CN117750911A

CN117750911A - Transcatheter device for repairing leaflets of a heart valve of a subject

Info

Publication number: CN117750911A
Application number: CN202280051118.XA
Authority: CN
Inventors: M·格雷罗; B·P·墨菲; T·Z·奥巴; S·沙菲; M·周; K·甘茨; M·弗朗西斯; M·M·卡扎尔巴什
Original assignee: Edwards Lifesciences Corp
Current assignee: Edwards Lifesciences Corp
Priority date: 2021-05-25
Filing date: 2022-05-13
Publication date: 2024-03-22

Abstract

The catheter (100) has a proximal portion, a steerable distal portion, and a longitudinal axis therebetween. The wire (110) may be advanced distally from the catheter, forming a wire loop. A fastening element (116) may be coupled to the wire such that distal sliding of the fastening element over the wire constricts the wire loop and cuts tissue disposed within the wire loop. A helical needle (140) defining a helical lumen having a suture (144) is configured to be advanced distally from the catheter and to extend rotationally through and secure together cut tissue edges. The needle and the suture may be configured to extend along the cutting edge to suture the cutting edge during distal sliding of the fastening element. Other embodiments are also described.

Description

Transcatheter device for repairing leaflets of a heart valve of a subject

Cross reference to related applications

The present application claims U.S. provisional patent application 63/192,829 to Guerrero et al filed 5/25 of 2021 and entitled transcatheter device and method (Transcatheter device and methods for repairing a leaflet of a heart valve of a subject) for repairing leaflets of a heart valve in a subject; U.S. provisional patent application 63/285,948 to Guerrero et al, filed on 3/12/2021 and entitled transcatheter device and method for repairing leaflets of a heart valve in a subject; and U.S. provisional patent application 63/311,919 by Guerrero et al entitled "transcatheter device and method for repairing leaflets of a heart valve of a subject" filed on month 2 and 18 of 2022.

Each of the above references is incorporated by reference herein in its entirety.

Background

The function of the mammalian heart is based on the contraction of the heart muscle and the creation of pressure that causes blood to flow from the heart chamber to the desired artery. Blood from the body returns to the atrium through the veins. Valves between each atrium and the corresponding ventricle and between the ventricles and the corresponding arteries ensure that no regurgitation occurs when the myocardium contracts and pressure is created in the ventricles. The valves between the atria and ventricles of the heart are called mitral and tricuspid valves, and are each formed of a plurality of leaflets that coapt with each other when the valve is closed and have a space formed therebetween when the valve is open.

Proper closure of the mitral and tricuspid valves is critical to the normal function of the heart, and many medical conditions (some life threatening) are caused by improper closure of the valves, which can cause regurgitation (regurgitation) from the ventricles to the corresponding atria. One reason for improper closure of such valves is excess tissue in one or more of the leaflets of the valve, which can lead to leaflet prolapse (e.g., carpentier type II regurgitation). Fig. 1 schematically shows excess tissue in the leaflet and its improper closure. Specifically, fig. 1 shows a mitral valve 10 having a first leaflet 12 and a second leaflet 14 surrounded by an annulus 15. The second leaflet 14 has excess tissue 16 such that the leaflets 12 and 14 coapt at a point (or edge) 17 with a gap 18 along the coaptation line.

Prior art for treating such conditions includes surgical removal of excess tissue of the leaflets in invasive open heart surgery. Such procedures require the surgeon to cut excess portions of tissue 16, for example, using scissors or a suitable scalpel, and then use sutures to hold the cut edges of the tissue together. In addition to being invasive, the procedure requires a high degree of skill from the surgeon.

Thus, there is a need for improved techniques and devices to repair leaflet function from heart small She Yichu excess tissue.

Disclosure of Invention

Flails or prolapse of valve leaflets can be treated by restraining, moving, or removing excess tissue from the valve leaflet She Yichu, according to some applications herein.

In some applications, excess tissue of the valve leaflet is removed during transluminal or transcatheter procedures. The excess tissue is cut using a cutting device such as a suitably configured cutting wire (e.g., wire loop, etc.), thereby forming a cutting edge.

In some applications, when the cutting edge is formed, it is secured together by an attachment device (e.g., an edge attachment device). The attachment means may be, for example, a helical needle. In some applications, the helical needle follows the cutting device. In this way, the cutting edges are grasped before being moved away from each other. The cutting edges may then be more permanently secured together, such as by stitching, which allows the cutting edges to heal. In some applications, the suture may be present in the lumen of the helical needle and may remain in place during and after retraction of the helical needle.

In some applications, during cutting of tissue, the tissue may be held by another transluminally introduced tool such as a clamp, snare, hook, or the like. Excess tissue and clamps may be removed after the excess tissue is less than She Caxie, for example, through a catheter.

In some applications, prolapse or flails caused by excess tissue of the valve leaflet are counteracted by the implantable element during transluminal or transcatheter procedures.

In some applications, the excess tissue may be counteracted by constraining a portion of the excess tissue or leaflet to another portion of the leaflet or another cardiac tissue using an implantable element. In some applications, such constraints result in a portion of the leaflet that is different from the lip of the leaflet presenting a surrogate coaptation surface.

In some applications, the excess tissue may be counteracted by causing the leaflets comprising the excess tissue to follow a tortuous path around the implant, thereby "depleting" the excess tissue.

According to some applications, provided herein is a system for use with a subject, the system comprising a longitudinal catheter configured to be transluminally advanced toward an anatomical site of the subject. The longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The system may include a wire distally advanceable from the catheter, the wire forming a wire loop having a closed distal end.

The fastening element may be slidably coupled to the wire. Distal sliding of the fastening element over the wire may retract the wire loop and cut tissue disposed within the wire loop, thereby forming cut tissue and a cutting edge at the anatomical site.

The system may include a helical needle defining a helical lumen. The helical needle may be configured to be advanced distally from the longitudinal catheter and to extend rotationally through the cutting edges at the anatomical site and secure the cutting edges together. A suture may extend through the helical lumen of the helical needle.

The helical needle and the suture may be configured to extend along the cutting edge of the anatomical portion to suture the cutting edge during distal sliding of the fastening element.

In some applications, the system may include a tissue anchor configured to anchor to tissue at the anatomical site. At least one of the wire loop and the helical needle may be attachable to the tissue anchor.

In some applications, the helical needle may comprise a needle body terminating in a detachable distal tip. The detachable distal tip may be configured to attach to the tissue anchor and detach from the needle.

In some applications, a distal end of the suture is attached to the detachable distal tip of the helical needle.

In some applications, after detaching the detachable distal tip of the helical needle from the needle body, the needle body may be retracted helically away from the detachable distal tip while sliding over and along the suture.

In some applications, the system may include a push wire extending through the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

In some applications, the wire and the helical needle are adapted to be removed from the anatomical site after cutting the tissue disposed within the wire loop while leaving the suture in the anatomical site to suture the cutting edge.

In some applications, the system includes a clamp having a distal clamping end. The clamp is advanceable from the longitudinal guide to engage the cut tissue before the cut tissue is completely removed from the anatomical site.

In some applications, the clamp is adapted to be removed from the anatomical site, the cut tissue being clamped to the clamp after the wire and the helical needle are removed from the anatomical site.

In some applications, the clamp is configured to be advanced through the longitudinal catheter alongside the helical needle.

In some applications, the helical needle follows the fastening element at a fixed distance from the fastening element, at least during distal sliding of the fastening element.

In some applications, the anatomical site comprises a heart valve and the cut tissue comprises a portion of a leaflet of the heart valve.

In some applications, the helical needle and the suture may be configured to extend rotationally through the cutting edge at the anatomical site as the cutting edge is formed.

In some applications, in at least a first state of the system, the fastening element may be operatively coupled to the helical needle. In some applications, the fastening element is distally advanceable over the wire only upon subsequent advancement of the helical needle.

In some applications, the system includes a user interface that enables a user to control the system. The user interface may include a unified engagement element that when actuated controls movement of the fastening element and the helical needle in unison.

In some applications, the unified engagement element, when actuated, controls movement of the fastening element and the helical needle at a fixed distance from each other.

In some applications, the user interface includes a first engagement element that controls movement of the fastening element when actuated, and may include a second engagement element that controls movement of the helical needle when actuated.

In some applications, the unified engagement element may include a third engagement element that is different from the first engagement element and the second engagement element.

In some applications, the user interface includes a coupling element functionally associated with the first engagement element and the second engagement element.

In some applications, in a first operational state of the coupling element, the first engagement element and the second engagement element may be coupled to form the unified engagement element. In some applications, actuation of one of the first engagement element and the second engagement element consistently controls movement of the fastening element and the helical needle or at a fixed distance from each other.

In some applications, the first engagement element and the second engagement element may be uncoupled in the second operational state of the coupling element. In some applications, actuation of the first engagement element controls only movement of the fastening element, and actuation of the second engagement element controls only movement of the helical needle.

In some applications, at least one of the wire and the helical needle is adapted to be advanced to or removed from the anatomical site through the longitudinal catheter.

In some applications, the system includes a longitudinal mount adapted to be advanced distally from the longitudinal catheter such that the helical needle is adapted to rotate about the longitudinal mount and be stabilized or guided by the mount during rotation of the helical needle.

In some applications, the system may include a tissue engagement tool including a first beam, a second beam, and a third beam distally advanceable from the longitudinal conduit, the tissue engagement tool being adapted to position the first beam and the third beam on a first side of the tissue and the second beam on an opposite side of the tissue. In some applications, the tissue engagement tool is adapted to form a bump in the tissue by moving the second beam relative to the first beam and the third beam, and the wire loop is adapted to constrain the bump on the first side of the tissue.

According to some applications, provided herein is a system for use with a subject, the system comprising a cutting device. The cutting device may be advanceable and steerable toward an anatomical site of the subject. Movement of the cutting device at the anatomical site causes cutting of tissue engaged by the cutting device, thereby forming a cutting edge at the anatomical site.

The system may include an edge attachment device configured to at least temporarily secure the cutting edge at the anatomical site.

In some applications, in at least a first state of the system, the edge attachment device may be operably coupled to the cutting device. In some applications, the cutting device is distally advanceable at the anatomical site only upon subsequent advancement of the edge attachment device to secure the cutting edges to one another as the cutting edges are formed.

In some applications, in the first state of the system, the edge attachment device may be operably coupled to the cutting device such that the cutting device is distally advanceable only when the edge attachment device is subsequently advanced a fixed distance from the cutting device.

In some applications, the system may include a user interface that enables a user to control the system. The user interface may include a unified engagement element that, when actuated, consistently controls movement of the cutting device and the edge attachment device.

In some applications, the unified engagement element, when actuated, controls movement of the cutting device and the edge attachment device at a fixed distance from each other.

In some applications, the user interface includes a first engagement element that, when actuated, controls movement of the cutting device. In some applications, the user interface may include a second engagement element that, when actuated, controls movement of the edge attachment device.

In some applications, the unified engagement element includes a third engagement element that is different from the first engagement element and the second engagement element.

In some applications, the user interface may include a coupling element functionally associated with the first engagement element and the second engagement element.

In some applications, in a first operational state of the coupling element, the first engagement element and the second engagement element may be coupled to form the unified engagement element. In some applications, actuation of one of the first engagement element and the second engagement element may consistently control movement of the cutting device and the edge attachment device.

In some applications, the first engagement element and the second engagement element may be uncoupled in the second operational state of the coupling element. In some applications, actuation of the first engagement element controls only movement of the cutting device, and actuation of the second engagement element controls only movement of the edge attachment device.

