one or more actuation extension, plate, or disc 7084.
  • the actuation extension, plate, or disc 7084 can be configured such that engagement of the inner tilting arm 7060 of the paddle 7015 by the one or more actuation extension, plate, or disc 7084 tilts the inner tilting arms 7060 of the paddles toward or away from one another.
  • the tilting of the tilting arm 7060 can allow the one or more additional anchors 7021 to be moved to corresponding native valve leaflets while the first leaflet 20 is attached to the first anchor 7021.
  • the actuator end 7051 is moved distally to tilt all of the anchors 7021.
  • the actuator 7150 can be used to move the next paddle 7015 to an open position and one or more of the lines 7096 can be pulled to move the movable arm 7092 of the next gripping member 7033 toward an open position.
  • the device 7001 is moved to position a second leaflet 22 in the open gripping member 7033 and the outer arm 7062 of a second one of the anchors 7021.
  • the line 7096 can then be slackened to close the gripping member 7033 and attach the gripping member 7033 to the second leaflet 22.
  • the line 7096 can be removed from the gripping member 7033 any at any time after the second leaflet is secured in the first anchor.
  • the actuator 7150 can also move the second paddle to the closed position or the second paddle can be moved to the closed position after the anchors 5721 are tilted back together.
  • This process for capturing native valve leaflets can be repeated for a third anchor 7021 (if included) and any additional anchors (if included).
  • the actuator end 7051 can pull the tilt arms 7060 into the central body 7031 to move the anchors to a more upright orientation.
  • a valve repair device 7301 is configured to move gripping members 73608 inward (e.g. toward one another) and outward (away from one another).
  • the valve repair device 7301 can take a variety of different forms, such as any of the forms disclosed herein.
  • the valve repair device 7301 includes a central body 7331 and a plurality of anchors 7321.
  • the central body 7331 can take a variety of different forms.
  • the central body 7331 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the central body 7331 includes a bore or passage 7335 that one or more actuation elements extend into.
  • the central body 331 can be controllably inserted into the steering catheter 303, and the controlled tethers can be held to prevent or inhibit them from being drawn fully into the subject’s body (thereby causing the central body to advance toward the anchors along the controlled tethers).
  • an end-body 431 or lock (being similar in form and cinching function to the locking center bodies of prior examples and variations), is advanced along the tether 405 by proximally pulling on the tether.
  • the tether is pulled back through the end-body to draw the leaflet anchors 401, 421, 425, 427 together.
  • the anchors 401, 421, 425, 427 draw the leaflets 20, 22 together to reduce regurgitation through the native valve in the area of the anchors.
  • the intermediate leaflet anchors 421 , 425 naturally adjust their positions on the tether 405.
  • a distal leaflet anchor 451 is permanently affixed to a single, unitary controlled tether 453 (e.g., it is unitary in that it is not made of separate sections) that is long enough to extend through the length of the steering catheter from its distal to its proximal end.
  • intermediate leaflet anchors 455 and a proximal leaflet anchor 457 can have anchor-tether sections 459 that are strung on the unitary controlled tether 453.
  • a tether cutting device in an implant catheter is employed to cut off and remove most of the long, unitary controlled tether 453 from the implant after the implant is fully assembled and the anchors are cinched together by the end-body 431.
  • one or more (springtype) spring spacers 471 are placed on the segments of implant-controlled tether 473 extending between some or all consecutive pairs of leaflet anchors 475 that are attached to leaflets 477 (e.g., pairs of leaflet anchors that occur consecutively along the implant-controlled tether).
  • the one or more spring spacers 471 are placed by feeding them up the extension-tether section, each being fed between a respective consecutive pair of anchors that the spring spacer will separate. These spring spacers can help maintain anchors at preferred distances from one another.
  • these spring spacers 471 can be formed as one of the forms of spacer described above, or they can be of other configurations, such as an accordion-folded pledget, wherein the implant-controlled tether 473 penetrates and extends through each accordion fold (as depicted).
  • the anchors are configured as T-shaped toggle anchors. This type of anchor can provide for enhanced support for lateral loads occurring between consecutive anchors, and particularly on consecutive anchors attached to different leaflets. Other types of anchors are also possible (e.g., anchors described elsewhere herein).
  • a valve repair device is configured to be attached to two leaflets, pull the leaflets together during systole, and allow the leaflets to move apart during diastole.
  • the device can be configured to pull the leaflets together during systole and allow the leaflets to move apart during diastole in a variety of different ways.
  • a valve repair device 8201 includes a pair of anchors 8221 and a resilient coupling member 8231.
  • the pair of anchors 8221 can take a variety of different forms.
  • the pair of anchors 8221 can be any of the anchors disclosed herein.
  • the anchors 8221 each include a first arm 8290, a second arm 8292, and a hinge portion 8294 that connects the first arm 8290 to the second arm 8292.
  • the anchor 8221 can have optional barbs 8237.
  • the resilient coupling member 8231 can take a variety of different forms.
  • the resilient coupling member 8231 can be an elastic member, such as an elastic cord, spring, etc.
  • the coupling member 8231 has a fixed unbiased or unstretched length. Lengths of the coupling member 8231 with a fixed unbiased or unstretched length can be selected outside a patient’s body before delivery and implantation of the device 8201. When more than one device 8201 is used, the resilient coupling members can optionally have different lengths.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

An implantable device to be positioned within a heart valve, using a delivery system. The device can include leaflet anchors for attaching to valve leaflets. A set of tethers can move the anchors closer, into contact with one another, and/or into contact with a central body. The set of tethers can allow the anchors to move apart, and/or away from a central body.

Description

HEART VALVE REPAIR DEVICES AND METHODS
RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63/638,892, filed on April 25, 2024 and U.S. Provisional Patent Application No. 63/569,803, filed on March 26, 2024, which are incorporated herein by reference in their entireties.
BACKGROUND
[0002] A healthy heart has a generally conical shape that tapers to a lower apex. The heart is four-chambered through which blood flows, A native human heart includes four chambers: two atria (upper chambers) - the left atrium and the right atrium, and two ventricles (lower chambers) - the left ventricle and the right ventricle. A wall, the septum, separates the right and left sides of the heart (i.e., of each pair of chambers). For each of the four chambers, there is a respective native valve (the mitral, tricuspid, aortic, and pulmonary valves, respectively) preventing the upstream (backward) flow into that chamber.
[0003] On the right side of the heart, deoxygenated blood from the body is received in the right atrium and passes downstream (forward) through the tricuspid valve to the right ventricle. From the right ventricle it is pumped downstream through the pulmonary valve to the lungs by way of a blood vessel for blood with low oxygen levels, the pulmonary artery. On the left side of the heart, oxygenated blood from the lungs is received in the left atrium and passes downstream through the mitral valve to the left ventricle. From the left ventricle it is pumped downstream through the aortic valve to the remainder of the body by way of a blood vessel for oxygen rich blood, the aorta. During each heartbeat, there is a diastolic phase (cardiac diastole) when the chambers relax and fill passively with blood, and a systolic phase when the heart contracts and pumps blood into the two blood vessels downstream of the ventricles (i.e., the pulmonary artery and the aorta). The systolic phase includes an atrial systole, when the atria contract to eject blood from within the atria downstream into their respective ventricles; and ventricular systole, when the ventricles contract to eject blood from within the ventricles downstream into their respective downstream blood vessels.
[0004] Structurally, the tricuspid, aortic, and pulmonary heart valves have three leaflets, while the mitral valve has two leaflets (also known as cusps). In each case, the leaflets operate as flaps that open and close to allow the downstream (forward) flow of blood when pressure urges the blood forward through the valve and obstructs the flow of blood through the valve when pressure urges the blood to flow upstream (backward) through the valve (as occurs for the mitral and tricuspid valves during ventricular systole).
[0005] For example, the mitral valve, which connects the left atrium to the left ventricle, includes an annulus portion, which is an annular portion of the valve’s tissue surrounding a mitral valve orifice, and a pair of leaflets extending downward from the annulus portion into the left ventricle. The mitral valve annulus portion can form a "D" -shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes. An anterior leaflet can be larger than a posterior leaflet, forming a generally "C "-shaped boundary between the abutting sides of the leaflets when they are closed together.
[0006] With the mitral valve operating properly, the anterior leaflet and the posterior leaflet of the mitral valve function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle. During atrial systole, after the left atrium received oxygenated blood from the pulmonary veins during cardiac diastole, the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole" or "diastole"), and the oxygenated blood that is collected in the left atrium flows into the left ventricle. Subsequently, during ventricular systole, the muscles of the left atrium relax and the muscles of the left ventricle contract, and the resulting increased blood pressure in the left ventricle urges the sides of the two leaflets together, thereby closing the one-way mitral valve so that blood cannot flow back to the left atrium. This pressurized blood is instead expelled out of the left ventricle through the aortic valve. To prevent the two leaflets from prolapsing under pressure and folding back through the mitral annulus toward the left atrium, a plurality of fibrous cords called chordae tendineae tether the leaflets to papillary muscles in the left ventricle.
[0007] The native heart valves serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system. In abnormal situations, these heart valves may be dysfunctional (e.g., damaged, or otherwise malformed), and thus less effective, such as by congenital malformations, inflammatory processes, infectious conditions, disease, and the like. Such dysfunctionality may result in serious cardiovascular compromise or death. One form of dysfunctionality is valvular regurgitation. [0008] Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the mitral valve fails to close properly and blood flows upstream into the left atrium from the left ventricle during ventricle systole. Likewise, tricuspid regurgitation occurs when the tricuspid valve fails to close properly and blood flows upstream into the right atrium from the right ventricle during ventricle systole.
[0009] Mitral regurgitation is one of the most common forms of valvular heart disease. Mitral regurgitation can have many different causes, such as leaflet prolapse, dysfunctional papillary muscles, stretching of the mitral valve annulus resulting from dilation of the left ventricle, more than one of these, etc. Mitral regurgitation at a central portion of the leaflets can be referred to as central jet mitral regurgitation and mitral regurgitation nearer to one commissure (i.e., location where the leaflets meet) of the leaflets can be referred to as eccentric jet mitral regurgitation. Central jet regurgitation occurs when the edges of the leaflets do not meet in the middle and thus the valve does not close, and regurgitation is present. Regurgitation in any of the three-leaflet valves is likewise a serious form of heart disease having many different causes and being characterized by various forms of valve failure mechanisms.
[0010] Prior art FIG. 1 shows a device for repairing leaflets, e.g., an anterior leaflet 20 and a posterior leaflet 22, of a dysfunctional mitral valve MV. A catheter or catheter device 11 is positioned in the left atrium LA above the left ventricle LV. The catheter device is coupled to an implant 13. The implant can be positioned to repair the dysfunctional mitral valve MV.
[0011] While devices like this provide significant potential for potentially lifesaving repairs, there are still challenges. For example, one challenge is that, when treating a beating heart, the leaflets are in motion (both in shape and location) with the continuing operation of the heart. Thus, a repair device must navigate and operate relative to a moving target. Moreover, one or both leaflets of the dysfunctional valve may be deformed and/or damaged. As a result, the leaflets might not regularly move into a position and configuration in which they can be readily treated by the repair device. Moreover, the two or three target leaflets might have unusually large gaps therebetween, and they might be tethered into an unnaturally open position, such as by changes in the underlying structure (e.g., a dilated ventricle). SUMMARY
[0012] This summary provides some examples, and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.
[0013] In some implementations, treatment or repair systems, devices, and related methods include helping to treat or repair native valves, including native two- and three- leaflet heart valves. The devices herein can be valve repair devices, implantable devices, valve treatment devices, implants, treatment devices, etc. While sometimes described as an implantable device or valve repair device for illustration purposes in examples herein, similar configurations can be used on other devices, e.g., treatment devices, removable devices, devices that are not necessarily implanted and can be removed after treatment, etc.
[0014] Tn some implementations, there is provided a device (e.g., treatment device, repair device, valve repair device, implantable device, implant, valve treatment device, etc.) that is configured to be positioned within a native heart valve to allow the native heart valve to form a more effective seal and/or reduce or inhibit regurgitation. The device can be part of a system (e.g., treatment system, repair system, valve repair system, valve treatment system, etc.).
[0015] In some implementations, the device includes an anchor portion. In some implementations, one or more anchors of the anchor portion are moveable between an open position and a closed position.
[0016] In some implementations, the device can be positioned within a heart valve, using a delivery system comprising catheters. In some implementations, the device can include leaflet anchors for attaching to valve leaflets, and one or more connectors forming decouplable or detachable connections between the anchors and the delivery system. In some implementations, the one or more connectors are severable connectors forming severable connections between the anchors and the delivery system. [0017] In some implementations, a set of tethers is actuatable to move the anchors closer and/or into contact after the connectors have decoupled or detached leaving the anchors separated from the delivery system. In some implementations, the device can optionally include a spacer positioned to be compressed by opposing surfaces of the anchors when around the spacer.
[0018] In some implementations, a system can include a transvascular delivery system including a steering catheter system and/or an implant catheter system. The system can also include a device (e.g., treatment device, repair device, valve repair device, implantable device, implant, valve treatment device, etc.) that is introduced via the implant catheter system. The implant catheter system can optionally be guided by a steering catheter system.
[0019] In some implementations, the device includes a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to tissue (e.g., one or more leaflets, an annulus, etc.) of a valve.
[0020] In some implementations, a valve repair device includes a central body, a plurality of anchors, a plurality of tethers attached to the plurality of anchors, and an actuator. In some implementations, the plurality of anchors can be attached to the central body via the plurality of tethers. In some implementations, the actuator can be coupled to the central body.
[0021] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
[0022] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body. For example, slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
[0023] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
[0024] In some implementation, the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while one or more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors.
[0025] In some implementations, the actuator is configured to open the one or more anchors that are against the central body. In some implementations, the actuator can simultaneously open the one or more anchors that are against the central body.
[0026] In some implementations, an anchor of the plurality of anchors comprises a paddle. In some implementations, each anchor of the plurality of anchors comprises a paddle.
[0027] In some implementations, the anchor can comprise an actuator engagement extension. In some implementations, the paddle of the anchor comprises an actuator engagement extension.
[0028] In some implementations, the actuator engages the actuator engagement extension to move the paddle from a closed position to an open position. In some implementations, the actuator engagement extension is configured to engage the actuator when the anchor is disposed against the central body.
[0029] In some implementations, the paddle comprises a plurality of actuator engagement extensions. For example, in some implementations, a first actuator engagement extension of the plurality of actuator engagement extensions can be used to open the paddle, while a second actuator engagement extension can be used to close the paddle.
[0030] In some implementations, the actuator is configured to engage the anchor to move the anchor to a closed position. In some implementations, the actuator is configured to engage the anchor to move the anchor to an open position.
[0031] In some implementations, the anchor can comprise a plurality of actuator engagement extensions. In such implementations, the actuator can be configured to engage a first one of the plurality of actuator engagement extensions to move the anchor to a closed position and can be further configured to engage a second one of the plurality of actuator engagement extensions to move the anchor to an open position.
[0032] In some implementations, the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body. For instance, by while a tether pulls an anchor toward the central body, the anchor can be permitted to tilt relative to the central body. In some implementations, the anchor can be configured to tilt away from the central body as it is pulled toward the central body.
[0033] In some implementations, each tether is connected to a closed end of each anchor. For instance, a tether can be connected to a closed end of the corresponding anchor.
[0034] In some implementations, a valve repair system includes a valve repair device and a delivery system.
[0035] In some implementations, the delivery system can include one or more catheters and a control handle.
[0036] In some implementations, the valve repair device includes a central body, a plurality of anchors, a plurality of tethers attached to the plurality of anchors, and an actuator. In some implementations, the plurality of anchors can be attached to the central body via the plurality of tethers. In some implementations, the actuator can be coupled to the central body.
[0037] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
[0038] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body. For example, slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
[0039] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
[0040] In some implementations, the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while one or more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors. [0041] In some implementations, the actuator is configured to open all anchors that are against the central body.
[0042] In some implementations, the actuator can simultaneously open the one or more anchors that are against the central body.
[0043] This disclosure includes methods of repairing a heart valve e.g. native heart valve and/or simulated heart valve). In some implementations, methods of repairing a heart valve include opening a plurality of anchors that are against a central body.
[0044] In some implementations, the plurality of anchors can be simultaneously opened. For example, in some implementations, an implantable device includes an actuator that opens and/or simultaneously opens the plurality of anchors.
[0045] In some implementations, a first anchor of the plurality of anchors is positioned such that a first native heart valve leaflet is in the first anchor. For example, in some implementations, the implantable device can be moved toward the first native heart valve leaflet such that the open first anchor receives the first native heart valve leaflet.
[0046] In some implementations, the first anchor is closed to capture the first leaflet. In some implementations, the plurality of anchors that are against the central body (e.g. , including but not limited to the first anchor) are closed to capture the first leaflet.
[0047] In some implementations, the central body and a remaining one or more anchors are moved away from the first anchor.
[0048] In some implementations, the plurality of anchors are coupled to the central body with a plurality of tethers. In some examples, each tether can couple a corresponding anchor to the central body.
[0049] In some implementations, the remaining one or more anchors that are against the central body are opened. For example, an actuator can be used to open the remaining one or more anchors that are against the central body.
[0050] In some implementations, the remaining one or more anchors that are against the central body are simultaneously opened. For example, an actuator can be used to simultaneously open the remaining one or more anchors that are against the central body. [0051] In some implementations, a second anchor of the plurality of anchors is positioned such that a second native heart valve leaflet is in the second anchor. For example, in some implementations, the device can be moved toward the second native heart valve leaflet such that the open second anchor receives the second native heart valve leaflet.
[0052] In some implementations, the plurality of anchors that are against the central body are closed to capture the second leaflet. For example, an actuator can be used to close the plurality of anchors that are against the central body, including the second anchor.
[0053] In some implementations, the plurality of anchors that are against the central body are simultaneously closed to capture the second leaflet. For example, an actuator can be used to simultaneously close the plurality of anchors that are against the central body, including the second anchor.
[0054] The present disclosure further includes a vale repair device (e.g. , a heart valve repair device for use in the heart of a real and/or simulated subject). In some implementations a valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors.
[0055] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
[0056] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body.
[0057] In some implementations, a connection between each tether and each anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body. For instance, the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.
[0058] In some implementations, the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body. For example, when an anchor is sufficiently close to the central body, the anchor can interact with the central body to move from the tilted position to the more upright position. An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.
[0059] In some implementations, the central body includes a central post and a retaining wall.
[0060] In some implementations, the retaining wall and the central post are configured to pivot the anchors to a more upright or vertical position. For example, when an anchor is sufficiently close to the central body, the retaining wall can interact with the anchor to cause the anchor to pivot to the more upright position.
[0061] hi some implementations, the anchors and the central body are configured such that pulling the anchors against the central body pivots the anchors to the more upright position. For example, when an anchor is sufficiently close to the central body, the central body can interact with the anchor to cause the anchor to pivot to the more upright position.
[0062] In some implementations, each of the plurality of anchors includes a tilting flange. For example, the tilting flange can interact with a portion of the central body to cause the anchor to tilt.
[0063] In some implementations, the central body includes a bottom wall.
[0064] In some implementations, the tilting flange of an anchor can engage the bottom wall to move the anchor to the more upright position. For example, when an anchor is sufficiently close to the central body, the bottom wall can interact with the anchor to cause the anchor to move to the more upright position.
[0065] In some implementations, rotation of the central body relative to the anchors moves the anchors to the more upright position.
[0066] In some implementations, the central body includes a plurality of petals configured to engage the plurality of anchors upon rotation of the central body relative to the plurality of anchors.
[0067] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body. For example, slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
[0068] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
[0069] This disclosure further provides for a valve repair system. In some implementations, a valve repair system includes a valve repair device and a delivery system.
[0070] In some implementations, the delivery system can include one or more catheters and a control handle.
[0071] In some implementations, the valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors. In some implementations, the plurality of anchors can be attached to the central body via the plurality of tethers.
[0072] In some implementations, each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
[0073] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the central body.
[0074] In some implementations, a connection between a tether and a corresponding anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body. For instance, the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.
[0075] In some implementations, the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body. For example, when an anchor is sufficiently close to the central body, the anchor can interact with the central body to move from the tilted position to the more upright position. An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.
[0076] This disclosure provides methods for repairing a heart valve (e.g., a heart valve in a real or simulated subject). In some implementations the method for repairing a heart valve includes attaching an anchor is to a leaflet of the native heart valve.
[0077] In some implementations, the anchor is pulled toward a central body in a tilted orientation. For example, the anchor can be attached to the central body via a tether. In some implementations, the anchor can be pulled toward the central body via the tether.
[0078] hi some implementations, the anchor is engaged with the central body to move the anchor from the tilted position relative to the central body to a more upright position relative to the central body.
[0079] hi some implementations, the central body is rotated relative to the anchor to move the anchor to the more upright position.
[0080] Implementations of this disclosure provide a valve repair device (e.g. , a heart valve repair device for repairing a valve in a heart of a real or simulated subject). In some implementations, a valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.
[0081] hi some implementations, the plurality of tethers are attached to the plurality of anchors. For example, a tether can be attached to a corresponding anchor.
[0082] In some implementations, the plurality of tethers are wound around the plurality of spools. For example, a tether can attach the corresponding anchor to a corresponding spool.
[0083] In some implementations, rotation of the plurality of spools in a first direction pulls the plurality of tethers to pull the plurality of anchors toward the central body.
[0084] In some implementations, rotation of the plurality of spools in a second direction slackens the tethers to allow the plurality of anchors to be spaced apart from the central body.
[0085] In some implementations, the device includes a plurality of springs bias the plurality of anchors away from the central body. [0086] In some implementations, the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body.
[0087] In some implementations, each tether is connected to a closed end of each anchor.
[0088] Implementations of the present disclosure provide a valve repair system (e.g. , a heart valve repair system for repairing a valve in a heart of a real or simulated subject). In some implementations, the valve repair system includes a valve repair device and a delivery system.
[0089] In some implementations, the delivery system can include one or more catheters and a control handle.
[0090] In some implementations, the valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.
[0091] In some implementations, the plurality of tethers are attached to the plurality of anchors. For example, a tether can be attached to a corresponding anchor.
[0092] In some implementations, the plurality of tethers are wound around the plurality of spools. For example, a tether can attach the corresponding anchor to a corresponding spool.
[0093] In some implementations, a valve repair device includes a center clip and a plurality of anchors. The center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve. For example, the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
[0094] hi some implementations, a plurality of tethers are attached to the plurality of anchors. For example, a tether can be attached to a corresponding anchor. In some implementations, the corresponding anchor can be attached to the center clip via the tether.
[0095] In some implementations, the plurality of tethers are configured to pull the plurality of anchors toward the center clip.
[0096] In some implementations, tethers are configured to allow the anchors to tilt as the anchors are pulled toward the center clip. [0097] In some implementations each tether is connected to a closed end of each anchor.
[0098] In some implementations, a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
[0099] In some implementations, the delivery system can include one or more catheters and a control handle.
[00100] In some implementations, the valve repair device includes a center clip and a plurality of anchors.
[00101] In some implementations, the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve. For example, the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
[00102] In some implementations, this disclosure provides a method of repairing a valve (e.g., a native heart valve of a real or simulated subject. In some implementations, the method includes attaching a plurality of anchors to a plurality of leaflets of the native heart valve.
[00103] In some implementations, the plurality of anchors are captured with a center clip after the plurality of anchors have been attached to leaflets of the native heart valve. For example, the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
[00104] In some implementations, a valve repair device (e.g., a valve repair device for repairing a heart of a real or simulated subject) includes a central body and a plurality of anchors.
[00105] In some implementations, the central body has a plurality of expandable strips.
[00106] In some implementations, the valve repair device includes a plurality of anchors attached to the plurality of expandable strips. For example, an anchor can be attached to a corresponding expandable strip. In some implementations, the plurality of anchors are attached directly to the plurality of expandable strips. [00107] In some implementations, the expandable strips are configured to move the plurality of anchors inward and outward.
[00108] In some implementations, each anchor comprises a paddle and a gripping member attached to the paddle.
[00109] In some implementations, the paddle comprises a fixed arm and a movable arm.
[00110] In some implementations, the fixed arm of each paddle is fixed to one of the expandable strips.
[00111] In some implementations, the gripping member is attached to the movable arm of the paddle.
[00112] In some implementations, a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
[00113] In some implementations, the delivery system can include one or more catheters and a control handle.
[00114] In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00115] In some implementations, the central body has a plurality of expandable strips.
[00116] In some implementations, the plurality of anchors are attached to the plurality of expandable strips. For example, an anchor can be attached to a corresponding expandable strip. In some implementations, the plurality of anchors are attached directly to the plurality of expandable strips.
[00117] In some implementations, the expandable strips are configured to move the plurality of anchors inward and outward.
[00118] In some implementations, a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject) includes a central body and a plurality of anchors. [00119] In some implementations, each anchor comprises a paddle and a gripping member.
[00120] In some implementations, the paddles are connected to the central body.
[00121] In some implementations, the gripping members are configured to move toward and away from the central body while the paddles are connected to the central body and the gripping members are coupled to the paddles.
[00122] In some implementations, the gripping members are movable toward and away from the central body by tilting the paddles toward and away from the central body.
[00123] In some implementations, the paddles are tilted by pulling a portion of the paddles into (e.g., toward) the central body.
[00124] In some implementations, the gripping members are movable toward and away from the central body by sliding the gripping members along the paddles.
[00125] In some implementations, the plurality of anchors comprises three paddles and three gripping members.
[00126] In some implementations, a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
[00127] In some implementations, the delivery system can include one or more catheters and a control handle.
[00128] In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00129] In some implementations, each anchor comprises a paddle and a gripping member.
[00130] In some implementations, the paddles are connected to the central body.
[00131] In some implementations, the gripping members are configured to move toward and away from the central body while the paddles are connected to the central body and the gripping members are coupled to the paddles. [00132] In some implementations, a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject) includes a first anchor, a second anchor, and a coupling member attached to the first anchor and the second anchor.
[00133] In some implementations, the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.
[00134] In some implementations, the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
[00135] In some implementations, the coupling member comprises one or more of an elastic material and a spring.
[00136] In some implementations, a valve repair system includes e.g. , a valve repair system for repairing a heart of a real or simulated subject) a valve repair device and a delivery system.
[00137] In some implementations, the delivery system can include one or more catheters and a control handle.
[00138] In some implementations, the valve repair device includes a first anchor, a second anchor, and a coupling member attached to the first anchor and the second anchor.
[00139] In some implementations, the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.
[00140] In some implementations, the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
[00141] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body. The central body can include a bore.
[00142] In some implementations, the valve repair device includes an actuation element (e.g., a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.). In some implementations, the actuation element includes a worm gear attached to the actuation element, e.g., attached to a distal end of the actuation element. [00143] In some implementations, the valve repair device includes a plurality of anchors. In some implementations, each anchor includes a paddle.
[00144] In some implementations, the paddle can include a first arm that is hingeably attached to a second arm by a hinge portion. In some implementations the hinge portion comprises an actuation gear. In some implementations, the first arm, second arm, and hinge portion can comprise a gripping member of the paddle.
[00145] In some implementations, the worm gear is attached to a distal end of the actuation element such that it extends from a bore of the central body. The worm gear can engage one or more actuation gears of one or more anchors that are engaged with the central body.
[00146] In some implementations, rotating the actuation element and the worm gear in a first direction causes the second arm of the paddle to move and/or pivot in an opening direction via the actuation gear. Moving and/or pivoting the second arm of the paddle in the opening direction can move the anchor, paddle, and/or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.
[00147] In some implementations, rotating the actuation element and the worm gear in a second direction causes the second arm of the paddle to move in a closing direction via the actuation gear. Moving and/or pivoting the second arm of the paddle in the closing direction can move the anchor, paddle, and/or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.
[00148] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.
[00149] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers. [00150] In some implementations, the paddles or the gripping members of the valve repair device include a locking mechanism that prohibits rotation of the second arm of the paddles when the locking mechanism is in a locked condition.
[00151] In some implementations, the paddles or the gripping members of the valve repair device include a biasing member arranged between the first arm and the second arm. The biasing member can be configured to bias the second arm in the closing direction, e.g., toward a closed condition.
[00152] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00153] In some implementations, each of the anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
[00154] In some implementations, the valve repair device includes a pivot arm. In some implementations, the anchor includes the pivot arm. The pivot arm can extend away from the central body and pass through a portion of the second arm and back to the central body.
[00155] In some implementations, the second arm can include a hinge barrel that the pivot arm passes through. In some implementations, the second arm can include an opening on an outer surface of the gripping member that the pivot arm passes through.
[00156] In some implementations, the valve repair device includes an actuation element that can extend through a bore of the central body. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[00157] In some implementations, the actuation element can include an actuation arm connected to the gripping member. In some implementations, the actuation arm can be connected to the first arm. In some implementations, the actuation arm can be connected to the hinge portion. [00158] In some implementations, movement of the actuation element in a proximal direction causes the second arm to pivot in an opening direction. Moving and/or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.
[00159] In some implementations, movement of the actuation element in a distal direction causes the second arm to pivot in a closing direction. Moving and/or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.
[00160] In some implementations, the valve repair device includes a plurality of paddles. In such implementations, the pivot arm can extend from a paddle of the plurality of paddles, through the second arm, and back to the one of the plurality of paddles. In some implementations, the second arm can include a hinge barrel that the pivot arm passes through. In some implementations, the second arm can include an opening on an outer surface of the gripping member that the pivot arm passes through.
[00161] In some implementations, when the gripping member is in a closed condition, further movement of the actuation element in the distal direction applies additional force in the closing direction via the second arm of the gripping member.
[00162] In some implementations, the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition. In some implementations, the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition by the hinge portion of the gripping member.
[00163] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition. [00164] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
[00165] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.
[00166] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
[00167] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00168] In some implementations, an anchor of the plurality of anchors includes a gripping member. The gripping member can have a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm. In some implementations, each anchor includes a gripping member.
[00169] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element extends through a bore of the central body. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[00170] In some implementations, the actuation element includes an actuation arm. In some implementations, the actuation arm can be connected to the second arm via a tether connected to an end portion of the actuation arm. In some implementations, the tether can comprise one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[00171] In some implementations, movement of the actuation element in a distal direction causes tension in the tether to cause the second arm to pivot in an opening direction. Moving and/or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.
[00172] In some implementations, movement of the actuation element in a proximal direction causes the end of the actuation arm to engage the second arm to pivot the second arm in a closing direction. Moving and/or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.
[00173] In some implementations, while the anchor and/or gripping member is in a closed condition, further movement of the actuation element in the proximal direction applies additional force in the closing direction via engagement of the end of the actuation arm and the second arm of the gripping member.
[00174] In some implementations, the actuation arm biases the gripping member in the closing direction, e.g., toward the closed condition.
[00175] In some implementations, the actuation arm can include a spring portion that biases the end of the actuation arm in the closing direction, e.g., biases the gripping member toward a closed condition.
[00176] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.
[00177] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.
[00178] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition. [00179] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
[00180] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.
[00181] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
[00182] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00183] In some implementations, an anchor of the plurality of anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm. In some implementations, each anchor includes a gripping member.
[00184] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[00185] In some implementations, the actuation element extends through a bore of the central body and out of an opening disposed distally of the hinge portion and to the gripping member, e.g., the second arm.
[00186] In some implementations, retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction. In some implementations, the actuation element can be retracted in a retraction direction. Moving and/or pivoting the second arm in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.
[00187] In some implementations, extending the actuation element releases tension on the actuation element to allow the second arm to pivot in the closing direction. In some implementations, the actuation element can be extended in an extending direction. Moving and/or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.
[00188] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.
[00189] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.
[00190] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.
[00191] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
[00192] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.
[00193] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers. [00194] In some implementations, the actuation element comprises one or more tethers of the plurality of tethers.
[00195] In some implementations, tension is not applied to the second arm of the gripping member unless the anchor is pulled against the central body by the tethers. In some implementations, tension via the one or more tethers can be applied to the gripping member while the anchor is pulled against the central body.
[00196] In some implementations, the actuation element and the one or more tethers are formed from a single suture.
[00197] In some implementations, the actuation element comprises one or more tethers of the plurality of tethers, and when the anchor is spaced apart from the central body by the one or more tethers, the second arm remains in a closed condition while the actuation element is retracted.
[00198] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00199] In some implementations, an anchor of the plurality of anchors includes a gripping member. In some implementations, each of the anchors of the plurality of anchors includes a corresponding gripping member. In some implementations, the gripping member includes a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
[00200] In some implementations, the valve repair device includes a routing member. In some implementations, the routing member can comprise one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[00201] In some implementations, the routing member extends distally beyond the hinge portion. In some implementations, the routing member can be retracted to a retracted position that is proximal of the hinge portion. [00202] In some implementations, the valve repair device include an actuation element that extends through a bore of the central body, around the routing member, and to the second arm of the gripping member.
[00203] In some implementations, retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction. In some implementations, the actuation element can be retracted in a retraction direction. Moving and/or pivoting the second arm in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.
[00204] In some implementations, when the routing member is retracted to the retracted position, further retraction of the actuation element in the retraction direction applies tension to the actuation element to cause the second arm to pivot in the closing direction. Moving and/or pivoting the second arm in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition. In some implementations, the closing direction can be a clockwise direction.
[00205] In some implementations, extending the actuation element releases tension on the actuation element to allow the second arm to pivot in the closing direction. In some implementations, the actuation element can be extended in an extended direction.
[00206] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.
[00207] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.
[00208] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition. [00209] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
[00210] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.
[00211] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
[00212] In some implementations, a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00213] In some implementations, an anchor of the anchors plurality of anchors includes a gripping member. In some implementations, each anchor of the plurality of anchors includes a corresponding gripping member.
[00214] In some implementations, the griping member includes a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
[00215] In some implementations, the first arm includes a catch member arranged on the first arm.
[00216] In some implementations, the second arm includes a flexible portion. The flexible portion can include a head having a barbed end. In some implementations, the catch member of the first arm can be engaged by the barbed end of the head attached to the flexible portion of the second arm. [00217] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[00218] In some implementations, the actuation element extends through a bore of the central body, around the hinge portion, and to the head of the second arm of the gripping member.
[00219] In some implementations, retracting the actuation element applies tension to the actuation element which causes the head of the second arm to pivot to disengage the barbed end from the catch member. In some implementations, the actuation element is retracted in a retraction direction.
[00220] In some implementations, further retraction of the actuation element (e.g., further retraction of the actuation once the barbed end is disengaged from the catch member) causes the second arm to pivot in an opening direction. Moving and/or pivoting the second arm in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.
[00221] In some implementations, the second arm comprises a U-shaped end. In some implementations, the flexible portion of the second arm is arranged in a gap of the U-shaped end of the second arm.
[00222] In some implementations, the flexible portion of the second arm contacts the U- shaped end of the actuation arm before the second arm moves in the opening direction because of the retraction of the actuation element. That is, responsive to retraction of the actuation element, the flexible portion of the second arm can contact the U-shaped end of the second arm before the second arm moves toward the opening condition.
[00223] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition. [00224] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.
[00225] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.
[00226] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
[00227] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.
[00228] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
[00229] In some implementations a valve repair device (e.g., a valve repair device to be used for repairing a heart of a real or simulated subject) is disclosed. In some implementations, the valve repair device includes a central body and a plurality of anchors.
[00230] In some implementations, an anchor of the plurality of anchors includes a gripping member. In some implementations, each of the anchors includes a gripping member.
[00231] In some implementations, the gripping member includes a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
[00232] In some implementations, the second arm includes an extension portion extending from the second arm. The extension portion can include a rod, shaft, barb, dart, protrusion, etc. In some implementations, the extension portion can be biased in an extending direction, e.g., extending away from the second arm.
[00233] In some implementations, the extension portion can include a folding barbed portion extending from the second arm. The folding barbed portion can be biased in an extending direction, e.g., extending away from the second arm.
[00234] In some implementations, the valve repair device includes an actuation element. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[00235] In some implementation, the actuation element extends through a bore of the central body, around the hinge portion, through an opening in the second arm, and to the extension portion and/or the folding barbed portion.
[00236] In some implementations, retracting the actuation element applies tension to the actuation element to cause the extending portion and/or folding barbed portion to move toward the second arm.
[00237] In some implementations, further retraction of the actuation element after the folding barbed portion is folded against the second arm causes the second arm to pivot in an opening direction. Moving and/or pivoting the second arm in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition. In some implementations, the opening direction can be a counterclockwise direction.
[00238] In some implementations the extension portion and/or folding barbed portion is integrally formed with the second arm.
[00239] In some implementations the extension portion and/or folding barbed portion can comprise and/or be formed from a shape-setting alloy and is shape-set in an extended condition.
[00240] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition. [00241] In some implementations, the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.
[00242] In some implementations, at least a portion of the gripping member can be formed from a shape-set alloy. For instance, one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy. In some implementations, the shape-set alloy is shape-set in the closed condition.
[00243] In some implementations, the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
[00244] In some implementations, the valve repair device includes a plurality of tethers attached to the plurality of anchors. In some implementations, one or more tethers can be associated with a corresponding anchor.
[00245] In some implementations, the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
[00246] In some implementations, a valve repair device has a central body. In some implementations a valve repair device has a central body and a plurality of anchors.
[00247] In some implementations, an anchor of the plurality of anchors has a mounting plate. In some implementations, each anchor of the plurality of anchors has a mounting plate and a paddle. The mounting plate can include a first alignment feature for engaging a corresponding second alignment feature of the central body. The paddle can be attached to the mounting plate.
[00248] In some implementations, each of the anchors can be individually released from the central body and re-engaged with the central body.
[00249] In some implementations, the first alignment feature engages the second alignment feature of the central body to align the anchor in a desired position relative to the central body. [00250] In some implementations, the first alignment feature is a protrusion and the second alignment feature is an opening.
[00251] In some implementations, the first alignment feature is an opening and the second alignment feature is a protrusion.
[00252] In some implementations, the first alignment feature is a rectangular protrusion and the second alignment feature is a rectangular opening.
[00253] In some implementations, the first alignment feature is a rectangular opening and the second alignment feature is a rectangular protrusion.
[00254] In some implementations, the first alignment feature is a cross-shaped protrusion and the second alignment feature is a cross-shaped receptacle.
[00255] In some implementations, the first alignment feature is a cross-shaped receptacle and the second alignment feature is a cross-shaped protrusion.
[00256] In some implementations, the first alignment feature is at least a portion of a cylinder and the second alignment feature is a rounded groove in the central body.
[00257] In some implementations, the first alignment feature is a locking eyelet extending from the mounting plate and the second alignment feature is an opening in the central body for receiving the locking eyelet.
[00258] In some implementations, the valve repair device includes one or more tethers extending from the central body to the mounting plate of an anchor of the plurality of anchors. In some implementations, each of the anchors of the plurality of anchors are coupled to the central body via one or more tethers.
[00259] In some implementations, releasing tension on a tether of the one or more tethers allows the anchor of the plurality of anchors to move away from the central body. In some implementations, applying tension to the tether of the one or more tethers pulls the anchor into engagement with the central body. [00260] In some implementations, the central body includes a central bore. In such implementations, one or more tethers can extend through the central bore and out of an opening in the central body. In some implementations, the opening in the central body is arranged proximal of the second alignment feature.
[00261] In some implementations, the central body includes a central bore. In such implementations, one or more tethers extend through the central bore and out of an opening in the central body that is arranged distal of the second alignment feature.
[00262] In some implementations, the central body includes a central bore. In such implementations, one or more tethers extend through the central bore and out of an opening in the central body. In some implementations, the opening is arranged to one side of the second alignment feature.
[00263] In some implementations, the central body includes a central bore. In such implementations, one or more tethers extend through the central bore and out of openings in the central body. In some implementations, the openings are arranged on two sides of the second alignment feature.
[00264] In some implementations, the valve repair device also includes a locking member that can be compressed against a locking surface of the central body to lock the position of one or more tethers extending between the locking member and the locking surface.
[00265] In some implementations, the locking member and the locking surface have a tapered shape.
[00266] In some implementations, the locking member and the locking surface have a frustoconical shape.
[00267] In some implementations, a single tether extends from the central body, through the mounting plate of the anchor of the plurality of anchors, and back into the central body. In some implementations, each anchor of the plurality of anchors has a single tether extending from the central body, through the mounting plate of the respective anchor, and back into the central body. [00268] In some implementations, the paddles of the anchors can be independently opened by actuation elements engaging each of the paddles.
[00269] In some implementations, the anchor of the plurality of anchors further includes a gripping member. In some implementations, each of the plurality of anchors includes a respective gripping member. In some implementations, the gripping member has a first arm hingeably connected to a second arm by a hinge portion, wherein the first arm of the gripping member is attached to the mounting plate.
[00270] In some implementations, the anchor include a second mounting plate attached to the second arm of the gripping member. In some implementations, each of the plurality of anchors includes a respective second mounting plate attached to the second arm of the gripping member.
[00271] In some implementations, the second mounting plate includes a routing flange with an opening for the actuation element, e.g., to receive the actuation element. The actuation element extends through the opening in the routing flange so that retracting the actuation element in a proximal direction through the central body causes the gripping member to open.
[00272] In some implementations, the mounting plate includes a bore and an actuation element extends through the bore of the mounting plate to engage the paddle.
[00273] In some implementations, extending the actuation element in a distal direction causes the paddle to open and retracting the actuation element in a proximal direction causes the paddle to close.
[00274] In some implementations, extending the actuation element in a distal direction causes the paddle to close and retracting the actuation element in a proximal direction causes the paddle to open.
[00275] In some implementations, rotating the actuation element in a first direction causes the paddle to open and rotating the actuation element in a second direction causes the paddle to close. [00276] In some implementations, the actuation element is a tube that extends through the bore of the mounting plate to engage a distal end of the paddle.
[00277] In some implementations, the distal end of the paddle has a proximally extending pin that is received by the actuation element. In some implementations, the actuation element is tube-shaped.
[00278] In some implementations, the actuation element threadably engages the distal end of the paddle.
[00279] In some implementations, the valve repair device also includes a locking pin extending through a central bore of the central body. In some implementations, a locking eyelet is attached to a mounting plate of the anchor. In some implementations, each mounting plate is attached to a corresponding locking eyelet. In such implementations, openings are provided in the central body for receiving the locking eyelets of the anchor and/or anchors.
[00280] In some implementations, the locking pin threadably engages with a threaded proximal opening of the central bore.
[00281] In some implementations, the locking eyelet of one anchor is offset from the locking eyelets of the other anchors so that the locking eyelets of all of the plurality of anchors can be moved into alignment with the locking pin.
[00282] In some implementations, the locking eyelets can be axially offset or staggered axially relative to each other. In some implementations, the locking eyelets are configured to align with a central longitudinal axis of the valve repair device when moved into alignment with the locking pin.
[00283] In some implementations, the valve repair device also includes a sheath extending along the actuation element to the paddle so that when the sheath is in an extended condition the sheath engages the bore of the mounting plate so that the anchor is engaged with the central body. When the sheath is retracted to a retracted condition, the anchor is able to move away from the central body. In some implementations, each paddle is associated with a corresponding sheath. [00284] In some implementations, the actuation element is biased to move the anchor laterally away from the central body when the sheath is retracted to the retracted condition.
[00285] In some implementations, the anchors are moved to a distally staggered bailout position by extending the actuation element and sheath for each anchor to a different distance.
[00286] In some implementations, the valve repair device includes a gripping member attached to the paddle of each anchor.
[00287] In some implementations, the gripping member has a first arm, a second arm, a hinge portion hingeably attaching the first arm to the second arm, and a secondary actuation element connected to the second arm.
[00288] In some implementations, tension applied to the secondary actuation element opens the gripping member by moving the second arm away from the first arm.
[00289] In some implementations, a valve repair system includes a delivery system with one or more catheters and a control handle and any of the valve repair devices described herein.
[00290] In some implementations, the delivery system includes a positioning arm extending from a catheter of the delivery system to engage an anchor of the valve repair device.
[00291] In some implementations, the positioning arm comprises the actuation element of the valve repair device, e.g., the actuation element associated with the anchor of the valve repair device.
[00292] In some implementations, extending the positioning arm from the catheter allows the positioning arm to flex laterally to allow the anchor to move away from the central body.
[00293] In some implementations, the positioning arm is biased to flex laterally outward and away from the central body. [00294] In some implementations, retracting the positioning arm into the catheter causes the positioning arm to straighten so that the anchor is moved into engagement with the central body.
[00295] In some implementations, a sheath is extended along the positioning arm to cause the positioning arm to straighten so that the anchor is moved into engagement with the central body.
[00296] In some implementations, the delivery system further includes a guide extending through the positioning arm to a distal cap.
[00297] In some implementations, the distal cap is connected to the central body of the valve repair device.
[00298] In some implementations, the distal cap includes a stop for engaging the anchors when the anchors are moved into engagement with the distal cap.
[00299] In some implementations, extending the positioning arm moves the anchor along the guide and into engagement with the distal cap.
[00300] In some implementations, applying a force to the positioning arm in the extending direction after the anchor has engaged the distal cap compresses the positioning arm.
[00301] In some implementations, compressing the positioning arm causes the positioning arm to straighten.
[00302] In some implementations, the positioning arm can comprise and/or be formed from a hypotube with a central lumen and a plurality of segments.
[00303] In some implementations, the plurality of segments of the hypotube are cut from a single tube.
[00304] In some implementations, each segment extends from a first end to a second end. [00305] In some implementations, the first end and/or the second end include a plurality of retaining slots and a plurality of corresponding keyed retaining tabs.
[00306] In some implementations, the retaining slots are rotationally symmetric.
[00307] In some implementations, the retaining slots of the first end of a segment are rotationally offset from the retaining slots of the second end of the segment.
[00308] In some implementations, the plurality of retaining slots and plurality of corresponding keyed retaining tabs have a T-shape.
[00309] In some implementations, the plurality of retaining slots and plurality of corresponding keyed retaining tabs have an arrow shape.
[00310] In some implementations, compressing the hypotube causes slanted sides of the arrow-shaped keyed retaining tabs to engage slanted sides of the arrow-shaped retaining slots.
[00311] Any of the above method(s) can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, anthropomorphic ghost, simulator, such as a computer simulator, e.g., with the body parts, tissue, etc. being simulated). With a simulation, the body parts can optionally be referred to as “simulated’- (e.g., simulated heart, simulated tissue, etc.) and can comprise, for example, computerized and/or physical representations.
[00312] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).
[00313] A further understanding of the nature and advantages of the implementations are set forth in the following description and claims, particularly when considered in conjunction with the accompanying drawings in which like parts bear like reference numerals. Other features and advantages will become apparent from the following detailed description and claims, particularly when considered with the accompanying drawings. The detailed description of implementations, as set out below to enable one to build and use the implementations, are not intended to limit the enumerated claims, but rather, they are intended to serve as examples of the claimed invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[00314] To further clarify various aspects of implementations of the present disclosure, a more particular description of the certain examples and implementations will be made by reference to various aspects of the appended drawings. These drawings depict only example implementations of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures might be drawn to scale for some examples, the figures are not necessarily drawn to scale for all examples. Examples and other features and advantages of the present disclosure will be described and explained with additional specificity and through the use of the accompanying drawings in which:
[00315] FIG. 1 A shows a cutaway view of a heart with a device positioned to repair a mitral valve.
[00316] FIG. IB shows a cutaway view of a heart with the device shown in FIG. 1 A attached to leaflets of the mitral valve.
[00317] FIG. 2 illustrates a cutaway view of the human heart in a diastolic phase;
[00318] FIG. 3 illustrates a cutaway view of the human heart in a systolic phase;
[00319] FIG. 4 illustrates a cutaway view of the human heart in a systolic phase showing valvular regurgitation;
[00320] FIG. 5 is the cutaway view of FIG. 4 annotated to illustrate mitral valve leaflets in the systolic phase;
[00321] FIG. 6 illustrates a healthy mitral valve with the leaflets closed as viewed from an atrial side of the mitral valve;
[00322] FIG. 7 illustrates a dysfunctional mitral valve with a visible gap between the leaflets as viewed from an atrial side of the mitral valve; [00323] FIG. 8 illustrates a tricuspid valve viewed from an atrial side of the tricuspid valve;
[00324] FIGS. 9 illustrates a cutaway view of a heart showing an implant catheter and treatment/repair device extended from within a steering catheter system and positioned within a mitral valve.
[00325] FIG. 10 illustrates details of the treatment/repair device illustrated in FIG. 9;
[00326] FIG. 10A illustrates the treatment/repair device of FIG. 10 with an implementation of a mechanism for opening and closing paddles of the device;
[00327] FIG. 10B illustrates an implementation of a mechanism for opening and closing paddles of the device of FIG. 10A;
[00328] FIGS. 10C and 10D illustrate an implementation of paddles that can be used in a device similar to the device of FIG. 10;
[00329] FIGS. 10E and 10F illustrate an implementation of a treatment/repair device that is similar to the treatment/repair device of FIG. 10;
[00330] FIG. 11 illustrates the implant catheter and treatment/repair device of FIG. 9, with a first leaflet anchor of the treatment/repair device located and oriented to clip on to a portion of a first leaflet.
[00331] FIG. 12 illustrates the implant catheter and treatment/repair device of FIG. 11 , with the first leaflet anchor clipped on to the first leaflet and released from a central body of the treatment/repair device, and with a second leaflet anchor of the treatment/repair device located and oriented to clip on to a portion of a second leaflet.
[00332] FIG. 13 illustrates the implant catheter and treatment/repair device of FIG. 12, with the first and second leaflet anchors clipped on to the respective first and second leaflets and released from the central body, and with the central body positioned at a central, coaptation location between the leaflets.
[00333] FIG. 14 illustrates the treatment/repair device of FIG. 13, with the anchors connected to, and locked into position with respect to, a central body, and with the implant catheter disconnected from the treatment/repair device and removed from the subject’s body. [00334] FIG. 15 illustrates a view of an example 3 -anchor implementation of the treatment/repair device of FIG. 9, positioned within a tricuspid valve.
[00335] FIG. 16 illustrates the treatment/repair device of FIG. 1 , with a first leaflet anchor of the treatment/repair device located and oriented to clip on to a portion of a first leaflet.
[00336] FIG. 17 illustrates the treatment/repair device of FIG. 16, with the first leaflet anchor clipped on to the first leaflet and released from a central body of the treatment/repair device, and with a second leaflet anchor of the treatment/repair device located and oriented to clip on to a portion of a second leaflet.
[00337] FIG. 18 illustrates the treatment/repair device of FIG. 17, with the first and second leaflet anchors respectively clipped on to the first and second leaflets and released from the central body, and with a third leaflet anchor of the treatment/repair device located and oriented to clip on to a portion of a third leaflet.
[00338] FIG. 19 illustrates the treatment/repair device of FIG. 18, with the first, second and third leaflet anchors respectively clipped on to the first, second and third leaflets, and released from the central body, and with the central body positioned at a central, coaptation location between the leaflets.
[00339] FIG. 20 illustrates the treatment/repair device of FIG. 19, with the anchors moved into contact with the central body.
[00340] FIG. 21 illustrates an example expansion central body of the treatment/repair device of FIG. 20.
[00341] FIG. 22 is a schematic illustration of an example of a valve repair system.
[00342] FIG. 23 illustrates the valve repair system of FIG. 22 with paddles and clasps in an open condition.
[00343] FIG. 24 illustrates the valve repair system of FIG. 23 with a leaflet and an anchor tethered to a remainder of a valve repair device.
[00344] FIG. 25 illustrates the valve repair system of FIG. 24 with two leaflets and two anchors tethered to a remainder of the valve repair device. [00345] FIG. 26 illustrates the valve repair system of FIG. 25 with the two anchors and attached leaflets pulled back to the remainder of the valve repair device by the tethers.
[00346] FIG. 27 illustrates the valve repair system of FIG. 26 where the delivery system has been separated from the device.
[00347] FIG. 28 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.
[00348] FIG. 29 illustrates the valve repair system of FIG. 28 with the anchors pulled to the central body by tethers.
[00349] FIG. 30 illustrates the valve repair system of FIG. 29 with the anchors pulled downward into the central body to move the anchors to a more upright position.
[00350] FIG. 31 illustrates the valve repair system of FIG. 30 where the delivery system has been separated from the device.
[00351] FIG. 32 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.
[00352] FIG. 33 illustrates the valve repair system of FIG. 32 with the anchors pulled toward the central body by tethers.
[00353] FIG. 34 illustrates the valve repair system of FIG. 33 with the anchors pulled against the central body to move the anchors to a more upright position.
[00354] FIG. 35 is a perspective view of a valve repair system.
[00355] FIGS. 36 and 37 are top views of a valve repair system.
[00356] FIGS. 38-42 are schematic illustrations of a valve repair system.
[00357] FIG. 43 is a perspective view of a delivery system for delivering anchors to native heart valve leaflets.
[00358] FIG. 44 is a side view of a portion of a valve repair system. [00359] FIG. 45 is a perspective view of a portion of the valve repair system illustrated by FIG. 44.
[00360] FIG. 46 is the top view of the valve repair system illustrated by FIG. 44.
[00361] FIG. 47 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.
[00362] FIG. 48 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.
[00363] FIGS. 49-56 are cross-sectional views of a valve repair system.
[00364] FIG. 57 A is a perspective view of a valve repair device with an expandable central body.
[00365] FIG. 57 illustrates a perspective view of an expandable/expansion member in an expanded configuration;
[00366] FIG. 58 illustrates a perspective view of the expandable/expansion member of FIG. 57 in a collapsed configuration;
[00367] FIG. 59 illustrates an exploded perspective view of the expandable/expansion member and an example actuation mechanism for the expandable coaptation element;
[00368] FIG. 60 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 59;
[00369] FIG. 61 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 59;
[00370] FIG. 62 illustrates a perspective view of the expandable/expansion member and the actuation mechanism of FIG. 59;
[00371] FIG. 63 illustrates a front view of the expandable/expansion member and the actuation mechanism of FIG. 59; [00372] FIG. 64 illustrates a front view of an example expandable/expansion member and an example actuation mechanism for an expandable coaptation element;
[00373] FIG. 65 illustrates an exploded view of the actuation mechanism of FIG. 64;
[00374] FIG. 66 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 64;
[00375] FIG. 67 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 64;
[00376] FIG. 68 illustrates a perspective view of the sectioned expandable/expansion member and the actuation mechanism of FIG. 67 ;
[00377] FIG. 69 illustrates an example expandable/expansion member and an example actuation mechanism for an expandable coaptation element;
[00378] FIGS. 70-72 are schematic illustrations of a valve repair system.
[00379] FIGS. 73 and 74A-74E are schematic illustrations of a valve repair system.
[00380] FIGS. 75A-75D illustrate a consecutively inserted, center-coupled implementation of a treatment/repair system.
[00381] FIG. 76 is a cutaway view of a central body of the consecutively inserted, center- coupled implementation of a treatment/repair system of FIGS. 25A-75D, being connected to an implant catheter and tethered anchors.
[00382] FIG. 77 is a cutaway view of an example central body, including a spacer.
[00383] FIG. 78 is a cutaway view of an example central body.
[00384] FIG. 79 illustrates an example end-coupled implementation of a treatment/repair system.
[00385] FIG. 80 illustrates an example end-coupled implementation of a treatment/repair system. [00386] FIGS. 80A and 80B illustrate an implementation of the treatment/repair system of FIGS. 79 or 80 on a native mitral valve.
[00387] FIG. 81 illustrates an example end-coupled implementation of a treatment/repair system.
[00388] FIGS. 82-85 are schematic illustrations of a valve repair device.
[00389] FIGS. 86 and 87 illustrate implantation of the valve repair device illustrated by FIGS. 82-85 on leaflets of a native heart valve.
