WO2014149892A1 - Manchon ventriculaire - Google Patents

Manchon ventriculaire Download PDF

Info

Publication number
WO2014149892A1
WO2014149892A1 PCT/US2014/021389 US2014021389W WO2014149892A1 WO 2014149892 A1 WO2014149892 A1 WO 2014149892A1 US 2014021389 W US2014021389 W US 2014021389W WO 2014149892 A1 WO2014149892 A1 WO 2014149892A1
Authority
WO
WIPO (PCT)
Prior art keywords
cuff
heart
pump
cannula
disc
Prior art date
Application number
PCT/US2014/021389
Other languages
English (en)
Inventor
Justin Aron CALLAWAY
Cori G. PIERCE
Julien DUHAMEL
Kevin Bourque
J. Donald Hill
Original Assignee
Thoratec Corporation
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
Priority claimed from US13/842,578 external-priority patent/US9199019B2/en
Application filed by Thoratec Corporation filed Critical Thoratec Corporation
Publication of WO2014149892A1 publication Critical patent/WO2014149892A1/fr
Priority to EP15757834.5A priority Critical patent/EP3113807B1/fr
Priority to PCT/US2015/019308 priority patent/WO2015134944A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/861—Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
    • A61M60/863—Apex rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857—Implantable blood tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices

Definitions

  • This disclosure relates to ventricular cuffs.
  • Heart assist devices or pumps can be inserted in the circulatory system to pump blood from either ventricle or atrium of a heart to the vasculature.
  • a pump supplementing a ventricle is known as a ventricular assist device, or VAD.
  • VAD ventricular assist device
  • a VAD is useful when the ventricle alone is incapable of providing adequate blood flow.
  • a cuff for attachment to a heart defines an opening to admit a cannula of a heart pump.
  • the cuff can be sufficiently rigid to promote flattening of ihe myocardium in a region where the cuff is attached.
  • the cuff includes two or more layers of, for example, felt, fabric, mesh, or another material.
  • the two or more layers may be joined by sutures or an adhesive, such as a silicone adhesive.
  • the cuff includes a wire insert, which may be covered in silicone and positioned between two layers of felt.
  • a housing of a heart pump includes one or more anchors.
  • the anchors admit fasteners, such as sutures, that can secure the implanted heart pump.
  • multiple anchors are located at the perimeter of the heart pump, for example, spaced apart around an outer edge of the housing.
  • Each anchor may be a suture anchor, for example, an eyelet or other opening through which a suture can be passed to capture a portion of the housing.
  • fabric cover is implanted around a blood pump to reduce tissue adhesion and facilitate later removal of ihe blood pump.
  • a blood pump in another general aspect, includes a housing disposed about a pump mechanism.
  • the housing has a proximal side configured to face toward a heart and an inflow cannula extending from the proximal side.
  • the housing has an outer perimeter, and the housing includes a plurality of suture anchors disposed along the outer perimeter of the housing.
  • the suture anchors are eyelets defined through the housing.
  • the housing has a peripheral side oriented generally perpendicular to the proximal side, and one or more of the eyelets defines a passage from the peripheral side to the proximal side.
  • the passage extends from the peripheral side inward toward the inflow cannula.
  • the passage has a central axis, and the central axis is oriented at an angle of between 20 degrees and 50 degrees of the peripheral side.
  • the housing is configured to receive a ventricular cuff about the inflow cannula with the ventricular cuff adjacent the proximal side, and each of the plurality of suture anchors defines a passage oriented to direct a needle through the ventricular cuff when the ventricular cuff is positioned about the inflow cannula with the ventricular cuff adjacent the proximal side.
  • the outer perimeter of the housing is generally circular and the housing has a
  • the suture anchors are spaced apart along at least a portion of the circumference.
  • Thee suture anchors are disposed around more than half of the circumference.
  • the suture anchors are spaced apart at an angular distance of between 10 and 50 degrees.
  • the inflow cannula defines a central longitudinal axis, and the suture anchors each have an opening disposed in a plane, the plane being generally perpendicular to the central longitudinal axis of the inflow cannula.
  • a cuff for attachment to a heart includes an attachment component configured to engage a blood pump to attach the cuff to the blood pump.
  • the cuff also includes a sewing ring for attachment to the heart.
  • the sewing ring is coupled to the attachment component, and the attachment component and the sewing ring each define a central opening configured to admit an inflow cannula of a blood pump.
  • the sewing ring includes a member that provides rigidity to flatten a portion of a myocardium of the heart when the cuff is attached to the heart.
  • the sewing ring includes two or more disc-shaped layers of fabric.
  • the two or more disc-shaped lay ers are formed of a felt, a mesh, or a woven material.
  • the two or more disc-shaped layers are formed of polytetrafluoroethylene, polyester, or polyethylene terephthalate.
  • the two or more disc-shaped layers are formed of polytetrafluoroethylene felt.
  • the two or more disc-shaped layers are attached to each other by sutures or an adhesive.
  • Each of the two or more disc-shaped layers has a thickness between approximately 1.3 millimeters and 2,3 millimeters, and a maximum water permeability of between approximately 450 ml/cm2/mm and 650 ml/cm2/mm.
  • the sewing ring includes an insert disposed between the disc-shaped lay ers, the insert being more rigid than the disc-shaped layers.
  • the insert is formed of polyether ether ketone, titanium, a titanium alloy, a cobalt chromium alloy, or a shape-memory polymer.
  • the insert is covered in silicone.
  • the insert is a lattice or web that defines a central opening that admits the inflow cannula of the blood pump.
  • the insert has an inner perimeter, an outer perimeter, and a plurality of extensions that extend radially inward between the outer perimeter and the inner perimeter.
  • the insert is formed of a resilient material.
  • the insert is formed of a nickel-titanium alloy.
  • the sewing ring has a flexural modulus of greater than 50 psi.
  • the sewing ring has a flexural modulus of at least 60 psi.
  • the sewing ring has a flexural modulus of at feast 75 psi.
  • the sewing ring has a flexural modulus of at least 100 psi.
  • the sewing ring has a flexural modulus of at least 125 psi.
  • the sewing ring has a flexural modulus of at least 150 psi.
  • the sewing ring has a flexural modulus of less than 1500 psi.
  • the sewing ring has a flexural modulus of less than 1000 psi.
  • the sewing ring has a flexural modulus of less than 750 psi.
  • a method in another general aspect, includes attaching a cuff to a heart, the cuff being sufficiently rigid such that at least a portion of a my ocardium of the heart is flattened by the attaching.
  • the method also includes forming an opening in the myocardium, positioning an inflow cannula of a blood pump through a central opening in the cuff and into the opening in the myocardium, and attaching the blood pump to the cuff.
  • Implementations may include one or more of the following features.
  • the method includes attaching one or more sutures to one or more suture anchors disposed on an exterior of the blood pump. Attaching the one or more sutures to one or more suture anchors includes passing a suture through an eyelet disposed along an outer perimeter of the blood pump and through a portion of the cuff.
  • Attaching the one or more sutures to one or more suture anchors includes passing a suture through an eyelet disposed along an outer perimeter of the blood pump and through a portion of the myocardium. Attaching the one or more sutures to one or more suture anchors includes attaching sutures at multiple suture anchors disposed around an outer perimeter of the blood pump, the sutures extending through a sewing ring of the cuff and maintaining the position of the sewing ring generally along a plane perpendicular to the inflow cannula. Attaching the blood pump to the cuff includes engaging a coupling mechanism configured to prevent translation of the inflow cannula through the central opening of the cuff.
  • Engaging the coupling mechanism includes holding the cuff at an outer edge of the cuff and applying a counterforce with the cuff against the blood pump.
  • Attaching the blood pump to the cuff includes engaging a locking mechanism after engaging the coupling mechanism.
  • Forming the opening in the myocardium includes cutting the opening in the myocardium through the cuff afier the cuff is attached to the heart.
  • Attaching the cuff to the heart includes attaching the cuff to the heart after forming the opening in the myocardium, the central opening of the cuff being positioned over the opening in the my ocardium.
  • Attaching the cuff to the heart includes attaching to the heart a cuff that includes a sewing ring that includes two or more layers of fabric.
  • Attaching the cuff to the heart includes attaching to the heart a cuff that includes a generally planar insert disposed between two or more layers of fabric, the generally planar insert being more rigid than the two or more layers of fabric.
  • the method includes surrounding the blood pump within an implantable fabric cover defining a pocket around the blood pump. The forming is performed before the attaching. The forming and the positioning of the inflow cannula are performed substantially in one step.
  • a method includes: attaching a cuff to a heart, the cuff having a central opening; forming an opening in the heart; positioning an inflow cannula of a blood pump through the central opening in the cuff and into the opening in the heart; and attaching the blood pump to the cuff with a suture anchored to a suture anchor on the exterior of the blood pump.
  • a method includes: attaching a cuff to a heart, the cuff having a central opening; forming an opening in the heart; positioning an inflow cannula of a blood pump through the central opening in the cuff and into the opening in the heart; attaching the blood pump to the cuff; and enclosing the implanted blood pump within an implantable fabric cover,
  • a system in another general aspect, includes a blood pump having an inflow cannula defining a lumen and a central axis and a cuff for attachment to a heart.
  • the cuff includes a fabric disc defining a central opening.
  • the cuff or the inflo w cannula includes a portion extending radially outward from the central axis. The portion is configured to contact an endocardium of the heart when the blood pump is implanted with the inflow cannula, extending into the heart through the central opening of the cuff.
  • the inflow cannula includes a proximal end that flares outward.
  • the cuff includes a flexible portion that is configured to deflect inward to enter a hole in the heart, and is configured to expand outward within the heart to rest against the endocardium.
  • the cuff has a proximal portion and a distal portion ihai each extend radially outward from the central axis, and a distance between the proximal portion and the distal portion is adjustable to capture a portion of a myocardium of the heart between the proximal portion and the distal portion.
  • the cuff includes a proximal portion and a distal portion and a length between the proximal portion and distal portion, wherein the length is adjustable.
  • the cuff includes a member configured to exert a force on heart tissue located between the proximal portion and the distal portion.
  • the cuff includes a frame that is resilient or has a shape memory. The frame is configured to expand a proximal portion of the cuff radially outward from the central axis within the heart to capture a portion of the heart located about the cuff.
  • the frame is configured to contract along the central axis when deployed in a hole in the heart,
  • a cuff for attachment to a heart defines an opening to admit a cannula of a heart pump.
  • a coupling mechanism couples the cuff about the cannula, and a locking mechanism secures the position of the cuff set by the coupling mechanism.
  • an implantable system in another general aspect, includes a cuff, a surface defining channels, and a clip having arms that extend into the channels. The arms travel along the channels during movement of the clip between an unlocked position of the clip and a locked position of the clip.
  • the clip permits the cuff to be coupled about a cannula when the clip is in the unlocked position, and the clip is configured to secure the cuff relative to the cannula when the clip is in the locked position.
  • the implantable system includes a cover, and the clip is captured between the cover and the surface.
  • the cannula has a longitudinal axis, and the clip moves between the unlocked position and the locked position in a plane perpendicular to the longitudinal axis.
  • the cover and the surface define a slot, and the clip travels along a linear direction through the slot to enter the locked position.
  • the channels define detents, and when the cuff is not coupled to the cannula, movement of the clip from the unlocked position toward the locked position engages the arms into the detents to impede the clip from entering the locked position.
  • Each of the arms can engage a detent independent of whether another arm engages a detent, and engagement of any of the arms with a detent impedes the clip from entering the locked position.
  • the arms include teeth configured to limit rotation of the cuff about the cannula when the clip is in the locked position.
  • a sealing ring is disposed about the cannula, and the sealing ring is engageabie to an inner surface of the cuff to couple the cuff to the cannula.
  • the clip includes a visual indicator disposed such that the visual indicator is exposed when the clip is not in the locked position and the visual indicator is obscured when the clip is in the locked position.
  • the clip includes a latch that impedes the clip from exiting the locked position.
  • an implant in another general aspect, includes a cuff defining an opening configured to receive a cannula coupled to a heart pump and a coupling mechanism having a first position and a second position. The cuffis uncoupled from the cannula in the first position and the coupling mechanism couples the cuff to the cannula in the second position.
  • the implant includes a. locking mechanism configured to secure the coupling mechanism in the second position, and the locking mechanism is configured to be moved to a locked position after the coupling mechanism is in the second position.
  • a first action positions the coupling mechanism in the second position
  • a second action activates the locking mechanism to secure the coupling mechanism in the second position
  • the second action occurs subsequent to and separate from the first action.
  • the cannula includes a flange and a circumferential ridge, and the coupling mechanism is configured to capture the cuff about the cannula between the flange and the circumferential ridge.
  • the cannula includes (1) an attachment portion between the flange and the circumferential ridge and (ii) an inflow portion, and the aitaehmeni portion has an outer diameier greater than an outer diameier of the inflow portion.
  • the cuff includes an inner portion, an outer portion, and a member each disposed concentrically about the opening, the member being disposed between the inner portion and the outer portion, and the outer portion extending in a direction generally perpendicular to the member.
  • the coupling mechanism includes a clamp coupled to the cuff and disposed about the opening.
  • the clamp has a first end and a second end, the clamp configured such that bringing the first end near the second end opens the clamp and moving the two ends apart closes the clamp.
  • the locking mechanism includes a cam that defines a channel, the cam being coupled to the first end of the clamp and being configured to rotate about the first end, the second end of the clamp being disposed in the channel and being configured to travel within the channel.
  • the channel includes a curved portion, the curved portion being configured to limit the motion of the second end of the clamp in the channel when the clamp is closed.
  • the coupling mechanism includes an attachment member coupled about the opening of the cuff, the attachment member having one or more flanged portions that extend outward from the opening, and the locking mechanism includes a clip configured engage the flanged portions to limit movement of the cuff rel ative to the cannul a.
  • the clip is configured to enter a slot in the pump to secure the cuff to the pump.
  • the attachment member includes one or more extensions each including a contact portion that extends toward the opening, the cannula includes a t apered circumferential ridge, and the second position of the coupling mechanism, the contact portions are disposed between the pump and the circumferential ridge along the length of the cannula.
  • a cuff for attachment to a heart includes a member defining an opening, a seal coupled to the member and disposed about the opening, and a clamp coupled to the seal and disposed about the opening.
  • the clamp has a first end and a second end, and the clamp is configured such that (i) bringing the first end near the second end opens the clamp and (it) moving the first end and the second end apart closes the clamp.
  • Implementations can include one or more of the following features.
  • a cam defining a channel, the cam being coupled to the first end of the clamp and being configured to rotate about the first end, the second end of the clamp being disposed in the channel and being configured to travel within the channel.
  • a cuff for atiachment to a heart includes a member defining an opening, a linking member coupled to the member and disposed about the opening, and an attachment member coupled to the linking member and disposed about the opening.
  • the linking member extends about an outer surface of ihe attachment member.
  • the attachment member is configured to attach the cuff to a cannula disposed through the opening.
  • the attachment member has at least one flanged portion extending outward from the opening in a plane generally
  • Implementations can include one or more of the following features.
  • the linliing member is molded over a portion of the attachment member, and the attachment member is coupled to the member through the linking member.
  • the attachment member includes at least one extension disposed generally perpendicular to the member, the extension having a tapered portion disposed on a surface of the extension facing ioward the opening.
  • the atiachment member defines circumferential groove configured to admit a sealing ring.
  • the linking member includes an elastomer. The linking member is configured to form a seal.
  • a method of attaching a ventricular assist device to a patient includes: attaching a cuff to a heart, the cuff defining an opening; removing tissue of the heart through the opening of the cuff; inserting a cannula through the opening of ihe cuff; engaging a coupling mechanism to set a position of the cuff relative to the cannula; and engaging a locking mechanism to secure the position of the cuff relative to the cannula.
  • mplementations can include one or more of the following features. For example, selecting a location near the apex of the heart to attach the cuff.
  • Engaging the coupling mechanism includes inserting a tapered portion of the cannula into the cuff so that one or more extensions of the cuff engage a groove defined adjacent to the tapered portion.
  • Engaging the locking mechanism includes inserting a clip that engages the cuff and a pump coupled to the cannula.
  • Engaging the coupling mechanism includes closing a clamp coupled to the cuff so that the clamp engages a groove defined in the cannula.
  • Engaging the locking mechanism includes capturing an end of a clamp to secure the clamp in a locked position.
  • Engaging the coupling mechanism to set a position of the cuff relative to the cannula includes positioning the cuff such that an inner surface of the cuff engages a sealing ring disposed about the cannula and a bottom surface of the cuff engages a surface of the cannula or a surface of a pump that is coupled to the cannula.
  • Engaging the locking mechanism includes moving a clip in a plane perpendicular to the cannula.
  • Engaging the locking mechanism includes moving a clip into a locked position about the cuff, the clip limiting travel of the cannula out of the cuff.
  • Engaging the locking mechanism includes engaging a latch that secures the clip in the locked position.
  • a system in another general aspect, includes a cuff having an annular member defining an opening and an attachment member disposed about the opening.
  • the attachment member includes a flanged portion oriented generally parallel to the annular member, and the flanged portion e tends outward from the opening.
  • a clip is configured to be coupled about the attachment member between the annular member and the flanged portion.
  • the system includes a pump assembly that includes a cannula, and the clip is configured to travel relative to the pump assembly from an unlocked position to a locked position in which the clip secures the cuff about the cannula.
  • the clip is configured to travel along a substantially linear path from the unlocked position to the locked position.
  • the clip impedes rotation of the cuff about the cannula.
  • the cuff includes ridges disposed on the attachment member, and the clip is configured to engage the ridges to impede rotation of the cuff.
  • the clip is configured to engage the pump assembly such that the travel of clip to the locked position is impeded when the cuff is improperly seated about the cannula.
  • the clip is configured to engage the pump assembly such thai travel of clip to the locked position is impeded when the cuff is not coupled to the pump assembly.
  • the system includes a visual indicator that is visible when the clip is not in the locked position and is obscured when the clip is in the locked position. When the clip is in the locked position, engagement of the clip and the pump assembly impedes travel of the clip out of the locked position.
  • the clip has arms that are configured to extend about the cuff in the locked position, the arms being configured such that any of the arms can engage the pump assembly to impede travel of the clip into the locking position,
  • a system in another general aspect, includes a cuff having a member defining an opening and an attachment member disposed about the opening.
  • the attachment member includes (i) a clamp having a first end and a second end, and (ii) a cam defining a channel.
  • the cam is coupled to the first end of the clamp and is configured to rotate about the first end.
  • the second end of the clamp is disposed in the channel and is configured to travel within the channel.
  • a ventricular assist system for coupling with a heart of a patient.
  • the ventricular assist system may include a pump comprising a pump housing and an inflow cannula coupled thereto.
  • the pump housing may further comprise a lip, outer ridge, notch or groove along at least an outer portion of the pump housing.
  • the system may further include a ventricular cuff comprising a disc.
  • the disc may have a central opening for receiving the inflow cannula of the pump. Further, the disc may be moveable between an open configuration for receiving the inflow cannula of the pump and a closed configuration for coupling the disc to the pump thereby securing the ventricular cuff to the pump.
  • the ventricular cuff may further comprises one or more hooks or teeth extending from the disc and configured to couple with the lip, outer ridge, notch or groove of the pump housing.
  • the disc may comprise an annular segment with a wedge opening between ends of the annular segment in the open configuration.
  • the ends of the annular segment may be joined such that the disc has a circular or ring shape in the closed configuration.
  • the ends of the annular segment may comprise corresponding engagement features for locking the disc with the inflow cannula of the blood pump in the closed configuration.
  • the engagement features comprise snap-fit engagement features.
  • the engagement features comprise an ear clamp.
  • the engagement features comprise a screw/band clamp.
  • the screw/band clamp comprises a lockout feature.
  • the lockout feature may be configured to allow operator actuation of the screw/band clamp only when the lockout feature is coupled with a corresponding key.
  • the lockout feature may prevent inadvertent turning of the screw/band clamp when the key is not coupled with the lockout feature.
  • the one or more hooks or teeth extend from an outer perimeter of the disc. In some embodiments, the one or more hooks or teeth extend along the entire outer perimeter of the disc.
  • the lip, outer ridge, notch or groove of the pump may extend along a top housing portion of the pump,
  • a ventricular cuff for use with a ventricular assist device.
  • the ventricular cuff may include a disc comprising a generally circular shape and a central opening configured to receive an inflo cannula of a blood pump.
  • the disc may have a diameter being greater than 3 cm such that the disc has a size sufficient to substantially flatten the apex of the heart of the patient when the disc is coupled thereto.
  • the larger disc diameter may flatten the apex to create more space between the central opening of the disc and walls of the left ventricle of the heart.
  • the diameter of the disc may be greater than 4 cm or greater than 5 cm.
  • an accommodation opening may be provided along an outer perimeter of the disc. The accommodation opening may be configured to be orientated toward the right ventricle of the heart so that the disc does not overlap with and flatten the right ventricle when attached to the heart.
  • a portion of the disc may comprise a felt material.
  • the disc may comprise at least two layers of felt coupled together. An insert may disposed between the at least two lay ers of felt with the insert comprising a material more rigid than the felt layers.
  • a ventricular cuff for use with a ventricular assist de vice may be provided.
  • the v entricular cuff may comprise a disc comprising a generally circular or ring shape and a central opening configured to receive an inflow cannula of a blood pump.
  • the disc may further have an open configuration for receiving the inflow cannula of the blood pump and a closed configuration for locking the blood pump with the disc.
  • the disc may comprise an annular segment with a wedge opening between ends of the annul ar segment in the open configuration. The ends of the annular segment may be joined such that the disc has a circular or ring shape in the closed configuration.
  • the ends of the annular segment comprise corresponding engagement features for locking the disc with the inflow cannula of the blood pump in the ciosed configuration.
  • the engagement features may comprise snap-fit engagement features.
  • the engagement features may comprise an ear clamp.
  • the engagement features may comprise a screw/band clamp.
  • the screw/band clamp may comprise a lockout feature, the lockout feature configured to allow operator actuation of the screw/band clamp only when the lockout feature is coupled with a