According to some applications, provided herein is a system for use with a subject, the system comprising a cutting device that is advanceable and steerable toward an anatomical site of the subject. Movement of the cutting device at the anatomical site may cause cutting of tissue engaged by the cutting device, thereby forming a cutting edge at the anatomical site.

The system may include an edge attachment device configured to at least temporarily secure the cutting edge at the anatomical site as the cutting edge is formed.

The system may include a user interface that enables a user to control the system. The user interface may include a unified engagement element that, when actuated, consistently controls movement of the cutting device and the edge attachment device.

In some applications, in a first operational state of the coupling element, the first engagement element and the second engagement element may be coupled to form the unified engagement element. In some applications, actuation of one of the first engagement element and the second engagement element consistently controls movement of the cutting device and the edge attachment device.

In some applications, the system may include a longitudinal catheter configured to be advanced transluminally toward the anatomical site of the subject. The longitudinal catheter may have a proximal portion and a steerable distal portion. The cutting device and the edge attachment device may be adapted to be advanced and steered distally from the longitudinal catheter to the anatomical site.

In some applications, the cutting device and/or the edge attachment device are adapted to be advanced through the longitudinal catheter to the anatomical site.

In some applications, the cutting device and/or the edge attachment device are adapted to be removed from the anatomical site after cutting tissue and securing the cutting edges together.

In some applications, the system may include a permanent edge attachment device adapted to permanently attach the cutting edge at the anatomical site.

In some applications, the edge attachment device is adapted to temporarily secure the cutting edge at the anatomical site, and the permanent edge attachment device is adapted to permanently attach the cutting edge.

In some applications, the edge attachment device comprises a needle and the permanent edge attachment device comprises a suture that extends through a lumen of the needle.

In some applications, the needle is a helical needle and the lumen is a helical lumen.

In some applications, the cutting device includes a wire forming a wire loop having a closed distal end. A fastening element may be slidably coupled to the wire such that distal sliding of the fastening element over the wire constricts the wire loop and cuts tissue disposed within the wire loop.

In some applications, the system may include a clamp having a distal clamping end. The clamp is advanceable to the anatomical site to engage the cut tissue before the cut tissue cut by the cutting device is completely removed from the anatomical site.

In some applications, the clamp is adapted to be removed from the anatomical site, the cut tissue being clamped to the clamp after at least one of the cutting device and the edge attachment device is removed from the anatomical site.

In some applications, the system may include a tissue anchor configured to anchor to tissue at the anatomical site to anchor at least one of the cutting device and the edge attachment device.

In some applications, the anatomical site comprises a heart valve, and the tissue engaged and thereby cut by the cutting device comprises a portion of a leaflet of the heart valve.

According to some applications, provided herein is a method of removing tissue from an anatomical site of a subject. The method includes transluminally advancing a longitudinal catheter toward the anatomical site, the longitudinal catheter having a proximal portion and a steerable distal portion.

The method may include distally advancing a wire loop from the longitudinal catheter. The wire loop may have a closed distal end, a proximal end. A fastening element may be slidably coupled to the wire loop.

The method may include distally advancing a helical needle from the longitudinal catheter. The spiral needle may comprise a spiral lumen. A suture may extend through the helical lumen.

The method may include placing the wire loop around tissue at the anatomical site.

The method may include sliding the fastening element distally relative to the wire loop, thereby cutting the tissue disposed within the wire loop and forming a cut tissue and a cutting edge at the anatomical site.

The method may include advancing the helical needle and the suture along the cutting edge during distal sliding of the fastening element to secure the cutting edges to one another.

In some applications, the method may include advancing a tissue anchor through the longitudinal catheter to the anatomical site. The tissue anchor may be anchored to tissue at the anatomical site.

In some applications, the method includes, after advancement of the helical needle, anchoring a detachable distal tip of the helical needle to the tissue anchor. The detachable distal tip may have a distal end of the suture attached thereto.

The method may include detaching the detachable distal tip of the helical needle from a body of the helical needle.

The method may include helically retracting the body of the helical needle from the detachable distal tip as it slides over the suture, thereby removing the helical needle from the anatomical site while leaving the suture in the anatomical site, thereby securing the cutting edge.

In some applications, the removing includes pushing the removable distal tip of the helical needle distally relative to the needle body using a pushing wire extending through the helical needle, thereby removing the removable distal tip from the needle body.

In some applications, the method may include, after cutting the tissue, removing the wire loop from the anatomical site.

In some applications, the method may include, prior to completing cutting the tissue disposed within the wire loop, advancing a clamp having a distal clamping end to the anatomical site and clamping the cut tissue into the clamping end of the clamp. The clamp and the cutting clamp tissue may be removed from the anatomical site.

In some applications, advancement of the clip through the longitudinal catheter. In some applications, the clamp is located alongside the helical needle during advancement of the clamp.

In some applications, the helical needle is maintained at a fixed distance from the fastening element during sliding of the fastening element and advancement of the helical needle.

In some applications, the anatomical site comprises a heart valve, and the tissue disposed within the wireform comprises a portion of a leaflet of the heart valve.

In some applications, advancement of the helical needle and suture occurs as the cutting edge is formed.

In some applications, distal sliding of the fastening element relative to the wire loop may be operably coupled to advancement of the helical needle. In some applications, the fastening element is distally advanceable relative to the wire loop only upon subsequent advancement of the helical needle.

In some applications, the method may include controlling sliding of the fastening element relative to the wire loop and advancement of the helical needle by a user actuating a unified engagement element of a user interface to consistently control movement of the fastening element and the helical needle.

In some applications, controlling sliding of the fastening element relative to the wire loop and advancement of the helical needle by user actuation of the unified engagement element includes controlling movement of the fastening element and the helical needle at a fixed distance from each other.

In some applications, the user interface includes a first engagement element that, when actuated, controls movement of the fastening element. In some applications, the user interface may include a second engagement element that, when actuated, controls movement of the helical needle.

In some applications, in a first operational state of the coupling element, the first engagement element and the second engagement element may be coupled to form the unified engagement element. In some applications, actuation of one of the first engagement element and the second engagement element may consistently control movement of the fastening element and the helical needle.

In some applications, the method includes ensuring that the coupling element of the user interface is in the first operational state before the fastening element is slid distally relative to the wire loop and before the helical needle is advanced.

In some applications, at least one of advancement of the wire loop and advancement of the helical needle is through the longitudinal catheter.

The above methods may be performed on living animals or mimics, such as cadavers, cadaveric hearts, simulators (e.g., simulated body parts, hearts, tissues, etc.), and the like.

According to some applications, provided herein is a method of removing tissue from a valve leaflet She Yichu of a heart valve of a subject. The method includes resecting tissue from the valve leaflet with a loop of wire to form a cutting edge. The method may include securing the cutting edges together as they are formed, and before the tissue is completely removed She Caxie from the valve.

In some applications, the securing the cutting edges together includes advancing a helical needle through the cutting edges.

In some applications, the method may include, prior to the resecting, advancing the wire loop to the heart valve by passing through a lumen longitudinal catheter.

In some applications, advancing the helical needle includes advancing the helical needle a fixed distance relative to a fastening element of the wire loop.

In some applications, the helical needle comprises a helical lumen and has a suture extending through the helical lumen. In some applications, the method may include removing the helical needle from the heart valve while the suture is attached to the cutting edge.

According to some applications, provided herein is a method of removing tissue from an anatomical site of a subject. The method includes cutting tissue engaged by a cutting device at the anatomical site using the cutting device disposed at the anatomical site, thereby forming cut tissue and a cutting edge.

The method may include, at least temporarily, securing the cutting edges together with an edge attachment device while the cutting edges are formed and before the cutting tissue is completely removed from the anatomical site.

The cut may be operably coupled to the fixed together cut edges. In some applications, the cutting device is only able to cut tissue at the anatomical site when the edge attachment device is subsequently advanced to secure the cutting edges to one another during formation of the cutting edges by the cutting device.

In some applications, the cut may be operably coupled to the fixed together cut edges. In some applications, the cutting device is only able to cut tissue at the anatomical site when the edge attachment device is subsequently advanced to a fixed distance from the cutting device.

In some applications, the method may include controlling the cutting and the securing together by a user actuating a unified engagement element of a user interface to consistently control movement of the cutting device and the edge attachment device.

In some applications, controlling the cutting and the securing together by the user actuating the unified engagement element includes controlling movement of the cutting device and the edge attachment device at a fixed distance from each other.

In some applications, the user interface includes a first engagement element that, when actuated, controls movement of the cutting device. The user interface may include a second engagement element that, when actuated, controls movement of the edge attachment device.

In some applications, the method may include, prior to the cutting and prior to the securing together, ensuring that the coupling element of the user interface is in the first operational state.

The method may include controlling the cutting and the securing together by a user actuating a unified engagement element of a user interface to consistently control movement of the cutting device and the edge attachment device.

In some applications, controlling the cutting and the securing together includes actuating the unified engagement element to control movement of the cutting device and the edge attachment device at a fixed distance from each other.

In some applications, the first operational state of the coupling element, the first engagement element and the second engagement element may be coupled to form the unified engagement element. In some applications, actuation of one of the first engagement element and the second engagement element consistently controls movement of the cutting device and the edge attachment device.

In some applications, the method may include transluminally advancing a longitudinal catheter toward the anatomical site. The longitudinal catheter may have a proximal portion and a steerable distal portion.

In some applications, the method may include distally advancing and steering the cutting device and the edge attachment device from the longitudinal catheter to the anatomical site.

In some applications, advancement and steering of the cutting device and the edge attachment device is through the longitudinal catheter.

In some applications, the method may include removing the cutting device and/or the edge attachment device from the anatomical site after the cutting and the securing together.

In some applications, the securing together includes temporarily securing the cutting edges together at the anatomical site by the edge attachment device. In some applications, the method may include permanently attaching the cutting edge at the anatomical site.

In some applications, the temporarily securing together includes advancing a needle through the cutting edge to hold them together. In some applications, the permanent attachment includes extending a suture through the needle.

In some applications, the needle is a helical needle.

In some applications, the cutting device comprises a loop of wire having a closed distal end. In some applications, a fastening element may be slidably coupled to the wire loop. Cutting the tissue may include sliding the fastening element distally relative to the wire loop that contracts the wire loop, and cutting tissue disposed within the wire loop.

In some applications, the method may include engaging the cut tissue with a clamp having a distal clamping end advanced to the anatomical site before the cut tissue is completely removed from the anatomical site.

In some applications, the method may include removing the clamp from the anatomical site, the cut tissue being clamped to the clamp after at least one of the cutting device and the edge attachment device is removed from the anatomical site.

In some applications, the method may include anchoring a tissue anchor to tissue at the anatomical site, and anchoring at least one of the cutting device and the edge attachment device to the anatomical site.

According to some applications, provided herein is a system for use with a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

In some applications, the system includes a longitudinal mount that is distally advanceable from the longitudinal catheter. The mount may have a first curved surface and a second surface.

In some applications, the system may include a helical needle defining a helical lumen. The helical needle can be configured to advance distally from the longitudinal catheter and extend axially and rotationally about the first curved surface of the longitudinal mount and through tissue of the leaflet, pulling the tissue against the second surface of the longitudinal mount.

In some applications, the system may include a suture extending through the lumen of the helical needle. In some applications, the system may include a suture that does not extend through the helical lumen, but is otherwise attached or coupled to the helical needle (in which case the needle need not have a helical lumen).