[00390] FIG. 88 is a perspective view of a valve repair device with gear-actuated paddles and its aesthetic features;
[00391] FIG. 89 is side view of the valve repair device of FIG. 88 with a paddle in an option condition;
[00392] FIG. 90 is a side view of the valve repair device of FIG. 88 with the paddle in a closed condition;
[00393] FIG. 91 is a side view of the valve repair device of FIG. 88 with one of the paddles separated from a central body and valve leaflets captured by the paddle engaged by the central body and the paddle separated from the central body;
[00394] FIG. 92 is a side view of the valve repair device of FIG. 91 with the paddles including optional locking mechanisms;
[00395] FIG. 93 is a side view of the valve repair device of FIG. 91 with the paddles including optional biasing members;
[00396] FIG. 94 is a side view of a gripping member of a valve repair device and its aesthetic features showing the gripping member in a closed condition, wherein a second arm of the gripping member including a hinge for pivoting around a pivot arm extending from the central body;
[00397] FIG. 95 shows the gripping member of FIG. 94 in an open condition and positioned to capture a valve leaflet; [00398] FIG. 96 shows the gripping member of FIG. 95 in a closed condition with a valve leaflet captured by the gripping member;
[00399] FIG. 97 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation arm of an actuation element includes a tether for connecting to a second arm of the gripping member;
[00400] FIG. 98 shows the gripping member of FIG. 97 in an open condition and positioned to capture a valve leaflet;
[00401] FIG. 99 shows the gripping member of FIG. 97 in a closed condition with a valve leaflet captured by the gripping member;
[00402] FIG. 100 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body that is disposed distally to a hinge portion of the gripping member;
[00403] FIG. 101 shows the gripping member of FIG. 100 in an open condition and positioned to capture a valve leaflet;
[00404] FIG. 102 shows the gripping member of FIG. 100 in a closed condition with a valve leaflet captured by the gripping member;
[00405] FIG. 103 shows the gripping member of FIG. 100 in a closed condition with a valve leaflet captured by the gripping member and the gripping member separated from the central body and tethered to the central body by attachment sutures or tethers;
[00406] FIG. 104 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body and around a routing member before engaging the gripping member;
[00407] FIG. 105 shows the gripping member of FIG. 104 in an open condition and positioned to capture a valve leaflet;
[00408] FIG. 106 shows the gripping member of FIG. 104 in an open condition and with the routing member retracted so that the actuation element extends proximal to a hinge portion of the gripping member; [00409] FIG. 107 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the retracted position;
[00410] FIG. 108 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the extended position;
[00411] FIG. 109 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the retracted position;
[00412] FIG. 110 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a flexible portion and a head having a barbed end and a hook for engaging a catch member of a first arm of the gripping member;
[00413] FIG. 110A is a partial front view of the gripping member of FIG. 110;
[00414] FIG. 11 1 shows the gripping member of FIG. 110 in the closed condition with the head and barbed end of the second arm disengaged from the catch member of the first arm;
[00415] FIG. 112 shows the gripping member of FIG. 110 in an open condition and positioned to capture a valve leaflet;
[00416] FIG. 113 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member;
[00417] FIG. 114 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member, wherein the barbed end is engaged with the catch member of the first arm;
[00418] FIG. 115 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a folding barbed portion in an extended condition;
[00419] FIG. 116 shows the gripping member of FIG. 115 in the closed condition with the folding barbed portion in a retracted condition; [00420] FIG. 117 shows the gripping member of FIG. 115 in an open condition and positioned to capture a valve leaflet;
[00421] FIG. 118 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member and the folding barbed portion in the retracted condition;
[00422] FIG. 119 shows the gripping member of FIG. 110 in a closed condition with a valve leaflet captured by the gripping member and the folding barbed portion in the extended condition;
[00423] FIG. 120 shows a top perspective view of an example of a valve repair device and its aesthetic features;
[00424] FIG. 121 shows a top perspective view of the valve repair device of FIG. 120 with an anchor in an open condition;
[00425] FIG. 122 shows a cross-sectional view of the valve repair device of FIG. 120;
[00426] FIG. 123 shows a top perspective view of the valve repair device of FIG. 120 with an anchor in a released condition;
[00427] FIG. 124 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 123;
[00428] FIG. 125 shows a cross-sectional view of the valve repair device of FIG. 123;
[00429] FIG. 126 shows a cross-sectional view of the valve repair device of FIG. 120 with the anchor in a retracted condition;
[00430] FIG. 127 shows a cross-sectional view of the valve repair device of FIG. 120 with actuation elements locked;
[00431] FIG. 128 shows a cross-sectional view of the valve repair device of FIG. 120 with a locking element retracted;
[00432] FIG. 129 shows a cross-sectional view of the valve repair device of FIG. 120 with a handshake coupling decoupled; [00433] FIG. 130 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 120;
[00434] FIG. 131 shows a top perspective view of an example of a valve repair device and its aesthetic features;
[00435] FIG. 132 shows a top perspective view of the valve repair device of FIG. 131 with an anchor having a paddle in an open condition and a gripping member in a closed condition;
[00436] FIG. 133 shows a top perspective view of the valve repair device of FIG. 132 with the gripping member in an open condition;
[00437] FIG. 134 shows a side view of the valve repair device of FIG. 133;
[00438] FIG. 135 shows a top perspective view of the valve repair device of FIG. 131 with an anchor in a released condition;
[00439] FIG. 136 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 135;
[00440] FIG. 137 shows a cross-sectional view of the valve repair device of FIG. 135;
[00441] FIG. 138 shows a cross-sectional view of the valve repair device of FIG. 131 with the anchor in a retracted condition;
[00442] FIG. 139 shows a cross-sectional view of the valve repair device of FIG. 131 with actuation elements locked;
[00443] FIG. 140 shows a cross-sectional view of the valve repair device of FIG. 131 with a locking element retracted;
[00444] FIG. 141 shows a cross-sectional view of the valve repair device of FIG. 131 with a handshake coupling decoupled;
[00445] FIG. 142 shows a cross-sectional view of the valve repair device of FIG. 131 with a delivery mechanism retracted; [00446] FIG. 143 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 131;
[00447] FIG. 144 shows a top perspective view of an example of a valve repair device and its aesthetic features;
[00448] FIG. 145 shows a top perspective view of the valve repair device of FIG. 144 with an anchor having a paddle in an open condition and a gripping member in a closed condition;
[00449] FIG. 146 shows a top perspective view of the valve repair device of FIG. 145 with the gripping member in an open condition;
[00450] FIG. 147 shows a side view of the valve repair device of FIG. 146;
[00451] FIG. 148 shows a top perspective view of the valve repair device of FIG. 144 with an anchor in a released condition;
[00452] FIG. 149 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 148;
[00453] FIG. 150 shows a cross-sectional view of the valve repair device of FIG. 148;
[00454] FIG. 151 shows a cross-sectional view of the valve repair device of FIG. 144 with the anchor in a retracted condition;
[00455] FIG. 152 shows a cross-sectional view of the valve repair device of FIG. 144 with actuation elements locked;
[00456] FIG. 153 shows a cross-sectional view of the valve repair device of FIG. 144 with a locking element retracted;
[00457] FIG. 154 shows a cross-sectional view of the valve repair device of FIG. 144 with a handshake coupling decoupled;
[00458] FIG. 155 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 144; [00459] FIG. 156 shows the valve repair device of FIG. 144 with anchors moved to an elongated position;
[00460] FIG. 157 shows a top perspective view of an example of a valve repair device and its aesthetic features;
[00461] FIG. 158 shows the valve repair device of FIG. 157 with an anchor in an open condition;
[00462] FIG. 159 shows a bottom perspective view of an anchor of the valve repair device of FIG. 157 in a closed condition;
[00463] FIG. 160 shows a bottom perspective view of an anchor of the valve repair device of FIG. 158;
[00464] FIG. 161 shows a side view of the valve repair device of FIG. 158 positioned for leaflet capture;
[00465] FIG. 162 shows a partial cross-sectional view of the valve repair device of FIG. 157 with an anchor in the retracted condition;
[00466] FIG. 163 shows a partial cross-sectional view of the valve repair device of FIG. 162 with the anchor in a released condition;
[00467] FIG. 164 shows a top perspective view of the valve repair device of FIG. 163 ;
[00468] FIG. 165 shows a cross-sectional view of an anchor locking mechanism of the valve repair device of FIG. 157;
[00469] FIG. 166 shows a perspective view of the anchor locking mechanism of the valve repair device of FIG. 157 ;
[00470] FIG. 167 shows a cross-sectional view of the valve repair device of FIG. 157 with an actuation element retracted;
[00471] FIG. 168 shows a cross-sectional view of the valve repair device of FIG. 157 with a delivery mechanism retracted; [00472] FIG. 169 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 157;
[00473] FIG. 170 shows the valve repair device of FIG. 157 with anchors moved to a delivery configuration;
[00474] FIG. 171 shows a side view of an example of a valve repair device with anchors in a released condition;
[00475] FIG. 172 shows a side view of the valve repair device of FIG. 171 with the anchors in a retracted condition;
[00476] FIG. 173 shows a side view of an example of a valve repair device with anchors in a released condition;
[00477] FIG. 174 shows a side view of the valve repair device of FIG. 173 with the anchors in a retracted condition;
[00478] FIG. 175 shows a side view of an example of a valve repair device with anchors in a released condition;
[00479] FIG. 176 shows a side view of the valve repair device of FIG. 175 with the anchors in a retracted condition;
[00480] FIG. 177 shows a side view of a hypotube and its aesthetic features usable and/or for use in a valve repair device;
[00481] FIG. 178 shows a top perspective view of a segment of the hypotube of FIG. 177;
[00482] FIG. 179 shows a top view of the hypotube of FIG. 177;
[00483] FIG. 180 shows a side view of a hypotube and its aesthetic features usable and/or for use as an actuation element in a valve repair device;
[00484] FIG. 181 shows a top perspective view of a segment of the hypotube of FIG. 180;
[00485] FIG. 182 shows a top view of the hypotube of FIG. 180; [00486] FIG. 183 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a bent condition; and
[00487] FIG. 184 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a straight condition.
DETAILED DESCRIPTION
[00488] The following description refers to the accompanying drawings, which illustrate example implementations of the present disclosure. Other implementations having different structures and operation do not depart from the scope of the present disclosure.
[00489] Some implementations of the present disclosure are directed to systems, devices, methods, etc. for treating or repairing a defective heart valve. For example, various implementations of devices, valve repair devices, implantable devices, implants, and systems (including systems for delivery thereof) are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.
[00490] The techniques, methods, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation/simulated subject (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and/or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.
[00491] The examples summarized above and defined by the enumerated claims may be better understood by referring to the following detailed description, which should be read with the accompanying illustrative drawings, in which like parts bear like reference numerals. This detailed description disclosing examples, set out below to enable one to build and use the implementations, is not intended to limit the enumerated claims, but rather, it is intended to provide examples of them. Therefore, implementations having differing structures and methods, will not depart from the scope of the invention defined in the claims.
[00492] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection can be direct as between the components or can be indirect such as using one or more intermediary components. Also as described herein, reference to a "member," "element," "component," or "portion" shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements. Also as described herein, the terms "substantially" and "about" are defined as at least close to (and includes) a given value or state (preferably within 10 of and more preferably within 1 of).
[00493] Numerous variations of the example implementations described herein are within the scope of the invention, some of which are described for various implementations. To the extent they are viable, these variations are also envisioned for use with other implementations. Thus, a treatment or repair device herein may include any combination or sub-combination of the features and variations disclosed herein, and it may exclude some described features.
[00494] FIGS. 2-3 show cutaway views of a human heart H during distinct phases of a cardiac (heartbeat) cycle. A right ventricle RV and a left ventricle LV are separated from a right atrium RA and a left atrium LA, respectively, by a tricuspid valve TV and a mitral valve MV; i.e., the atrioventricular valves. Additionally, an aortic valve AV separates the left ventricle LV from an ascending aorta AA, and a pulmonary valve PV separates the right ventricle from a pulmonary artery PA. Each of these valves defines respective orifices, and has flexible leaflets (e.g., mitral valve anterior and posterior leaflets 20, 22 as also depicted in FIGS. 4-7, and tricuspid valve leaflets 30, 32, 34 as depicted in FIG. 8) extending inward across the respective orifices that come together or "coapt" in the flow stream to form the one-way, fluid-occluding surfaces. Organ repair systems, and more particularly native heart valve repair systems of the present application are frequently described and/or illustrated with respect to the mitral valve MV ; and therefore, the anatomical structures of the mitral valve, the left atrium LA and left ventricle LV will be explained in greater detail. However, the devices described herein can also be used to repair other native valves, e.g., the devices can be used to repair a tricuspid valve TV, an aortic valve AV, a pulmonary valve PV, and/or an atrioventricular valve. [00495] The left atrium LA receives oxygenated blood from the lungs via pulmonary veins PVS. At the beginning of the cardiac cycle, during a diastolic phase, or diastole (as depicted in FIG. 2), blood that was previously collected in the left atrium LA (during the end of a prior cardiac cycle) moves through the mitral valve MV and into the left ventricle LV by expansion of the left ventricle LV. At the same time, additional blood flows into the left atrium from the pulmonary veins. During a subsequent systolic phase, first there is an atrial systole in which the atria contract, and then there is a ventricular systole in which the ventricles contract.
[00496] In the atrial systole of the systolic phase, the left atrium contracts to eject additional blood from within the left atrium downstream into the left ventricle. In the ventricular systole of the systolic phase, as depicted in FIG. 3, the left ventricle LV contracts to force the blood through the aortic valve AV to the ascending aorta AA, where it circulates back through the rest of the body. During ventricular systole, the two leaflets of the mitral valve MV close to prevent the blood from regurgitating from the left ventricle LV back into the left atrium LA. At the same time, with the left atrium relaxing, blood is again collected in the left atrium from the pulmonary vein for the start of the next cardiac cycle.
[00497] The right atrium RA receives deoxygenated blood from the body via two veins, a posterior (inferior) vena cava IVC and an anterior (superior) vena cava SVC; and it receives deoxygenated blood from the coronary venous network via the coronary sinus CS. At the beginning of the cardiac cycle, during the diastolic phase, blood that was previously collected in the right atrium RA during the end of the prior cardiac cycle moves through the tricuspid valve TV and into the right ventricle RV by expansion of the right ventricle RV. At the same time, additional blood flows into the right atrium from the vena cava. In the atrial systole of the systolic phase, the right atrium contracts to eject additional blood from within the right atrium downstream into the right ventricle. In the ventricular systole of the systolic phase, the right ventricle RV contracts to force the blood through the pulmonary valve PV to the pulmonary artery PA, where it flows to the lungs. During ventricular systole, the three leaflets of the tricuspid valve TV close to prevent the blood from regurgitating from the right ventricle RV back into the right atrium RA. At the same time, blood is collected in the right atrium from the vena cava for the start of the next cardiac cycle.
[00498] Referring now to FIGS. 2-8, the mitral valve MV includes two leaflets, an anterior leaflet 20 and a posterior leaflet 22. The mitral valve MV also includes an annulus 24 (see FIG. 6), which is a variably dense fibrous ring of tissues that encircles the anterior and posterior leaflets 20, 22. Referring to FIGS. 4-5, the mitral valve MV is anchored to a wall of the left ventricle LV by chordae tendineae CT. The chordae tendineae CT are a plurality of cord-like tendons that connect papillary muscles PM (i.e., the muscles located at the base of the chordae tendineae CT and within the walls of the left ventricle LV) to the anterior and posterior leaflets 20, 22 of the mitral valve MV. The papillary muscles PM serve to limit the movements of the anterior and posterior leaflets 20, 22 of the mitral valve MV and prevent the mitral valve MV from being reverted.
[00499] The mitral valve MV opens and closes in response to pressure differences between the left atrium LA and the left ventricle LV. Rather than opening or closing the mitral valve MV, the papillary muscles PM support and/or brace the anterior and posterior leaflets 20, 22 against the high pressure occurring in the left ventricle LV, that pressure being needed to circulate blood throughout the body. Together the papillary muscles PM and the chordae tendineae CT are known as parts of the subvalvular apparatus, which functions to keep the mitral valve MV from prolapsing or flailing into the left atrium LA when the mitral valve closes. As depicted in a Left Ventricular Outflow Tract (LVOT) view depicted in FIG. 4, the anatomy of the anterior and posterior leaflets 20, 22 is such that the inner sides of the leaflets coapt at their free end portions, and from there the anterior and posterior leaflets 20, 22 recede or spread apart from each other. The anterior and posterior leaflets 20, 22 spread apart in the atrial direction, until each leaflet meets with the mitral annulus 24.
[00500] Various disease processes can impair proper function of one or more of the native valves of the heart H. These disease processes include degenerative processes (e.g., Barlow's Disease, fibroelastic deficiency, etc.), inflammatory processes (e.g., Rheumatic Heart Disease), and infectious processes (e.g., endocarditis, etc.). In addition, damage to the left ventricle LV or the right ventricle RV from prior heart attacks (i.e., myocardial infarction secondary to coronary artery disease) or other heart diseases (e.g., cardiomyopathy, etc.) can distort a native valve's geometry, which can cause the native valve to dysfunction.
[00501] Dysfunctional native valves malfunction in diverse ways, including: (1) valve stenosis; and (2) valve regurgitation. Although both stenosis and regurgitation can affect any valve, stenosis is often found to affect the aortic and pulmonary valves, and regurgitation is often found to affect the atrioventricular valves (i.e., the mitral and tricuspid valves). [00502] Both valve stenosis and valve regurgitation increase the workload of the heart H and may lead to serious conditions if left untreated, such as endocarditis, congestive heart failure, permanent heart damage, and cardiac arrest, possibly leading to an ultimately death. Because the left side of the heart (i.e., the left atrium LA, the left ventricle LV, the mitral valve MV, and the aortic valve AV) are primarily responsible for circulating the flow of blood throughout the body, there are substantially higher pressures on the left side heart, and a dysfunction of the mitral valve MV or the aortic valve AV is particularly problematic and often life threatening.
[00503] Valve stenosis can cause a native valve not to open properly and/or completely and thereby cause improper blood flow (e.g., obstructed blood flow, jetting, etc.). Often, valve stenosis results from buildup of calcified material on the leaflets of a valve, which causes the leaflets to thicken and impairs the ability of the valve to function properly.
[00504] Valve regurgitation generally occurs when the leaflets of the valve do not close completely, thereby causing blood to leak back into the prior (upstream) chamber (e.g., a mitral valve failure to close completely, causing blood to leak from the left ventricle to the left atrium). There are three main mechanisms by which a native valve becomes regurgitant (e.g., incompetent), which include Carpentier's type I, type II, and type III malfunctions.
[00505] A Carpentier type I malfunction involves the dilation of an annulus such that normally functioning leaflets are distracted from each other and fail to form a tight seal (e.g., the leaflets do not coapt properly). Included in a type I mechanism malfunction are perforations of the leaflets, as are present in endocarditis. A Carpentier type II malfunction involves prolapse of one or more leaflets of a native valve above a plane of coaptation. A Carpentier type III malfunction involves restriction of the motion of one or more leaflets of a native valve such that the leaflets are abnormally constrained below the plane of the annulus. Leaflet restriction can be caused by rheumatic disease or dilation of a ventricle.
[00506] Malfunctioning native heart valves may need to be replaced or repaired. Replacement can involve replacing the subject's native valve with a biological or mechanical substitute. Repair can involve the preservation and correction of the subject's native valve. In some implementations, the devices described by the present application are used to repair the function of a defective native valve. That is, the devices are configured to help close the leaflets of the native valve to inhibit blood from regurgitating. Some of the devices described in the present application are designed to easily grasp and secure the native leaflets. In some implementations, the native leaflets are grasped and/or secured around a coaptation element (e.g., a spacer, gap filler, wedge, plug, foam, sponge, etc.) that beneficially acts as a filler in the regurgitant orifice to help inhibit back flow or regurgitation, though this is not necessary for all implementations.
[00507] Many patients undergoing valve surgery, such as surgery to the mitral valve MV, suffer from a degenerative disease that causes a malfunction in a leaflet of a native valve (e.g., the mitral valve MV), which can result in prolapse, flail, and/or regurgitation. Referring to FIG. 6, when a healthy mitral valve MV is in a closed position, the anterior leaflet 20 and the posterior leaflet 22 coapt, which prevents blood from leaking from the left ventricle LV to the left atrium LA. Referring to FIGS. 4 and 7, mitral regurgitation MR can occur when the anterior leaflet 20 and/or the posterior leaflet 22 of the mitral valve MV is displaced such that the anterior and posterior leaflets 20, 22 do not properly coapt or close. This failure to coapt causes a gap 26 between the anterior leaflet 20 and the posterior leaflet 22, which can allow blood to flow backwards (e.g., into the left atrium LA from the left ventricle LV, as illustrated by the mitral regurgitation MR flow path depicted in FIG. 4).
[00508] Referring to FIG. 7, the gap 26 may have a width W between about 2.5 mm and about 17.5 mm, between about 5 mm and about 15 mm, between about 7.5 mm and about 12.5 mm, or about 10 mm. In some situations, the gap 26 may have a width W greater than 15 mm or even 17.5 mm. As set forth above, there are several different ways that a leaflet (e.g., anterior and posterior leaflets 20, 22 of mitral valve MV) may malfunction, which can thereby lead to valvular regurgitation.
[00509] In any of the above-mentioned situations, improvement of the valve function might be achievable using a treatment/repair device or implant capable of engaging the anterior leaflet 20 and the posterior leaflet 22 to close the gap 26 and prevent the regurgitation of blood through the mitral valve MV. As depicted in FIG. 5, an abstract representation of a device 10, or implant, is shown implanted between the anterior and posterior leaflets 20, 22 such that regurgitation does not occur during systole (compare FIG. 4 with FIG. 5). [00510] In some implementations, the coaptation element (e.g., spacer, coaptation element, gap filler, plug, wedge, sheet, barrier, etc.) of the device 10 has a generally tapered or sloped shape (e.g., triangular shape, etc.) that naturally adapts to the native valve geometry and to its expanding leaflet nature (toward the annulus 24). In this application, the terms spacer, coaptation element, and gap filler are used interchangeably and refer to an element that fills a portion of the space between native valve leaflets and/or that is configured such that the native valve leaflets engage or "coapt" against (e.g., such that the native leaflets coapt against the coaptation element, spacer, etc. instead of only against one another).
[00511] The mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from functioning properly, allowing for the regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA, as depicted in FIG. 4). The regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable. In addition, regurgitation can occur due to the chordae tendineae CT becoming dysfunctional (e.g., the chordae tendineae CT may stretch or rupture), which allows the anterior leaflet 20 and the posterior leaflet 22 to be reverted such that blood is regurgitated into the left atrium LA. The problems occurring due to dysfunctional chordae tendineae CT can be repaired by repairing the chordae tendineae CT or the structure of the mitral valve MV (e.g., by securing the anterior and posterior leaflets 20, 22 at the affected portion of the mitral valve).
[00512] With reference to FIGS. 7-8, the systems, devices, procedures, and concepts disclosed herein are described in detail for treating/repairing the structure of a native valve, often using a mitral valve as an illustrative example. On the left side of a heart the systems, devices, and procedures can be used between the anterior and posterior leaflets 20, 22 of the mitral valve MV to connect them and help prevent or inhibit regurgitation of blood from the left ventricle into the left atrium. The devices, procedures and concepts disclosed herein can also be used to treat/repair a single leaflet of a native valve.
[00513] Like the mitral valve, the other valves (e.g., aortic, pulmonic, and tricuspid valves) can be treated/repaired using the devices, procedures and concepts disclosed herein. For example, like the left side of the heart, on the right side of a heart such devices, procedures and concepts can be used between any two of the three leaflets on the tricuspid valve (e.g., the anterior leaflet 30, the septal leaflet 32 and the posterior leaflet 34) to connect them and prevent or inhibit regurgitation of blood from the right ventricle into the right atrium. Moreover, the devices, procedures and concepts disclosed herein can be used between all three tricuspid valve leaflets 30, 32, 34 to connect all three of them and prevent or inhibit regurgitation of blood from the right ventricle to the right atrium.
[00514] The devices, procedures, systems, and concepts disclosed herein can also be used to treat/repair a single leaflet of a valve. In sum, depending on the situation, the described devices, procedures, systems, and concepts might be used to treat or repair any native valve, as well as any component of a native valve.
[00515] In some implementations, the systems herein can be configured as organ repair systems for repairing an organ, e.g., the heart, or a valve of a heart. In some implementations, the systems can be configured to treat/repair another part of the body. In some implementations, the systems herein are valve treatment/repair systems for repairing or treating a valve. In some implementations, the systems herein include a treatment and/or repair device (e.g., a valve repair device, a valve repair implant, a valve treatment device, a treatment device, an implant, a device, etc.).
[00516] In some implementations, the treatment/repair systems herein comprise a delivery system having a distal end that is inserted into a subject (e.g., a living patient, a simulation, etc.), and a proximal end that remails outside of the subject. The delivery system can include an implant catheter system having catheter components (e.g., delivery and/or implant catheters) configured and sized to receive, deliver, and implant, or otherwise deploy, the treatment/repair device within a subject.
[00517] The treatment/repair devices herein can be used by medical personnel in repairing or treating the subject’s native valve. In some implementations, this is done by repairing and/or supporting one or more leaflets of the subject’s valve.
[00518] In some implementations, the device can be delivered to the valve by the delivery system through the subject’s vascular system. The delivery and/or implant catheter(s) can have a distal end for insertion into a proximal end of a steering catheter system, and a proximal end for manipulation by a user of the delivery system.
[00519] In some implementations, the system is provided with an array of controllable parts that are for various actuation activities, some of which are described herein and others which are known in the art. In some implementations, the system is configured such that a user (e.g., medical personnel) can operate various controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbles, etc.) to control the system. In some implementations, the system can comprise mechanisms known to be useable in other transvascular devices, though the actuation activities and related controllable parts themselves may be unique.
[00520] In some implementations, the system is provided with a wide array of related parts and methods, such as may be described herein, either directly or indirectly.
[00521] Additional details and background information on systems, devices, and methods for transvascular heart valve treatment/repair (with associated mechanisms, components, operations, steps, etc.) that can be used with the systems, devices, methods, etc. herein can be found in U.S. Pat. No. 8,449,599 and U.S. Patent Application Publication Nos. 2014/0222136, 2014/0067052, 2016/0331523, and PCT patent application publication Nos. W02020/076898, each of which is incorporated herein by reference in its entirety for all purposes. In some implementations, leaflet anchors described in any of these incorporated references can optionally be used as leaflet anchors in the implementations described herein. Also, coaptation elements, spacers, etc. described in any of these incorporated references can optionally be used as a central body in any of the implementations described herein.
[00522] An example transvascular technique that can be used with the systems, devices, methods, etc. herein for treating/repairing a native valve can comprise advancing a catheter or catheter device into an atrium (e.g., inserting the catheter device into the right femoral vein, up the inferior vena cava and into the right atrium). In some implementations, the tricuspid valve is treated from the right atrium. In transeptal transvascular techniques, the septum can be punctured from the right atrium, and the catheter device passed into the left atrium. In some instances, the catheter device can be coupled to a device (e.g., treatment device, repair device, implant, etc.). The device can be positioned to repair a dysfunctional native valve. [00523] The delivery systems herein can comprise one or more components forming a steering catheter system and/or an implant catheter system. In some implementations, the delivery systems can have one or more components forming a steering catheter system and an implant catheter system.
[00524] In some implementations, the implant catheter system includes one or more implant catheters capable of placing and implanting, or otherwise deploying, a treatment or repair device. Optionally, the one or more implant catheters can be steerable catheters capable of navigating a subject’s vascular system, thereby also forming all or part of the steering catheter system rather than being a separate system. The delivery system can further include additional devices for transvascular procedures, such as sheaths, control guidewire, external catheter control systems and controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbles, etc.), and the like.
[00525] In some implementations, a steering catheter system includes one or more steering catheters capable of navigating a subject’s vascular system.
[00526] In some implementations, e.g., ones having a separate steering catheter system, the one or more steering catheters can be either individually or collectively configured to guide the one or more implant catheters through the subject’ s vascular system. In some implementations, this can involve positioning a distal end of the steering catheter system upstream of a defective valve (relative to a blood flow direction) and pointing the distal end of the implant catheter system downstream (in the blood flow direction) through the valve.
[00527] In some implementations, the implant catheter system starts off inserted within the steering catheter system prior to its insertion into the subject’s body or is inserted into a proximal end of the steering catheter system after the steering catheter system’s distal end is positioned upstream of the valve. With the steering catheter system in place and the implant catheter inserted, the implant catheter system is extended downstream from within steering catheter system, toward the valve.
[00528] The component parts of the treatment/repair device can be configured to traverse the subject’s vascular system through the delivery system in an operational configuration. In some implementations, the treatment/repair device can be structurally configured with a first, small-form-factor (e.g., small diameter) delivery configuration structurally laid out for traversing the delivery system through the subject’s vascular system, and a second, operational configuration structurally appropriate for valve treatment or repair operations. In some such implementations, the implant catheter includes one or more actuators functional to actuate the treatment/repair device from the delivery configuration to the operational configuration while the device is located at its installation location within the subject’ s heart.
[00529] In some implementations, the component parts of the device can be configured for simultaneously traversing the subject’s vascular system through the delivery system as a single implantable unit.
[00530] In some implementations, the component parts of the device can be configured to transvascularly traverse the delivery system through the subject’s vascular system on a piece- by-piece basis. In some implementations, the pieces are assembled into an implantable device within the body (e.g., within the heart during an implantation procedure).
[00531] In some implementations herein, a treatment/repair system includes and uses a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to tissue (e.g., tissue of an organ). In some implementations, the system is in the form of and/or comprises a treatment or repair device that includes at least one of or a plurality of independently actuatable leaflet anchors (e.g., clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.) are also possible.
[00532] In some implementations, a leaflet anchor is an attachment device structured (once it is in an operational configuration) with a leaflet-attachment mechanism to affix itself to a leaflet, in any one or more of a variety of ways. This attachment mechanism can be, for example, in the form of an attachment-body (e.g., a bar). In some implementations, there will be a plurality of attachment-bodies (a first attachment-body, a second attachment-body, a third attachment-body, etc.), each of which can have any of a variety of cross sections (e.g., a relatively flat, paddle-type cross), and longitudinally extending in any of a wide variety of shapes (e.g., a straight line or a circle) to form compressive structures (e.g., paddles or rings).
[00533] In some implementations, the attachment-bodies can be configured affix to the leaflet, such as by pressing against the leaflet and thereby constraining the movement of the leaflet with respect to the anchor. For example, in some implementations of a clamp-type anchor, two attachment-bodies in the form of paddles can be configured such that they are attached at one end with a hinge to form a jaw that can bite down and clamp or clasp on to a leaflet and thereby affix to the leaflet. In some implementations, this clasp-type anchor attachment apparatus (or attachment mechanism) can be provided with two control apparatuses (or control mechanisms), one that actuates the attachment apparatus between an open configuration and an attached configuration (optionally using a spring to load the jaw towards an open or closed position), and one that locks the attachment apparatus onto a leaflet. In some implementations, the control apparatuses can be controlled using control wires, such as sutures, wires, lines, tethers, etc.
[00534] Likewise, any leaflet anchor herein can be provided with various other forms of tissue-attachment mechanisms such as friction devices, adhesion devices, tissue piercing mechanisms and/or various forms of grapnel. The anchor(s) can take and/or comprise a variety of forms, e.g., clasps, clamps, clips, darts, staples, hooks, bars, rods, screws, knots, toggle anchors, etc.
[00535] In some implementations, each leaflet anchor can comprise or be in the form of a toggle anchor, having a bar with a centrally attached respective anchor tether (e.g., a tether or tether section associated with a specific anchor). The bar can be made to longitudinally pierce, penetrate, and pass through a wall of a leaflet, pulling the anchor tether with it like a needle pulling a thread. To do this maneuver, the bar can be oriented parallel to the anchor tether, and then an end of the bar is pushed through a wall of a leaflet using a sharp point or edge (the point either being on an end of the bar or on a separate penetrator that contains or is attached to the toggle anchor). In some implementations, a structural support member can be used to support leaflet structures during penetration.
[00536] In some implementations, after passing through the wall, the anchor tether is pulled and the bar thereby toggles, (rotates) to laterally press against the wall of tissue with a distal (anchor) end of the anchor tether pulled back against, and extending back through, the penetrated wall of tissue in a T-shaped configuration (where the bar forms the top of an uppercase T). This T-shaped toggle anchor (also known as a T-element anchor) prevents or inhibits the bar from passing back through the hole in the tissue (leaflet) when pulled by the anchor tether. The anchor can use variations for the structure of a toggle anchor bar, such as a bar made of an elongated accordion-folded fabric with the anchor tether extending through multiple leaves of the accordion that are then squeezed into an accordion-folded structure to forming the bar.
[00537] In some implementations, the device also includes one or more connectors, such as decouplable, detachable, or severable connectors. At least one of these one or more connectors is an anchor connector or anchor severable connector (e.g., a first anchor connector, a first anchor severable connector, a second anchor connector, a second anchor severable connector, etc.) in the form of a fastener or connection that fastens, attaches, or couples the structure of an associated anchor of the one or more anchors, either directly or indirectly, to the structure of a catheter of the delivery catheter system/implant catheter system.
[00538] In some implementations, each anchor connector structurally fastens, couples, attaches, etc. the anchor and catheter together rigidly. Each such anchor connector provides for the user (via the delivery or implant catheter system) to first position the associated anchor for affixing it to a valve portion like a leaflet, and then, after the anchor is affixed to that leaflet, with user actuation, to decouple, detach, or sever the connection provided by the anchor connector, and thereby unfasten and release the anchor from the implant catheter. The decoupling/detaching/severing of the anchor connector thereby removes that connector’s constraint on the anchor from becoming separated from the implant catheter. The implant catheter can then move separately away from the anchor, to, for example, position one or more other anchors at other leaflets or leaflet locations.
[00539] In some implementations, a connector (e.g., a severable connector, an anchor connector, a catheter connector, etc.) can be a structure forming a connection that, in a first, unsevered state, joins and fastens the structures of two distinct components (e.g., an anchor and a delivery catheter) to the extent that they are constrained (typically with substantial rigidity) so as to move in sync with one another, in one or more degrees of freedom (and typically in six degrees of freedom). In some implementations, a severable connector can be controllably decouplable/detachable to a second, decoupled state (e.g., detached state, severed state, etc.) that breaks (ends) the constraint on the in-sync movement in at least one of the constrained degrees of freedom (and typically in six relative degrees of freedom) from one another. Put another way, the connector or severable connector forms a decouplable/detachable/severable connection between a first component and a second component. In some implementations, the decouplable/detachable/severable connection includes a coupled, connected, or unsevered state in which the connector constrains the first component and the second component to move in sync with one another in a set of one or more constrained degrees of freedom. In some implementations, the decouplable/detachable/severable connection can also include a decoupled, detached, or severed state in which the first component and the second component are not constrained by the connector to relatively move in sync with one another, e.g., in at least one constrained degree of freedom of the set of one or more constrained degrees of freedom.
[00540] In some implementations, two objects moving in sync with regard to one or more degrees of freedom encompasses a state in which the two objects move (e.g., translate and/or rotate) together in the one or more degrees of freedom, at the same time, to retain their positions relative to one another, such as would occur with a rigid connection between the two objects.
[00541] The transition from the coupled to decoupled states (e.g., from connected to detached states, from unsevered to severed states, etc.) can controllably occur via a variety of physical connection structures, such as being held by a retractable mechanical stop, being held by a clamp or clasp, being held by an integral connector that can be cut, etc. In some implementations, the connector structure can be formed by (e.g., include) integral portions of one or both of the two distinct components, and/or by wholly separate structural elements that attach to one or both of the two distinct components.
[00542] In some implementations, six degrees of freedom of the connector might be three translational degrees of freedom (e.g., respectively translating along a given set of x, y and z axes that are normal to one another, one of which might be parallel to the direction in which the end of the implant catheter is facing), and three rotational degrees of freedom (e.g., respectively rotating around the given set of x, y, and z axes). A rigid connection between two distinct components can be inflexible to the degree necessary for medical personnel to functionally control the position and orientation of one component (e.g., an anchor) using nothing but movement of the other component (e.g., a distal tip of an implant catheter). A certain degree of flexibility is inherent in any material (particularly in transvascular devices), but there is also a level of rigidity that can provide functionality for the device when used in this type of procedure. [00543] In some implementations, at least some of the anchors (e.g., one or more clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.) that are connected to the implant catheter system (and/or to other anchors) by connectors, are each further connected to a controlled tether system having one or more controlled tethers (e.g., sutures or other types of cords). In some implementations, each controlled tether connects its respective anchor to the implant catheter system such that control is maintained on the anchor via a controllable connection between the anchor and the implant catheter system after the connector decouples, detaches, releases, severs, etc. to break the connector’s constraint between the relative movement of the implant catheter and the anchor.
[00544] In some implementations, either the controlled tether controllably connects the anchor to the implant catheter system separately from the implant catheter system’ s connection to other anchors, or the controlled tether connects the anchor to the implant catheter system via one or more other anchors of the plurality of anchors. In the case wherein the controlled tether separably connects the anchor to the implant catheter system, the controlled tether either can be affixed to the implant catheter system only at a distal catheter section that is within the subject’s body or can extend back through the implant catheter system to a proximal end of the implant catheter system, so that it might be directly accessed by medical personnel.
[00545] In some implementations, a tether can be a structure physically joining two or more distinct components (e.g., joining an anchor and an implant catheter system, or an anchor and another anchor, or other components, etc.). In some implementations, a tether can join components such that they are flexibly unconstrained with regard to moving separately from one another in one or more (and typically six) degrees of freedom, but are constrained not to separate from one another (in one or more degrees of freedom) by farther than a defined tether limitation (e.g., an amount of tether slack, e.g., an available length of tether to extend). This unconstrained movement within a defined tether limitation can be large enough to allow for the independent movement of the components at a distance adequate to facilitate separate placement of the components in functionally independent locations (e.g., placement wherein a first leaflet anchor is attached to a first portion of a first leaflet while an implant catheter is positioned with a second leaflet anchor at a first portion of a second leaflet at a different location). In some implementations of a tether joining more than two distinct components, in combination the components can be constrained not to separate from one another (in one or more degrees of freedom) by farther than a defined tether limitation. [00546] As used herein, this tether flexibility should be understood as being flexible to the degree necessary for medical personnel to functionally control the position and orientation of one component (e.g., a distal tip of an implant catheter) free of functionally significant impeding forces delivered through the tether from a contrary movement or position of another tethered component (e.g., a tethered anchor), so long as that tethered component is within the freedom of movement provided by the extent of the tether limitation. In simplified terms, the tether is flexible enough to allow anchors to be attached to leaflets at a greater distance from one another than anchors directly connected to one another. As such, mechanical extension devices other than a simple cord (e.g., a series of flexible rods and/or joints) are within the scope herein, so long as they provide usable tether flexibility.
[00547] As used herein, a tether may be understood to include multiple individual (separate) sections of tether that are connected, such as by having one tether section loop through an eyelet formed by another tether section to form the tether as a whole. Also, as used herein, limited portions of tethers, and of their tether sections, will be referred to as segments of the respective tethers and/or tether sections. For example, a tether or tether section can be said to have a first- end segment, a second-end segment, and an intermediate or center segment (see, e.g., FIG. 78 and the related disclosure).
[00548] A controlled tether is a tether controllably configured such that the tether can be controllably actuated to move one or more connected components relative to other components (e.g., to coapt leaflet anchors, and thereby their respective leaflets, after the leaflet anchors are attached to their respective leaflets). A controlled tether can be formed by (e.g., include) integral portions of one or both joined components, and/or by wholly separate structural elements (such as sutures) that attach or pass through one or both of the two joined components.
[00549] In some implementations a controlled tether (or section thereof) can be a looped tether. In some implementations, a looped tether (or looped tether section) can connect from a proximal end, which is actuatable and removable from or with the implant catheter system (e.g., an end of which could remain outside the subject during initial insertion), to a distal end forming a loop (e.g., a bight) that connects to a primary connection point associated with some portion of a treatment or repair device. As a result, the looped tether can be used to controllably actuate or connect (e.g., hold together) that portion of the device while needed for implantation, and then the (looped) tether can be removed without physically cutting or severing device from the looped tether.
[00550] In some implementations, a looped tether is configured for this removable operation by serially extending (end-to-end) from a segment at a first end of the tether (e.g., a controlled- tether first-end segment or an extension-tether first-end segment), which is at a proximal end of the implant catheter system (protruding from a proximal, user end of the implant catheter), down along (through or aside) the implant catheter system to its distal (implantation) end, optionally through and out of a central body positioned at a distal end of the implant catheter system, to the tether’s primary connection point (e.g., a respective anchor) of the device, slidably received by and passing through (looped around) that primary connection point, back into and through the central body (optionally), back along (through or aside) the implant catheter system to its proximal end, to a segment at a second end of the tether (e.g., a controlled- tether second-end segment or an extension-tether second-end segment) at the proximal end of the implant catheter system (protruding from the proximal, user end of the implant catheter along with the first-end segment of the looped tether). A looped tether of this type can be removed from a body while leaving an implanted implant by pulling on the first-end segment of the tether while releasing the second-end segment to be pulled around the path of the tether loop by the first-end segment. Other forms of looped tethers or other releasable tethers, which can be used to controllably actuate or connect (e.g., hold together) the device or components thereof, and then removed without physically cutting or severing the device, are within the scope of this disclosure as well.
[00551] In some implementations, the treatment or repair device includes a system (e.g., controlled tether system, tether system, adjustment system, coaptation system, actuation system, connection system, control system, etc.). In some implementations, the system can include a central body configured as a coaptation element and/or a spacer. The central body can be configured to be actuatable to guide (e.g., move, adjust, etc.) and maintain the position of the anchors, and thereby the leaflets. More particularly, with anchor connectors being in a decoupled or detached state and the central body positioned and located between the anchors and facing opposing surfaces of anchors, the central body operates to pull and guide leaflets, using a level of force (e.g., connection force, adjustment force, etc.) up to a maximum level of force (e.g., a maximum allowable level such as a safety limit), to a single location where they are closely positioned, held, and maintained to improve their operation as an operable valve closure element.
[00552] In some implementations, as a spacer, the central body is configured with a gapfilling shape, structure and composition that obstructs gaps between leaflets to reduce regurgitation. In some implementations, the central body structure is shaped and positioned with respect to the leaflets such that, upon coaptation, opposing surfaces of the anchors, and their respective leaflets, close around the central body during appropriate portions of the cardiac cycle. In some implementations, the central body/spacer can be configured to seal against opposing surfaces of two or three anchors, and thereby against two or three nativevalve leaflets, depending in part upon the type of valve for which it is adapted. The central body/spacer can be shaped in any of a variety of shapes, as might be appropriate for the intended use. For example, the variety of shapes can include cylindrical capsule shapes, such as an elongated cylindrical shape characterized by a longitudinal cross-section that is: round, oval, ovoid, crescent shaped, or even rectangular. In some implementations, the central body can have an upstream (e.g., atrial, or upper) portion positioned in or adjacent to an atrium, a downstream (e.g., ventricular, or lower) portion positioned in or adjacent to the ventricle, and a side surface that extends between native leaflets. In some implementations, the spacer can, for example, be structured as a tubular- shaped braided wire composed of a nitinol mesh.
[00553] In some implementations, the spacer can be a compliant spacer with a low compressibility that, when mechanically compressed, compressively expands in some dimensions to be wider and/or longer (or expanding in one or more other dimensions) such that it both conforms to adjacent opposing surfaces and fills up adjacent spaces, and possibly extrudes therebeyond.
[00554] In some implementations, anchors are simultaneously inserted into the subject. In some implementations, at least some of the anchors are individually pulled to a central location by a system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, control system, etc.) having distinct and separately extending controlled tethers. This can be done with two- and three-leaflet valves and can incorporate procedures for treating/repairing three-leaflet valves using only two leaflet anchors. [00555] With reference to FIGS. 2-14, in some implementations (e.g., a simultaneously inserted, center-coupled implementation), of a treatment or repair system, a treatment or repair device 101 usable and/or for use by medical personnel in treating or repairing a subject’s native valve, is delivered through the vascular system to the valve by a delivery system for valve treatment/repair. In some implementations, the delivery system is provided with a steering catheter system including a steering catheter 103, which can operate similar to other steering catheter systems.
[00556] In some implementations, the delivery involves positioning a distal end of the steering catheter 103 upstream of the defective native valve (e.g., mitral valve MV, etc.) (relative to a blood flow direction 105) and pointing the distal end of the steering catheter downstream (in the blood flow direction) through the native valve.
[00557] In some implementations, the delivery system is provided with a delivery catheter system or implant catheter system including a delivery catheter or implant catheter 111. In some implementations, the implant catheter starts off within a steering catheter system prior to its insertion into the subject’s body. In some implementations, the implant catheter is inserted into a steering catheter system proximal end (which extends outside the subject’s body for access by a user) after the steering catheter system is positioned upstream of the native valve. In some implementations, with the steering catheter system in place and the implant catheter inserted, a distal, implantation end of the implant catheter is extended from within steering catheter system downstream toward the native valve (e.g., as depicted in FIG. 9). In some implementations, the implant catheter can be steerable. In some implementations, the implant catheter can be used without a separate steerable catheter.
[00558] At its distal end, the delivery or implant catheter 111 mounts and carries some or all portions of a device 101 (e.g., treatment device, repair device, valve treatment device, valve repair device, implantable device, implant, etc.). In some implementations, device 101 comprise two leaflet anchors, e.g., a first leaflet anchor 113 and a second leaflet anchor 115. In some implementations, each anchor has a respective leaflet- attachment mechanism (e.g., a first leaflet- attachment mechanism, and a second leaflet- attachment mechanism) in the form of an actuatable clip with independent actuators and actuation controls such that each anchor can be separately and independently affixed to respective leaflet locations. [00559] In some implementations, clip anchors can be configured such that each includes two paddles, an outer paddle 117 and an inner paddle 119. In some implementations, the two paddles are connected at one end with a hinge 120. In some implementations, these clip anchors are configured to affix to a leaflet by clipping onto a leaflet, e.g., by actuating the hinge to bite down onto, and thereby grasp, an edge of the leaflet requiring constraint for improved valve operation.
[00560] In some implementations, the device 101 also includes an anchor connector (e.g., a decouplable connector, a detachable connector, a severable connector, etc. ) for each respective anchor, e.g., a first anchor connector 121 for the first leaflet anchor 113 and a second anchor connector 123 for the second leaflet anchor 115. In some implementations, the first anchor connector forms a first anchor decouplable connections (e.g., detachable connection, severable connection, releasable connection, etc.), and a second anchor connector forms a second anchor decouplable connection (e.g., detachable connections, severable connection, releasable connection, etc.). In some implementations, the device is further provided with an optional central body 131 (e.g., a spacer, a coaptation element, a plug, a gap filler, etc.) and a centerbody connector 133. In some implementations, the center-body connector 133 is a structural fastener that forms a center-body decouplable connection (e.g., detachable connections, severable connection, releasable connection, etc.) that fastens the central body 131 to the delivery/implant catheter 111 when in a connected state or unsevered state (e.g., it restricts and/or constrains their relative movement to be in-sync).
[00561] In some implementations, the first and second connectors 121, 123 respectively form a first anchor decouplable connection and a second anchor decouplable connection that fasten their respective first and second leaflet anchors 113, 115 to the central body 131 when in a connected state or unsevered state, and thereby indirectly fasten the first and second anchor connectors to the delivery/implant catheter 111 via the central body. In some implementations, these first and second anchor decouplable connections are distinct and independent of one another in that the decoupling or detaching of one of the first anchor and second anchor connectors does not decouple or detach the connection made by the other connector (e.g., it does not release the constraint to move in-sync). Various connector technologies and/or mechanisms, such as those for decoupling or detaching implants from implant catheters (e.g., clasps, clamps, releases, ties, fasteners, loops, etc.), may be appropriate for use as the connectors or as part of the connectors. [00562] In their connected states, the connectors restrict and/or constrain relative movement from between their respective devices, typically in six degrees of freedom. For example, in its connected state, the first anchor connector restricts and/or constrains relative movement between the first leaflet anchor and the central body, typically requiring them to move in sync in six degrees of freedom. Decoupling or releasing the connector connections places them in decoupled, detached, or released states, which remove the restrictions and/or constraints on insync (relative) movement between the respective devices (as compared with their unsevered states). The removed restrictions and/or constraints are typically in six degrees of freedom, but can be in fewer degrees of freedom.
[00563] While the term “sever” in various forms is used herein, it should be understood that in the context of this application and the claims, the term “sever,” “severable,” “severing,” etc. and similar terms encompass decoupling, disconnection, detachment, removal, etc. (even if no cutting is done).
[00564] In some implementations, the treatment/repair device 101 also includes a system or mechanism, such as a controlled tether system or mechanism or other adjustment system/mechanism. In some implementations, the system includes a respective controlled tether for each anchor, e.g., a first controlled tether 141 for the first leaflet anchor 113 and a second controlled tether 143 for the second leaflet anchor 115.
[00565] In some implementations, each controlled tether is in the form of a flexible cord (e.g., a suture). In some implementations, each controlled tether is a looped tether that extendibly fastens a primary connection (being one or more points on its respective anchor) to the central body 131 (and thereby to the delivery/implant catheter 111). In some implementations, it does so by serially extending (end-to-end) from a first-end segment at a proximal end of an implant catheter of the implant catheter system to its distal (implantation) end, through and out of the central body 131 (positioned at a distal end of the implant catheter system) to the controlled tether’s respective anchor, slidably being received by and passing through (looped around) one or more anchor slidable restraints (e.g., a first anchor slidable restraint, a second anchor slidable restraint, a third anchor slidable restraint, an intermediate anchor slidable restraint and a last anchor slidable restraint) along a length of the respective anchor, back into and through and/or aside the central body and implant catheter to its proximal end, to a second-end segment at the proximal end of the implant catheter system (along with the first-end segment of the controlled tether).
[00566] In some implementations, both the first-end and second-end segments of each controlled tether are accessible by the user, either directly or using a control mechanism (e.g., one or more of a button, switch, lever, slider, knob, gear, motor, threaded component, screw, cam, gimble, etc.) for implantable devices. In use, individually and controllably the user increases the controlled tether’s slack (the tether limitation) by feeding (inserting) one or both controlled tether’s ends into the delivery/implant catheter 111 to increase the available tether length between the central body 131 and the anchor, allowing the respective anchor more relative separation in any direction from the central body. Individually and controllably, the user reduces each controlled tether’s slack by drawing (pulling) one or both controlled tethers’ ends out from the implant catheter to decrease the available tether slack between the central body and the anchor, restricting the respective anchor to less relative separation in any direction from the central body. This controllable slack provides for the anchor to move independently of the central body and implant catheter with six degrees of freedom to a controllable extent, and to be drawn back to the central body for affixing in place on the central body.
[00567] In some implementations, independent movement of the anchor is limited by a respective tether limitation that the respective anchor cannot move beyond (e.g., the tether length available for movement). That tether limitation is the degree of slack given to the respective controlled tether. In some implementations, the tether limitation changes by half the amount of controlled tether length adjusted by the user because the controlled tether loops back on itself.
[00568] Using slidable eyelet-type restraints that can be formed as part of the anchor structure, each controlled tether slidingly and/or fixedly connects to its anchor at two locations along the anchor, and slidably feeds back into the central body 131 at two locations along the central body. This two-point controlled tether connection between the anchor and central body provides better control over the relative positions of the anchor and the central body when the controlled tether slack is later removed (e.g., the controlled tether is tightened).
[00569] Prior to insertion into the subject’s body, some, or all portions of the device 101, e.g., the first and second leaflet anchors 113, 115 and/or the first anchor connector 121 (in a connected state). In some implementations, the first and second leaflet anchors 113, 115 and/or the first anchor connector 121 (in a connected state) are mounted together on the distal end of the delivery/implant catheter 111. As mounted on the implant catheter prior to insertion, the structure of these portions of the device has a structural form factor sized and shaped within the limitations imposed by the delivery system for the mounted portions to simultaneously traverse the delivery system through the subject’s vascular system (as a single implantable unit).
[00570] In some implementations, these portions of the device 101 can be structurally adapted to switch between a first, small-form-factor (e.g., small diameter) delivery configuration, and a second, operational configuration configured for treatment or repair operations (as depicted in FIG. 9). The delivery configuration is appropriate for the mounted portions of the device to traverse the delivery system through the subject’s vascular system as a single implantable unit (optionally with a delivery configuration similar to those of other systems).
[00571] In some implementations, the implant catheter includes one or more actuators that function to actuate the device 101 from the delivery configuration to the operational configuration with the device located within the subject’s heart. These actuators and their controls can be handle-type controls similar other actuators and controls (e.g., one or more of buttons, switches, levers, sliders, knobs, gears, motors, threaded components, screws, cams, gimbles, etc.) for the deployment of implants from within delivery systems.
[00572] With the delivery or implant catheter 111 extended from within steering catheter 103, pointing downstream toward the mitral valve MV, the implant catheter moves downstream into and partially or entirely through the mitral valve to the extent needed based upon the geometry of the device and the valve. If it is first delivered to the heart in a delivery configuration, either before or after passing through the mitral valve MV, the delivery/implant catheter 111 actuates the device 101 from delivery configuration to operational configuration (as depicted in FIG. 9).
[00573] As depicted in FIGS. 10-11, with the delivery/implant catheter 111 moved downstream into and through the mitral valve MV, and the device 101 actuated into the operational configuration, the user actuates the implant catheter to move the device. [00574] In some implementations, the implant catheter is moved, positioning the first leaflet anchor 113 at a first position within the heart, being located and oriented to affix the anchor (by clipping on) to a first portion of the edge of a first leaflet 151 requiring constraint for improved operation (e.g., a first portion of the edge of the anterior leaflet 20). The first leaflet anchor 113 is then actuated to attach it to the first portion of the edge of the first leaflet (e.g., the hinge 120 of the first leaflet anchor is actuated to anchor, e.g., clamp down, etc., on the leaflet edge, affixing it to the leaflet).
[00575] The anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue herein can take a variety of different forms, e.g., clamping mechanisms, clasping mechanisms, suction mechanisms, adhering mechanisms, etc. In some implementations, the anchoring systems, apparatuses, mechanism, etc. are separate and/or independent from systems, apparatuses, mechanisms, etc. for the controlled tether. In some implementations, anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue can be comparable to other anchor actuation systems, such as those that use sutures, threaded members, cams, shafts, and/or springs, etc. for controlled opening and closing of a clamp, clasp, etc. In some implementations, a clamping system, apparatus, or mechanism is used to clamp onto tissue, e.g., onto a leaflet, for anchoring.
[00576] FIG. 10A illustrates a treatment or repair device 101 that includes an example clamping mechanism 200. In some implementations, the clamping mechanism comprises a line 202, such as a suture or wire, and a biasing element 204, such as a spring, resilient member, etc. In some implementations, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 toward one another. In some implementations, the biasing element 204 biases the outer paddle 117 and the inner paddle 119 away from one another.
[00577] In some implementations, such as when the biasing element biases the outer paddle 117 and the inner paddle 119 toward one another, the line 202 can be routed such that pulling on the line moves the outer paddle 117 and the inner paddle 119 away from one another to open the paddles. In some implementations, such as when the biasing element biases the outer paddle 117 and the inner paddle 1 19 away from one another, the line 202 can be routed such that pulling on the line moves the outer paddle 117 and the inner paddle 119 toward one another to close the paddles. [00578] Once in the closed position, the relative positions of the outer paddle 117 and the inner paddle 119 can optionally be locked.
[00579] FIG. 10B illustrates an example of a clamping mechanism 300. In some implementations, the clamping mechanism 300 comprises an actuation element 302 (e.g., wire, rod, tube, shaft, suture, etc.), an optional follower 304, and a drive link 306 (e.g., strut, shaft, plate, etc.). In the illustrated example, the optional follower 304 is attached to a distal end of the actuation element 302. In some implementations, the optional follower 304 can be attached to the actuation element 302 by a fastener 307, such as a clip, nut, cap, washer, etc.
[00580] In some implementations, the drive link 306 is pivotably coupled to the optional follower 304 at a pivot axis 308. In some implementations, the follower 304 is omitted and line the drive link 306 is pivotally connected directly to the actuation element 302. In some implementations, the drive link 306 is pivotally connected to the outer paddle 117 at a pivot axis 310. In some implementations, movement of the actuation element 302 in the direction 320 moves the drive link 306, which in turn moves the outer paddle toward 117 an open condition. In some implementations, movement of the actuation element 302 in the direction 322 moves the drive link 306, which in turn moves the outer paddle toward a closed condition. An optional biasing element can bias the outer paddle 117 toward or away from the inner paddle 119. Once in the closed position, the relative positions of the outer paddle 117 and the inner paddle 119 can optionally be locked.
[00581] The first leaflet anchor 113 and the second leaflet anchor 115 can take a variety of different forms. In some implementations, the anchors 113, 115 can be configured to snap to an open position and to snap to a closed position. For example, the first leaflet anchor 113 and the second leaflet anchor 1 15 can be configured like a snap hair clip.
[00582] Referring to FIGS. 10C and 10D, in some implementations, a leaflet anchor 413 includes a first arm 417 and a second arm 419. In some implementations, the first arm 417 and the second arm 419 are formed from a single piece curved and/or bent material, such as a piece of metal or plastic that has spring-like properties. In some implementations, the first arm 417 and the second arm 419 are connected together at a closed end 430.