  • the lockout feature may prevent inadvertent turning of the screw/band clamp when the key is not coupled with the lockout feature.
  • the ventricular cuff may comprise one or more hooks or teeth extending from the disc.
  • the one or more hooks or teeth may be configured to cooperate with a hp, outer ridge, notch or groove of an attached pump.
  • the one or more hooks may extend from an outer perimeter of the disc.
  • the one or more hooks extend along the entire outer perimeter of the disc.
  • the lip, outer ridge, notch or groove of the pump may extend along a top housing portion of the attached pump.
  • a method of securing a ventricular cuff to an apex of a heart of a patient may be provided.
  • the method may comprise securing one or more pledgets or anchors to tissue of the heart and then securing ends of one or more sutures to the heart via the one or more pledgets or anchors.
  • the one or more sutures may be fed through the ventricular cuff.
  • the ventricular cuff may be positioned against the apex of the heart and the cuff may be fastened to the heart with the one or more sutures.
  • one or more anchors may be secured to tissue of the heart.
  • the one or more anchors may comprise a distal tissue peneirating end with one or more barbs for securing the one or more anchors in the tissue.
  • the anchors may further comprise a suture engagement feature at a proximal end of thereof for securing ends of the one or more sutures to the heart.
  • a plurality of pledgets or anchors are secured to the heart to form a perimeter which is greater than an outer perimeter of the disc of the ventricular cuff.
  • the method may further include flattening the apex of the heart beyond the outer perimeter of the disc by tightening the sutures.
  • a plurality of pledgets or anchors may be secured to the heart to form a perimeter which corresponds in shape and/or size to an outer perimeter of the disc of the ventricular cuff.
  • the method may further include flattening the apex of the heart by tightening the sutures to the cuff such that the anchors or pledgets are positioned under the disc,
  • Fig. I is a perspective view of a pump installed at a heart.
  • FIG. 2 A is a perspective view of a ventricular cuff.
  • Fig, 2B is a side vie of a cannula for coupling to the ventricular cuff.
  • Fig, 3 is an exploded view of the ventricular cuff.
  • Fig. 4A is a perspecti v e view of a tube from which a seal member of the ventricul ar cuff can be fabricated.
  • Fig, 4B is a perspective view of a seal member of the ventricular cuff.
  • Fig. 5A is a perspective view of a earn of the ventricular cuff.
  • Figs. 5B to 5E are respectively top, bottom, lateral side, and opposite lateral side views of the ventricular cuff
  • Fig. 6 is a side cross-sectional view of the ventricular cuff coupled to the cannula across line 6-6 of Fig. 8D.
  • FIGs. 7A to 7D are top views illustrating the closing of a clamp of the ventricular cuff.
  • FIGs. 8A to 8D and 9A to 9C are perspective views illustrating the coupling of the ventricular cuff to the pump.
  • FIGs. lOAto 10D are perspective views illustrating a process for implanting the ventricular cuff and the pump
  • Fig. 11 A is a perspective view of a ventricular cuff.
  • Fig, 1 IB is a side view of a cannula for coupling to the ventricular cuff of Fig. 11 A.
  • Fig. 12 A is a perspective view of an attachment member of the ventricular cuff of Fig. 11 A,
  • Fig. 12B is a side cutaway view of an extension of the attachment member.
  • Fig. 13A is a perspective view illustrating the top of a clip.
  • Fig. 13B is a perspective view illustrating the bottom of the clip.
  • Fig. 13C is a side view of a post of the clip.
  • Figs. 14Ato 14C are perspective views illustrating the engagement of the clip with a pump.
  • Figs. 15A to ISC are perspective views illustrating the coupling of the pump of Fig. 14A to the ventricular cuff of Fig. l lA using the clip.
  • Fig. 16 is a side cross-sectional view of the ventricular cuff of Fig. 11A coupled to the cannula of Fig. 11B across line 16- 16 of Fig, 15C.
  • Fig, 17 A is a perspective view of a ventricular cuff.
  • Fig. 17B is a side view of a cannula for coupling to the ventricular cuff of Fig. 17A.
  • Fig. 18A is a perspective view of an attachment member of the ventricular cuff of Fig. 17A.
  • Fig, 18B is a cross-sectional view of a portion of the ventricular cuff of Fig. 17A.
  • Figs. 19 A and 19B are cross-sectional views illustrating the engagement of the ventricular cuff of Fig. 17A with the cannula of Fig. 17B.
  • Fig, 20 is a side cross-sectional v iew of the ventricular cuff of Fig, 17A coupled to the cannula of Fig, 17B and secured to the pump of Fig, 14A using the clip.
  • Fig. 2.1 is a perspective view of a pump, a cannula, and a ventricular cuff.
  • Fig. 22A is a perspective view of the cuff of Fig. 21.
  • Fig, 22B is a side view of the ventricular cuff of Fig. 21 .
  • Fig, 22C is a perspective view of an attachment member of the ventricular cuff of Fig. 21.
  • Fig. 22D is a side cutaway view of the ventricular cuff of Fig. 21.
  • Figs. 23A and 23B are side cutaway views of the cannula and ventricular cuff of Fig, 21 .
  • Figs. 24A and 24B are cross-sectional view of sealing rings.
  • Fig. 25A is a perspective view of the pump of Fig. 21 .
  • Fig, 25B is an exploded v ie w of the pump of Fig. 21.
  • Fig, 26A is a top perspective view of a clip that cooperates with the pump and the ventricular cuff of Fig. 21.
  • Fig. 26B is a bottom perspective view of the clip of Fig. 26 A.
  • Fig, 26C is a side view of an end portion of an arm of the clip of Fig. 26A.
  • Fig, 26D is a side cross-sectional view of a tooth of the clip of Fig. 26A.
  • Fig. 27 is a perspective view of a surface of the pump of Fig. 21.
  • Figs. 28A to 28C are perspective views illustrating different motions of the clip of Fig. 26A relati ve to the pump of Fig. 2.1.
  • Figs. 29 A to 29C are bottom views of different positions of the clip of Fig. 26A relative to the pump of Fig. 21.
  • Figs. 3 OA to 30C are top perspective views of different positions of the clip of Fig. 26 A relative to the pump of Fig. 21.
  • Fig. 31 is a side cutaway view of the pump, the cannula, and the ventricular cuff of Fig. 21 .
  • FIG. 32 is a perspective view of a pump installed at a heart.
  • Fig, 33 is a perspective view of the pump of Fig. 32 and a cuff attached to the heart.
  • Fig. 34A is an exploded view of the cuff of Fig. 33.
  • Fig, 34B is a side view of the cuff of Fig, 33.
  • Fig, 34C is a top view of an insert that may be included in the cuff of Fig. 33
  • Fig. 34D is an exploded view of the cuff of Fig. 33 including the insert.
  • Fig. 35 is a side cutaway view of two different cuffs and associated pumps.
  • Fig, 36A is a side view of the pump of Fig, 32.
  • Fig. 36B is a top view of the pump of Fig. 32.
  • Figs. 37A and 37B are perspective views of a portion of the pump of Fig. 32.
  • Fig, 37C is a side cutaway view of a portion of the pump of Fig. 32. and a needle
  • Fig. 38 is a top view of an alternative cuff.
  • Fig. 39 is a cross-sectional view of the pump of Fig. 32 with a flexible cover.
  • Fig, 40 is a flow chart illustrating a process for implanting a pump
  • Fig, 41 is a cross-sectional view of an assembly of a cuff and an inflow cannula.
  • Figs. 42A and 42B are cross-sectional views of another assembly of a cuff and an inflow cannula.
  • Figs. 43 and 44 are cross-sectional view r s of alternative cuffs.
  • Fig. 45 shows a comparison between a 5.5 mm high apical cuff and a taller 8 mm high apical cuff according to embodiments of the present invention.
  • Fig. 46 shows an optional tool engagement feature for use with apical cuffs according to embodiments of the present invention .
  • Fig. 47 shows an exemplary tool for coupling with an apical cuff according to embodiments of the present invention.
  • FIGs. 48A-48B show another exemplary tool for couplmg with an apical cuff according to embodiments of the present invention
  • FIGs. 49A-49B show yet another exemplary tool for coup ling with an apical cuff according to embodiments of the present invention.
  • Figs. 50A-50B show exemplary sewing rings which may be configured to avoid abutment or overlap of the right ventricle of the heart according to
  • Figs. 51 -53 show various exemplary embodiments of a cuff according to embodiments of the present invention.
  • Fig. 54 illustrates another exemplary embodiment of a cuff that may be secured to a pump using a screw/band ("worm gear") clamp according to embodiments of the present invention.
  • Figs. 55 A-55B illustrate an exemplary key for use with the exemplary cuff shown in Fig. 54 according to embodiments of the present invention.
  • Fig. 56 shows an exemplary cross-sectional view of a cuff with a pump engagement feature according to embodiments of the present invention.
  • Fig. 57 shows an exemplary pump for coupling with the engagement features of the cuff illustrated in Fig. 56 according to embodiments of the present invention.
  • Fig, 58 shows a cross-sectional view of an exemplary coupling between a pump, a cuff, and a heart according to embodiments of the present invention.
  • Figs. 59A-59C illustrate an exemplary method of attaching a cuff to the apex of the heart according to embodiments of the present invention.
  • Fig. 60A-6QC illustrate an alternative method of attaching a cuff to the apex of the heart according to embodiments of the present invention.
  • FIGs. 61A-61 C illustrate yet another method of attaching a cuff to the apex of the heart according to embodiments of the present invention.
  • Figs. 62A-62B illustrate exemplary anchors that may be used to secure a suture to heart tissue according to embodiments of the present invention.
  • a ventricular assist system 10 for treating, for example, a patient with a weakened left ventricle, includes a blood pump 12 that receives blood from a patient's heart 14.
  • the pump 12 is coupled to a cuff 20, which in turn is attached to the heart 14.
  • the cuff 20 is attached to the heart by, for example, sutures that attach a portion of the cuff 20 to the apex of the left ventricl e of the heart 14.
  • the pump 12 receives blood from the heart through an inflow cannula 50 (Fig. 2B) of the pump 12 disposed through an opening in the cuff 20.
  • the cuff 20 defines an opening 30 that admits the inflow cannula 50.
  • the cuff 20 includes a coupling mechanism, for example, a clamp 26 that couples the cuff 20 to the cannula 50.
  • the cuff 20 also includes a locking mechanism in the form of a cam 28 that secures the clamp 26 in a closed position. The locking mechanism, by maintaining the position of the coupling mechanism, limits the possibility of the cuff 20 accidentally becoming uncoupled from the cannula 50.
  • the locking mechanism can secure the cuff 20 to the cannula 50 such that, for example, removal of the cuff 20 from the cannula 50 requires more than one action, or the cannula 50 is no longer tree to rotate or translate with respect to the cannula 50 without significant outside influence, such as by a clinician.
  • the cuff 20 is illustrated in a view illustrating individual disassembled parts, including a fastening member 22, a linking member 24, the clamp 26, and the cam 28,
  • the components illustrated can be preassembled and delivered to a clinician as a single unit.
  • the fastening member 22 is generally ring-shaped and includes a contact surface 23 to contact heart tissue.
  • the fastening member 22 is composed of a material through which sutures can be placed, for example a fabric such as poiytetrafluoroethylene (PTFE) felt.
  • PTFE poiytetrafluoroethylene
  • sutures or staples bind the fastening member 22 to heart tissue to couple the cuff 20 to the heart 14.
  • the fastening member 22 and the linking member 24 are pre- assembled together as one unit.
  • the linking member 24 can be fabricated by reshaping a tube 25 formed of, for example, an elastomer such as silicone.
  • the linking member 2.4 is formed, for example, by folding an upper portion 32 of the tube 25 and a lower portion 33 of the tube 25 about an outer circumference 31 of the tube 25.
  • the resulting linking member 24 defines a circumferential groove 34 between generally parallel ring-shaped portions 35, 36.
  • the linking member 24 also includes a circumferential inner surface 40 that forms a seal with the cannula 50.
  • the linking member 24 can also be fabricated to include ring-shaped reinforcement members 37, 38 (Fig. 6) that includes, for example, a mesh material or a knitted fabric formed of a material such as polyester.
  • a knitted fabric or mesh material is embedded into a silicone sheet.
  • the silicone sheet is die-cut into ring- shaped portions 35, 36 that respectively include the ring-shaped reinforcement members 38, 37.
  • the ring-shaped portions 35, 36 are then placed in a silicone mold and overmolded with additional silicone.
  • the molded silicone binds the ring-shaped portions 35, 36 together and creates a flexible connection between the ring-shaped portions 35, 36, which include the reinforcement members 38, 37.
  • the clamp 26 includes a circular portion 70 formed of a resilient material, such as metal wire.
  • the circular portion 70 can be formed of stainless steel or a cobalt chromium alloy, each of which can provide implantability, long term stability, and resiliency.
  • the circular portion 70 is disposed in the circumferential groove 34 of the linking member 24.
  • the linking member 24 is thus couples the clamp 26 to the fastening member 22.
  • Sutures 42 pass through the fastening member 22 and the ring-shaped portions 35, 36 of the linking member 24, capturing the circular portion 70 in the linking member 24 and coupling the linking member 24 to the fastening member 22.
  • the reinforcement members 37, 38 limit tearing of the linking member 24 by the sutures 42.
  • the linking member 24 can be coupled to the fastening member 22 by an adhesive or by overmolding the linking member 24 over a portion of the fastening member 22.
  • the clamp 26 has a relaxed posiiion toward which it wants to return after a load is applied to open or close the clamp 26.
  • the circular portion 70 is expanded by moving the arms 72, 74 closer together.
  • the circular portion 70 is contracted by increasing the distance between the arms 72, 74. Expansion of the circular portion 70 beyond the relaxed position loads the circular portion 70, causing the circular portion 70 to exert a force that tends to contract the circular portion 70 (e.g., an inward radial force). Conversely, compression of the circular portion 70 beyond the relaxed position loads the circular portion 70 such that the circular portion 70 exerts a force to expand the circular portion 70 (e.g., an outward radial force).
  • the clamp 26 includes a pivot arm 72 and a travelling arm 74 that extend from the circular portion 70.
  • the pivot arm 72 and the travelling arm 74 provide leverage to expand and contract the circular portion 70, thus opening and closing the clamp 26.
  • the pivot arm 72 includes a pivot end 73
  • the travelling arm 74 includes a travelling end 75.
  • the ends 73, 75 extend generally perpendicular to their respective arms 72, 74,
  • the ends 73, 75 each pass through the cam 28 and are captured in the cam 28 by a cap 76, 77.
  • the cam 28 includes a top side 78, a bottom side 79, and opposite lateral sides 80, 81 .
  • the cam 28 can be formed of, for example, polyether ether ketone (PEEK) or stainless steel.
  • PEEK polyether ether ketone
  • the cam 28 defines a pivot hole 82 that admits the pivot end 73, and defines a channel 83 that admits the travelling end 75, about the pivot hole 82, in the fop side 78, the cam 28 defines a recess 84 that receives the cap 76.
  • the cam 28 Opposite the recess 84, the cam 28 includes a boss 89 that extends from the bottom side 79, The height, H, of the boss 89 maintains a space between the pivot arm 72 and the bottom side 79.
  • the travelling arm 74 can contact the bottom side 79.
  • the two arms 72, 74 travel in different planes separated by the distance H. Because the boss 89 maintains the pivot arm 72 at a distance from the bottom side 79, the travelling arm 74 can move relative to the pivot arm 72. without contacting the pivot arm 72.
  • the cap 77 is disposed adjacent to the top side 78 and the cap 76 is disposed in the recess 84 such that the caps 76, 77 do not contact each other during operation of ihe clamp 26.
  • the channel 83 defines a path, such as a curve, between a detent 85 and an end 86 located near the pivot hole 82.
  • the detent 85 includes a hooked portion of the channel 83 that captures the travelling end 75 to secure the clamp 26 in the closed position.
  • the cam 28 includes an extension 87 that indicates proper placement of ihe cuff 20 relative to the pump 12. As the cuff 20 becomes coupled to the cannula 50, the extension 87 engages the surface 13 of the pump 12 to indicate proper placement of the cuff 20 relative to the pump 12. In addition, the extension 87 aligns the cam 28 in a plane generally parallel to the surface 13, Alignment of the cam 28 with respect to the surface 13 reduces the likelihood that the cam 28 may engage a portion of the pump 12 and improperly impede the clamp 26 from closing completely.
  • the cam 28 also includes a raised portion 88 extending from the top side 78, which facilitates manipulation of the cam 28.
  • the raised portion 88 is rounded to rest against the outer circumference of the pump 12 when the cam 28 is locked (see Fig. 9C).
  • the raised portion 88 defines a slot 90 in which a tool or surgical instrument can be inserted to unlock ihe cam 28.
  • the slot 90 can be used to pry open ihe clamp 26, for example, if tissue in-growth makes manual manipulation of the cam 28 difficult.
  • Manipulation of the cam 28 moves the clamp 26 between open and closed positions.
  • the clamp 26 permits a proximal portion 52. of the cannula 50 to pass through the opening 30.
  • the clamp 26 presses inward to couple the cuff 20 to the cannula 50.
  • the clamp 26 presses the linking member 24 into engagement with the cannula 50, and the circumferential inner surface 40 of the linking member 24 forms a seal with the cannula 50.
  • the cannula 50 is shown by itself here but is generally an integrated component of the pump 12.
  • the pump 12 can receive different interchangeable cannulas to achieve an appropriate fit in a particular anatomy.
  • the cannula 50 includes the proximal portion 52 that passes through the opening 30 into the heart 14 and a distal portion 54 housed within the pump 12.
  • the cannula 50 includes a circumferential tapered portion 56, a circumferential ridge 58, and a circumferential flange 62.
  • the cannula 50 defines a circumferential groove 60 in which the clamp 26 and the linking member 24 are received.
  • the proximal portion 52 is passed through the opening 30, such that the circumferential tapered portion 56 engages the circumferential inner surface 40 of the linking member 24, guiding the cannula 50 into alignment with the cuff 20. Further advancement of the cannula 50 causes the circumferential ridge 58 to travel past the circular portion 70 of the clamp 26. The action of the circumferential ridge 58 passing the circular portion 70 provides a clinician tactile feedback about the proper location of the components. The circumferential flange 62 limits further travel of the cannula 50 relative to the cuff 20, positioning the circular portion 70 of the clamp 26 about the circumferential groove 60.
  • the fastening member 22 is disposed about the cannula 50, generally about the circumferential ridge 58.
  • the cuff 20 is sized so that the inner diameter of the cuff 20 is greater than the outer diameter of the proximal portion 52 , which facilitates insertion of the proximal portion 52. With the clamp 2.6 in its open position, the size of the inner diameter of the cuff 20 approximates that of the outer diameter of the circumferential ridge 58. The circumferential ridge 58 is rounded, permitting the linking member 24 to slide over the circumferential ridge 58 and into the circumferential groove 60. Thus a clinician can determine that the cuff 20 is properly positioned relative to the cannula 50 by experiencing the tactile sensation of the linking member 24 entering the circumferential groove 60.
  • the cuff 20 is coupled to the cannula 50 by moving the clamp 26 to its closed position.
  • the inner diameter of the clamp 26 is smaller than the outer diameier of the circumferential ridge 58.
  • the clamp 26 presses the linking member 24 into the circumferential groove 60, forming a seal and capturing the cannula 50 in the cuff 20.
  • the outer diameter of the cannula 50 at the circumferential groo ve 60 is larger than the outer diameter of the proximal portion 52.
  • the differential in diameter allows passage of a coring tool through the cuff 20.
  • the coring tool can be slightly larger than the proximal portion 52 of the cannula 50,
  • the differential in diameter can allow the clinician to further confirm proper placement of the cuff 20 relative to the cannula 50.
  • a clinician can confirm proper placement by applying a small axial load that would tend to separate the cannula 50 from the cuff 20. If the cannula 50 and the cuff 20 separate easily, then ihe cuff 20 is improperly seated. If cannula 50 and the cuff 20 remain coupled, however, the cuff 2.0 is properly seated.
  • the circular portion 70 Because the circular portion 70 is loaded, the circular portion 70 exerts a force on the end 75 in the direction of arrow Fj to separate the pivot arm 72 and the travelling arm 74. Nevertheless, the open position is stable because the force acts away from the length of the channel 83 and instead presses the travelling end 75 into the end 86 of the channel 83. As a result, the open position can be maintained while the cannula 50 is placed relative to the clamp 26,
  • the clamp 26 is in an unstable position between the open position and the closed position. Force exerted by the loaded circular portion 70 continues to rotate the cam 28 in the plane and close the clamp 26. The distance between the pivot arm 72 and the travelling arm 74 increases, and the circular portion 70 contracts, resulting in an overlap of the circuiar portion 70 of a distance, Dj . The clinician is not required to apply additional force on the cam 28 to move the clamp 26 to the closed position.
  • the clamp 26 exerts a force in the direction of arrow F?, moving the end 75 through the channel 83. As the travelling end 75 proceeds through the channel 83, the cam 28 continues to rotate about the pivot end 73, as indicated by arrow R 2 .
  • the cannula 50 is captured within the clamp 26.
  • the size of the circul ar portion 70 in the closed position can be selected to permit rotation of the cannula 50 relative to the cuff 20 or to limit such rotation.
  • the closed position is stable.
  • the circuiar portion 70 is in its unloaded, relaxed position.
  • the clamp 26 does not exert a force on the travelling end 75 in either direction along the channel 83.
  • the travelling end 75 is located in the channel 83 near the detent 85 but not in the detent 85.
  • the cam 28 impedes the clamp 26 from opening.
  • the circular portion 70 is slightly compressed beyond its relaxed position, such that the overlap distance 3 ⁇ 4 is larger than D 2 .
  • the loaded circular portion 70 exerts a force on the travelling end 75 in the direction of arrow Fi, which presses the travelling end 75 into the detent 85. Because the circular portion 70 forces the travelling end 75 into the detent 85, the travelling end 75 is impeded from traveling through the channel 83 and mo ving the clamp 26 into the open position.
  • the travelling end 75 must be dislodged from the detent 85.
  • the clinician applies a force, for example, in the direction of arrow U, to overcome the force of the loaded circular portion 70.
  • the force rotates the cam 28 in the plane such that the travelling end 75 slides out of the detent 85.
  • the clamp 26 can be opened by exerting a force on the side 81 away from the circular portion 70, which rotates the cam 28 opposite the direction of arrows R; and R2 until the open position is reached.
  • the cannula 50 can then be removed or repositioned relative to the clamp 26 before the clamp 26 is closed again.
  • the cuff 20 is in the open position before being coupled to the cannula 50 of the pump 12.
  • the cuff 20 will first be attached to the heart 14 and then heart tissue will be removed to admit the proximal portion 52 of the cannula 50.
  • heart tissue can also be removed before the cuff 20 is attached to the heart 14.
  • the cannula 50 is fixedly coupled to the pump ⁇ 2, for example, the cannula 50 can be sealed and welded to the pump 12. Alternatively, the cannula 50 can be removably coupled to the pump 12, for example, by a threaded connection or by a mechanism that permits the cannula 50 to snap into place.
  • a clinician can select a cannula 50 that best fits the anatomy of the patient, and can couple the cannula 50 to the pump 12 prior to or during a procedure.
  • the distal portion 54 is housed within the pump 12 and the proximal portion 52 extends from a top surface 13 of the pump 12.
  • a clinician may select a cannula 50 that extends an appropriate distance into the heart 14. For example, a clinician may a cannula 50 with a first length for a left VAD so that the cannula 50 extends the proper distance into the heart 14. For implantation of a right VAD, however, the clinician may use a cannula with a different length so that the cannula extends a different distance into a heart. [8153] To couple the cannula 50 to the cuff 20, the pump 12 and the cannula 50 are advanced to ward the cuff 20 so that the proximal portion 52 of the cannula 50 enters the opening 30.
  • the circumferential ridge 58 engages the circumferent l inner surface 40 of the linking member 24, Further travel of the cannula 50 relative to the cuff 20 advances the circumferential ridge 58 through the linking member 24, so that the clamp 26 and the linking member 24 are disposed about the circumferential groove 60.
  • Advancing the circumferential ridge 58 through the linking member 24 produces tactile feedback for the clinician, such as a snap-like sensation.
  • the tactile feedback indicates that the cuff 20 is properly seated against the circumferential flange 62 and that the circular portion 70 is disposed about the circumferential groove 60.
  • the circumferential ridge 58 slightly expands the circular portion 70.