In some applications, the at least one longitudinal catheter is adapted to advance the mount of tissue adjacent the leaflet through the lumen in an advancement direction. In some applications, the at least one longitudinal catheter is further adapted to transluminally advance the spiral needle and the suture along and through the leaflet about the mount, thereby pulling tissue of the leaflet against the second surface of the mount. In some applications, the at least one longitudinal catheter is further adapted to secure the distal end of the suture. In some applications, the at least one longitudinal catheter is further adapted to remove the mount and the helical needle from the heart valve while maintaining the suture helically through the tissue of the leaflet. In some applications, the at least one longitudinal catheter is additionally adapted to tension the suture, thereby deforming the tissue of the leaflet disposed within the suture.

In some applications, the system includes at least one locking element configured to be applied to the suture by the at least one catheter after tensioning the suture to secure the suture in its tensioned state.

In some applications, the helical needle includes a needle body that terminates in a detachable distal tip, and wherein a distal end of the suture is attached to the detachable distal tip of the helical needle.

In some applications, the system includes a push wire extending through the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

In some applications, the catheter is adapted to move the helical needle by retracting the needle body helically away from the detachable distal tip after the detachable distal tip of the helical needle is detached from the needle body while sliding over and along the suture.

In some applications, the system includes a user interface that enables a user to control the motion of the catheter and its operation.

In some applications, at least one of the mount and the helical needle is adapted to be advanced to or removed from the heart chamber through the longitudinal catheter. In some applications, the mount and the helical needle are adapted to be advanced through a single lumen of the longitudinal catheter. In some applications, the longitudinal catheter includes at least two lumens, and each of the mount and the helical needle is adapted to be advanced through a different lumen of the at least two lumens of the longitudinal catheter.

In some applications, the mount has a crescent-shaped cross-section in a direction perpendicular to a longitudinal axis of the mount, the crescent-shaped shape defining an outer curved surface as the first curved surface and an inner curved surface defining a cavity as the second curved surface. In some applications, the helical needle is adapted to pull tissue into the cavity during rotation thereof.

In some applications, the first curved surface is an arc of a first circle having a first radius and the second curved surface is an arc of a second circle having a second radius. In some applications, the second radius is not less than the first radius. In some applications, when the mount is defined by the helical needle, a gap exists between the mount and the helical needle along at least a portion of the mount.

In some applications, the spiral needle comprises a shape memory material.

According to some applications, provided herein is a method of deforming a leaflet of a heart valve of a subject, the leaflet extending between a root attached to a heart wall and a lip adapted to coapt with at least one other leaflet. The method includes transluminally advancing a longitudinal catheter toward the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion.

In some applications, the method may include distally advancing a longitudinal mount from the longitudinal catheter. The longitudinal mount may have a first curved surface and a second curved surface.

In some applications, the method may include advancing a helical needle distally along and through the leaflet from the longitudinal catheter around the first curved surface of the mount, thereby pulling tissue of the leaflet against the second surface of the mount. In some applications, the helical needle includes a helical lumen and a suture extending through the helical lumen.

In some applications, the method may include, after advancement of the helical needle, securing the distal end of the suture adjacent the leaflet.

In some applications, the method may include removing the mount and the helical needle from the heart valve while maintaining the suture helically through the tissue of the leaflet.

In some applications, the method may include tensioning the suture, thereby deforming the tissue disposed within the suture.

In some applications, securing the distal end of the suture includes sliding a locking element onto the distal end of the suture to secure the distal end of the suture.

In some applications, the method includes, after tensioning the suture, sliding another locking element onto the suture to secure the suture in its tensioned state.

In some applications, the method includes, after advancement of the helical needle, removing a removable distal tip of the helical needle from a body of the helical needle. In some applications, removing the helical needle includes helically retracting the body of the helical needle from the detachable distal tip as it slides over the suture.

In some applications, at least one of advancement of the mount, advancement of the helical needle, and removal of the mount and the helical needle is performed through the longitudinal catheter. In some applications, advancement of the mount and advancement of the helical needle are performed through a single lumen of the longitudinal catheter. In some applications, advancement of the mount is through a first lumen of the longitudinal catheter and advancement of the helical needle is through a second lumen of the longitudinal catheter, the first lumen being different from the second lumen.

In some applications, the mount has a crescent-shaped cross-section in a direction perpendicular to a longitudinal axis of the mount, the crescent-shaped shape defining an outer curved surface as the first curved surface and an inner curved surface defining a cavity as the second curved surface. In some applications, the advancing of the spiral needle includes pulling tissue of the leaflet into the cavity during rotation of the spiral needle.

In some applications, the first curved surface is an arc of a first circle having a first radius and the second curved surface is an arc of a second circle having a second radius, the second radius being no less than the first radius. In some applications, the advancing of the spiral needle includes pulling tissue of the leaflet into a gap between the mount and the spiral needle during rotation of the spiral needle.

In some applications, advancing the mount includes advancing the mount along the leaflet in a direction substantially perpendicular to the lip of the leaflet, thereby deforming the tissue of the leaflet disposed within the suture to shorten a width of the leaflet.

In some applications, advancing the mount includes advancing the mount along the leaflet in a direction substantially parallel to the lip of the leaflet or the root of the leaflet, thereby deforming the tissue of the leaflet disposed within the suture to shorten a length of the leaflet between the root and the lip.

In some applications, advancing the mount includes advancing the mount along the root of the leaflet. In some applications, advancement of the spiral needle around the mount pulls tissue of the root of the leaflet, abutting a heart wall surrounding the heart valve, such that the tissue disposed within the suture deforms to shorten a length of the leaflet along the root of the leaflet.

In some applications, the advancement of the longitudinal catheter is through a coronary artery surrounding the leaflet. In some applications, advancing the spiral needle around the mount includes advancing the spiral needle through the wall of the coronary artery and through the leaflet adjacent the root of the leaflet such that the tissue disposed within the suture is deformed to shorten a length of the leaflet along the root of the leaflet.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

In some applications, the system includes an implant including a first leaflet engaging portion and a second leaflet engaging portion, the first and second leaflet engaging portions adapted to engage the lips of the leaflet. In some applications, the implant includes at least one tether extending between the first leaflet-engaging portion and the second leaflet-engaging portion.

In some applications, the at least one catheter is adapted to transluminally deliver the implant to the heart chamber adjacent the heart valve. In some applications, the at least one conduit is adapted to engage the first leaflet-engaging portion to a first position on the lip of the leaflet. In some applications, the at least one conduit is adapted to engage the second leaflet-engaging portion to a second position on the lip of the leaflet. In some applications, the at least one conduit is adapted to pull the first leaflet-engaging portion and the second leaflet-engaging portion toward each other by tensioning the at least one tether between the first leaflet-engaging portion and the second leaflet-engaging portion.

In some applications, the system comprises at least one locking element, wherein the catheter is further adapted to slide the at least one locking element onto at least one end of the at least one tether after tensioning thereof to maintain tension in the at least one tether.

In some applications, the implant includes a unitary frame having the first leaflet-engaging portion and the second leaflet-engaging portion as ends thereof. In some applications, the unitary frame includes a central portion, and first and second arm portions connecting the central portion to each of the first and second leaflet-engaging portions, respectively. In some applications, the at least one tether comprises a single tether. In some applications, a hollow lumen extends through the unitary frame, and the tether extends through the lumen and from the first leaflet engaging portion and the second leaflet engaging portion.

In some applications, the unitary frame has a resting state in which a first distance between ends of the first and second arm portions connected to the first and second leaflet-engaging portions, respectively, is greater than a second distance between ends of the first and second arm portions engaged with the central portion. In some applications, a third distance between edges of the first leaflet-engaging portion and the second leaflet-engaging portion is less than the second distance.

In some applications, the first and second arm portions are adapted to pivot relative to the central portion to reduce the second and third distances when a force pushing toward each other is applied to the leaflet engaging portions when the unitary frame is in the resting state.

In some applications, the unitary frame is substantially planar. In some applications, the unitary frame is at least one of a flexible frame and a resilient frame. In some applications, the unitary frame is formed from a shape memory material.

In some applications, the catheter is adapted to engage the first leaflet engaging portion and the second leaflet engaging portion to the lips of the leaflet when the unitary frame is in a resting state of the unitary frame. In some applications, tensioning of the tether transitions the unitary frame from the resting state to a second operating state in which edges of the first leaflet-engaging portion and the second leaflet-engaging portion are pulled toward each other relative to their positioning in the resting state.

In some applications, the catheter is adapted to engage the first and second leaflet-engaging portions with the leaflet by placing the first and second arm portions and the central portion against a downstream surface of the leaflet such that the first and second leaflet-engaging portions extend above the lip of the leaflet to the upstream surface thereof.

In some applications, the catheter is adapted to deform a portion of the lip of the leaflet between the first leaflet engaging portion and the second leaflet engaging portion by tensioning of the tether and create a bulge in the downstream surface of the leaflet. In some applications, the first arm portion and the second arm portion are adapted to be substantially perpendicular to the lip of the leaflet after the bulge is created.

In some applications, the first and second leaflet-engaging portions include first and second clips, and the catheter is adapted to engage the first and second leaflet-engaging portions to the lips of the leaflet by clamping the first and second clips to the lips of the leaflet at the first and second locations along the lips, respectively.

In some applications, the catheter is adapted to engage the first leaflet engaging portion and the second leaflet engaging portion to the lip in a direction substantially perpendicular to the lip of the leaflet.

In some applications, the at least one tether comprises a plurality of tethers, each tether connecting the first leaflet-engaging portion and the second leaflet-engaging portion to each other, and wherein the conduit is adapted to tension each tether of the plurality of tethers.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The method includes transluminally delivering an implant to a heart chamber adjacent the heart valve, the implant including a first leaflet engaging portion, a second leaflet engaging portion, and at least one tether extending between the first leaflet engaging portion and the second leaflet engaging portion.

In some applications, the method includes engaging the first leaflet engaging portion with a first location on the lip of the leaflet.

In some applications, the method includes engaging the second leaflet engaging portion with a second location on the lip of the leaflet.

In some applications, the method includes pulling the first leaflet-engaging portion and the second leaflet-engaging portion toward each other by tensioning the at least one tether between the first leaflet-engaging portion and the second leaflet-engaging portion.

In some applications, the method includes securing the at least one tether after tensioning thereof to maintain the first leaflet-engaging portion and the second leaflet-engaging portion drawn toward each other.

In some applications, the implant includes a unitary frame having the first leaflet-engaging portion and the second leaflet-engaging portion as ends thereof. In some applications, the unitary frame includes a central portion, and first and second arm portions connecting the central portion to each of the first and second leaflet-engaging portions, respectively. In some applications, the at least one tether comprises a single tether. In some applications, a hollow lumen extends through the unitary frame, and the tether extends through the lumen and from the first leaflet engaging portion and the second leaflet engaging portion. In some applications, tensioning of the tether reduces a distance between ends of the first leaflet-engaging portion and the second leaflet-engaging portion, thereby deforming the leaflet and creating a bulge in the downstream surface of the leaflet.

In some applications, the coaptation of the first and second leaflet-engaging portions includes placing the first and second arm portions and the central portion against a downstream surface of the leaflet such that the first and second leaflet-engaging portions extend above the lips of the leaflet to the upstream surface thereof.