[00583] In some implementations, the first arm 417 and/or the second arm 419 are shape set to snap to a closed configuration (FIG. 10C) and to snap to an open configuration (FIG. 10D). In some implementations, moving the first arm 417 past a center or snap-over line 420 in the direction indicated by arrow 422 causes the leaflet anchor to snap to the closed condition illustrated by FIG. 10C. In some implementations, moving the first arm 417 past the center or snap-over line 420 in the direction indicated by arrow 424 causes the leaflet anchor to snap to the open condition illustrated by FIG. 10D.
[00584] FIGS. 10E and 10F illustrate an example of a clamping mechanism 500 that uses the leaflet anchor 413 illustrated by FIGS. 10C and 10D. In some implementations, as illustrated, the clamping mechanism 500 includes a base 502 (e.g., a frame, a coaptation element, and/or a tube, etc.) an actuation element 504 (e.g., a wire, a hypotube, a flexible shaft, etc.), and the leaflet anchor 413. The closed end 430 of the leaflet anchor 413 can be fixed to or coupled to a distal end 432 of the base 502. In some implementations, the actuation element 504 can extend through the base 502 and can be releasably coupled to the first arm 417.
[00585] Referring to FIG. 10E, in some implementations, pushing the first arm 417 with the actuation element 504 past a center or snap-over line 420 in the direction indicated by arrow 524 causes the leaflet anchor 413 to snap to the open condition. Referring to FIG. 10F, in some implementations, pulling the first arm 417 with the actuation element 504 past the center or snap-over line 420 in the direction indicated by arrow 522 causes the leaflet anchor to snap to the closed condition.
[00586] In some implementations, the first leaflet anchor 1 13 can be a separable anchor. In some implementations, with the first leaflet anchor 113 attached to the first location on the first leaflet, the user actuates a control decoupling or detaching the first anchor connector 121 and thereby releasing the first leaflet anchor from its primary connection to the implant catheter (e.g., its connection by the first anchor connector). Therefore, the central body and the implant catheter are freed to translate and rotate together in six degrees of freedom relative to the first leaflet anchor. In some implementations, the decoupling or detachment of the separably attached first leaflet anchor 113 leaves only the first controlled tether 141 loosely connecting the first leaflet anchor 113 to the delivery /implant catheter 111. Thus, they are constrained by one another only in that they cannot separate from one another by a distance farther than is allowed by the length of the slack, which is a limitation of the first anchor tether. [00587] In some implementations, the first anchor connector 121 provides for the delivery or implant catheter 111 and central body 131 to position the first leaflet anchor 113 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet, to decouple/detach/sever/release/unfasten the first leaflet anchor from the implant catheter, central body and second leaflet anchor 115. In some implementations, the delivery/implant catheter 111, central body 131 and second leaflet anchor 115 can then move separately from the first leaflet anchor 113, such as to position the second leaflet anchor 115 at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22). The second leaflet anchor 1 15 can be a separable anchor.
[00588] In some implementations, the user then gives the first controlled tether 141 adequate slack to allow the implant catheter to freely move (with the second leaflet anchor 115 still attached) to a second location (such as at a location on a second leaflet 153 requiring constraint) without pulling the first leaflet anchor 113 and the first leaflet 151 along with it, and without being detrimentally pulled and tugged upon by the motion of the first leaflet due to the operation of the heart.
[00589] In some implementations, as depicted in FIG. 12, with the delivery or implant catheter 111 extending through the mitral valve MV, the device 101 is actuated into an operational configuration. In some implementations, the first leaflet anchor 113 is affixed to the first leaflet 151, and the first anchor connector 121 is decoupled/detached/severed/unfastened/released to free the first leaflet anchor from direct attachment to the implant catheter (though it can still be indirectly attached via tethered connections to other components that can still be directly attached to the implant catheter). In some implementations, the user actuates the implant catheter to move the implant catheter and its attached portions of the device, positioning the second leaflet anchor at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22). This positioning occurs without pulling the first leaflet anchor and the first leaflet to the second leaflet.
[00590] If the first controlled tether slack is not already adequate, the user can controllably release (lengthen) slack on the first controlled tether 141 to provide for this movement without detrimental resistance from the first leaflet. This can be done by the user releasing slack on an end of the controlled tether suture at the proximal end of the implant catheter, as for other transvascular mechanisms having wires, chords, lines, etc. for control. The implant catheter can then be actuated to position the second leaflet anchor 115 at the second position. The second leaflet anchor 115 can then be actuated to attach it to the first portion of the edge of the second leaflet (e.g., the second leaflet anchor is actuated to clamp down on the leaflet edge to affix it to the leaflet).
[00591] In some implementations, with the second leaflet anchor 115 attached to the first location on the second leaflet 153, the user actuates a control causing the second anchor connector 123 to decouple/detach/sever/unfasten and thereby release the second leaflet anchor from the implant catheter. Therefore, the delivery /implant catheter 111 and central body 131 are freed to translate and rotate in six degrees of freedom relative to the second leaflet anchor 1 15.
[00592] The decoupling or detachment of the separably attached second leaflet anchor 115 leaves only the second controlled tether 143 loosely connecting the second leaflet anchor to the implant catheter. Thus, they are constrained by one another only in that they cannot separate from one another by a distance farther than is allowed by the length of the slack, which is a limitation of the first anchor tether.
[00593] In some implementations , the second anchor connector 123 provides for the delivery or implant catheter 111 to first position the second leaflet anchor 115 for affixing to a second leaflet 153, and then, after the second leaflet anchor is affixed to the second leaflet, to decouple/detach/unfasten/sever and thereby release the second leaflet anchor 115 from attachment directly to the implant catheter (within the limits allowed by the slack in the second controlled tether 143). The delivery/implant catheter 111 can then move separately from the second leaflet anchor 115, such as to position the implant catheter and central body 131 at location central to the leaflets.
[00594] In some implementations, the system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, control system, etc.) is configured such that a user can give the second controlled tether 143 adequate slack to allow the implant catheter to freely move to a location between the leaflets without pulling either the first leaflet anchor 113 and the first leaflet 151, or the second leaflet anchor 1 15 and second leaflet 153, along with it (and without being detrimentally pulled and tugged upon by the heartbeat-driven motion of the first and second leaflets due to the heart activity).
[00595] In some implementations, as depicted in FIG. 13, the delivery or implant catheter 111 and central body 131 are configured such that they can be manipulated by a user to be positioned at a coaptation location between the leaflets. This positioning occurs without pulling the second leaflet anchor and the second leaflet to the coaptation location. Once the delivery/implant catheter 111 is at the coaptation location, one or more controls (e.g., handle controls, buttons, knobs, switches, sliders, gears, other controls, etc.) can be actuated at the proximal end of the delivery system, e.g., on a handle. In some implementations, the controls respectively tighten the first and second controlled tethers 141, 143, to shorten and remove their respective slack. The controls can be configured to controllably tighten one controlled tether at a time, or all controlled tethers at once.
[00596] While the location of the distal end of the delivery/implant catheter 111 will establish a location towards which the first and second leaflets 151, 153 are drawn, the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual location where the resulting device 101 (e.g., the pair of anchors and the central body) will end up. Based on the attachment of the respective controlled tethers, each anchor will define an opposing surface that can be drawn closer and/or into contact with the central body.
[00597] With the first and second leaflet anchors 113, 115 connected to the delivery/implant catheter 111 and central body 131 (e.g., in contact with, closer to, etc.), and thereby connected to one another, an anchor-lock locking mechanism locks the anchors into position (or region) relative to the central body and one another, thereby constraining relative movements of the first leaflet anchor, the second leaflet anchor, and the central body. In some examples, this entails holding the anchors and central body in contact and stationary (e.g., completely stationary, mostly stationary, portions (e.g., connected surfaces) are completely stationary while other portions/extensions can move, etc.) relative to each other. A variety of structural/mechanical locking mechanisms can be used as the anchor-lock to effectuate this locking of the anchors. For example, the central body can be provided with one or more locks that structurally mate and interlock with each tethered anchor to lock them in position. [00598] In some implementations, the first and second anchor connectors 121, 123 can be configured to act as all or part of the anchor-lock locking mechanism. In some implementations, the anchors can be configured with locking mechanisms that lock directly to one another to form the anchor-lock. In some implementations, segments of the first and second controlled tethers 141, 143 can be cut off and used as part of the anchor-lock to lock the first and second leaflet anchors 113, 115 into position with respect to the central body and/or one another. In some implementations, distal segments of the tightened controlled tethers are actuated (e.g., pulled), thereby tensioning or pulling on the anchors to cinch them toward the central body (and thereby moving the anchors together toward one another and/or into contact with each other and/or with another portion of the device, e.g., a central body, spacer, etc.). In some implementations, the actuated controlled tethers can be locked together to lock the anchors into their relative positions, and then the distal segments of the controlled tethers can be decoupled/detached/severed/cut/etc. from their respective remaining (proximal) controlled tether segments (and from the implant catheter) to permanently leave the distal segments holding the anchors in their fully connected (e.g., in contact) relative positions. The term “cinch” includes pulling and/or tightening.
[00599] In some implementations, once the first and second leaflet anchors 113, 115 are locked into position with respect to the central body 131 and one another, the first and second controlled tethers 141, 143 and the delivery/implant catheter 111 are disconnected from the device 101 and removed from the subject’s body (see, FIG. 14). In some implementations, the second-end segment of each controlled tether is freed to advance into the delivery/implant catheter (to pass up through the anchor slidable restraints and then back down the implant catheter) while the first-end segment is continuously pulled from the implant catheter until the full length of the controlled tether comes out of the delivery/implant catheter. In some implementations, where distal segments of the controlled tethers were cut from proximal segments, each proximal segment may need to be individually pulled from the implant catheter.
[00600] With all of the controlled tethers (or segments thereof) removed, a control can be actuated causing the center-body connector 133 to decouple/detach/sever/unfasten, releasing the central body from the delivery or implant catheter (if the central body is the last component released from the implant catheter, the entire device can then be decoupled or released from the delivery or implant catheter). When fully released, the central body 131 and connected locked anchors are completely freed to translate and rotate in six degrees of freedom with the leaflets. Finally, the delivery system can be removed from the subject.
[00601] By making one or more inserted anchors separable from one another (and the rest of the implant) prior to leaflet attachment, anchors can be attached to leaflets without resistance from other previously attached anchors. The device can be placed without suffering the difficulties that may be caused by leaflets having excessive spacing and movement relative to one another.
[00602] The devices and/or systems herein can comprise a wide variety of simultaneous, center-coupled implementations, some of which are expressly described herein. To the extent appropriate (e.g., can be implemented), these are also envisioned for use with other implementations. For example, other implementations can include combinations or subcombinations of the features and components disclosed for the implementations below.
[00603] In some simultaneously inserted center-coupled implementations, the device can include three or more anchors. In some implementations, a treatment/repair device is provided with three anchors, at least two of which are separably attached to a central body. This is particularly advantageous when implanted to improve the operation of a valve with three leaflets, such as the tricuspid, aortic and pulmonary valves.
[00604] In FIGS. 15-20, an example simultaneously inserted center-coupled implementation with three anchors is depicted during implantation in a tricuspid valve TV. Unless indicated otherwise, elements of the device are substantively the same as similarly named items in the earlier referenced implementations. Where possible, reference numbers are incremented by 100 from the related center-coupled implementation.
[00605] In some implementations, device 201 (e.g., treatment device, repair device, valve treatment device, valve repair device, implantable device, implant, etc.) is delivered through the vascular system to the tricuspid valve TV by a delivery system for valve treatment or repair having similarities to the center-coupled implementation. An implant catheter is inserted into the subject’s body and extended downstream toward the tricuspid valve. At its distal end, the implant catheter carries the device 201, which includes three anchors, a first leaflet anchor 213, a second leaflet anchor 215, and a third leaflet anchor 217, each with a leaflet-attachment mechanism in the form of an actuatable clip configured to clip on to the edge of a leaflet that requires constraint for improved valve operation (e.g., a third leaflet-attachment mechanism).
[00606] In some implementations, the device 201 also includes a connector for each anchor, e.g., a first anchor connector, a second anchor connector, and/or a third anchor connector. In some implementations, the device is further provided with an optional central body 231, and a center-body connector rigidly fastening the central body to the implant catheter. In some implementations, the first, second and third anchor connectors are configured to fixedly and/or rigidly fasten their respective anchors to the central body 231 in six degrees of freedom, and thereby indirectly rigidly fasten them to the implant catheter via the central body.
[00607] The device 201 also includes a first controlled tether 241, a second controlled tether 243, and/or a third controlled tether 245, each in the form of a flexible suture. Each controlled tether fastens its respective anchor to the central body 231 , and thereby the implant catheter. Each controlled tether can controllably be given slack for the anchor to move independently of the central body and implant catheter, being limited by a respective tether limitation (slack), being the tether length available for movement. Each controlled tether slidingly and/or fixedly connects to its anchor at two locations along the anchor, and to the central body 231 at two locations along the central body.
[00608] In some implementations, each controlled tether is a looped tether that extendibly fastens a primary connection (being one or more points on its respective anchor) to the central body 131 (and thereby to the delivery/implant catheter 111). It can be done by serially extending (end-to-end) from a first end (e.g., a third controlled-tether first-end segment) at a proximal end of the implant catheter system to its distal (implantation) end, through and out of the central body 131 (positioned at a distal end of the implant catheter system) to the controlled tether’ s respective anchor, slidably being received by and passing through (looped around) one or more slidable restraints along a length of the respective anchor, back into and through and/or aside the central body and implant catheter to its proximal end, to a second end (e.g., a third controlled-tether second-end segment) at the proximal end of the implant catheter system (along with the first-end segment of the controlled tether).
[00609] The device 201 can optionally be structurally configured with a first, small-form- factor delivery configuration and a second, operational configuration configured for valve treatment or repair operations. In some implementations, a small-form-factor, side-by-side serial delivery configuration (e.g., spaced at 120° angles) might be slim enough to pass through a transvascular catheter system. In others, a more complex delivery configuration might be necessary.
[00610] With the implant catheter extended from within steering catheter system, pointing downstream toward the tricuspid valve TV, the implant catheter moves downstream into and partially or entirely through the tricuspid valve to the extent needed based upon the geometry of the device and the valve. If it is first delivered to the heart in a delivery configuration, either before or after passing through the tricuspid valve TV, the implant catheter can actuate the device 201 from a delivery configuration to an operational configuration.
[00611] As depicted in FIG. 16, with the implant catheter moved downstream into and through the tricuspid valve TV, and the device 201 actuated into the operational configuration, the implant catheter can be actuated to move the implant catheter and the device, positioning the first leaflet anchor 213 at a first position within the heart, being located and oriented to grasp a first portion of the edge of a first leaflet 251 requiring constraint for improved operation. The first leaflet anchor 213 can then be actuated to attach it to the first portion of the edge of a first leaflet.
[00612] With the first leaflet anchor 213 attached to the first leaflet 251, the first anchor connector can be decoupled/detached/severed/unfastened to release the first leaflet anchor from the implant catheter. The central body 231 and implant catheter can be freed to translate and rotate together relative to the first leaflet anchor 213. The decoupling or detachment of the separably attached first leaflet anchor 213 leaves only the first controlled tether 241 loosely connecting the first leaflet anchor 213 to the implant catheter.
[00613] The first anchor connector provides for the implant catheter and central body 231 to position the first leaflet anchor 213 in a correct position for affixing to the first leaflet 251, and then after the first leaflet anchor is affixed to the first leaflet, to unfasten and release the first leaflet anchor from the implant catheter, central body, second leaflet anchor 215 and third leaflet anchor 217. The implant catheter, central body 231, second leaflet anchor 215 and third leaflet anchor 217 can then move separately from the first leaflet anchor 213 to position the second leaflet anchor 215 at a second position within the heart to grasp a first portion of the edge of a second leaflet 253 requiring constraint for improved operation.
[00614] As depicted in FIG. 17, the first controlled tether 241 can be given adequate slack to allow the implant catheter to freely move to a second location at a second leaflet 253 without pulling the first leaflet anchor 213 and the first leaflet 251 along with it. The implant catheter and the attached portions of the device can be moved to a second position within the heart, positioning (locating and orienting) the second leaflet anchor to grasp a first portion of the edge of a second leaflet 253 requiring constraint for improved operation.
[00615] If the first controlled-tether slack is not already adequate, the slack can be controllably released on the first controlled tether 241 to provide for this movement without detrimental resistance from the first leaflet. The implant catheter can be actuated to position the second leaflet anchor 215 at the second position. The second leaflet anchor 215 can be actuated to attach it to the first portion of the edge of the second leaflet.
[00616] With the second leaflet anchor 215 attached to the second leaflet 253, the second anchor connector can be decoupled/detached/severed/unfastened to release the second leaflet anchor from the implant catheter. In some implementations, the decoupling or detachment of the separably attached second leaflet anchor 115 leaves only the second controlled tether 143 loosely connecting the second leaflet anchor to the implant catheter.
[00617] In some implementations, the second anchor connector provides for the implant catheter and central body 231 to position the second leaflet anchor 215 in a correct position for affixing to a second leaflet 253, and then after the second leaflet anchor is affixed to the second leaflet, to unfasten and release the second leaflet anchor from the implant catheter, central body 231 and third leaflet anchor 217. The implant catheter, central body and third leaflet anchor can then move separately from the second leaflet anchor 215 and the first leaflet anchor 213 to position the at a third position within the heart to grasp a first portion of the edge of a third leaflet 255 requiring constraint for improved operation.
[00618] As depicted in FIG. 18, the second controlled tether 243 can be given adequate slack to allow the implant catheter to freely move to a third location at a third leaflet 255 without pulling the first leaflet anchor 213 and the first leaflet 251 , or the second leaflet anchor 215 and the second leaflet 253, along with it. The implant catheter and portions of the device can be moved to a third position within the heart, positioning (locating and orienting) the third leaflet anchor to grasp a first portion of the edge of a third leaflet 255 requiring constraint for improved operation.
[00619] If the first controlled-tether slack and second controlled-tether slack are not already adequate, slack on the first controlled tether 241 and second controlled tether 243 can be controllably released to provide for this movement without substantial detrimental resistance from the second leaflet 253. The implant catheter can be actuated to position the third leaflet anchor 217 at the third position. The third leaflet anchor 217 can be actuated to attach it to the first portion of the edge of the third leaflet.
[00620] With the third leaflet anchor 217 attached to the third leaflet 255, the third anchor connector can be decoupled/detached/severed/unfastened to release the third leaflet anchor from the implant catheter. In some implementations, the decoupling or detachment of the separable third leaflet anchor leaves only the third controlled tether 245 loosely connecting the third leaflet anchor to the implant catheter.
[00621] In some implementations, the third anchor connector provides for the implant catheter to first position the third leaflet anchor 217 for affixing to a third leaflet 255, and then, after the third leaflet anchor is affixed to the third leaflet, to decouple/detach/sever/unfasten and thereby release the third leaflet anchor 217 from the implant catheter (within the limits allowed by the slack in the third controlled tether 245). The implant catheter can then move separately from the third leaflet anchor 217, such as to position the implant catheter and central body 231 at location central to the leaflets.
[00622] As depicted in FIG. 19, the third controlled tether 245 can be given adequate slack to allow the implant catheter to freely move to a location (e.g., a central location, a commissural location, etc.) between the leaflets without pulling either the first leaflet anchor 213 and the first leaflet 251, the second leaflet anchor 215 and second leaflet 253, or the third leaflet anchor 217 and third leaflet 255 along with it.
[00623] In some implementations, the implant catheter and central body 231 are then positioned at a coaptation location between the leaflets (e.g., a central location, a commissural location, etc.). Once the implant catheter is at the coaptation location, the user actuates controls (e.g., one or more handle controls, buttons, knobs, switches, touchscreens, etc.) to respectively tighten the first, second and third controlled tethers 241, 243, 245, to shorten and remove (or reduce) their respective slack. The leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the location where the resulting device 201 (e.g., the connected anchors and the central body) will end up.
[00624] As depicted in FIG. 20, with the first, second and third leaflet anchors 213, 215, 217 connected to (e.g., in contact with) the central body 231. The anchors can be locked into position (or relative regions) with respect to the central body and one another. A variety of mechanisms can be used to effectuate this locking of the anchors. For example, as part of the anchor-lock, the central body can be provided with one or more mechanical locks (e.g., clips, clamps, portions that structurally mate, interlocking portions, etc.) to lock each tethered anchor in position and/or relative to each other. In some implementations, these are locked into contact and/or stationary relative to each other (e.g., completely stationary, mostly stationary, with portions that are stationary (e.g., contact surfaces) and other portions (e.g., extensions) that can move somewhat, etc.)
[00625] Optionally, the anchor connectors can be configured to act as all or a part of the anchor-lock. Optionally, the anchors can be configured with mechanical locks that lock directly to one another as part of the anchor-lock. Optionally, distal segments of the first, second and third controlled tethers can be cut off and used as part of the anchor-lock to lock the first, second and third leaflet anchors 213, 215, 217 into position with respect to the central body and/or one another. In some implementations, distal segments of the tightened controlled tethers are cinched together toward the central body and one another, and then decoupled/detached/severed/released from their respective remaining proximal segments (and the implant catheter) to permanently hold the anchors in their final connected positions.
[00626] In some implementations, with the first, second and third leaflet anchors 213, 215, 217 locked into position with respect to the central body 231 and one another, the first, second and third controlled tethers 241, 243, 245 and the implant catheter are disconnected from the device 201 and removed from the subject’ s body (see, FIG. 14). More particularly, the second- end segment of each controlled tether is freed to advance into the implant catheter (to pass up through the anchor slidable restraints and then back down the implant catheter) while the first- end segment is continuously pulled from the implant catheter until the full length of the controlled tether comes out of the implant catheter. [00627] In some implementations, once the first, second and third leaflet anchors 213, 215, 217 are locked into position with respect to the central body 231 and one another, the implant catheter is disconnected from the device 201 and removed from the subject’s body. Therefore, the central body 231 and the three attached anchors are freed to translate and rotate with the valves in six degrees of freedom.
[00628] By making one or more inserted anchors separable from one another (and the rest of the implant) prior to leaflet attachment, anchors can be attached to leaflets without resistance from other previously attached anchors. The device was placed without suffering the difficulties caused by leaflets having excessive spacing and movement.
[00629] While the described 3 -anchor implementation connects three leaflets on a tricuspid valve, other scenarios are also within the scope of this disclosure. For example, on a mitral valve (or any three-leaflet valve), two of the three anchors can be attached to a first leaflet while the third leaflet anchor is attached to a second leaflet. During the process of implanting, the anchors can be attached alternately to the two leaflets (e.g., to the first leaflet, then to the second, then again to the first), or the single-anchor leaflet can be attached to its anchor either before or after the leaflet with two anchors. Advantageously, this can offer additional structural support to a damaged leaflet at risk of further structural failure, and/or better attachment to a leaflet having characteristics indicating poor anchor-attachment characteristics. In some implementations, two anchors on one leaflet can be placed adjacent to each other on the leaflet (e.g., in contact, etc.) or can be placed spaced apart along the leaflet.
[00630] Using two anchors on one leaflet (which can be done with any devices herein having only two anchors, devices having three anchors, and/or devices having more anchors) and bringing them closer together can plicate a portion of the leaflet, which could help treat various leaflet issues, e.g., prolapse, etc.
[00631] With reference again to FIGS. 9-14, in some simultaneously inserted center-coupled implementations, the second leaflet anchor 115 can be inseparably connected to the central body 131 (e.g., connected to the central body without the use of a controllable anchor connector such that the second leaflet anchor cannot be controllably separated from the central body while within the body of a subject). In some implementations, this inseparably connected anchor is still separably connected to the delivery/implant catheter 111, in that the central body 131 is separably connected to the implant catheter. In some implementations, the first leaflet anchor 113 is separably connected to the central body 131 by a first anchor connector 121.
[00632] In some implementations, the first anchor connector 121 still provides for the delivery or implant catheter 111 to position the first leaflet anchor 1 13 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet 151, to decouple/detach/sever/unfasten and thereby release the first leaflet anchor from the implant catheter, central body 131 and second leaflet anchor. The delivery/implant catheter 111 and central body 131 can then separate and move away from the first leaflet anchor 1 13, such as to position the second leaflet anchor 115 at a second position within the heart, where it can be attached to the first portion of the edge of the second leaflet 153.
[00633] In some implementations, such as with the second leaflet anchor 115 attached by a non-severable-connector (e.g., a connector that is not a severable connector), the location of the second leaflet 153 is used as a coaptation location (to the extent that the catheter remains rigidly in place). In some implementations (e.g., as described previously), the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual location where the resulting device 101 will end up once the anchors are locked into position with respect to the central body (and one another), and the delivery/implant catheter 111 is disconnected from the de vice 101.
[00634] Center-coupled implementations with multiple or all anchors separable can provide the user with a greater flexibility in the choice of which anchor attaches to which leaflet. Nevertheless, implementations with one or more anchors that are inseparable can provide benefits in the form of procedural simplicity of fewer connectors to decouple/detach/sever and fewer anchors to lock into position (with respect to the central body). These can also benefit from the cost and size advantages of a less complicated structure.
[00635] When combined three or more anchors, one anchor might be inseparable while the others are separable. In some implementations, two or more anchors might be inseparable while at least one is separable. In some implementations, greater flexibility during use is emphasized, e.g., with two separable anchors. In some implementations, the cost and size of a less complicated structure can be emphasized, e.g., with non or only one anchor separable. [00636] In some simultaneously inserted center-coupled implementations, the system (e.g., controlled tether system, tether system, etc.) includes one or more multi-anchor controlled tethers that each have an anchor-tether section with a plurality of anchor-tether segments (e.g., a first anchor-tether segment, a second anchor-tether segment and a third anchor-tether segment), each anchor-tether segment extending from an anchor-tether segment connection point (or a plurality of anchor-tether segment connection points) on the anchor-tether section to a respective one of the anchors having anchor connectors (thereby joining the anchor-tether segments). In forming the anchor-tether section, the anchor-tether segments can be connected at the connection points with connection mechanisms, or they can be unitary (e.g., form a unitary tether that is unitary at their connection points in their original formation). The connection points can be located at or within the central body prior to and/or after the anchor connectors are decoupled/detached/severed.
[00637] In some implementations, the system is a controlled tether system that includes an extension-tether section that is configured to extendibly fasten a primary connection point of the anchor-tether segments (and thereby to connect to their respective anchors) to the delivery/implant catheter 111 (optionally through central body 131). In some implementations, to removably make this connection, the extension-tether section serially extends (end-to-end) from an extension-tether first-end segment at a proximal end of the implant catheter system (protruding from a proximal, user end of the implant catheter), down along (through or aside) the implant catheter to its distal (implantation) end, into the central body 131 positioned at a distal end of the implant catheter, slidably received by and connecting to (loopingly passing around/through) the primary connection point of the anchor-tether segments, back out of the central body, back along (through or aside) the implant catheter to its proximal end, to an extension-tether second-end segment at the proximal end of the implant catheter system (protruding from the proximal, user end of the implant catheter system along with the extension-tether first-end segment of the extension-tether section).
[00638] In some implementations, the connection is formed between the extension- tether section and the primary connection point of the anchor- tether segments by an intermediate segment of the extension-tether section looping around the primary connection point of the interconnected anchor-tether segments. This configuration provides for the extension-tether section to be slidingly disconnected from the interconnected anchor-tether segments (by pulling on one end of the extension-tether section) once the anchor-lock constrains relative movement of the connected leaflet anchors.
[00639] In some simultaneously inserted center-coupled implementations, the controlled tethers do not extend end-to-end from the catheter proximal end to their anchors and back. Instead, each controlled tether (e.g., the first controlled tether) extends end-to-end from a first tether end (e.g., a first controlled- tether first-end segment) at a proximal end of the implant catheter system (protruding from a proximal, user end of the implant catheter), down along (through or aside) the implant catheter to its distal (implantation) end, through and out of the central body 131 positioned at (and separably connected to) a distal end of the implant catheter system, to the controlled tether’ s respective anchor.
[00640] In some implementations, at the controlled tether’s respective anchor, the controlled tether is affixed to the controlled tether’s respective anchor. Thus, the first controlled tether serially extends from a first controlled- tether first-end segment at a proximal end of the implant catheter system, through a center-body slidable restraint on a central body separably attached to a distal end of the implant catheter system (by a center-body connector), to a first controlled- tether second-end segment affixed to the controlled tether’ s respective anchor.
[00641] In some implementations, at the controlled tether’s respective anchor, it is slidably received by and passes through one or more slidable restraints along a length of the respective anchor, and then back to the central body, to which it fixedly connects. In some implementations, the first controlled tether serially extends from a first controlled-tether first- end segment at a proximal end of the implant catheter system, through a center-body slidable restraint on a central body separably attached to a distal end of the implant catheter system (by a center-body connector), through a slidable restraint on the controlled tether’s respective anchor (e.g., a first slidable restraint on a first leaflet anchor, back to a first controlled-tether second-end segment affixed to the central body.
[00642] In some implementations, each controlled tether can slidingly connect to its respective anchor at one or more locations along the anchor. In some implementations, each tether slidingly connects to the central body 131 at one location along the central body, and to the respective anchor at two locations (as depicted in FIGS. 12-13). This provides a two-point tether connection between each respective anchor and the central body to limit the orientation of the anchor when connected (e.g., when in contact with each other and/or with the central body).
[00643] In some implementations, while the anchor-affixed and center-body-affixed versions reduce both the overall required length of tether required, and the total number of tether ends extending from the proximal end of the implant catheter, some form of tether severing mechanism (e.g., a tether cutter) may be needed to separate one or more tether segments at the distal end of the controlled tether. The severing of the controlled tethers leaves one or more proximal tether segments for removal from the subject after implantation is complete. The tether cutter can be configured to individually cut each controlled tether, or it can be configured to cut all controlled tethers (that need to be cut) at once.
[00644] In some simultaneously inserted center-coupled implementations, rather than being in the form of a fully flexible cord such as a suture, one or more of the controlled tethers can be in a less flexible form, such as a mechanism or shaft having its bending and torsional flexibility selectively established to allow more flexibility in some degrees of freedom than in others. While limiting free independent movement of the anchors during the relevant periods of implantation, this form of controlled tether might provide some normalizing force to limit the movement and orientation of the anchors with respect to one another and the central body to limit complications from the ebb and flow of the blood during implantation. In some implementations, slack describes the extent to which the controlled tether can flexibly allow movement within its moveable degrees of freedom.
[00645] In some simultaneously inserted center-coupled implementations, the anchor is a T- shaped toggle anchor.
[00646] With reference to FIGS. 20-21, while center bodies of various implementations can be provided with a coaptation element or spacer in a variety of forms, e.g., such as a tubular braided wire formed of a nitinol mesh, a molded component, etc. In some center-coupled implementations, the central body 261 can be a spacer. In some implementations, the spacer can be a resilient spacer, e.g., a spacer formed of a pliant body (material and structure) having a functionally low pliant compressibility with respect to obstructed blood flow, etc. This pliant body can be made of a variety of materials, e.g., a rubber-like material and/or material structure (e.g., combination of materials), having elastomeric properties providing a viscous-like behavior of low rigidity / high fluidity that leads to deformation rather than compression under a compressive load, wherein the body substantially resumes its original shape when a deforming force is removed). As such, this resilient spacer can be formed as a relatively incompressible, pliant, unitary body that is moldable under compression without significant loss of volume. Example materials can include elastomers such as a medical grade silicone, such as would be appropriate for cosmetic medical use, e.g., polymers that are non-reactive, flexible, temperature-resistant, water-resistant, and biocompatible.
[00647] A functionally low pliant compressibility with respect to obstructed blood flow of a pliant body can comprise a combination of an adequate level of pliancy, and a low enough level of compressibility, to provide for a medically relevant dimensional expansion of the pliant body into the blood flow in response to a functionally available level of force from the mechanism moving the anchors into contact with the spacer (or another type of central body). In some implementations, this can be a force leading to a dimensional expansion that has a medically significant effect on the regurgitation of blood when the pliant body is compressed with a force available from the system and/or mechanism for moving the anchors into contact with and compressing the spacer.
[00648] In some implementations, when compressed with a force between opposing surfaces of the anchors, the resilient spacer is pliant enough to conform to the shape of the anchors, and it is incompressible enough to dimensionally expand to fill in gaps therebetween and (generally) protrude out from between the anchors to the extent the coaptation forces are at a high enough level. This expansion both compliantly maintains the relative positions of the anchors, and can provide a flow-blocking obstruction to prevent or inhibit regurgitation through the valve.
[00649] In some implementations, the pliability of the resilient spacer also provides for the resilient spacer to conformingly hold the anchors in positions relative to one another such that they have a less-than-rigid connection to one another. Therefore, the anchors can move relative to one another in response to forces applied to them by the leaflets and blood flow. Thus, the resilient spacer central body can provide for connected anchors (e.g., anchors in contact with the spacer, central body, etc.) to move relative to one another, thereby adapting to the blood flow and natural movement of the leaflets during the cardiac cycle. [00650] In some implementations, the resilient spacer material and structure is not simply adapted to be clamped down into a squished shape of reduced volume and dimensions (like existing spacers). Instead, it is sized, structurally formed, and shaped such that when it is mechanically compressed between the anchors, it compressively expands its dimensions to bulge outward and be wider and/or longer than its uncompressed shape. Thereby, potentially the resilient spacer extrudes to extend beyond the anchor opposing surfaces (e.g., in a balloonlike fashion) to fill spaces adjacent to and beyond the boundaries of the anchors in response to forces (e.g., compression forces, actuation forces, movement forces, connection forces, etc.) that are available from the system and/or mechanism (e.g., connection system adjusting connection and position between the anchors and spacer). This effect can occur because of the material and structure’s typically unitary form (e.g., it is not simply a flexible mesh on a frame) and functionally low compressibility.
[00651] In some implementations, when the first, second and third leaflet anchors 213, 215, 217 are drawn to the compliant central body 261 by their respective controlled tethers, the controlled tethers are pulled with a centering force adequate to force the anchors to act as compressive bodies that deform the compliant central body to fill all voids between the anchors, and typically, to protrude past the boundaries of the anchors into the space between the leaflets. In doing so, the leaflets are also drawn further together, which further improves the seal. In some implementations, the anchors are attached to a structural part of the compliant central body directly via the controlled tethers. The structural part can be a central, shaft-shaped catheter around which the spacer forms a pliant periphery.
[00652] Advantageously, this compliant central body allows leaflets to function and move relative to one another more normally during valve operation, particularly as compared to devices that do not use a central body, or ones that use a central body that rigidly hold leaflets.
[00653] The above-described apparatus and systems provide and/or can be used in one or more methods for treating/repairing a native valve of a subject (e.g., a living subject, a simulation, etc.), the valve having a plurality of leaflets (e.g., a first leaflet and a second leaflet, and in some cases a third leaflet). In some implementations, the method entails providing a treatment or repair device 101 mounted at a distal end of a delivery catheter or implant catheter 111. The methods can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc. [00654] In some implementations, the device 101 includes the first leaflet anchor 113, the second leaflet anchor 115, the first anchor connector 121, and/or the system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, etc.). In some implementations, the first anchor connector forms a decouplable/detachable/severable connection between the first leaflet anchor 113 and the delivery or implant catheter 111. In some implementations, the second leaflet anchor is connected to the implant catheter independently of the first anchor connector. In some implementations, the system is actuatable to move the first and second leaflet anchors closer together and/or into contact (e.g., with each other and/or with an optional central body, coaptation element, or spacer), even with the first connection decoupled or detached (e.g., in its decoupled state, detached state, or severed state).
[00655] In some implementations, the method includes the steps of delivering the treatment/repair device mounted on the implant catheter to the valve, positioning the first leaflet anchor 113 at the first leaflet, attaching the first leaflet anchor to the first leaflet, decoupling/detaching/severing the first anchor connector 121, positioning the second leaflet anchor 115 at the second leaflet, attaching the second leaflet anchor to the second leaflet, connecting the first and second leaflet anchors, and releasing the device 101 from the implant catheter.
[00656] In some implementations, the first anchor connector 121 is decoupled/detached/severed after the first leaflet anchor 113 is attached to the first leaflet. In some implementations, the second leaflet anchor 115 is in turn positioned at the second leaflet after the first anchor connector is decoupled/detached/severed. Once the second leaflet anchor is positioned at the second leaflet, the second leaflet anchor can be attached to the second leaflet.
[00657] In some implementations, after the first and second leaflet anchors are attached to the respective first and second leaflets (and the first anchor connector 121 is decoupled/detached/severed), the first and second leaflet anchors are moved closer together and/or into contact (with each other and/or another portion of the device) using the system (e.g., controlled tether system, tether system, coaptation system, connection system, actuation system, control system, etc.). In some implementations, once they are connected and/or moved into a desired relative position, the device 101 is released from the implant catheter. [00658] In some implementations, this method can include the use of the anchor-lock. In some implementations, the device 101 includes the anchor-lock, which has a locking mechanism that locks the relative positions of the first and second leaflet anchors (with respect to one another). In some implementations, after the first and second leaflet anchors are connected (e.g., in contact, connected to each other via contact with another portion or central body, etc.), the first and second leaflet anchors are locked in their relative positions with respect to one another using the anchor-lock.
[00659] In some implementations, the system can originally be provided without adequate slack for the second leaflet anchor 115 to be positioned at the second leaflet without interference from the connection to the first leaflet. The method can further include controllably releasing slack on the system. In some implementations, this will generally occur after the step of decoupling/detaching/severing the first anchor connector 121, and before the step of attaching the second leaflet anchor to the second leaflet.
[00660] In the case of a valve with three leaflets, the device 101 can include the second anchor connector forming a decouplable/detachable/severable connection between the second leaflet anchor 115 and the implant catheter. In some implementations, a third leaflet anchor is connected to the implant catheter independently of the first and second anchor connectors, and the system is actuatable to move the first, second and third leaflet anchors closer and/or into contact (with each other and/or another portion of the device, e.g., a central body, spacer, edge, surface, etc.) after the first and second decouplable/detachable connections are decoupled/detached/severed.
[00661] In some implementations, after the second leaflet anchor 115 is attached to the second leaflet (of the three leaflets), the second anchor connector is decoupled/detached/severed. In some implementations, the third leaflet anchor is positioned at the third leaflet, and the third leaflet anchor is attached to the third leaflet. In some implementations, in the step of moving, the first, second and third leaflet anchors are moved closer to and/or into contact with one another (or with another portion of the device).
[00662] In some implementations of the methods in which the various systems, devices, apparatuses, etc. herein can be used, including without limitation in the above-described method for treating/repairing a native valve of a subject (e.g., a living subject, a simulation, etc.), the various systems, devices, apparatuses, etc. herein can include one or more anchors that are detached from leaflets and/or reattachable to leaflets, and the methods can include detaching one or more anchors from one or more leaflets and/or reattaching one or more anchors to one or more leaflets.
[00663] In some implementations, after an anchor connector is decoupled/detached/severed, the system (e.g., controlled tether system, tether system, coaptation system, actuation system, connection system, control system, etc.) can be used to connect the respective leaflet anchor to the implant catheter. In some implementations, the implant catheter can be used to reposition the respective anchor with respect to its leaflet (or another leaflet). In some implementations, the leaflet anchor can then be attached in that new position, and the method can proceed as before.
[00664] In some implementations, the method further can include moving the first leaflet anchor and the implant catheter using the system, detaching the first anchor connector from the first location (e.g., detaching from tissue at a first location), and attaching the first leaflet anchor at another location (e.g., a different tissue location).
[00665] The methods described above can be performed on a living subject or on a simulation, such as on a cadaver, cadaver heart, simulator (e.g., with the body parts, heart, tissue, etc. being simulated), etc.
[00666] In some implementations, each of a plurality of leaflet anchors is consecutively inserted into the subject, some of which (a plurality) are separately pulled (independently from one another) toward and to a central body by distinct controlled tethers. Additional details of these implementations can be drawn from similar aspects of the first (simultaneously inserted, center-coupled) implementation. These consecutively inserted implementations are applicable to two- and three-leaflet valves (as is further described) and can incorporate presently used procedures for repairing three-leaflet valves using only two leaflet anchors.
[00667] FIGS. 22-27 illustrate an example of a valve repair system 2200 that includes a valve repair device 2201 with a plurality of tethered anchors 2221 that are controlled by a single actuator 2250. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 2201 includes a central body 2231, a plurality of tethered anchors 2221 , and an actuator end 2251. [00668] The central body 2231 can take a variety of different forms. In some implementations, the central body 2231 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 2231 includes a bore or passage 2235 that a shaft 2253 of the actuator end 2251 extends through.
[00669] The plurality of tethered anchors 2221 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 22-27, the anchors each include a paddle 2215 and an optional gripping member 2233, such as a clasp. In some implementations, a paddle alone can be secured to a native valve leaflet and the optional gripping member 2233 can be omitted.
[00670] The paddle 2215 can take a variety of different forms. In some implementations, the paddle 2215 can be any of the paddles disclosed by the present application. In some implementations, the paddle 2215 includes an inner arm 2260 and an outer arm 2262. The outer arm 2262 can be pivotally and/or flexibly coupled to the inner arm 2260. The outer arm 2262 can move between a closed position (FIG. 22) and an open position (FIG. 24).
[00671] In some implementations, the outer arm 2262 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position and the actuator 2250 moves the outer arm to the open position against the bias. In some implementations, the outer arm 2262 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position and the actuator 2250 moves the outer arm to the closed position against the bias. In some implementations, the outer arm 2262 is not biased open or closed.
[00672] In some implementations, the outer arm 2262 is opened and/or closed by moving the actuator end 2251. The outer arm 2262 can be opened and/or closed by the actuator end in a variety of different ways. In some implementations, an arrangement that allows all paddles 2215 that are against the central body 2231 to be opened and/or closed by the single actuator end 2251 can be used.
[00673] In the example illustrated by FIGS. 22-26, the outer arm 2262 includes an actuation extension or link 2264. In some implementations, the actuation extension or link 2264 can be configured such that engagement of the actuation extension or link 2264 by the actuator end 2251 moves the outer arm 2262 toward the open or closed position. In the example illustrated by FIGS. 22-26, upward or proximal movement of the actuation extension or link 2264 causes the outer arm 2262 to move toward the open position.
[00674] In some implementations, the inner arm 2260 of each paddle 2215 is coupled to the central body 2231 by one or more control tethers 2241. In some implementations, the one or more control tethers 2241 extend from the inner arm 2260, through the central body 2231, and through a catheter 2272, such as an implant catheter, a steerable catheter, and/or a guide sheath of a delivery system. The one or more control tethers 2241 are used to selectively pull the anchors 2221 toward the central body 2231 and to be selectively slackened to allow the central body to move away from the anchors 2221.
[00675] The actuator 2250 can take a variety of different forms. In some implementations, the actuator 2250 includes a proximal shaft 2280 and the actuator end 2251. The proximal shaft 2280 can be selectively connected and disconnected from the actuator end 2251 at a joint 2283. This allows the actuator end 2251 to be operated by the proximal shaft 2280 during implantation of the valve repair device 2201 and allows the actuator end 2251 to be disconnected at the joint 2283 and left with the remainder of the valve repair device 2201 after the implantation procedure.
[00676] The actuator end 2251 can take a variety of different forms. Any arrangement that allows all paddles 2215 that are against the central body 2231 to be opened and/or closed by the actuator end 2251 can be used. In the example illustrated by FIGS. 22-26, the actuator end 2251 includes the shaft 2253 and an actuation extension, plate, or disc 2284. In some implementations, the actuation extension, plate, or disc 2284 can be configured such that engagement of the actuation extension or link 2264 of the paddle 2215 by the actuation extension, plate, or disc 2284 moves the outer arm 2262 of the paddles toward the open or closed position. In the example illustrated by FIGS. 22-26, upward or proximal movement of actuation extension, plate, or disc 2284 causes the outer arm 2262 to move toward the open position. In some implementations, all paddles 2215 that are against the central body 2231 are moved (i.e., opened or closed) by a single movement of the actuation extension, plate, or disc 2284. [00677] The optional gripping member 2233 can take a variety of different forms. In some implementations, the optional gripping member 2233 can be any of the gripping members or clasps disclosed herein. In some implementations, the optional gripping member 2233 includes a fixed arm 2290, a movable arm 2292, and a hinge portion 2294 that connects the fixed arm 2290 to the movable arm 2292.
[00678] In some implementations, the gripping member can have optional barbs 2237. In in some implementations, the fixed arm 2290 is fixed to the outer arm 2262 of the paddle 2215. The movable arm 2292 can be moved relative to the fixed arm 2290 between an open position (FIG. 22) and a closed position (FIG. 23). The movable arm 2292 can be moved relative to the fixed arm 2290 in a variety of different ways. In some implementations, a line 2296 (e.g., suture, wire, chord, hypotube, etc.) can be used to move the movable arm 2292. The line 2296 can be attached to the movable arm 2292 and pulled to open the gripping member 2233. In some implementations, the hinge portion 2294 is shape set and/or provides a spring bias to bias the gripping member 2233 to the closed position. Relieving tension or slackening the line 2296 allows the gripping member 2233 to move to the closed position.
[00679] FIGS. 23-27 illustrate implantation of the device 2201 onto native heart valve leaflets 20, 22 or 30, 32, 34. Referring to FIG. 23, the actuator end 2251 is moved in the direction 2300 by the proximal shaft 2280. The actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 of each of the paddles that are against the central body 2231.
[00680] In some implementations, the device 2201 can include two tethered anchors 2221 when the device is configured to treat a mitral valve or two leaflets of a tricuspid valve and the device 2201 can include three tethered anchors 2221 when the device 2201 is configured to treat a tricuspid valve. The device can include any number of tethered anchors 2221.
[00681] In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 to move the outer arm 2262 of all of the paddles 2215 that are against the central body 2231 toward an open position as indicated by arrows 2302. One or more of the lines 2296 can be pulled in the direction indicated by arrows 2304 to move the movable arm 2292 of the gripping member 2233 toward an open position. [00682] In some implementations, the device 2201 is moved to position a leaflet 20 in the open gripping member 2233 and the outer arm 2262 of one of the anchors 2221. In some implementations, the line 2296 can then be slackened to close the gripping member 2233 and attach the gripping member 2233 to the first leaflet 20. The actuator end 2251 is moved distally to close the outer arms 2262 of all of the paddles 2215, with the first leaflet secured in the first anchor 2221. The line 2296 can be removed from the gripping member 2233 any at any time after the first leaflet is secured in the first anchor.
[00683] Referring to FIG. 24, the one or more tethers 2241 are slackened to allow the remainder of the device 2201 to be moved away from the first leaflet 20 and the attached first anchor 2221 by one or more catheters 2272 of the valve repair system 2200.
[00684] In some implementations, the actuator end 2251 can be moved again in the direction 2300 by the proximal shaft 2280. The actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 of each of the paddles that that remain against the central body 2231 again. In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 to move the outer arm 2262 of all of the paddles 2215 that remain against the central body 2231 toward an open position. As shown in FIG. 24, because the anchor holding the leaf is not positioned against the central body 2231 , this anchor remains closed, while the remaining anchors against the central body are opened. One or more of the lines 2296 can be pulled to move the movable arm 2292 of the gripping member 2233 toward an open position.
[00685] In some implementations, the device 2201 is moved to position a second leaflet 22 in the open gripping member 2233 and the outer arm 2262 of a second one of the anchors 2221. The line 2296 can then be slackened to close the gripping member 2233 and attach the gripping member 2233 to the second leaflet 20. The actuator end 2251 is moved distally to close the outer arms 2262 of all of the remaining paddles 2215 (e.g., paddles positioned against the central body 2231), with the second leaflet 22 secured in the second anchor 2221. The line 2296 can be removed from the gripping member 2233 any at any time after the second leaflet is secured in the first anchor.
[00686] Referring to FIG. 25, the one or more tethers 2241 that are attached to the second anchor 2221 can be slackened to allow the remainder of the device 2201 to be moved away from the first leaflet and second leaflets 20, 22 and the attached first and second anchors 2221 by the one or more catheters 2272 of the valve repair system 2200.
[00687] In some implementations, this process for capturing native valve leaflets can be repeated for a third anchor 2221 and any additional anchors that are tethered to the central body to 2231. The actuator end 2251 can be moved again in the direction 2300 by the proximal shaft 2280 for each additional anchor. In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 of each of the paddles that that remain against the central body 2231.
[00688] In some implementations, the actuation extension, plate, or disc 2284 engages the actuation extension or link 2264 to move the outer arm 2262 of the paddles 2215 that remain against the central body 2231 toward an open position. One or more of the lines 2296 can be pulled to move the movable arm 2292 of the gripping member 2233 toward an open position.
[00689] Referring to FIG. 26, once all of the anchors 2221 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 2241 can draw the anchors 2221 back against the central body 2231 . This pulls the native heart valve leaflets toward the central body. The tethers 2241 can be tied, locked or otherwise secured together to hold the anchors 2221 against the central body 2231.
[00690] In some implementations, the anchors can be secured to the central body 2231 by something other than the tethers 2241. For example, the anchors and/or the central body 2231 can include a connection arrangement, fastener, or coupler that secures the anchors 2221 to the central body 2231 when the anchors 2221 are pulled against the central body 2231. The tethers 2241 or portions of the tethers that are proximal to an area where the tethers can be tied, locked or otherwise secured together can be removed.
[00691] Referring to FIG. 27, after the anchors 2221 are secured to the central body 2231, the catheter 2272 and the proximal shaft 2280 can be decoupled from the device 2201. This leaves the device 2201 secured to the native valve leaflets.
[00692] In some implementations, a valve repair device is configured such that tethered anchors are allowed to tilt as the tethered anchors are brought back to a central body. This can reduce stress applied to leaflet tissue as the leaflets and the tethered anchors are pulled toward the central body. Figures 28-31 illustrate an example of a system where anchors 2821 are allowed to tilt as the anchors are pulled back to a central body 2831. In some implementations, once the anchors 2821 are moved back to the central body 2831, the anchors are rotated or pivoted to a more upright or vertical position against and/or in the central body 2831.
[00693] In the example illustrated by FIGS. 28-31 a valve repair system 2800 includes a valve repair device 2801 with a plurality of tethered anchors 2821 that are controlled by one or more catheters (not shown), such as any of the catheters disclosed herein. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 2801 includes a central body 2831, and a plurality of tethered anchors 2821.
[00694] The central body 2831 can take a variety of different forms. In some implementations, the central body 2831 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 2831 includes a central post 2810, a base or bottom wall 2812, and an outer or retaining wall 2814.
[00695] The central post 2810 can take a variety of different forms. In some implementations, an outer surface of the central post 2810 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets. The central post 2810 can include a plurality of tether passages 2820. In some implementations, the tether passages 2820 extend from an opening 2827 near the bottom wall 2812 to a proximal end 2822 of the central body 2831.
[00696] The base or bottom wall 2812 can take a variety of different forms. In some implementations, the base or bottom wall 2812 extends radially outward from the central post 2810. The retaining wall 2814 can take a variety of different forms. In some implementations, the retaining wall 2814 extends longitudinally from an outer circumference of the base or bottom wall 2812 in a proximal direction.
[00697] The plurality of tethered anchors 2821 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 28-31, the tethered anchors 2821 includes an inner arm 2860 and an outer arm 2862. [00698] In some implementations, the outer arm 2862 can be pivotally and/or flexibly coupled to the inner arm 2860. The outer arm 2862 can move between a closed position and an open position. In some implementations, the outer arm 2862 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position relative to the inner arm 2860. In some implementations, the outer arm 2262 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position. In some implementations, the tethered anchors 2821 may not be biased open or closed.
[00699] The tethered anchors 2821 can be opened and closed in a variety of different ways. In some implementations, the inner arm 2860 and the outer arm 2862 can be pulled relatively apart to open and close the tethered anchors 2821.
[00700] In some implementations, the tethered anchors are coupled to the central body 2831 by one or more control tethers 2841. In some implementations, the one or more control tethers 2841 are positioned on the anchors 2821 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 2831.
[00701] In the example illustrated by FIGS. 28-31 , the tethers are attached to a closed or distal end 2823 of the anchors 2821. In some implementations, the one or more control tethers 2841 extend from the closed or distal end 2823 of the anchors 2821, into the openings 2827 and through the tether passages 2820 that are through the central body 2831, and through a catheter (not shown), such as an implant catheter, a steerable catheter, and/or a guide sheath of a delivery system.
[00702] In the example illustrated by FIGS. 28-31, the system 2800 includes an optional tether guide catheter 2852. In some implementations, the optional tether guide catheter 2852 includes guide openings 2854 that the tethers 2841 extend through between the anchors 2821 and the openings 2827. In some implementations, the tether guide catheter 2852 can be moved/positioned such that the tethers 2841 first pull the anchors 2821 toward the central body 2831 and then into the central body (and/or pull the central body 2831 over the anchors 2821). When the optional tether guide catheter 2852 is omitted, the tethers can pull the anchors 2821 past or over the retaining wall 2814 and then down and into the central body 2831. [00703] In some implementations, the one or more control tethers 2841 are used to selectively pull the anchors 2821 against and into the central body 2831 and/or to be selectively slackened to allow the central body to move away from the anchors 2821.
[00704] In some implementations, the one or more control tethers 2841, the central body 2831, and optionally, the optional tether guide catheter 2852, are configured to pull the anchors toward the central body 2831 in a tilted orientation, and then rotate or pivot the anchors to a more upright or vertical position against the central body 2831. In some implementations, the anchors 2821 remain in the more upright or vertical position against the central body 2831 when the device 2801 is implanted and removed from the delivery system.
[00705] FIGS. 28-31 illustrate implantation of the device 2801 onto native heart valve leaflets 20, 22 or 30, 32, 34 according to one or more implementations of this disclosure. Referring to FIG. 28, the tethered anchors 2821 have already been attached to two native valve leaflets 20, 22. However, the tethered anchors 2821 could be attached to any number of native valve leaflets. For example, three tethered anchors 2821 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve. The device can include any number of tethered anchors 2821.
[00706] In some implementations, once all of the anchors 2821 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 2841 can draw the anchors 2821 against the central body 2831 as indicated by arrows 2870. Referring to FIGS. 28 and 29, in some implementations, the attachment of the tethers 2841 to the closed or distal end 2823 allows the anchors 2821 to tilt (e.g., along with the natural shape of the leaflets) as the tethers 2841 draw the anchors 2821 back against the central body 2831. This can reduce stress (indicated by the arrows next to the leaflets 20, 22) on the leaflets as the leaflets are pulled toward the central body 2831.
[00707] Referring to FIG. 30, in some implementations, once the anchors 2821 are positioned against the central body 2831, the anchors are rotated or pivoted to a more upright or vertical position. The anchors can be rotated or pivoted to a more upright or vertical position in a variety of different ways. For example, in implementations with two tethers such as the example shown in FIGS. 24 and 25, the two tethers 2241 can be independently controlled to first allow the anchors to tilt as they are drawn to the central body 2231 and then to rotate or pivot the anchors to a more upright or vertical position against the central body 2231.
[00708] In the example illustrated by FIG. 30, the tethers 2841 are pulled into the openings 2827 to pull the anchors 2821 into the central body 2831 (and/or pull the central body 2831 over the anchors 2821). As the anchors 2821 are pulled into the central body 2831 and/or the central body 2831 is pulled over the anchors 2821, the anchors 2821 are engaged between the retaining wall 2814 and the central post 2810 to rotate or pivot the anchors to a more upright or vertical position.
[00709] When the optional tether guide catheter 2852 is included, the tether guide catheter can be advanced into the central body 2831 as the tethers 2841 are pulled into the openings 2827. As such, the tether guide catheter can assist in the pulling of the anchors 2821 into the central body 2831 (and/or pull the central body 2831 over the anchors 2821).
[00710] In some implementations, the tethers 2841 can be tied, locked or otherwise secured together to hold the anchors 2821 in the central body 2831. In some implementations, the anchors can be secured to the central body 2831 by something other than the tethers 2841 . For example, the anchors and/or the central body 2831 can include a connection arrangement, fastener, or coupler that secures the anchors 2821 to the central body 2831. The tethers 2841 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.
[00711] Referring to FIG. 31, in some implementations, after the anchors 2821 are secured in the central body 2831, the device 2801 can be decoupled from the delivery system. For example, locks 3100 can be placed over the tethers 2841 to secure them in place relative to the central body 2831. This leaves the device 2801 secured to the native valve leaflets.
[00712] FIGS. 32-34 illustrate an example of a valve repair device 3401 where anchors 3421 are allowed to tilt as the anchors are pulled back to a central body 3431. In some implementations, as the anchors 3421 engage the central body 3431, the anchors are rotated or pivoted to a more upright or vertical position against and/or on the central body 3431.