  • the clamp 26 contracts to its open position, contributing to the tactile feedback experienced by the clinician.
  • the cuff 20 is disposed about the cannula 50, with the linking member 24 partially disposed in the circumferential groove 60.
  • the clamp 26 can be closed to capture the cannula 50 in the cuff 20.
  • the clinician manipulates the cam 28 to begin rotating the cam 28 about the pivot end 73, in the direction of arrow R .
  • the resilient force of the clamp 26 moves the travelling end 75 through the channel 83 defined in the cam 28, continuing the rotation of the cam 28 about the pivot end 73, in the direction of arrow C ⁇ .
  • the circular portion 70 of the clamp 26 contracts and presses the linking member 24 into the circumferential groove 60, The contraction of the circular portion 70 captures the cannula 50 within the cuff 20 because the circumferential ridge 58 cannot pass through the circular portion 70.
  • the clamp 26 is in a closed position and the cam 28 is in a locked position, maintaining the clamp 26 in the closed position.
  • the travelling end 75 of the clamp 2.6 is located in the detent 85 defined in the cam 2.8. From this position, the clamp 26 is unlikely to be opened accidentally, because significant force is required to remove the travelling end 75 from the detent 85.
  • the top side 78 of the cam 2.8 is disposed against the top surface 13 of the pump 12, and the raised portion 88 of the cam 28 rests against the outer circumference of the pump 12.
  • implantation of pump 12 to the heart 14 can include selecting a location to attach the cuff 20.
  • the apex 15 of the left ventricle can be selected as an operation site.
  • the cuff 20 is placed in contact with the heart 14 at the selected operation site.
  • the cuff 20 is attached to the heart 14, for example, with sutures.
  • a cardiac bypass system is activated so that blood does not circulate through the heart 14.
  • a core section of heart tissue is removed through the opening 30 of the cuff 20.
  • the cuff 20 can be atiached to the heart 14 and a core section of heart tissue can be removed in the absence of a cardiac bypass.
  • the core section of heart tissue can be removed before attaching the cuff 20 to the heart 14.
  • FIG. IOC heart tissue has been removed so that the proximal portion 52 can be admitted through the opening 30 of the cuff 20.
  • the clamp 26 of the cuff 20 is moved to its open position (not shown) and the proximal portion 52 of the cannula 50 is received through the opening 30.
  • the proximal portion 52 advances through the opening 30 until the circular portion 70 of the clamp 26 is disposed about the circumferential groove 60.
  • the clinician determines that the circular portion 70 is located about the circumferential groove 60 based on (i) snap-like tactile feedback of the
  • the clinician couples the cuff 20 to the cannula 50 by rotating the cam 28 in a plane generally parallel to the top surface 13 of the pump 12. Rotation of the cam 28 moves the clamp 26 to its closed position, in which the cannula 50 is captured within the cuff 20. The clinician rotates the 8 further in the plane to engage the locking mechanism of the cam 28,
  • orientation of the cuff 20 to the cannula 50 can be secured such that axial movement of the cannula 50 relative to the cuff 20 and rotation of the cannula 50 relative to the cuff 20 are both impeded.
  • the size of the cuff 20 can be selected such that, when the pump 12 is coupled to the cuff 20, the distance between the heart 14 and the top surface 13 of the pump 12 is small.
  • the total height of the cuff 20 may be, for example, between approximately 2mm and approximately 10mm. Because the cam 28 can be moved to a locked position by planar movement, the locking mechanis does not require clearance between the cuff 20 and the top surface 13.
  • the inflow cannula 50 can define two or more circumferential grooves between two or more circumferential ridges. Multiple circumferential grooves can provide different locations along the length of the cannula 50 at which the cuff 20 can be coupled. A clinician couple the cuff 20 at a particular
  • the thickness of the fastening member 22 can be selected to adjust the length that the cannula 50 extends into the heart 14.
  • the use of a thicker fastening member 22 can result in the cannula 50 extending a shorter depth into the heart 14 than the use of a thinner fastening member 22.
  • a clinician may select a cuff 20 that includes a fastening member 22 of an appropriate thickness to set the distance that the cannula 50 extends into the heart 14.
  • a clinician may also adjust the distance that the cannula 50 extends into the heart by adding one or more spacers, such as a ring-shaped fabric washer, between the cuff 20 and the heart 14. For example, a clinician may place a spacer between the surface of the heart 14 and the contac t surface 23 of the fastening member 22.
  • spacers such as a ring-shaped fabric washer
  • Sutures can be placed through the fastening member 22 and through the spacer to attach the cuff 20 at an appropriate distance from the heart 14.
  • the lengih of the proximal portion 52 of the cannula 50 can be varied to achieve a desired length of extension of the proximal portion 52 into the heart 14.
  • several inflow cannulas having proximal portions of different lengths can be fabricated.
  • a clinician can select an inflow cannula that has a proximal portion corresponding to the desired length of extension into the heart of a particular patient, and can couple the selected inflow cannula to a pump before or during a procedure.
  • the cuff 20 may include a resilient metal split ring.
  • a break or gap in the split ring permits the diameter of the split ring to expand as it travels over the circumferential groove 58 of the cannula 50. Once the split ring is located about the circumferential groo ve 60, the split ring contracts into the circumferential groove 60 to couple the cuff 20 to the cannula 50.
  • the split ring may thus be operated without arms extending from the split ring and without a cam.
  • an alternative cuff 120 and an alternative cannula 150 can be used to couple a pump 250 (Fig. 14A) to heart tissue.
  • a coupling mechanism for example, an attachment member 126, couples the cuff 120 to the cannula 150.
  • a locking mechanism in the form of a clip 200 Fig. 13A impedes the cuff 120 from becoming uncoupled from the cannula 150.
  • the cuff 120 defines an opening 130 that admits a proximal portion 152 of the cannula 150,
  • the cuff 120 includes an annular fastening member 12.2, a linking member 124, and the attachment member 12.6.
  • the fastening member 122 can be sutured to heart tissue, and can include, for example, a fabric such as PTFE felt.
  • the linking member 124 is formed of, for example, an elastomer such as silicone, and includes a reinforcement member 128 (Fig. 16) such as a mesh ring.
  • the linking member 124 is disposed about an outer circumference of the attachment member 126 and serves as a linking member to couple the attachment member 126 to the fastening member 122, as discussed further below.
  • the linking member 124 is coupled to the fastening member 122 by, for example, sutures.
  • the linking member 124 can also be molded directly to the fastening member 122.
  • the linking member 124 includes a bottom surface 125 configured to engage a generally fiat
  • circumferential flange 162 of the cannula 150 forming a face seal with the circumferential flange 162.
  • the cannula 150 includes the proximal portion 152. that enters the opening 30 of the cuff 120 and a distal portion 154 that is housed in the pump 250,
  • the cannula 150 includes a first circumferential taper 156 that engages extensions 136 of the aitaelimeni member 126 and deflects ihem away from ihe cannula 150 as the cannula 150 advances through the opening 130
  • the cannula 150 includes a second circumferential taper 158 and defines a circumferential groove 160 between the second circumferential taper 158 and the circumferential flange 162.
  • the attachment member 126 is formed of, for example, a rigid material such as metal.
  • the attachment member 126 includes a ring portion 132. having a wall 133 with cutouts 134 that define flexible extensions 136.
  • Each extension 136 includes a lower tapered portion 138 (Fig. 12B) disposed on a free end 139 of the extension 136, facing inward toward the opening 130.
  • each low r er tapered portion 138 includes upper tapered portion 140, and the width of each lower tapered portion 138, W, decreases along the length of each lower tapered portion 138, between the upper tapered portion 140 and the free end 139.
  • the extensions 136 can have equal sizes or can be selected to have differing sizes. For example, asymmetrical lengths of the extensions 136 can cause the extensions 136 to engage the circumferential tapers 156, 158 sequentially rather than consecutively during travel of the cannula 150 relative to the cuff 120, reducing the force required to couple the cannula 150 to the cuff 120 or to uncouple the cannula 150 from the cuff 120.
  • the amount of feree required to deflect the extensions is correlated with the angle of the taper of the circumferential tapers 156, 158 and the tapered portions 138, 140.
  • the steepness of the taper angles can be selected such that different amounts of force along the length of the cannula 150 are required to couple the cuff 120 to the cannula 150 can remove the cuff 120 from the cannula 150,
  • the engagement of tapers with a steep angle results in a lower percentage of axial force being transmitted radially outward than the engagement of shallower tapers.
  • the tapers of the lower tapered portions 138 and the circumferential taper 156 are less steep than the tapers of the upper tapered portions 140 and the circumferential taper 158. Accordingly, more force is required to decouple the cuff 120 than to couple the cuff 120 to the cannula 150.
  • the amount of feree required to couple the cuff 120 to and decouple the cuff 12.0 from the cannula 150 can be adjusted by the materials selected for the attachment member 126, the thickness of the extensions 136, the length and width of the extensions 136, and the geometry of the cutouts 134.
  • the attachment member 126 includes flanged portions 146, disposed between the extensions 136 along the outer circumference of the attachment member 126, at the bottom 1 1 of the attachment member 126.
  • the flanged portions 146 extend generally perpendicular to the wall 133.
  • the flanged portions 146 are disposed in a plane generally parallel to the circumferential flange 162. of the cannula 150.
  • the flanged portions 146 are captured between the clip 200 and the circumferential flange 162, impeding the cuff 120 from becoming uncoupled from the cannula 150,
  • the flanged portions 146 define holes 148 through which material of the linking member 12.4 is molded or adhesive is applied to form mechanical locks that secure the linking member 124 to the attachment member 126.
  • Material of the linking member 124 is also molded or adhesively bonded through the cutouts 134 and over the ring portion 132.
  • silicone can be molded over the attachment member 126 and can be molded over a portion of the fastening member 12.2.
  • the linking member 124 can also be coupled to the attachment member 126 with adhesive or sutures.
  • the linking member 124 covers the flanged portions 146, an outer surface 142 of the wall 133, and a portion of an inner surface 144 of the wall 133 (Fig. 16).
  • the flanged portions 146 and extensions 36 are disposed symmetrically along the circumference of the attachment member 126, permitting the extensions 136 to engage the circumferential tapers 156, 158 evenly about the cannula 150, and permitting the flanged portions 146 to evenly press the bottom surface 125 of the linking member 124 into engagement with the circumferential flange 162.
  • the attachment member 126 can include more or fewer flanged portions 146 and extensions 36 than those illustrated,
  • a clinician inserts the proximal portion 152 of the cannula 150 through the opening 130, As the cannula 150 advances through the opening 130, the first circumferential taper 1 56 passes the upper tapered portion 140 of the low er tapered portions 138.
  • the engagement of the lower tapered portions 138 with the first circumferential taper 156 ends abruptly, permitting the extensions 136 to straighten so that the lower tapered portions 138 reside in the circumferential groove 160.
  • the sudden decrease in resistance to advancement of the cannula 150 produces a tactile snap-like sensation, indicating to the clinician that the cannula 150 is coupled to the cuff 120.
  • the upper tapered portion 140 of the lower tapered portions 138 engage the second circumferential taper 158, impeding the cannula 150 from separating from the cuff 120.
  • the bottom surface 125 of the linking member 124 engages the circumferential flange 162, limiting further advancement of the cannula 150 relative to the cuff 120.
  • the cannula 150 can be separated from the cuff 12.0 by a force sufficient to deflect the extensions 1 36.
  • the clip 200 is used to secure the cuff 120 about the cannula 150.
  • the clip 200 cooperates with features of the pump 250, described below, to limit travel of the cuff 120 relative to the cannula 1 50.
  • the clip 200 includes a top side 202, a bottom side 204, and opposite lateral sides 206, 208.
  • the clip 200 can be formed of, for example, a rigid plastic, such as PEEK, or metal, such as titanium.
  • the clip 200 includes guide rails 212 and arms 214, and defines a recess or opening 215 or opening.
  • the guide rails 212 guide the clip 200 through a linear motion as the clip 2.00 is received by the pump 2.50.
  • the opening 215 admits a tool or a finger of the clinician to facilitate disengagement of the clip 200 from its locked position relative to the cuff 120.
  • the arms 214 are curved and resilient and define an opening 2.20, As the clip 200 moves relative to the pump 250, the pump 250 forces the arms 214 laterally outward, expanding the opening 220 and allowing the arms 214 to extend about the linking member 124 of the cuff 120. In the locked position of the clip 200, the pump 250 forces the arms 214 laterally inward to engage the linking member 124 and to secure the cuff 120 to the pump 250.
  • the arms 214 include teeth 216 that extend from inner wails 217 of the arms 214 toward the opening 220.
  • the teeth 216 are disposed over the flanged portions 146 of the attachment member 126, thus capturing the flanged portions 146 between the teeth 216 and the circumferential flange 162 of the cannula 150. Between the teeth 216 are gaps 218 that permit the arms 214 to flex laterally as the clip 200 is received by the pump 250.
  • the teeth 216 engage the finking member 124 of the cuff 120 to impede rotation of the cuff 120 relative to the clip 200 and the pump 250.
  • Each arm 214 includes a post 219 extending from the bottom side 204 that is received in one of the channels 254 (Fig. 14A) defined by the pump 250. As the pump 250 receives the clip 200, the posts 2.19 travel through the channels 254, directing the lateral flexion of the arms 214.
  • the posts 219 each include angled walls 221 , 222 (Fig. 13C) that engage angled walls 257, 258 (Fig. 16) of the pump 250 that define the channels 254, capturing the posts 2.19 in the channels 254.
  • the pump 250 is coupled to the cannula 150 and receives a clip 200.
  • the pump 250 defines generally parallel slots 252 that receive the guide rails 212 of the clip 200.
  • the pump 250 in a top side 256, also defines the channels 254 that receive the posts 219 between the angled walls 257, 258 (Fig. 16).
  • the angled walls 257, 258 capture the posts 219, impeding the posts 219 from leaving the channels 254 and maintaining the arms 214 in a plane above the top side 256.
  • the portion of the pump 250 that defines the channels 254 can be an integral component of, for example, a motor housing of the pump, or can be a separate component that attaches to the pump 250, for example, with welds, screws, or other fastening mechanisms.
  • the pump 250 defines an entry recess 255 at each channel 254 that admits the post 219. The distance between the entry recesses 255 is larger than the distance between the posts 219 when the arms 214 of the clip 200 are not flexed.
  • the clinician flexes the arms 214 outward, loading the resilient arms 214 and permitting the posts 219 to enter the channels 254 at the entry recesses 255.
  • the arms 214 flex inward to their natural resting condition, moving the posts 219 in the channels 254 away from the entry recesses 255.
  • the clip 200 will not separate from the pump 250 until the clinician flexes the arms 214 outward and upward, permitting the posts 219 to leave the channels 254 at the entry recesses 255.
  • the pump 250 can be provided with the clip 200 already positioned in the channels 254, and thus already captured by the pump 250, to streamline the implantation procedure.
  • a first portion 260 of the channels 254 curves outward about the cannula 150 to spread the arms 214, permitting the arms 2.14 to extend about the cannula 150 and the linking member 124 of the cuff 120.
  • a second portion 262 of the channels 254 curves inward toward the cannula 150, moving the arms 214 inward about the cannula 150.
  • the guide rails 212 of the clip 200 enter the slots 252, and the posts 219 are captured in the channels 254.
  • the clip 200 travels in a generally linear direction relative to the pump 250, in the direction of arrow 1;, until the clip 200 reaches the position of Fig. 14C.
  • the force in the direction of arro Ij causes the posts 219 to deflect outward in the channels 254.
  • the insertion force required in the direction of arrow 1; lessens as the inward deflection force of the arms 214 drive the clip 200 through the second portion 262 of the channels 254.
  • the clip 200 travels linearly as the posts 219 travel through the channels 254, until the position of Fig, 14C is reached in which the arms 214 are in their relaxed position.
  • the clip 200 is retracted in a direction opposite the arrow l ⁇ , and the posts 219 travel in the opposite direction through the channels 254.
  • the second portion 262 expands the arms 214 and the first poriion 260 permits the arms 214 to become closer together.
  • the angle of the first portion 260 is less steep than the angle of the second portion 262, which results in the force to remove the clip 200 being higher than the force to move the clip 200 into the locking position.
  • a clinician moves the pump 250 and the cannula 150 relative to the cuff 120, in the direction of arrow B, so that the proximal portion 152 enters the opening 130 of the cuff 120.
  • the first circumferential taper 156 deflects the extensions 136 away from the cannula 150.
  • the first circumferential taper 156 and the second circumferential taper 158 advance past the tapered portions 138 of the extensions 136.
  • the deflected extensions 136 straighten, forcing the tapered portions 138 into the circumferential groove 160.
  • the clinician experiences tactile feedback, such as a snap-like sensation, that indicates that the cannula 150 is coupled to the cuff 120.
  • the bottom surface 125 of the linking member 124 engages the circumferential flange 162 of the cannula 150.
  • the bottom surface 125 engages a surface of the pump 250 as an alternative to, or in addition to, engaging a portion of the cannula 150.
  • the clinician advances the clip 200 into the pump 250.
  • the guide rails 212 of the clip 200 travel in the slots 252, guiding the clip 200 as it travels linearly in a plane abo ve the top side 256, in the direction of arro I 2 .
  • the arms 214 flex laterally due to engagement of the posts 219 with the angled walls 257, 258 defining the channels 254.
  • the arms 214 move laterally outward to admit the linking member 124 and then laterally inward to engage the linking member 124,
  • the clip 200 in its locked position, limits travel of the cuff 120 relative to the cannula 150.
  • the engagement of the posts 219 with the angled walls 257, 258 that define the channels 254 forces the arms 214 inward such that the teeth 216 of the arms 214 are disposed over the flanged portions 146 of the attachment member 126.
  • the flanged portions 146 are captured between the teeth 216 and the circumferential flange 162,
  • the engagement of the teeth 216 to the linking member 124 presses the bottom surface 125 against the circumferential flange 162, forming a seal (Fig. 16).
  • the pump 250 and the cannula 150 are in a position suitable for long-term stability relative to the cuff 120 and the heart. While the clip 200 is in its locked position, an extremely large force is required to remove the cuff 120 from the cannula 150. For example, the force required to forcibly separate the purnp 250 or cannula 150 from the cuff 120 while the clip 200 is in its locked position can be as large as the force required to tear the cuff 120 from the heart.
  • the distance that the cannula 150 extends into a heart can be selected in a similar manner as described above. For example, a cannula 150 with a proximal portion 152 having a particular length can be selected, one or more spacers can be placed between the fastening member 122 and a heart, or the thickness of the fastening member 122 can be selected for a particular patient.
  • an alternate implementation includes a cuff 320 and a cannula 350 configured to cooperate with the pump 250 and the clip 200.
  • the cuff 320 defines an opening 330 that admits a. proximal portion 352 of the cannula 350.
  • A. coupling mechanism in the form of an attachment member 32.6 engages a sealing ring 502 (Fig. 19A), such as an o-ring, disposed about the cannula 350 to couple the cuff 320 to the cannula 350.
  • the clip 200 (Fig. 13 A) acts as a locking mechanism to impede the cuff 320 from becoming uncoupled from the cannul 350.
  • the cuff 320 includes an annular fastening member 322. that a clinician can fasten to heart tissue.
  • the fastening member 322 can be formed of a fabric such as PTFE felt.
  • the cuff 320 includes a linking member 324 coupled to the fastening member 322, for example, by sutures or direct molding.
  • the linking member 324 is formed of, for example, an elastomer such as silicone.
  • the linking member 324 includes a reinforcement member 325 (Fig. 18B), such as a mesh ring.
  • the linliing member 324 couples the attachment member 326 to the fastening member 322, as described below.
  • the linking member 324 includes a bottom surface 328 that engages a circumferential flange 362 of the cannula 350,
  • the primary- sealing mechanism between the cuff 320 and the cannula 350 is the sealing ring 502, and as a result, the linking member 324 and the circumferential flange 362 are not required to form a seal. Nevertheless, in some implementations, the linking member 324 may form a secondary seal with the circumferential flange 362.
  • the bottom surface 328 engages a surface of the pump 250 as an alternative to, or in addition to, engaging a portion of the cannula 350.
  • the cannula 350 includes the proximal portion 352, the circumferential flange 362, and a distal portion 354 housed within the pump 250.
  • the cannula 350 includes a circumferential taper 356 that engages a circumferential taper 405 of the attachment member 326, guiding the cuff 320 into alignment with the cannula 350,
  • the cannula 350 defines a circumferential groove 360 between a fsrst circumferential ridge 358 and a second circumferenti l ridge 359.
  • the circumferential groove 360 receives the sealing ring 502.
  • the attachment member 326 is formed of, for example, a rigid material such as metal or PEEK.
  • the attachment member 326 includes a cylindrical portion 402, which defines an inner circumferential groo ve 404 that admits a portion of the sealing ring 502.
  • the sealing ring 502 is formed of, for example, an elastomer such as silicone or implantable-grade ethylene propylene diene monomer (EPDM).
  • EPDM implantable-grade ethylene propylene diene monomer
  • the attachment member 326 does not define an inner circumferential groove 404 and instead has a substantially cylindrical inner surface.
  • the attachment member 326 includes a flanged portion 406, for example, a circumferential flange that extends in a plane generally perpendicular to an outer wall 403 of the cylindrical portion 402.
  • the attachment member 326 includes the inner circumferential taper 405 that engages the sealing ring 502, compressing the sealing ring 502 and permitting the sealing ring 502 to enter the inner circumferential groo ve 404.
  • the linking member 324 is molded o ver the attachment member 326, and the flanged portion 406 and the cylindrical portion 402 define holes 407 that admit material of the linking member 324.
  • the material of the linking member 324 that extends through the holes 407 forms mechanical locks that couple the linking member 32.4 to the attachment member 32.6.
  • the linking member 324 is molded over an inner circumferential wall 408 and an outer circumferential surface 410 of the cylindrical portion 402, as well as a top surface 412, a bottom surface 414, and a circumferential side surface 416 of the flanged portion 406.
  • the sealing ring 502 is disposed in the circumferential groove 360.
  • the clinician moves the proximal portion 352 through the opening 330 of the cuff 320.
  • the sealing ring 502 engages the circumferential taper 405 of the attachment member 326, compressing the sealing ring 502 into the circumferential groove 360.
  • the sealing ring 502 advances past the circumferential taper 405 to the position of Fig. 19B.
  • the sealing ring 502 expands into the circumferential groo v e 404 of the attachment member 326 and the bottom surface 328 of the linking member 32.4 engages the circumferential flange 362,
  • the sealing ring 502 is partially disposed in the circumferential groove 404 and partially disposed in the circumferential groove 360 of the cannula 350.
  • the engagement of the sealing ring 502 between the cuff 320 and the cannula 350 limits travel of the cannula 350 relative to the cuff 320, coupling the cannula 350 to the cuff 320.
  • the expansion of the sealing ring 502 into the circumferential groove 404 provides snap- like tactile feedback to the clinician, indicating that the cannula 350 is coupled to the cuff 320.
  • the sealing ring 502 also creates a hemostatic seal between the cannula 350 and the cuff 320.