In some applications, the first leaflet engaging portion and the second leaflet engaging portion include a first clip and a second clip, and the engaging of the first leaflet engaging portion includes clamping the first clip to the lip of the leaflet at a first location and clamping the second clip to the lip at a second location.

In some applications, the first clip and the second clip into a direction substantially perpendicular to the lips of the leaflet.

In some applications, the at least one tether comprises a plurality of tethers, each tether connecting the first leaflet-engaging portion and the second leaflet-engaging portion to each other, and wherein the tensioning comprises tensioning each tether of the plurality of tethers.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. In some applications, the longitudinal catheter may have a proximal portion and a steerable distal portion with a longitudinal axis therebetween.

In some applications, the system comprises a penetrating implant comprising: a piercing element comprising a base from which a piercing tip extends; and a fixation element adapted to fix the piercing tip of the piercing element.

In some applications, the at least one catheter is adapted to transluminally deliver the penetrating implant to the heart chamber. In some applications, the at least one implant may be adapted to create a folded region of the leaflet by folding the leaflet. In some applications, the at least one implant may be adapted to insert the piercing tip of the piercing element through at least two layers of the leaflet at the fold region. In some applications, the at least one implant may be adapted to secure the at least one fold at the fold region by connecting the fixation element to the piercing tip of the piercing element such that the base of the piercing element and the fixation element are on the same side of the leaflet with the at least two layers disposed therebetween.

In some applications, the fixation element includes a cylindrical housing defining a hollow adapted to receive the piercing tip. In some applications, the fixation element comprises an elastomer.

In some applications, the at least one catheter is adapted to transluminally deliver the penetrating implant to the heart chamber while the penetrating tip is secured by the securing element. In some applications, the at least one catheter is further adapted to separate the piercing element or the piercing tip from the fixation element prior to insertion of the piercing tip of the piercing element.

In some applications, the at least one catheter is adapted to transluminally deliver the penetrating implant to the heart chamber upon separation of the penetrating member from the fixation member.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The method includes transluminally delivering a penetrating implant to a heart chamber adjacent the heart valve, the penetrating implant including: a piercing element having a base from which a piercing tip extends; and a fixation element adapted to fix the piercing tip of the piercing element.

In some applications, the method includes creating a folded region of the leaflet by folding the leaflet into at least one fold.

In some applications, the method includes inserting the piercing tip of the piercing element through at least two layers of the leaflet at the fold region.

In some applications, the method includes securing the at least one fold at the fold region by connecting the securing element to the piercing tip of the piercing element.

In some applications, after the securing, the base of the penetrating element and the securing element are on the same side of the leaflet with the at least two layers disposed therebetween.

In some applications, the fixation element comprises a cylindrical housing defining a hollow. In some applications, wherein the securing includes inserting the piercing tip into the hollow.

In some applications, the fixation element comprises an elastomer. In some applications, the securing includes penetrating the piercing tip into the elastomer.

In some applications, the transluminal delivery includes transluminal delivery of the penetrating implant to the heart chamber when the penetrating tip is secured by the securing element. In some applications, the method includes, after the transluminal delivery and prior to the insertion, separating the penetrating element or the penetrating tip from the fixation element.

In some applications, the transluminal delivery includes transluminal delivery of the penetrating implant to the heart chamber when the penetrating member is separated from the fixation member.

In some applications, the generating a fold region includes generating a fold region disposed at an upstream side of the heart valve. In some applications, after the securing, the base of the penetrating element and the securing element are on the upstream side of the leaflet.

In some applications, the generating a fold region includes generating a fold region disposed at a downstream side of the heart valve. In some applications, after the securing, the base of the penetrating element and the securing element are on the downstream side of the leaflet.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve, the small She Baohan first and second notches. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

In some applications, the system comprises a tether implant comprising: a tether, the tether having a proximal end and a distal end; and at least one locking element adapted to secure at least one end of the tether.

In some applications, the at least one catheter is adapted to transluminally deliver the tether to the heart chamber. In some applications, the at least one catheter may be adapted to pass the distal end of the tether from a first side of the leaflet through the first notch in the leaflet to a second side of the leaflet. In some applications, the at least one conduit may be adapted to additionally pass the distal end of the tether from the second side of the leaflet through the second notch in the leaflet to the first side of the leaflet. In some applications, the at least one conduit may be adapted to tension the tether through the first and second notches to pull the first and second notches toward each other. In some applications, the at least one catheter may be adapted to secure the proximal and distal ends of the tether using the at least one locking element to maintain tension in the tether.

In some applications, the system includes a grasping tool extending distally from the at least one longitudinal catheter. In some applications, the grasping tool is adapted to grasp the distal end of the tether during passage of the distal end through the catheter.

In some applications, the tether implant comprises a plurality of tethers, each tether having a corresponding proximal end and a corresponding distal end. In some applications, the tether implant comprises a plurality of locking elements adapted to secure at least one end of each of the plurality of tethers. In some applications, the catheter is adapted to deliver, pass through, otherwise pass through, tension, and secure each tether of the plurality of tethers.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve, the small She Baohan first and second notches. The method includes transluminally delivering a tether to a heart chamber adjacent the heart valve, the tether having a proximal end and a distal end.

In some applications, the method includes passing the distal end of the tether from a first side of the leaflet through the first notch in the leaflet to a second side of the leaflet.

In some applications, the method includes additionally passing the distal end of the tether from the second side of the leaflet through the second notch in the leaflet to the first side of the leaflet.

In some applications, the method includes tensioning the tether through the first and second notches to pull the first and second notches toward each other.

In some applications, the method includes, after the tensioning, securing the proximal end and the distal end of the tether using at least one locking element to maintain tension in the tether.

In some applications, at least one of the traversing and the additional traversing includes grasping the distal end of the tether using a grasping tool extending distally from the at least one longitudinal catheter.

In some applications, the steps of transluminal delivery, traversing, additional traversing, tensioning, and securing are performed for each tether of the plurality of tethers.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. In some applications, the longitudinal catheter has a proximal portion and a steerable distal portion with a longitudinal axis therebetween.

In some applications, the system includes an implant including a first beam, a second beam, and a third beam, and having a first operational state and a second operational state.

In some applications, the at least one catheter is adapted to transluminally deliver the implant to the heart chamber. In some applications, the at least one catheter is adapted to place the implant onto the leaflet in the first operational state. In some applications, the at least one conduit is adapted to transition the implant from the first operational state toward the second operational state, thereby causing the leaflet to follow a tortuous path between the first beam and the third beam.

In some applications, at least two of the first beam, the second beam, and the third beam are substantially parallel to one another in at least one of the first operating state and the second operating state.

In some applications, the implant is at least one of a flexible implant and a resilient implant. In some applications, the implant comprises a resilient metal. In some applications, the implant comprises a shape memory material. In some applications, the implant includes an elastic component.

In some applications, the catheter is adapted to place the implant on the leaflet in the first operational state by placing the implant such that the lip of the leaflet engages a portion of the implant and the first, second, and third beams are substantially perpendicular to the lip of the implant.

In some applications, the catheter is adapted to place the implant on the leaflet in the first operational state such that two of the first, second, and third beams are disposed on or near one side of the leaflet and the remaining ones of the first and third beams are disposed on or near the opposite side of the leaflet.

In some applications, the implant includes a base from which a plurality of beams including the first beam, the second beam, and the third beam extend. In some applications, each beam of the plurality of beams has an end distal from the base. In some applications, the first beam, the second beam, and the third beam are substantially parallel to one another. In some applications, in the first operational state, the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams. In some applications, in the second operational state, the base and the ends of the first, second, and third beams are in a single plane.

In some applications, the plurality of beams includes at least five beams. A first subset of the plurality of beams includes one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams includes the other two of the first beam, the second beam, and the third beam. In some applications, the first subset and the second subset of the plurality of beams are mutually exclusive. In some applications, in the first operating state, the plane is defined by the ends and the base of all beams in the second subset, and the ends of all beams in the first subset are disposed outside the plane. In some applications, in the second operational state, the base and the ends of the beams in the first and second subsets are in the single plane.

In some applications, in the first operating state, the ends of all beams in the first subset are disposed in a second plane that is angled with respect to the plane.

In some applications, the first beam, the second beam, and the third beam are substantially perpendicular to the base in at least one of the first operating state and the second operating state.

In some applications, the catheter is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the base extends along the lip of the leaflet, thereby placing the implant onto the leaflet.

In some applications, the implant includes first and second U-shaped portions, each U-shaped portion including a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other. In some applications, the implant includes engagement elements that hold the second beam of each of the first and second U-shaped portions together to form a unified beam.

In some applications, the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion. In some applications, the second beams of the first and second U-shaped portions may pivot relative to the engagement element about respective longitudinal axes of the second beams such that the first and second U-shaped portions may pivot relative to one another.

In some applications, the first U-shaped portion and the second U-shaped portion are identical to each other.

In some applications, the engagement element comprises a longitudinally extending cylinder.

In some applications, in the first operational state, the first U-shaped portion and the second U-shaped portion are substantially in a single plane, and in the second operational state, the unified beam is disposed outside of a plane formed by the first beams of the first U-shaped portion and the second U-shaped portion.

In some applications, in the first operating state, a first distance exists between the first beams of the first and second U-shaped portions, and in the second operating state, a second distance exists between the first beams of the first and second U-shaped portions, the second distance being less than the first distance.

In some applications, the catheter is adapted to rotate the first and second U-shaped portions relative to one another, thereby transitioning the implant from the first operational state to the second operational state.

In some applications, the catheter is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the bases of the first and second U-shaped portions extend along the lip of the leaflet, the unified beam is disposed on or near one side of the leaflet, and the first beams of the first and second U-shaped portions are disposed on or near the opposite side of the leaflet, thereby placing the implant onto the leaflet.

In some applications, the implant includes a central U-shaped portion including a pair of central beams and a connecting section. In some applications, the implant includes a first side portion and a second side portion, each side portion including at least one beam and being connected to one of the center beams by a respective one of the first and second bends. In some applications, the at least one beam of each of the first side portion and the second side portion is substantially parallel to at least one of the center beams. In some applications, the first and second flexures facilitate movement of the respective first and second side portions in at least two directions relative to the pair of center beams.

In some applications, in the first operational state, the central U-shaped portion is in the first plane and each of the first and second side portions is in a different plane than the first plane and is disposed outside of the central U-shaped portion. In some applications, in the second operational state, the central U-shaped portion and the first and second side portions are in the first plane, wherein the first and second side portions are disposed within the central U-shaped portion.

In some applications, the implant is formed from a single length of flexible or resilient material.

In some applications, each of the first and second side portions includes a pair of side rails connected to one another by an additional bend, the pair of side rails being substantially parallel to one another.

In some applications, the implant is laterally symmetrical about a central longitudinal axis of the central U-shaped portion.

In some applications, in the first operating state, a first distance exists between the first side portion and the second side portion, and in the second operating state, a second distance exists between the first side portion and the second side portion, the second distance being less than the first distance.

In some applications, the implant has an intermediate operational state in which the first side portion and the second side portion are in the first plane and disposed outside of the central U-shaped portion. In some applications, for transitioning the implant from the first operational state to the second operational state, the catheter is adapted to transition the implant from the first operational state to the intermediate operational state by pivoting the first and second side portions in a first direction relative to the central U-shaped portion to place the first and second side portions into the first plane, and to transition the implant from the intermediate operational state further to the second operational state by rotating the first and second side portions in a second direction relative to the central U-shaped portion to move the first and second side portions into the interior of the central U-shaped portion.