[00713] In the example illustrated by FIGS. 32-34 a valve repair system includes a valve repair device 3401 with a plurality of tethered anchors 3421 that are controlled by one or more catheters (not shown), such as any of the catheters disclosed herein. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 3401 includes a central body 3431, and a plurality of tethered anchors 3421.
[00714] The central body 3431 can take a variety of different forms. In some implementations, the central body 3431 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 3431 includes a central post 3410 and a base or bottom wall 3412. The central post 3410 can take a variety of different forms. An outer surface of the central post 3410 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets. The central post 3410 can include a plurality of tether passages 3420. In some implementations, the tether passages 3420 extend from an opening 3427 near the bottom wall 3412 to a proximal end 3422 of the central body 3431.
[00715] The base or bottom wall 3412 can take a variety of different forms. In some implementations, the base or bottom wall 3412 extends radially outward from the central post 3410.
[00716] The plurality of tethered anchors 3421 can take a variety of different forms. For example, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 32-34, the tethered anchors 3421 includes an inner arm 3460, an outer arm 3462, and a tilting flange or projection 3463. The outer arm 3462 can be pivotally and/or flexibly coupled to the inner arm 3460. The outer arm 3462 can move between a closed position and an open position. In some implementations, the outer arm 3462 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position relative to the inner arm 3460. In some implementations, the outer arm 3462 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position. In some implementations, the tethered anchors 3421 may not be biased open or closed.
[00717] In some implementations, the tethered anchors 3421 can be opened and closed in a variety of different ways. For example, the inner arm 3460 and the outer arm 3462 can be pulled relatively apart to open and close the tethered anchors 3421. In some implementations, the tilting flange or projection 3463 is fixed to and extends from a closed end 3423 of the tethered anchors 3421.
[00718] In some implementations, the tethered anchors are coupled to the central body 3431 by one or more control tethers 3441. In some implementations, the one or more control tethers 3441 are positioned on and/or coupled to the anchors 3421 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 3431. In the example illustrated by FIGS. 32-34, the tethers are attached at or near a closed end 3423 of the anchors 3421. In some implementations, the one or more control tethers 3441 extend from the closed end 3423 of the anchors 3421, into the openings 3427 and through the tether passages 3420 that are through the central body 3431 , and through a catheter (not shown), such as an implant catheter, a steerable catheter, and/or a guide sheath of a delivery system.
[00719] In some implementations, the one or more control tethers 3441 can be used to selectively pull the anchors 3421 against and onto the central body 3431 and/or to be selectively slackened to allow the central body to move away from the anchors 3421. In some implementations, the one or more control tethers 3441 and the central body 3431 are configured to pull the anchors toward the central body 3431 in a tilted orientation.
[00720] In some implementations, the anchors 3421 and the central body 3431 are configured to engage one another and rotate or pivot the anchors to a more upright or vertical position against the central body 3431. In some implementations, the anchors 3421 remain in the more upright or vertical position against the central body 3431 when the device 3401 is implanted and removed from the delivery system.
[00721] FIGS. 32-34 illustrate implantation of the device 3401 onto native heart valve leaflets 20, 22 or 30, 32, 34. Referring to FIG. 32, the tethered anchors 3421 have already been attached to two native valve leaflets 20, 22. However, the tethered anchors 3421 could be attached to any number of native valve leaflets. For example, three tethered anchors 3421 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve. The device can include any number of tethered anchors 3421 .
[00722] In some implementations, once all of the anchors 3421 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 3441 can draw the anchors 3421 against the central body 3431. Referring to FIG. 32, the attachment of the tethers 3441 to the closed or distal end 3423 allows the anchors 3421 to tilt (e.g., along with the natural shape of the leaflets) as the tethers 3441 draw the anchors 3421 back against the central body 3431. This can reduce stress on the leaflets as the leaflets are pulled toward the central body 3431.
[00723] Referring to FIGS. 33 and 34, as the anchors 3421 are pulled against the central body 3431, the anchors are rotated or pivoted to a more upright or vertical position. In some implementations, the anchors can be rotated or pivoted to a more upright or vertical position in a variety of different ways.
[00724] In the example illustrated by FIGS. 33 and 34, the tethers 3441 are pulled into the openings 3427 to pull the tilting flanges or projections 3463 of the anchors 3421 into engagement with the base or bottom wall 3412 (and/or pull the base or bottom wall 3412 into engagement with the tilting flanges or projections 3463). In some implementations, the engagement between the tilting flanges or projections 3463 and the base or bottom wall 3412 causes the anchors 3421 to rotate or pivot to a more upright or vertical position as illustrated by FIG. 34. That is, once the anchors 3421 are pulled sufficiently close to the central body 3431 , the tilting flanges 3463 of the anchors can interact with and/or engage with the base or bottom wall 3412.
[00725] In some implementations, the tethers 3441 can be tied, locked or otherwise secured together to hold the anchors 3421 on (e.g., against) the central body 3431. In some implementations, the anchors can be secured to the central body 3431 by something other than the tethers 3441. For example, the anchors and/or the central body 3431 can include a connection arrangement, fastener, or coupler that secures the anchors 3421 to the central body 3431. The tethers 3441 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.
[00726] Referring to FIG. 34, after the anchors 3421 are secured in the central body 3431, the device 3401 can be decoupled from the delivery system. For example, locks 3490 can be placed over the tethers 3441 to secure them in place relative to the central body 3431. This leaves the device 3401 secured to the native valve leaflets.
[00727] FIG. 35 illustrates an example of valve repair device 3401 that includes a base or bottom wall 3412 with a tapered upper surface 3510. In some implementations, the tapered upper surface 3510 can be shaped to move the anchors 3421 more gradually to the more upright or vertical position and/or to control how upright the anchors 3421 become as the tilting flanges or projections 3463 are moved into engagement with the bottom wall 3412. In some implementations, a shallow or less inclined tapered surface 3510 will move the anchors to a more upright position. In some implementations, a steep or more inclined tapered surface 3510 will move the anchors to a less upright position.
[00728] The anchors 3421 of the FIG. 35 example can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIG. 35, the tethered anchors 3421 include an inner arm 3460 coupled to an inner mounting plate 3461, an outer arm 3462 mounted to an outer mounting plate 3465 that includes the tilting flange or projection 3463, and a hinge portion 3467 that connects the inner and outer arms 3460, 3462. The outer arm 3462 can move between a closed position and an open position. In some implementations, the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460.
[00729] The tethered anchors 3421 can be opened and closed in a variety of different ways. In some implementations, the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463. For example, the outer arm 3462 can be biased by the hinge portion 3467 to the open position relative to the inner arm 3460 and the base or bottom wall 3412 can be moved distally or away from the tilting flange or projection 3463 to allow the outer arm 3462 to open. The base or bottom wall 3412 can be moved back into engagement with the tilting flange or projection 3463 to close the outer arm 3462. This configuration can be implanted in the same or a similar way as shown in the example of FIGS. 22-27.
[00730] FIGS. 36 and 37 are top views of an example of valve repair device 3401 that includes a base or bottom wall 3412 with extensions or petals 3610 and cutouts 3612. The anchors 3421 can be moved to the more upright or vertical position in a variety of different ways. In some implementations, the base or bottom wall 3412 is rotated to move the anchors 3421 between the tilted position and the upright position.
[00731] Referring to FIG. 36, in some implementations, the anchors are free to assume the tilted position when the cutouts 3612 are aligned with the tilting flanges or projections 3463.
I l l [00732] Referring to FIG. 37, in some implementations, rotating the base or bottom wall 3412 such that the extensions or petals 3610 engage the flanges or projections 3463 moves the anchors 3412 to the more upright or vertical position. In some implementations, the flanges or projections 3463 are tapered or inclined such that the rotation of the base or bottom wall 3412 gradually moves the anchors 3421 between the tilted position and the more upright or vertical position.
[00733] The tethered anchors 3421 can be opened and closed in a variety of different ways. In some implementations, the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463 when the cut outs 3612 are aligned with the tilting flanges or projections 3463. For example, the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460. With the extensions or petals 3610 out of the way of the flanges or projections 3463, the outer arm 3462 and/or the tilting flanges or projections 3463 can be pushed or pulled by an actuator to open the anchors 3421.
[00734] In the example illustrated by FIGS. 38-42, a valve repair system 5200 includes a valve repair assembly 5201 with a plurality of anchors 5221 that are controlled by one or more catheters (not shown), such as any of the catheters disclosed herein. The valve repair assembly can take a variety of different forms. In some implementations, the valve repair assembly 5201 includes a center clip 5231, and the plurality of anchors 5221.
[00735] The center clip 5231 can take a variety of different forms. In some implementations, the center clip 5231 can include a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the center clip 5231 includes a central base 5210 and a plurality of clipping arms 5214 or an annular or semi-annular clipping wall. The central base 5210 can take a variety of different forms. An outer surface of the central base 5210 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets.
[00736] The plurality of clipping arms 5214 or an annular or semi-annular clipping wall can take a variety of different forms. In some implementations, the clipping arms 5214 are biased to a closed or clamping configuration (See FIG. 42). The plurality of clipping arms 5214 or an annular or semi-annular clipping wall can be elongated and/or straightened when loaded into a catheter 5252 (See FIG. 38).
[00737] In some implementations, the clipping arms 5214 can be made from a metal, such as steel or ni tinol. Any number of clipping arms can be included. In some implementations, the clipping arms 5214 are evenly spaced around a perimeter of the center base 5210 when the clipping arms are in the closed position. The size, number, and/or spacing of the clipping arms 5214 can be selected to approximate an annular wall around the center base 5210 when the clipping arms are in the closed position.
[00738] In some implementations, the clipping arms 5214 can move between a closed position and an open position. In some implementations, the clipping arms 5214 can be biased (e.g. by shape setting, etc.) to the closed position. The clipping arms can be opened and closed in a variety of different ways.
[00739] Referring to FIG. 38, clipping arms 5214 can be loaded into the catheter 5252 in an open, straightened configuration. Referring to FIGS. 39-42, the clipping arms 5214 can curl toward the closed, curved configuration, as the arms are moved out of the catheter 5252. For instance, the clipping arms 5214 can be biased to the curved configuration such that the clipping arms assume the curved configuration upon exiting the catheter.
[00740] The plurality of anchors 5221 can take a variety of different forms. In some implementations, the plurality of anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 40-42, the anchors 5221 includes an inner arm 5260 and an outer arm 5262. The outer arm 5262 can be flexibly coupled to the inner arm 5260.
[00741] In some implementations, the outer arm 5262 can move between a closed position and an open position. In some implementations, the outer arm 5262 can be biased (e.g. by shape setting, etc.) to the closed position relative to the inner arm 5260. The anchors 5221 can be opened and closed in a variety of different ways, including but not limited to, any of the ways disclosed in the present application.
[00742] In some implementations, the anchors 5221 are connected to one or more tethers 5241. In some implementations, the one or more tethers 5241 can optionally be positioned on the anchors 5221 in a manner that allow the anchors to tilt as the anchors are pulled toward the center clip 5231. In the example illustrated by FIGS. 40-41, the tethers are attached to a closed or distal end 5223 of the anchors 5221. The one or more tethers 5241 can be used to selectively pull the anchors 5221 toward one another.
[00743] FIGS. 38-42 illustrate implantation of the device 5201 onto native heart valve leaflets 20, 22 or 30, 32, 34. In this example, the tethered anchors 5221 have already been attached to two native valve leaflets 20, 22. However, the tethered anchors 2821 could be attached to any number of native valve leaflets. For example, three tethered anchors 2821 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve. The device can include any number of tethered anchors 2821.
[00744] The anchors 5221 can be attached to the leaflets in a variety of different ways, including but not limited to any of the ways disclosed in this patent application. In some implementations, the tethers 5241 can take the form illustrated by FIG. 40 and the device 5201 can be positioned by the tethers 5241 in the manner shown in FIG. 40.
[00745] In some implementations, once all of the anchors 5221 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 5241 can draw the anchors 2821 toward one another. The catheter 5252 can be positioned for deployment with the clipping arms 5214 in the catheter in the elongated configuration (see FIG. 38.).
[00746] Referring to FIG. 40, the center clip 5231 can be pushed out of the catheter 5252 such that the clipping arms curl out of the catheter 5252 and create a space for accepting the anchors 5221. Referring to FIG. 41, the catheter 5252 moves the center clip 5231 to place the anchors 5221 in the clipping arms 5214.
[00747] Referring FIG. 42, the center clip 5231 can be moved further out of the catheter 5252 such that the clipping arms 5214 close to secure the anchors 5221 in the center clip 5231. After the anchors 5221 are secured in the center clip 5231, the device 5201 can be released from the catheter 5252.
[00748] The tethered anchors and central bodies or bases can be moved toward and away from one another in a variety of different ways. FIG. 43 illustrates an example of a system 3800 where anchors 3821 are selectively moved toward and away from a central member or body 3831. In the example illustrated by FIG. 43, the system 3800 includes a plurality of anchors 3821, a plurality of tethers 3841, center member or body 3831, an implant catheter 3850, and a plurality of tether control members 3852.
[00749] The central body 3831 can take a variety of different forms. In some implementations, the central body 3831 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 3831 includes a central post 3810 and optional coupling features 3812.
[00750] The central post 3810 can take a variety of different forms. In some implementations, an outer surface of the central post 3810 can have recesses 3811 that accept the anchors 3821. In some implementations, the recesses 3811 extend along a height of the center post 3810.
[00751] The plurality of tethered anchors 3821 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIG. 43, the tethered anchors 3821 includes an inner arm 3860, and an outer arm 3862. In some implementations, the outer arm 3862 can be pivotally and/or flexibly coupled to the inner arm 3860. The outer arm 3862 can move between a closed position and an open position.
[00752] In some implementations, the outer arm 3862 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position relative to the inner arm 3860. In some implementations, the outer arm 3862 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position. In some implementations, the tethered anchors 3821 are not biased open or closed.
[00753] The tethered anchors 3821 can be opened and closed in a variety of different ways. In some implementations, the inner arm 3860 and the outer arm 3862 can be pulled relatively apart to open and close the tethered anchors 3821. In some implementations, an optional tilting flange or projection 3863 is fixed to and extends from a closed end 3823 of the tethered anchors 3821. [00754] In some implementations, the tethered anchors are coupled to the implant catheter 3850 by the control tethers 3841. The control tethers 3841 can take a variety of different forms. In some implementations, the control tethers 3841 can be sutures, wires, tubes such as hypo tubes, etc.
[00755] In some implementations, the control tethers 3841 are shaped and/or shapeset to extend away from the implant catheter 3850 and/or the central body 3831 when the control tethers 3841 are unconstrained.
[00756] In some implementations, the one or more control tethers 3841 are positioned on the anchors 3821 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 3831 and/or the implant catheter 3850. In the example illustrated by FIG. 43, the tethers 3841 are attached at or near a closed or distal end 3823 of the anchors 3821.
[00757] In some implementations, the one or more control tethers 3841 extend from the closed or distal end 3823 of the anchors 3821 , into slots or channels 3827 that extend along the implant catheter 3850. In some implementations, the tethers 3841 are sized to be able to move laterally and/or longitudinally int and out of the slots or channels 3827.
[00758] The plurality of tether control members 3852 can take a variety of different forms. In some implementations, the tether control members 3852 comprise tubes, such as hypo tubes, plastic tubes, etc. In some implementations, the tether control members 3852 are sized to fit in and slide within the slots or channels 3827, but are too large to be pulled laterally out of the slots.
[00759] In some implementations, by distally advancing the tether control members 3852 in the slots or channels, the tethers 3841 are pulled into the slots or channels 3827. This pulls the anchors 3821 toward the implant catheter 3850. Conversely, proximately retracting the tether control members 3852 allows the tethers 3841 to flex and extend out of the slots or channels 3827. This allows the implant catheter 3850 and the anchors 3821 to move relatively apart.
[00760] In some implementations, pulling the tethers 3841 into the slots or channels 3827 moves the anchors 3821 into the recesses 3811 of the central post 3810. In some implementations, the coupling features 3812 couple the anchors 3821 to the central post 3810 when the anchors 3821 are pulled into the recesses 3811. In some implementations, the coupling features 3812 can comprise female-type sockets while the anchors comprise a corresponding male terminal. In some implementations, the coupling features 3812 can comprise a male-terminal, while the anchors comprise a female-type socket. Other types of coupling features, including fasteners and the like can be used without departing from the scope of this disclosure.
[00761] In some implementations, an actuator is configured to both open the paddles and close the paddles and/or that is configured to increase a range of movement or stroke of the paddles. FIGS. 44-48 illustrate an example of a valve repair system that includes a valve repair device 3901 with a plurality of tethered anchors 3921 that are controlled by a single actuator 3950. In some implementations, the anchors 3921 and the actuator 3950 are configured to both open and close the anchors.
[00762] The valve repair device can take a variety of different forms. In some implementations, the valve repair device 3901 includes a central body 3931 (FIG. 44), a plurality of tethered anchors 3921, and an actuator end 3951.
[00763] The central body 3931 can take a variety of different forms. In some implementations, the central body 3931 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 3931 includes passages 3939 that tethers 3941 extend through. In some implementations, the central body 3931 includes a bore or passage 3935 that a shaft 3953 of the actuator end 3951 extends through.
[00764] The plurality of tethered anchors 3921 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the examples illustrated by FIGS. 44-48, the anchors can each include a paddle 3915, a base member 3962. In some implementations, the anchors can each include an optional gripping member 3933, such as a clasp (See FIGS. 47-48). In some implementations, a paddle alone can be secured to a native valve leaflet and the optional gripping member 3933 can be omitted.
[00765] The paddle 3915 can take a variety of different forms. In some implementations, the paddle 3915 can be any of the paddles disclosed by the present application. In some implementations, the paddle 3915 includes a single arm 3960 coupled to a base member 3962 of the anchor 3921.
[00766] In some implementations, the single arm 3960 can be pivotally and/or flexibly coupled to the base member 3962 of the anchor 3921. The single arm 3960 can move between a closed position and an open position. In some implementations, the single arm 3960 is not biased open or closed. However, in some implementations the single arm can be biased to the closed position or the open position.
[00767] In some implementations, the single arm 3960 is opened and/or closed by moving the actuator end 3951. The single arm 3960 can optionally be opened and/or closed by the actuator end 3951 in a variety of different ways. In some implementations, the actuator end 3951 can be configured to both open and close all paddles 3915 of all the anchors that are against the central body 3931.
[00768] In the examples illustrated by FIGS. 44-48, the paddle 3915 includes an upper actuation extension or link 3964 and a lower extension or link 3965. In some implementations, the upper actuation extension or link 3964 and the lower extension or link 3965 can be configured such movement of the actuator end 3951 in a proximal direction moves the single arm 3960 toward the open position. In some implementations, the upper actuation extension or link 3964 and the lower extension or link 3965 can be configured such movement of the actuator end 3951 in a distal direction moves the single arm 3960 toward the closed position.
[00769] In some implementations, the anchors 3921 are coupled to the central body 3931 by one or more control tethers 3941. In some implementations, the one or more control tethers 3941 can be configured to bring the anchors 3921 into contact with the central body 3931. The one or more control tethers 3941 can be configured to bring the anchors 3921 into contact with the central body 3931 in any manner disclosed herein.
[00770] In some implementations, the one or more control tethers optionally extend through the central body 3931 , and through a catheter, such as an implant catheter, a steerable catheter, and/or a guide sheath of a delivery system. Thus, pulling the tethers bring the anchors 3921 into contact with the central body 3931. [00771] In some implementations, the one or more control tethers 3941 are configured to bring the anchors 3921 toward the central body in the same manner as the example illustrated by FIG. 43. The one or more control tethers 3941 are used to selectively pull the anchors 3921 against the central body 3931 and to be selectively slackened to allow the central body to move away from the anchors 3921.
[00772] The single actuator 3950 can take a variety of different forms. In some implementations, the single actuator 3950 includes a proximal shaft 3980 and the actuator end 3951. The proximal shaft 3980 can be selectively connected and disconnected from the actuator end 3951. This allows the actuator end 3951 to be operated by the proximal shaft during implantation of the valve repair device 3901 and allows the actuator end 3951 to be disconnected and left with the remainder of the valve repair device 3901 after the implantation procedure.
[00773] The actuator end 3951 can take a variety of different forms. Any arrangement that allows all paddles 3915 that are against the central body 3931 to be opened and closed by the single actuator end 3951 can be used.
[00774] In the examples illustrated by FIGS. 44-48, the actuator end 3951 includes the shaft 3953, a lower actuation extension, plate, or disc 3984, and an upper actuation extension, plate, or disc 3985. The lower actuation extension, plate, or disc 3984, and the upper actuation extension, plate, or disc 3985 can be configured such that engagement of the upper actuation extension or link 3964 an/or the lower extension or link 3965 by the lower actuation extension, plate, or disc 3984, and/or the upper actuation extension, plate, or disc 3985 moves the single arm 3960 of the paddles toward the open or closed position.
[00775] In the examples illustrated by FIGS. 44-48, upward or proximal movement of the lower actuation extension, plate, or disc 3984, and the upper actuation extension, plate, or disc 3985 causes the single arm 3862 to move toward the open position. For example, the lower actuation extension, plate, or disc 3984 engages the lower extension or link 3965 and the upper actuation extension, plate, or disc 3985 engages the upper actuation extension or link 3964 when the actuator end 3951 is moved proximally as indicated by arrow 3991. This opens the single paddle arm 3960. [00776] In the examples illustrated by FIGS. 44-48, downward or distal movement of the lower actuation extension, plate, or disc 3984, and the upper actuation extension, plate, or disc 3985 causes the single arm 3862 to move toward the closed position. For example, the upper actuation extension, plate, or disc 3985 engages the lower extension or link 3965 when the actuator end 3951 is moved distally (opposite of arrow 3991). This closes the single paddle arm 3960. In some implementations, all paddles 3915 that are against the central body 3931 are moved (i.e., opened or closed) by a single movement of the actuator end 3951.
[00777] Referring to FIGS. 47 and 48, the optional gripping member 3933 can take a variety of different forms. In some implementations, the optional gripping member 3933 can be any of the gripping members or clasps disclosed herein. In the example illustrated by FIG. 47, the optional gripping member 3933 includes a gripping arm 4290, an actuating arm 4292, and a pivoting portion 4294 that connects the gripping arm 4290 to the actuating arm 4292.
[00778] In the example illustrated by FIG. 48, the optional gripping member 3933 includes a first arm 3990, a second arm 3992, and a hinge portion 3994 that connects the first arm 3990 to the second arm 3992. In some implementations, the gripping members can have optional barbs 3937. In in some implementations, the gripping member 3933 is pivotally connected to the base member 3962 of the anchor 3921.
[00779] In the example illustrated by FIG. 47, the gripping member 3933 is configured to capture a leaflet between the single paddle arm 3960 and the gripping arm 4290. In some implementations, the closed position is when the gripping arm is as close as possible to the single paddle arm 3960.
[00780] In the example illustrated by FIG. 48, the gripping member 3933 is configured to capture a leaflet between the first arm 3990 and the second arm 3992. In some implementations, the closed position is when the second arm 3992 is as close as possible to the first arm 3990. The second arm 3992 can be moved relative to the first arm 3990 between an open position and a closed position.
[00781] In the example illustrated by FIG. 47, the gripping arm 4290 can be moved to the open position in a variety of different ways. In some implementations, a line 4296 (e.g., suture, wire, chord, hypotube, etc.) can be used to hold the base member 3962 while a catheter 4297 is advanced in direction 4298. This advancing of the catheter 4297 engages the actuating arm 4292 to open the gripping member 3933. In some implementations, a biasing member 4299, such as a spring, can provide a spring bias to bias the gripping member 3933 to the closed position. Retracting the catheter 4297 allows the gripping member 3933 to move to the closed position.
[00782] In the example illustrated by FIG. 48, The second arm 3992 can be moved to the open position in a variety of different ways. For example, a line 3996 (e.g., suture, wire, chord, hypotube, etc.) can be used to move the second arm 3992. The line 3996 can be attached to the second arm 3992 and pulled to open the gripping member 3933. In some implementations, the hinge portion 3994 is shape set and/or provides a spring bias to bias the gripping member 3933 to the closed position. Relieving tension or slackening the line 3996 allows the gripping member 3933 to move to the closed position.
[00783] The device 3901 can be implanted onto native heart valve leaflets 20, 22 or 30, 32, 34. The actuator end 3951 is moved in the direction 3991 by the proximal shaft. The lower actuation extension, plate, or disc 3984 engages the lower extension or link 3965 and the upper actuation extension, plate, or disc 3985 engages the upper actuation extension or link 3964 of each of the paddles that are against the central body 3931 when the actuator end 3951 is moved proximally as indicated by arrow 3991.
[00784] In some implementations, the device 3901 can include two tethered anchors 3921 when the device is configured to treat a mitral valve or two leaflets of a tricuspid valve and the device 3901 can include three tethered anchors 3921 when the device 3901 is configured to treat a tricuspid valve. The device can include any number of tethered anchors 3921. In some implementations, all of the paddles 3915 that are against the central body 3931 are moved toward an open position when the actuator end 3951 is moved proximally.
[00785] In the example illustrated by FIG. 47, the line 4296 can be pulled while the catheter 4297 is advanced to engage the actuating arm 4292 and move the gripping arm 4290 of the gripping member 3933 toward the open position, away from the single paddle arm 3960. The gripping member 3933 can be biased to the closed position in the FIG. 47 example.
[00786] In the example illustrated by FIG. 48, one or more of the lines 3996 can be pulled to move the second arm 3992 of the gripping member 3933 toward to the open position, away from the first arm 3990. The gripping member 3933 can be biased to the closed position in the FIG. 48 example.
[00787] In some implementations, the device 3901 can be implanted by being moved to position a leaflet 20 in the open paddle arm 3960 and/or the optional open gripping member 3933. When the gripping member 3933 is biased closed, the catheter 4297 can be retracted (FIG. 47) or the line 3996 can be slackened (FIG. 48) to close the gripping member 3933 and attach the gripping member 3933 to the first leaflet 20. In some implementations, the actuator end 3951 can optionally be moved distally to close the first arm 3960 of all of the paddles 3915, with the first leaflet secured in the first anchor 3921. The catheter 4297 or the line 3996 can be removed from the gripping member 3933 any at any time after the first leaflet is secured in the first anchor.
[00788] In some implementations, the one or more tethers 3941 are slackened to allow the remainder of the device 3901 to be moved away from the first leaflet 20 and the attached first anchor 3921 by one or more catheters of the valve repair system. This process can be repeated to attach all the anchors 3921 to the leaflets.
[00789] In some implementations, once all the anchors 3921 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the tethers 3941 can draw the anchors 3921 back against the central body 3931. This pulls the native heart valve leaflets toward the central body 3931.
[00790] In some implementations, the tethers 3941 can be tied, locked or otherwise secured together to hold the anchors 3921 against the central body 3931. In some implementations, the anchors can be secured to the central body 3931 by something other than the tethers 3941. For example, the anchors and/or the central body 3931 can include a connection arrangement, fastener, or coupler that secures the anchors 3921 to the central body 3931 when the anchors 3921 are pulled back against the central body 3931. The tethers 3941 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.
[00791] In some implementations, after the anchors 3921 are secured to the central body 3931 , the actuator end 3951 is moved distally (opposite of arrow 3991). This movement causes the upper actuation extension, plate, or disc 3985 to engage the lower extensions or links 3965 of all of the paddle arms 3960 to close all of the paddle arms. In some implementations, the actuator end 3951 can be secured in place to set the closed position of the paddle arms. The delivery system components can be decoupled from the device 3901, leaving the device 3901 secured to the native valve leaflets.
[00792] FIGS. 49-56 illustrate an example of a valve repair system 4400 that includes a valve repair device 4401 and a delivery system 4403. The valve repair device 4401 includes a plurality of tethered anchors 4421 that are controlled by a plurality of spools 4450. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 4401 includes a central body 4431 , a plurality of tethered anchors 4421 , and the plurality of spools 4450.
[00793] The central body 4431 can take a variety of different forms. In some implementations, the central body 4431 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 4431 includes a bore 4435 that the spools 4450 are rotatably disposed in. The central body 4431 can accept one or more shafts 4453 that are configured to rotate the spools 4450.
[00794] The plurality of tethered anchors 4421 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 49-56, the anchors 4421 each include a gripping member 4433, such as a clasp.
[00795] In some implementations, the tethered anchors 4421 can optionally be connected to the central body 4431 by an optional biasing member 4432, such as a spring, a shape set arm or wire, etc. The biasing member can bias the tethered anchors to a selected position. For example, the optional biasing member 4432 can bias the anchors 4421 away from the central body 4431 (see the anchor 4421 on the right in FIG. 50).
[00796] In some implementations, the optional biasing member 4432 can bias the anchors 4421 toward from the central body 4431. When the optional biasing member 4432 is configured to bias the anchors 4421 toward from the central body 4431, the central body 4431 can be moved away from the anchors 4421 due to attachment of the anchors to the leaflets and/or due to movement of the leaflets. [00797] The gripping member 4433 can take a variety of different forms. In some implementations, the gripping member 4433 can be any of the gripping members or clasps disclosed herein. In some implementations, the gripping member 4433 includes a fixed arm 4490, a movable arm 4492, and a hinge portion 4494 that connects the fixed arm 4490 to the movable arm 4492. The gripping member can have optional barbs 4437.
[00798] In in some implementations, the fixed arm 4490 is fixed to the biasing member 4432. The movable arm 4492 can be moved relative to the fixed arm 4490 between an open position (left anchor in FIG. 50) and a closed position (right anchor in FIG. 50).
[00799] The movable arm 4492 can be moved relative to the fixed arm 4490 in a variety of different ways. In some implementations, further tensioning of tethers 4441 by the spools 4450 after the anchors 4421 are pulled up to the central body 4431 can cause the movable arm 4492 to open. The tethers 4441 can be attached to the movable arm 4492 and pulled to open the gripping member 4433.
[00800] In some implementations, the hinge portion 4494 is shape set and/or provides a spring bias to bias the gripping member 4433 to the closed position. Relieving tension or slackening the tether 4441 allows the gripping member 4433 to move to the closed position. Further slackening of the tether 4441 after the gripping member 4433 has moved to the closed position allows the anchor 4421 and the central body 4431 to be moved relatively apart.
[00801] In some implementations, the anchors 4421 are coupled to the central body 4431 by one or more control tethers 4441. The one or more control tethers 4441 can extend from the movable arm 4492, into the central body 4431, and are wrapped around the spools 4450.
[00802] In some implementations, the one or more control tethers 4441 can be used to selectively pull the anchors 4421 against the central body 4431. In some implementations, once the anchors 4421 are against the central body 4431, the control tethers 4441 can be further pulled to move the anchors 4421 to the open position. The tethers 4441 can also be slackened to allow the anchors to close and allow the central body to move away from the anchors 4421.
[00803] The delivery system 4403 for implanting the device 4401 on a native heart valve can take a variety of different forms. In the example illustrated by FIGS. 49-56, the delivery system includes a catheter 4480 and a plurality of shafts 4453 that are configured to rotate the spools 4450.
[00804] In some implementations, the catheter 4480 can be releasably coupled to the central body 4431 of the device 4401. In some implementations, the plurality of shafts 4453 can be concentric shafts. A smallest of the shafts 4453 can be extended into the central body 4431 and to a distal one of the spools 4450, through any spools that are proximal to the distal spool. A middle sized one of the shafts 4453 can be extended into the central body 4431 and to a middle one of the spools, through any spools that are proximal to the middle spool. A largest sized one of the shafts 4453 can be extended into the central body 4431 and into a proximal one of the spools. The system 4400 can have any number of spools 4450 and associated shafts 4453. When the device 4401 includes two spools 4450, there is no middle spool or associated shaft. When the device 4401 includes more than three spools and shafts, the device includes more than one middle spool.
[00805] In some implementations ,when a shaft 4453 is engaged with its respective spool 4450, the shaft can rotate the spool in a first direction to selectively pull the anchors 4421 against the central body 4431 and then to pull the anchors 4421 to the open position. The tethers 4441 can rotate the spool 4450 in a second direction to selectively slacken the tethers to allow the anchors to close and then allow the central body to move away from the anchors 4421.
[00806] FIGS. 51-56 illustrate implantation of the device 4401 onto native heart valve leaflets 20, 22 or 30, 32, 34. Referring to FIG. 51, a middle one of the spools 4450 is rotated by the middle one of the shafts 4453. However, the spools can be used in any order. Rotation of the spool 4450 pulls on the corresponding tether 4441.
[00807] In some implementations, the tether 4441 pulls on the movable arm 4492 to open the anchor 4421. The device 4401 is moved by the delivery system 4403 to position a leaflet 20 in the open gripping member 4433 either before or after the anchor 4421 is opened.
[00808] Referring to FIG. 52, the tether 4441 can then be slackened by rotating the spool in the opposite direction (opposite to the direction that opened the gripping member) to close the gripping member 4433 and attach the gripping member 4433 to the first leaflet 20. [00809] Referring to FIG. 53, the tether(s) 4441 of the anchor connected to the leaflet 20 is slackened to allow the remainder of the device 4401 to be moved away from the first leaflet 20 and the attached first anchor 4421 by the delivery system 4403. In some implementations, the optional biasing member 4432 biases the anchor 4421 attached to the first leaflet 20 away from the central body 4431 when the tether 4441 is slackened.
[00810] Referring to FIG. 53, a distal one of the spools 4450 is rotated by an inner or smallest one of the shafts 4453. Again, the spools can be used in any order. Rotation of the spool 4450 pulls on the corresponding tether 4441. The tether 4441 pulls on the movable arm 4492 to open the anchor 4421. The device 4401 is moved by the delivery system 4403 to position a leaflet 22 in the open gripping member 4433.
[00811] Referring to FIG. 54, the tether 4441 can then be slackened to close the gripping member 4433 and attach the gripping member 4433 to the second leaflet 22. The tether 4441 of the anchor connected to the leaflet 22 can be slackened to allow the remainder of the device 4401 to be moved away from the second leaflet 20 to allow the device to capture any additional leaflets. This process can be repeated for each spool, shaft and native valve leaflet.
[00812] Referring to FIG. 55, once all of the anchors 4421 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) shafts 4453 can be rotated, to rotate the spools 4450, and pull on the tethers 4441 to draw the anchors 4421 back against the central body 4431. In some implementations the spools are not rotated so far that the anchors start to reopen. In some implementations, there can be a tactile indicator provided to an operator (e.g., increased resistance in the tether) that indicates the that further rotation of the spool can cause the anchors to reopen. In this manner, the tethers 4441 pull the native heart valve leaflets toward the central body. The spools 4450 can be locked or otherwise secured to hold the anchors 4421 against the central body 4431.
[00813] Referring to FIG. 56, after the anchors 4421 are secured to the central body 4431, the delivery system 4403 can be decoupled from the device 4401. This leaves the device 4401 secured to the native valve leaflets.
[00814] In some implementations, anchors are movable toward and away from on another by attaching the anchors to an expandable/expansion member 21018. The expandable/expansion member 21018 can take a variety of different forms. Referring to FIG. 57A, an example of a valve repair device 5701 includes an expandable/expansion member 21018 and a plurality of anchors 5721.
[00815] The expandable/expansion member 21018 can take a variety of different forms. In some implementations, the expandable/expansion member 21018 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the expandable/expansion member 21018 can include structure configured to mount an actuation mechanism 21020 (FIG. 59) within the expandable/expansion member 21018.
[00816] In some implementations, the proximal end portion 21022 (FIGS. 57-63) of the expandable/expansion member 21018 includes a first pair of radially opposed openings 21036, and a second pair of radially opposed openings 21038 distal to the first pair of radially opposed openings 21036 and the distal end portion 21024 of the expandable/expansion member 21018 includes a third pair of radially opposed openings 21040.
[00817] In some implementations, the actuation mechanism 21020 is configured as a threaded connection. Referring to FIG. 59, the example actuation mechanism 21020 includes a distal member 21042 (e.g., tube, body, shaft, etc.) configured to threadably couple with a proximal member 21044 (e.g., tube, body, shaft, etc.). The distal member 21042 and the proximal member 21044 can be configured in a variety of ways. In the illustrated example, the distal member 21042 is formed as a cylindrical tube having a circular cross section. In some implementations, however, the distal member 21042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
[00818] In some implementations, the distal member 21042 includes a proximal end 21046, a distal end 21048 opposite the proximal end 21046, and an inner passage 21050 extending through the distal member 21042 from the proximal end 21046 to the distal end 21048. The inner passage 21050 includes female threads 21052 (FIGS. 60-61) for threadably coupling with the proximal member 21044.
[00819] In some implementations, the distal member 21042 is sized to be received within the passage 21027 of the expandable/expansion member 21018. In some implementations, the distal member 21042 includes structure for fixing the distal member 21042 in position within the passage 21027 relative to the expandable/expansion member 21018. In the illustrated example, the distal end 21048 includes a pair of opposed projections 21054 configured to be received within the third pair of radially opposed openings 21040, as shown in FIGS. 60-63.
[00820] In some implementations, the proximal member 21044 is formed as a cylindrical tube having a circular cross section. In some implementations, the proximal member 21044 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
[00821] In some implementations, the proximal member 21044 includes a proximal end 21056, a distal end 21058 opposite the proximal end 21056, and an inner passage 21059 extending through the proximal member 21044 from the proximal end 21056 to the distal end 21058.
[00822] In some implementations, the proximal member 21044 can include male threads 21060 (FIGS. 60-61) extending along at least a portion of the exterior of the proximal member 21044. The male threads 21060 are configured to mate with the female threads 21052 of the distal member 21042.
[00823] In some implementations, the proximal member 21044 is sized to be received within the passage 21027 of the expandable/expansion member 21018. In some implementations, the actuation mechanism 21020 can include structure for restricting axial movement of the proximal member 21044 within the passage 21027 relative to the expandable/expansion member 21018.
[00824] In some implementations, the structure restricts axial movement of the proximal member 21044 within the passage 21027 relative to the expandable/expansion member 21018 while allowing rotational movement of the proximal member 21044 relative to the expandable/expansion member 21018. The structure for restricting axial movement of the proximal member 21044 can be configured in a variety of ways.
[00825] In some implementations, the actuation mechanism 21020 includes a circumferential, radially extending ridge 21062 at the proximal end 21056. In some implementations, the ridge 21062 is configured to engage with a stop 21064 and an end cap 21066 to restrict axial movement of the proximal member 21044 within the passage 21027. The stop 21064 can be configured in a variety of ways. In some implementations, the stop 21064 is configured to inhibit movement of the proximal member 21044 distally within the passage 21027.
[00826] In some implementations, the stop 21064 is formed as a ring having a central passage 21068 sized to receive a portion of the proximal member 21044 therethrough. In some implementations, the stop 21064 is further sized to be received within the passage 21027.
[00827] In some implementations, the stop 21064 can include structure configured to fix the position of the stop 21064 relative to the expandable/expansion member 21018. In some implementations, the stop 21064 includes a pair of opposed projections 21070 configured to be received within the second pair of radially opposed openings 21038 of the expandable/expansion member 21018, as shown in FIGS. 60-63.
[00828] The end cap 21066 can be configured in a variety of ways. In some implementations, the end cap 21066 is configured to inhibit movement of the proximal member 21044 proximally within the passage 21027. In some implementations, the end cap 21066 is formed as a ring having a distal end 21072, a proximal end 21074 opposite the distal end 21072, and a central passage 21076 extending through the end cap 21066 from the distal end 21072 to the proximal end 21074.
[00829] In some implementations, the central passage 21076 is sized to receive at least a portion of the proximal end 21056 of the proximal member 21044. In some implementations, the proximal end 21056 of the proximal member 21044 can further include one or more engagement surfaces 21077 accessible through the central passage 21076 of the end cap 21066. In some implementations, the one or more engagement surfaces 21077 are configured to be engaged to rotate the proximal member 21044.
[00830] In some implementations, the end cap 21066 is further sized to be received within the passage 21027. In some implementations, the end cap 21066 can include structure configured to fix the position of the end cap 21066 relative to the expandable/expansion member 21018.
[00831] In some implementations, the end cap 21066 includes a pair of opposed projections 21078 at the distal end 21072 that are configured to be received within the first pair of radially opposed openings 21036 of the expandable/expansion member 21018, as shown in FIGS. 60- 63.
[00832] In some implementations, the end cap 21066 can include a radial flange 21080 at the proximal end 21074 configured to inhibit over insertion of the end cap 21066 into the passage 21076.
[00833] Referring to FIGS. 60-63, in some implementations, when assembled, the actuation mechanism 21020 can move the expandable/expansion member 21018 between the first and the second configurations. In particular, the distal member 21042 is received within the passage 21027 of the expandable/expansion member 21018.
[00834] In some implementations, the pair of opposed projections 21054 on the distal member 21042 are received within the third pair of radially opposed openings 21040 thus both axially and rotationally fixing the distal member 21042 relative to the expandable/expansion member 21018.
[00835] In some implementations, the distal end portion 21024 of the expandable/expansion member 21018 and/or the distal member 21042 can be configured to move or flex to allow the pair of opposed projections 21054 to be positioned adjacent the third pair of radially opposed openings 21040.
[00836] In some implementations, the distal end portion 21024 of the expandable/expansion member 21018 includes one or more open-ended longitudinal slots 21082 that allow the distal end portion 21024 to flex outward as the pair of opposed projections 21054 are moved into position to be received within the third pair of radially opposed openings 21040. In some implementations, once the pair of opposed projections 21054 are received within the third pair of radially opposed openings 21040, the distal end portion 21024 returns back to its normal state.
[00837] In some implementations, the stop 21064 is received within the passage 21027 such that the pair of opposed projections 21070 are received within the second pair of radially opposed openings 21038 of the expandable/expansion member 21018. In some implementations, the proximal end portion 21022 of the expandable/expansion member 21018 and/or the stop 21064 can be configured to move or flex to allow the pair of opposed projections 21070 to be positioned adjacent the second pair of radially opposed openings 21038.
[00838] In some implementations, the proximal end portion 21022 of the expandable/expansion member 21018 includes one or more open-ended longitudinal slots 21084 that allow the proximal end portion 21022 to flex outward as the pair of opposed projections 21070 are moved into position to be received within the second pair of radially opposed openings 21038. In some implementations, once the pair of opposed projections 21070 are received within the second pair of radially opposed openings 21038, the proximal end portion 21022 returns back to its normal state.
[00839] In some implementations, the proximal member 21044 is received within the passage 21027 proximate to the distal member 21042. In some implementations, the distal end 21058 of the proximal member 21044 is received in the passage 21050 in the proximal end 21046 of the distal member 21042 such that the male threads 21060 of the proximal member 21044 threadably engage the female threads 21052 of the distal member 21042. In some implementations, the proximal member 21044 is threaded into the distal member 21042 until the ridge 21062 engages the stop 21064.
[00840] In some implementations, the distal end 21072 of the end cap 21066 is received within the passage 21027 such that the pair of opposed projections 21078 are received within the first pair of radially opposed openings 21036 of the expandable/expansion member 21018. The proximal end portion 21022 of the expandable/expansion member 21018 and/or the end cap 21066 can be configured to move or flex to allow the pair of opposed projections 21078 to be positioned adjacent the first pair of radially opposed openings 21036.
[00841] In some implementations, the proximal end portion 21022 of the expandable/expansion member 21018 includes the open-ended longitudinal slots 21084 that allow the proximal end portion 21022 to flex outward as the pair of opposed projections 21078 are moved into position to be received within the first pair of radially opposed openings 21036. In some implementations, once the pair of opposed projections 21078 are received within the first pair of radially opposed openings 21036, the proximal end portion 21022 returns back to its normal state. [00842] As shown in FIGS. 60-61, in some implementations, when assembled, the ridge 21062 is sandwiched between the end cap 21066 and the stop 21064 such that axial movement of the proximal member 21044 relative to the proximal end portion 21022 of the expandable/expansion member 21018 is inhibited. Rotational movement of the proximal member 21044, however, is allowed.
[00843] In some implementations, a rotational device or tool (not shown) can engage the one or more engagement surfaces 21077 via the passage 21076 in the end cap 21066 to rotate the proximal member 21044 in a first rotational direction (i.e., to thread the proximal member 21044 into the distal member 21042). With the proximal member 21044 axially fixed to the proximal end portion 21022 of the expandable/expansion member 21018 and the distal member 21042 axially fixed to the distal end portion 21024 of the expandable/expansion member 21018, threading the proximal member 21044 into the distal member 21042 draws the proximal end portion 21022 of the expandable/expansion member 21018 toward the distal end portion 21024. As a result, the strips 21028 of the intermediate portion 21026 bend or flex outward.
[00844] Any number of strips 21028 can be included. For example, the expandable/expansion member 21018 can include two strips 21028 and two attached anchors 5721 when the device 5701 is configured for a mitral valve, can include three strips 21028 (see FIG. 57A) and three attached anchors 5721 when the device 5701 is configured for a tricuspid valve. The expandable/expansion member 21018 can include strips that are in addition to the strips 21028 with attached anchors 5721. These additional strips strengthen and/or help to stabilize the expandable/expansion member 21018 as the anchors 5721 are moved toward and away from one another. Since the intermediate portion 21034 of the strips 21028 are attached to the anchors 5721, the outward expansion of the strips 21028 causes the outward separation of the anchors 5721. In some implementations, the strips can optionally be configured to flex laterally and/or rotationally to allow relative movement between anchors 5721 that are attached to native valve leaflets and/or to allow relative movement between an anchor that is attached to a native valve leaflet and a remainer of the anchors 5721 and/or the expandable/expansion member 21018.
[00845] Conversely, in some implementations, rotating the proximal member 21044 in a second rotational direction (i.e., to thread the proximal member 21044 out of the distal member 21042) pushes the proximal end portion 21022 of the expandable/expansion member 21018 away from the distal end portion 21024. As a result, the strips 21028 of the intermediate portion 21026 are pulled inward causing the inward movement of the anchors 5721.
[00846] FIGS. 64-68 illustrate an example expandable mechanism 22016 usable to move anchors 5721 relatively apart. The expandable mechanism can be the same as or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism can comprise one or more of a balloon, expandable container, expandable material, self-expanding material, self-expanding frame, stent, mechanically-expandable frame, pivoting and/or scissoring extensions and/or struts, expanding pully mechanism, Hoberman mechanism, cam, worm screw, rack and pinion, foam, etc.
[00847] In some implementations, the expandable mechanism 22016 can be connected to a plurality of anchors 5721. The example expandable mechanism 22016 includes an expandable/expansion member 22018 and an actuation mechanism 22020 (FIGS. 64-65)
[00848] The expandable/expansion member 22018 can be configured in a variety of ways. In the illustrated example, the expandable/expansion member 22018 is substantially similar to the expandable/expansion member 21018 of FIGS. 57-58, thus the description of the expandable/expansion member 21018 applies equally to the expandable/expansion member 22018.
[00849] In some implementations, the expandable/expansion member 22018 is configured as an elongated cylindrical shape having a proximal end portion 22022, a distal end portion 22024, an intermediate portion 22026, and a passage 22027 extending through the expandable/expansion member 22018 from the proximal end portion 22022 to the distal end portion 22024.
[00850] In some implementations, the intermediate portion 22026 can comprise and/or be formed from a plurality of strips 22028 (FIG. 64) that are configured to bend or flex.
[00851] In some implementations, the expandable/expansion member 22018 can include structure configured to mount the actuation mechanism 22020 within the expandable/expansion member 22018. In some implementations, the proximal end portion 22022 of the expandable/expansion member 22018 includes a first pair of radially opposed openings 22036, and a second pair of radially opposed openings 22038 distal to the first pair of radially opposed openings 22036 and the distal end portion 22024 of the expandable/expansion member 22018 includes a third pair of radially opposed openings 22040.
[00852] In some implementations, the expandable/expansion member 22018 is movable between a first configuration (i.e., collapsed or narrow configuration) and a second configuration (i.e., expanded or wide configuration). As shown in FIG. 64, in some implementations, in the first configuration, each of the plurality of strips 22028 extend parallel to a longitudinal axis LA2 of the expandable/expansion member 22018 and, in the second configuration (see FIG. 57), the strips 22028 bend or flex outward such that the intermediate portion 22026 expands radially outward.
[00853] In some implementations, the actuation mechanism 22020 is configured to move the expandable/expansion member 22018 between the first and the second configurations. The actuation mechanism 22020 can be configured in a variety of ways. Referring to FIGS. 65-68, in some implementations, the actuation mechanism 22020 includes a distal member 22042 and a proximal member 22044.
[00854] The distal member 22042 and the proximal member 22044 can be configured in a variety of ways. In the illustrated example, the distal member 22042 is formed as a cylindrical tube having a side wall 22045 with a circular cross section. In some implementations, however, the distal member 22042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
[00855] In some implementations, the distal member 22042 includes a proximal end 22046, a distal end 22048 opposite the proximal end 22046, and an inner passage 22050 extending through the distal member 22042 member from the proximal end 22046 to the distal end 22048. In some implementations, the proximal end 22046 includes a coupling portion 22051 configured to couple to an actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.) (not shown).
[00856] In some implementations, the distal member 22042 includes one or more locking members 22052 configured to engage the proximal member 22044 to lock the position of the distal member 22042 relative to the proximal member 22044. The one or more locking members 22052 can be configured in a variety of ways. [00857] In the illustrated example, each locking member 22052 can comprise and/or be formed from the side wall 22045. For example, each locking member 22052 can be formed from laser cuts through the side wall 22045. Each locking member 22052 can include a first end 22053, a second end 22057 opposite the first end 22053, and an intermediate portion 22059 between the first end 22053 and the second end 22057.
[00858] In some implementations, each locking member 22052 is configured to pivot about the intermediate portion 22059 between a first position in which the locking member 22052 is parallel with the side wall 22045, as shown in FIGS. 65-68, and a second position (not shown) in which the locking member 22052 pivots such that the first end 22053 extends external to the side wall 22045 and the second end 22057 extends into the passage 22050.
[00859] In some implementations, each locking member 22052 is biased to the second position. For example, at least a portion of the distal member 22042 can include a shape memory alloy and the one or more locking members 22052 can be shape set to the second position.
[00860] In some implementations, the distal member 22042 is sized to be received within the passage 22027 of the expandable/expansion member 21018. In some implementations, the distal member 22042 can include structure for fixing the distal member 22042 in position within the passage 22027 relative to the expandable/expansion member 22018. In the illustrated example, the distal end 22048 includes a pair of apertures 22061.
[00861] In some implementations, the proximal member 22044 is formed as a cylindrical tube having a side wall 22055 with a circular cross section. In some implementations, however, the proximal member 22044 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
[00862] In some implementations, the proximal member 22044 includes a proximal end 22056, a distal end 22058 opposite the proximal end 22056, and an inner passage 22063 extending through the proximal member 22044 from the proximal end 22056 to the distal end 22058. In some implementations, the proximal member 22044 includes structure configured to interact with the one or more locking members 22052 of the distal member 22042. In some implementations, the structure is formed as two series of slots 22060 formed in the side wall 22055 on opposite sides of each other. Each slot 22060 can be arranged transverse (e.g., perpendicular) to the longitudinal axis LA2 and each series of slots 22060 can be aligned with a locking member 22052.
[00863] In some implementations, the proximal member 22044 is sized to be received within the passage 22027 of the expandable/expansion member 22018. In some implementations, the proximal member 22044 includes structure for restricting rotational movement of the proximal member 22044 within the passage 22027 relative to the expandable/expansion member 22018. The structure for restricting axial movement of the proximal member 21044 can be configured in a variety of ways. In some implementations, the proximal member 22044 includes one or more tabs 22062 extending axially from the proximal end 22056.
[00864] In some implementations, the actuation mechanism 22020 includes an end cap 22066. The end cap 22066 can be configured in a variety of ways. In some implementations, the end cap 22066 is configured to inhibit movement of the proximal member 22044 proximally and rotationally within the passage 22027.
[00865] In some implementations, the end cap 22066 is formed as a ring having a distal end 22072, a proximal end 22074 opposite the distal end 22072, and a central passage 22076 extending through the end cap 22066 from the distal end 22072 to the proximal end 22074. In some implementations, the end cap 22066 is configured to receive each of the one or more tabs 22062 in a groove or recess 22077 to inhibit rotation of the proximal member 22044 within the passage 22027.
[00866] In some implementations, the distal end 22072 of the end cap 22066 is sized to be received within the passage 22027. In some implementations, the end cap 22066 can include structure configured to fix the position of the end cap 22066 relative to the expandable/expansion member 22018.
[00867] In some implementations, the end cap 22066 includes a pair of opposed projections 22078 at the distal end 22072 that are configured to be received within the first pair of radially opposed openings 22036 of the expandable/expansion member 22018, as shown in FIGS. 60- 63. In some implementations, the end cap 22066 can include a radial flange 22080 at the proximal end 22074 configured to inhibit over insertion of the end cap 22066 into the passage 22076. [00868] In some implementations, the actuation mechanism 22020 includes a stop 22084 (FIG. 65) to restrict movement of the distal member 22042 relative to the expandable/expansion member 22018. The stop 22084 can be configured in a variety of ways. In some implementations, the stop 22084 is formed as a ring having a central passage 22088 sized to receive the distal end 22048 of the distal member 22042 therein.
[00869] In some implementations, the stop 22084 is further sized to be received within the passage 22027 of the expandable/expansion member 22018. In some implementations, the stop 22084 can include structure configured to fix the position of the distal member 22042 relative to the expandable/expansion member 22018. In some implementations, the stop 22084 includes a pair of opposed first projections 22090 extending radially outward and configured to be received within the third pair of radially opposed openings 22040 of the expandable/expansion member 22018, as shown in FIGS. 64 and 67. In some implementations, the stop 22084 includes a pair of opposed second projections 22092 extending radially inward and configured to be received within the pair of apertures 22061 at the distal end 22048 of the distal member 22042.
[00870] In some implementations, when assembled, the actuation mechanism 22020 can move the expandable/expansion member 22018 between the first and the second configurations. Referring to FIGS. 66-68, the distal member 22042 is received within the passage 22027 of the expandable/expansion member 21018. In some implementations, the stop 22084 is positioned within the 22027 such that the pair of opposed first projections 22090 are received within the third pair of radially opposed openings 22040 of the expandable/expansion member 22018 and the pair of opposed second projections are received within the pair of apertures 22061 at the distal end 22048 of the distal member 22042. As a result, the distal member 22042 is held in position relative to the expandable/expansion member 22018.
[00871] Further, in some implementations, the proximal member 22044 is received within the passage 22027 of the expandable/expansion member 22018 and the proximal end 22046 of the distal member 22042 is received within the passage 22063 of the proximal member 22044. In some implementations, the distal end 22072 of the end cap 22066 is secured to the proximal member. [00872] In some implementations, the distal end 22072 of the end cap 22066 can be received within the passage 22027 such that the projections 22078 of the end cap 22066 are received in the first pair of radially opposed openings 22036 of the expandable/expansion member 22018. As a result, the end cap 22066 fixes the proximal member 22044 at the proximal end portion 22022 of the expandable/expansion member 22018.
[00873] In some implementations, the proximal member 22044 is separate from the end cap 22066 and the proximal member 22044 is separately attached to the expandable/expansion member 22018. For example, the proximal member 22044 can be secured to the expandable/expansion member 22018 in the same or similar manner that the proximal member 21044 is attached to the expandable/expansion member 21018 in the implementation illustrated by FIGS. 59-63.
[00874] In some implementations, the device (e.g., device 101 or another device herein) can be delivered by a delivery system (e.g., delivery system 102). In some implementations, the delivery system can include a first actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.) (not shown) that extends through the passage 22076 in the end cap 22066, through the passage 22063 in the proximal member 22044, and couples to the coupling portion 22051 at the proximal end 22046 of the distal member 22042.
[00875] In some implementations, the delivery system can include an optional second actuation element (e.g., actuation shaft, actuation rod, actuation tube, actuation wire, etc.) (not shown) that extends coaxially through the first actuation element (not shown) and into the passage 22050 of the distal member 22042.
[00876] In some implementations, with the first and/or second actuation member (not shown) in position within the passage 22050 adjacent the one or more locking members 22052, the locking members 22052 are held in the first configuration by the first actuation member and/or the second actuation member. Conversely, when the first actuation member and/or the second actuation member (not shown) is moved within the passage 22050 such that the first and/or second actuation member (not shown) is not adjacent the one or more locking members 22052, the locking members 22052 move to their second configuration (e.g., the outwardly extending, locking configuration). [00877] In some implementations, to move the expandable/expansion member 22018 between the first configuration and the second configuration, the distal member 22042 can be moved axially within the passage 22063 of the proximal member 22044.