  • the distance that the cannula 350 extends into a heart can be selected in a similar manner as described above. For example, a cannula 350 with a proximal portion 352 having a particular length can be selected, one or more spacers can be placed between the fastening member 322 and a heart, or the thickness of the fastening member 322 can be selected for a particular patient.
  • an alternate implementation includes a cuff 620 that couples to a cannula 650 of a pump 750.
  • the cuff 620 defines an opening 630 that admits a proximal portion 652 of the cannula 650.
  • a coupling mechanism in the form of an attachment member 626 engages a sealing ring 802 (Fig. 23B), for example, an o-ring disposed about the cannula 650, to couple the cuff 620 to the cannula 650.
  • a clip 700 (Fig. 25A) acts as a locking mechanism to impede the cuff 620 from becoming uncoupled from the cannula 650.
  • the cuff 620 can be coupled to the pump 750 with a low profile, for example, in a distance from a heart that is approximately the height of the cuff 620 along the cannula 650.
  • the cuff 620 is coupled to the pump 750 by moving the cannula 650 axially through the cuff 620.
  • the locking mechanism for example, the clip 700, can then be engaged to secure the position of the cuff 62.0 about the cannula 650. Similar to the cam 28 and the clip 200, the clip 700 moves into a locked position by moving in a plane perpendicular to a cannula, which facilitates attachment of the cuff 620 to the pump 750 in the low profile.
  • the cuff 620 includes an annular fastening member 622 that a clinician can fasten to heart tissue.
  • the fastening member 622 can be formed of a fabric such as PTFE felt.
  • the cuff 620 includes a linking member 624 coupled to the fastening member 622, for example, by sutures or direct molding.
  • the linking member 624 is formed of, for example, an elastomer such as silicone.
  • the linking member 624 includes a reinforcement member 625 (Fig. 22D), such as a mesh ring.
  • the linking member 624 couples the attachment member 626 to the fastening member 622, as described below.
  • the linking member 624 includes a bottom surface 628 that engages a circumferential flange 662 (Fig. 23B) of the cannula 650.
  • the primary sealing mechanism between the cuff 620 and the cannula 650 is the sealing ring 802, and as a result, the linking member 624 need not form a seal about the cannula 650.
  • the linking member 624 may form a secondary seal through engagement with the circumferential flange 662.
  • the bottom surface 628 engages a surface of the pump 750 as an alternative to, or in addition to, engaging a portion of the cannula 650.
  • the linking member 624 defines a circumferential groove 632 in the outer diameter of the cuff 620, located between the fastening member 622 and a flanged portion 634 of the linking member 624.
  • the circumferential groove 632 receives a portion of the clip 700 to secure the cuff 620 to the pump 750, as described further below.
  • the linking member 624 includes ridges 636 in the circumferential groove 632, for example, disposed on the flanged portion 634.
  • the ridges 636 are spaced apart and extend approximately halfway along the height, H 2 , of the circumferential groove 632.
  • the attachment member 626 is formed of, for example, a rigid material such as metal or PEEK.
  • the attachment member 626 includes a cylindrical portion 640 that has an outer wall 644 and an inner surface 642 that engages the sealing ring 802.
  • the attachment member 626 includes a flanged portion 646, for example, a circumferential flange that extends in a plane generally perpendicular to the outer wall 644.
  • the linking member 624 is molded over the attachment member 626.
  • the flanged portion 646 and the cylindrical portion 640 define holes 647 that admit material of the linking member 624.
  • the material of the linking member 624 that extends through the holes 647 forms mechanical locks that couple the linking member 624 to the attachment member 626.
  • the linking member 624 is molded over an inner circumferential wall 648, which can have a larger inner diameter than the rest of the cylindrical portion 640.
  • the Jinking member 624 is also molded over an outer circumferential surface 610 of the cylindrical portion 640, as well as a top surface 612, a bottom surface 614, and a circumferential side surface 616 of the flanged portion 646.
  • the inner surface 642 of the attachment member 626 remains exposed.
  • the cannula 650 includes the proximal portion 652, the circumferential flange 662, and a distal portion 654 housed within the pump 750.
  • the cannula 650 includes a circumferential taper 656 that engages the attachment member 626, guiding the cuff 620 into alignment with the cannula 650,
  • the cannula 650 defines a circumferent al groove 660 between a fsrst circumferential ridge 658 and a second circumferential ridge 659
  • the sealing ring 802 is disposed in the circumterential groove 660 and is formed of, for example, an elastomer such as silicone or implantable-grade EPDM.
  • the clinician moves the proximal portion 652. through the opening 630 of the cuff 620 (Fig. 23A).
  • the sealing ring 802. engages the inner surface 642 of the attachment member 626, compressing the sealing ring 802 into the circum erential groove 660 (Fig. 23B).
  • the engagement of the sealing ring 802 wi th the inner surface 642 and the engagement of the bottom surface 628 with the circumferential flange 662 provide tactile feedback to the clinician that the appropriate position has been achieved.
  • the engagement of the sealing ring 802 between the cuff 620 and the cannula 650 limits travel of the cannula 650 relative to the cuff 620, coupling the cannula 650 to the cuff 620.
  • the compression of the sealing ring 802 between the cuff 620 and the cannula 650 also creates a hemostatic seal between the cannula 650 and the cuff 620. From the position shown in Fig. 23B, the clinician can move the clip 700 into a locked position about the cuff 62.0 to secure the cuff 620 about the cannula 650, as described further below.
  • the sealing ring 802. has a cross-section 810 that is substantially trapezoidal.
  • the force required to insert the cannula 650 into the cuff 620 using the sealing ring 802 is typically smaller than the force required to insert the cannula 650 using a sealing ring that has a round cross-section and a similar cross- sectional width, in some instances, a lower insertion force is desirable to facilitate installation of the cannula 650 relative to the implanted cuff 620.
  • the cross-section 810 has an inner side 81 1, and outer side 812, a top side 813, and a bottom side 814. Adjacent sides 81 1 , 812, 813, 814 are connected by- rounded corners 815.
  • the inner side 81 1 faces toward the cannula 650 and is substantially flat. As a result, the inner surface of the sealing ring 810 is substantially cylindrical.
  • the top side 813 faces away from the pump 750, and the bottom side 814 faces toward the pump 750.
  • the top side 813 and the bottom side 814 are substantially parallel to each other, for example, both sides 813, 814 are substantially perpendicular to the inner side 81 1.
  • the top side 813 and the bottom side 814 have different lengths.
  • the length, Li, of the top side 813 can be, for example, between one-fourth and three-fourths of the length, L 2 , of the bottom side 814.
  • the length, Li, of the top side 813 can be approximately half or approximately two-thirds of the length, L?, of the bottom side 814.
  • the outer side 812 is angled, for example, forming substantially straight angled edge.
  • an alternative sealing ring has a cross-section 860.
  • the cross-section 860 includes an upper portion 862 and a lower portion 864, connected by a narrow neck 866.
  • the sealing ring 850 thus includes two stacked discs, connected by an annular band.
  • the cross-section 860 includes outer sides 870 engage the inner surface 642 of the cuff 620, and inner sides 872. that engage the cannula 650 in the circumferential groove 660.
  • the clip 700 cooperates with features of the pump 750, described below, to limit movement of the cuff 620 (not shown) relative to the cannula 650.
  • the clip 700 has an unlocked position, in which the cuff 620 can be coupled about the cannula 650.
  • the clip 700 also has a locked position, in which the clip 700 secures the cuff 620 relative to the cannula 650.
  • a component such as a motor housing 753 or an element attached to the motor housing 753, provides an upper surface 752 that defines channels 754,
  • the clip 700 includes arms 714 that extend into the channels 754 and travel along the channels 754 as the clip 700 moves into its locked position.
  • the pump 750 captures the clip 700 between the upper surface 752 and a cover 770.
  • the cover 770 is attached over the upper surface 752 by, for example, screws 772. or welds.
  • the upper surface 752 and the cover 770 define a slot 740 for the clip 700 to travel within.
  • the slot 740 permits the clip 700 to travel in a plane, for example, to travel in a linear direction, A, in a plane perpendicular to a longitudinal axis, Y, of the cannula 650.
  • the clip 700 includes a top side 702 that faces the cover 770, a bottom side 704 that faces the upper surface 752, and opposite lateral sides 706, 708.
  • the clip 700 can be formed of, for example, metal, such as titanium, or a rigid plastic, such as PEEK.
  • the clip 700 includes guide rails 712 and defines a recess or opening 715.
  • the guide rails 712 stabilize the clip 700 laterally and guide me clip 700 through a linear motion in the slot 740.
  • the opening 715 admiis a tool or a finger of the clinician to facilitate retrac tion of the clip 700.
  • the arms 714 of the clip 700 are curv ed and define an opening 720.
  • the arms 714 are resilient and can deflect laterally to capture the cuff 620.
  • Each arm 714 includes a post 719 that extends from the bottom side 704 of the clip 700.
  • Each post 719 is received in one of the channels 754 (Fig. 25B) defined in the upper surface 752.
  • the posts 719 are substantially cylindrical and extend perpendicular to, for example, a plane defined along the top side 702. of the clip 700. When the clip 700 is located in the slot 740, the posts 719 extend substantially parallel to the longitudinal axis, Y, of the cannula 650. As the clip 700 moves relative to the pump 750, the posts 719 travel through the channels 754.
  • the arms 714 In the locked position of the clip 700, the arms 714 extend about the cuff 620 and extend into the circumferential groove 632.
  • the arms 714 have a substantially smooth inner surface 722 that engages the linking member 62.4 in the circumferential groove 632.
  • the arms 714 also include teeth 716 (Fig. 26B) that fit between the ridges 636 to limit rotation of the cuff 620 relative to the clip 700,
  • the teeth 716 can be disposed on the arms 714 and on a central extension 724 of the clip 700.
  • Three teeth 716 are shown, positioned to press radially inward on the cuff 620 when the clip 700 is in its locked position. More teeth or fewer than three teeth can be used to promote rotational stability of the cuff 620.
  • the teeth 716 have an angled or chamfered edge 726 (Fig. 26D), permitting the teeth 716 to engage the cuff 620 when the cuff 620 is not fully seated against the circumferential flange 662.
  • the chamfered edge 726 engages the flanged portion 634 of the cuff 620, forcing the cuff 620 toward the upper surface 752 into a fully seated position against the circumferential groove
  • the clip 700 includes substantially flat end portions 730 that are captured between the upper surface 752 and the cover 770.
  • the cover 770 impedes the end portions 730 from moving away from the surface 752, and thus holds the posts 719 in the channels 754. Engagement of the end portions 730 between the upper surface 752 and the cover 770 also limits twisting along the arms 714 in response to axial loads exerted along the arms 714.
  • the end portions 730, the teeth 716, and stabilizing posts 732 on the arms 714 can each have a height, H 2 , along the longitudinal axis, Y, that is substantially the same as a corresponding height of the slot 740, thereby limiting travel of the clip 700 along the longitudinal axis and limiting tilting of the clip 700 within the slot 740.
  • the clip 700 includes a latch 733 that engages the cover 770 to limit retraction of the clip 700 from the locked position.
  • the latch 733 includes a deflection beam 737 and an extension 738 located on a free end 739 of the deflection beam 737.
  • the extension 738 extends from the top side 702 of the clip 700,
  • the deflection beam 737 provides a resilient force that holds the extension 738 in a mating receptacle of, for example, the cover 770, unless overcome by a sufficient force.
  • the clip 700 includes ramp features 735 that extend from the bottom side 704.
  • the ramp features 735 wedge the clip 700 between the cover 770 and the upper surface 752, stabilizing the clip 700 along the longitudinal axis, Y, of the cannula 650 when the clip 700 is in the locked position.
  • the ramp features 735 By forcing the top side 702 toward the co ver 770, the ramp features 735 also force engagement of the latch 733 to the mating receptacle.
  • the clip 700 includes visual indicators 736 on the bottom side 704 that indicate when the clip 700 is out of the locked position.
  • the visual indicators 736 are, for example, recesses containing a colored material that is easily noticeable by a clinician.
  • the visual indicators 736 are exposed, and thus visible from the bottom of the pump 750, when the clip 700 is not in the locked position.
  • the visual indicators 736 are obscured when the clip 700 is in the locked position,
  • the channels 754 in the surface 752 direct travel of the arms 714 as the clip 700 moves in the slot 740.
  • the posts 719 move through the channels 754.
  • the channels 754 have a width, W 3 ⁇ 4 that is larger than a diameter of the posts 719, which permits different lateral positions of the posts 719 in the channels 754, As described further below, the width, W 2 , permits the posts 719 travel along different paths in the channels 754, rather than being constrained to travel along a single path.
  • the channels 754 are defined by inner wails 760 and outer wails 762.
  • a lateral distance, D, between the inner walls 760 is greater than a distance between the posts 719 when the arms 714 are not flexed.
  • positioning the posts 719 in the channels 754 flexes the arms 714 away from each other, causing the arms 714 to exert a resilient inward force against the inner walls 760.
  • the posts 719 slide along the inner walls 760 unless displaced by, for example, the cuff 620.
  • the channels 754 define features that receive the posts 719.
  • Each channel 754 defines, for example, a first end 764, a second end 765, and a detent 766, each of which can receive one of the posts 719.
  • the posts 719 reside in the first ends 764 in an unlocked position of the clip 700, for example, when the clip 700 is fully retracted. At the first ends 764, the posts 719 engage the walls to impede the clip 700 from separating from the pump 750 by sliding out of the slot 740 along arrow A.
  • the posts 719 reside in the second ends 765 when the clip 700 is in the locked position.
  • the posts 719 reside in the detents 766 when the clip 700 is in a restrained position, for example, in which engagement of the posts 719 in the detents 766 impedes the clip 700 from travelling further toward the locked position.
  • the unlocked position, the locked position, and the restrained position are stable positions of the clip 700 within the slot 740.
  • each post 719 travels along a path 767 between the second end 765 and the first end 764.
  • the pump 750 can be provided to a clinician with the clip 700 in the locked position, with the posts 719 residing in the second ends 765.
  • the arms 714 are in a relaxed state in the locked position. The clinician retracts the clip 700 to permit the cannula 650 to be coupled to the cuff 620.
  • the clip 700 enters the restrained position when the cuff 620 is not properly coupled to the cannula 650, for example, when the cuff 620 is not located about the cannula 650 or the cuff 620 is improperly placed about the cannula 650.
  • the placement of the clip 700 in the restrained discourages premature locking of the clip 700 and indicates to the clinician that the cuff 620 is not properly placed about the cannula 650, Patient safety is enhanced because the clip 700 does not enter the locked position if doing so would not actually secure the cuff 620 to the pump 750.
  • the clip 700 can enter the restrained position when only one of the posts 719 engages one of the detents 766. Either post 719 can independently impede the clip 700 from entering the locked position.
  • the cuff 620 may be seated only partially against the circumferential flange 662. For example, the cuff 620 may be placed in a tilted orientation such that the cuff 620 is not aligned in a plane perpendicular to the cannula 650. With the cuff 620 partially seated, one of the posts 719 may avoid the detent 766. Engagement of the other post 719 with its corresponding detent 766, however, will place the clip 700 in the restrained position rather than permitting the clip 700 to enter the locked position.
  • the flanged portions 634, 646 of the cuff 620 cover the detents 766.
  • the cuff 620 blocks the posts 719 from entering the detents 766 and permits the posts 719 to enter the second ends 765.
  • the posts 719 move along a path 769.
  • the posts 719 slide along the outer circumference of the flanged portion 646, engaged to the cuff 620 by the resilient force of the arms 714, until the posts 719 reach the second ends 765.
  • the arms 714 (not shown) extend into the circumferential groove 632, capturing the flanged portions 634, 646 between the arms 714 and the circumferential flange 662 of the cannula 650.
  • the teeth 716 extend radially inward into the circumferential groove 632, becoming enmeshed between the ridges 636 to limit rotation of the cuff 620 relative to the cannula 650.
  • Figs. 29A and 29B when a clinician installs the pump 750, the visual indicators 736 on the clip 700 are exposed to the clinician's view.
  • the visual indicators 736 indicate that the clip 700 is not securing the cuff 620, and thus that installation is incomplete.
  • the visual indicators 736 are exposed in the unlocked position (Fig. 29A) and in the restrained position (Fig. 29B).
  • the cover 770 defines a mating receptacle 774, for example, a recess or an opening, that cooperates with the latch 733.
  • the latch 733 does not secure the position of the clip 700 in the unlocked position (Fig. 30A) or the restrained position (Fig. SOB).
  • the extension 738 extends into the mating receptacle 774 to impede retraction of the clip 700 in the direction of the arrow R.
  • the extension 738 includes an angled leading edge 742 and an angled trailing edge 744 that engage the cover 770.
  • the leading edge 742 engages an outer edge 746 of the cover 770 as the clip 700 travels into the locked position.
  • the engagement of the leading edge 742 with the outer edge 746 deflects the deflection beam 737, permitting the extension 738 to slide under the outer edge 746 and into the mating receptacle 774.
  • the trailing edge 744 engages an inner surface 748 of the mating receptacle 774 to limit removal of the clip 700.
  • the trailing edge 742 has a steeper slope than the leading edge 742.
  • the trailing edge 742 can have a slope of between approximately 70 degrees and approximately 85 degrees, and the leading edge can have a slope of between approximately 10 degrees to approximately 60 degrees.
  • the amount of force required to dislodge the extension 738 from the mating receptacle 774 is greater than the force required to insert the extension into the mating receptacle 774,
  • a clinician can engage a tool with the deflection beam 737 to move the extension 738 out of the mating receptacle 774, which permits the clip 700 to be retracted.
  • a plug can be fabricated for a cuff 20, 120, 320, 620.
  • a plug can be placed in the opening 30, 130, 330, 630 of an implanted cuff 20, 120, 320, 620 after a pump 12, 250, 750 has been expianted.
  • the plug can fill the opening 30, 130, 330, 630 to prevent blood from escaping through the cuff 20, 120, 320, 62.0 after the pump 12, 250, 750 is removed.
  • Plugs can include features similar to those described for the cannulas 50, 150, 350, 650.
  • a plug can be coupled to a corresponding cuff 20, 120, 320, 620 using one or more of the same mechanisms that couple a cuff 20, 120, 320, 620 to a cannula 50, 150, 350, 650, A.
  • plug can be further secured to a heart or to a cuff 20, 120, 320, 620 by sutures.
  • a plug may further be configured to fill the opening through any of ihe further cuffs described below.
  • a ventricular assist system 9.10 for treating, for example, a patient with a weakened left ventricle includes a blood pump 912 that receives blood from a patient's heart 914.
  • the pump 912 is coupled to a cuff 920, which in turn is attached to the heart 914.
  • the cuff 920 is attached to the heart 14 by, for example, sutures that attach a portion of the cuff 920 to the apex of the left ventricle of ihe heart 914,
  • the pump 912 receives blood from ihe heart through an inflow cannula 950 (Fig. 33) of the pump 912 disposed through an opening 922 (Fig. 33) in the cuff 920.
  • the ventricular assist system 910 may be implanted in ihe thoracic cavity of a patient.
  • the cuff 920 limits the risk of inflow cannula malposition due to potential post-operative pump migration. Inflow cannula malposition is an adverse clinical event that may reduce pump performance and endanger the patient.
  • the cuff 920 helps maintain a space around the inflow cannula 950 so that the inflow cannula 950 does not become partially or completely occluded by surfaces of the heart (e.g., by the septal wail of the heart).
  • the cuff 920 is sufficiently stiff to promote flattening of the myocardium when the sewing ring is atiached to the heart 914.
  • the rigidity or resilience of the cuff 920 reshapes the myocardium in a manner that the geometry of the myocardium in the region of the cuff 920 is flatter than the natural or previous geometry of the myocardium.
  • the cuff 920 can exert a resilient force that resists bending of the cuff 920 and flattens an area of the myocardium in contact with the cuff 920.
  • the cuff 920 also aids installation of the pump 912
  • Exemplary cuff 920 is relatively rigid and has a higher bending resistance to bending than conventional ventricular cuffs.
  • the relatively increased stiffness of the cuff 920 permits a clinician to hold the cuff 920 (e.g., at outer edges of the cuff 920) and apply counter-pressure with the cuff 920 against the inflow cannula 950 during installation of the pump 912.
  • the pump 912 includes anchors 960, such as eyelets or other openings defined in the housing 964, where sutures 962 or other fasteners can attach to the pump 912.
  • the sutures 962 secure the pump 912 to, for example, the cuff 920, the myocardium of the heart 914, ribs of the patient, or other structures.
  • the sutures 962 limit rotation of the pump 912. relative to the heart 914 and other movement of the pump 912 relative to the heart 914, Securing the pump 912 using the anchors 960 and flattening the myocardium in the region of the pump 912 help limit the risk of inflow cannula malposition, as discussed further below.
  • the cuff 920 includes an attachment component such as a ring 1010 that engages the inflow cannula 950 and/or other portions of the pump 912 to secure the cuff 920 and pump 912 together.
  • the ring 1010 is formed by a patterned metal component (e.g. titanium) covered with, for example, silicone.
  • the ring 1010 may include, for example, an attachment member (having one or more features of any of the attachment members 26, 126, 326, 626), and a linking member (having one or more features of any of the linking members 24, 124, 324, 624).
  • the cuff 920 is secured to the pump 912 using the techniques described above.
  • the cuff 920 may be coupled to and locked to the pump 912 in the same manner that any of the cuffs 20, 120, 320, 62.0 are locked and coupled to the pumps 12, 2.50, 750.
  • a clinician may lock the cuff 920 to the pump 912 using any of the locking mechanisms described above, such as using the clips 200, 700.
  • the cuff 920 includes two disc-shaped layers 1020, 1022, and together, the layers 1020, 1022 form a sewing ring 1025.
  • a clinician places sutures, staples, or other fasteners through the sewing ring 1025 and the heart 914. In some implementations, only one disc or more than two discs are included in the sewing ring 1025.
  • the layers 1020, 1022 are formed of, for example, a felt, a mesh, a woven material, or another fabric.
  • the layers 1020, 1022 are formed of
  • the layers 1020, 102.2 are each formed of PTFE felt. In some implementations, the layers 1020, 1022 are each formed of a woven polyester.
  • the layers 102.0, 1022 are joined together by sutures, for example, sutures at the inner diameter and outer diameter of the layers 1020, 1022. In some embodiments, sutures at the inner diameter and outer diameter of the layers 1020, 1022.
  • the layers 1020, 1022 are additionally or alternatively joined by an adhesive, such as a silicone adhesive, or another fastener.
  • the layers 1020, 1022 have a stiffness that tends to flatten the myocardium of the heart 914 when the cuff 920 is installed. This flattening reduces the probability of inflow cannula malposition. As an additional advantage, in some implementations, the stiffness of the layers 1020, 1022 (and of the sewing ring 1025 as a whole) makes the cuff 920 easier for the clinician to hold.
  • the relative stiffness of the cuff 920 may aid a clinician in pressing the cuff 92.0 against the pump 912 when attaching the pump 912 and the cuff 920, For example, the clinician may more easily apply a counterforce against the pump 912 when the inflow cannula 950 is inserted into the cuff 920, permitting the cuff 920 to be more easily seated against the pump 912.
  • the sewing ring 1025 has a flexural modulus of greater than 50 psi (pound-force per square inch). In some implementations, the flexural modulus of the sewing ring 1025 is at least 60 psi, at least 75 psi, at least 90 psi, at least 100 psi, at least 125 psi, or at least 150 psi. The sewing ring 1025 may- have a flexural modulus in one of these ranges along a portion of, a majority of, or substantially all of the sewing ring 1025, In some implementations, the sewing ring 1025 has a flexural modulus in one of the ranges indicated above across the entire diameter of the sewing ring.