In some applications, the first direction is about an axis perpendicular to a longitudinal axis of the center beam and the second direction is about an axis parallel to the longitudinal axis of the center beam.

In some applications, the catheter is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the first and second bends engage with the lip of the leaflet and the connection section of the U-shaped portion is distal to the lip of the leaflet, wherein the U-shaped portion is disposed on or near one side of the leaflet and the first and second side portions are disposed on or near the opposite side of the leaflet, thereby placing the implant onto the leaflet.

In some applications, the catheter is adapted to transluminally deliver the implant to the heart chamber when the implant is in the first operational state.

In some applications, the catheter is adapted to transluminally deliver the implant to the heart chamber when the implant is in a ready-to-operate state, wherein the first side portion and the second side portion are in the first plane and outside of the central U-shaped portion. In some applications, the catheter is further adapted to transition the implant from the ready-to-operate state to the first operating state by pivoting the first and second side portions relative to the U-shaped portion about an axis perpendicular to the longitudinal axis of the central beam prior to placement of the implant on the leaflet.

In some applications, the implant includes a tubular body disposed along a central longitudinal axis. In some applications, the implant includes a first substantially U-shaped clip and a second substantially U-shaped clip, each substantially U-shaped clip having: a first elongate portion disposed on or adjacent an outer surface of the tubular body; and a second elongate portion disposed on or near an inner surface of the tubular body, the first and second elongate portions being connected by an end portion. In some applications, the implant includes a resilient element that holds the second elongated portions of the first clip and the second clip together.

In some applications, in the first operating state, the clip is disposed on a first side of the tubular body, and in the second operating state, the clip is disposed on a second side of the tubular body, the second side being opposite the first side.

In some applications, the catheter is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the end portion engages with the lip of the leaflet, wherein the tubular body and the second elongated portion of the first and second clips are disposed on or near one side of the leaflet and the first elongated portions of the first and second clips are disposed on or near an opposite side of the leaflet, thereby placing the implant onto the leaflet.

In some applications, the catheter is adapted to transluminally deliver the implant to the heart chamber when the U-clip is separated from the tubular body. In some applications, the catheter is further adapted to place the first clip and the second clip onto the tubular body prior to or during placement of the implant onto the leaflet.

In some applications, the catheter is adapted to transition the implant from the first operational state to the second operational state by pulling the first clip and the second clip apart from each other around the circumference of the tubular body and against the force of the resilient element.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The method includes transluminally delivering an implant having a first operational state and a second operational state to a heart chamber adjacent the heart valve, the implant including a first beam, a second beam, and a third beam.

In some applications, the method includes placing the implant onto the leaflet in the first operational state.

In some applications, the method includes causing the leaflet to follow a tortuous path between the first beam and the third beam by transitioning the implant from the first operational state toward the second operational state while the implant is on the leaflet.

In some applications, the placement of the implant includes placing the implant such that the lips of the leaflets engage a portion of the implant and the first, second, and third beams are substantially perpendicular to the lips of the implant.

In some applications, the placement of the implant includes placing the implant onto the leaflet in the first operating state such that two of the first, second, and third beams are disposed on or near one side of the leaflet and the remaining ones of the first and third beams are disposed on or near the opposite side of the leaflet.

In some applications, the implant includes a base from which extends a plurality of beams including the first beam, the second beam, and the third beam, each beam of the plurality of beams having an end remote from the base, the first beam, the second beam, and the third beam being substantially parallel to one another. In some applications, in the first operational state, the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams. In some applications, in the second operational state, the base and the ends of the first, second, and third beams are in a single plane. In some applications, the transition of the implant from the first operational state toward the second operational state includes moving the ends of the first, second, and third beams relative to one another such that the ends of the first, second, and third beams are in the single plane.

In some applications, the plurality of beams includes at least five beams, a first subset of the plurality of beams includes one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams includes another two of the first beam, the second beam, and the third beam, the first subset and the second subset of the plurality of beams being mutually exclusive. In some applications, in the first operating state, the plane is defined by the ends and the base of all beams in the second subset, and the ends of all beams in the first subset are disposed outside the plane. In some applications, in the second operational state, the base and the ends of the beams in the first and second subsets are in the single plane.

In some applications, placing the implant onto the leaflet includes sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that the base extends along the lip of the leaflet with one of the first, second, and third beams on one side of the leaflet and the other two of the first, second, and third beams on the opposite side of the leaflet.

In some applications, the implant comprises a first U-shaped portion and a second U-shaped portion, each U-shaped portion comprising: a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other; and an engagement element that holds the second beam of each of the first and second U-shaped portions together to form a unified beam.

In some applications, the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion.

In some applications, the second beams of the first and second U-shaped portions may pivot relative to the engagement element about respective longitudinal axes of the second beams such that the first and second U-shaped portions may pivot relative to one another.

In some applications, the transitioning of the implant includes rotating the first U-shaped portion and the second U-shaped portion relative to one another.

In some applications, placement of the implant includes sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that the bases of the first and second U-shaped portions extend along the lip of the leaflet, the unified beam is disposed on or near one side of the leaflet, and the first beams of the first and second U-shaped portions are disposed on or near the opposite side of the leaflet.

In some applications, the implant includes a central U-shaped portion including a pair of central beams and a connecting section, and first and second side portions, each side portion including at least one beam and connected to one of the central beams by a respective one of first and second bends.

In some applications, the at least one beam of each of the first side portion and the second side portion is substantially parallel to at least one of the center beams. In some applications, the first and second flexures facilitate movement of the respective first and second side portions in at least two directions relative to the pair of center beams.

In some applications, in the first operational state, the central U-shaped portion is in the first plane and each of the first and second side portions is in a plane different from the first plane and is disposed outside of the central U-shaped portion, and in the second operational state, the central U-shaped portion and the first and second side portions are in the first plane, wherein the first and second side portions are disposed within the central U-shaped portion.

In some applications, the implant has an intermediate operational state in which the first side portion and the second side portion are in the first plane and disposed outside of the central U-shaped portion. In some applications, transitioning the implant from the first operational state toward the second operational state includes transitioning the implant from the first operational state to the intermediate operational state by pivoting the first side portion and the second side portion in a first direction relative to the central U-shaped portion to place the first side portion and the second side portion into the first plane. In some applications, the transitioning includes transitioning the implant from the intermediate operating state to the second operating state by rotating the first and second side portions in a second direction relative to the central U-shaped portion to move the first and second side portions into the interior of the central U-shaped portion.

In some applications, placement of the implant includes sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that the first and second bends engage with the lip of the leaflet and the connection section of the U-shaped portion is distal to the lip of the leaflet, with the U-shaped portion disposed on or near one side of the leaflet and the first and second side portions disposed on or near the opposite side of the leaflet.

In some applications, the transluminal delivery includes transluminal delivery of the implant to the heart chamber when the implant is in the first operating state.

In some applications, the transluminal delivery includes transluminal delivery of the implant to the heart chamber when the implant is in a ready-to-operate state, wherein the first side portion and the second side portion are in the first plane and outside of the central U-shaped portion. In some applications, the method includes transitioning the implant from the ready operating state toward the first operating state prior to placement of the implant.

In some applications, the transition of the implant from the ready state includes pivoting the first side portion and the second side portion relative to the U-shaped portion about an axis perpendicular to a longitudinal axis of the center beam.

In some applications, the implant comprises: a tubular body disposed along a central longitudinal axis; a first substantially U-shaped clip and a second substantially U-shaped clip, each substantially U-shaped clip having: a first elongate portion disposed on or adjacent an outer surface of the tubular body; and a second elongate portion disposed on or near an inner surface of the tubular body, the first and second elongate portions being connected by an end portion; and a resilient element holding the second elongated portions of the first and second clips together.

In some applications, placement of the implant includes sliding the implant onto the lips of the leaflet when the implant is in the first operating state such that the end portion engages with the lips of the leaflet, wherein the tubular body and the second elongated portion of the first and second clips are disposed on or near one side of the leaflet and the first elongated portions of the first and second clips are disposed on or near an opposite side of the leaflet.

In some applications, the transluminal delivery includes transluminal delivery of the implant to the heart chamber when the U-shaped clip is separated from the tubular body. In some applications, the method includes sliding the first clip and the second clip onto the tubular body to form the first operational state prior to or during placement of the implant.

In some applications, the transitioning of the implant includes pulling the first clip and the second clip apart from one another around the circumference of the tubular body and against the force of the resilient element.

In some applications, the system comprises an implant comprising: a core; and a fixation element adapted to fix tissue around the core.

In some applications, the at least one catheter is adapted to transluminally deliver the implant to the heart chamber. In some applications, the at least one catheter is adapted to position a portion of the leaflet around the core by placing the core against the first surface of the leaflet. In some applications, the at least one conduit is adapted to secure the portion of the leaflet extending around the core from a second opposing surface of the leaflet using the securing element, thereby deforming the region of the leaflet.

In some applications, the core and the fixation element are configured and arranged to cooperate with each other to retain the core and the fixation element in their implanted position on the leaflet.

In some applications, the at least one conduit comprises: a first catheter adapted to transluminally deliver the core; and a second catheter adapted to transluminally deliver the fixation element.

In some applications, the core comprises a tubular core and the fixation element comprises a fixation clip having a first longitudinal portion and a second longitudinal portion connected by an end portion.

In some applications, the catheter is adapted to position the portion of the leaflet around the tubular core when a longitudinal axis of the tubular core is substantially perpendicular to the lip of the leaflet.

In some applications, the catheter is adapted to secure the portion of the leaflet around the tubular core by the fixation clip when the first and second longitudinal portions of the fixation clip are substantially perpendicular to the lip of the leaflet.

In some applications, the catheter is adapted to place the fixation clip such that the end portion thereof is distal from the lip of the leaflet, thereby securing the portion of the leaflet extending around the core.

In some applications, the catheter is adapted to puncture tissue of the leaflet extending around the core while securing the portion of the leaflet.

In some applications, once the fixation element is fixed, the catheter is further adapted to remove the core from the heart valve such that the leaflets remain fixed only by the fixation element.

In some applications, the core includes first and second plates having a neck portion therebetween, the plates having a larger diameter than the neck portion such that a recess is formed between the plates around the neck portion. In some applications, the fixation element includes a panel having a groove formed therein, the groove having a plate receiving area and a neck receiving area, the plate receiving area adapted to receive one of the first plate and the second plate of the core, and the neck receiving area adapted to receive the neck of the core, wherein the first plate extends on one side of the panel and the second plate extends on an opposite side of the panel.

In some applications, the first plate and the second plate are substantially the same size. In some applications, the first plate and the second plate are substantially parallel to each other.

In some applications, the plate receiving area is sized to allow at least one of the first plate and the second plate to pass therethrough, and the neck receiving area is sized to limit the first plate and the second plate to pass therethrough.

In some applications, the thickness of the face plate is less than the height of the recess of the core.

In some applications, the catheter is adapted to position a portion of the leaflet about the core by placing the first plate against the first surface of the leaflet. In some applications, the catheter is adapted to secure the portion of the leaflet extending around the core by inserting the first plate on which the portion of the leaflet is disposed into the plate receiving region of the panel and moving the panel relative to the core such that the neck portion of the core slides into the neck receiving portion while the first plate and the second plate remain outside the panel on opposite sides thereof.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve. The method includes transluminally delivering an implant to a heart chamber adjacent the heart valve, the implant including a core and a fixation element adapted to fix tissue around the core.