[00878] In some implementations, the distal member 22042 can be moved proximally within the passage 22063 by pulling on the first actuation element (not shown) which is coupled to the proximal end 22046 of the distal member 22042. Since the distal end 22048 of the distal member 22042 is fixed to the distal end portion 22024 of the expandable/expansion member 22018 by the stop 22084 and the end cap 22066 fixes the proximal member 22044 in place relative to the expandable/expansion member 22018, pulling on the first actuation element (not shown) with sufficient force moves the distal end portion 22024 of the expandable/expansion member 22018 closer to the proximal end portion 22022 of the expandable/expansion member 22018. As a result, the strips 22028 of the intermediate portion 22026 bend or flex outward. Since the strips 22028 are attached to the anchors 5721, the outward expansion of the strips 22028 causes the anchors to move apart.
[00879] In some implementations, once the expandable/expansion member 22018, and thus the expandable coaptation element, has been expanded to the desired width or diameter, the distal member 22042 can be locked in position relative to the proximal member 22044. In particular, the first actuation member and/or second actuation member (not shown) can be moved axially within the passage 22050 such that the first actuation member and/or the optional second actuation member (not shown) is not adjacent the one or more locking members 22052. As a result, one or more locking members 22052 pivot to their second configuration resulting in the first end 22053 of each of the locking members 22052 engaging with one of the slots 22060 in the proximal member 22044. In some implementations, the engagement of the first end 22053 of each of the locking members 22052 with a corresponding slot 22060 locks the distal member 22042 from moving axially within the passage 22063 in the proximal direction.
[00880] In some implementations, the expandable/expansion member 22018 can be configured to be normally in the first configuration (i.e., collapsed or narrow), in the second configuration (i.e., expanded or wide), or some intermediate position between the first and the second configuration. In some implementations, movement of the distal member 22042 relative to the proximal member 22044 pulls the expandable/expansion member 22018 inward toward the first position against a bias of the frame member and/or the expandable/expansion member 22018 or, in some implementations, pushes the frame member and/or the expandable/expansion member 22018 outward to the second position against a bias of the frame member and/or the expandable/expansion member 22018.
[00881] FIG. 69 illustrates an example expandable mechanism 22116 usable and/or for use in moving anchors 5721 toward and away from one another. The expandable mechanism 22116 can be the same as or similar to any of the expandable mechanisms described anywhere in this disclosure. The expandable mechanism can comprise one or more of a balloon, expandable container, expandable material, self-expanding material, self-expanding frame, stent, mechanically-expandable frame, pivoting and/or scissoring extensions and/or struts, expanding pully mechanism, Hoberman mechanism, cam, worm screw, rack and pinion, foam, etc.
[00882] In the illustrated example, the expandable/expansion member 22118 is substantially similar to the expandable/expansion member 21018 of FIGS. 57-58, thus the description of the expandable/expansion member 21018 applies equally to the expandable/expansion member 22118. In particular, the expandable/expansion member 22118 is configured as an elongated cylindrical shape having a proximal end portion 22122, a distal end portion 22124, an intermediate portion 22126, and a passage 22127 extending through the expandable/expansion member 22118 from the proximal end portion 22122 to the distal end portion 22124. In some implementations, the intermediate portion 22126 can comprise and/or be formed from a plurality of strips 22128 that are configured to bend or flex.
[00883] In some implementations, the expandable/expansion member 22118 is movable between a first configuration (i.e., collapsed or narrow configuration) (e.g., FIG. 88 for expandable/expansion member 21018) and a second configuration (i.e., expanded or wide configuration), as shown in FIG. 69. In some implementations, in the first configuration, each of the plurality of strips 22128 extend parallel to a longitudinal axis LA3 of the expandable/expansion member 22118 and, in the second configuration, the strips 22128 bend or flex outward such that the intermediate portion 22126 expands radially outward.
[00884] The actuation mechanism 22120 can be configured in a variety of ways, e.g., in any of the ways other actuation mechanisms are configured herein. In the illustrated example, the actuation mechanism 22120 includes a distal member 22142 and a proximal member 22144. In some implementations, the distal member 22142 and proximal member 22144 are arranged coaxially in a telescoping fashion such that a portion of the proximal member 22144 is received within the distal member 22142 and can move axially relative to the distal member 22142 or vice versa. In some implementations, the movement of the distal member 22142 and the proximal member 22144 axially relative to each other moves the expandable/expansion member 22118 between a first configuration and a second configuration. The distal member 22142 and the proximal member 22144 are movable relative to each other by any suitable means, such as for example, any of the actuation mechanisms disclosed herein.
[00885] The plurality of anchors 5721 can take a variety of different forms. In some implementations, the plurality of tethered anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIG. 57A, the anchors each include a paddle 5715 and an optional gripping member 5733, such as a clasp. In some implementations, a paddle alone can be secured to a native valve leaflet and the optional gripping member 5733 can be omitted.
[00886] The paddle 5715 can take a variety of different forms. In some implementations, the paddle 5715 can be any of the paddles disclosed by the present application. In some implementations, the paddle 5715 includes an inner arm 5760 and an outer arm 5762. The outer arm 5762 can be pivotally and/or flexibly coupled to the inner arm 5760.
[00887] In some implementations, the outer arm 5762 can move between a closed position and an open position. In some implementations, the outer arm 5762 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position and the actuator 5750 can move the outer arm to the open position against the bias.
[00888] In some implementations, the outer arm 5762 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position and an actuator can move the outer arm to the closed position against the bias. In some implementations, the outer arm 5762 is not biased open or closed.
[00889] In some implementations, the inner arm 5760 of each paddle 5715 is attached to one of the strips 21028 of the expandable/expansion member 21018. The one or more strips 21028 are used to selectively pull the anchors 5721 inward or toward one another and to selectively move the anchors 5721 away from one another. [00890] The optional gripping member 5733 can take a variety of different forms. In some implementations, the optional gripping member 5733 can be any of the gripping members or clasps disclosed herein. In some implementations, the optional gripping member 5733 includes a fixed arm 5790, a movable arm 5792, and a hinge portion 5794 that connects the fixed arm 5790 to the movable arm 5792. In some implementations, the gripping member can have optional barbs 5737. In in some implementations, the fixed arm 5790 is fixed to the outer arm 5762 of the paddle 5715, such as to an extension 5780 of the outer arm 5762.
[00891] In some implementations, the movable arm 5792 can be moved relative to the fixed arm 5790 between an open position and a closed position. The movable arm 5792 can be moved relative to the fixed arm 5790 in a variety of different ways. In some implementations, a line 5796 (e.g., suture, wire, chord, hypotube, etc.) can be used to move the movable arm 5792. The line 5796 can be attached to the movable arm 5792 and pulled to open the gripping member 5733. In some implementations, the hinge portion 5794 is shape set and/or provides a spring bias to bias the gripping member 5733 to the closed position. Relieving tension or slackening the line 5796 allows the gripping member 5733 to move to the closed position.
[00892] In some implementations, the device 5701 can include two anchors 5721 when the device is configured to treat a mitral valve or two leaflets of a tricuspid valve. In some implementation, the device 5701 can include three anchors 5721 when the device 5701 is configured to treat a tricuspid valve. The device can include any number of anchors 5721. The strips 21028 of the expandable/expansion member 21018 move all attached anchors toward and away from one another.
[00893] In some implementations, the device 5701 is moved to position a leaflet 20 in an open gripping member 5733 and the outer arm 5762 of one of the anchors 5721. The line 5796 can then be slackened to close the gripping member 5733 and attach the gripping member 5733 to the first leaflet 20. The line 5796 can be removed from the gripping member 5733 any at any time after the first leaflet is secured in the first anchor.
[00894] In some implementations, the strips 21028 of the expandable/expansion member 21018 can be flexible to allow the one or more additional anchors 5721 to be moved to corresponding native valve leaflets while the first leaflet 20 is attached to the first anchor 5721. In some implementations, an actuator 5750 can be used to move the next paddle 5715 to an open position and one or more of the lines 5796 can be pulled to move the movable arm 5792 of the next gripping member 5733 toward an open position.
[00895] In some implementations, the device 5701 is moved to position a second leaflet 22 in the open gripping member 5733 and the outer arm 5762 of a second one of the anchors 5721. The line 5796 can then be slackened to close the gripping member 5733 and attach the gripping member 5733 to the second leaflet 22. The line 5796 can be removed from the gripping member 5733 any at any time after the second leaflet is secured in the first anchor. In some implementations, the actuator 5750 can also move the second paddle to the closed position or the second paddle can be moved to the closed position after the anchors 5721 are drawn back together.
[00896] This process for capturing native valve leaflets can be repeated for a third anchor 5721 (if included) and any additional anchors (if included). In some implementations, once all of the anchors 5721 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the strips 21028 of the expandable/expansion member 21018 can draw the anchors 5721 toward one another. If not already done so (e.g., at the same time the gripping members are attached to the native valve leaflets), any paddles that are still open can 5715 can be closed.
[00897] In some implementations, after the anchors 5721 are pulled together by the strips 21028 of the expandable/expansion member 21018, the delivery system can be decoupled from the device 5701. This leaves the device 5701 secured to the native valve leaflets.
[00898] FIGS. 70-72 illustrate an example of a device 7001 where gripping members 7033 are movable toward and away from on another by paddles 7015 that are tillable toward and away from one another. In some implementations, the paddles 7015 can be tilted toward and away from one another in a variety of different ways.
[00899] In the example illustrated by FIGS. 70-72, a valve repair system 7000 includes the valve repair device 7001 with a plurality of anchors 7021 that are tiltable toward and away from one another by an actuator 7050. The valve repair device can take a variety of different forms. In some implementations, the valve repair device 7001 includes a central body 7031, a plurality of anchors 7021, and an actuator end 7051. [00900] The central body 7031 can take a variety of different forms. In some implementations, the central body 7031 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 7031 includes a bore or passage 7035 that a shaft 7053 of the actuator end 7051 extends through and that inner tilting arms 7060 of paddles 7015 extend into.
[00901] The plurality of anchors 7021 can take a variety of different forms. In some implementations, the plurality of anchors can be any of the anchors disclosed by the present application.
[00902] In the example illustrated by FIGS. 70-72, the anchors each include a paddle 7015 and an optional gripping member 7033, such as a clasp. In some implementations, a paddle alone can be secured to a native valve leaflet and the optional gripping member 7033 can be omitted.
[00903] The paddle 7015 can take a variety of different forms. In some implementations, the paddle 7015 can be any of the paddles disclosed by the present application. In some implementations, the paddle 7015 includes the inner tilting arm 7060 and an outer arm 7062. In some implementations, the outer arm 7062 can be pivotally and/or flexibly coupled to the inner arm 7060.
[00904] In some implementations, the outer arm 7062 can move between a closed position (FIG. 71) and an open position (FIG. 70). In some implementations, the outer arm 7062 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position and is moved to the open position (e.g., in any of the ways disclosed herein) against the bias. In some implementations, the outer arm 7062 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position and moved to the closed position against the bias. In some implementations, the outer arm 7062 is not biased open or closed.
[00905] In some implementations, the inner tilting arm 7060 is tilted by moving the actuator end 7051. The inner tilting arm 7060 can be tilted by the actuator end 7051 in a variety of different ways. Any arrangement that allows all paddles 7015 that have at least a portion of the inner tilting arm 7060 in the bore or passage 7035 of the central body 7031 to be tilted toward and away from one another by the actuator end 7051 can be used.
[00906] In the example illustrated by FIGS. 70-72, engagement of a portion of the inner tilting arm 7060 in the central body 7031 by the actuator end 7051 tilts the inner arms 7060 toward or away from one another. In the example illustrated by FIGS. 70-72, upward or proximal movement of the actuator end 7051 causes the inner arm 7060 to tilt inward or move to a more upright position. In some implementations, downward or distal movement of the actuator end 7051 causes the inner arm 7060 to tilt outward or move to a more tilted position.
[00907] In some implementations, the outer arm 7062 is opened and/or closed relative to the inner arm 7060 with an actuation element 7150, such as a line, wire, hypotube, suture, etc. In some implementations, the outer arm 7062 is opened by pulling with the actuation element 7150. Any arrangement that allows the paddles 7015 to be opened and/or closed can be used.
[00908] In some implementations, the inner tilting arm 7060 of each paddle 7015 is coupled to the central body 7031 by the actuator 7050. In some implementations, and the inner tilting arm 7060 is optionally coupled by one or more tethers or other coupling arrangements that prevent or inhibit the inner tilting arm 7060 from completely separating from the central body 7031.
[00909] The actuator 7050 can take a variety of different forms. In some implementations, the actuator 7050 includes a proximal shaft 7080 and the actuator end 7051. In some implementations, the proximal shaft 7080 can be selectively connected and disconnected from the actuator end 7051 at a joint 7083. This allows the actuator end 7051 to be operated by the proximal shaft 7080 during implantation of the valve repair device 7001 and allows the actuator end 7051 to be disconnected at the joint 7083 and left with the remainder of the valve repair device 7001 after the implantation procedure.
[00910] The actuator end 7051 can take a variety of different forms. Any arrangement that tilts the inner tilting arm 7060 of the paddles 7015 by pulling the inner tilting arm into the central body 7031 and/or pushing the inner tilting arm out of the central body 7031 can be used.
[00911] In the example illustrated by FIGS. 70-72, the actuator end 7051includes the shaft 7053 and one or more actuation extension, plate, or disc 7084. In some implementations, the actuation extension, plate, or disc 7084 can be configured such that engagement of the inner tilting arm 7060 of the paddle 7015 by the one or more actuation extension, plate, or disc 7084 tilts the inner tilting arms 7060 of the paddles toward or away from one another.
[00912] In the example illustrated by FIGS. 70-72, upward or proximal movement of the one or more actuation extension, plate, or disc 7084 pulls the one or more inner tilting arms 7060 further into the central body 7031 to move the one or more tilting arms to a more upright position. In some implementations, downward or distal movement of the one or more actuation extension, plate, or disc 7084 pushes the one or more inner tilting arms 7060 further out of the central body 7031 to move the one or more tilting arms to a more tilted position.
[00913] The optional gripping member 7033 can take a variety of different forms. In some implementations, the optional gripping member 7033 can be any of the gripping members or clasps disclosed herein. In some implementations, the optional gripping member 7033 includes a fixed arm 7090, a movable arm 7092, and a hinge portion 7094 that connects the fixed arm 7090 to the movable arm 7092. The gripping member can have optional barbs.
[00914] In some implementations, the fixed arm 7090 is fixed to the outer arm 7062 of the paddle 7015. In some implementations, the movable arm 7092 can be moved relative to the fixed arm 7090 between an open position and a closed position.
[00915] The movable arm 7092 can be moved relative to the fixed arm 7090 in a variety of different ways. In some implementations, a line 7096 (e.g., suture, wire, chord, hypotube, etc.) can be used to move the movable arm 7092. The line 7096 can be attached to the movable arm 7092 and pulled to open the gripping member 7033. In some implementations, the hinge portion 7094 is shape set and/or provides a spring bias to bias the gripping member 7033 to the closed position. Relieving tension or slackening the line 7096 allows the gripping member 7033 to move to the closed position.
[00916] In some implementations, the device 7001 can include two anchors 7021 when the device is configured to treat a mitral valve or two leaflets of a tricuspid valve and the device 7001 can include three anchors 7021 when the device 7001 is configured to treat a tricuspid valve. The device can include any number of anchors 7021. The actuator end 7051 tilts all anchors toward and away from one another. [00917] In some implementations, the device 7001 is moved to position a leaflet 20 in an open gripping member 7033 and the outer arm 7062 of one of the anchors 7021. The line 7096 can then be slackened to close the gripping member 7033 and attach the gripping member 7033 to the first leaflet 20. The line 7096 can be removed from the gripping member 7033 any at any time after the first leaflet is secured in the first anchor.
[00918] In some implementations, the tilting of the tilting arm 7060 can allow the one or more additional anchors 7021 to be moved to corresponding native valve leaflets while the first leaflet 20 is attached to the first anchor 7021.
[00919] In some implementations, the actuator end 7051 is moved distally to tilt all of the anchors 7021. In some implementations, the actuator 7150 can be used to move the next paddle 7015 to an open position and one or more of the lines 7096 can be pulled to move the movable arm 7092 of the next gripping member 7033 toward an open position.
[00920] In some implementations, the device 7001 is moved to position a second leaflet 22 in the open gripping member 7033 and the outer arm 7062 of a second one of the anchors 7021. In some implementations, the line 7096 can then be slackened to close the gripping member 7033 and attach the gripping member 7033 to the second leaflet 22. The line 7096 can be removed from the gripping member 7033 any at any time after the second leaflet is secured in the first anchor. In some implementations, the actuator 7150 can also move the second paddle to the closed position or the second paddle can be moved to the closed position after the anchors 5721 are tilted back together.
[00921] This process for capturing native valve leaflets can be repeated for a third anchor 7021 (if included) and any additional anchors (if included). In some implementations, once all of the anchors 7021 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the actuator end 7051 can pull the tilt arms 7060 into the central body 7031 to move the anchors to a more upright orientation.
[00922] In some implementations, after the anchors 7021 are tilted to the more upright position, the delivery system can be decoupled from the device 7001. This leaves the device 7001 secured to the native valve leaflets. [00923] In some implementations, a valve repair device 7301 is configured to move gripping members 73608 inward (e.g. toward one another) and outward (away from one another). The valve repair device 7301 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 7301 includes a central body 7331 and a plurality of anchors 7321.
[00924] The central body 7331 can take a variety of different forms. In some implementations, the central body 7331 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 7331 includes a bore or passage 7335 that one or more actuation elements extend into.
[00925] The plurality of anchors 7321 can take a variety of different forms. In some implementations, the plurality of anchors can be any of the anchors disclosed by the present application. In the example illustrated by FIGS. 73 and 74A-74E, the anchors each include a paddle 73606 and a gripping member 73608, such as a clasp.
[00926] The paddle 73606 can take a variety of different forms. In some implementations, the paddle 73606 can be any of the paddles disclosed by the present application. In some implementations, the paddle 73606 can include an outer arm 7362. In some implementations, the outer arm 7362 can move between a closed position and an open position.
[00927] In some implementations, the outer arm 7362 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position and is moved to the open position (e.g., in any of the ways disclosed herein) against the bias. In some implementations, the outer arm 7362 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position and moved to the closed position against the bias. In some implementations, the outer arm 7362 is not biased open or closed.
[00928] In some implementations, the paddle 73606 is fixedly connected to the central body 7331 . In some implementations, the paddle 73606 is coupled to the central body 7331 by one or more tethers. When included, the one or more tethers can allow the paddle 73606 to move toward and away from the central body 7331 in any of the manners disclosed herein. [00929] In some implementations, the outer arm 7362 is opened and/or closed with an actuation element, such as any of the actuation elements used to open any of the paddles as described herein (e.g., wire, rod, tube, shaft, flexible shaft, hypotube, suture, etc.). Any arrangement that allows the paddles 73606 to be opened and/or closed can be used.
[00930] The gripping member 73608 can take a variety of different forms. In some implementations, the optional gripping member 73608 can be any of the gripping members or clasps disclosed herein. In some implementations, the optional gripping member 73608 includes a sliding arm 7390, a movable arm 7392, and a hinge portion 7394 that connects the sliding arm 7390 to the movable arm 7392. In some implementations, the gripping member can have optional barbs 73609.
[00931] In in some implementations, the sliding arm 7390 is coupled to the outer arm 7362 of the paddle 73606. The movable arm 7392 can be moved relative to the sliding arm 7390 between an open position and a closed position. The movable arm 7392 can be moved relative to the sliding arm 7390 in a variety of different ways. In some implementations, a line 7396 (e.g., suture, wire, chord, hypotube, etc.) can be used to move the movable arm 7392. The line 7396 can be attached to the movable arm 7392 and pulled to open the gripping member 73608.
[00932] In some implementations, the hinge portion 7394 is shape set and/or provides a spring bias to bias the gripping member 73608 to the closed position. Relieving tension or slackening the line 7396 allows the gripping member 7033 to move to the closed position.
[00933] In some implementations, the device 7301 can include two anchors 7321 when the device is configured to treat a mitral valve or two leaflets of a tricuspid valve and the device 7301 can include three anchors 7321 when the device 7301 is configured to treat a tricuspid valve as illustrated by FIG. 73. The device can include any number of anchors 7321.
[00934] In the example shown in FIGS. 74A-74E, the gripping member 73608 is configured to slide inward and outward relative to the central body 7331 to facilitate capture of spaced apart leaflets. In some implementations, the gripping member 73608 is slidably connected to the paddle 73606, such that the gripping member 73608 can be moved along the paddle in the direction X. In some implementations, a gripper control mechanism 73611 can be used to move the gripping member 73608 along the paddle 73606 in the direction X. [00935] In some implementations, the gripper control mechanism 73611 can also be used to move the gripping member 73608 between the closed position (as shown in FIG. 74A) and the open position (as shown in FIG. 74B). In some implementations, the gripper control mechanism 73611 is separate from a mechanism 7396 that is used to open and close the gripping members 73608. The gripper control mechanism(s) 73611 and/or 7396 can take any form described in the present application.
[00936] In some implementations, the valve repair device 7301 includes an optional biasing member 5122 (e.g., a spring) configured to maintain the gripping member 73608 in a desired position along the paddle 73606 (e.g., the position shown in FIGS. 74A and 74E - pulled toward the central body 7331).
[00937] In some implementations, the gripping member 73608 includes a single row of barbs 73609 at a proximal end of the gripping members, however, it should be understood that the features described herein regarding FIGS. 74A-74E can be used with any of the examples of the valve repair device described in the present application.
[00938] Referring to FIG. 74A, the gripping member 73608 is shown in a first position on the paddle 73606 and in a closed position. Referring to FIG. 74B, the gripping member 73608 is shown after it has been moved in the direction Z to an open position by the gripper control mechanism 7396. Referring to FIG. 74C, the gripping member 73608 is shown after it has been moved along the paddle 73606 in the direction D to a second position. In some implementations, the gripping member 73608 is moved along the paddle in the direction D by the gripper control mechanism 73611.
[00939] In some implementations that include the biasing member 5122, enough force needs to be applied on the gripping member 73608 to move the gripping member in the direction D, which will cause the biasing member to expand. While the illustrated example shows the gripping member 73608 being moved to an open position (as shown in FIG. 74B) prior to the gripping member 73608 being moved along the paddle 73606 in the direction D to the second position (as shown in FIG. 74C), it should be understood that gripping member 73608 can be moved in the direction D to the second position prior to the gripping member 73608 being moved in the direction Z to an open position or the movements can be simultaneous. [00940] Referring to FIG. 74D, the gripping member 73608 is moved to a closed position in the direction Y by the gripper control member 7396 to secure the gripping member 73608 to valve tissue (not shown). In the position shown in FIG. 74D, the biasing member 5122 is being maintained in an extended position (e.g., as a result of the force applied to the gripping member 73608 by the gripper control mechanism 73611 (or another mechanism) to keep the gripping member in the second position).
[00941] Referring to FIG. 74E, after the gripping member 73608 is secured to the valve tissue, the force maintaining the gripping member 73608 in the second position can be released, which causes the tensioning force applied by the biasing member 5122 to pull or urge the gripping member 73608 along the paddle 73606 in the direction M. In some implementations, the movement of the gripping member 73608 in the direction M pulls the attached leaflet to toward the central body 7031.
[00942] In some implementations, the device 7301 is moved to position a leaflet 20 in an open gripping member 73608 and the outer arm 7362 of one of the anchors 7321. If the gripping member 73608 does not initially reach the native valve leaflet or cannot reach a desired insertion depth of the leaflet in the gripping member 73608, the gripper control mechanism 73611 can pull the gripping member 73608 along the paddle 73606. As a result, the gripping member 73608 can be extended to an appropriate position for capturing the native valve leaflet.
[00943] In some implementations, the line 7396 can then be slackened to close the gripping member 73608 and attach the gripping member 7033 to the first leaflet 20. In some implementations, the line 7096 can be removed from the gripping member 7033 any at any time after the first leaflet is secured in the first anchor.
[00944] In some implementations, the extension of one or more of the gripping members 73608 can allow the one or more additional anchors 7321 to be moved to corresponding native valve leaflets while the first leaflet 20 is attached to the first anchor 7321. In some implementations, the paddle 73606 can be moved to an open position and one or more of the lines 7396 can be pulled to move the movable arm 7392 of the next gripping member 73608 toward an open position. [00945] In some implementations, the device 7301 is moved to position a second leaflet 22 in the open gripping member 73608 and the outer arm 7362 of a second one of the anchors 7321. If the gripping member 73608 does not initially reach the native valve leaflet or cannot reach a desired insertion depth of the leaflet in the gripping member 73608, the gripper control mechanism 73611 can pull the gripping member 73608 along the paddle 73606. As a result, the gripping member 73608 can be extended to an appropriate position for capturing the second native valve leaflet.
[00946] In some implementations, the line 7396 can then be slackened to close the gripping member 73608 and attach the gripping member 73608 to the second leaflet 22. The line 7396 can be removed from the gripping member 73608 any at any time after the second leaflet is secured in the first anchor.
[00947] In some implementations, this process for capturing native valve leaflets can be repeated for a third anchor 7321 and any additional anchors (if included). Once all of the anchors 7321 are attached to a native valve leaflet (e.g., mitral valve leaflets 20, 22, or tricuspid valve leaflets 30, 32, 34) the gripper control mechanism 73611 can be used (slackened in the illustrated example, but can pull the gripping member 73608 if the spring is oppositely arranged or the spring is omitted) to move the anchors toward the central body 7331.
[00948] In some implementations, after the anchors 7321 are pulled toward the central body 7331, the delivery system can be decoupled from the device 7301. This leaves the device 7301 secured to the native valve leaflets.
[00949] With reference to FIGS. 2-8, 75A, 75B, 75C, 75D, 76, and 77, in some implementations (e.g., in consecutively inserted, center-coupled examples of a treatment or repair system), a treatment or repair device 301 usable and/or for use by medical personnel in treating or repairing a subject’s native mitral heart valve MV, can be constructed or assembled within the heart (at the location of the valve) using a delivery system. Referring to FIG. 75 A, in some implementations, the delivery system is provided with a steering catheter system and/or a steering catheter 303, which can operate similar to other steering catheter systems or steering catheters. Advancing the delivery through the vascular system can involve positioning a distal end of the steering catheter 303 in place upstream of the valve (relative to a blood flow direction) and pointing the distal end of the steering catheter downstream (in the blood flow direction) through the valve.
[00950] Referring to FIGS. 75B-75D, in some implementations, the delivery system is further provided with an implant catheter system that includes one or more implant catheters (which can be the same as or similar to other catheters herein; and can be in addition to or in place of a steering catheter). In some implementations, the implant catheter system comprises a plurality of implant catheters. In some implementations, each implant catheter has a catheter distal end that traverses the steering catheter system for implantation of a treatment/repair device, and a catheter proximal end (e.g., a first catheter proximal end, a second catheter proximal end, and a third catheter proximal end) that is user accessible for a user to remotely manipulate and operate the device during implantation.
[00951] In some implementations, a first implant catheter 311 of the plurality of implant catheters either starts off within the steering catheter system prior to its insertion into the subject’s body or is inserted into a proximal (user) end of the steering catheter system (the proximal end of which extends outside the subject’s body) after the distal end of the steering catheter system is positioned upstream of the mitral valve MV. In some implementations, with the steering catheter system inserted in place and the first implant catheter 311 inserted in the steering catheter system, a first catheter distal end of the first implant catheter 311 is extended from within steering catheter system, downstream toward the mitral valve (similar to the implant catheter depicted in FIG. 9).
[00952] In some implementations, at its first catheter distal end, the first implant catheter 311 carries a first leaflet anchor 313 of the plurality of leaflet anchors of the device. Each leaflet anchor of the plurality of leaflet anchors is in the form of an actuatable clip with independent actuators and actuation controls such that each anchor can be separately and independently affixed to respective leaflet locations. In some implementations, the leaflet anchors are structurally adapted to affix to a leaflet by clipping onto a leaflet.
[00953] In some implementations, each of the plurality of leaflet anchors is provided with and attached to the distal end of an implant catheter (of the one or more implant catheters) by a respective anchor connector (of a plurality of anchor connectors), e.g., the first leaflet anchor 313 is attached to the first implant catheter 311 by a first anchor connector 321 , a second leaflet anchor 315 is attached to a second implant catheter 316 by a second anchor connector 323, a third leaflet anchor is attached to a third implant catheter by a third anchor connector, and so on. Additional leaflet anchors can optionally be is attached to implant catheters by respective additional anchor connectors. In some implementations, each anchor connector has a respective catheter connector (e.g., a first catheter connector adapted to connect to the first catheter distal end of the first anchor connector’ s implant catheter, a second catheter connector adapted to connect to a second catheter distal end of the second anchor connector’ s implant catheter, and a third catheter connector adapted to connect to a third catheter distal end of the third anchor connector’s implant catheter).
[00954] In some implementations, the anchor connectors are constructed to actuate between a connected state (e.g., an unsevered state, etc.) and a detached/decoupled state (e.g., a severed state, etc.). In its connected state, the anchor connector’s leaflet anchor is constrained not to move in one or more (and typically six) degrees of freedom relative to its delivery/implant catheter (e.g., they are constrained to move in sync with one another). In the anchor connector’ s detached/decoupled state, the relative movement of the leaflet anchor and its connected implant catheter are no longer constrained by the anchor connector.
[00955] In some implementations, each leaflet anchor is also provided with and attached to a respective anchor tether in the form of a controlled tether (of a plurality of controlled tethers), e.g., a first controlled tether 341 is attached to the first leaflet anchor 313, and a second controlled tether 343 is attached to the second leaflet anchor 315. In some implementations, each of the first and second controlled tethers is in the form of a flexible cord (e.g., a suture, wire, line, braid, thread, yam, etc.).
[00956] In some implementations, with each anchor connector connected to the distal end of its delivery or implant catheter, the controlled tether extends from a distal end of the controlled tether at its respective leaflet anchor to a proximal end of the controlled tether at the catheter proximal end of the connected implant catheter. In some implementations, while the implant catheter can be removed after the anchor is connected to a leaflet, each controlled tether fastens its respective anchor to the steering catheter 303 by serially extending through the steering catheter from a respective tether distal end (e.g., a first tether distal end, a second tether distal end, and a third tether distal end) at its respective anchor to a tether proximal end (e.g., a first tether proximal end, a second tether proximal end, and a third tether proximal end) protruding from the proximal (user) end of the steering catheter. In some implementations, each controlled tether is accessible, controllable and actuatable by the user at the proximal end of the steering catheter, either directly or using control mechanisms (e.g., knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbles, etc.) for implantable devices
[00957] In some implementations, the treatment/repair device can further be provided with a central body 331 that locks, e.g., a locking central body, and with a center-body connector 333 connecting the central body to a center-body implant catheter 335. In some implementations, the central body forming one or more center-body orifices that are sized and shaped (adapted) to receive the proximal ends of the controlled tethers of the implanted individual leaflet anchors, and through which the first and second controlled tethers 341, 343 extend. In some implementations, with the controlled tethers threaded through the center-body orifice, the central body is slidable along the controlled tethers to their distal ends.
[00958] In some implementations, once the central body is inserted into the heart, the controlled tethers can be pulled through the central body from their proximal ends to move the leaflet anchors closer and/or into contact (with each other and/or another portion of the device). The controlled tethers can be configured to pull against edges of the central body, which in turn can help orients the forces to move the leaflet anchors closer and/or into contact.
[00959] In some implementations, in use, a first connected assemblage including the first implant catheter 311, the first anchor connector 321, the first leaflet anchor 313 and the first controlled tether 341 is controllably inserted into the steering catheter 303 by the user. Using the first implant catheter, the first leaflet anchor is guided to a leaflet of the valve. In some implementations, the first leaflet anchor 313 is affixed to the valve leaflet, and the first anchor connector 321 is then decoupled/detached/severed. In some implementations, the first implant catheter 31 1, and any remaining portions of the first anchor connector 321 that are still attached to it, are then withdrawn from the steering catheter 303.
[00960] In some implementations, from the time of the insertion, the first controlled tether 341 extends from the first leaflet anchor 313 (which is attached to the leaflet) to the proximal end of the steering catheter outside of the subject’s body. After the implantation of the first leaflet anchor is completed, each of the other assemblages of an implant catheter, an anchor connector, an anchor, and a controlled tether are implanted, in that they: 1) are inserted into the steering catheter; 2) affix their anchor to a leaflet; 3) detach/decouple/sever their anchor connector, and 4) remain affixed to the leaflet as the implant catheter is withdrawn from the steering catheter (in a fashion like that with which the first assemblage was done).
[00961] Once all of the anchors are serially inserted and attached to the leaflets, a user (outside the subject’s body) can feed each of the controlled tethers through a center-body orifice that forms a passage through the locking central body 331, thereby stringing the central body on the full set of controlled tethers. In some implementations, this center-body passage forms an anchor- lock in the form of a cinch-type cable lock 351 that allows the controlled tethers to be pulled through the central body in only one direction, such that the central body can be advanced toward the anchors along the controlled tethers, but not drawn away from the anchors along the controlled tethers. Using its center-body implant catheter 335, the central body 331 can be controllably inserted into the steering catheter 303, and the controlled tethers can be held to prevent or inhibit them from being drawn fully into the subject’s body (thereby causing the central body to advance toward the anchors along the controlled tethers).
[00962] As used herein, a cable lock can comprise a device in which a cable (e.g., a tether) is locked in place by a cord-lock element (e.g., a cog, tongue, lock, clamp, set screw, cam, lever, etc.) that squeezes the cord to lock the cord, e.g., to prevent or inhibit relative movement of the cord to the cable lock in one or both of the directions in which the cord extends through the cable lock. This squeezing can occur through various ratcheting or sliding mechanisms, as with cable locks.
[00963] In some implementations, using the center-body implant catheter 335, the locking central body 331 can be placed or positioned within the center of the valve, and the controlled tethers can be pulled proximally to move the anchors toward (and to) the location of the central body, and to lock the anchors to the central body, thereby assembling the device in a form that is operable to assist in improved valve operation.
[00964] In some implementations, with the anchors fully against and locked onto the central body, a tether severing device (e.g., a tether cutter 345 on the locking central body 331 or center-body implant catheter 335) severs the controlled tethers such that distal segments of the controlled tethers, and their respective anchors, remain cinched and locked in place with respect to the locking central body 331 to maintain connection of the anchors. [00965] In some implementations, the central body and locking mechanism forms the anchor- lock that constrains the relative movement of the first, second and third leaflet anchors after being moved into contact with the central body. The remaining (cut-off) proximal segments of the controlled tethers are then pulled proximally through the steering catheter to remove them from the subject’s body.
[00966] In some implementations, with all of the proximal segments of the controlled tethers removed, a control can be actuated causing the center-body connector 333 to decouple/detach/sever, releasing the central body, and thereby releasing the assembled device from the center-body implant catheter. In some implementations, the central body 331 and the first and second leaflet anchors 313, 315 are completely freed to translate and rotate in six degrees of freedom with the leaflets (relative to the center-body implant catheter 335 and the rest of the delivery system). In some implementations, the center-body implant catheter 335 and the steering catheter are removed from the subject, and the procedure is finished using typical procedures.
[00967] In some implementations, by making the attachment of one or more inserted anchors separable from one another (and the rest of the implant) prior to leaflet attachment, anchors can be attached to leaflets without interference or resistance from other previously attached anchors. The device can therefore be placed without suffering the difficulties caused by leaflets having excessive spacing and movement relative to one another.
[00968] In some implementations, the procedure/method can differ from some other implementations in that it provides for greater numbers of anchors and/or anchors with larger form factors to be used through a steering catheter of limited size, and that it further insolates the anchoring procedures from interference by other anchors. It should be appreciated that combinations of these implementations, such as ones in which multiple anchors are inserted on each of multiple consecutively inserted implant catheters, are within the scope herein.
[00969] While some implementations are described as connecting three leaflets on a tricuspid valve, other scenarios are also within the scope of the concepts herein. For example, multiple anchors can be attached to one or more leaflets on either a two-leaflet valve or another three-leaflet valve. During the process of implanting, the anchors can be attached alternately between the leaflets (e.g., back, and forth between two or three leaflets), or between two points on a leaflet, and then to another leaflet. Advantageously, this can offer additional structural support to a damaged leaflet at risk of further structural failure, and/or better attachment to a leaflet having characteristics indicating poor anchor-attachment characteristics.
[00970] A wide variety of consecutively inserted, center-coupled examples are within the scope herein, some of which are expressly described herein. To the extent they are usable, these variations are also envisioned for use with other examples herein. Thus, a treatment/repair system and/or device can include any combination or sub-combination of the features and variations disclosed herein and can exclude some described features.
[00971] With reference to FIG. 78, in some consecutively inserted, center-coupled examples, rather than each controlled tether being unitary (e.g., a unitary anchor tether long enough to extend through the length of the steering catheter), each controlled tether can be formed in two sections: a relatively short anchor-tether section 363 (e.g., three controlled tethers would have a first anchor-tether section, a second anchor-tether section and a third anchor-tether section); and a looped extension-tether section 365 (e.g., a first extension-tether section, a second extension-tether section, and a third extension- tether section).
[00972] In some implementations, each anchor-tether section 363 can be permanently attached to its respective anchor 367 at a distal end of the anchor-tether section (e.g., a first distal end, a second distal end, and a third distal end). In some implementations, at a proximal end of the anchor-tether section 363 (e.g., a first proximal end, a second proximal end, and a third proximal end), the anchor-tether section forms an eyelet 369 (e.g., a first eyelet, a second eyelet and a third eyelet) in the form of a slidable eyelet-type restraint through which serves as the primary connection for the extension- tether section 365. This connection can be made prior to the insertion of the anchor into the subject.
[00973] In some implementations, each looped extension-tether section 365 has a proximal, first-end segment 371, a proximal, second-end segment 373 and a distal, intermediate segment 375. For example, a first controlled tether would have a first first-end segment, a first second- end segment, and a first intermediate segment. Likewise, a second controlled tether would have a second first-end segment, a second second-end segment, and a second intermediate segment, and a third controlled tether would have a third first-end segment, a third second-end segment, and a third intermediate segment. [00974] In some implementations, the intermediate segments are intermediate the first-end segments and the second-end segments with respect to (along) the extension-tether sections. In some implementations, when each anchor and its respective two tether sections (the anchortether section and extension-tether section) are first implanted, the first-end segment 371 and second-end segment 373 of the extension- tether section 365 are restrained such that they extend out of the proximal end of the steering catheter, while the intermediate segment 375 forms a bight that extends through the eyelet of the anchor-tether section 363 such that the respective anchor can be brought closer and/or into contact by pulling on the first and second-end segments of the extension-tether section 365.
[00975] As with some consecutively inserted, center-coupled examples described previously, when all of the anchors have been affixed to their respective leaflets, the locking central body 331 can be implanted within the center of the valve. In some implementations, the looped extension- tether sections 365 of the controlled tethers can be pulled proximally to move the anchors toward and to the location of the central body, cinching the controlled tethers to lock the respective anchors 367 to the central body, thereby assembling the device in a form that is operable to assist in improved valve operation. In some implementations, the anchortether sections 363 are long enough such that, after assembly of the device (by cinching and locking), they extend through the central body and are restrained (locked) by the locking central body to maintain the structure of the implant.
[00976] In some implementations, rather than having a tether cutting device that is operated inside of the heart, each of the looped, extension-tether sections can be removed from the subject’s body by pulling on the first-end segment of each looped extension-tether section while releasing the second-end segments. As a result, the second-end segments of the extension-tether sections slide up to and out of the eyelets, and then are pulled from the body.
[00977] In some consecutively inserted, center-coupled examples, rather than each anchor having its own associated implant catheter, a single implant catheter (or implant catheter system) is repeatedly used, to consecutively implant each anchor one at a time. To this end, in some implementations, the catheter-connector of the first anchor connector 321 has a quickrelease mechanism to decouplably or detachably be first attached to the first implant catheter 311 during an implantation procedure, and then unattached during an implantation procedure, such that the second anchor connector 323 can be attached to the first implant catheter during implantation. For example, a single implant catheter 311 can be repeatedly routed through the steerable catheter 303, attach a leaflet anchor to the native valve leaflet, separate from the leaflet anchor, be pulled out of the steerable catheter, be attached to the next leaflet anchor, and then be routed through the steerable catheter again to deploy the next anchor. This allows a series of anchors to be implanted using a single implant catheter.
[00978] In some implementations, each leaflet anchor has its own tether. In some implementations, the first of a series of leaflet anchors has a tether and subsequent leaflet anchors have a loop that the tether of the first anchor is routed through (see the example of FIGS. 79 and 80). In implementations with a first anchor with a tether that is threaded through loops of subsequent tethers can be implemented with a single implant catheter or multiple implant catheters (e.g., each anchor is connected to its own implant catheter as described above).
[00979] Quick-release mechanisms and/or devices are generally capable of being attached and detached in a short enough timeframe to be used in the setting of an implantation of an implant or device without negatively impacting the subject.
[00980] In some consecutively inserted, center-coupled examples, rather than each anchor connector rigidly fastening (restricting) its respective anchor in six degrees of freedom, a reduced number of degrees of freedom can be rigidly restricted. For example, some pivoting and/or translating of the anchor might allow the anchor the ability to resiliently adapt to the changing leaflet position during the ebb and flow of the blood. This reduced restriction can come at a cost of user controllability. User preference and/or case-specific facts might best determine the preferable form of the connectors.
[00981] In some consecutively inserted, center-coupled examples, some or all of the consecutively inserted implant catheters can carry more than one anchor in a manner similar to the first example. Advantageously, this limits the number of implant catheter insertions while allowing for a larger number of anchors to be inserted.
[00982] In some partially simultaneous or hybrid anchor-delivery examples, for each consecutive set of simultaneously delivered anchors, more than one anchor is fastened to the catheter by a single controlled tether. In some implementations, either each anchor has one or more respective anchor slidable restraints (e.g., eyelets) through which the single multi-anchor controlled tether serially extends, or each anchor is affixed to a first-end segment of a short length of an anchor-tether section that has an eyelet at its proximal end (through which the single multi-anchor tether serially extends).
[00983] In some consecutively inserted, center-coupled examples, rather than being in the form of a fully flexible cord such as a suture, one or more of the tethers (or tether sections) can be in a less flexible form, such as a mechanism or shaft having its bending and torsional flexibility selectively established to allow more flexibility in some degrees of freedom than in others. While partially limiting the free independent movement of the anchors during the relevant periods of implantation, this form of tether might provide some normalizing force to limit the movement and orientation of the anchors with respect to one another and the central body through the ebb and flow of the blood during implantation. In some implementations, slack describes the extent to which the tether can flexibly allow movement within its moveable degrees of freedom.
[00984] In some consecutively inserted, center-coupled examples, the anchor is a T-shaped toggle anchor. In some implementations, other types of anchors are used (e.g., any of the other anchors described herein, clips, clasps, darts, hooks, staples, screws, coils, etc.)
[00985] In some implementations, system/device can include a central body. In some implementations, the central body can include a compliant spacer 381. In some implementations, the compliant spacer can be formed with a unitary, relatively incompressible, pliant periphery (having low compressibility) with adequately low rigidity to be moldable under compression without significant loss of volume. Center bodies and structural details of other center bodies described elsewhere herein and can be incorporated here.
[00986] In some implementations, a compliant central body (e.g., its spacer) allows leaflets to function and move relative to one another more normally during valve operation, particularly as compared to devices that do not use a central body, or ones that use a central body that rigidly hold leaflets.
[00987] In some end-coupled examples, a finally implanted plurality of leaflet anchors (e.g., group of anchors) are strung along a single, implant controlled tether (a first controlled tether) formed by one or more lengths of tether running along a single path that has a distal leaflet anchor at a distal end of the implant-controlled tether (which might be the first leaflet anchor that is implanted). In some implementations, the group of anchors includes one or more (e.g., a plurality of) additional leaflet anchors slidably connected to the implant-controlled tether proximal to the distal leaflet anchor. This can be accomplished in a variety of different ways. In some implementations, the distal leaflet anchor has a tether and subsequent leaflet anchors have a loop that the tether of the distal anchor is routed through. This example with a distal anchor with a tether that is threaded through loops of subsequent tethers can be implemented with a single implant catheter or multiple implant catheters as described above. In some implementations, the additional leaflet anchors include a proximal leaflet anchor (the proximal leaflet anchor also being referred to as a second leaflet anchor), and an intermediate leaflet anchor (possibly being one of one or more intermediate leaflet anchors) intermediate the distal and proximal leaflet anchors.
[00988] In other words, in the group of anchors being formed by the distal leaflet anchor and the additional leaflet anchors, the proximal leaflet anchor can be at a proximal end of the group of anchors, and the distal leaflet anchor can be at a distal end of the group of anchors, with one or more intermediate leaflet anchors, including a third intermediate leaflet anchor, a fourth intermediate leaflet anchor, and so on, being intermediate the distal and proximal leaflet anchors. In some implementations, each leaflet anchor is provided with a respective leafletattachment mechanism (e.g., a first, distal leaflet-attachment mechanism, a third, intermediate leaflet- attachment mechanism and a second, proximal leaflet-attachment mechanism).
[00989] In some implementations, an anchor-lock is included that locks onto the implant- controlled tether proximate to the proximal leaflet anchor, constraining any proximal movement of the proximal leaflet anchor (proximally) up the implant-controlled tether. To this end, the anchor- lock can include an end-body that is integral with the proximal leaflet anchor, or it can form a separate end-body that is connected to the implant catheter using an end-body connector. In some implementations, it is configured to apply a distal force to the proximal leaflet anchor, such as by being positioned proximally to the proximal leaflet anchor or by otherwise holding the proximal leaflet anchor from moving distally. In some implementations, the intermediate leaflet anchors are slidably strung on the implant-controlled tether intermediate the distal and proximal leaflet anchors, and are held on the implant-controlled tether by the distal leaflet anchor and the end-body. [00990] In some implementations, the group of leaflet anchors are implanted using a delivery system including an implant catheter having a catheter proximal end and a catheter distal end. In some implementations, the group of leaflet anchors can be separably connected to the implant catheter using one or more anchor connectors (e.g., a distal anchor connector forms a distal anchor detachable/decouplable/severable connection, an intermediate anchor connector forms an intermediate anchor detachable/decouplable/severable connection, and a proximal anchor connector forms a proximal anchor detachable/decouplable/severable connection), with the respective connections being severed after their respective leaflet anchors are attached to leaflets.
[00991] In some implementations, the one or more anchor connectors can be in the form of a connector cartridge that consecutively detaches/decouples/severs its connection to a first- implanted through a last-implanted leaflet anchor, which may or may not be the distal and proximal leaflet anchors, respectively.
[00992] With all of the leaflet anchors (of the group of anchors) attached to leaflets, in some implementations, the implant-controlled tether can be pulled proximally through an end-body orifice formed by (on) the anchor-lock end-body to draw the distal leaflet anchor toward the proximal leaflet anchor, connecting (e.g., bringing into contact, connecting with another portion in between, bringing into contact with another portion, etc.) the distal and proximal leaflet anchors, and any intermediate leaflet anchors that they draw together in the process. With the distal and proximal leaflet anchors moved into position, in some implementations, the anchor-lock locks onto the implant-controlled tether, constraining the distal and proximal leaflet anchors (e.g., the first and second leaflet anchors) from moving apart from one another with respect to the implant-controlled tether. Optionally, the anchor-lock can be a one-way cinching mechanism that automatically locks on as it moves distally along the implant- controlled tether. With the distal and proximal leaflet anchors fully connected and the anchorlock locked onto the implant-controlled tether, in some implementations, the full group of anchors is thereby connected and end-coupled in place along the implant-controlled tether. The segment of the implant-controlled tether that extends proximally from the anchor-lock can then be separated (e.g., cut or otherwise disconnected) from the remaining anchor-connected portion of the implant-controlled tether (e.g., the distal portion) and removed from the subject. [00993] In some implementations, end-coupled anchors can be constrained together consecutively along a single implant-tether pathway between two longitudinal-ends of a segment of the implant-controlled tether. In some implementations, the implant-tether segment forming the path can be made of multiple lengths of tether material connected and/or looped, serially and/or in parallel, along the implant-tether pathway between longitudinal ends defined by the proximal and distal leaflet anchors. The terms ‘distal’ and ‘proximal’ anchor can be used in reference to the anchor’s position along the implant-controlled tether, and not the location of the implanted anchor within the heart. The terms ‘first-implanted’ and ‘last- implanted’ refer to the chronological order in which the anchors are attached to the leaflets, which may be or may not be the sequence order in which they are positioned along the tether or mounted on the implant catheter.
[00994] In some implementations, the implant-controlled tether includes two connected implant-tether sections, a looped, extension-tether section that forms the proximal portion of the implant-controlled tether, and a distal anchor-tether section that forms the distal portion of the implant-controlled tether (and that is affixed to the distal leaflet anchor). In some implementations, the extension-tether section extends between an extension-tether proximal- end segment at a catheter proximal end of an implant catheter of the delivery system, and an extension-tether distal-end segment connected to a proximal end of the distal anchor-tether section.
[00995] In some implementations, in assembling and connecting the implant, no pair of intermediate leaflet anchors along the implant-controlled tether are directly and separately moved towards an intermediate position by the anchor-lock alone. Instead, the entire force is exerted at the location of the proximal and distal leaflet anchors, with the distal leaflet anchor being proximally pulled by the distal end of the distal anchor-tether section, and with the proximal leaflet anchor being restrained and/or distally pushed by the end-body supported on the implant catheter. It should be noted that the intermediate leaflet anchors can nevertheless be moved toward one another by the natural rhythm and forces of the leaflets, as each leaflet will exert forces on its respective leaflet anchor or anchors.
[00996] In some implementations, the various systems, apparatuses, devices, etc. herein can be configured such that after decoupling an anchor, central body, other component from the delivery or implant catheter, then the delivery or implant catheter can be coupled or recoupled to the anchor, central body, or other component. This can be done using a tether or similar device that allows freedom of movement in the decoupled state, but can be used (e.g., tensioned, etc.) to bring the delivery/implant catheter back into contact with the anchor, central body, or other component. The configuration can be similar to the tether and control systems and mechanisms described herein with respect to bringing the anchors and/or central body together. In some implementations, after recoupling, the delivery or implant catheter can be used to (1) detach the anchor, central body, or other component from a first location, and/or (2) reposition and/or attach the anchor, central body, or other component to a second location (different from the first location) (e.g., to a different tissue location).
[00997] Where not specifically described and not functionally precluded, additional details and features of other examples herein can be included here.
[00998] With reference to FIG. 79, prior to implantation, end-coupled examples can include a plurality of leaflet anchors including a distal leaflet anchor 401 integrally attached to a distal end 403 of an implant-controlled tether. In some implementations, the implant-controlled tether includes two sections, the first section being a distal anchor-tether section 405. The distal leaflet anchor 401 can be a first-implanted leaflet anchor. In some implementations, at its proximal end, the distal anchor-tether section 405 forms a distal anchor-tether eyelet 407, and at a distal end the distal anchor-tether section 405 can be attached to the distal leaflet anchor. In some implementations, the distal anchor-tether section is long enough to extend across the full length of the locked leaflet anchors when the locking operation is complete.
[00999] In some implementations, the second section of the implant-controlled tether is a looped, extension- tether section 411 having a first-end segment and a second-end segment, both of which extend out of the proximal end of the delivery system. In some implementations, the implant-controlled tether also includes a longitudinal intermediate segment 415. In some implementations, the intermediate segment 415 of the extension-tether section loops through and extends around the distal anchor-tether eyelet 407 of the distal anchor-tether section 405. This looped configuration provides for the extension-tether section to be removed by pulling on one of its end segments after the locking operation is complete.
[001000] In addition to the distal leaflet anchor 401, the plurality of anchors can include one or more additional anchors. In some implementations, as depicted, the plurality of anchors can include four additional anchors, including a (second) proximal leaflet anchor 427, which can be a last-implanted leaflet anchor. Intermediate the distal and proximal leaflet anchors are a third, fourth and fifth leaflet anchor, each of which are intermediate leaflet anchors 421, and each of which can be implanted in their order from the distal leaflet anchor 401 to the proximal leaflet anchor 427. In some implementations, each additional anchor has a respective anchor- tether section, including three intermediate anchor-tether sections 423 and a proximal anchortether section 429 (e.g., a second anchor-tether section). The additional anchor-tether sections form eyelets through which the implant-controlled tether (e.g., the combined, extension-tether section 411 and distal anchor-tether section 405) is threaded, providing for the entire group of anchors to be tethered via the implant-controlled tether. Tn a minimum 2-anchor case, there are no intermediate leaflet anchors 421 or intermediate anchor- tether sections 423.
[001001] In some implementations, chronologically after the distal leaflet anchor 401 is attached to its respective leaflet and detached/decoupled/severed from a catheter distal end of an implant catheter of the implant catheter system, for the additional anchors (e.g., the intermediate leaflet anchors 421 and/or the proximal leaflet anchor 427), the additional anchortether sections (first the intermediate anchor-tether sections 423 and then the proximal anchortether section 429) of the additional anchors are guided to the respective heart valve leaflet by the implant catheter, where the additional anchor is then attached to the leaflet. One by one each additional anchor can be consecutively attached, with each respective additional anchortether section being strung along the extension-tether section 411. When all anchors of the group of anchors have been affixed to leaflets, the result is a series of consecutively placed leaflet anchors that are serially located in consecutive order along a single, implant controlled tether in a stitched configuration.
[001002] In some implementations, when the group of anchors are all attached to their respective leaflets, an end-body 431 (being similar in form and cinching function to the locking center bodies of prior examples and variations), which is separably connected to the implant catheter with an end-body connector, is advanced along the implant controlled tether by proximally pulling on the extension-tether section such that the implant controlled tether is pulled back through the end-body while using the implant catheter to hold the end-body. In some implementations, the distal anchor-tether section 405 is pulled through the end-body causing the end-body to be cinched up onto the distal anchor-tether section, causing the distal leaflet anchor 401 and the proximal leaflet anchor 427 to be mutually pulled toward one another by the distal anchor-tether section. This pulling on the extension-tether section 411 relative to the end-body’s implant catheter leads to the completion of the implant assembly. When this occurs, the intermediate leaflet anchors 421 naturally adjust their positions based on their relative locations on the various leaflets, and on the tension and pathway over which the distal anchor-tether section 405 extends.
[001003] In some implementations, the extension-tether section 411 is then removed from the subject’s body while leaving the implanted device in place, by pulling on the first-end segment of the extension-tether section while releasing the second-end segment so as to be pulled through and around the path of the extension-tether section’ s loop.
[001004] In some implementations, the systems, devices, methods, etc. herein comprise a stitching of the leaflets, wherein each stich is a planned distance from the previous stich. Part of the stitching can extend back and forth between multiple leaflets, while other parts can progress across a single leaflet. The stiches can be placed along a leaflet at a predetermined spacing by selecting the attachment locations, and/or by using spacers between consecutive anchors.
[001005] FIGS. 80 A and 80B illustrate one of the many potential uses for the examples of FIGS. 79 and 80. Referring to FIG. 80A, a distal leaflet anchor 401 is attached to a leaflet 20. Then, a leaflet anchor 421 is routed along the tether 405 and attached to a leaflet 22. Then a leaflet anchor 425 is routed along the tether 405 and attached to the leaflet 22. Then a leaflet anchor 427 is routed along the tether 405 and attached to the leaflet 20. This sequence forms a back-and-forth stitch pattern. Any number of anchors can be used. While the mitral valve is illustrated, the sequence illustrated by FIGS. 80A and 80B can be applied to any valve, such as a tricuspid valve. Further, the example illustrated by FIGS. 80A and 80B can be used in a tricuspid valve in the same or similar way to the example illustrated by FIGS. 16-20.
[001006] Referring to FIG. 80B, in some implementations, when the group of anchors are all attached to the, an end-body 431 or lock (being similar in form and cinching function to the locking center bodies of prior examples and variations), is advanced along the tether 405 by proximally pulling on the tether. The tether is pulled back through the end-body to draw the leaflet anchors 401, 421, 425, 427 together. As a result, the anchors 401, 421, 425, 427 draw the leaflets 20, 22 together to reduce regurgitation through the native valve in the area of the anchors. The intermediate leaflet anchors 421 , 425 naturally adjust their positions on the tether 405. The end body 431 or lock is fixed on the tether 405 to secure the relative positions of the leaflet anchors 401, 421 , 425, 427 and complete the native valve repair. The tether 405 can be cut off at the end body 431 and be removed.