  • the flexural modulus of the sewing ring 1025 is, for example, less than 1500 psi, less than 1000 psi, or less than 750 psi.
  • a flexural modulus under one of these ranges can facilitate insertion of a needle through the sewing ring 1025 without requiring an excessive amount of insertion force.
  • the fabric of the layers 1020, 1022 can provide the rigidity that causes the sewing ring 1025 to have a flexural modulus in these ranges, without any additional component formed of, for example, metal or polymer. Because the sewing ring 1025 is fabric, in some implementations, a clinician is able to insert a needle through any exposed portion the sewing ring 1025 without the needle being impeded by structures of the sewing ring 1025. In some implementations, another component in the sewing ring 1025, such as the insert 1030 described below, can contribute to the rigidity of the sewing ring 1025, so that the sewing ring 1025 as a whole has a flexural modulus in one of the ranges indicated above.
  • one or more of the layers 1020, 1022 individually has a flexural modulus of greater than 50 psi, for example, a flexural modulus at feast 60 psi, at least 75 psi, at least 90 psi, at least 100 psi, at least 125 psi, or at least 150 psi.
  • the flexural modulus of each of the layers 1020, 1022. can be, for example, less than 1500 psi, less than 1000 psi, or less than 750 psi.
  • the sewing ring 1025 includes only a single layer of fabric or other material that provides a flexural modulus in the ranges indicated above,
  • the cuff 920 may be installed at the heart 914.
  • a clinician or a tool holds the cuff 920 by the ring 1010 and/or the sewing ring 1025 as the pump 912 is subsequently positioned relative to the cuff 920.
  • a tool or the clinician's fingers may grasp the cuff 920 by pressing against the outer edges of the sewing ring 1025.
  • the clinician moves the pump 912 toward the cuff 920 in the direction of arrow A.
  • a coupling mechanism attaches the cuff 920 to the pump 912.
  • the cuff 920 may be required to provide a particular amount of counterforce for the pump 912 to become coupled to the cuff 920.
  • the cuff 920 held by the clinician's fingers or a tool, provides counterforce in the direction of arrow B, to permitting the coupling mechanism to engage.
  • the sewing ring 1025 may be sufficiently rigid that, while the cuff 920 is held through inward force from the outer edges of the sewing ring 1025, the sewing ring 1025 does not buckle or deform, and the cuff 920 exerts a sufficient amount of force against the pump 912 that a coupling mechanism the pump 912 and the cuff 920.
  • the layers 1020, 1022 each have a thickness of between approximately 1.3 mm and 2.3 mm, or approximately 1.8 mm, and may have a maximum water permeability of between approximately 450 ml/cm2/min and 650 ml/cm2/min, or approximately 550 ml/cm7min. Accordingly the use of two such layers 1020, 1022 together in the sewing ring 1025 provides a higher stiffness than a single layer of lower density, higher porosity PTFE felt, for example, a single layer having a thickness of approximately 2.9 mm and a maximum water permeability of approximately 750 ml/cm /min.
  • a high-density, low-porosity felt material for the layers 1020, 1022 may be obiained by compressing a lower density felt material, (such as compressing the
  • an insert 1030 such as a lattice or web of a firm or resilient material, is included in the sewing ring 1025, forming a sewing ring 1025a (Fig. 34D).
  • the insert 1030 is generally planar.
  • the insert 1030 may be positioned between the layers 1020, 102.2, and may be formed of a material stiffer than the material of the layers 1020, 102.2.
  • the insert 1030 may be formed of polyether ether ketone (PEEK), titanium, a cobalt chromium alloy, a shape-memory polymer, or another material
  • PEEK polyether ether ketone
  • the insert 1030 can be molded, machined, printed, stamped, formed of wire, laser cut from a metal sheet, or formed in another manner.
  • the insert is formed of a super-elastic material such as titanium alloy (e.g. nickel-titanium alloy).
  • the insert 1030 retains its shape when bent, permitting a clinician to manually shape the sewing ring 102.5a as desired for a particular implantation (e.g., shaping the sewing ring 1025a with one bent edge, in a conical shape, etc.). After implantation, the sewing ring 1025a shapes the myocardium to substantially conform to the shape of the sewing ring 1025a, [8261]
  • the insert 1030 defines windows or openings 1032 through the insert 1030. The openings 1032 define areas where sutures may be placed through the insert 1030 to achieve hemostasis.
  • the insert 1030 may be formed as, for example, a web, lattice, or mesh that defines the openings 1032, thereby providing regions where needles can pass through unimpeded while providing strength and stiffness across substantially the entire sewing ring 1025.
  • sutures can be inserted without interference from, for example, extensions or supports 1034 that extend radially, connecting an inner ring 1036 and an outer ring 1038 of the insert 1030.
  • the insert 1030 may be co vered in silicone or another material.
  • the insert 1030 may be embedded within in a sheet of silicone, with the silicone covering the openings 1032.
  • the insert 1030 includes one or more anchors 1040 located at the outer edge of the insert 1030.
  • the anchors 1040 are openings defined in the insert 1030 through which sutures may be placed to secure the cuff 920 to the myocardium.
  • the insert 1030 has a flexural modulus of greater than 50 psi, for example, a flexural modulus at least 60 psi, at least 75 psi, at least 90 psi, at least 100 psi, at least 125 psi, or at least 150 psi.
  • the sewing ring 1025a as a whole has a flexural modulus in one of these ranges.
  • some ventricular cuffs provide a flexible interface that allows myocardial tissue to be free from restriction after implantation.
  • a pump 1108 is attached to a heart 1 114 using a cuff 1110.
  • the cuff 1110 is compliant and conforms to the shape of a heart 1114 to which the cuff 1110 is attached.
  • the pump 1108 includes an inflow cannula 1130 that extends into a space 1120 within the heart 1114.
  • the space 1120 in which the inflow cannula 1130 resides is primarily defined by the natural geometiy of the heart 11 14.
  • a distance, D i, between the inflow cannula 1130 may change as the patient moves (e.g., as the pump 1108 tilts, twists, or otherwise moves relative to the heart 1114.
  • the stiffness of the cuff 920 substantially flattens the myocardium, which expands a space 917 around the inflow cannula 950 and helps maintain an appropriate distance, D 2 , between the inflow cannula 950 and inner walls 913 of the ventricle. This, in turn, reduces the potential for inflow cannula malposition because of the expanded space 1000 within the ventricle created near the inflow cannula 950. Malpositioning is associated with several risks including decreased pump poor performance and adverse clinical events. If the cannula inflow gets close to or contacts internal structures (e.g. the septum or ventricular walls), the inflo may become partially or completely occluded.
  • malpositioning of the inflow near internal structures can alter flow patterns and even form regions of stasis. Accordingly, malpositioning may increase the risk of hemolysis and thrombosis.
  • the myocardium By making interface of the cuff 920 and pump 912 with the heart 914 (e.g., myocardium) stiffer, the myocardium can be flattened and clinical outcomes can be improved.
  • a clinician attaches the cuff 920 to the heart 914 using sutures 940 placed at or near the outer edge of the sewing ring 1025, permitting the cuff 920 to substantially flatten the myocardium across substantially the entire region of the myocardium that engages the cuff 920.
  • flattening the myocardium may limit inflow cannula malposition or reduce the risk of occlusion of the inlet tip of the inflow cannula 950 in the event of malposition.
  • the stiffness of the cuff 920 for example, the stiffness of the sewing ring 1025, may cause the flattening of the myocardium,
  • Sutures anchored to the pump 912 can also promote flattening of the myocardium.
  • sutures 941 may be placed through the sewing ring 1025 and a portion of the pump 912, such as the anchors 960. These sutures 941 can hold the sewing ring 1025 near or against the pump 912, further flattening the myocardium or maintaining the shape defined by the cuff 920.
  • one or more sutures may be placed through an anchor 960 and the myocardium, as shown in Fig. 32, in addition to or instead of through the sewing ring 1025.
  • the sewing ring 1025 when generally perpendicular to the inflow cannula 950, can extend along a majority of the diameter of the pump 912.
  • the sewing ring 1025 can have an outer diameter that is at least 50%, at least 75%, or at least 90% of the outer diameter of the pump 912.
  • the sewing ring 1025 extends along substantially all of a proximal side of the pump 912, extending to an outer peripheral wall 982 of the pump 912.
  • the pump 912 can he secured relative to the heart 914 using one or more of the anchors 960.
  • the pump 912 includes the anchors 960 at locations on the exterior of the pump 912, for example, spaced apart around an outer perimeter 961 of a housing 964 of the pump 912.
  • the outer perimeter 961 is generally circular and represents the circumference of the housing 964.
  • the anchors 960 are spaced apart along at least a portion of the circumference.
  • the anchors 960 may he disposed around more than half of the circumference of the housing 964. in the example shown, the anchors 960 are located around the entire circumference of the pump 912 except in a region 970 where a cuff lock 972 is located.
  • the anchors 960 are spaced apart around the pump 912. at an angle a, which may be, for example, between 10 degrees and 50 degrees, or approximately 30 degrees.
  • the pump 912 includes eight anchors 960, but more or fewer anchors 960 may be included. In some implementations, at least three anchors 960 are included.
  • the anchors 960 include suture eyelets 965 located at an edge of the housing 964.
  • the eyelets 965 are defined to be adjacent to the sewing ring 1025 of the cuff 920 when the pump 912 is implanted.
  • each eyelet 965 has an exit opening adjacent the cuff 920 when the cuff 920 is engaged to the proximal side 994 of the housing 964.
  • a clinician may pass sutures or other fasteners through the eyelets 965.
  • the clinician may also pass the sutures through the cuff 920 and'or the myocardium.
  • Passing the sutures through the cuff 920 and'or myocardium at locations adjacent the anchors 960 may help maintain the cuff 920 in a substantially fiat against a proximal side 994 of the pump 912, ihus flattening the cuff 920 and myocardium.
  • sutures may extend through sewing ring 1025 at or near the outer edge of the sewing ring 1025, pulling the outer edge of the sewing ring 1025 toward (e.g., close to or against) the pump 912.
  • the sutures may connect the anchors 960 to any of various structures located within the thoracic cavity, such as the patient's ribs, a portion of the myocardium (e.g., a portion spaced apart from the cuff), synthetic material such as Gore-Tex, or other structures.
  • the clinician may secure the other end of each suture at a distance from the anchors 960 (e.g., approximately 0.5 cm, 1 cm, 3cm, 5cm, etc.), as selected by the clinician.
  • the anchors 960 do not increase the outer diameter of the pump 912.
  • the features in which the eyelets 965 are defined occupy space in the region where the edge 968 of the pump housing 964 has been cut, e.g., with a radius.
  • the housing 964 has a rounded, chamfered, or beveled edge where no anchors 960 are placed.
  • the eyelets 965 are defined in a motor cap 990, which is part of the housing 964 of the pump 912.
  • the motor cap 990 has a side surface 992 and also has a proximal side 994 oriented perpendicular to the side surface 992.
  • the inflow cannula 950 of the pump 912 extends from ihe proximal side 994, in a direction generally perpendicular to the proximal side 994 (See Fig. 36A).
  • the proximal side 994 faces the cuff 920 when the pump 912 is implanted.
  • Each eyelet 965 defines a passage that angles inward from an outer wall of the pump 912. In some implementations, each eyelet 965 extends toward the inflow cannula 950 in the center of the proximal side 994. The passage extends between an entry opening 996 defined in the side surface 992. and an exii opening 998 defined in the proximal side 994. The passage defined by each eyelet 965 is oriented at an angle ⁇ (Fig. 37C) from the substantially cylindrical peripheral wall 982 (Fig. 36A) of the pump housing 964. In some implementations, the angle ⁇ is between approximately 20 degrees and 50 degrees, or is approximately 35 degrees.
  • each eyelet 965 is oriented to direct a needle travelling through the eyelet 965 into the sewing ring 1025.
  • the eyelets 965 may accommodate a curved needle 980 and may define a curved or linear path through the pump housing 964.
  • the eyelets are designed to accommodate a #1 -0 suture and needle.
  • the diameter of the eyelet 965 may be approximately 0,034 inches,
  • a clinician may selectively fasten the anchors 960 to portions of a patient's anatomy to limit potential for subsequent malposition of the inflow cannula 950. For example, the clinician may select the particular anchors 960 at which to attach sutures according to the needs of the patient. The clinician may attach sutures or other fasteners at fewer than all of the anchors 960, may attach secure different anchors 960 to different tissues or different regions of tissue, and may connect the anchors 960 to locations at different distances from the pump 912 and cuff 920.
  • the pump 912 includes eight anchors 960
  • a clinician may select to secure the pump 912 using only three anchors 960 that are evenly spaced apart around the pump 912, or may select to secure the pump 912 using five of the anchors 960 that are adjacent to each other, or may use another set of the anchors 960.
  • anchors 960 are disposed at portions of the pump housing 964 other than the outer edge of the motor cap 990.
  • anchors 960 may additionally or alternatively be placed on the peripheral wall 982 or other surfaces of the housing 964.
  • an alternative cuff 1200 defines a radial opening 1210.
  • the cuff 1200 includes fasteners 1204 that permit a clinician to close the opening 1202 after the cuff 1200 is placed about the inflow cannula 950 of the pump 912.
  • the fasteners 1204 may be snapped together to capture the inflow cannula 950 in a central opening 1210 defined in the cuff 1200.
  • the cuff 1200 defines, in an outer edge 1212, indentations or recesses 1214 that a tool or clinician's finger may engage to force the fasteners 1204 against each other.
  • a clinician may attach a portion of the cuff 1200 to the heart 914 (e.g., attach the cuff 1200 partially around the
  • the clinician may then mate the pump 912 to the cuff 1200, close the cuff 1200 with the fasteners 1204, and attach the rest of the cuff 1200 to the heart to form a hemostatic seal.
  • a cover 1230 may be placed around the pump 912 during implantation to facilitate later removal of the pump 912. After the pump 912 is implanted, various tissues may adhere to the pump 912 over time. Adhered tissues may make remova l of the pump 912 from the patient's body difficult, since the clinician may need to scrape off or cut off tissues adhered to various surfaces of the pump 912. To limit tissue adhesion and tissue growth on the pump 912, a clinician may surround a portion of or ail of the housing 964 of the pump 912 with the cover 1230. As a result, the cover 1230 forms a pouch or pocket around the pump 912 and acts as a barrier to block tissue adhesion to the pump 912.
  • the cover 12.30 remains implanted with the pump 912. Tissues may adhere to the exterior of the cover 1230, but do not contact the surface of the pump 912.
  • the co ver 1230 unlike the pump 912, may be easily dissected at the time the pump 912 is removed.
  • the cover 1230 is opened and the pump 912. removed from the patient's body.
  • a clinician cuts apart the cover 1230 to access the pump 912. The surgeon may then remove the pump 912, and may also remove the cover 1230.
  • the cover 1230 is formed of a flexible material, for example, one or more layers of a fabric.
  • the cover 1230 may be formed of polyester, PET, PTFE, or another biocompatible material
  • the cover 1230 is part of a cuff 1240 that attaches to the heart 914.
  • the cuff 1240 includes a sewing ring 1241 comprising a fabric layer 1242. formed of, for example, PTFE felt, and a silicone layer 1244.
  • the cover 1230 is attached to the outer edge 1246 of the cuff 1240, for example, along some of or all of the outer circumference of ihe sewing ring 1241.
  • the cover 1230 may be attached to the sewing ring 1241 with, for example, sutures, staples, adhesives or other means.
  • a portion of the cover 1230 may be disposed between the fabric layer 1242 and the silicone layer 1244, or between other layers of the sewing ring 1241.
  • the cover 1230 is shown closed around the pump 912. Before closing the cover 1230, the cover 1230 has an opening 1233 that admits the pump 912 into an interior space 1232 within ihe cover 1230 during implantation. Side walls 1235 of the cover 1230, representing the cover 1230 before being closed, are illustrated in dashed lines. The opening 1233 is located between the side walls 1235.
  • the clinician closes the opening in the cover 1230 to enclose the pump 912.
  • the cover 1230 may be closed using, for example, sutures, staples, adhesives, or other fasteners. Even when the cover 1230 is closed, the cover 1230 defines an opening to allow an outflow conduit and a driveiine cable to exit the cover 1230.
  • a cover is separate from the cuff 1240.
  • a cover may be placed around the pump 912 and then be sutured to the sewing ring 1241 or otherwise secured around the pump 912.
  • the sewing ring 1241 extends radially outward from the inflow cannula 950 to or beyond the outer perimeter 961 of the pump 912. That is, the outer diameter of the sewing ring 1241 can be as large as or larger than the outer diameter of the pump 912 at the proximal side 994. As a result, after the pump 912 is seated against the cuff 1240, the outer edge of the sewing ring 1241 remains exposed and accessible to the clinician. The clinician may then place a cover over the pump 912, and may attach the edge of the cover to the fabric at the exposed regions of the sewing ring 1241 with sutures or another fastener.
  • a portion 1243 of the sewing ring 1241 extends distally, for example, past the proximal side 994 of the pump 912. when the cuff 1240 is seated against the pump 912. In some implementations, the portion 1243 extends around a majority of, or substantially all of, the circumference of the pump 912. The clinician may attach a cover around the pump 1242 by attaching a fabric or other material to the portion 1243.
  • FIG. 40 an example of a process 1300 for implanting the pump 912 is illustrated.
  • the process 1300 describes implantation with an apical approach, but other implantation locations and techniques may be used.
  • a clinician attaches the cuff 920 to a heart (1310).
  • the clinician locates the apex of the left ventricle, and sutures the sewing ring 1025 of the cuff 920 to the myocardium.
  • the cuff 920 can be sufficiently rigid to flatten at least a portion of a myocardium of the heart (e.g., a portion adjacent the cuff) when the cuff 920 is attached to the heart 914.
  • the cuff 920 may include two or more layers of fabric, and may include a generally planar insert 1030 that is more rigid than the layers of fabric.
  • the clinician forms an opening in the myocardium (1320).
  • the clinician may use a coring tool to excise a cylindrical segment of the myocardium.
  • the clinician cuts the opening through a central opening in the cuff 920.
  • the clinician cuts the opening in the myocardium and afterward attaches the cuff 920 to the heart 914, with the central opening of the cuff 92.0 located over the opening of the myocardium.
  • the clinician inserts the inflow cannula 950 of the pump 912 through the central opening in the cuff 920 and into the opening in the myocardium (1330).
  • the clinician then attaches the pump 912 to the cuff 920 (1340).
  • the clinician may engage a coupling mechanism that is configured to limit translation of the inflow cannula through the central opening of the cuff 920.
  • the clinician holds the cuff 920 by pressing inward on the outer edge of the cuff 920.
  • the clinician applies a counterforce against the inflow cannula 950 or the pump 912, in a direction along the central axis of the inflow cannula 950, to seat the cuff 920 on the inflow cannula 950 or another portion of the pump 912.
  • the clinician engages a locking mechanism after engaging the coupling mechanism.
  • the clinician may slide a clip into position, by moving the clip in a plane generally perpendicular to the inflow cannula 950.
  • the clinician optionally attaches one or more sutures to one or more suture anchors disposed on an exterior of the pump 912.
  • the clinician passes sutures through eyelets disposed along an outer perimeter of the pump 912 and through the sewing ring 1025 of the cuff 920.
  • the clinician additionally or alternatively may pass the sutures through a por tion of the my ocardium.
  • Sutures attached at various suture anchors around the pump maintain the position of the sewing ring 1025 extending generally along a plane perpendicular to the inflow cannula 950.
  • the process 1300 includes covering the pump 912 with the cover 1230.
  • the clinician wraps a fabric around the housing 964 of the pump 912, and closes the fabric to encase the pump 912, shielding the exterior of the pump 912 from tissue adhesion.
  • an assembly 1400 includes a cuff 1410 and an inflow cannula 1430 that are connected together prior to implantation, and then implanted as a single unit. Pre -attaching the cuff 1410 and inflow cannula 1430 may reduce ihe number of components the clinician must install during implantation. In addition, using the assembly 1400 may reduce the complexity of the implantation procedure and may reduce ihe risk of bleeding after implantation.
  • the cuff 1410 includes a fabric ring 1412, for example, a ring of polyester velour or PTFE felt, that a clinician may suture to the heart 914.
  • the fabric ring 1412 is attached to a body 1414 that extends around the inflow cannula 1430.
  • a clamp or clip 1416 extends around the body 1414 and the inflow cannula 1430 to secure the cuff 1410 to the inflow cannula 1430.
  • an adhesive or other fastener secures the cuff 1410 and inflow cannula 1430,
  • the inflow cannula 1430 has a distal end 1438 that includes one or more attachment features, such as screw threads or clips, to attach to the pump 912.
  • the inflow cannula 1430 defines a central axis 1432 and defines an inlet 1434 at a proximal end 1436.
  • the inflow cannula 1430 flares outward from the central axis 1432 at the proximal end 1436. When implanted, the flared proximal end 1436 contacts the endocardium, e.g., the inner surface of the heart 914.
  • the flared proximal end 1436 separates the endocardium 915 from the inlet 1434, limiting the potential for occlusion of the inlet 1434 by the endocardium 915.
  • the region of the heart 914 adjacent the inflow cannula 1430 is secured between the fabric ring 1412 on ihe exterior of the heart 914 and the flared proximal end 1436 on the interior of the heart 914.
  • the clinician To implant the assembly 1400, the clinician first cuts an opening in the myocardium. The clinician then inserts the proximal end 1436 into ihe opening, and sutures the fabric ring 1412 to the myocardium. With the assembly 1400 attached to the heart, the clinician attaches the distal end 1438 of the inflow cannula 1430 to the pump. For example, the distal end 1438 may be recei ved into the housing of the pump, and may be secured by threads, a clip, or another fastening mechanism. [8296] Referring to Figs.
  • a cuff and cannula assembly 1450 includes an inflow cannula 1460 having a fabric 1470 attached directly to the exterior of the inflow cannula 1460.
  • the inflow cannula 1460 has a circumferential ridge 1462 that extends around the exterior of the inflow cannula 1460.
  • the fabric 1470 for example, a ring of a polyester velour or PTFE felt, is positioned on the ridge 1462 and extends around the inflow cannula 1460.
  • holes 1464 are defined through the ridge 1462.
  • Sutures 1472. extend through the holes 1464 and the fabric 1470 to secure the fabric 1470 to the inflow cannula 1460.
  • the assembly 1450 may be provided to a clinician with the fabric 1470 already secured to the inflow cannula 1460.
  • a clinician places sutures 1480 to secure the fabric 1470 to the myocardium.
  • a cuff 1500 includes a proximal portion 1510 that extends into the heart 14 and contacts the endocardium 915.
  • positioning a portion of an inflow cannula, cuff, or other component against the endocardium 915 can separate the endocardium 915 from the inlet of an inflow cannula, reducmg the risk of occlusion of the inflow cannula.
  • the cuff 1500 which is separate from the inflow cannula 950 of the pump 912, engages the interior of the heart 914 and the exterior of the heart 914. After a hole is cored in the heart 914, the cuff 1500 is deployed to capture a portion of the myocardium between the proximal portion 1510 and a distal portion 1512, which results in flattening of the myocardium.
  • the clinician may insert the inflow cannula 950 of the pump 912 through the center of the cuff 1500 and attach the cuff 1500 to the pump 912.
  • the cuff 1500 remains in place on the heart 915, with the inflow cannula 950 extending through the cuff 1500, to limit the risk of pump malposition and occlusion of the inflow cannula 950.
  • the proximal portion 1510 and/or the distal portion 1512 can have a flexural modulus of greater than 50 psi, for example, a flexural modulus at least 60 psi, at least 75 psi, at least 90 psi, at least 100 psi, at least 125 psi, or at least 150 psi.
  • the cuff 1500 includes a fabric 1502, such as a ring of a polyester veiour or PTFE felt, and a member 1504 formed of, for example, a flexible material such as silicone.