In some applications, the method includes disposing a portion of the leaflet about the core by placing the core against a first surface of the leaflet.

In some applications, the method includes securing the portion of the leaflet extending around the core from a second opposing surface of the leaflet using the securing element, thereby causing deformation of the region of the leaflet.

In some applications, the transluminal delivery includes transluminal delivery of the core to a first heart chamber adjacent the first surface of the leaflet using a first catheter, and transluminal delivery of the fixation element to a second heart chamber adjacent the second opposing surface of the leaflet using a second catheter.

In some applications, the core comprises a tubular core and the fixation element comprises a fixation clip having a first longitudinal portion and a second longitudinal portion connected by an end portion. In some applications, the disposing includes disposing the portion of the leaflet around the tubular core when a longitudinal axis of the tubular core is substantially perpendicular to the lip of the leaflet. In some applications, the securing includes securing the portion of the leaflet around the tubular core when the first and second longitudinal portions of the securing clip are substantially perpendicular to the lip of the leaflet.

In some applications, after the securing, the end portion of the securing clip is distal from the lip of the leaflet.

In some applications, the securing includes puncturing the tissue of the leaflet with the securing clip.

In some applications, the method includes, after the securing, removing the core from the heart valve such that the leaflets remain secured only by the securing element.

In some applications, the core includes first and second plates having a neck portion therebetween, the plates having a larger diameter than the neck portion such that a recess is formed between the plates around the neck portion. In some applications, the fixation element includes a panel having a groove formed therein, the groove having a plate receiving area and a neck receiving area, the plate receiving area adapted to receive one of the first plate and the second plate of the core, and the neck receiving area adapted to receive the neck of the core, wherein the first plate extends on one side of the panel and the second plate extends on an opposite side of the panel. In some applications, the positioning includes positioning a portion of the leaflet about the core by placing the first plate against the first surface of the leaflet.

In some applications, the securing includes inserting the first plate on which the portion of the leaflet is disposed into the plate-receiving region of the panel and moving the panel relative to the core such that the neck portion of the core slides into the neck-receiving portion while the first plate and the second plate remain outside the panel on opposite sides thereof, securing the portion of the leaflet surrounding the inclusion.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The system may include a constraint implant.

In some applications, the at least one longitudinal catheter is adapted to transluminally deliver the constraining implant to the heart chamber and constrain the lip using the constraining implant so as to present the intermediate region as an alternative apposition surface to the at least one other leaflet.

In some applications, the catheter is adapted to fold the leaflet to present the intermediate region thereof prior to use of the constraint implant.

In some applications, the alternate apposition surface comprises at least a portion of the fixation element.

In some applications, the conduit is adapted to constrain the lip of the leaflet to a downstream surface of the leaflet.

In some applications, the constraining element comprises a U-shaped clip and the catheter is adapted to constrain the lip by folding the lip toward the downstream surface of the leaflet and securing the fold using the U-shaped clip.

In some applications, the constraining element includes a plurality of U-shaped pins, and the catheter is adapted to constrain the lip by folding the lip toward the downstream surface of the leaflet and securing the fold by positioning the U-shaped pins at a plurality of positions along the fold.

In some applications, the catheter is adapted to constrain the lips of the leaflet to a heart wall downstream of the heart valve.

In some applications, the constraining element includes at least one tissue anchor, and the catheter is adapted to anchor the lip of the leaflet to the heart wall using the at least one tissue anchor.

In some applications, the restraining element comprises at least one pledget having a first end portion and a second end portion connected by a longitudinal portion, the first end portion and the second end portion having a larger cross-section than the longitudinal portion. In some applications, the catheter is adapted to constrain the lips of the leaflet at the fold by anchoring the first end of the at least one pledget to a first location in the heart wall upstream of the heart valve and anchoring the second end of the at least one pledget to a second location in the heart wall downstream of the heart valve by the lips of the leaflet such that the longitudinal portion of the at least one pledget extends along a surface of the leaflet from the first location to the second location.

In some applications, the catheter is adapted to anchor the first end and the second end of the at least one pledget into the coronary sinus adjacent the heart wall.

In some applications, the catheter is adapted to anchor the first and second ends of the at least one pledget into a coronary artery within the heart wall.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip. The method includes transluminally delivering a constraining element to the heart chamber adjacent the heart valve.

In some applications, the method includes presenting the intermediate region as an alternative apposition surface for apposition with the at least one other leaflet by constraining the lip using the constraining element.

In some applications, the alternate apposition surface includes at least a portion of the constraining element.

In some applications, the constraining includes folding the leaflet to present the intermediate region.

In some applications, the constraining element includes a generally U-shaped clip and the constraining includes folding the lip of the leaflet toward the downstream surface of the leaflet and securing the fold using the U-shaped clip.

In some applications, the constraining element includes a plurality of U-shaped pins and the constraining includes folding the lips of the leaflet toward the downstream surface of the leaflet and securing the fold at a plurality of positions along the fold using the U-shaped pins.

In some applications, the constraining includes constraining the lips of the leaflet to a heart wall downstream of the heart valve.

In some applications, the constraining element includes at least one tissue anchor, and the constraining includes anchoring the lip of the leaflet to the heart wall.

In some applications, the restraining element comprises at least one pledget having a first end portion and a second end portion connected by a longitudinal portion, the first end portion and the second end portion having a larger cross-section than the longitudinal portion. In some applications, the constraining includes anchoring the first end of the at least one pledget to a first location in the heart wall upstream of the heart valve, and anchoring the second end of the at least one pledget to a second location in the heart wall downstream of the heart valve by the lip of the leaflet such that the longitudinal portion of the at least one pledget extends along an upstream surface of the leaflet from the first location to the second location.

In some applications, the first end and the second end of the at least one pledget are anchored in the coronary sinus adjacent the heart wall.

In some applications, the first end and the second end of the at least one tampon are anchored in a coronary artery within the heart wall.

The system may include an implant including a constraint element and a manual apposition element.

In some applications, the at least one longitudinal catheter is adapted to transluminally deliver the constraining element and the artificial apposition element to the heart chamber. In some applications, the at least one conduit is adapted to constrain the lip using the constraining implant so as to present the intermediate region. In some applications, the at least one catheter is adapted to mount the artificial apposition element onto the intermediate region of the leaflet so as to present an artificial apposition surface for apposition with the at least one other leaflet.

In some applications, the artificial apposition element comprises a shape memory material. In some applications, the artificial apposition element comprises a wire mesh.

In some applications, the catheter is adapted to transluminally deliver the artificial apposition element to the heart chamber in a compressed form and allow the artificial apposition element to decompress after delivery or its installation.

In some applications, the at least one conduit comprises: a first catheter adapted to transluminally deliver the constraining element; and a second catheter adapted to transluminally deliver the artificial apposition element.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip. The method includes transluminally delivering a constraining element and a prosthetic coaptation element to the heart chamber adjacent the heart valve.

The method may include presenting the intermediate region of the leaflet by constraining the lip of the leaflet with the constraining element.

In some applications, the method includes presenting a manual apposition surface for apposition with the at least one other leaflet by mounting the manual apposition element onto the middle region of the leaflet.

In some applications, the method includes, prior to constraining the lips of the leaflet, folding the leaflet to present the middle region thereof.

In some applications, the constraining element includes at least one tissue anchor, and the constraining includes anchoring the lip of the leaflet to the heart wall using the at least one tissue anchor.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The system includes a leaflet-engaging surface implant that includes a flexible leaflet-engaging surface and a tether.

In some applications, the at least one longitudinal catheter is adapted to transluminally deliver the leaflet-engaging surface implant to the heart chamber. In some applications, the at least one conduit is adapted to attach the leaflet-engaging surface to a surface of the leaflet using the tether. In some applications, the at least one conduit is adapted to deform the leaflet engaging surface when attached to the leaflet, thereby deforming or shortening the leaflet along at least one dimension thereof.

In some applications, the leaflet-engaging surface is inelastic. In some applications, the catheter is adapted to deform the leaflet-engaging surface by tensioning the tether that attaches the leaflet-engaging surface to the surface of the leaflet. In some applications, the catheter is further adapted to fix tension in the tether to maintain the leaflet in a deformed or shortened orientation.

In some applications, the leaflet-engaging surface is elastic. In some applications, the catheter is further adapted to stretch the leaflet-engaging surface prior to its attachment to the surface of the leaflet and attach the leaflet-engaging surface to the surface of the leaflet in a stretched position. In some applications, the catheter is adapted to deform the leaflet engaging surface by releasing tension of the leaflet engaging surface after attachment to the surface of the leaflet.

In some applications, the at least one conduit comprises at least two conduits adapted to hold opposite sides of the leaflet engaging surface for stretching the leaflet engaging surface.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve. The method includes transluminally delivering a leaflet-engaging surface implant to the heart chamber adjacent the heart valve, the leaflet-engaging surface implant including a tether and a leaflet-engaging surface.

In some applications, the method includes attaching the leaflet-engaging surface to a surface of the leaflet using the tether.

In some applications, the method includes deforming the leaflet engagement surface when attached to the leaflet, thereby deforming or shortening the leaflet along at least one dimension thereof.

In some applications, the leaflet-engaging surface is inelastic. In some applications, the deformation of the leaflet-engaging surface includes tensioning the tether that attaches the leaflet-engaging surface to the surface of the leaflet. In some applications, the method includes fixing tension in the tether to maintain the leaflet in a deformed or shortened orientation.

In some applications, the leaflet-engaging surface is elastic. In some applications, the method includes stretching the leaflet-engaging surface prior to attaching the leaflet-engaging surface to the surface of the leaflet. In some applications, the attaching includes attaching the leaflet-engaging surface to the surface of the leaflet in a stretched position. In some applications, the deforming includes releasing the stretching of the leaflet-engaging surface after the attaching.

In some applications, the stretching includes pulling opposite sides of the leaflet-engaging surface away from each other using two conduits.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root of the leaflet being adjacent a coronary artery. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The system includes an implant comprising: a guidewire having a first end and a second end; and first and second tampons adapted to be attached to respective first and second ends of the guide wire.

In some applications, the at least one longitudinal catheter is adapted to transluminally deliver the guidewire and the first and second tampons to the heart chamber via the coronary arteries. In some applications, the at least one longitudinal catheter is adapted to pierce the first end of the guidewire through two locations in the leaflet, thereby forming a fold in the leaflet, the two locations and the fold being between the root of the leaflet and the lip of the leaflet. In some applications, the at least one longitudinal catheter is adapted to deploy the first and second tampons at the first and second ends of the guidewire while tensioning the guidewire to maintain the fold in the leaflet and reduce the length of the leaflet from the root to the lip.

In some applications, the system includes a tampon delivery system adapted to transluminally deliver the first tampon over the guidewire to the first end of the guidewire through the at least one catheter and through the coronary artery.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root of the leaflet being adjacent a coronary artery. The method includes transluminally delivering an implant through the coronary artery to a heart chamber adjacent the heart valve, the implant including: a guidewire having a first end and a second end; and first and second tampons adapted to be attached to respective first and second ends of the guide wire.

The method may include piercing the first end of the guidewire through two locations in the leaflet, thereby forming a fold in the leaflet, the two locations and the fold being between the root of the leaflet and the lip of the leaflet.

The method may include deploying the first and second tampons at the first and second ends of the guidewire while tensioning the guidewire to maintain the fold in the leaflet and reduce a length of the leaflet from the root to the lip.