[001007] It should be noted that this example can provide for a stitching of the leaflets, wherein each stitch is a planned distance from the previous stitch. Part of the stitching can extend back and forth between multiple leaflets, while other parts can progress across a single leaflet. The stitches can be placed along a leaflet at a predetermined spacing by selecting the attachment locations, and/or by using spacers between consecutive anchors.
[001008] With reference to FIG. 80, in some end-coupled examples, a distal leaflet anchor 451 is permanently affixed to a single, unitary controlled tether 453 (e.g., it is unitary in that it is not made of separate sections) that is long enough to extend through the length of the steering catheter from its distal to its proximal end. In some implementations (similar to other examples described previously), intermediate leaflet anchors 455 and a proximal leaflet anchor 457 can have anchor-tether sections 459 that are strung on the unitary controlled tether 453. In some implementations, a tether cutting device in an implant catheter is employed to cut off and remove most of the long, unitary controlled tether 453 from the implant after the implant is fully assembled and the anchors are cinched together by the end-body 431.
[001009] With reference to FIG. 81, in some end-coupled examples, one or more (springtype) spring spacers 471 are placed on the segments of implant-controlled tether 473 extending between some or all consecutive pairs of leaflet anchors 475 that are attached to leaflets 477 (e.g., pairs of leaflet anchors that occur consecutively along the implant-controlled tether). The one or more spring spacers 471 are placed by feeding them up the extension-tether section, each being fed between a respective consecutive pair of anchors that the spring spacer will separate. These spring spacers can help maintain anchors at preferred distances from one another. Structurally, these spring spacers 471 can be formed as one of the forms of spacer described above, or they can be of other configurations, such as an accordion-folded pledget, wherein the implant-controlled tether 473 penetrates and extends through each accordion fold (as depicted). [001010] With reference to FIG. 81, in some implementations, rather than the additional leaflet anchors having anchor-tether sections that form eyelets through which an extensiontether section slidably extends, leaflet anchors 475 can include structurally integral orifices making slidable restraints 481 (e.g., a proximal anchor slidable restraint and an intermediate anchor slidable restraint) through which the segments of implant-controlled tether 473 slidably extend.
[001011] In some end-coupled examples, the anchors are configured as T-shaped toggle anchors. This type of anchor can provide for enhanced support for lateral loads occurring between consecutive anchors, and particularly on consecutive anchors attached to different leaflets. Other types of anchors are also possible (e.g., anchors described elsewhere herein).
[001012] In some implementations, a valve repair device is configured to be attached to two leaflets, pull the leaflets together during systole, and allow the leaflets to move apart during diastole. The device can be configured to pull the leaflets together during systole and allow the leaflets to move apart during diastole in a variety of different ways. In some implementations, a valve repair device 8201 includes a pair of anchors 8221 and a resilient coupling member 8231.
[001013] The pair of anchors 8221 can take a variety of different forms. In some implementations, the pair of anchors 8221 can be any of the anchors disclosed herein. In the example illustrated by FIGS. 82-87, the anchors 8221 each include a first arm 8290, a second arm 8292, and a hinge portion 8294 that connects the first arm 8290 to the second arm 8292. In some implementations, the anchor 8221 can have optional barbs 8237.
[001014] In the example illustrated by FIGS. 82-87, the anchor 8221 is configured to capture a leaflet between the first arm 8290 and the second arm 8292. In some implementations, the closed position is when the second arm 8292 is as close as possible to the first arm 8290. In some implementations, the second arm 8292 can be moved relative to the first arm 8290 between an open position and a closed position.
[001015] The resilient coupling member 8231 can take a variety of different forms. In some implementations, the resilient coupling member 8231 can be an elastic member, such as an elastic cord, spring, etc. In some implementations, the coupling member 8231 has a fixed unbiased or unstretched length. Lengths of the coupling member 8231 with a fixed unbiased or unstretched length can be selected outside a patient’s body before delivery and implantation of the device 8201. When more than one device 8201 is used, the resilient coupling members can optionally have different lengths.
[001016] In some implementations, the coupling member 8231 is adjustable in length. For example a first portion of the resilient coupling member 8231 can be connected to a first anchor 8221 that is attached to a first leaflet 20 and a second portion of the resilient coupling member 8231 can be connected to a second anchor 8221 that is attached to a second leaflet 22. In some implementations, the first portion and the second portion can be drawn through a lock that secures the first portion and the second portion together. The amount or length of the first and second portions of the resilient coupling member 8231 pulled through the lock can set the lengths of the first and second portions that are between the lock and the anchor 8221. When more than one device 8201 is used, the resilient coupling members 8231 can be set to different lengths.
[001017] In some implementations, the coupling member 8231 is configured to pull the first and second anchors 8221 together or closer together. This reduces a gap between the leaflets 20, 22 or 30, 32, 34 when the native heart valve is in systole to reduce or inhibit regurgitation through the native valve. Even if the coupling member 8231 does not pull the first and second leaflets completely together, the device 8201 can be beneficial in its reduction of regurgitation through the native valve during systole.
[001018] FIGS. 82 and 83 illustrate some implementations where the anchors 8221 are attached to leaflets 20, 22. In FIGS. 82 and 83 the native valve the native valve is in diastole. The leaflets move apart in diastole to allow blood to flow through the native valve. In some implementations, the coupling member 8231 resiliently stretches to allow the native valve leaflets 20, 22 to move apart. Allowing the native valve leaflets 20, 22 to move apart in the areas of the device 8201 reduces a gradient across the native valve during systole and/or increases blood flow through the native valve during diastole as compared to a device that does not allow the native valve leaflets to move apart from one another during diastole.
[001019] FIGS. 84 and 85 illustrate some implementations where the anchors 8221 attached to leaflets 20, 22. In FIGS. 82 and 83 the native valve is in systole. The leaflets move toward one another in systole to block or inhibit blood to flow through the native valve. In some implementations, the coupling member 8231 pulls the native valve leaflets 20, 22 together or closer together then they would otherwise move without the device 8201. Pulling the native valve leaflets 20, 22 together or closer together reduces regurgitation through the native during systole as compared to a native valve without the device.
[001020] Any number of devices 8201 can be implanted on the native valve leaflets. In the example illustrated by FIGS. 82-85, three devices 8201 are implanted on two leaflets. However, any number of devices 8201 can be implanted on any number of leaflets. In some implementations, the devices 8201 can be implanted on the mitral valve. In some implementations, the devices 8201 can be implanted on the tricuspid valve.
[001021] The devices can be implanted at any position along the native valve leaflets. In some implementations, the devices 8201 are implanted in an area of the leaflets where regurgitation is occurring. In some implementations, the devices 8201 can be implanted along an entire width of the native valve leaflets.
[001022] The devices 8201 can be implanted on the native valve leaflets in a variety of different ways. FIGS. 86 and 87 illustrate an example of a tool 8600 for implanting the device is 8201 on leaflets of a native heart valve. The tool 8600 can take a variety of different forms. In some implementations, as illustrated by FIGS. 86 and 87, the tool 8600 includes an outer catheter 8602, an inner catheter 8604, and an implant operator 8606. In some implementations, the outer catheter 8602 and the inner catheter 8604 are configured to position the anchors 8221 relative to the native valve leaflets 20, 22 and to route control elements to the implant operator 8606. The control elements can be used to open and close the anchors 8221.
[001023] The implant operator 8606 can take a variety of different forms. In some implementations, the implant operator 8606 is configured to hold one or more of the anchors 8221 and to open and close the one or more anchors.
[001024] FIG. 86 illustrates some implementations where the outer catheter 8602 and the inner catheter 8604 position a first one of the anchors 8221 at a native valve leaflet 22. In some implementations, the implant operator 8606 opens a first one of the anchors 8221. The anchor is moved to position the native valve leaflet 22 in the anchor 8221. In some implementations, the implant operator 8606 closes the first one of the anchors 8221 to secure the leaflet 22 in the first one of the anchors 8221. The implant operator 8606 can be released from the first one of the anchors 8221. In some implementations, the implant operator 8606 can be moved and attached to a second one of the anchors 8221 or a second tool 8600 can already be attached to the second one of the anchors 8221 and the first tool can be removed.
[001025] FIG. 87 illustrates some implementations where the outer catheter 8602 and the inner catheter 8604 position a second one of the anchors 8221 at a native valve leaflet 20. In some implementations, the implant operator 8606 opens a second one of the anchors 8221. The anchor is moved to position the native valve leaflet 20 in the anchor 8221. In some implementations, the implant operator 8606 closes the second one of the anchors 8221 to secure the leaflet 20 in the second one of the anchors 8221. The implant operator 8606 can then be released from the second one of the anchors 8221. In some implementations, the tool 8600 can be removed, leaving the device 8201 implanted on the native valve leaflets 20, 22.
[001026] In some implementations, a valve repair device is configured to move gripping members inward (e.g. toward one another) and outward (away from one another). The valve repair device can take a variety of different forms, such as any of the forms disclosed herein. Figure 88 illustrates a valve repair device according to some implementations. As shown in FIG. 99, the valve repair device 8700 includes a central body 8702 and a plurality of anchors 8704.
[001027] Referring now to Figures 89 and 90, the valve repair device 8700 is shown with one anchor 8704 to illustrate the operation of the anchor 8704, though the valve repair device 8700 can include two anchors 8704 (e.g., as shown in Figures 91-93), three anchors 8704 (e.g., as shown in Figure 88), or any number of anchors 8704.
[001028] Referring to Figures 88-93, the central body 8702 can take a variety of different forms. In some implementations, the central body 8702 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
[001029] In some implementations, the central body 8702 includes a bore or passage 8706 that one or more actuation elements 8708 extend into. In some implementations, the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypo tube, etc. [001030] The plurality of anchors 8704 can take a variety of different forms. In some implementations, the plurality of anchors 8704 can be any of the anchors disclosed by the present application. In the example illustrated by Figures 88-93, the anchors 8704 include a paddle 8710 that can optionally include a gripping member, such as a clasp (not shown).
[001031] In some implementations, the paddle 8710 can be separable from the central body 8702 such as any of the paddles and anchors disclosed by this patent application. Mechanisms similar to the mechanism described herein and shown in Figures 88-93 for opening and closing the paddle 8710 can also be used to open and close a gripping member or clasp.
[001032] Referring now to Figure 88, the paddles 8710 of the plurality of anchors 8704 are shown in a closed condition. The paddles 8710 include a first arm 8712 and a second arm 8714. In some implementations, an optional gripping member can be provided on either the first arm 8712, the second arm 8714, or both the first arm 8712 and the second arm 8714.
[001033] In some implementations, the paddle 8710 or the optional gripping member can include an optional friction enhancing portion. In some implementations, the friction enhancing portion can include one or more of a barbed portion, a texturized portion, and an adhesive portion. The friction enhancing portion (not shown) can extend from the gripping member or clasp, or from the first arm 8712, or the second arm 8714, or from the first arm 8712 and the second arm 8714.
[001034] In the example illustrated by Figures 88-93, the paddle 8710 is configured to capture a leaflet between the first arm 8712 and the second arm 8714. In some implementations, the closed position is when the second arm 8714 is as close as possible to the first arm 8712. The second arm 8714 can be moved relative to the first arm 8712 between an open condition and a closed condition.
[001035] In some implementations, the first arm 8712 and the second arm 8714 are hingeably connected by a hinge portion 8718. As shown in Figures 88-93, the hinge portion 8718 can be include a hinge pin 8720 that extends through portions of the first arm 8712 and the second arm 8714 and through an actuation gear 8722. In some implementations, the hinge pin 8720 is rotatably attached to the first arm 8712 and fixedly attached to the second arm 8714 and the actuation gear 8722 so that the hinge pin 8720 and the actuation gear 8722 rotate with the rotation of the second arm 8714. That is, rotating the gear 8722 causes the second arm 8714 to rotate in the same direction to open or close the paddle 8710.
[001036] In some implementations, the actuation elements 8708 can comprise any of the actuation elements described herein, including, but not limited to a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[001037] In some implementations, the actuation gear 8722 of the hinge portion 8718 is engaged by and is caused to rotate by a worm gear 8724 that is attached to the distal end of the actuation element 8708. Rotating the actuation element 8708 in a clockwise or a counterclockwise direction causes the actuation gear 8722 — and, consequently, the second arm 8714 — to rotate in open and closing directions, depending on the handedness of the worm gear 8724. In this manner, the worm gear 8724 and the actuation gear 8722 interface convert rotating motion of the actuation element 8708 to rotational motion that is orthogonal to the actuation element 8708. An additional benefit of the worm gear 8724 is that the actuation gear 8722 can re-engage the worm gear 8724 after the anchor 8704 is separated from and then retracted back toward the central body 8702.
[001038] In some implementations, the first arm 8712 of the paddle 8710 can include a cylindrical portion 8726 that mates with the central body. In some implementations, the paddle 8710, e.g., the first arm 8712 of the paddle 8710 can fit in a corresponding groove or channel 8728 of the central body 8702.
[001039] In some implementations, the first arm 8712 of the paddle 8710 can be directly attached to the central body 8702 via one or more attachment sutures or tethers 8730 (Figures 91-93) or can be indirectly attached via other components. As with other examples shown herein, the paddle 8710 can be separated from the central body 8702 to facilitate capture of one or more leaflets 20, 22 of the native valve. When the paddle 8710 is separated from and is then recoupled to the central body 8702 by the attachment sutures or tethers 8730, the cylindrical portion 8726 of the first arm 8712 can fit into the groove 8728 of the central body 8702 to assist in appropriately aligning the anchor 8704 to the central body 8702. [001040] Figure 89 illustrates capturing a native valve leaflet using the device 8700. As shown in the figure, the paddle 8710 is shown being moved into the open condition to facilitate capture of a leaflet 20, 22 of the native valve. To open the paddle 8710, the actuation element 8708 is rotated in a first direction 8732 to cause the actuation gear 8722 and the second arm 8714 to rotate in an opening direction 8734 (e.g., counterclockwise). Once the paddle 8710 is in the open condition, the paddle 8710 is moved so that the leaflet 20, 22 is disposed between the first arm 8712 and the second arm 8714.
[001041] Referring now to Figure 90, the paddle 8710 is shown being moved into the closed condition to capture the leaflet 20, 22 of the native valve between the first arm 8712 and the second arm 8714 of the paddle 8710. To close the paddle 8710, the actuation element 8708 is rotated in a second direction 8736 to cause the actuation gear 8722 and the second arm 8714 to rotate in a closing direction 8738 (e.g., clockwise) to capture the leaflet 20, 22 between the first arm 8712 and the second arm 8714.
[001042] In some implementations, the hinge portion 8718 of the paddle 8710 provides a rigid connection between the first arm 8712 and the second arm 8714 to facilitate the application of force in the closing direction 8738 via the second arm 8714. That is, when the anchor 8704 is in the closed condition, further rotation of the actuation element 8708 in the second direction 8736 applies additional closing force to the leaflet 20, 22 to prohibit the leaflet 20, 22 from pulling out of the paddle 8710.
[001043] Referring now to Figure 91, one of the anchors 8704 of the valve repair device 8700 is shown separated from the central body 8702 with a leaflet 20, 22 captured by the paddle 8710. The separated anchor 8704 is attached to the central body 8702 via a pair of attachment sutures or tethers 8730 that can be used to retract the anchor 8704 toward the central body 8702.
[001044] The anchor 8704 that remains engaged by the central body 8702 can be opened and closed by rotating the actuation element 8708. As shown in Figure 91, the actuation element 8708 is rotated in the second direction 8736 to cause the second arm 8714 to rotated in the closing direction 8738 to capture another of the leaflets 20, 22. Rotation of the actuation element 8708, however does not impact the closed condition of the anchor 8704 that is separated from the central body 8702.
[001045] In some implementations, the hinge portions 8718 of the paddles 8710 include optional locking or latching mechanisms 8740 that can be locked to prohibit rotation of the hinge portion 8718. As shown in Figure 92, the locking mechanism 8740 of the anchor 8704 that has been separated from the central body 8702 is shown in a locked condition. The locking mechanism 8740 of the anchor 8704 that is engaged by the central body 8702 is shown in an unlocked condition to facilitate closing of the paddle 8710 via rotation of the actuation element 8708 to move the second arm 8714 in the closing direction 8738.
[001046] In some implementations, locking the hinge portion 8718 in the closed condition helps to maintain the anchor 8704 in the closed condition while it is separated from the central body 8702 and is disengaged from the worm gear 8724 and actuation element 8708. That is, after capturing a leaflet 20, 22 of the native valve, the locking member 8740 maintains the paddle 8710 in the closed condition as the anchor 8704 is separated from the central body 8702 so that another anchor 8704 can be positioned to capture one or more other leaflets 20, 22.
[001047] Referring now to Figure 93, the hinge portion 8718 of the paddles 8710 include optional spring or biasing members 8742. In some implementations, the biasing members 8742 bias the second arms 8714 of the paddles 8710 in the closing direction 8738. The closing force provided by the biasing members 8742 helps to maintain the anchor 8704 that is separated from the central body 8702 and is disengaged from the worm gear 8724 and actuation element 8708 in the closed condition. That is, after capturing a leaflet 20, 22 of the native valve, the biasing member 8742 maintains the paddle 8710 in the closed condition as the anchor 8704 is separated from the central body 8702 so that another anchor 8704 can be positioned to capture one or more other leaflets 20, 22.
[001048] In some implementations, the biasing members 8742 can also accommodate different leaflet thicknesses. For example, the biasing member can be configured to close the second arm 8714 to form a leaflet gap (the area in the clasp that accepts the leaflet) that is as narrow or narrower than the thinnest expected leaflet and allows the leaflet gap to become at least as large as the thickest expected leaflet.
[001049] In some implementations, the biasing member 8742 can be combined with, for example, the locking mechanisms 8740 described above so that the paddles 8710 are biased to be normally closed and can also be locked in position by the locking mechanisms 8740.
[001050] Referring now to Figures 94-96, in some implementations, a valve repair device 8800 is configured to move gripping members inward (e.g. toward one another) and outward (away from one another). In some implementations, the valve repair device 8800 includes a central body 8802 and a plurality of anchors 8804. As shown in Figures 94-96, the valve repair device 8800 is shown with one anchor 8804 to illustrate the operation of the anchor 8804, though the valve repair device 8800 can include two anchors 8804, three anchors 8804, or any number of anchors 8804.
[001051] In some implementations, the central body 8802 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 8802 includes a bore or passage 8806 that one or more actuation elements 8808 extend into. In some implementations, the actuation elements 8808 can include any of the actuation elements described herein, including, but not limited to a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[001052] The valve repair device can further include a plurality of anchors 8804. In some implementations, the plurality of anchors 8804 can be any of the anchors disclosed by the present application. In the example illustrated by Figures 94-96, the anchors 8804 include a gripping member 8810, such as a clasp. The anchors 8804 can also include a paddle and can be separable from the central body 8802 such as any of the paddles and anchors disclosed by this patent application.
[001053] Referring now to Figure 94, the gripping member 8810 of one of the plurality of anchors 8804 is shown in a closed condition. As shown in the Figure, the gripping member 8810 includes a first arm 8812, a second arm 8814, and an optional barbed portion 8816. While the optional barbed portion 8816 is shown extending from the first arm 8812, the barbed portion 8816 can optionally extend from the second arm 8814, or from the first arm 8812 and the second arm 8814.
[001054] In the example illustrated by Figures 94-96, the gripping member 8810 is configured to capture a leaflet between the first arm 8812 and the second arm 8814. In this example, the closed position is when the second arm 8814 is as close as possible to the first arm 8812. The second arm 8814 can be moved relative to the first arm 8812 between an open condition and a closed condition.
[001055] In some implementations, the first arm 8812 and the second arm 8814 are hingeably connected by a hinge portion 8818. As shown in Figure 94, the gripping member 8810 is integrally formed such that the first arm 8812, the second arm 8814, and the hinge portion 8818 are formed from a single piece of material. The gripping member 8810 can be formed by, for example, cutting the first arm 8812, the second arm 8814, the optional barbed portion 8816, and the hinge portion 8818 from a sheet of shape-memory alloy, such as, for example, nitinol. In some implementations the hinge portion 8818 can be formed by selectively removing material to increase the flexibility of the hinge portion 8818 relative to the first arm 8812 and the second arm 8814. In implementations when the gripping member 8810 comprises and/or is formed from a shape-memory alloy, the gripping member 8810 can be shape set to be biased toward the open condition or the closed condition. Alternatively, an optional biasing member (not shown) is connected between the first arm 8812 and the second arm 8814 to bias the gripping member 8810 toward the open condition or the closed condition.
[001056] In some implementations, the second arm 8814 includes a hinge 8820 that allows the second arm 8814 to pivot around a pivot arm or hinge mount 8822. As shown in Figure 94, the hinge 8820 can be a hinge barrel, although a skilled artisan would understand that other types of hinges and/or hingeable points of connection for the pivot arm 8822 can be used without departing from the scope of this disclosure.
[001057] In some implementations, the pivot arm 8822 is attached to and extends from the central body 8802, through the hinge 8820, and back to the central body 8802 to form a U- shape around the gripping member 8810. That is, the U-shaped pivot arm 8822 and central body 8802 surround an opening 8824 through which portions of the gripping member 8810 can pass as the actuation element 8808 is extended and retracted to open and close the gripping member 8810.
[001058] In some implementations, the pivot arm 8822 can be directly attached to the central body 8802 such as via sutures (e.g., Figures 100-103) or can be indirectly attached, such as, for example, via a paddle (not shown). In some implementations, the gripping member 8810 or a paddle can be separable from the central body 8802 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve. That is, the gripping member 8810 or paddle can be connected to and/or separated from the central body 8802 by one or more tethers or suture attachments as described above (e.g., with respect to device 8700).
[001059] In some implementations, an actuation arm 8826 connects the actuation element 8808 to the gripping member 8810 and/or first arm 8812 so that extension and retraction of the actuation element 8808 moves the first arm 8812 in a proximal direction 8828 (Figure 95) or a distal direction 8832 (Figure 96). As the first arm 8812 is moved by the actuation element 8808, the pivot arm 8822 maintains the relative position of the hinge 8820 relative to the central body 8802. In this manner, the connection of the first arm 8812 to the second arm 8814 via the hinge portion 8818 causes the second arm 8814 to pivot around the connection of the hinge barrel 8820 to the pivot arm 8822 as the first arm 8812 is moved by the actuation element 8808.
[001060] Referring now to Figure 95, the gripping member 8810 is shown being moved into the open condition to facilitate capture of a leaflet 20, 22 of the native valve. To open the gripping member 8810, the actuation element 8808 is retracted in the proximal direction 8828 into the central body 8802 to cause the first arm 8812 to move in a proximal direction 8828. Moving the first arm 8812 in the proximal direction 8828 also moves the hinge portion 8818 and a portion of the second arm 8814 that is between the hinge 8820 and the hinge portion 8818 to move in the proximal direction 8828, thereby causing the portion of the second arm 8814 that extends beyond the hinge barrel 8820 to pivot in an opening direction 8830 (e.g., counterclockwise). Once the gripping member 8810 is in the open condition, the gripping member 8810 is moved so that the leaflet 20, 22 is disposed between the first arm 8812 and the second arm 8814. [001061] Referring now to Figure 96, the gripping member 8810 is shown being moved into the closed condition to capture the leaflet 20, 22 of the native valve between the first arm 8812 and the second arm 8814 of the gripping member 8810. To close the gripping member 8810, the actuation element 8808 is extended in a distal direction 8832. This causes the first arm 8812 to move in the distal direction 8832 via the actuation arm 8826. Moving the first arm 8812 in the distal direction 8832 also moves the hinge portion 8818 and a portion of the second arm 8814 that is between the hinge barrel 8820 and the hinge portion 8818 in the distal direction 8832. This causes the portion of the second arm 8814 that extends beyond the hinge barrel 8820 to pivot in a closing direction 8834 (e.g., clockwise toward the closed condition) to capture the leaflet 20, 22 between the first arm 8812 and the second arm 8814.
[001062] In some implementations, as the second arm 8814 closes against the leaflet 20, 22, the rigid connection between the pivot arm 8822 and the central body 8802 maintains the position of the hinge barrel 8820 relative to the first arm 8812 to facilitate the application of force in the closing direction 8834. That is, further movement of the actuation element 8808 in the distal direction 8832 applies additional closing force to the leaflet 20, 22 to prohibit the leaflet 20, 22 from pulling out of the gripping member 8810. In some implementations, the hinge portion 8818 biases the gripping member 8810 to the closed condition so that the gripping member 8810 tends to close as force applied to the actuation element 8808 in the proximal direction 8828 is released.
[001063] Figures 97-99 illustrate a valve repair device 8900 configured to move gripping members inward (e.g. toward one another) and outward (away from one another). In some implementations, the valve repair device 8900 includes a central body 8902 and a plurality of anchors 8904. As shown in Figures 97-99, the valve repair device 8900 is shown with one anchor 8904 to illustrate the operation of the anchor 8904, though the valve repair device 8900 can include two anchors 8904, three anchors 8904, or any number of anchors 8904.
[001064] The valve repair device 8900 includes a central body 8902 that can take a variety of different forms. In some implementations, the central body 8902 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 8902 includes a bore or passage 8906 that one or more actuation elements 8908 extend into. In some implementations, the actuation element 8908 can include any of the actuation elements described herein, including, but not limited to a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
[001065] In some implementations, the valve repair device 8900 can include a plurality of anchors. The plurality of anchors 8904 can take a variety of different forms. For example, the plurality of anchors 8904 can be any of the anchors disclosed by the present application. In the example illustrated by Figures 97-99, the anchors 8904 include a gripping member 8910, such as a clasp. The anchors 8904 can also include a paddle and can be separable from the central body 8902 such as any of the paddles and anchors disclosed by this patent application.
[001066] Referring now to Figure 97, the gripping member 8910 of one of the plurality of anchors 8904 is shown in a closed condition. As shown in the figure, the gripping member 8910 includes a first arm 8912, a second arm 8914, and an optional barbed portion 8916. While the barbed portion 8916 is shown extending from the first arm 8912, the barbed portion 8916 can optionally extend from the second arm 8914, or from the first arm 8912 and the second arm 8914.
[001067] As illustrated by Figures 97-99, the gripping member 8910 is configured to capture a leaflet between the first arm 8912 and the second arm 8914. In this example, the closed position is when the second arm 8914 is as close as possible to the first arm 8912. The second arm 8914 can be moved relative to the first arm 8912 between an open (e.g., Figure 98) condition and a closed condition (e.g., Figure 97).
[001068] In some implementations, the first arm 8912 and the second arm 8914 are hingeably connected by a hinge portion 8918. As shown in Figures 97-99, the gripping member 8910 can be integrally formed such that the first arm 8912, the second arm 8914, and the hinge portion 8918 are formed from a single piece of material.
[001069] In some implementations, the gripping member 8910 can be formed by, for example, cutting the first arm 8912, the second arm 8914, the optional barbed portion 8916, and the hinge portion 8918 from a sheet of shape-memory alloy, such as, for example, nitinol. In some implementations, the hinge portion 8918 can be formed by selectively removing material to increase the flexibility of the hinge portion 8918 relative to the first arm 8912 and the second arm 8914. When the gripping member 8910 comprises and/or is formed from a shape-memory alloy, the gripping member 8910 can be shape set to be biased toward the open condition or the closed condition. Alternatively, an optional biasing member (not shown) is connected between the first arm 8912 and the second arm 8914 to bias the gripping member 8910 toward the open condition or the closed condition.
[001070] In some implementations, the gripping member 8910 can be attached to the central body 8902 via an optional connection member 8920. The gripping member 8910 can also be directly attached to the central body 8802 such as via sutures (e.g., Figures 100-103) or can be indirectly attached via a paddle (not shown). The gripping member 8910, connection member 8920, or paddle can be separable from the central body 8902 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve (e.g., separable via suture attachments and/or tethers).
[001071] In some implementations, the actuation element 8908 can further include an actuation arm 8922 that connects the actuation element 8908 to the second arm 8914 of the gripping member 8810 to facilitate the opening and closing of the gripping member 8810. The actuation arm 8922 extends from a base 8924, through a spring portion 8926, and to an actuation end 8928 to form a J-shape. In some implementations, tether 8930 is connected between the end 8928 of the actuation arm 8922 and the second arm 8914.
[001072] In some implementations, the spring portion 8926 and the actuation end 8928 of the J-shaped actuation arm 8922 form an opening 8932 through which the hinge portion 8918 and second arm 8914 are passed as the actuation element 8908 is extended and retracted to open and close the gripping member 8910.
[001073] In some implementations, the actuation arm 8922 can be directly attached to the actuation element 8908 such as via sutures (e.g., sutures shown in Figures 100-103). In some implementations, the actuation arm can be indirectly attached to the central body, such as, for example, via a paddle (not shown). In some implementations, the actuation arm 8922 can be separable from the central body 8902 with the gripping member 8910 or a paddle as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve.
[001074] In some implementations, the spring portion 8926 of the actuation arm 8922 biases the end 8928 of the actuation arm toward the central body 8902 so that when the gripping member 8910 is in the closed condition, the end 8928 of the actuation arm 8922 presses against the second arm 8914 of the gripping member 8910. As the actuation arm 8922 is moved distally, the end 8928 of the actuation arm is pushed outwards by the hinge portion 8918 against the spring force of the spring portion 8926 until the gripping member 8910 moves out of the opening 8932 of the actuation arm 8922, as shown in Figure 98.
[001075] Moving the actuation arm 8922 in a distal direction 8934 (Figure 98) or a proximal direction 8938 (Figure 99) moves the second arm 8914 between open and closed positions. As the actuation arm 8922 is moved in the distal direction 8934, tension applied between the actuation arm end 8928 and the second arm 8914 by the tether 8930 pulls the second arm 8914 in an opening direction 8936 (e.g., counterclockwise) from the closed position to the open position. Moving the actuation arm 8922 in the proximal direction 8938, the end 8928 of the actuation arm 8922 pushes the second arm 8914 in a closing direction 8940 (e.g., clockwise) to close the gripping member 8910.
[001076] Referring now to Figure 98, the gripping member 8910 is shown being moved into the open condition to facilitate capture of a leaflet 20, 22 of the native valve. To open the gripping member 8910, the actuation element 8908 is extended in the distal direction 8934 so that the actuation arm 8922 is moved in the distal direction 8934. As the actuation arm 8922 moves distally, the end 8928 of the actuation arm 8922 moves along the second arm 8914 and over the hinge portion 8918 so that the gripping member 8910 moves out of the opening 8932 of the actuation arm 8922. The distal movement of the end 8928 of the gripping member 8910 applies tension to the tether 8930 to pull the second arm 8914 in the opening direction 8936 to open the gripping member 8910 to facilitate capture of the leaflet 20, 22. Once the gripping member 8910 is in the open condition, the gripping member 8910 is moved so that the leaflet 20, 22 is disposed between the first arm 8912 and the second arm 8914.
[001077] Referring now to Figure 99, the gripping member 8910 is shown being moved into the closed condition to capture the leaflet 20, 22 of the native valve between the first arm 8912 and the second arm 8914 of the gripping member 8910. To close the gripping member 8910, the actuation element 8908 is retracted in the proximal direction 8938 to release the tension applied to the tether 8930 and to move the end 8928 of the actuation arm 8922 over the hinge portion 8918 of the gripping member 8910 so that the gripping member 8910 moves into the opening 8932 of the actuation arm 8922. As the end 8928 moves over the hinge portion 8918 and onto the second arm 8914, the spring force applied by the spring portion 8926 maintains the end 8928 of the actuation arm 8922 in contact with the second arm 8914 and thereby imparts a force in the closing direction 8940 to the second arm 8914 of the gripping member 8910. In this way, the actuation arm 8922 causes the second arm 8914 to move in the closing direction 8940 to capture the leaflet 20, 22 between the first arm 8912 and the second arm 8914.
[001078] As the second arm 8914 closes against the leaflet 20, 22, the spring force exerted by the spring portion 8926 onto the second arm 8914 via the end 8928 of the actuation arm 8922 facilitates the application of force in the closing direction 8940. Further movement of the actuation element 8908 in the proximal direction 8938 moves the end 8928 of the actuation arm 8922 toward the end of the second arm 8914 and closer to the point of capture of the leaflet 20, 22, thereby applying additional closing force to the leaflet 20, 22 to prohibit the leaflet 20, 22 from pulling out of the gripping member 8910. In some implementations, the hinge portion 8918 of the gripping member 8910 provides a spring force that biases the second arm 8914 in the closing direction 8934 so that the gripping member 8910 tends to close as force applied to the actuation element 8908 in the distal direction 8934 is released.
[001079] Figures 100-103 illustrate a valve repair device 9000 configured to move gripping members inward (e.g. toward one another) and outward (away from one another). In some implementations, the valve repair device 9000 includes a central body 9002 and a plurality of anchors 9004. As shown in Figures 100-103, the valve repair device 9000 includes one anchor 9004 to illustrate the operation of the anchor 9004, though the valve repair device 9000 can include two anchors 9004, three anchors 9004, or any number of anchors 9004.
[001080] In some implementations, the valve repair device 9000 includes a central body 9002, which can take a variety of different forms. For example, the central body 9002 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9002 includes one or more bores or passages 9006 that one or more actuation elements 9008 extend through. [001081] In some implementations, the valve repair device 9000 includes a plurality of anchors 9004, which can take a variety of different forms. For example, the plurality of anchors 9004 can be any of the anchors disclosed by the present application. As shown in Figures 100-103, the anchors 9004 include a gripping member 9010, such as a clasp. The anchors 9004 can also include a paddle and can be separable from the central body 9002 such as any of the paddles and anchors disclosed by this patent application.
[001082] In some implementations, the gripping member 9010 includes one or more actuation element accepting features 9009 that the actuation element can extend through. The actuation element accepting feature(s) 9009 can take a variety of different forms. For example, the actuation element accepting feature(s) 9009 can be a ring, loop, tube, etc. attached to the gripping member 9010 or integrally formed with the gripping member 9010. In the example illustrated by Figure 100, the actuation element accepting feature 9009 comprises a passage through the arm 9012 of the gripping member 9010 that the actuation element extends through.
[001083] In some implementations, the actuation element 9008 extends distally through a proximal portion of the passage 9006 in the central body 9002, out of the central body 9002, into and through the actuation element accepting feature 9009, out of the actuation element accepting feature 9009, back into the central body 9002, through a distal portion of the passage 9006 in the central body 9002, out of the central body 9002, and to the arm 9014.
[001084] In some implementations, the actuation element 9008 can include any of the actuation elements described herein, including, but not limited to a wire, a flexible shaft, a suture, a hypotube, etc.
[001085] Referring now to Figure 100, the gripping member 9010 of one of the plurality of anchors 9004 is shown in a closed condition. In some implementations, the gripping member 9010 includes a first arm 9012, a second arm 9014, and an optional barbed portion 9016. While the barbed portion 9016 is shown extending from the first arm 9012, the barbed portion 9016 can optionally extend from the second arm 9014, or from the first arm 9012 and the second arm 9014. [001086] As shown in Figures 100-103, the gripping member 9010 is configured to capture a leaflet between the first arm 9012 and the second arm 9014. In this example, the closed position is when the second arm 9014 is as close as possible to the first arm 9012. The second arm 9014 can be moved relative to the first arm 9012 between an open condition and a closed condition.
[001087] In some implementations, the first arm 9012 and the second arm 9014 are hingeably connected by a hinge portion 9018. In some implementations, the gripping member 9010 is integrally formed such that the first arm 9012, the second arm 9014, and the hinge portion 9018 are formed from a single piece of material. The gripping member 9010 can be formed by, for example, cutting the first arm 9012, the second arm 9014, the optional barbed portion 9016, and the hinge portion 9018 from a sheet of shape-memory alloy, such as, for example, nitinol. In some implementations, the hinge portion 9018 can be formed by selectively removing material to increase the flexibility of the hinge portion 9018 relative to the first arm 9012 and the second arm 9014.
[001088] When the gripping member 9010 comprises and/or is formed from a shapememory alloy, the gripping member 9010 can be shape set to be biased toward the open condition or the closed condition. Alternatively, an optional biasing member (not shown) is connected between the first arm 9012 and the second arm 9014 to bias the gripping member 9010 toward the open condition or the closed condition.
[001089] As shown in Figures 100-103, the gripping member 9010 is attached to the central body 9002 via one or more tether portions 9020 of the actuation element 9008 that extend from one or more openings of the passage 9006 in the central body 9002. The tether portions 9020 attach the first arm 9012 to the central body 9002 or paddle to maintain the position of the first arm 9012 during the opening of the gripping member 9010.
[001090] In some implementations, the gripping member 9010 can be directly attached to the central body 9002 by the attachment tether portions 9020 or can be indirectly attached, such as, for example, via a paddle (not shown). The gripping member 9010 or a paddle can be separable from the central body 9002 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve. [001091] In some implementations, the attachment sutures or tether portions 9020 are formed from the actuation element 9008 so that tension is not applied to the second arm 9014 of the gripping member 9010 unless the anchor 9004 is pulled against the central body 9002 by the tether portions 9020 of the actuation element 9008. In these implementations, the tether portions 9020 are part of the actuation element 9008 that can be formed from a single suture, tether, wire, flexible shaft, and the like.
[001092] In some implementations, the central body 9002 extends to a distal end 9022 that is arranged distally beyond the hinge portion 9018 of the gripping member 9010. In some implementations, the actuation element 9008 extends from one of the one or more openings to the passage 9006 in the central body 9002 that is arranged near the distal end 9022 of the central body 9002 to the second arm 9014 so that retraction of the actuation element 9008 causes the gripping member 9010 to open.
[001093] Referring now to Figure 101, the gripping member 9010 is shown being moved into the open condition to facilitate capture of a leaflet 20, 22 of the native valve. To open the gripping member 9010, the actuation element 9008 is pulled into and through the central body 9002 in a retraction direction 9024. Retracting the actuation element 9008 into the central body 9002 generates tension in the actuation element 9008 that pulls on the second arm 9014 to cause the second arm 9014 to move in an opening direction 9026 (e.g., counterclockwise) to open the gripping member 9010 (e.g., to an open condition). Once the gripping member 9010 is in the open condition, the gripping member 9010 is moved so that the leaflet 20, 22 is disposed between the first arm 9012 and the second arm 9014.
[001094] Referring now to Figure 102, the gripping member 9010 is shown being moved into the closed condition to capture the leaflet 20, 22 of the native valve between the first arm 9012 and the second arm 9014 of the gripping member 9010. In some implementations, the hinge portion 9018 of the gripping member 9010 provides a spring force that biases the second arm 9014 in a closing direction 9030. Consequently, as tension on the actuation element 9008 is released as indicated by arrow 9028 the second arm 9014 of the gripping member 9010 moves in the closing direction 9030 (e.g., clockwise) to capture the leaflet 20, 22 between the first arm 9012 and the second arm 9014. The leaflet 20, 22 is then retained within the gripping member 9010 by the spring force of the hinge portion 9018 of the gripping member 9010. [001095] Referring now to Figure 103, the gripping member 9010 is shown separated from the central body 9002 as is mentioned above. That is, after securing one of the leaflets 20, 22 the gripping member 9010 can be separated from the central body 9002 to facilitate capture of the remaining leaflets 20, 22. The gripping member 9010 and the captured leaflet 20, 22 can be allowed to move in an outward direction 9032 away from the central body 9002 by providing slack in the tether portions 9020 of the actuation element 9008. For example, providing slack in the actuation suture 9008 allows the tether portions 9020 to extend as illustrated by Figure 103. The slack provided in the actuation element 9008 also inhibits the actuation element 9008 from re-opening the second arm 9014 while the gripping member 9010 is separated from the central body 9002.
[001096] Figures 104-109 illustrate a valve repair device 9100 configured to move gripping members inward (e.g. toward one another) and outward (away from one another). The valve repair device 9100 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 9100 includes a central body 9102 and a plurality of anchors 9104. Referring now to Figures 104-109, the valve repair device 9100 is shown with one anchor 9104 to illustrate the operation of the anchor 9104, though the valve repair device 9100 can include two anchors 9104, three anchors 9104, or any number of anchors 9104.
[001097] The valve repair device 9100 can include a central body 9102, which can take a variety of different forms. In some implementations, the central body 9102 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9102 includes a central bore or passage 9106 that one or more actuators or actuation elements 9108 extend into.
[001098] The valve repair device 9100 can include a plurality of anchors 9104, which can take a variety of different forms. In some implementations, the plurality of anchors 9104 can be any of the anchors disclosed by the present application. In the example illustrated by Figures 104-109, the anchors 9104 include a gripping member 9110, such as a clasp. The anchors 9104 can also include a paddle and can be separable from the central body 9102 such as any of the paddles and anchors disclosed by this patent application. [001099] Referring now to Figure 104, the gripping member 9110 of an anchor of the plurality of anchors 9104 is shown in a closed condition. As shown in the figure, the gripping member 9110 includes a first arm 9112, a second arm 9114, and an optional barbed portion 9116. While the barbed portion 9116 is shown extending from the first arm 9112, the barbed portion 9116 can optionally extend from the second arm 9114, or from the first arm 91 12 and the second arm 9114. In some implementations, the gripping member 9110 is configured to capture a leaflet between the first arm 9112 and the second arm 9114. In some implementations, the closed position is when the second arm 9114 is as close as possible to the first arm 9112. The second arm 9114 can be moved relative to the first arm 9112 between an open condition (Figure 105) and a closed condition (Figure 104).
[001100] In some implementations, the first arm 9112 and the second arm 9114 are hingeably connected by a hinge portion 9118. In some implementations, the gripping member 9110 is integrally formed such that the first arm 9112, the second arm 9114, and the hinge portion 9118 are formed from a single piece of material.
[001101] In some implementations, the gripping member 9110 can be formed by, for example, cutting the first arm 9112, the second arm 9114, the optional barbed portion 9116, and the hinge portion 9118 from a sheet of shape-memory alloy, such as, for example, nitinol. The hinge portion 9118 can be formed by selectively removing material to increase the flexibility of the hinge portion 9118 relative to the first arm 9112 and the second arm 9114. In some implementations, the gripping member 91 10 can be formed from a braided sheet of shape-memory alloy.
[001102] When the gripping member 9110 comprises and/or is formed from a shapememory alloy, the gripping member 9110 can be shape set to be biased toward the open condition or the closed condition. Alternatively, an optional biasing member (not shown) is connected between the first arm 9112 and the second arm 9114 to bias the gripping member 9110 toward the open condition or the closed condition.
[001103] In some implementations, the gripping member 91 10 can be attached to the central body 9102 via an optional connection member 9120. The connection member 9120 attaches the first arm 9112 to the central body 9102 to maintain the position of the first arm 9112 during the opening of the gripping member 9110. [001104] In some implementations, the gripping member 9110 can also be directly attached to the central body 9102 such as via sutures (e.g., Figures 100-103) or can be indirectly attached via a paddle (not shown). In some implementations, the gripping member 9110, connection member 9120, or a paddle can be separable from the central body 9102 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve (e.g., separable via one or more sutures or tethers).
[001105] In some implementations, the gripping member 9110 is opened by applying tension to the actuator or actuation element 9108 that extends from the opening 9106 in the central body 9102, around a routing member 9122, and to the second arm 9114. In some implementations, the actuation elements 9108 can include any of the actuation elements described herein, including, but not limited to a wire, a flexible shaft, a suture, a hypotube, etc.
[001106] In some implementations, the routing member 9122 has a rounded shape that extends to or beyond the hinge portion 9118 so that the actuation element 9108 is arranged on a distal side of the hinge portion 9118. The routing member 9122 can be moved proximally and distally via a routing control member 9124. In some implementations, the routing member 9122 and the actuation element 9108 can pass through a slot 9126 provided in the first arm 9112, the second arm 9114, and/or the hinge portion 9118 of the gripping member 9110 so that the routing member 9122 can be moved distally and proximally relative to the hinge portion 9118 of the gripping member 9110. That is, the routing member 9122 can be moved inside and outside of the gripping member 9110 to change the path of the actuation element 9108 relative to the hinge portion 9118 so that retraction of the actuation element 9108 can cause the gripping member 9110 to open.
[001107] Referring now to Figure 105, the gripping member 9110 is shown being moved into the open condition to facilitate capture of a leaflet 20, 22 of the native valve. To open the gripping member 9110, the actuator or actuation element 9108 is withdrawn into the opening 9106 in the central body and/or withdrawn by the routing member 9122 in a retraction direction 9128. Retracting the actuation element 9108 into the central body 9102 generates tension to the actuation element 9108 that is routed around the routing portion 9122 to pull on the second arm 9114 to cause the second arm 9114 to move in an opening direction 9130 (e.g., counterclockwise) to open the gripping member 9110. Once the gripping member 9110 is in the open condition, the gripping member 9110 is moved so that the leaflet 20, 22 is disposed between the first arm 9112 and the second arm 9114.
[001108] Referring now to Figures 106-107, the gripping member 9110 is shown being moved into the closed condition to capture the leaflet 20, 22 of the native valve between the first arm 9112 and the second arm 9114 of the gripping member 9110. To initiate the closure of the gripping member 9110, the router or routing member 9122 is retracted by moving the routing control member 9124 in a proximal direction 9132 so that the routing member 9122 is arranged proximal of the hinge portion 9118. Withdrawing the routing member 9122 inside of the gripping member 9110 allows the actuator or actuation element 9108 to move inside of the hinge portion 9118 of the gripping member 9110 (e.g., move proximal to the hinge portion 9118) so that retracting the actuation element 9108 in the retraction direction 9128 causes the second arm 9114 to move in a closing direction 9134 (e.g., clockwise) until the leaflet 20, 22 is captured between the second arm 9114 and the first arm 91 12 as is shown in Figure 107. Further retraction of the actuation element 9108 applies additional force in the closing direction 9134 to secure the leaflet 20, 22 in the gripping element 9110 and prohibit the leaflet 20, 22 from pulling out of the gripping member 9110.
[001109] Referring now to Figures 108-109, an alternative closing procedure is shown for the gripping member 9110 where the hinge portion 9118 of the gripping member 9110 provides a spring force that biases the second arm 9114 in the closing direction 9134. In the example shown in Figure 108, tension on the actuator or actuation element 9108 is released or the actuation element 9108 is moved in an extending direction 9136 and the spring force provided by the hinge portion 9118 causes the second arm 9114 to move in the closing direction 9134 to capture the leaflet 20, 22 between the first arm 9112 and the second arm 9114.
[001110] Referring now to Figure 109, after the leaflet 20, 22 is captured, the routing portion 9122 can be withdrawn in the proximal direction 9132 so that the actuator or actuation element 9108 is moved inside of the gripping member 9110 and proximal of the hinge portion 9118. Once the router or routing member 9122 is retracted, further retraction of the actuation element 9108 in the retraction direction 9128 applies additional force in the closing direction 9134 to secure the leaflet 20, 22 in the gripping element 9110 and prohibit the leaflet 20, 22 from pulling out of the gripping member 9110. [001111] Figures 110-1 14 illustrate a valve repair device 9200 configured to move gripping members inward (e.g. toward one another) and outward (away from one another). The valve repair device 9200 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 9200 includes a central body 9202 and a plurality of anchors 9204. Referring to Figures 110-114, a valve repair device 9200 is shown with one anchor 9204 to illustrate the operation of the anchor 9204, though the valve repair device 9200 can include two anchors 9204, three anchors 9204, or any number of anchors 9204.
[001112] The valve repair device can include a central body 9202, which can take a variety of different forms. In some implementations, the central body 9202 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9202 includes a central bore or passage 9206 that one or more actuation elements 9208 extend into.
[001113] In some implementations, the one or more actuation elements 9208 can include any of the actuation elements described herein, including, but not limited to a wire, a flexible shaft, a suture, a hypotube, etc.
[001114] In some implementations, the valve repair device 9200 includes a plurality of anchors 9204, which can take a variety of different forms. In some implementations, the plurality of anchors 9204 can be any of the anchors disclosed by the present application. In the example illustrated by Figures 1 10-114, the anchors 9204 include a gripping member 9210, such as a clasp. In some implementations, the anchors 9204 can also include a paddle. In some implementations, the anchors 9204 and/or paddles can be separable from the central body 9202 such as any of the paddles and anchors disclosed by this patent application.
[001115] In some implementations, the anchors 9204 can include a gripping member 9210. Referring now to Figure 110, the gripping member 9210 of one of the plurality of anchors 9204 is shown in a closed condition. In some implementations, the gripping member 9210 includes a first arm 9212, a second arm 9214, and an optional barbed portion 9216. While the barbed portion 9216 is shown extending from the first arm 9212, the barbed portion 9216 can optionally extend from the second arm 9214, or from the first arm 9212 and the second arm 9214.
[001116] In the example illustrated by Figures 110-114, the gripping member 9210 is configured to capture a leaflet between the first arm 9212 and the second arm 9214. In this example, the closed position is when the second arm 9214 is as close as possible to the first arm 9212. The second arm 9214 can be moved relative to the first arm 9212 between an open condition and a closed condition.
[001117] In some implementations, the first arm 9212 and the second arm 9214 are hingeably connected by a hinge portion 9218. In the illustrated example of a gripping member 9210, the first arm 9212, the second arm 9214, and the hinge portion 9218 are integrally formed from a single piece of material.
[001118] In some implementations, the gripping member 9210 can be formed by, for example, cutting the first arm 9212, the second arm 9214, the optional barbed portion 9216, and the hinge portion 9218 from a sheet of shape-memory alloy, such as, for example, nitinol. The hinge portion 9218 can be formed by selectively removing material to increase the flexibility of the hinge portion 9218 relative to the first arm 9212 and the second arm 9214.
[001119] When the gripping member 9210 comprises and/or is formed from a shapememory alloy, the gripping member 9210 can be shape set to be biased toward the open condition or the closed condition. In some implementations, an optional biasing member (not shown) is connected between the first arm 9212 and the second arm 9214 to bias the gripping member 9210 toward the open condition or the closed condition.
[001120] In some implementations , the gripping member 9210 can be attached to the central body 9202 via an optional connection member 9220. The connection member 9220 attaches the first arm 9212 to the central body 9202 to maintain the position of the first arm 9212 during the opening of the gripping member 9210. In some implementations, the gripping member 9210 can also be directly attached to the central body 9202 such as via sutures (e.g., Figures 100-103) or can be indirectly attached via a paddle (not shown). In some implementations, the gripping member 9210, connection member 9220, or a paddle can be separable from the central body 9202 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve. [001121] As shown in Figures 110- 114, the second arm 9214 includes a flexible portion 9222. In some implementations, the flexible portion 9222 is optionally arranged in a gap 9224 formed inside of a U-shaped end 9226 of the second arm 9214. In some implementations, the U-shaped end 9226 is bent or formed away from the first arm 9212 (e.g., when viewed in profile as illustrated in Figures 110-114). That is, when viewed from a top or plan view, the end of the second arm 9214 (e.g., the end not hingeably connected to the first arm 9212) can be U-shaped with the bottom of the U formed away from the first arm 9212. In this manner, the flexible portion 9222 can be moved away from the first arm 9212 before the flexible portion 9222 contacts the U-shaped end 9226.
[001122] In some implementations, the flexible portion 9222 includes a head 9228 that includes an optionally barbed end 9230. The head 9228 can be provided at the end of the flexible portion 9222 of the second arm 9214.
[001123] In some implementations, the barbed end 9230 of the head includes a hook 9234. In some examples, when the second arm 9214 is in the closed position, the optional hook 9234 (e.g., Figure 111) of the barbed end 9230 engages and latches onto a catch member 9232 provided on the first arm 9212. The barbed end 9230 and hook 9234 can be disengaged from the catch member 9232 to open the gripping member 9210 by tilting and moving the head 9228 away from the first arm 9212 (e.g., by bending the flexible portion 9222 of the second arm 9214).
[001124] In some implementations, the gripping member 9210 is opened by applying of tension to the actuation element 9208 that extends from the opening 9206 in the central body 9202, around the hinge portion 9218, around the U-shaped end 9226, and to the head 9228 at the end of the flexible portion 9222 of the second arm 9214. In this manner, the actuation element can selectively bend the flexible portion 9222 (e.g., the head 9228) away from the first arm 9212.
[001125] Referring now to Figures 111-112, the gripping member 9210 is shown being moved into the open condition to facilitate capture of a leaflet 20, 22 of the native valve. To open the gripping member 9210, the actuation element 9208 is withdrawn into the opening 9206 in the central body 9202 in a retraction direction 9236. As shown in the figures, the retraction direction can follow a path of the actuation element (e.g., through the bore of the central body, and around the anchor to the flexible portion 9222 of the second arm 9214).
[001126] In some implementations, retracting the actuation element 9208 into the central body 9202 generates tension to the actuation element 9208 that is routed around the hinge portion 9218 to pull on the head 9228 of the second arm 9214 to apply force to the head 9228 in an opening direction 9238, e.g., to pull the second arm 9214 of the anchor 9204 toward an open condition. In some implementations, the force applied to the head 9228 causes the flexible portion 9222 to bend in the opening direction 9238 so that the head 9228 tilts in such a way to cause the hook 9234 to disengage from the catch member 9232.
[001127] In some implementations, further application of force in the opening direction 9238 by the actuation element 9208 causes the head 9228 and the flexible portion 9222 to bend outward in the opening direction 9238 until the flexible portion 9222 engages the Ilshaped end 9226 of the second arm 9214. As is shown in Figure 112, further retraction of the actuation element 9208 in the retraction direction 9236 once the flexible portion 9222 has engaged the U-shaped end 9226 causes the second arm 9214 to pivot in the opening direction 9238 to open the gripping member 9210. Once the gripping member 9210 is in the open condition, the gripping member 9210 can be moved so that the leaflet 20, 22 is disposed between the first arm 9212 and the second arm 9214.
[001128] Referring now to Figures 113-114, the gripping member 9210 is shown being moved into the closed condition to capture the leaflet 20, 22 of the native valve between the first arm 9212 and the second arm 9214 of the gripping member 9210. In some implementations, the hinge portion 9218 of the gripping member 9210 provides a spring force that biases the gripping member 9210 towards a closed condition. Consequently, as tension on the actuation element 9208 is released in an extension direction 9240, the second arm 9214 of the gripping member 9210 moves in a closing direction 9242 (e.g., clockwise) to capture the leaflet 20, 22 between the first arm 9212 and the second arm 9214.
[001129] Further release of the tension on the actuation element 9208 in the extending direction 9240 allows the flexible arm 9222 and the head 9228 of the second arm 9214 to move away from the U-shaped end 9226 and toward the leaflet 20, 22. As shown in Figure 114, the barbed end 9230 can penetrate the leaflet 20, 22 to engage the catch member 9232 of the first arm 9212 to secure the second arm in the closed condition. The leaflet 20, 22 is then retained within the gripping member 9210 by the spring force of the hinge portion 9218 of the gripping member 9210 and by the head 9228 and barbed end 9230 of the second arm 9214.
[001130] Figures 115-119 illustrate a valve repair device 9300 configured to move gripping members inward (e.g. toward one another) and outward (away from one another). The valve repair device 9300 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 9300 includes a central body 9302 and a plurality of anchors 9304. Referring now to Figures 115-119, the valve repair device 9300 is shown with one anchor 9304 to illustrate the operation of the anchor 9304, though the valve repair device 9300 can include two anchors 9304, three anchors 9304, or any number of anchors 9304.
[001131] The valve repair device can include a central body 9302, which can take a variety of different forms. In some implementations, the central body 9302 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9302 includes a central bore or passage 9306 that one or more actuation elements 9308 extend into.
[001132] In some implementations, the one or more actuation elements 9308 can include any of the actuation elements described herein, including, but not limited to a wire, a flexible shaft, a suture, a hypotube, etc.
[001133] The valve repair device can include a plurality of anchors 9304, which can take a variety of different forms. For example, the plurality of anchors 9304 can be any of the anchors disclosed by the present application. In the example illustrated by Figures 115-119, the anchors 9304 include a gripping member 9310, such as a clasp. In some implementations, the anchors 9304 can also include a paddle and can be separable from the central body 9302 such as any of the paddles and anchors disclosed by this patent application (e.g., separable via one or more tethers coupled between the paddle and/or gripping member 9310 and the central body 9302). [001134] Referring now to Figure 1 15, the gripping member 9310 of one of the plurality of anchors 9304 is shown in a closed condition. The gripping member 9310 includes a first arm 9312, a second arm 9314, and an optional barbed portion 9316. While the barbed portion 9316 is shown extending from the first arm 9312, the barbed portion 9316 can optionally extend from the second arm 9314, or from the first arm 9312 and the second arm 9314. In the example illustrated by Figures 115-119, the gripping member 9310 is configured to capture a leaflet between the first arm 9312 and the second arm 9314. In this example, the closed position is when the second arm 9314 is as close as possible to the first arm 9312. The second arm 9314 can be moved relative to the first arm 9312 between an open condition (Figure 116) and a closed condition (Figure 1 15).