  • the fabric 1502 may be attached to the distal portion 1512 of the member 1504.
  • the fabric 1502 may be captured in silicone of the member 1504.
  • the clinician may attach the fabric 1502 to the heart 914, for example, with sutures.
  • some implementations of the cuff 1500 may be attached to the heart 915 without the fabric 1502 and without sutures or other fasteners,
  • the member 1504 defines a central axis 1506.
  • the member 1504 includes the proximal portion 1510, which is formed as one or more extensions or tabs that extend outward from the central axis 1506.
  • the proximal portion 1510 is a circumferential ring that extends radially ouiward from ihe central axis 1506 in a plane generally perpendicular to the central axis 1506.
  • the proximal portion 1510 has a width, W , larger than the inner diameter, ID, of the opening in the heart 914. As a result, to pass through the opening, the proximal portion 1510 deflects inward toward the central axis 1506.
  • the proximal portion 1510 Once the proximal portion 1510 has passed through the myocardium into, for example, a ventricle of the heart 914, the proximal portion 1510 expands outward, limiting the cuff 1500 from separating from the heart 914. The proximal portion 1510 rests on the endocardium 915, along the inner surface of the heart 914.
  • an inflow cannula may be placed through the member 1504 and secured within the member 1504.
  • the presence of the proximal portion 1510 against the endocardium 915 can reduce the risk that heart tissue encroaches on the internal lumen of the inflow cannula.
  • the cuff 1500 remains around the inflow cannula 950 of the pump 912, securing the pump 912 to the heart 914.
  • the distal portion 1512 of the member 1504 extends generally radially outward from the central axis 1506, for example, as a
  • the proximal portion 1510 also extends generally radially outward from the central axis 1506, for example, as a circumferential flange.
  • the length, Li, of the member 1504 between ihe proximal portion 1510 and ihe distal portion 1512 can be configured to exert pressure on the portions of the myocardium captured between the proximal portion 1 510 and the distal portion 1512,
  • the member 1504 is elastic, expandable, or otherwise adjustable to change the length, L3.
  • the length, L 3 ⁇ 4 may be adjusted to exert a desired amount of force on the myocardium to flatten the myocardium and secure the position of ihe cuff 1500 relative to the heart 914.
  • the length, L may also be adjusted to accommodate varying thicknesses of heart walls.
  • the member 1504 may have corrugated walls that may expand or compress to adjust the length, L;,.
  • the member 1504 may include a resilient member, such as a spring, located between the proximal portion 1510 and the distal portion 1512 to exert a compressive force against tissue located between the proximal portion 1510 and the distal portion 1512.
  • the member 1504 may include a frame 1540 (shown in dashed lines) or other component with a shape memory, for example, an internal frame formed of nickel-titanium alloy, a polymer, or other material. After placement of the cuff 1500 into the opening in the heart 914, the frame 1540 may contract to decrease the length, L3, and compress the myocardium between the proximal portion 1510 and the distal portion 1512. For example, heat may activate the shape memory of the frame 1540 and cause the cuff member 1504 to contract.
  • the cuff 1500 is configured to maintain its position on the heart 914 without being sutured to the heart.
  • the cuff 1500 may be secured to the heart 914 by the capture of the myocardium between the proximal portion 1510 and the distal portion 1512. Accordingly, the fabric 1502 or other material may be omitted. Engagement with the heart 915 can also flatten the myocardium as discussed above.
  • a cuff 1500 that can be secured to the heart without sutures includes the frame 1 540, which may be formed of, for example, a super-elastic or shape memory material, such as nickel-titanium alloy or a polymer.
  • the frame 1540 may be covered in, for example, fabric, PTFE felt, polyester, silicone, or another biocompatible material. In some implementations of the cuff 1500, the frame 1540 is exposed and does not have a covering.
  • the proximal portion 1510 In preparation for placement on the heart 915, the proximal portion 1510 is deflected inward toward the axis 1506, which permits the proximal portion 1510 to enter a hole in the heart 915 having an inner diameter, ID, less than the width, W 3 , or outer diameter of the proximal portion 1510.
  • the clinician may use a tool to hold the proximal portion 1510 in the deilected position while inserting the proximal portion 1510 through the hole in the heart 915.
  • the proximal portion 1510 expands outward, for example, due to the resiliency or shape memory of the frame 1540.
  • the frame 1540 may be configured to respond to body heat or other conditions to regain its natural form, in which the proximal portion 1510 extends radially outward.
  • the shape memory or resiliency of the frame 1540 also causes the cuff 1500 to contract, exerting a force on the myocardium between the proximal portion 1510 and the distal portion 1512.
  • a tool may be used to expand the proximal portion 1510 within the heart 914 and/or to adjust the length, L 3 , in addition to or instead of the resiliency or shape memory of the frame 1540.
  • the member 1504 may be divided into a proximal component that includes the proximal portion 1510 and a distal component that includes the distal portion 1512.
  • the proximal and distal components may be rigid or have rigid inner frames, formed, for example, of meta l or PEEK, rather than a flexible material.
  • the proximal component and distal component may threadedly connect to each other. Rotation of the proximal and distal components relative to each other may adjust the length, L 3 , between the proximal portion 1510 and distal portion 1512 to capture tissue disposed between.
  • a clinician may use a clip or other tool to hold the proximal component while rotating the distal component to adjust the length, L 3 .
  • Fig, 44 shows an example of cuff 1550 that has a proximal component 1560 that can be adjusted relative to a distal component 1570.
  • the proximal component 1560 has a portion 1562 that extends radially outward from an axis 1552 through a central opening 1554 in ihe cuff 1550.
  • the proximal component 1560 also ineludes screw threads 1564 that mesh with screw threads 1574 of the distal component 1570.
  • a clinician may use a tool 1580 to hold the proximal component 1560, while the proximal component 1560 and the distal component 1570 are rotated relative to each other to tighten the portion 1562 against the endocardium 915.
  • This force may capture the myocardium between the proximal component 1560 and the distal component 1570.
  • capture of the myocardium in this manner may be used to couple the cuff 1550 to the heart 914 without sutures or other fasteners.
  • Fig. 45 shows a comparison between a 5.5 mm high ring 1602 for a low profile apical cuff and a taller 8 mm high ring 1604 for a high profile apical cuff according to embodiments of the invention.
  • Whil e a lower profile apical cuff with ring 1602 (e.g., less than 6.5 mm or 5,5 mm high) may be desired in many situations, taller cuffs with a high ring 1604 (e.g., greater than 6.5 mm or 8.5 mm high) may be desirable in certain situations.
  • the rings 1602, 1604 may include, for example, an attachment member (having one or more features of any of the attachment members 26, 126, 326, 626), and a linking member (having one or more features of any of the linking members 24, 124, 324, 624).
  • the added height from ring 1604 may facilitate the use of a tool to hold a cuff in place while inserting the inflow cannula through the cuff and cored hole in the heart.
  • a tool engagement feature 1606 may be provided in ring 1604.
  • the engagement feature 1606 may comprise a circumferential slot for receiving a clamp mechanism of a corresponding tool.
  • the engagement feature 1606 may be separated from the cuff lock by a tab 1608.
  • Tab 1608 may keep a clamp tool from contacting the cuff lock 1610 during actuation of the lock. While illustrated as a groove/slot, it should be understood that engagement feature 1606 may take other forms as described throughout the application and/or as is apparent to one of skill in the art. For example, in some embodiments, engagement features 1606 may comprise a lip for cooperation with a groo ved surface of a corresponding tool.
  • Fig. 47 shows an exemplary tool 1700 for coupling with an apical cuff 1702 according to some embodiments.
  • Tool 1700 may be used by an operator to hold the cuff 1702 at a distance so as keep the operator's hands out of the way and to allow the operator to maintain visibility of the operating field while suturing the cuff 1702 onto the heart. Additionally, tool 1700 may allow the operator to clamp and manipulate the cuff 1702 during alignment and coupling with a corresponding pump.
  • Tool 1700 includes a clamp 1704 for coupling with and holding an apical cuff 1702. Clamp 1704 ma be closed to a clamped configuration by manipulation of handle 1706.
  • Handles 1706 may include a locking feature 1708 for locking tool 1700 in the clamped position.
  • Apical cuff 1702 may be any one of the apical cuffs described in this application or variations thereof. While clamp 1704 is illustrated as a ring clamp, it should be understood that other clamp configurations are possible, such as opposing clamp jaws. Handles 1706 may have a length in a range of about 3 cm to about 10 cm for example. Locking feature 1708 may comprise one or more engagement features extending between handles 1706, m the illustrated embodiment, engagement feature 1708 comprises an protrusion extending laterally from handle 1706. The protrusion includes a number of teeth configured to cooperate with engagement features in the opposing handle 1706.
  • locking feature 1708 engages and maintains the handles 1706 in the clamped position until user actuation of the locking feature 1708 (e.g., disengagement of the teeth with the corresponding engagement feature) release handles 1706 from the clamped position
  • Figs. 48A-48B show another exemplary tool 1800 for coupling with an apical cuff 1 802 according to some embodiments.
  • Tool 1800 may be similarly used by an operator to hold a cuff 1802 from a distance so as keep the operator's hands out of the way and to allow the operator to maintain visibility of the operating field while suturing the cuff 1802 onto the heart. Additionally tool 1800 may allow the operator to clamp and manipulate the cuff 1802 during alignment and coupling with a corresponding pump 1803, as shown in Fig. 48B.
  • Tool 1800 may rest on a clinician's hand with a plurality of contact points 1804.
  • a clamp 1806 may extend from the one or more contact points 1804 and may be configured to engage the apical cuff 1802.
  • tool 1800 includes three contact points 1804.
  • the contact points 1804 have a concave engagement surface for cooperating with the clinician's fingers and hand and allow the clinician to apply a lamping force with the clamps 1806 using the clinicians forefinger and thumb.
  • tool 1800 may be used with a cuff including a ring 1604 with a corresponding engagement feature 606. The taller cuff may be advantageous for engagement of a tool 1800 without contacting a cuff lock.
  • some embodiments may comprise one, two, four, or more contact points, etc.
  • Figs. 49A-49B show yet another exemplary tool 1900 for coupling with an apical cuff 1902 according to some embodiments.
  • Tool 1900 may be similarly used by an operator to hold a cuff 1902 from a distance so as keep the operator's hands out of the way and to allow the operator to maintain visibility of the operating field while suturing the cuff 1902 onto the heart. Additionally, tool 1900 may allow the operator to clamp and manipulate the cuff 1902 during alignment and coupling with a corresponding pump 1903, as shown in Fig. 49B.
  • Tool 1900 may seat and/or clamp the outer diameter of cuff 1902, in some embodiments, the tool 1900 may seat and/or clamp an outer perimeter of a metal ring of a cuff 1902.
  • tool 1900 may seat and/or clamp an outer perimeter of a felt sewing ring of a cuff 1902, This clamp 1900 may be used with both low profile apical cuffs with ring 1602 or taller cuffs with ring 1604, described above.
  • Tool 1900 includes opposing jaws 1904.
  • Jaws 1904 may include a groove 1906 for seating portions of the felt of a cuff 1902, for example.
  • Jaws 1904 may further include engagement features 1908 at a distal end of each jaw 1904 for locking the jaws 1904 into a clamped position.
  • engagement features 1908 comprise locking teeth. While illustrated as locking teeth, other engagement features may be used such as sna -fit engagement features or the like.
  • sewing rings/cuffs in some of the figures are illustrated as having a diameter that corresponds to a diameter of an attached pump, it should be understood that sewing ring/cuff diameters may be larger than a diameter of the attached pump. In some embodiments, a larger diameter, perimeter, size, and/or shape sewing ring/cuff may beneficially provide additional flattening of the apex of the heart and improve the positioning of the inflow cannula of an attached pump.
  • a sewing ring/cuff may have a diameter of 3 cm or more, such as 4 cm, 5 em, 6 cm, or larger.
  • sewing rings/cuffs are generally shown as having an annular, circular, or round configuration, some sewing rings/cuffs may be partial annular configuration or annular configurations with various sized openings to allow for differently sized inflow cannulas.
  • some sewing rings/cuffs may have an annular segment configuration or the like.
  • a sewing ring/cuff with a large diameter/perimeter may abut or overlap with the right ventricle (RV) of the heart. It may be preferable in most cases to avoid suturing the RV of the heart and/or flattening the RV of the heart.
  • RV right ventricle
  • a sewing ring/cuff may be configured with openings for accommodating the RV of the heart and to avoid suturing and/or flattening the RV of the heart.
  • Figs. 50A -50B show exemplary sewing rings 2000, 2002 with such openings for accommodating the RV of a heart.
  • Sewing ring 2000, 2002 may include a wedge shaped opening 2004, 2005.
  • the wedge shaped opening 2004, 2005 may be beneficial when sewing ring 2000, 2002 has a larger diameter and may overlap or abut the right ventricle (RV) of the heart.
  • RV right ventricle
  • a wedge shaped opening 2004, 2005 of a sewing ring 2000 may be oriented to avoid contact/overlap with the RV and may thereby avoid inadvertent flattening and suturing of the RV when sutming a cuff to the apex of the heart.
  • Some embodiments of cuffs may have similar configurations.
  • Fig, 51 shows another exemplary embodiment 2100 of a cuff similar to the cuff illustrated in Fig, 38.
  • Cuff 2100 may have an open configuration for receiving an inflow cannula of a pump and a closed configuration for securing the cuff 2100 to the pump.
  • the cuff 2100 may define an opening 2102 for receiving an inflow cannula of a pump.
  • Cuff 2100 further includes a sewing ring 2130. While the sewing ring is illustrated as not extending to the outer perimeter 2111 of the cuff 2100, other embodiments may include larger diameter sewing rings 2.130 that extend to the outer perimeter 21 11 of cuff 2100 or beyond the cuff 2100. For example, similar to the embodiment illustrated in Fig.
  • the web 2140 may be disposed or sandwiched between two felt layers 1010, 1020.
  • the cuff 2100 comprises two half circle segments 2 04 with a first end and a second end.
  • the segments 2104 may be coupled at a pivot or hinge joint 2106 at one end and may include engagement features 2108 coupled to one another at the second end of each segment 2104.
  • the cuff 2100 permits a clinician to close opening 2.102 by moving the engagement features toward one another after the cuff 2100 is placed about the inflow cannula of a pump.
  • the engagement features 2108 may lock with one another to capture the inflow cannula in the opening 2102. In the illustrated embodiments, even when cuff 2100 is in an open configuration, the engagement features 2108 may still couple the segments 2104 to one another. Accordingly, segments 2.104 may still move relative to one another but the engagement featitres 2108 may prevent the cuff 2100 from fully opening.
  • engagement features 2108 engage with one another to lock segments 2104 together and to close opening 2102.
  • Fig. 52 shows another exemplary embodiment 2200 of a cuff similar to the cuff illustrated in Fig. 38.
  • Cuff 2200 may have an open configuration for receiving an inflow cannula of a pump and a closed configuration for securing the cuff 2200 to the pump.
  • Cuff 2200 may define an opening 2202 for receiving an inflow cannula of a pump.
  • Cuff 2200 further includes a sewing ring 2.230. While the sewing ring is illustrated as not extending to the outer perimeter 22.11 of the cuff 2.200, other embodiments may include larger diameter sewing rings 2230 that extend to the outer perimeter 2211 of cuff 2200. For example, similar to the embodiment illustrated in Fig.
  • the web 2240 may be disposed or sandwiched between two felt layers 1010, 1020.
  • the cuff 2200 permits a clinician to close opening 2202 after the cuff 2.200 is placed about the inflow cannula of a pump.
  • the engagement features 2208 may lock with one another to capture the inflow cannula in the opening 2202.
  • Cuff 2200 further includes arms 22.10 which extend from the outer perimeter 2211 of cuff 2.200. Arms 2210 may provide a clinician an easily accessible feature that may be manually pressed together in order to couple engagement features 2208 together and to close opening 2202 around an inflow cannula.
  • Engagement features 2208 may be snap-fit engagement features or the like.
  • Fig. 53 shows another exemplary embodiment 2300 of a cuff.
  • Cuff 2300 may define an opening 2302 for receiving an inflow cannula of a pump.
  • Cuff 2300 may have an open configuration for receiving an inflow cannula of a pump and a closed configuration for securing the cuff 2300 to the pump.
  • Cuff 2300 further includes a sewing ring 2330. While the sewing ring 2330 is illustrated as not extending to the outer perimeter 2311 of the cuff 2300, other embodiments may include larger diameter sewing rings 2330 that extend to the outer perimeter 2311 of cuff 2300.
  • the web 2340 may be disposed or sandwiched between two felt layers 1010, 1020.
  • the cuff 2300 pennits a clinician to close opening 2302 after the cuff 2300 is placed about the inflow cannula of a pump.
  • the free ends of outer perimeter 2311 of cuff 2300 ma include engagement features 2308.
  • the engagement features 2308 may comprise an ear clamp with overlapping ends and corresponding teeth. As the ends of outer perimeter 2311 are pushed together, the teeth of the engagement features 2308 may cooperate and lock with one another to capture the inflow cannula in the opening 2302.
  • the outer end 2312 may include a pull tab 2313 which may be pulled aw r ay to release the clamp 2308.
  • FIG. 54 illustrates a cuff 2400 that may include a screw/band ("worm gear") clamp 2408 for securing cuff 2400 to a pump.
  • Cuff 2400 may have an open configuration for recei ving an inflow cannula of a pump and a closed configuration for securing the cuff 2.400 to the pump.
  • Clamp 2408 includes a screw or worm gear 2410 that cooperates with grooves 2412 to tighten and loosen clamp 2408.
  • Fig. 55A-55B illustrate an exemplary key 2450.
  • Screw 2410 may have an actuation end 2414 that couples with a lockout feature 2416, When key 2450 couples with lockout feature 2416, as shown in Fig. 55A, the key 2450 may be used turn screw 2410 to tighten or loosen clamp 2408. When key 2.450 is removed from the lockout feature 2416, as shown in Fig. 55B, lockout feature 2416 may prevent inadvertent turning of screw 2410 without the key 2450.
  • Cuffs 2100, 2200, 2300, 2400 have an open configuration for receiving an inflow cannula of a pump and a closed configuration for securing the cuff around the infl ow cannula to thereby attach the pump to the cuff. A cuff with the open configuration and closed configuration may be advantageous as a separate locking clip or like component is not required.
  • Fig. 56 shows an exemplary cross-sectional view of a cuff 2500.
  • Cuff 2500 may be any of the cuffs described herein (e.g., cuff 20, 1200, 2100, 2200, 2300, 2400, etc. or variations thereof).
  • Cuff 2500 includes a sewing ring 2540 around opening 2502.
  • Cuff 2500 includes a hook feature 2510 or teeth that extend axiaily from at least some portions of the outer perimeter 2511.
  • the hook feature 2510 may be configured to couple with a lip, outer ridge, notch or groove on an outer perimeter and'or top portion of a pump. While illustrated as extending from the outer perimeter 2511, some embodiments may have feet (e.g., two feet, three feet, or more, etc.) that extend from the cuff 2500 to capture a lip or groove of an attached pump.
  • Fig. 57 shows an exemplary pump 2600 for coupling with the hook features 2510 of cuff 2500.
  • Pump 2600 includes inflow cannula 2610 extending from a housing 2620.
  • the infl ow cannula 2610 may extend through an opening of cuff 2500.
  • Pump 2600 may include an o-ring groove 2621 for housing an o-ring 2622 along the base of the inflow cannula 2610 where the inflow cannula 2610 couples with housing 2620.
  • O-ring 2622 may help prevent leakage between the coupling of the pump 2600 to the heart.
  • Housing 2620 may include a lip 2.623 that protrudes out from a perimeter of the housing 2620. Lip 2623 may cooperate with hook features 2510 of cuff 2500 as illustrated in Fig. 58.
  • Fig. 58 shows a cross-sectional view of an exemplary coupling between a pump, a cuff, and a heart.
  • a cuff 2500 may be coupled with a heart 2550 via sutures 2560.
  • Inflow cannula 2610 extends through cuff 2500 and into heart 2550.
  • hook features 2510 of cuff 2500 may be closed around and engage lip 2623 of pump housing 2620 so as to further secure pump 2600 to cuff 2500. While illustrated as a lip 2623, other pumps may include grooves for cooperating with hook features 251 0 of a cuff 2500.
  • the engagement between hook features 2510 of a cuff 2500 and a corresponding lip 2623 or groove of pump 2600 may help transfer some loads from the cuff 2500 to the pump 2600 to provide less stress on the cuff 2500.
  • This integrated coupling/locking cuff design is further advantageous as a
  • Fig. 59A-59C illustrated an exemplary method of attaching a cuff 2700 to the apex of the heart.
  • the apex may first be located and the cuff 2700 may be positioned.
  • Sutures 2750 may then be placed evenly on the perimeter of the sewing ring of cuff 2700 to secure it onto the heart.
  • two, three, four or more sutures may be used to secure cuff 2700 to the heart.
  • sewing ring of cuff 2700 may act as a pledget or anchor for sutures 2750.
  • eight sutures 2750 or more may be used.
  • the heart may be cored before suturing the cuff 2700 onto the apex of the heart. In other embodiments, the heart may be cored after suturing the cuff 2700 onto the apex of the heart.
  • Fig, 60A-60C illustrate an alternative method of attaching a cuff 2700 to the apex of the heart.
  • the apex may first be located and sutures 2750 may be secured at pledgets or anchors around the apex of the heart.
  • the sutures 2750 may be secured at locations under cuff 2700 when the cuff 2700 is placed against the apex.
  • the secured sutures 2750 may then be fed through the sewing ring of cuff 2700.
  • Cuff 2700 may then be pushed towards the apex of the heart to overlap with the pledgets or anchors of the sutures 2750.
  • cuff 2700 Once positioned adjacent the heart, cuff 2700 may be adjusted to a desired position.
  • the sutures 2750 may then be tightened and fastened to the sewing ring of cuff 2700.
  • the operator's field of view is not obstructed nor interferes with the securing of the cuff 2700.
  • Fig. 61A-6IC illustrates yet another method of attaching a cuff 2700 to the apex of the heart.
  • the apex may first be located and sutures 2750 may be secured at pledgets or anchors around the apex of the heart.
  • the secured sutures 2750 may be secured at locations that are spaced apart from an outer perimeter 2711 of the cuff 2700 when the cuff 2700 placed against the apex.
  • the sutures may be secured at locations that are spaced between 0.5-2.0 cm away from the outer perimeter 2711 of the cuff 2700.
  • the sutures 2750 may then be fed through sewing ring of cuff 2700.
  • Cuff 2700 may then be pushed against the surface of the heart.
  • the sutures 2750 may then be tightened and fastened to the sewing ring of cuff 2700.
  • the method may provide additional flattening of the apex of the heart due to the sutures 2750 being secured at positions spaced apart from the outer perimeter of cuff 2700 and fastened to cuff 2700.
  • the fastening and tigh tening of the sutures may provide an additional 1 cm of flattening around the outer perimeter of the cuff 2700, Accordingly the method may allow a clinician to adjust the flattening of the apex depending on the tightening of the sutures 2750.
  • FIGs. 62A-62B illustrate exemplary anchors 2800, 2900 that may be used to secure a suture to heart tissue.
  • Anchors 2800, 2900 include a tissue penetrating distal end 2810, 2910.
  • the tissue penetrating distal end 2810, 2910 may include one or more barbs 2812, 2912 for securing the anchor 2800, 2900 in the tissue.
  • a proximal end of anchors 2800, 2900 may include a suture engagement feature 2814, 2914.
  • Suture engagement feature 2814 of anchor 2800 may comprise a hook feature that permits a clinician to slide a suture into the engagement feature 2814.
  • Suture engagement feature 2914 of anchor 2900 may comprise an eyelet that may require a clinician to thread a suture through the eyelet of the anchor 2900. While illustrated and described with two barbs 2812, 2912, it should be understood that embodiments may include three, four, five, or more barbs 2812, 2912 for securing an anchor 2800, 2900 to tissue once inserted therein.
  • the myocardium may be flattened using (i) sutures connected to the housing of a pump, (ii) a cuff having an appropriate flexural modulus, (iii) a member that extends into the heart to engage the