According to some applications, provided herein is a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root of the leaflet being attached to a heart wall. The system includes at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve. The longitudinal catheter may have a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The system may include a clip implant including a polymer having: a clip portion defining a bend; and a wire finger attached to the clip portion.

In some applications, the at least one longitudinal catheter is adapted to transluminally deliver the clip implant to the heart chamber. In some applications, the at least one catheter is adapted to mount the clip implant onto the leaflet such that the curve engages the lip of the leaflet and the wire fingers extend to a point of contact between the root of the leaflet and the heart wall such that the clip implant mechanically constrains the leaflet flails.

In some applications, the wire portion is substantially U-shaped and comprises two longitudinal portions connected by an end portion, and wherein the catheter is adapted to mount the clip implant such that the end portion is disposed at the contact point.

In some applications, the catheter is adapted to mount the clip implant such that the wire portion is disposed against or adjacent to a downstream surface of the leaflet.

According to some applications, provided herein is a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root of the leaflet being attached to a heart wall. The method includes transluminally delivering to a heart chamber adjacent the heart valve by a clip implant, the clip implant including a polymer having: a clip portion defining a bend; and a wire finger attached to the clip portion.

The method may include mounting the clip implant onto the leaflet such that the curve engages the lip of the leaflet and the wire fingers extend to a contact point between the root of the leaflet and the heart wall such that the clip implant mechanically constrains the leaflet flails.

In some applications, the mounting includes mounting the clip implant such that the wire portion is disposed against or adjacent a downstream surface of the leaflet.

According to some applications, provided herein is a system for use with leaflets of a heart valve of a subject. The system may include a catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

In some applications, the system may include a device including a first beam, a second beam, and a third beam, and having a first operational state and a second operational state.

The catheter may be adapted to transluminally deliver the device to the heart chamber. In some applications, the catheter may be adapted to position the device at the leaflet in the first operational state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet. In some applications, the catheter is configured to transition the device from the first operational state toward the second operational state when the first beam and the third beam remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet.

In some applications, the device is an implant. In some applications, the implant is at least one of a flexible implant and a resilient implant. In some applications, the implant comprises a resilient metal. In some applications, the implant comprises a shape memory material. In some applications, the implant includes an elastic component.

In some applications, the catheter is adapted to position the implant on the leaflet in the first operating state by positioning the implant such that the first, second, and third beams are substantially perpendicular to the lips of the leaflet.

In some applications, the implant includes a base from which extends a plurality of beams including the first beam, the second beam, and the third beam, each beam of the plurality of beams having an end remote from the base, the first beam, the second beam, and the third beam being substantially parallel to one another. In some applications, in the first operational state, the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams. In some applications, in the second operational state, the base and the ends of the first, second, and third beams are in a single plane.

In some applications, the plurality of beams includes at least five beams. In some applications, a first subset of the plurality of beams includes one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams includes another two of the first beam, the second beam, and the third beam, the first subset and the second subset of the plurality of beams being mutually exclusive. In the first operating state, the plane is defined by the ends and the base of all beams in the second subset, and the ends of all beams in the first subset are disposed outside the plane. In some applications, in the second operational state, the base and the ends of the beams in the first and second subsets are in the single plane.

In some applications, the catheter is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the base extends along the lip of the leaflet, thereby positioning the implant on the leaflet.

In some applications, the implant includes first and second U-shaped portions, each U-shaped portion including a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other. The implant may include engagement elements that hold the second beam of each of the first and second U-shaped portions together to form a unified beam. In some applications, the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion. The second beams of the first and second U-shaped portions are pivotable relative to the engagement element about respective longitudinal axes of the second beams such that the first and second U-shaped portions are pivotable relative to each other.

In some applications, the unified beam includes a second beam of the implant, and the first beams of the first and second U-shaped portions include the first and third beams of the implant, respectively.

In some applications, the implant includes a central U-shaped portion including a pair of central beams and a connecting section, and first and second side portions, each side portion including at least one beam and connected to one of the central beams by a respective one of first and second bends. In some applications, the at least one beam of each of the first side portion and the second side portion is substantially parallel to at least one of the center beams. In some applications, the first and second flexures facilitate movement of the respective first and second side portions in at least two directions relative to the pair of center beams.

In some applications, the U-shaped portion includes the second beam, and the first side portion and the second side portion include the first beam and the third beam, respectively.

In some applications, the catheter is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the first and second bends engage with the lip of the leaflet and the connection section of the U-shaped portion is distal to the lip of the leaflet, thereby positioning the implant on the leaflet.

In some applications, the catheter is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the end portion engages with the lip of the leaflet, thereby placing the implant onto the leaflet. In some applications, the tubular body and the second elongated portions of the first and second clips form the second beam of the implant, and the first elongated portion of the first clip forms the first and second beams of the implant.

In some applications, the catheter is adapted to form a bulge in the leaflet by transitioning the device from the first operating state toward the second operating state while the first and third beams remain on a first side of the leaflet and the second beam remains on the second, opposite side of the leaflet.

In some applications, the system includes an attachment device transluminally deliverable through the catheter and configured to at least temporarily secure two sections of the leaflet at the bulge.

In some applications, the catheter is further adapted to hold the two sections of the leaflet together to retain the bulge by moving the first beam and the third beam toward each other.

In some applications, the attachment device is configured to secure the two sections together when the two sections are held together.

In some applications, the attachment device includes a helical needle defining a helical lumen, the helical needle configured to be advanced distally from the longitudinal catheter and to extend rotationally through and secure the two sections at the protuberance together.

In some applications, the system includes a suture extending through the helical lumen of the helical needle, wherein the suture is attached to a detachable needle tip of the helical needle and configured to secure the two sections at the protuberance after removal of the helical needle from the cardiac chamber.

In some applications, the system includes a push wire extending through the lumen of the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

In some applications, the system includes a cutting device configured to cut tissue through the leaflet. In some applications, the at least one catheter is further adapted to transluminally deliver the cutting device to the heart chamber, and operate the cutting device to cut a portion of the leaflet disposed between the two sections at the bulge, thereby forming a cutting edge.

In some applications, the cutting edge is at least temporarily secured by the attachment device.

In some applications, the cutting device is adapted to extend distally from the second beam of the device. In some applications, after the device transitions from the first operational state to the second operational state, and after the two sections are secured together, the at least one catheter is further adapted to pull the device proximally such that during the pulling of the device, the cutting device cuts the tissue of the leaflet between the two sections at the projections.

In some applications, the cutting device is further configured to clamp the cut tissue prior to its complete cutting, and the at least one catheter is further adapted to transluminally remove the cutting device and the cut tissue clamped by the cutting device from the heart chamber.

According to some applications, provided herein is a method for repairing leaflets of a heart valve of a subject. The method includes transluminally delivering a device to a heart chamber adjacent the heart valve, the device including a first beam, a second beam, and a third beam and having a first operational state and a second operational state.

In some applications, the method may include positioning the device at the leaflet in the first operational state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet.

In some applications, the method may include transitioning the device from the first operational state to the second operational state while the first beam and the third beam remain on the first side of the leaflet and the second beam remains on the second, opposite side of the leaflet.

In some applications, the device comprises an implant, and wherein the transluminal delivery comprises transluminal delivery of the implant, the positioning comprises positioning the implant, and the translating comprises translating the implant.

In some applications, positioning the implant includes positioning the implant such that the first beam, the second beam, and the third beam are substantially perpendicular to the lips of the leaflet.

In some applications, the implant includes a base from which extends a plurality of beams including the first beam, the second beam, and the third beam, each beam of the plurality of beams having an end remote from the base, the first beam, the second beam, and the third beam being substantially parallel to one another. In some applications, positioning the implant in the first operational state includes placing the implant such that the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams. In some applications, in the second operational state, the base and the ends of the first, second, and third beams are in a single plane. In some applications, the transition of the implant from the first operational state toward the second operational state includes moving the ends of the first, second, and third beams relative to one another such that the ends of the first, second, and third beams are in the single plane.

In some applications, the plurality of beams includes at least five beams. In some applications, a first subset of the plurality of beams includes one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams includes another two of the first beam, the second beam, and the third beam, the first subset and the second subset of the plurality of beams being mutually exclusive. In some applications, positioning the implant in the first operational state includes positioning the implant such that the plane is defined by the ends and the base of all beams in the second subset, and the ends of all beams in the first subset are disposed outside the plane. In some applications, the conversion of the implant includes moving the ends of all of the beams in the first subset such that in the second operational state, the ends of the beams in the first subset and the second subset are in the single plane.

In some applications, positioning the implant in the first operating state includes positioning the implant such that the ends of all beams in the first subset are disposed in a second plane that is angled relative to the plane.

In some applications, positioning the implant includes positioning the implant when the first beam, the second beam, and the third beam are substantially perpendicular to the base.

In some applications, positioning the implant on the leaflet includes sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that the base extends along the lip of the leaflet.

In some applications, the implant includes first and second U-shaped portions, each U-shaped portion including a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other. In some applications, the implant includes engagement elements that hold the second beam of each of the first and second U-shaped portions together to form a unified beam. In some applications, the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion. In some applications, the second beams of the first and second U-shaped portions may pivot relative to the engagement element about respective longitudinal axes of the second beams such that the first and second U-shaped portions may pivot relative to one another. In some applications, positioning the implant in the first operating state includes positioning the implant such that the first beams of the first and second U-shaped portions are at a first distance from each other.

In some applications, positioning the implant in the first operational state includes positioning the implant on the leaflet when the first and second U-shaped portions are in a single plane, and the translating includes pivoting the first and second U-shaped portions relative to one another to movably position the unified beam outside of a plane formed by the first beams of the first and second U-shaped portions.

In some applications, the converting includes pivoting the first and second U-shaped portions relative to each other to reduce a distance between the first beams of the first and second U-shaped portions to a second distance present between the first beams of the first and second U-shaped portions, the second distance being less than the first distance.

In some applications, positioning the implant includes sliding the implant onto the lips of the leaflet when the implant is in the first operating state such that the bases of the first and second U-shaped portions extend along the lips of the leaflet, the unified beam functioning as the second beam and being located on the second opposite side of the leaflet, and the first beams of the first and second U-shaped portions functioning as the first and third beams of the device and being disposed on the first side of the leaflet.

In some applications, the implant includes a central U-shaped portion including a pair of central beams and a connecting section. In some applications, the implant includes a first side portion and a second side portion, each side portion including at least one beam and being connected to one of the center beams by a respective one of the first and second bends. In some applications, the at least one beam of each of the first side portion and the second side portion is substantially parallel to at least one of the center beams. In some applications, the first and second flexures facilitate movement of the respective first and second side portions in at least two directions relative to the pair of center beams. In some applications, positioning the implant in the first operational state includes positioning the implant on the leaflet when the central U-shaped portion is in a first plane, and each of the first and second side portions is in a different plane than the first plane and disposed outside of the central U-shaped portion. In some applications, the converting includes moving the first side portion and the second side portion into the first plane within the central U-shaped portion.

In some applications, positioning the implant in the first operational state includes positioning the implant on the leaflet when a first distance exists between the first side portion and the second side portion, and transitioning the implant includes reducing the distance between the first side portion and the second side portion to a second distance that is less than the first distance.