[001135] In some implementations, the first arm 9312 and the second arm 9314 are hingeably connected by a hinge portion 9318. In some implementations, a gripping member 9310 can be integrally formed such that the first arm 9312, the second arm 9314, and the hinge portion 9318 are formed from a single piece of material.
[001136] In some implementations, the gripping member 9310 can be formed by, for example, cutting the first arm 9312, the second arm 9314, the optional barbed portion 9316, and the hinge portion 9318 from a sheet of shape-memory alloy, such as, for example, nitinol. The hinge portion 9318 can be formed by selectively removing material to increase the flexibility of the hinge portion 9318 relative to the first arm 9312 and the second arm 9314.
[001137] When the gripping member 9310 comprises and/or is formed from a shapememory alloy, the gripping member 9310 can be shape set to be biased toward the open condition or the closed condition. In some implementations, an optional biasing member (not shown) is connected between the first arm 9312 and the second arm 9314 to bias the gripping member 9310 toward the open condition or the closed condition.
[001138] In some implementations, the gripping member 9310 can be attached to the central body 9302 via an optional connection member 9320. The connection member 9320 attaches the first arm 9312 to the central body 9302 to maintain the position of the first arm 9312 during the opening of the gripping member 9310. In some implementations, the gripping member 9310 can also be directly attached to the central body 9302 such as via sutures (e.g., Figures 100-103) or can be indirectly attached via a paddle (not shown). The gripping member 9310, connection member 9320, or a paddle can be separable from the central body 9302 as with other examples shown herein (e.g., via one or more tethers) to facilitate capture of one or more leaflets 20, 22 of the native valve.
[001139] In some implementations, the second arm 9314 includes an extension portion such as an optional folding or hinged barb portion 9322 that extends towards the first arm 9312. The folding barbed portion 9322 can be moved from an extended position (Figure 115) to a retracted position (Figure 116) where the folding barbed portion 9322 is flat against or flush with the second arm 9314.
[001140] In some implementations, the folding barbed portion 9322 is moved from the extended position to the retracted position via application of tension from the actuation element 9308 that extends through an opening 9324 in the second arm 9314 to connect to the folding barbed portion 9322. Once the folding barbed portion 9322 reaches the retracted position, further application of tension to the actuation element 9308 causes the second arm 9314 to pivot outwards to open the gripping member 9310.
[001141] In some implementations, the folding barbed portion 9322 can be a separate component or can be integrally formed with the second arm 9314. In some implementations, the folding barbed portion 9322 is cut from a portion of the second arm 9314 and is folded outward and shape set in an extended condition so that the folding barbed portion 9322 is biased in the extending direction. In examples where the folding barbed portion 9322 is biased to fold open to the extended position, releasing tension on the actuation element 9308 allows the folding barbed portion 9322 to extend from the retracted position to the extended position.
[001142] Referring now to Figures 116-117, the gripping member 9310 is shown being moved into the open condition to facilitate capture of a leaflet 20, 22 of the native valve. To open the gripping member 9310, the actuation element 9308 is withdrawn into the opening 9306 in the central body 9302 in a retraction direction 9326. Retracting the actuation element 9308 into the central body 9302 generates tension to the actuation element 9308 that is routed around the hinge portion 9318, through the opening 9324 in the second arm 9314, and to the optional folding barbed portion 9322 to fold the folding barbed portion 9322 in a folding direction 9328 toward the second arm 9314. [001143] As is shown in Figure 117, further retraction of the actuation element 9308 in the retraction direction 9326 once the folding barbed portion 9322 is flat again or flush with the second arm 9314 causes the second arm 9314 to pivot in the opening direction 9330 to open the gripping member 9310. Once the gripping member 9310 is in the open condition, the gripping member 9310 is moved so that the leaflet 20, 22 is disposed between the first arm 9312 and the second arm 9314.
[001144] Referring now to Figures 118-119, the gripping member 9310 is shown being moved into the closed condition to capture the leaflet 20, 22 of the native valve between the first arm 9312 and the second arm 9314 of the gripping member 9310. To close the gripping member 9310 actuation element 9308 is extended in an extending direction 9332 to allow the second arm 9314 to be moved in a closing direction 9334 (e.g., clockwise) by a spring force exerted by the hinge portion 9318 until the leaflet 20, 22 is captured between the second arm 9314 and the first arm 9312 as is shown in Figure 118. In some implementations, a biasing spring can be used to bias the second arm 9314 toward the closing condition.
[001145] Further extension of the actuation element 9308, as shown in Figure 119, allows the folding barbed member 9322 to fold in an extending direction 9336 to engage the captured leaflet 20, 22 to secure the leaflet 20, 22 in the gripping element 9310 and prohibit the leaflet 20, 22 from pulling out of the gripping member 9310.
[001146] In some implementations, a valve repair device 9400 is configured to move anchors — including paddles and/or gripping members — inward (e.g. toward one another) and outward (away from one another). The valve repair device 9400 can take a variety of different forms, such as any of the forms disclosed herein. Referring now to Figures 120-130, in some implementations, the valve repair device 9400 includes a central body 9402 and a plurality of anchors 9404. As shown in these figures, the operation of one of the plurality of anchors 9404 is shown. Also, while the valve repair device 9400 is shown with three anchors 9404, the valve repair device 9400 can include two anchors 9404, three anchors 9404, or any number of anchors 9404.
[001147] The valve repair device 9400 can include a central body 9402. The central body 9402 can take a variety of different forms. For example, the central body 9402 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9402 includes a central bore or passage 9406 that one or more actuation elements 9408 extend into. In some implementations, a separate actuation element 9408 extends to each of the anchors 9404 so that the anchors 9404 can be opened and closed independently.
[001148] The valve repair device 9400 can include a plurality of anchors 9404. The plurality of anchors 9404 can take a variety of different forms. For example, the plurality of anchors 9404 can be any of the anchors disclosed by the present application. In the example illustrated by Figures 120-130, the each of the anchors 9404 include a gripping member 9410, such as a clasp. The anchors 9404 can also include a paddle and can be separable from the central body 9402 such as any of the paddles and anchors disclosed by this patent application.
[001149] Referring now to Figure 120, the gripping members 9410 of the plurality of anchors 9404 are shown in a closed condition. As shown, the gripping member 9410 includes a first arm 9412, a second arm 9414, and an optional barbed portion 9416. While the barbed portion 9416 is shown extending from the first arm 9412, the barbed portion 9416 can optionally extend from the second arm 9414, or from the first arm 9412 and the second arm 9414. In the example illustrated by Figures 120-130, the gripping member 9410 is configured to capture a leaflet between the first arm 9412 and the second arm 9414. In some implementations, the closed position is when the second arm 9414 is as close as possible to the first arm 9412. The second arm 9414 can be moved relative to the first arm 9412 between an open condition and a closed condition.
[001150] In some implementations, the first arm 9412 and the second arm 9414 are hingeably connected by a hinge portion 9418. In the illustrated example of a gripping member 9410, the first arm 9412, the second arm 9414, and the hinge portion 9418 are integrally formed from a single piece of material.
[001151] In some implementations, the gripping member 9410 can be formed by, for example, cutting the first arm 9412, the second arm 9414, the optional barbed portion 9416, and the hinge portion 9418 from a sheet of shape-memory alloy, such as, for example, nitinol. In some implementations, the hinge portion 9418 can be formed by selectively removing material to increase the flexibility of the hinge portion 9418 relative to the first arm 9412 and the second arm 9414.
[001152] When the gripping member 9410 can comprise and/or be formed from a shapememory alloy, the gripping member 9410 can be shape set to be biased toward the open condition or the closed condition. In some implementations, an optional biasing member (not shown) is connected between the first arm 9412 and the second arm 9414 to bias the gripping member 9410 toward the open condition or the closed condition.
[001153] In some implementations , the anchors 9404 include a first mounting plate 9420 that is coupled to the first arm 9412 of the gripping member 9410. The first mounting plate 9420 includes one or more openings 9422 for receiving one or more attachment sutures or tethers 9424 that extend from corresponding openings 9426 in the central body 9402 that connect with the passage 9406 through the central body 9402. The attachment sutures or tethers 9424 attach to the first arm 9412 to the central body 9402 or paddle to maintain the position of the first arm 9412 during the opening of the anchor 9404 and/or the gripping member 9410.
[001154] In some implementations, the anchors 9404 can be separable from the central body 9402 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve. In some implementations, a separate attachment suture or tether 9424 extends to each of the anchors 9404 so that the anchors 9404 can be released and retracted independently from each other.
[001155] In some implementations, the attachment sutures or tethers 9424 are formed from the actuation element 9408 so that tension is not applied to the second arm 9414 of the gripping member 9410 unless the anchor 9404 is pulled against the central body 9402 by the attachment sutures or tethers 9424. In these implementations, the actuation element 9408 and the attachment sutures or tethers 9424 can be formed from a single suture.
[001156] In some implementations , the first mounting plate 9420 coupled to the first arm 9412 also includes a first alignment feature 9428 that is configured to engage with a corresponding second alignment feature 9430 of the central body 9402. As shown in Figures 121-129, the first alignment feature 9428 can be formed from a rectangular opening or receptacle in the first mounting plate 9420 and the second alignment feature 9430 can comprise and/or be formed from a corresponding rectangular protrusion or boss extending from the central body 9402. In some implementations, the second alignment feature 9430 can optionally include a filet or chamfer 9432 to facilitate a smooth engagement between the first mounting plate 9420 and the central body 9402 as the anchor 9404 is retracted toward and engages with the central body 9402. In some examples, the first alignment feature 9428 of the anchor 9404 is a protrusion for engaging with an opening or receptacle that forms the second alignment feature 9430 of the central body 9402.
[001157] In some implementations, the anchors 9404 also include a second mounting plate 9434 that is coupled to the second arm 9414 of the gripping member 9410. The second mounting plate 9434 includes a routing flange or projection 9436 extending away from the second mounting plate 9434 adjacent the hinge portion 9418 of the gripping member 9410. The routing flange or projection 9436 includes an opening 9438 through which the actuation element 9408 extends between exiting the passage 9406 and attaching to the second mounting plate 9434 and the second arm 9414 so that applying tension to the actuation element 9408 in a retracting direction 9440 causes the second arm 9414 of the gripping member 9410 to move in an opening direction 9442.
[001158] Referring now to Figures 123-125, one of the anchors 9404 is shown released or disengaged from the central body 9402. For instance, after capturing a leaflet 20, 22 within the gripping member 9410, the anchor 9404 can be released from the central body 9402 by relaxing tension on the attachment sutures or tethers 9424. Once released, movement of the leaflet 20, 22 is allowed to pull the anchor 9404 away from the central body 9402 as the valve repair device 9400 is moved to open and position another anchor 9404 to capture another leaflet 20, 22. Once all of the leaflets 20, 22 of the native valve are captured by the plurality of anchors 9404, tension is applied to the attachment sutures or tethers 9424 to retract the anchors 9404 back toward the central body 9402. As the anchors 9404 approach the central body 9402, the first alignment feature 9428 of the first mounting plate 9420 engages the second alignment feature 9430 of the central body 9402 to guide the anchor 9404 into the desired position against the central body 9402 as can be seen, for example, in Figure 126. [001159] Once the anchors 9404 are retracted and pulled against the central body 9402, the attachment sutures or tethers 9424 can be locked in place by extending and compressing a locking member 9444 against a corresponding locking surface 9446 of the central body 9402. As can be seen in Figure 127, the locking member 9444 and the locking surface 9446 can both have a frustoconical or a similarly tapered shape. The attachment sutures or tethers 9424 are locked in place by being compressed between the locking member 9444 and the locking surface 9446. Once the attachment sutures or tethers 9424 are locked in place, the locking member 9444 can be secured in a wide variety of ways, such as, for example, via a friction fit with the locking surface 9446, a threaded portion, a biased portion that engages a catch, or the like. Tn some examples, the locking member 9444 can be retracted to unlock the attachment sutures or tethers 9424 to allow the anchor 9404 to be released.
[001160] When the valve repair device 9400 has captured the valve leaflets 20, 22 (or 30, 32, 34) and the anchors 9404 are secured against the central body 9402, the actuation element 9408 can be disconnected from the gripping member 9410 and retracted through a delivery system 9448 that is used to position and implant the valve repair device 9400 in the native valve of a patient.
[001161] In some examples of a valve repair device 9400, the actuation element 9408 extends through a central locking element 9450. The central locking element 9450 extends through a coupling 9452 formed by a first half 9454 connected to the locking member 9444 and a second half 9456 connected to a lock actuation element 9458 extending through the delivery system 9448. In the illustrated example, e.g., in Figure 128, each of the first half 9454 and the second half 9456 of the coupling 9452 have a corresponding handshake shape. In some examples, the handshake shape is identical between the first half 9454 and the second half 9456. In some examples, the handshake shape of the first half 9454 and the second half 9456 are mirror images.
[001162] In some implementations, the first half 9454 and the second half 9456 of the coupling 9452 are prohibited from moving laterally while the central locking element 9450 extends through the coupling 9452, thereby maintaining the coupling 9452 in an attached or a coupled condition. When the central locking element 9450 is retracted into the lock actuation element 9458 of the delivery system 9448 beyond the position of the coupling 9452, as shown in Figure 129, the second half 9456 of the coupling 9452 is allowed to disconnect and separate from the first half 9454 of the coupling 9452.
[001163] Referring now to Figure 130, a cross-sectional view of a catheter 9460 of the delivery system 9448 is shown. The catheter 9460 includes a central lumen 9462 through which the central locking element 9450 and the lock actuation element 9458 extend. A plurality of outer lumens 9464 surround the central lumen 9462. The actuation elements 9408 of each anchor 9404 and the attachment sutures or tethers 9424 extend through the plurality of outer lumens 9464 to engage the valve repair device 9400.
[001164] In some implementations, a valve repair device 9500 is disclosed. The valve repair device 9500 is configured to move anchors — including paddles and/or gripping members — inward (e.g. toward one another) and outward (away from one another). The valve repair device 9500 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 9500 includes a central body 9502 and a plurality of anchors 9504. Referring now to Figures 131-143, the operation of one of the plurality of anchors 9504 is shown to illustrate the operation of the anchor 9504. Also, while the valve repair device 9500 is shown with three anchors 9504, the valve repair device 9500 can include two anchors 9504, three anchors 9504, or any number of anchors 9504.
[001165] The valve repair device 9500 includes a central body 9502, which can take a variety of different forms. For example, the central body 9502 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9502 includes a central bore or passage 9506 that one or more actuation elements 9508 extend into.
[001166] In some implementations, a separate actuation element 9508 extends to each of the anchors 9504 so that the anchors 9504 can be opened and closed independently. The actuation elements 9508 can take on a wide variety of forms, such as, for example, a wire, a rod, a tube, a shaft, a suture, or the like. That is, the actuation elements 9508 can be formed from a material that is suitable for pushing, pulling, or pushing and pulling on actuatable components of the valve repair device 9500. [001167] The valve repair device 9500 includes a plurality of anchors 9504, which can take a variety of different forms. For example, the plurality of anchors 9504 can be any of the anchors disclosed by the present application and can be separable from the central body 9502 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 (or 30, 32, 34) of the native valve. In the example illustrated by Figures 131-143, the anchors 9504 each include a paddle 9510 that can be opened and closed independent of the paddles 9510 of the other anchors 9504.
[001168] In some implementations, the anchors 9504 include a mounting plate 9512 that engages and interfaces with the central body 9502 of the valve repair device 9500 to maintain the position of the anchor 9504 relative to the central body 9502 when the anchor 9504 or a portion of the anchor 9504 is opened by an actuation element 9508 or retracted to the central body 9502 by one or more attachment sutures or tethers 9514.
[001169] In some implementations, the attachment sutures or tethers 9514 extend from openings 9516 of the central body 9502 that are connected to the passage 9506 and to corresponding openings 9518 of the mounting plate 9512. A separate attachment suture or tether 9514 extends to each of the anchors 9504 so that the anchors 9504 can be released and retracted independently from each other. As can be seen in Figures 137-138, the attachment sutures or tethers 9514 can be formed by a loop of a single attachment suture or tether 9514 so that releasing or applying tension to the attachment suture or tether 9514 allows the corresponding anchor 9504 to separate from or re-engage with the central body 9502.
[001170] In some implementations, the mounting plate 9512 includes a first alignment feature 9520 that is configured to engage with a corresponding second alignment feature 9522 of the central body 9502. In the example shown in Figures 135-142, the first alignment feature 9520 can comprise and/or be formed from a rectangular protrusion or boss extending from the mounting plate 9512 and the second alignment feature 9522 is formed by a corresponding rectangular opening or receptacle in the central body 9502. When the mounting plate 9512 is engaged with the central body 9502 the rectangular shape of the first alignment feature 9520 and the corresponding second alignment feature 9522 maintain the position of the mounting plate 9512 relative to the central body 9502 to prohibit lateral motion between the anchor 9504 and the central body 9502. In some implementations, the first alignment feature 9520 and/or the second alignment feature 9522 can optionally include a filet or chamfer 9521 to facilitate a smooth engagement between the mounting plate 9512 and the central body 9502 as the anchor 9504 is retracted toward and engages with the central body 9502. In some examples, the first alignment feature 9520 is an opening or receptacle and the second alignment feature 9522 is a protrusion or boss.
[001171] In some implementations, the mounting plate 9512 also includes a central bore or passage 9524 through which an actuation element 9508 extends to open and close the paddle 9510 of the corresponding anchor 9504. As shown in at least Figures 132-134, the actuation element 9508 engages a distal end 9526 of a frame 9528 of the paddle 9510, the distal end 9526 being moveable in a distal and a proximal direction. In the illustrated example, the actuation element 9508 is a hollow tube that receives an elongated pin or shaft extending proximally from the distal end 9526 of the frame 9528. The actuation element 9508 can optionally include locking or attachment features — such as, for example, a threaded portion — for securely the actuation element 9508 to the elongated pin of the distal end 9526 of the frame 9528.
[001172] The paddle 9510 extends from the distal end 9526 of the frame 9528 to a fixed end 9530 that is attached to the mounting plate 9512. In the illustrated example, e.g., as shown in Figures 132-134, the fixed end 9530 of the paddle 9510 is split into two attachment portions 9532 that are secured to the mounting plate 9512 on either side of the central bore or passage 9524. The frame 9528 is hingeably connected to the distal end 9526 by a distal hinge portion 9534 so that that frame 9528 can flex or pivot radially outward and inward as the paddle 9510 is opened and closed by the actuation element 9508. An inner arm 9536 of the paddle 9510 extends between an inner hinge portion 9538 and an outer hinge portion 9540. The inner hinge portion 9538 hingeably attaches the inner arm 9536 of the paddle 9510 to the fixed end 9530 of the paddle 9510. The outer hinge portion 9540 hingeably attaches the inner arm 9536 of the paddle 9510 to the frame 9528 of the paddle 9510. In the closed condition, side portions or wings 9542 of the frame 9528 overlap the inner arm 9536 to increase the surface area of the leaflet 20, 22 captured by the paddle 9510.
[001173] Referring to Figures 132-134, the paddle 9510 is shown in an open condition that is achieved by extending the actuation element 9508 distally to move the distal end 9526 of the paddle 9510 in a distal direction. Because the fixed end 9530 is connected to the inner arm 9536 by the inner hinge portion 9538, the inner arm 9536 is connected to the frame 9528 by the outer hinge portion 9540, and the frame 9528 is connected to the distal end 9526 by the distal hinge portion 9534, movement of the distal end 9526 away from the fixed end 9530 causes the inner arm 9536 and frame 9528 of the paddle 9510 to pivot or flex radially outward to put the paddle 9510 in the open condition shown in Figures 132-134. Further extension of the distal end 9526 beyond the illustrated open condition moves the paddle 9510 to a fully open or bailout position similar to the arrangement of the anchors 9604 of the valve repair device 9600 shown in Figure 156.
[001174] In some implementations and as shown in the illustrated example, the fixed end 9530, attachment portions 9532, inner arm 9536, and the inner hinge portion 9538 can be formed from a single piece of material. Similarly, the distal end 9526, the frame 9528, and the distal hinge portion 9534 can also be formed from a single piece of material. In some implementations, the entire paddle 9510 can optionally be formed from a single piece of material. The portions of the paddle 9510 can be formed from any suitable material, such as, for example, a sheet of material that is cut and then folded or bent into the desired shape. In some examples, the paddle 9510 is cut from a sheet of a shape-memory alloy such as nitinol and then is bent and shape-set in the closed condition shown in, for example, Figure 131 to bias the paddle 9510 toward the closed condition.
[001175] The anchors 9504 of the valve repair device 9500 can optionally include gripping members 9544, such as clasps, that are attached to the inner arm 9536 of the paddle 9510. The optional gripping members 9544 are actuated separately from the paddle 9510 by a secondary actuation element 9546. Referring to Figures 132-134, when the paddle 9510 is in the open condition, the gripping member 9544 and the operation thereof are more clearly visible.
[001176] Referring now to Figure 132, the gripping member 9544 is shown in a closed condition. The gripping member 9544 includes a first arm 9547, a second arm 9548, and an optional barbed portion 9550. While the barbed portion 9550 is shown extending from the second arm 9548, the barbed portion 9550 can optionally extend from the first arm 9547, or from the first arm 9547 and the second arm 9548. In the example illustrated by Figures 131— 143, the gripping member 9544 is configured to capture a leaflet between the first arm 9547 and the second arm 9548. In this example, the closed position is when the second arm 9548 is as close as possible to the first arm 9547. The second arm 9548 can be moved relative to the first arm 9547 between an open condition and a closed condition by the secondary actuation element 9546. Referring to Figures 133-134, the gripping member 9544 is moved into the open condition by applying tension to the secondary actuation element 9546 to apply an opening force to the second arm 9548.
[001177] In some implementations, the first arm 9547 and the second arm 9548 are hingeably connected by a hinge portion 9552. The first arm 9547 is attached to the inner arm 9536 of the paddle 9510. In the illustrated example of the gripping member 9544, the first arm 9547, the second arm 9548, and the hinge portion 9552 are integrally formed from a single piece of material. The gripping member 9544 can be formed by, for example, cutting the first arm 9547, the second arm 9548, the optional barbed portion 9550, and the hinge portion 9552 from a sheet of shape-memory alloy, such as, for example, nitinol. In some implementations, the hinge portion 9552 can be formed by selectively removing material to increase the flexibility of the hinge portion 9552 relative to the first arm 9547 and the second arm 9548.
[001178] In some implementations, e.g., when the gripping member 9544 comprises and/or is formed from a shape-memory alloy, the gripping member 9544 can be shape set to be biased toward the open condition or the closed condition. In some implementations, an optional biasing member (not shown) is connected between the first arm 9547 and the second arm 9548 to bias the gripping member 9544 toward the open condition or the closed condition.
[001179] Referring now to Figures 135-137, one of the anchors 9504 is shown released or disengaged from the central body 9502. After capturing a leaflet 20, 22 within the paddle 9510 and the gripping element 9544, the anchor 9504 can be released from the central body 9502 by relaxing tension on the attachment sutures or tethers 9514. Once released, movement of the leaflet 20, 22 is allowed to pull the anchor 9504 away from the central body 9502 as the valve repair device 9500 is moved to open and position another anchor 9504 to capture another leaflet 20, 22. [001180] Once all of the leaflets 20, 22 (or 30, 32, 34) of the native valve are captured by the plurality of anchors 9504, tension is applied to the attachment sutures or tethers 9514 to retract the anchors 9504 back toward the central body 9502. As the anchors 9504 approach the central body 9502, the first alignment feature 9520 of the mounting plate 9512 engages the second alignment feature 9522 of the central body 9502 to guide the anchor 9504 into the desired position against the central body 9502 as can be seen, for example, in Figure 138.
[001181] Once the anchors 9504 are retracted and pulled against the central body 9502, the attachment sutures or tethers 9514 can be locked in place by extending and compressing a locking member 9556 against a corresponding locking surface 9558 of the central body 9502. As can be seen in Figure 139, the locking member 9556 and the locking surface 9558 can both have a frustoconical or a similarly tapered shape. The attachment sutures or tethers 9514 are locked in place by being compressed between the locking member 9556 and the locking surface 9558. Once the attachment sutures or tethers 9514 are locked in place, the locking member 9556 can be secured in a wide variety of ways, such as, for example, via a friction fit with the locking surface 9558, a threaded portion, a biased portion that engages a catch, or the like. In some examples, the locking member 9556 can be retracted to unlock the attachment sutures or tethers 9514 to allow the anchor 9504 to be released.
[001182] When the valve repair device 9500 has captured the valve leaflets 20, 22 and the anchors 9504 are secured against the central body 9502, the actuation element 9508 can be disconnected from the distal end 9526 of the paddle 9510 and retracted through a delivery system 9560 that is used to position and implant the valve repair device 9500 in the native valve of a patient, as can be seen in Figure 139.
[001183] In some examples of a valve repair device 9500, the actuation element 9508 extends through a central locking element 9562. As can be seen in Figure 139, the central locking element 9562 extends through a coupling 9564 formed by a first half 9566 connected to the locking member 9556 and a second half 9568 connected to a lock actuation element 9570 extending through the delivery system 9560. In the illustrated example, each of the first half 9566 and the second half 9568 of the coupling 9564 have a corresponding handshake shape. In some examples, the handshake shape of the first half 9566 and the second half 9568 are identical. In some examples, the handshake shape of the first half 9566 and the second half 9568 are mirror images.
[001184] The first half 9566 and the second half 9568 of the coupling 9564 are prohibited from moving laterally while the central locking element 9562 extends through the coupling 9564, thereby maintaining the coupling 9564 in an attached or a coupled condition. When the central locking element 9562 is retracted into the lock actuation element 9570 of the delivery system 9560 beyond the position of the coupling 9564, as shown in Figure 140, the second half 9568 of the coupling 9564 is allowed to disconnect and separate from the first half 9566 of the coupling 9564, as can be seen in Figure 141.
[001185] Referring now to Figure 143, a cross-sectional view of a catheter 9572 of the delivery system 9560 is shown. The catheter 9572 includes a central lumen 9574 through which the central locking element 9562 and the lock actuation element 9570 extend. A plurality of outer lumens 9576 surround the central lumen 9574. The actuation elements 9508, secondary actuation element 9546, and the attachment sutures or tethers 9514 of each anchor 9504 extend through the plurality of outer lumens 9576 to engage the valve repair device 9500.
[001186] In some implementations, a valve repair device 9600 is configured to move anchors — including paddles and/or gripping members — inward (e.g. toward one another) and outward (away from one another). The valve repair device 9600 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 9600 includes a central body 9602 and a plurality of anchors 9604.
Referring to Figures 144-156, the operation of one of the plurality of anchors 9604 is shown to illustrate the operation of the plurality of anchors 9604. Also, while the valve repair device 9600 is shown with three anchors 9604, the valve repair device 9600 can include two anchors 9604, three anchors 9604, or any number of anchors 9604.
[001187] The valve repair device can include a central body 9602, which can take a variety of different forms. For example, the central body 9602 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9602 includes a central bore or passage 9606 (Figure 150) that one or more actuation elements can extend into.
[001188] In some implementations, a separate actuation element 9608 extends to each of the anchors 9604 so that the anchors 9604 can be opened and closed independently. The actuation elements 9608 can take on a wide variety of forms, such as, for example, a wire, a rod, a tube, a shaft, a suture, or the like. That is, the actuation elements 9608 can be formed from a material that is suitable for pushing, pulling, or pushing and pulling on actuatable components of the valve repair device 9600.
[001189] The valve repair device can include a plurality of anchors 9604, which can take a variety of different forms. For example, the plurality of anchors 9604 can be any of the anchors disclosed by the present application and can be separable from the central body 9602 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve. In the example illustrated by Figures 144-156, the anchors 9604 each include a paddle 9610 that can be opened and closed independent of the paddles 9610 of the other anchors 9604.
[001190] In some implementations, the anchors 9604 include a mounting plate 9612 that engages and interfaces with the central body 9602 of the valve repair device 9600 to maintain the position of the corresponding anchor 9604 relative to the central body 9602 when the anchor 9604 or a portion of the anchor 9604 is opened by an actuation element 9608 or retracted to the central body 9602 by one or more attachment sutures or tethers 9614 (Figure 145).
[001191] The attachment sutures or tethers 9614 extend from openings 9616 of the central body 9602 that are connected to the passage 9606 and to corresponding openings 9618 of the mounting plate 9612 (Figures 148-149). A separate attachment suture or tether 9614 extends to each of the anchors 9604 so that the anchors 9604 can be released and retracted independently from each other. As can be seen in Figures 145-149, the attachment sutures or tethers 9614 can be formed by a loop of a single attachment suture or tether 9614 so that releasing or applying tension to the attachment suture or tether 9614 allows the corresponding anchor 9604 to separate from or re-engage with the central body 9602. [001192] In some implementations, the mounting plate 9612 includes a first alignment feature 9620 that is configured to engage with a corresponding second alignment feature 9622 of the central body 9602. In the example shown in Figures 148-149, the first alignment feature 9620 can comprise and/or be formed from a cross-shaped protrusion or boss extending from the mounting plate 9612 and the second alignment feature 9622 is formed by a corresponding cross-shaped opening or receptacle in the central body 9602. The specific shape of the alignment features are not intended to limit the scope of this disclosure and other shapes may be used (e.g., rectangular, triangular, circular, etc.) without departing from the scope of this disclosure.
[001193] When the mounting plate 9612 is engaged with the central body 9602 the crossshape of the first alignment feature 9620 and the corresponding second alignment feature 9622 maintains the position of the mounting plate 9612 relative to the central body 9602 to prohibit lateral motion between the anchor 9604 and the central body 9602. The first alignment feature 9620 and/or the second alignment feature 9622 can optionally include a filet or chamfer 9621 to facilitate a smooth engagement between the mounting plate 9612 and the central body 9602 as the anchor 9604 is retracted toward and engages with the central body 9602. In some examples, the first alignment feature 9620 is an opening or receptacle and the second alignment feature 9622 is a protrusion or boss.
[001194] In some implementations, the mounting plate 9612 also includes a central bore or passage 9624 through which an actuation element 9608 extends to open and close the paddle 9610 of the corresponding anchor 9604. As shown in at least Figures 145-147, the actuation element 9608 engages a distal end 9626 of a frame 9628 of the paddle 9610, the distal end 9626 being moveable in a distal and a proximal direction. In the illustrated example, the actuation element 9608 is a hollow tube that receives an elongated pin or shaft extending proximally from the distal end 9626 of the frame 9628. The actuation element 9608 can optionally include locking or attachment features — such as, for example, a threaded portion — for securely the actuation element 9608 to the elongated pin of the distal end 9626 of the frame 9628.
[001195] In some implementations, the paddle 9610 extends from the distal end 9626 of the frame to a fixed end 9630 that is attached to the mounting plate 9612. As shown in at least Figures 145-147, the fixed end 9630 of the paddle 9610 includes an attachment portion 9632 that is secured to the mounting plate 9612. The frame 9628 is hingeably connected to the distal end 9626 by a distal hinge portion 9634 so that that frame 9628 can flex or pivot radially outward and inward as the paddle 9610 is opened and closed by the actuation element 9608.
[001196] In some implementations, an inner arm 9636 of the paddle 9610 extends between an inner hinge portion 9638 and an outer hinge portion 9640. The inner hinge portion 9638 hingeably attaches the inner arm 9636 of the paddle 9610 to the fixed end 9630 of the paddle 9610. An outer arm 9637 of the paddle 9610 extends between the outer hinge portion 9640 and the distal end 9626 of the paddle 9610. The outer hinge portion 9640 hingeably attaches the inner arm 9636 and the outer arm 9637 of the paddle 9610 to the frame 9628 of the paddle 9610.
[001197] In some implementations, while in the closed condition, side portions or wings 9642 of the frame 9628 can overlap the inner arm 9636 to increase the surface area of the leaflet 20, 22 (or leaflets 30, 32, 34) captured by the paddle 9610.
[001198] Referring to Figures 145-147, the paddle 9610 is shown in an open condition that is achieved by extending the actuation element 9608 distally to move the distal end 9626 of the paddle 9610 in a distal direction. Because the fixed end 9630 is connected to the inner arm 9636 by the inner hinge portion 9638, the inner arm 9636 and outer arm 9637 are connected to the frame 9628 by the outer hinge portion 9640, and the frame 9628 is connected to the distal end 9626 by the distal hinge portion 9634, movement of the distal end 9626 away from the fixed end 9630 causes the inner arm 9636, outer arm 9637, and frame 9628 of the paddle 9610 to pivot or flex radially outward to put the paddle 9610 in the open condition shown in Figures 145-147. Further extension of the distal end 9626 beyond the illustrated open condition moves the paddle 9610 to a fully open or bailout position shown in Figure 156.
[001199] As can be seen in the illustrated example, the fixed end 9630, attachment portion 9632, inner arm 9636, outer arm 9637, and the inner hinge portion 9638 can be formed from a single piece of material. Similarly, the distal end 9626, the frame 9628, and the distal hinge portion 9634 can also be formed from a single piece of material. The entire paddle 9610 can optionally be formed from a single piece of material.
[001200] The portions of the paddle 9610 can be formed from any suitable material, such as, for example, a sheet of material that is cut and then folded or bent into the desired shape. In some examples, the paddle 9610 is cut from a sheet of a shape-memory alloy such as nitinol and then is bent and shape-set in the closed condition shown in, for example, Figure 144 to bias the paddle 9610 toward the closed condition.
[001201] In some implementations, these components may be formed from more than one piece of material and joined together, e.g., attached together at the hinges.
[001202] In some implementations, the anchors 9604 of the valve repair device 9600 can optionally include gripping members 9644, such as clasps, that are attached to the inner arm 9636 of the paddle 9610. The optional gripping members 9644 are actuated separately from the paddle 9610 by a secondary actuation element 9646.
[001203] Referring to Figures 145-147, when the paddle 9610 is in the open condition the gripping member 9644 and the operation thereof are more clearly visible. Referring now to Figure 145, the gripping member 9644 is shown in a closed condition. The gripping member 9644 includes a first arm 9647, a second arm 9648, and an optional barbed portion 9650. While the barbed portion 9650 is shown extending from the second arm 9648, the barbed portion 9650 can optionally extend from the first arm 9647, or from the first arm 9647 and the second arm 9648. In the example illustrated by Figures 144-156, the gripping member 9644 is configured to capture a leaflet between the first arm 9647 and the second arm 9648. In this example, the closed position is when the second arm 9648 is as close as possible to the first arm 9647. The second arm 9648 can be moved relative to the first arm 9647 between an open condition and a closed condition by the secondary actuation element 9646. As shown in Figures 146-147, the gripping member 9644 is moved into the open condition by applying tension to the secondary actuation element 9646 to apply an opening force to the second arm 9648.
[001204] In some implementations, the first arm 9647 and the second arm 9648 are hingeably connected by a hinge portion 9652. As shown in at least Figures 145-147, the first arm 9647 is attached to the inner arm 9636 of the paddle 9610. In the illustrated example, the gripping member 9644, the first arm 9647, the second arm 9648, and the hinge portion 9652 are integrally formed from a single piece of material. The gripping member 9644 can be formed by, for example, cutting the first arm 9647, the second arm 9648, the optional barbed portion 9650, and the hinge portion 9652 from a sheet of shape-memory alloy, such as, for example, nitinol. The hinge portion 9652 can be formed by selectively removing material to increase the flexibility of the hinge portion 9652 relative to the first arm 9647 and the second arm 9648.
[001205] In some implementations, e.g., when the gripping member 9644 comprises and/or is formed from a shape-memory alloy, the gripping member 9644 can be shape set to be biased toward the open condition or the closed condition. In some implementations, an optional biasing member (not shown) is connected between the first arm 9647 and the second arm 9648 to bias the gripping member 9644 toward the open condition or the closed condition.
[001206] Referring now to Figures 148-150, one of the anchors 9604 is shown released or disengaged from the central body 9602. After capturing a leaflet 20, 22 within the paddle 9610 and the gripping element 9644, the anchor 9604 can be released from the central body 9602 by relaxing tension on the attachment sutures or tethers 9614. Once released, movement of the leaflet 20, 22 is allowed to pull the anchor 9604 away from the central body 9602 as the valve repair device 9600 is moved to open and position another anchor 9604 to capture another leaflet 20, 22.
[001207] Once all of the leaflets 20, 22 (or 30, 32, 34) of the native valve are captured by the plurality of anchors 9604, tension is applied to the attachment sutures or tethers 9614 to retract the anchors 9604 back toward the central body 9602. As the anchors 9604 approach the central body 9602, the first alignment feature 9620 of the mounting plate 9612 engages the second alignment feature 9622 of the central body 9602 to guide the anchor 9604 into the desired position against the central body 9602 as can be seen, for example, in Figure 151.
[001208] Once the anchors 9604 are retracted and pulled against the central body 9602, the attachment sutures or tethers 9614 can be locked in place by extending and compressing a locking member 9656 against a corresponding locking surface 9658 of the central body 9602. In some implementations, the locking member 9656 and the locking surface 9658 can both have a frustoconical or a similarly tapered shape.
[001209] The attachment sutures or tethers 9614 are locked in place by being compressed between the locking member 9656 and the locking surface 9658. Once the attachment sutures or tethers 9614 are locked in place, the locking member 9656 can be secured in a wide variety of ways, such as, for example, via a friction fit with the locking surface 9658, a threaded portion, a biased portion that engages a catch, or the like. In some examples, the locking member 9656 can be retracted to unlock the attachment sutures or tethers 9614 to allow the anchor 9604 to be released.
[001210] Referring now to Figure 152, when the valve repair device 9600 has captured the valve leaflets 20, 22 (not shown) and the anchors 9604 are secured against the central body 9602, the actuation element 9608 can be disconnected from the distal end 9626 of the paddle 9610 and retracted into a delivery system 9660 that is used to position and implant the valve repair device 9600 in the native valve of a patient. To further disengage the valve repair device 9600 from the delivery system 9660, a central locking element 9662 used to actuate the locking member 9656 can be disengaged from the locking member 9656 and retracted through a coupling 9664 formed by a first half 9666 connected to the center body 9602 and a second half 9668 connected to a delivery or positioning element 9670 of the delivery system 9660 to the position shown in Figure 153.
[001211] In the illustrated example shown in Figures 153-154 each of the first half 9666 and the second half 9668 of the coupling 9664 have a corresponding handshake shape. In some implementations, the handshake shape is identical between the first half 9666 and the second half 9668. In some implementations, the handshake shape of the first half 9666 and the second half 9668 are mirror images.
[001212] In some implementations, the first half 9666 and the second half 9668 of the coupling 9664 are prohibited from moving laterally while the central locking element 9662 extends through the coupling 9664, thereby maintaining the coupling 9664 in an attached or a coupled condition. When the central locking element 9662 is retracted into the delivery or positioning element 9670 of the delivery system 9660 beyond the position of the coupling 9664, as shown in Figure 153, the second half 9668 of the coupling 9664 is allowed to disconnect and separate from the first half 9666 of the coupling 9664, as can be seen in Figure 154.
[001213] Referring now to Figure 155, a cross-sectional view of a catheter 9672 of the delivery system 9660 is shown. The catheter 9672 includes a central lumen 9674 through which the central locking element 9662 and the delivery or positioning element 9670 extend. A plurality of outer lumens 9676 surround the central lumen 9674. The actuation elements 9608, secondary actuation element 9646, and the attachment sutures or tethers 9614 of each anchor 9604 extend through the plurality of outer lumens 9676 to engage the valve repair device 9600.
[001214] Referring now to Figure 156, the anchors 9604 of the valve repair device 9600 are shown positioned in a delivery or bail-out configuration. In this arrangement, the actuation elements 9608 are extended in a distal direction until the paddles 9610 are fully open so that the inner arm 9636 of the paddle 9610 is about 180 degrees from the attachment portion 9632 of the fixed end 9630 of the paddle 9610 and the outer arm 9637 is about 180 degrees from the inner arm 9636. The gripping member 9644 can also be opened to a fully open condition where the first arm 9647 is about 180 degrees from the second arm 9648 of the gripping member 9644. This configuration of the paddle 9610 and gripping member 9644 reduces the overall width of the valve repair device 9600 to facilitate delivery through a lumen of the delivery system 9660.
[001215] In some implementations, a valve repair device 9700 is configured to move anchors — including paddles and/or gripping members — inward (e.g. toward one another) and outward (away from one another). The valve repair device 9700 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 9700 includes a central body 9702 and a plurality of anchors 9704. Referring now to Figures 157-170, the operation of one of the plurality of anchors 9704 is shown to illustrate the operation of the anchor 9704. Also, while the valve repair device 9700 is shown with three anchors 9704, the valve repair device 9700 can include two anchors 9704, three anchors 9704, or any number of anchors 9704. [001216] The valve repair device can include a central body 9702, which can take a variety of different forms. For example, the central body 9702 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. In some implementations, the central body 9702 includes a central bore or passage 9706 (Figure 161) that one or more actuation elements can extend into.
[001217] The valve repair device can include a plurality of anchors 9704, which can take a variety of different forms. For example, the plurality of anchors 9704 can be any of the anchors disclosed by the present application and can be separable from the central body 9702 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 (or 30, 32, 34) of the native valve. In the example illustrated by Figures 157-170, the anchors 9704 each include a paddle 9710 that can be opened and closed independent of the paddles 9710 of the other anchors 9704.
[001218] As can be seen in Figure 157, a separate actuation element 9708 extends to each of the anchors 9704 so that the anchors 9704 can be opened and closed independently. The actuation elements 9708 can take on a wide variety of forms, such as, for example, a wire, a rod, a tube, a shaft, a suture, or the like. That is, the actuation elements 9708 can be formed from a material that is suitable for pushing, pulling, or pushing and pulling on actuatable components of the valve repair device 9700. Each actuation element 9708 engages a corresponding anchor 9704 and can be manipulated to open and close a paddle 9710 of the anchor. In some implementations, the actuation elements are shape set wires. In some implementations, the actuation elements are wires that are not shape set.
[001219] In some implementations, the anchors 9704 include a mounting plate 9712 that engages and interfaces with the central body 9702 of the valve repair device 9700 to maintain the position of the anchor 9704 relative to the central body 9702 when the anchor 9704 or a portion of the anchor 9704 is opened by an actuation element 9708 or retracted to the central body 9702. In some implementations, the mounting plate 9712 also includes a central bore or passage 9714 through which an actuation element 9708 extends to open and close the paddle 9710 of the corresponding anchor 9704. In some implementations, the actuation element 9708 engages a threaded actuation piston 9716 (Figure 161) that extends through a threaded distal end 9718 (Figure 161) of the bore 9714 of the mounting plate 9712. Rotating the actuation piston 9716 with the actuation element 9708 causes the actuation piston 9716 to extend to open the paddle 9710 and retract to close the paddle 9710.
[001220] In some implementations, the paddle 9710 includes a moveable arm 9720 that is hingeably connected to the mounting plate 9712 by a hinge 9722 that allows the moveable arm 9720 to pivot between the closed condition (Figure 157) and the open condition (Figure 158). In some implementations, the moveable arm 9720 is connected to a distal end cap 9724 of the actuation piston 9716 by a linkage 9726 that is pivotably connected to both the moveable arm 9720 and the distal end cap 9724. As the actuation piston 9716 is extended, the linkage 9726 moves distally to pull moveable arm 9720 of the paddle 9710 to the open condition (Figure 158). Retracting the actuation piston 9716 moves the distal end cap 9724 in a proximal direction, thereby pushing the moveable arm 9720 to the closed condition via the linkage 9726. A bottom perspective view of an anchor 9704 of the valve repair device 9700 is shown in closed and open conditions in Figures 159-160, respectively, to illustrate the operation of the paddle 9710 more clearly.
[001221] Because the moveable arm 9720 of the paddle 9710 is actuated by a threaded actuation piston 9716 via the linkage 9726, external forces applied to the moveable arm 9720 — for example, by leaflets 20, 22 (or 30, 32, 34) pulling against the closed moveable arm 9720 — that are transmitted to the actuation piston 9716 via the linkage 9726 and the distal end cap 9724 are prohibited or inhibited from moving the actuation piston 9716 proximally or distally by the threaded connection between the threads of the threaded actuation piston 9716 and the threaded distal end 9718 of the bore 9714. That is, a separate locking mechanism is not required to retain the moveable arm 9720 of the paddle 9710 in the closed position after capturing the leaflet 20, 22. The threads of the actuation piston 9716 and the threaded distal end 9718 can be any suitable thread profile that preferably provides reduced backlash.
[001222] In some implementations, the paddle 9710 can optionally include a gripping member 9728 in addition to the paddle 9710. The gripping member 9728 can be any of the gripping members or clasps described herein. In the example illustrated in Figures 157-170, the gripping member 9728 is attached to the mounting plate 9712 and includes an optional barbed portion 9730 extending toward the movable arm 9720 from the gripping member 9728. While the gripping member 9728 is shown attached to the mounting plate 9712, the gripping member 9728 can optionally be attached to the moveable arm 9720, or to the mounting plate 9712 and the moveable arm 9720.
[001223] In some implementations, the paddle 9710 can also include a frame 9732 with side portions or wings 9734 that at least partially overlap the optional barbed portion 9730 to increase the surface area of the leaflet 20, 22 (or 30, 32, 34) captured by the paddle 9710. In the example illustrated by Figures 157-170, the paddle 9710 is configured to capture a leaflet between the mounting plate 9712 and the moveable arm 9720. In this example, the closed position is when the moveable arm 9720 is as close as possible to the mounting plate 9712.
[001224] In some implementations, the mounting plate 9712 includes a first alignment feature 9736 that is configured to engage with a corresponding second alignment feature 9738 of the central body 9702. In the example shown in Figures 159-164, the first alignment feature 9736 can comprise and/or be formed from a portion of a cylindrical housing of the central bore or passage 9714 of the mounting plate 9712 and the second alignment feature 9738 is formed by a corresponding rounded groove or channel in the central body 9702.
When the mounting plate 9712 is engaged with the central body 9702 the cylindrical shape of the first alignment feature 9736 and the corresponding round groove or channel of the second alignment feature 9738 maintains the position of the mounting plate 9712 relative to the central body 9702 to prohibit lateral motion between the anchor 9704 and the central body 9702. The first alignment feature 9736 and/or the second alignment feature 9738 are rounded to facilitate a smooth engagement between the mounting plate 9712 and the central body 9702 as the anchor 9704 is retracted toward and engages with the central body 9702.
[001225] As can be seen in Figures 161-164, the central body 9702 also includes an opening or receptacle 9740 for receiving a locking eyelet 9742 extending radially inward from each of the mounting plates 9712. The engagement of the locking eyelets 9742 with the opening or receptacle 9740 in the central body 9702 also helps restrain movement of the anchor 9704 relative to the central body 9702.
[001226] Figures 162-164 illustrate the movement of one of the anchors 9704 between a retracted condition (Figure 162) to a released or disengaged condition (Figures 163-164). After capturing a leaflet 20, 22 (or 30, 32, 34) with the paddle 9710, a sheath 9744 can be retracted along the actuation member 9708 to allow the actuation member 9708 to flex laterally so that the anchor 9704 can move laterally away from the central body 9702. In the example shown in Figures 163-164, an outer lumen 9776 of a catheter 9762 of a delivery system 9760 for positioning the valve repair device 9760 in the heart of the patient includes a slot or opening 9778 that permits the actuation element 9708 to flex or bend outwards while prohibiting the same for the sheath 9744.
[001227] In some implementations, the actuation member 9708 can optionally be biased to flex laterally outward and away from the central body 9702 or can be flexible and able to be flexed laterally outward by movement of the valve repair device 9700 away from the captured leaflet 20, 22 when positioning to capture another leaflet 20, 22.
[001228] Once all of the leaflets 20, 22 (or 30, 32, 34) of the native valve are captured by the plurality of anchors 9704, the sheath 9744 around each actuation element 9708 can be extended to straighten the actuation member 9708, thereby moving the anchors 9704 back into engagement with the central body 9702. As the anchors 9704 approach the central body 9702, the first alignment feature 9736 of the mounting plate 9712 engages the second alignment feature 9738 of the central body 9702 to guide the anchor 9704 into the desired position against the central body 9702 as can be seen, for example, in Figures 162-164.
[001229] In some implementations, retracting the anchors 9704 against the central body 9702 also brings the locking eyelets 9742 into engagement with the opening or receptacle 9740 of the central body 9702. Referring now to Figures 165-166, the opening or receptacle 9740 is connected with the central bore or passage 9706 of the central body 9702. When the anchors 9704 are retracted against the central body 9702, the locking eyelets 9742 extend into the central bore or passage 9706 so that openings 9746 of each of the locking eyelets 9742 can move into alignment. In some implementations, a locking pin 9748 can be extended into the central bore or passage 9706 and through each of the locking eyelets 9742 to lock the anchors 9704 in the retracted condition. As can be seen in Figures 165-166, the locking eyelets 9742 of each anchor 9704 are offset or staggered axially relative to each other so that the openings 9746 of all three locking eyelets 9742 can be aligned when the anchors 9704 are fully retracted against the central body 9702. The locking pin 9748 can be extended into the central bore or passage 9706 to engage the openings 9746 of the locking eyelets 9742, thereby locking the anchors 9704 in engagement with the central body 9702. In some implementations, to facilitate smooth engagement with the locking eyelets 9742, the locking pin 9748 can optionally include a tapered distal end 9750. The openings 9746 of the locking eyelets 9742 can similarly include optional filets or chamfers to facilitate for smooth engagement with the locking pin 9748 in the event that the locking eyelets 9742 are not fully aligned with the locking pin 9748.
[001230] In some implementations, the locking pin 9748 is actuated by a lock actuation element 9752 that engages a proximal end 9754 of the locking pin 9748 to extend the locking pin 9748 distally and to retract the locking pin 9748 in the proximal direction. In the illustrated example, the locking pin 9748 includes a threaded portion 9756 that extends through and engages a proximal threaded opening 9758 of the central bore or passage 9746. Rotating the locking pin 9748 with the lock actuation element 9752 causes the locking pin 9748 to move distally into engagement with the locking eyelets 9742 as is shown in Figures 165-166. Because the locking pin 9748 is orthogonal to the openings 9746 of the locking eyelets 9742 and because the locking pin 9748 is extended by way of the engagement between the threaded portion 9756 of the locking pin 9748 and the proximal threaded opening 9752 of the bore 9706, external forces that may be transmitted to the locking pin 9748 are prohibited from causing the locking pin 9748 to move in a retracting or proximal direction. That is, a separate locking mechanism is not required to retain the locking pin 9748 in the locked position after the locking eyelets 9742 have been secured within the central bore or passage 9706 by the locking pin 9748. The threads of the threaded portion 9756 and the proximal threaded opening 9752 can be any suitable thread profile that preferably provides reduced backlash.
[001231] When the valve repair device 9700 has captured the valve leaflets 20, 22 and the anchors 9704 are secured against the central body 9702, the actuation elements 9708 can be disconnected from the actuation pistons 9716 of each anchor 9704 and the actuation elements 9708 and corresponding sheaths 9744 can be retracted into the delivery system 9760 that is used to position and implant the valve repair device 9700 in the native valve of a patient, as can be seen in Figure 167. Similarly, the lock actuation element 9752 can be disconnected from the locking pin 9748 and retracted into the delivery system 9760 to fully disengage the delivery system 9760 from the valve repair device 9700 as can be seen in Figure 168.
[001232] Referring now to Figure 169, a cross-sectional view of the catheter 9762 of the delivery system 9760 is shown. The catheter 9762 includes a central lumen 9764 through which the lock actuation element 9752 extends. A plurality of outer lumens 9776 surround the central lumen 9764. The actuation elements 9708 and corresponding sheaths 9744 extend through the plurality of outer lumens 9776 to engage the valve repair device 9700. Each outer lumen 9776 also includes the slot or opening 9778 between the outer lumen 9776 and the exterior of the catheter 9762. The slot or opening 9778 is wide enough to allow the actuation element 9708 to pass through (see, e.g., Figure 164) while prohibiting passage of the corresponding sheath 9744.
[001233] Referring now to Figure 170, the anchors 9704 of the valve repair device 9700 are shown positioned in a delivery configuration. In this arrangement, one of the anchors 9704 remains engaged with the central body 9702. The remaining two anchors 9704 are extended distally with the actuation elements 9708 and sheaths 9744 in a staggered fashion so that one of the two anchors 9704 is arranged distally beyond the central body 9702 and the other of the two anchors 9704 is positioned distally of the first anchor 9704. Staggering the three anchors 9704 of the valve repair device 9700 reduces the width of a cross-section of the valve repair device 9700 taken at any given position along the length of the valve repair device 9700. Having been positioned in the staggered delivery configuration, the valve repair device 9700 can be loaded into and delivered through a smaller lumen of the delivery system 9760.
[001234] In some implementations, a valve repair device 9800 is configured to move anchors — including paddles and/or gripping members — inward (e.g. toward one another) and outward (away from one another). The valve repair device 9800 can take a variety of different forms, such as any of the forms disclosed herein. In some implementations, the valve repair device 9800 includes a central body 9802 and a plurality of anchors 9804.
Referring now to Figures 171-176, different ways of moving the anchors 9804 relative to the central body 9802 are shown. While the valve repair device 9800 is shown with two anchors 9804, the valve repair device 9800 can include two anchors 9804, three anchors 9804, or any number of anchors 9804.
[001235] The valve repair device can include a central body 9802, which can take a variety of different forms. For example, the central body 9802 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application. [001236] The valve repair device can include a plurality of anchors 9804, which can also take a variety of different forms. For example, the plurality of anchors 9804 can be any of the anchors disclosed by the present application and can be separable from the central body 9802 as with other examples shown herein to facilitate capture of one or more leaflets 20, 22 of the native valve. In the example illustrated by Figures 171-176, the anchors 9804 each include a paddle or gripping member 9806 that can be opened and closed independent of the paddles or gripping members 9806 of the other anchors 9804. The paddles or gripping members 9806 can take on a wide variety of forms, such as, for example, any of the paddles or gripping members described herein and can be actuated between open and closed positions to capture and retain leaflets 20, 22 of the native valve.
[001237] Referring now to Figures 171-172, each of the anchors 9804 is connected to a positioning arm or limb 9808 extending from a catheter 9810 of a delivery system 9812. The central body 9802 is also connected to a delivery arm 9814 extending from the catheter 9810. The positioning arms 9808 for each of the anchors 9804 are optionally biased in a radially outward direction 9816 so that each positioning arm 9808 tends to move the attached anchor 9804 outward as the positioning arm 9808 extends from the catheter 9810, as can be seen in Figure 171. In some implementations, the positioning arms 9808 can be flexible and allowed to move radially outward with the movement of a leaflet 20, 22 captured by the anchor 9804.
[001238] The positioning arms 9808 can take on a wide variety of forms such as, for example, a wire, a tube, a cut or segmented tube, or the like. In some examples, the positioning arm 9808 comprises and/or is formed from shape-memory alloy and is shape set to a deployed condition so that the positioning arm 9808 forms a bends in more than one direction as the positioning arm is extended from the catheter 9810, such as the example illustrated in Figure 171. Actuation elements such as wires, sutures, or the like can extend through the positioning arms 9808 that are formed from tubes to actuate the anchors 9804 in the deployed position.
[001239] Referring now to Figure 172, to move the anchors 9804 into engagement with the central body 9802, the catheter 9810 is extended or the positioning arms 9808 are retracted into the catheter 9810. In the example shown in Figure 172, both of the positioning arms 9808 are retracted simultaneously as the catheter 9810 is extended. In some implementations, to facilitate individual retraction of one of the positioning arms 9808, an additional tube or sheath can be extended over one of the positioning arms 9808 similar to, for example, the sheaths 9744 of the valve repair system 9700 described above.
[001240] In some implementations, as shown in Figures 173-174, a guide 9818 can extend through each of the positioning arms 9808 from the delivery system 9812 to a distal cap 9820 that is attached to the central body 9802. The guide 9818 can take on a wide variety of forms, such as, for example, as a wire, a suture, or the like. To move the anchors 9804 into engagement with the central body 9802, the positioning arms 9808 are extended distally along the guide 9818 to bring the anchors 9804 into engagement with the distal cap 9820. In some implementations, the distal cap 9820 can optionally include a catch or stop 9822 to engage each of the anchors 9804 to prohibit the anchors from spreading apart from the central body 9802.