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

Selon un aspect général, l'invention concerne un manchon à fixer à un cœur qui comprend un élément de fixation, conçu pour entrer en prise avec une pompe à sang de façon à fixer le manchon à la pompe à sang, et un anneau de couture à fixer au cœur. L'anneau de couture est couplé à l'élément de fixation, et l'élément de fixation et l'anneau de couture définissent chacun une ouverture centrale configurée pour admettre une canule d'entrée d'une pompe à sang. L'anneau de couture comprend un organe qui confère une rigidité pour aplatir une partie d'un myocarde du cœur, lorsque le manchon est fixé au cœur.
PCT/US2014/021389 2013-03-15 2014-03-06 Manchon ventriculaire WO2014149892A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP15757834.5A EP3113807B1 (fr) 2014-03-06 2015-03-06 Ballonnet ventriculaire
PCT/US2015/019308 WO2015134944A1 (fr) 2014-03-06 2015-03-06 Ballonnet ventriculaire

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US13/842,578 2013-03-15
US13/842,578 US9199019B2 (en) 2012-08-31 2013-03-15 Ventricular cuff
USPCT/US2013/056952 2013-08-28
PCT/US2013/056952 WO2014036060A1 (fr) 2012-08-31 2013-08-28 Manchon ventriculaire

Publications (1)

Publication Number Publication Date
WO2014149892A1 true WO2014149892A1 (fr) 2014-09-25

Family

ID=51580669

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2014/021389 WO2014149892A1 (fr) 2013-03-15 2014-03-06 Manchon ventriculaire

Country Status (1)

Country Link
WO (1) WO2014149892A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104840274A (zh) * 2015-05-18 2015-08-19 周宏� 人工植入瓣膜适配安装环
US10335527B2 (en) 2017-11-08 2019-07-02 The Regents Of The University Of Colorado, A Body Corporate Ventricular assist assembly, system, and method
CN111315284A (zh) * 2017-11-02 2020-06-19 伟伦公司 医疗设备用连接器
US10894116B2 (en) 2016-08-22 2021-01-19 Tc1 Llc Heart pump cuff
US11235137B2 (en) 2017-02-24 2022-02-01 Tc1 Llc Minimally invasive methods and devices for ventricular assist device implantation
WO2023029818A1 (fr) * 2021-09-06 2023-03-09 深圳核心医疗科技有限公司 Ensemble de connexion ventriculaire et système d'assistance ventriculaire

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6146325A (en) * 1999-06-03 2000-11-14 Arrow International, Inc. Ventricular assist device
US6238334B1 (en) * 1997-11-03 2001-05-29 Cardio Technologies, Inc. Method and apparatus for assisting a heart to pump blood
US20020045846A1 (en) * 2000-08-14 2002-04-18 Kaplon Richard J. Valved apical conduit with trocar for beating-heart ventricular assist device placement
US20120010455A1 (en) * 2009-11-15 2012-01-12 Thoratec Corporation Attachment Method
US20120226096A1 (en) * 2011-03-02 2012-09-06 Justin Aron Callaway Ventricular cuff

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6238334B1 (en) * 1997-11-03 2001-05-29 Cardio Technologies, Inc. Method and apparatus for assisting a heart to pump blood
US6146325A (en) * 1999-06-03 2000-11-14 Arrow International, Inc. Ventricular assist device
US20020045846A1 (en) * 2000-08-14 2002-04-18 Kaplon Richard J. Valved apical conduit with trocar for beating-heart ventricular assist device placement
US20120010455A1 (en) * 2009-11-15 2012-01-12 Thoratec Corporation Attachment Method
US20120226096A1 (en) * 2011-03-02 2012-09-06 Justin Aron Callaway Ventricular cuff

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104840274A (zh) * 2015-05-18 2015-08-19 周宏� 人工植入瓣膜适配安装环
US10894116B2 (en) 2016-08-22 2021-01-19 Tc1 Llc Heart pump cuff
US11583671B2 (en) 2016-08-22 2023-02-21 Tc1 Llc Heart pump cuff
US11235137B2 (en) 2017-02-24 2022-02-01 Tc1 Llc Minimally invasive methods and devices for ventricular assist device implantation
CN111315284A (zh) * 2017-11-02 2020-06-19 伟伦公司 医疗设备用连接器
CN111315284B (zh) * 2017-11-02 2023-04-28 伟伦公司 医疗设备用连接器
US10335527B2 (en) 2017-11-08 2019-07-02 The Regents Of The University Of Colorado, A Body Corporate Ventricular assist assembly, system, and method
US11364376B2 (en) 2017-11-08 2022-06-21 Regents Of The University Of Colorado, A Body Corporate Ventricular assist assembly, system, and method
WO2023029818A1 (fr) * 2021-09-06 2023-03-09 深圳核心医疗科技有限公司 Ensemble de connexion ventriculaire et système d'assistance ventriculaire

Similar Documents

Publication Publication Date Title
US11369785B2 (en) Ventricular cuff
US9981077B2 (en) Ventricular cuff
US11185683B2 (en) Ventricular cuff
WO2014149892A1 (fr) Manchon ventriculaire
JP7169984B2 (ja) 固定装置、固定システム、及び固定方法
CN109310441A (zh) 聚合物结扎夹
EP3517056A1 (fr) Pince de ligature avec des caractéristiques de rétention de tissus
KR20080080607A (ko) 이식물 연결장치
US9393008B2 (en) Suture clamp
EP3113807B1 (fr) Ballonnet ventriculaire
US20220296876A1 (en) Ventricular Cuff
US11607529B2 (en) Fixation devices for catheters
CN111956307B (zh) 一种用于腔镜手术的包含固定管和活动管的中空管组件
CN111938773B (zh) 一种用于腔镜手术包含侧扣件的中空管组件
CN116457053A (zh) 用于近侧可修整导管的导管适配器系统

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 14771018

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 14771018

Country of ref document: EP

Kind code of ref document: A1