[001241] In some implementations , the positioning arms 9808 of the valve repair device 9800 shown in Figures 173-174 can be formed from segmented or beaded hypotubes that are flexible in a relaxed condition and that become straight and rigid when subjected to a compression force in a compressed condition. Suitable hypotubes are described in greater detail below and are shown in Figures 177-184. In the example shown in Figure 174, when the anchors 9804 have engaged the distal cap 9820 of the central body 9802 further force is applied to the positioning arm 9808 in the distal direction to cause the positioning arm 9808 to straighten and become more rigid, thereby retaining the anchors 9804 in engagement with the central body 9802.
[001242] Figures 175-176 show an additional implementation of a valve repair device.
The example of the valve repair device 9800 shown in Figures 175-176 is similar to the valve repair device 9800 shown in Figures 173-174 except that the guides 9818 extend to distal caps or stops 9824 that are independent of the central body 9802. The positioning arms 9808 of Figures 175-176 are like the positioning arms 9808 of Figures 173-174 so that the positioning arms 9808 become rigid and straight when subjected to a compression force. To cause the positioning arms 9808 to straighten and become rigid, the guides 9818 can be retracted into the delivery system 9812 or the positioning arms 9808 can be extended from the delivery system 9812 to apply a compression force to the positioning arms 9808. [001243] Figures 177-184 illustrate hypotubes 9900 that can be used as the positioning arms 9808 of the valve repair device 9800. As noted above, the hypotubes 9900 shown in Figures 177-184 are flexible when in a relaxed or uncompressed condition and become straighter and more rigid when in a compressed condition.
[001244] Referring now to Figures 177-179, a section of a hypotube 9900 is shown that is formed such that the hypotube 9900 is flexible in a relaxed condition and rigid and straight in a compressed condition. The hypotube 9900 includes a central lumen or opening 9902 and a plurality of segments or links 9904. The segments or links 9904 are formed by cutting a tube of material radially via, for example, laser cutting with a repeating pattern to form segments or links 9904 having corresponding retaining features so that the segments 9904 remain connected even though the cutting operation completely separates each segment 9904 from the next.
[001245] Referring now to Figure 178, an enlarged view of a single segment 9904 of the hypotube 9900 is shown. The segment 9904 includes a plurality of rotationally symmetric T- shaped retaining slots 9906 and corresponding T-shaped keyed retaining tabs 9908. In the example shown in Figure 178, the retaining slots 9906 and keyed retaining tabs 9908 of a first end 9910 of the segment 9904 are also rotationally offset by about 60 degrees from the retaining slots 9906 and keyed retaining tabs 9908 of a second end 9912 of the segment 9904. Offsetting the retaining slots 9906 and keyed retaining tabs 9908 between the first end 9910 and the second end 9912 of the segment 9904 enable the hypotube 9900 to flex and bend in all directions when in the relaxed condition.
[001246] Referring now to Figures 180-184, the hypotube 9900 is shown having a different cutting pattern to create arrow-shaped retaining slots 9906 and retaining tabs 9908. Slanted sides 9914 of the arrow-shaped tabs 9908 and arrow-shaped slots 9906 provide an additional straightening force when the hypotube 9900 is in the compressed condition. The hypotube 9900 is shown in a relaxed and slightly bent condition in Figure 183 and a compressed and straight condition in Figure 184 to show how the arrow-shaped retaining slots 9906 and retaining tabs 9908 cause the hypotube 9900 to straighten. When subjected to a compression force that moves adjacent segments 9904 towards each other, the slanted side 9914 of one side of the arrow-shaped tab 9908 encounters the corresponding slanted side 9914 of the arrow-shaped slot 9906. Further movement of the segments 9904 towards each other causes the segments 9904 to be rotated by the slanted sides 9914 until a point 9916 of each arrow-shaped tab 9908 engages a bottom 9918 of the arrow-shaped slot 9906. The compression force applied between the segments 9904 prohibits the points 9916 of the arrowshaped tabs 9908 from moving past the bottom 9918 of the arrow-shaped slot 9906 as further rotation could only be accomplished by moving the point 9916 up the other slanted side 9914 of the arrow-shaped slot 9906 against the compression force that is moving the segments 9904 towards each other.
[001247] Additional features, modifications, delivery systems, and methods for using the devices and delivery systems are disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904). Any combination or sub-combination of the features disclosed by the present application can be combined with any combination or sub-combination of the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904). Patent Cooperation Treaty International Application No. PCT/US2019/012707 (International Publication No. WO 2019139904) is incorporated herein by reference in its entirety for all purposes.
[001248] Clasps or leaflet gripping devices disclosed herein can take a wide variety of different forms, such as those disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201). Combinations and sub-combinations of features in the present application can be combined with the features disclosed by Patent Cooperation Treaty International Application No. PCT/US2018/028171 (International Publication No. WO 2018195201), which is incorporated herein by reference in its entirety for all purposes.
[001249] Any of the various systems, devices, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with subjects, and the methods herein can comprise or consist of sterilization of one or more systems, devices, apparatuses, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).
[001250] EXAMPLES
[001251] Example 1. A valve repair device comprising: [001252] a central body;
[001253] a plurality of anchors;
[001254] a plurality of tethers attached to the plurality of anchors,
[001255] wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body;
[001256] an actuator operatively coupled to the plurality of anchors when the plurality of anchors are pulled against the central body by the tethers; and
[001257] wherein the actuator is configured to open the plurality of anchors that are against the central body.
[001258] Example 2. The valve repair device of example 1 wherein an anchor of the plurality of anchors comprises a paddle.
[001259] Example 3. The valve repair device of example 2 wherein the paddle comprises an actuator engagement extension.
[001260] Example 4. The valve repair device of example 3 wherein the actuator engages the actuator engagement extension to move the paddle from a closed position to an open position.
[001261] Example 5. The valve repair device of example 3 wherein the paddle comprises a plurality of actuator engagement extensions.
[001262] Example 6. The valve repair device of example 5 wherein the actuator is configured to engage a first actuator engagement extension of the plurality of actuator engagement extensions to move the anchor to a closed position and the actuator is configured to engage a second actuator engagement extension of the plurality of actuator engagement extensions to move the anchor to an open position.
[001263] Example 7. The valve repair device of example 1 wherein the actuator is configured to engage an anchor of the plurality of anchors to move the anchor to a closed position and the actuator is further configured to engage the anchor to move the anchor to an open position.
[001264] Example 8. The valve repair device of any one of examples 1-7 wherein the plurality of tethers are configured to allow the plurality of anchors to tilt as the plurality of anchors are pulled toward the central body.
[001265] Example 9. The valve repair device of any one of examples 1-8, wherein a tether of the plurality of tethers is connected to a closed end of an anchor of the plurality of anchors.
[001266] Example 10. A valve repair system comprising:
[001267] a delivery system comprising one or more catheters and a control handle;
[001268] a valve repair device coupled to the one or more catheters, the valve repair device comprising:
[001269] a central body;
[001270] a plurality of anchors;
[001271] a plurality of tethers attached to the plurality of anchors,
[001272] wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body; and
[001273] an actuator operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers,
[001274] wherein the actuator is configured to open the plurality of anchors that are against the central body.
[001275] Example 11. The valve repair system of example 10 wherein an anchor of the plurality of anchors comprises a paddle. [001276] Example 12. The valve repair system of example 1 1 wherein the paddle comprises an actuator engagement extension.
[001277] Example 13. The valve repair system of example 12 wherein the actuator engages the actuator engagement extension to move the paddle from a closed position to an open position.
[001278] Example 14. The valve repair system of example 11 wherein the paddle comprises a plurality of actuator engagement extensions.
[001279] Example 15. The valve repair system of example 14 wherein the actuator is configured to engage a first actuator engagement extension of the plurality of actuator engagement extensions to move the anchor to a closed position and the actuator is configured to engage a second actuator engagement extension of the plurality of actuator engagement extensions to move the anchor to an open position.
[001280] Example 16. The valve repair system of example 10 wherein an actuator of the plurality of actuators is configured to engage an anchor of the plurality of anchors to move the anchor to a closed position and the actuator is configured to engage the anchor to move the anchor to an open position.
[001281] Example 17. The valve repair system of any one of examples 10-16 wherein the plurality of tethers are configured to allow the plurality of anchors to tilt as the plurality of anchors are pulled toward the central body.
[001282] Example 18. The valve repair system of any one of examples 10-17, wherein a tether of the plurality of tethers is connected to a closed end of an anchor of the plurality of anchors.
[001283] Example 19. A method of repairing a native heart valve comprising:
[001284] simultaneously opening a plurality of anchors that are disposed against a central body;
[001285] positioning a first anchor of the plurality of anchors such that a first native heart valve leaflet is in the first anchor; [001286] simultaneously closing the plurality of anchors that are disposed against the central body to capture the first leaflet; and
[001287] moving the central body and a remaining one or more anchors away from the first anchor.
[001288] Example 20. The method of example 19 wherein the plurality of anchors are coupled to the central body with a plurality of tethers.
[001289] Example 21. The method of any one of examples 19-20 further comprising simultaneously opening the remaining one or more anchors that are disposed against the central body.
[001290] Example 22. The method of any one of examples 19-21 further comprising positioning a second anchor of the plurality of anchors such that a second native heart valve leaflet is in the second anchor.
[001291] Example 23. The method of example 22 further comprising simultaneously closing the plurality of anchors that are against the central body to capture the second leaflet.
[001292] Example 24. A valve repair device comprising:
[001293] a central body;
[001294] a plurality of anchors;
[001295] a plurality of tethers attached to the plurality of anchors;
[001296] wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body;
[001297] wherein a connection between each tether and each anchor allows the plurality of anchors to assume a tilted position relative to the central body as the plurality of anchors are pulled toward the central body; and
[001298] wherein the plurality of anchors and the central body are configured to move the plurality of anchors from the tilted position to a more upright position relative to the central body. [001299] Example 25. The valve repair device of example 24 wherein the central body includes a central post and a retaining wall.
[001300] Example 26. The valve repair device of example 25 wherein the retaining wall and the central post are configured to pivot the plurality of anchors to the more upright position.
[001301] Example 27. The valve repair device of example 24 wherein the plurality of anchors and the central body are configured such that pulling the plurality of anchors against the central body pivots the anchors to the more upright position.
[001302] Example 28. The valve repair device of example 27 wherein each of the plurality of anchors includes a tilting flange.
[001303] Example 29. The valve repair device of example 28 wherein the central body includes a bottom wall.
[001304] Example 30. The valve repair device of example 29 wherein the tilting flange engages the bottom wall to move the plurality of anchors to the more upright position.
[001305] Example 31. The valve repair device of any one of examples 24-30 wherein rotation of the central body relative to the plurality of anchors moves the plurality of anchors to the more upright position.
[001306] Example 32. The valve repair device of example 31 wherein the central body includes a plurality of petals configured to engage the plurality of anchors upon rotation of the central body relative to the plurality of anchors.
[001307] Example 33. The valve repair device of any one of examples 24-32 wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001308] Example 34. A valve repair system comprising:
[001309] a delivery system comprising one or more catheters and a control handle;
[001310] a valve repair device coupled to the one or more catheters, the valve repair device comprising: [001311] a central body;
[001312] a plurality of anchors;
[001313] a plurality of tethers, each tether attached to a corresponding anchor of the plurality of anchors;
[001314] wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body;
[001315] wherein a connection between each tether and the corresponding anchor allows the plurality of anchors to assume a tilted position relative to the central body as the plurality of anchors are pulled toward the central body; and
[001316] wherein the plurality of anchors and the central body are configured to move the plurality of anchors from the tilted position to a more upright position relative to the central body.
[001317] Example 35. The valve repair system of example 34 wherein the central body includes a central post and a retaining wall.
[001318] Example 36. The valve repair system of example 35 wherein the retaining wall and the central post are configured to pivot the plurality of anchors to the more upright position.
[001319] Example 37. The valve repair system of example 34 wherein the plurality of anchors and the central body are configured such that pulling the plurality of anchors against the central body pivots the plurality of anchors to the more upright position.
[001320] Example 38. The valve repair system of example 37 wherein each of the plurality of anchors includes a tilting flange.
[001321] Example 39. The valve repair system of example 38 wherein the central body includes a bottom wall.
[001322] Example 40. The valve repair system of example 39 wherein the tilting flange engages the bottom wall to move the plurality of anchors to the more upright position. [001323] Example 41. The valve repair system of any one of examples 34-40 wherein rotation of the central body relative to the plurality of anchors moves the plurality of anchors to the more upright position.
[001324] Example 42. The valve repair system of example 41 wherein the central body includes a plurality of petals configured to engage the plurality of anchors upon rotation of the central body relative to the plurality of anchors.
[001325] Example 43. The valve repair system of any one of examples 34-42 wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001326] Example 44. The valve repair system of any one of examples 34-43, wherein each tether is connected to a closed end of each the corresponding anchor.
[001327] Example 45. The valve repair system of any one of examples 34-44 wherein the plurality of tethers are configured to push the plurality of anchors away from the central body.
[001328] Example 46. The valve repair system of any one of examples 34-45 wherein the delivery system comprises a plurality of tether control members that are configured to pull the plurality of tethers into a slot of a catheter of the one or more catheters.
[001329] Example 47. The valve repair system of any one of examples 34-45 wherein a catheter of the one or more catheters includes a plurality of slots, wherein a plurality of tether control members are slidably disposed in the plurality of slots.
[001330] Example 48. The valve repair system of example 47 wherein distally sliding the tether control members in the slots pulls the tethers into the slots.
[001331] Example 49. A method of repairing a native heart valve comprising:
[001332] attaching an anchor to a leaflet of the native heart valve;
[001333] pulling the anchor toward a central body in a tilted orientation relative to the central body; and [001334] engaging the anchor with the central body to move the anchor from the tilted orientation to a more upright position relative to the central body.
[001335] Example 50. The method of example 49 wherein rotating the central body relative to the anchor moves the anchor to the more upright position.
[001336] Example 51. A valve repair device comprising:
[001337] a central body;
[001338] a plurality of spools disposed in the central body;
[001339] a plurality of anchors; and
[001340] a plurality of tethers, each tether wound around a corresponding spool of the plurality of spools and each tether attached to a corresponding anchor of the plurality of anchors.
[001341] Example 52. The valve repair device of example 51 wherein rotation of the plurality of spools in a first direction pulls the plurality of tethers to pull the plurality of anchors toward the central body.
[001342] Example 53. The valve repair device of example 52 wherein rotation of the plurality of spools in a second direction slackens the plurality of tethers to allow the plurality of anchors to be spaced apart from the central body.
[001343] Example 54. The valve repair device of any one of examples 51-53 further comprising a plurality of springs, a spring of the plurality of springs configured to bias an anchor of the plurality of anchors away from the central body.
[001344] Example 55. The valve repair device of any one of examples 51-54 wherein the plurality of tethers are configured to allow the plurality of anchors to tilt as the plurality of anchors are pulled toward the central body.
[001345] Example 56. The valve repair device of any one of examples 51-55, wherein each tether is connected to a closed end of the corresponding anchor.
[001346] Example 57. A valve repair system comprising: [001347] a delivery system comprising one or more catheters and a control handle;
[001348] a valve repair device coupled to the one or more catheters, the valve repair device comprising:
[001349] a central body;
[001350] a plurality of spools disposed in the central body;
[001351] a plurality of anchors; and
[001352] a plurality of tethers, each tether of the plurality of tethers wound around a corresponding spool of the plurality of spools and each tether attached to a corresponding anchor of the plurality of anchors.
[001353] Example 58. The valve repair system of example 57 wherein rotation of the plurality of spools in a first direction pulls the plurality of tethers to pull the plurality of anchors toward the central body.
[001354] Example 59. The valve repair system of example 58 wherein rotation of the plurality of spools in a second direction slackens the plurality of tethers to allow the plurality of anchors to be spaced apart from the central body.
[001355] Example 60. The valve repair system of any one of examples 57-59 further comprising a plurality of springs, a spring of the plurality of springs configured to bias a corresponding anchor of the plurality of anchors away from the central body.
[001356] Example 61. The valve repair system of any one of examples 57-60 wherein the plurality of tethers are configured to allow the plurality of anchors to tilt as the plurality of anchors are pulled toward the central body.
[001357] Example 62. The valve repair system of any one of examples 57-61, wherein each tether is connected to a closed end of a corresponding anchor.
[001358] Example 63. A valve repair device comprising:
[001359] a center clip; [001360] a plurality of anchors; and
[001361] wherein the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
[001362] Example 64. The valve repair device of example 63 further comprising a plurality of tethers attached to the plurality of anchors.
[001363] Example 65. The valve repair device of example 64 wherein the plurality of tethers are configured to pull the plurality of anchors toward the center clip.
[001364] Example 66. The valve repair device of any one of examples 64-65 wherein the plurality of tethers are configured to allow the plurality of anchors to tilt as the plurality of anchors are pulled toward the center clip.
[001365] Example 67. The valve repair device of any one of examples 64-66, wherein a tether of the plurality of tethers is connected to a closed end of an anchor of the plurality of anchors.
[001366] Example 68. A valve repair system comprising:
[001367] a delivery system comprising one or more catheters and a control handle;
[001368] a valve repair device coupled to the one or more catheters, the valve repair device comprising:
[001369] a center clip;
[001370] a plurality of anchors; and
[001371] wherein the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
[001372] Example 69. The valve repair system of example 68 further comprising a plurality of tethers attached to the plurality of anchors.
[001373] Example 70. The valve repair system of example 69 wherein the plurality of tethers are configured to pull the plurality of anchors toward the center clip. [001374] Example 71. The valve repair system of any one of examples 69-70 wherein the plurality of tethers are configured to allow the plurality of anchors to tilt as the plurality of anchors are pulled toward the center clip.
[001375] Example 72. The valve repair system of any one of examples 69-71 , wherein a tether of the plurality of tethers is connected to a closed end of an anchor of the plurality of anchors.
[001376] Example 73. A method of repairing a native heart valve comprising:
[001377] attaching a plurality of anchors to a plurality of leaflets of the native heart valve; and
[001378] capturing the plurality of anchors with a center clip after the plurality of anchors have been attached to leaflets of the native heart valve.
[001379] Example 74. A valve repair device comprising:
[001380] a central body having a plurality of expandable strips;
[001381] a plurality of anchors attached to the plurality of expandable strips; and
[001382] wherein the expandable strips are configured to move the plurality of anchors inward and outward.
[001383] Example 75. The valve repair device of example 74 wherein each anchor comprises a paddle and a gripping member attached to the paddle.
[001384] Example 76. The valve repair device of example 75 wherein the paddle comprises a fixed arm and a movable arm.
[001385] Example 77. The valve repair device of example 76 wherein the fixed arm of each paddle is fixed to a corresponding expandable strip.
[001386] Example 78. The valve repair device of any one of examples 76 and 77 wherein the gripping member is attached to the movable arm of the paddle.
[001387] Example 79. A valve repair system comprising: [001388] a delivery system comprising one or more catheters and a control handle;
[001389] a valve repair device coupled to the one or more catheters, the valve repair device comprising:
[001390] a central body having a plurality of expandable strips;
[001391] a plurality of anchors attached to the plurality of expandable strips; and
[001392] wherein the expandable strips are configured to move the plurality of anchors inward and outward.
[001393] Example 80. The valve repair system of example 79 wherein each anchor comprises a paddle and a gripping member attached to the paddle.
[001394] Example 81. The valve repair system of example 80 wherein the paddle comprises a fixed arm and a movable arm.
[001395] Example 82. The valve repair system of example 81 wherein the fixed arm of each paddle is fixed to a corresponding expandable strip.
[001396] Example 83. The valve repair system of any one of examples 81 and 82 wherein the gripping member is attached to the movable arm of the paddle.
[001397] Example 84. A valve repair device comprising:
[001398] a central body; and
[001399] a plurality of anchors each anchor comprising a paddle and a gripping member, the paddle connected to the central body, wherein the gripping members are configured to move toward and away from the central body while the paddles are connected to the central body and the gripping members are coupled to the paddles.
[001400] Example 85. The valve repair device of example 84 wherein the gripping member is movable toward and away from the central body by tilting the paddle toward and away from the central body. [001401] Example 86. The valve repair device of example 84 wherein the paddle is tilted by pulling a portion of the paddle into the central body.
[001402] Example 87. The valve repair device of example 84 wherein the gripping member is movable toward and away from the central body by sliding the gripping member along the paddle.
[001403] Example 88. The valve repair device of any one of examples 84-87 wherein the plurality of anchors comprise three paddles and three gripping members.
[001404] Example 89. A valve repair system comprising:
[001405] a delivery system comprising one or more catheters and a control handle;
[001406] a valve repair device coupled to the one or more catheters, the valve repair device comprising:
[001407] a central body; and
[001408] a plurality of anchors each anchor comprising a paddle and a gripping member, the paddle connected to the central body,
[001409] wherein the gripping member is configured to move toward and away from the central body while the paddle is connected to the central body and the gripping member is coupled to the paddle.
[001410] Example 90. The valve repair system of example 89 wherein the gripping member is movable toward and away from the central body by tilting the paddle toward and away from the central body.
[001411] Example 91. The valve repair system of example 89 wherein the paddle is tilted by pulling a portion of the paddle into the central body.
[001412] Example 92. The valve repair system of example 89 wherein the gripping member is movable toward and away from the central body by sliding the gripping member along the paddle. [001413] Example 93. The valve repair system of any one of examples 89-92 wherein the plurality of anchors comprises three paddles and three gripping members.
[001414] Example 94. A valve repair device comprising:
[001415] a first anchor;
[001416] a second anchor; and
[001417] a coupling member attached to the first anchor and the second anchor,
[001418] wherein the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole, and
[001419] wherein the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
[001420] Example 95. The valve repair device of example 94 wherein the coupling member comprises one or more of an elastic material and a spring.
[001421] Example 96. A valve repair system comprising:
[001422] a delivery system comprising one or more catheters and a control handle;
[001423] a valve repair device coupled to the one or more catheters, the valve repair device comprising:
[001424] a first anchor;
[001425] a second anchor; and
[001426] a coupling member attached to the first anchor and the second anchor,
[001427] wherein the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole, and
[001428] wherein the coupling member is configured to pull the first anchor relatively toward the second anchor during systole. [001429] Example 97. The valve repair system of example 96 wherein the coupling member comprises one or more of an elastic material and a spring.
[001430] Example 98. A valve repair device comprising:
[001431] a central body;
[001432] a plurality of tethers coupled to the central body;
[001433] a plurality of anchors coupled to the central body via the plurality of tethers, wherein the plurality of tethers is configured to pull the plurality of anchors toward the central body; and
[001434] an actuator coupled to the central body, wherein the actuator is configured to open and/or close anchors of the plurality of anchors that are pulled against the central body.
[001435] Example 99. The valve repair device of example 98 wherein an anchor of the plurality of anchors comprises a paddle.
[001436] Example 100. The valve repair device of example 99 wherein the paddle comprises an actuator engagement extension.
[001437] Example 101. The valve repair device of example 100 wherein the actuator engages the actuator engagement extension to move the paddle from a closed position to an open position.
[001438] Example 102. The valve repair device of example 100 wherein the paddle comprises a plurality of actuator engagement extensions.
[001439] Example 103. The valve repair device of example 102 wherein the actuator is configured to engage a first actuator engagement extension of the plurality of actuator engagement extensions to move the anchor to a closed position and is configured to engage a second actuator engagement extension of the plurality of actuator engagement extensions to move the anchor to an open position. [001440] Example 104. The valve repair device of example 98 wherein the actuator is configured to engage the anchor to move the anchor to a closed position and is configured to engage the anchor to move the anchor to an open position.
[001441] Example 105. The valve repair device of any one of examples 98-104 wherein the plurality of tethers are configured to allow the plurality of anchors to tilt as the plurality of anchors are pulled toward the central body.
[001442] Example 106. The valve repair device of any one of examples 98-105, wherein a tether of the plurality of tethers is connected to a closed end of an anchor of the plurality of anchors.
[001443] Example 107. A valve repair device comprising:
[001444] a central body comprising a bore;
[001445] an actuation element extending through the bore of the central body, wherein the actuation element comprises a worm gear attached to a distal end of the actuation element;
[001446] a plurality of anchors, each anchor comprising a paddle, the paddle comprising a first arm that is hingeably attached to a second arm by a hinge portion, wherein the hinge portion comprises an actuation gear that engages the worm gear of the actuation element, and wherein rotation of the actuation gear by the worm gear moves the paddle between an open condition and a closed condition;
[001447] wherein responsive to rotation of the actuation element in a first direction, the second arm of the paddle moves toward the open condition; and
[001448] wherein responsive to rotation of the actuation element in a second direction, the second arm of the paddle moves toward the closed condition.
[001449] Example 108. The valve repair device of example 107, further comprising:
[001450] a plurality of tethers attached to the plurality of anchors; [001451] wherein the plurality of tethers are configured to pull the plurality of anchors against the central body and to allow the plurality of anchors to be spaced apart from the central body; and
[001452] wherein rotating the actuation element in the first direction simultaneously opens all of the anchors that are disposed against the central body.
[001453] Example 109. The valve repair device of example 107, wherein the paddle further comprises a locking mechanism, and wherein the locking mechanism prohibits rotation of the second arm when the locking mechanism is in a locked condition.
[001454] Example 110. The valve repair device of example 107, wherein the paddle further comprise a biasing member arranged between the first arm and the second arm, and wherein the biasing member biases the second arm toward the closed condition.
[001455] Example 111. The valve repair device of example 110, wherein the paddle further comprises a locking mechanism, and wherein the locking mechanism prohibits rotation of the second arm when the locking mechanism is in a locked condition.
[001456] Example 112. A valve repair device comprising:
[001457] a central body;
[001458] a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising:
[001459] a first arm;
[001460] a second arm; and
[001461] a hinge portion hingeably connecting the first arm to the second arm;
[001462] a pivot arm connected to the central body and extending from the central body, through the second arm, and back to the central body;
[001463] an actuation element extending through a bore of the central body; [001464] an actuation arm connected to the actuation element and to the first arm of the gripping member;
[001465] wherein responsive to movement of the actuation element in a proximal direction, the second arm pivots in an opening direction; and
[001466] wherein responsive to movement of the actuation element in a distal direction, the second arm pivots in a closing direction.
[001467] Example 113. The valve repair device of example 112, wherein when the gripping member is in a closed condition, further movement of the actuation element in the distal direction applies additional force in the closing direction via the second arm of the gripping member.
[001468] Example 114. The valve repair device of example 112, further comprising a plurality of paddles and wherein the pivot arm extends from a paddle of the plurality of paddles, through the second arm, and back to the paddle of the plurality of paddles.
[001469] Example 115. The valve repair device of example 112, wherein the second arm of the gripping member is biased toward a closed condition.
[001470] Example 116. The valve repair device of example 115, wherein the second arm of the gripping member is biased toward the closed condition by the hinge portion.
[001471] Example 117. The valve repair device of example 112, wherein the gripping member is formed from a shape-set alloy and is shape-set in the closed condition.
[001472] Example 118. The valve repair device of example 112, wherein the gripping member comprises a barbed portion extending from the first arm.
[001473] Example 119. The valve repair device of example 112, further comprising a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors against the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001474] Example 120. A valve repair device comprising: [001475] a central body;
[001476] a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising:
[001477] a first arm;
[001478] a second arm; and
[001479] a hinge portion hingeably connecting the first arm to the second arm;
[001480] an actuation element extending through a bore of the central body;
[001481] an actuation arm connected to the actuation element; and
[001482] a tether connected to an end portion of the actuation arm and the second arm of the gripping member,
[001483] wherein movement of the actuation element in a distal direction applies tension to the tether to cause the second arm to pivot in an opening direction, and
[001484] wherein movement of the actuation element in a proximal direction causes the actuation arm to engage the second arm to pivot the second arm in a closing direction.
[001485] Example 121. The valve repair device of example 120, wherein when the gripping member is in a closed condition, further movement of the actuation element in the proximal direction applies additional force in the closing direction via the second arm of the gripping member.
[001486] Example 122. The valve repair device of example 120, wherein the actuation arm comprises a spring portion that biases the end of the actuation arm in the closing direction.
[001487] Example 123. The valve repair device of example 120, wherein the second arm of the gripping member is biased toward a closed condition.
[001488] Example 124. The valve repair device of example 123, wherein the second arm of the gripping member is biased toward a closed condition by the hinge portion. [001489] Example 125. The valve repair device of example 120, wherein the gripping member is formed from a shape-set alloy and is shape-set in a closed condition.
[001490] Example 126. The valve repair device of example 120, wherein the gripping member comprises a barbed portion extending from the first arm.
[001491] Example 127. The valve repair device of example 120, further comprising a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors against the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001492] Example 128. A valve repair device comprising:
[001493] a central body;
[001494] a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising:
[001495] a first arm,
[001496] a second arm, and
[001497] a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased in a closing direction; and
[001498] an actuation element extending through a bore of the central body and further extending out of an opening of the bore, the opening disposed distally of the hinge portion of the gripping member,
[001499] wherein retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction; and
[001500] wherein extending the actuation element releases tension on the actuation element to allow the second arm to pivot in the closing direction.
[001501] Example 129. The valve repair device of example 128, further comprising a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors against the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001502] Example 130. The valve repair device of example 129, wherein the actuation element comprises one or more tethers of the plurality of tethers, and wherein tension is not applied to the second arm of the gripping member unless the anchor is pulled against the central body by the tethers.
[001503] Example 131. The valve repair device of example 129, wherein the actuation element and the one or more tethers are formed from a single suture.
[001504] Example 132. The valve repair device of example 128, wherein the second arm of the gripping member is biased in a closing direction by the hinge portion.
[001505] Example 133. The valve repair device of example 132, wherein the actuation element comprises one or more tethers of the plurality of tethers, and wherein when the anchor is spaced apart from the central body by the one or more tethers, the second arm remains in a closed condition while the actuation element is retracted.
[001506] Example 134. The valve repair device of example 128, wherein the gripping member is formed from a shape-set alloy and is shape-set in the closed condition.
[001507] Example 135. The valve repair device of example 128, wherein the gripping member comprises a barbed portion extending from the first arm.
[001508] Example 136. A valve repair device comprising:
[001509] a central body;
[001510] a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising:
[001511] a first arm,
[001512] a second arm, and
[001513] a hinge portion hingeably connecting the first arm to the second arm; [001514] a routing member extending distally beyond the hinge portion of the gripping member, wherein the routing member can be retracted to a retracted position proximal of the hinge portion; and
[001515] an actuation element extending through a bore of the central body, around the routing member, and to the second arm of the gripping member,
[001516] wherein retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction.
[001517] Example 137. The valve repair device of example 136, wherein when the routing member is retracted to the retracted position, further retraction of the actuation element in the retraction direction applies tension to the actuation element to cause the second arm to pivot in the closing direction.
[001518] Example 138. The valve repair device of example 136, wherein the second arm of the gripping member is biased toward a closed condition.
[001519] Example 139. The valve repair device of example 138, wherein the second arm of the gripping member is biased toward the closed condition by the hinge portion.
[001520] Example 140. The valve repair device of example 138, wherein the gripping member is formed from a shape-set alloy and is shape-set in the closed condition.
[001521] Example 141. The valve repair device of example 138, wherein extending the actuation element releases tension on the actuation element to allow the second arm to pivot toward the closed condition.
[001522] Example 142. The valve repair device of example 136, wherein the gripping member comprises a barbed portion extending from the first arm.
[001523] Example 143. The valve repair device of example 136, further comprising a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors against the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001524] Example 144. A valve repair device comprising: [001525] a central body;
[001526] a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising:
[001527] a first arm;
[001528] a catch member arranged on the first arm of the gripping member;
[001529] a second arm comprising a flexible portion including a head having a barbed end configured to engage the catch member of the first arm while in a closed condition; and
[001530] a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased toward the closed condition;
[001531] an actuation element extending through a bore of the central body, and further extending around the hinge portion, and to the head of the second arm of the gripping member,
[001532] wherein retracting the actuation element, while the anchor is in a closed condition, applies tension to the actuation element to disengage the barbed end of the head of the second arm from the catch member, and
[001533] wherein further retraction of the actuation element after the barbed end is disengaged causes the second arm to pivot toward an open condition.
[001534] Example 145. The valve repair device of example 144, wherein the second arm comprises a U-shaped end, and wherein the flexible portion of the second arm is arranged in a gap of the U-shaped end of the second arm.
[001535] Example 146. The valve repair device of example 145, wherein responsive to retraction of the actuation element, the flexible portion of the second arm contacts the U-shaped end of the second arm before the second arm moves toward the opening condition.
[001536] Example 147. The valve repair device of example 144, wherein the second arm of the gripping member is biased in toward the closed condition by the hinge portion.
[001537] Example 148. The valve repair device of example 144, wherein the gripping member is formed from a shape-set alloy and is shape-set in the closed condition. [001538] Example 149. The valve repair device of example 144, wherein the gripping member comprises a barbed portion extending from the first arm.
[001539] Example 150. The valve repair device of example 144, further comprising a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors against the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001540] Example 151. A valve repair device comprising:
[001541] a central body;
[001542] a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising:
[001543] a first arm;
[001544] a second arm;
[001545] a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased toward a closed condition; and
[001546] a folding barbed portion extending from the second arm, wherein the folding barbed portion is biased away from the second arm;
[001547] an actuation element extending through a bore of the central body, around the hinge portion, through an opening in the second arm, and to the folding barbed portion;
[001548] wherein retracting the actuation element applies tension to the actuation element to cause the folding barbed portion to move in toward the second arm, and
[001549] wherein further retraction of the actuation element in the retraction direction after the folding barbed portion is folded against the second arm causes the second arm to pivot in toward an open condition.
[001550] Example 152. The valve repair device of example 151, wherein the folding barbed portion is integrally formed with the second arm. [001551] Example 153. The valve repair device of example 152, wherein the folding barbed portion is formed from a shape-setting alloy and is shape-set in an extended condition away from the second arm.
[001552] Example 154. The valve repair device of example 151, wherein the second arm of the gripping member is biased toward the closed condition by the hinge portion.
[001553] Example 155. The valve repair device of example 151, wherein the gripping member is formed from a shape-set alloy and is shape-set in the closed condition.
[001554] Example 156. The valve repair device of example 154, wherein the gripping member comprises a barbed portion extending from the first arm.
[001555] Example 157. The valve repair device of example 151, further comprising a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors against the central body and to allow the plurality of anchors to be spaced apart from the central body.
[001556] Example 158. A valve repair device comprising:
[001557] a central body;
[001558] a plurality of anchors, each anchor comprising:
[001559] a mounting plate having a first alignment feature for engaging a corresponding second alignment feature of the central body; and
[001560] a paddle, wherein the paddle is attached to the mounting plate;
[001561] wherein each of the plurality of anchors can be individually released from the central body and re-engaged with the central body; and
[001562] wherein the first alignment feature engages the second alignment feature of the central body to align the anchor in a desired position relative to the central body.
[001563] Example 159. The valve repair device of example 158, wherein the first alignment feature comprises a protrusion and the second alignment feature comprises an opening. [001564] Example 160. The valve repair device of example 159, wherein the first alignment feature comprises a rectangular protrusion or a cross-shaped protrusion and the second alignment feature comprises a rectangular opening or a cross-shaped opening.
[001565] Example 161. The valve repair device of example 159, wherein the first alignment feature comprises at least a portion of a cylinder and the second alignment feature comprises a rounded groove in the central body.
[001566] Example 162. The valve repair device of example 158, wherein the first alignment feature comprises an opening and the second alignment feature comprises a protrusion.
[001567] Example 163. The valve repair device of example 161, wherein the first alignment feature comprises a rectangular opening or a cross-shaped opening and the second alignment feature comprises a rectangular protrusion or a cross-shaped protrusion.
[001568] Example 164. The valve repair device of example 158, wherein the first alignment feature comprises a locking eyelet extending from the mounting plate and wherein the second alignment feature comprises an opening in the central body for receiving the locking eyelet.
[001569] Example 165. The valve repair device of any of examples 158-164, further comprising:
[001570] one or more tethers extending from the central body to the mounting plate of an anchor of the plurality of anchors,
[001571] wherein releasing tension on a tether of the one or more tethers allows the anchor to move away from the central body, and
[001572] wherein applying tension to the tether pulls the anchor into engagement with the central body.
[001573] Example 166. The valve repair device of example 165, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged proximal of the second alignment feature. [001574] Example 167. The valve repair device of any of examples 165, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged distal of the second alignment feature.
[001575] Example 168. The valve repair device of any of examples 165, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged to one side of the second alignment feature.
[001576] Example 169. The valve repair device of any of examples 165 or 168, wherein the central body comprises a central bore and one or more tethers extend through the central bore and out of openings in the central body that are arranged on two sides of the second alignment feature.
[001577] Example 170. The valve repair device of any of examples 165-169, further comprising:
[001578] a locking member;
[001579] a locking surface of the central body;
[001580] wherein the one or more tethers extend between the locking member and the locking surface; and
[001581] wherein the one or more tethers are locked by compressing the one or more tethers between the locking member and the locking surface.
[001582] Example 171. The valve repair device of example 170, wherein the locking member and the locking surface have a tapered shape.
[001583] Example 172. The valve repair device of any of examples 170-171, wherein the locking member and the locking surface have a frustoconical shape.
[001584] Example 173. The valve repair device of any of examples 165-172, wherein a single tether extends from the central body, through the mounting plate of the anchor, and back into the central body. [001585] Example 174. The valve repair device of any of examples 158-173, wherein the paddles of the anchors are independently opened by actuation elements engaging each of the paddles.
[001586] Example 175. The valve repair device of example 174, wherein each of the anchors further comprise a gripping member, the gripping member comprising a first arm connected to a second arm by a hinge portion, wherein the first arm of the gripping member is attached to the mounting plate.
[001587] Example 176. The valve repair device of example 175, further comprising a second mounting plate attached to the second arm of the gripping member, the second mounting plate comprising a routing flange,
[001588] wherein an actuation element extends through an opening in the routing flange so that retracting the actuation element in a proximal direction through the central body causes the gripping member to open.
[001589] Example 177. The valve repair device of any of examples 158-176, wherein the mounting plate comprises a bore and an actuation element extends through the bore of the mounting plate to engage the paddle.
[001590] Example 178. The valve repair device of example 177, wherein extending the actuation element in a distal direction causes the paddle to open; and wherein retracting the actuation element in a proximal direction causes the paddle to close.
[001591] Example 179. The valve repair device of example 177, wherein extending the actuation element in a distal direction causes the paddle to close; and wherein retracting the actuation element in a proximal direction causes the paddle to open.
[001592] Example 180. The valve repair device of example 177, wherein rotating the actuation element in a first direction causes the paddle to open; and wherein rotating the actuation element in a second direction causes the paddle to close.
[001593] Example 181. The valve repair device of any of examples 177-180, wherein the actuation element comprises a tube that extends through the bore of the mounting plate to engage a distal end of the paddle. [001594] Example 182. The valve repair device of example 181, wherein the distal end of the paddle comprises a proximally extending pin that is received by the actuation element.
[001595] Example 183. The valve repair device of any of examples 177-182, wherein the actuation element threadably engages a distal end of the paddle.
[001596] Example 184. The valve repair device of any of examples 158-183, further comprising:
[001597] a locking pin extending through a central bore of the central body;
[001598] a locking eyelet attached to each of the mounting plates; and
[001599] a plurality of openings in the central body for receiving the locking eyelets of each anchor.
[001600] Example 185. The valve repair device of example 184, wherein the locking pin threadably engages with a threaded proximal opening of the central bore.
[001601] Example 186. The valve repair device of any of examples 184-185, wherein the locking eyelet of an anchor is offset from the locking eyelets of the other anchors so that the locking eyelets of all of the plurality of anchors can be moved into alignment with the locking pin.
[001602] Example 187. The valve repair device of any of examples 174-186, further comprising:
[001603] a sheath extending along an actuation element of the actuation element to the paddle;
[001604] wherein when the sheath is in an extended condition, the sheath engages the bore of the mounting plate to engage the anchor with the central body; and
[001605] wherein when the sheath is in a retracted condition, the anchor is able to move away from the central body. [001606] Example 188. The valve repair device of example 187, wherein the actuation element is biased to move the anchor laterally away from the central body when the sheath is retracted to the retracted condition.
[001607] Example 189. The valve repair device of any of examples 187-188, wherein the anchors are moved to a distally staggered bailout position by extending the actuation element and sheath for each anchor to a different distance.
[001608] Example 190. The valve repair device of any of examples 158-189, further comprising a gripping member attached to the paddle of each anchor.
[001609] Example 191. The valve repair device of example 190, wherein the gripping member comprises:
[001610] a first arm;
[001611] a second arm;
[001612] a hinge portion attaching the first arm to the second arm; and
[001613] a secondary actuation element connected to the second arm so that tension applied to the secondary actuation element opens the gripping member by moving the second arm away from the first arm.
[001614] Example 192. A valve repair system comprising:
[001615] a delivery system comprising one or more catheters and a control handle; and
[001616] a valve repair device according to any of examples 158-191.
[001617] Example 193. The valve repair system of example 192, wherein the delivery system comprises a plurality of positioning arms, a positioning arm of the plurality of positioning arms extending from a catheter of the delivery system to engage an anchor of the valve repair device.
[001618] Example 194. The valve repair system of example 193, wherein the positioning arm comprises an actuation element associated with the anchor of the valve repair device. [001619] Example 195. The valve repair system of any of examples 193-194, wherein extending the positioning arm from the catheter allows the positioning arm to flex laterally to allow the anchor to move away from the central body.
[001620] Example 196. The valve repair system of example 195, wherein the positioning arm is biased to flex laterally outward and away from the central body.
[001621] Example 197. The valve repair system of any of examples 195-196, wherein retracting the positioning arm into the catheter causes the positioning arm to straighten so that the anchor is moved into engagement with the central body.
[001622] Example 198. The valve repair system of any of examples 195-196, wherein a sheath is extended along the positioning arm to cause the positioning arm to straighten so that the anchor is moved into engagement with the central body.
[001623] Example 199. The valve repair system of any of examples 193-198, wherein the delivery system further comprises a guide extending through the positioning arm to a distal cap.
[001624] Example 200. The valve repair system of example 199, wherein the distal cap is connected to the central body of the valve repair device.
[001625] Example 201. The valve repair system of example 200, wherein the distal cap further comprises a stop for engaging the plurality of anchors when the anchors are moved into engagement with the distal cap.
[001626] Example 202. The valve repair system of any of examples 199-201, wherein extending the positioning arm moves the anchor along the guide and into engagement with the distal cap.
[001627] Example 203. The valve repair system of example 202, wherein applying a force to the positioning arm in the extending direction after the anchor has engaged the distal cap compresses the positioning arm; and wherein compressing the positioning arm causes the positioning arm to straighten. [001628] Example 204. The valve repair system of any of examples 193-203, wherein the positioning arm is formed from a hypotube comprising a central lumen and a plurality of segments.
[001629] Example 205. The valve repair system of example 204, wherein the plurality of segments are cut from a single tube.
[001630] Example 206. The valve repair system of any of examples 204-205, wherein a segment of the plurality of segments extends from a first end to a second end, and at least one of the first end and the second end comprise a plurality of retaining slots and a plurality of corresponding keyed retaining tabs.
[001631] Example 207. The valve repair system of example 206, wherein the plurality of retaining slots are rotationally symmetric.
[001632] Example 208. The valve repair system of any of examples 206-207, wherein the first end and the second end comprise the plurality retaining slots such that the retaining slots of the first end of the segment are rotationally offset from the retaining slots of the second end of the segment.
[001633] Example 209. The valve repair system of any of examples 206-208, wherein the plurality of retaining slots and plurality of corresponding keyed retaining tabs have a T-shape.
[001634] Example 210. The valve repair system of any of examples 206-208, wherein the plurality of retaining slots and plurality of corresponding keyed retaining tabs have an arrow shape.
[001635] Example 211. The valve repair system of example 210, wherein compressing the hypotube causes slanted sides of the arrow-shaped keyed retaining tabs to engage slanted sides of the arrow-shaped retaining slots.
[001636] While various inventive aspects, concepts and features of the disclosures may be described and illustrated herein as embodied in combination in the examples herein, these various aspects, concepts, and features may be used in many alternative examples, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative examples as to the various aspects, concepts, and features of the disclosures-such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on-may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative examples, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts, or features into additional examples and uses within the scope of the present application even if such examples are not expressly disclosed herein.
[001637] Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, example or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.
[001638] Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of example methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (e.g., with the body parts, tissue, etc. being simulated), etc. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the examples in the specification.
[001639] While forms of the invention have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. Thus, although the invention has been described in detail with reference only to the preferred examples, those having ordinary skill in the art will appreciate that various modifications can be made without departing from the scope of the invention. Accordingly, the invention is not intended to be limited by the above discussion, and it is defined with reference to the following claims.

Claims

What is claimed is:
1. A valve repair device comprising: a central body; a plurality of anchors, each anchor comprising: a mounting plate having a first alignment feature for engaging a corresponding second alignment feature of the central body; and a paddle, wherein the paddle is attached to the mounting plate; wherein each of the plurality of anchors can be individually released from the central body and re-engaged with the central body; and wherein the first alignment feature engages the second alignment feature of the central body to align the anchor in a desired position relative to the central body.
2. The valve repair device of claim 1 , wherein the first alignment feature comprises a protrusion and the second alignment feature comprises an opening.
3. The valve repair device of claim 2, wherein the first alignment feature comprises a rectangular protrusion or a cross-shaped protrusion and the second alignment feature comprises a rectangular opening or a cross-shaped opening.
4. The valve repair device of claim 2, wherein the first alignment feature comprises at least a portion of a cylinder and the second alignment feature comprises a rounded groove in the central body.
5. The valve repair device of claim 1, wherein the first alignment feature comprises an opening and the second alignment feature comprises a protrusion.
6. The valve repair device of claim 4, wherein the first alignment feature comprises a rectangular opening or a cross-shaped opening and the second alignment feature comprises a rectangular protrusion or a cross-shaped protrusion.
7. The valve repair device of claim 1, wherein the first alignment feature comprises a locking eyelet extending from the mounting plate and wherein the second alignment feature comprises an opening in the central body for receiving the locking eyelet.
8. The valve repair device of any of claims 1-7, further comprising: one or more tethers extending from the central body to the mounting plate of an anchor of the plurality of anchors, wherein releasing tension on a tether of the one or more tethers allows the anchor to move away from the central body, and wherein applying tension to the tether pulls the anchor into engagement with the central body.
9. The valve repair device of claim 8, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged proximal of the second alignment feature.
10. The valve repair device of any of claims 8, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged distal of the second alignment feature.
11. The valve repair device of any of claims 8, wherein the central body comprises a central bore and the one or more tethers extend through the central bore and out of an opening in the central body that is arranged to one side of the second alignment feature.
12. The valve repair device of any of claims 8 or 11, wherein the central body comprises a central bore and one or more tethers extend through the central bore and out of openings in the central body that are arranged on two sides of the second alignment feature.
13. The valve repair device of any of claims 8-12, further comprising: a locking member; a locking surface of the central body; wherein the one or more tethers extend between the locking member and the locking surface; and wherein the one or more tethers are locked by compressing the one or more tethers between the locking member and the locking surface.
14. The valve repair device of claim 13, wherein the locking member and the locking surface have a tapered shape.
15. The valve repair device of any of claims 13-14, wherein the locking member and the locking surface have a frustoconical shape.
16. The valve repair device of any of claims 8-15, wherein a single tether extends from the central body, through the mounting plate of the anchor, and back into the central body.
17. The valve repair device of any of claims 1—16, wherein the paddles of the anchors are independently opened by actuation elements engaging each of the paddles.
18. The valve repair device of claim 17, wherein each of the anchors further comprise a gripping member, the gripping member comprising a first arm connected to a second arm by a hinge portion, wherein the first arm of the gripping member is attached to the mounting plate.
19. The valve repair device of claim 18, further comprising a second mounting plate attached to the second arm of the gripping member, the second mounting plate comprising a routing flange, wherein an actuation element extends through an opening in the routing flange so that retracting the actuation element in a proximal direction through the central body causes the gripping member to open.
20. The valve repair device of any of claims 1-19, wherein the mounting plate comprises a bore and an actuation element extends through the bore of the mounting plate to engage the paddle.
21. The valve repair device of claim 20, wherein extending the actuation element in a distal direction causes the paddle to open; and wherein retracting the actuation element in a proximal direction causes the paddle to close.
22. The valve repair device of claim 20, wherein rotating the actuation element in a first direction causes the paddle to open; and wherein rotating the actuation element in a second direction causes the paddle to close.
23. A valve repair device comprising: a central body; a plurality of anchors; a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body; an actuator operatively coupled to the plurality of anchors when the plurality of anchors are pulled against the central body by the tethers; and wherein the actuator is configured to open the plurality of anchors that are against the central body.
24. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; a plurality of anchors; a plurality of tethers attached to the plurality of anchors, wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body; and an actuator operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers, wherein the actuator is configured to open the plurality of anchors that are against the central body.
25. A valve repair device comprising: a central body; a plurality of anchors; a plurality of tethers attached to the plurality of anchors; wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body; wherein a connection between each tether and each anchor allows the plurality of anchors to assume a tilted position relative to the central body as the plurality of anchors are pulled toward the central body; and wherein the plurality of anchors and the central body are configured to move the plurality of anchors from the tilted position to a more upright position relative to the central body.
26. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; a plurality of anchors; a plurality of tethers, each tether attached to a corresponding anchor of the plurality of anchors; wherein the plurality of tethers are configured to pull the plurality of anchors toward the central body; wherein a connection between each tether and the corresponding anchor allows the plurality of anchors to assume a tilted position relative to the central body as the plurality of anchors are pulled toward the central body; and wherein the plurality of anchors and the central body are configured to move the plurality of anchors from the tilted position to a more upright position relative to the central body.
27. A valve repair device comprising: a central body; a plurality of spools disposed in the central body; a plurality of anchors; and a plurality of tethers, each tether wound around a corresponding spool of the plurality of spools and each tether attached to a corresponding anchor of the plurality of anchors.
28. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; a plurality of spools disposed in the central body; a plurality of anchors; and a plurality of tethers, each tether of the plurality of tethers wound around a corresponding spool of the plurality of spools and each tether attached to a corresponding anchor of the plurality of anchors.
29. A valve repair device comprising: a center clip; a plurality of anchors; and wherein the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
30. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a center clip; a plurality of anchors; and wherein the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
31. A valve repair device comprising: a central body having a plurality of expandable strips; a plurality of anchors attached to the plurality of expandable strips; and wherein the expandable strips are configured to move the plurality of anchors inward and outward.
32. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body having a plurality of expandable strips; a plurality of anchors attached to the plurality of expandable strips; and wherein the expandable strips are configured to move the plurality of anchors inward and outward.
33. A valve repair device comprising: a central body; and a plurality of anchors each anchor comprising a paddle and a gripping member, the paddle connected to the central body, wherein the gripping members are configured to move toward and away from the central body while the paddles are connected to the central body and the gripping members are coupled to the paddles.
34. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a central body; and a plurality of anchors each anchor comprising a paddle and a gripping member, the paddle connected to the central body, wherein the gripping member is configured to move toward and away from the central body while the paddle is connected to the central body and the gripping member is coupled to the paddle.
35. A valve repair device comprising: a first anchor; a second anchor; and a coupling member attached to the first anchor and the second anchor, wherein the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole, and wherein the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
36. A valve repair system comprising: a delivery system comprising one or more catheters and a control handle; a valve repair device coupled to the one or more catheters, the valve repair device comprising: a first anchor; a second anchor; and a coupling member attached to the first anchor and the second anchor, wherein the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole, and wherein the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
37. A valve repair device comprising: a central body; a plurality of tethers coupled to the central body; a plurality of anchors coupled to the central body via the plurality of tethers, wherein the plurality of tethers is configured to pull the plurality of anchors toward the central body; and an actuator coupled to the central body, wherein the actuator is configured to open and/or close anchors of the plurality of anchors that are pulled against the central body.
38. A valve repair device comprising: a central body comprising a bore; an actuation element extending through the bore of the central body, wherein the actuation element comprises a worm gear attached to a distal end of the actuation element; a plurality of anchors, each anchor comprising a paddle, the paddle comprising a first arm that is hingeably attached to a second arm by a hinge portion, wherein the hinge portion comprises an actuation gear that engages the worm gear of the actuation element, and wherein rotation of the actuation gear by the worm gear moves the paddle between an open condition and a closed condition; wherein responsive to rotation of the actuation element in a first direction, the second arm of the paddle moves toward the open condition; and wherein responsive to rotation of the actuation element in a second direction, the second arm of the paddle moves toward the closed condition.
39. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a second arm; and a hinge portion hingeably connecting the first arm to the second arm; a pivot arm connected to the central body and extending from the central body, through the second arm, and back to the central body; an actuation element extending through a bore of the central body; an actuation arm connected to the actuation element and to the first arm of the gripping member; wherein responsive to movement of the actuation element in a proximal direction, the second arm pivots in an opening direction; and wherein responsive to movement of the actuation element in a distal direction, the second arm pivots in a closing direction.
40. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a second arm; and a hinge portion hingeably connecting the first arm to the second arm; an actuation element extending through a bore of the central body; an actuation arm connected to the actuation element; and a tether connected to an end portion of the actuation arm and the second arm of the gripping member, wherein movement of the actuation element in a distal direction applies tension to the tether to cause the second arm to pivot in an opening direction, and wherein movement of the actuation element in a proximal direction causes the actuation arm to engage the second arm to pivot the second arm in a closing direction.
41. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm, a second arm, and a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased in a closing direction; and an actuation element extending through a bore of the central body and further extending out of an opening of the bore, the opening disposed distally of the hinge portion of the gripping member, wherein retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction; and wherein extending the actuation element releases tension on the actuation element to allow the second arm to pivot in the closing direction.
42. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm, a second arm, and a hinge portion hingeably connecting the first arm to the second arm; a routing member extending distally beyond the hinge portion of the gripping member, wherein the routing member can be retracted to a retracted position proximal of the hinge portion; and an actuation element extending through a bore of the central body, around the routing member, and to the second arm of the gripping member, wherein retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction.
43. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a catch member arranged on the first arm of the gripping member; a second arm comprising a flexible portion including a head having a barbed end configured to engage the catch member of the first arm while in a closed condition; and a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased toward the closed condition; an actuation element extending through a bore of the central body, and further extending around the hinge portion, and to the head of the second arm of the gripping member, wherein retracting the actuation element, while the anchor is in a closed condition, applies tension to the actuation element to disengage the barbed end of the head of the second arm from the catch member, and wherein further retraction of the actuation element after the barbed end is disengaged causes the second arm to pivot toward an open condition.
44. A valve repair device comprising: a central body; a plurality of anchors, an anchor of the plurality of anchors comprising a gripping member, the gripping member comprising: a first arm; a second arm; a hinge portion hingeably connecting the first arm to the second arm, wherein the second arm is biased toward a closed condition; and a folding barbed portion extending from the second arm, wherein the folding barbed portion is biased away from the second arm; an actuation element extending through a bore of the central body, around the hinge portion, through an opening in the second arm, and to the folding barbed portion; wherein retracting the actuation element applies tension to the actuation element to cause the folding barbed portion to move in toward the second arm, and wherein further retraction of the actuation element in the retraction direction after the folding barbed portion is folded against the second arm causes the second arm to pivot in toward an open condition.
45. A method of repairing a native heart valve comprising: simultaneously opening a plurality of anchors that are disposed against a central body; positioning a first anchor of the plurality of anchors such that a first native heart valve leaflet is in the first anchor; simultaneously closing the plurality of anchors that are disposed against the central body to capture the first leaflet; and moving the central body and a remaining one or more anchors away from the first anchor.
46. A method of repairing a native heart valve comprising: attaching an anchor to a leaflet of the native heart valve; pulling the anchor toward a central body in a tilted orientation relative to the central body; and engaging the anchor with the central body to move the anchor from the tilted orientation to a more upright position relative to the central body.
47. A method of repairing a native heart valve comprising: attaching a plurality of anchors to a plurality of leaflets of the native heart valve; and capturing the plurality of anchors with a center clip after the plurality of anchors have been attached to leaflets of the native heart valve.
PCT/US2025/021396 2024-03-26 2025-03-25 Heart valve repair devices and methods Pending WO2025207671A1 (en)

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KATREKAR DHRUVA, XIANG YICHEN, PALMER NATHAN, SAHA ANUSHKA, MELUZZI DARIO, MALI PRASHANT: "Comprehensive interrogation of the ADAR2 deaminase domain for engineering enhanced RNA editing activity and specificity", ELIFE, vol. 11, 18 January 2022 (2022-01-18), GB , pages 1 - 19, XP093362772, ISSN: 2050-084X, DOI: 10.7554/eLife.75555 *

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