In some applications, the implant has an intermediate operational state in which the first side portion and the second side portion are in the first plane and disposed outside of the central U-shaped portion. In some applications, transitioning the implant from the first operational state toward the second operational state includes transitioning the implant from the first operational state to the intermediate operational state by pivoting the first side portion and the second side portion in a first direction relative to the central U-shaped portion to place the first side portion and the second side portion into the first plane, and transitioning the implant from the intermediate operational state to the second operational state by rotating the first side portion and the second side portion in a second direction relative to the central U-shaped portion to move the first side portion and the second side portion into the interior of the central U-shaped portion.

In some applications, the pivoting in the first direction includes pivoting about an axis perpendicular to a longitudinal axis of the center beam, and the rotating in the second direction includes rotating about an axis parallel to the longitudinal axis of the center beam.

In some applications, positioning the implant includes sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that the first and second bends engage with the lip of the leaflet and the connection section of the U-shaped portion is distal to the lip of the leaflet.

In some applications, the implant comprises: a tubular body disposed along a central longitudinal axis; and a first substantially U-shaped clip and a second substantially U-shaped clip, each substantially U-shaped clip having: a first elongate portion disposed on or adjacent an outer surface of the tubular body; and a second elongate portion disposed on or near an inner surface of the tubular body, the first and second elongate portions being connected by an end portion. In some applications, the implant includes a resilient element that holds the second elongated portions of the first clip and the second clip together. In some applications, in the first operating state, the clip is disposed on a first side of the tubular body, and in the second operating state, the clip is disposed on a second side of the tubular body, the second side being opposite the first side. In some applications, positioning the implant includes sliding the implant onto the lips of the leaflet when the implant is in the first operating state such that the end portion engages with the lips of the leaflet, wherein the tubular body and the second elongated portion of the first and second clips function as the second beam and the first elongated portion of the first and second clips function as the first and third beams.

In some applications, the transluminal delivery includes transluminal delivery of the implant to the heart chamber when the U-shaped clip is separated from the tubular body. In some applications, the method includes sliding the first clip and the second clip onto the tubular body to form the first operational state prior to or during positioning of the implant.

In some applications, the transition of the device from the first operating state to the second operating state includes forming a bulge in the leaflet when the first beam and the third beam remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet. In some applications, the method includes, at least temporarily, securing two sections of the leaflet at the bulge using an attachment device.

In some applications, the method includes holding the two sections of the leaflet together to hold the bulge by moving the first beam and the third beam toward each other.

In some applications, the at least temporary fixation is performed while the two sections of the leaflet are held together.

In some applications, the method includes transluminally delivering the attachment device to the heart chamber adjacent the heart valve.

In some applications, the attachment means includes a helical needle defining a helical lumen, and the at least temporarily securing includes rotationally advancing the helical needle to extend through the two sections at the protuberance and secure the two sections together.

In some applications, a suture extends through the helical lumen of the helical needle, wherein the suture is attached to a detachable needle tip of the helical needle. In some applications, the method includes, after rotational advancement of the helical needle, anchoring the detachable distal tip of the helical needle to tissue of the leaflet. In some applications, the method includes removing the removable distal tip of the helical needle from a body of the helical needle. In some applications, the method includes helically retracting the body of the helical needle from the detachable distal tip as the helical needle is slid over the suture, thereby removing the helical needle from the anatomical site while leaving the suture in the anatomical site, thereby securing the two sections at the protrusion.

In some applications, the removing of the removable distal tip includes pushing the removable distal tip of the helical needle distally relative to the needle body using a pushing wire extending through the lumen of the helical needle.

In some applications, the method includes transluminally delivering a cutting device to the heart chamber. In some applications, the method includes cutting a portion of the leaflet disposed between the two sections at the bulge using the cutting device, thereby forming a cutting edge.

In some applications, the at least temporarily securing includes at least temporarily securing the cutting edge.

In some applications, transluminal delivery of the cutting device includes distally advancing the cutting device from the second beam of the device, and the cutting includes proximally pulling the device such that during pulling of the device, the cutting device cuts the tissue of the leaflet between the two sections at the bulge.

In some applications, the method includes clamping the cut tissue into a clamping end of a clamping device prior to completion of cutting the tissue between the two sections, and removing the clamping device and the cut tissue clamped to the clamping device from the heart chamber.

In some applications, the method includes distally advancing the clamping device from the second beam of the device prior to clamping.

In some applications, the cutting device is used as the gripping device, and advancement of the cutting device comprises advancement of the gripping device.

According to some applications, provided herein is a system for use with leaflets of a heart valve of a subject. The system includes a catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

In some applications, the system includes a cutting device distally advanceable from the catheter, adapted to cut tissue through leaflets of the heart valve, thereby forming cut tissue and a cutting edge at the heart valve.

In some applications, the system may include a helical needle defining a helical lumen, the helical needle configured to be advanced distally from the catheter and to extend rotationally through and secure together two tissue sections of the leaflet.

In some applications, the system includes a suture extending through the helical lumen of the helical needle.

In some applications, the spiral needle and the suture are configured to extend along the two tissue sections of the leaflet to suture the two tissue sections to one another.

In some applications, the cutting device includes a wire forming a wire loop having a closed distal end and a fastening element slidably coupled to the wire such that distal sliding of the fastening element over the wire contracts the wire loop and cuts tissue disposed within the wire loop, thereby forming the cut tissue and the cutting edge. In some applications, the helical needle and the suture are configured to secure the cutting edge together.

In some applications, the spiral needle includes a needle body terminating in a detachable distal tip configured to anchor to tissue at the heart valve and to be detached from the needle body.

In some applications, after detaching the detachable distal tip of the helical needle from the needle body, the needle body is adapted to retract helically away from the detachable distal tip while sliding over and along the suture.

In some applications, the system may include a push wire extending through the lumen of the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

In some applications, the cutting device and the helical needle are adapted to be removed from the heart chamber after the tissue is cut by the cutting device while leaving the suture in the leaflets of the heart valve, thereby securing the two tissue sections.

In some applications, the system may include a clamp having a distal clamping end, the clamp being distally advanceable from the catheter to engage the cut tissue before the cut tissue is completely removed She Caxie from the clip.

In some applications, the clamp is adapted to be removed from the heart chamber, the cut tissue being clamped to the clamp during or after the cutting device and the helical needle are removed from the heart chamber.

In some applications, the clamp is configured to be advanced through the catheter alongside the helical needle.

In some applications, the cutting device serves as the clamp.

In some applications, the system may include a retaining device including a first beam, a second beam, and a third beam, and having a first operational state and a second operational state, the securing device being distally advanceable from the catheter. In some applications, the catheter is adapted to transluminally deliver the fixation device to the heart chamber. In some applications, the catheter is adapted to position the device at the leaflet in the first operating state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet. In some applications, the catheter is adapted to transition the device from the first operational state to the second operational state while the first and third beams remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet.

In some applications, the cutting device is adapted to be advanced distally from the second beam of the holding device. In some applications, after the retaining device transitions from the first operational state to the second operational state, and after the two tissue sections are secured together, the catheter is further adapted to pull the retaining device proximally such that during the pulling of the retaining device, the cutting device cuts the tissue of the leaflet between the two sections at the projections.

In some applications, the catheter is adapted to form a bulge in the leaflet by transitioning the retaining device from the first operating state to the second operating state. In some applications, the helical needle and the suture are adapted to secure the two tissue sections of the leaflet at the bulge.

In some applications, the helical needle is configured to secure the two tissue sections together when the two tissue sections are held together.

According to some applications, provided herein is a method for repairing leaflets of a heart valve of a subject. In some applications, the method includes securing two sections of tissue of the leaflet of the heart valve together, and resecting tissue from between the two sections of tissue of the leaflet with a cutting device to form a cutting edge.

In some applications, the resecting occurs prior to the securing, and the securing includes securing the cutting edge as it is formed and prior to the tissue being completely removed from the valve leaflet She Caxie.

In some applications, the resecting is performed using a cutting wire that forms a wire loop that is distally advanceable from the catheter and includes distally sliding a fastening element over the wire to retract the wire loop and cut tissue disposed within the wire loop, thereby forming the cutting edge.

In some applications, the fixation occurs prior to the resecting, and the resecting comprises resecting the tissue from between the fixation sections to form an exposed cutting edge.

In some applications, the method includes transluminally delivering a device to a heart chamber adjacent the heart valve, the device including a first beam, a second beam, and a third beam and having a first operational state and a second operational state.

In some applications, the method includes positioning the device at the leaflet in the first operating state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet.

In some applications, the method includes transitioning the device from the first operational state to the second operational state while the first beam and the third beam remain on the first side of the leaflet and the second beam remains on the second, opposite side of the leaflet, thereby forming a bulge in the leaflet.

In some applications, securing the two sections together includes securing the two sections together at the protrusion.

In some applications, securing the two sections together includes advancing a helical needle through the two sections.

In some applications, the method includes, prior to the resecting, advancing the cutting device to the heart valve by transluminal catheter.

In some applications, the spiral needle includes a spiral lumen and has a suture extending through the spiral lumen, the method including removing the spiral needle from the heart valve while attaching the suture to the two sections.

According to some applications, provided herein is a system for use with a heart valve of a subject, the system comprising a catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The system may include a screw implant defining a pair of turns, wherein in a first operational state of the screw implant, the pair of turns have a first pitch, and in a second operational state of the screw implant, the pair of turns have a second pitch, the second pitch being less than the first pitch.

In some applications, the catheter is adapted to transluminally deliver the implant to the heart chamber. In some applications, the catheter is adapted to place the helical implant in the first operational state onto tissue of the heart valve. In some applications, the catheter is adapted to pull the tissue between the pair of turns while the helical implant remains in the first operational state. In some applications, the catheter is adapted to transition the helical implant from the first operational state toward the second operational state while the tissue remains between the pair of turns, thereby crimping the tissue.

In some applications, the catheter is adapted to place the helical implant in the first operating state onto the annulus of the heart valve.

In some applications, the at least one helical implant comprises a plurality of helical implants. In some applications, the catheter is adapted to transluminally deliver, place, pull, and transition each of the plurality of spiral implants at tissue in different locations along the annulus of the heart valve.

In some applications, the system includes a vacuum generator functionally associated with the catheter, and wherein the vacuum generator is configured to generate a vacuum that pulls the tissue of the heart valve between the pair of turns.

In some applications, the helical implant is at least one of a flexible implant and a resilient implant. In some applications, the helical implant comprises a resilient metal. In some applications, the helical implant comprises a shape memory material.

In some applications, the system includes a septum disposed between the distal end of the catheter and the vacuum generator, the septum adapted to prevent fluid flow into the proximal end of the catheter during operation of the vacuum generator.

In some applications, the distal end of the catheter is partially resected to define an implant deployment portal such that during placement of the spiral implant, a distal portion of the implant is disposed within the implant deployment portal and in contact with tissue of the heart valve, and a proximal portion of the spiral implant is separated from the tissue of the heart valve by the catheter.

According to some applications, provided herein is a method for repairing leaflets of a heart valve of a subject, the method comprising transluminally delivering a spiral implant to a heart chamber adjacent the heart valve, the spiral implant defining a pair of turns, wherein in a first operational state of the spiral implant, the pair of turns have a first pitch, and in a second operational state of the spiral implant, the pair of turns have a second pitch, the second pitch being less than the first pitch.

In some applications, the method may include placing the helical implant in the first operational state onto tissue of the heart valve.

In some applications, the method may include pulling the tissue between the pair of turns when the implant is held in the first operational state, and transitioning the helical implant from the first operational state toward the second operational state when the tissue is held between the pair of turns, thereby crimping the tissue.

In some applications, the placing includes placing the helical implant in the first operating state onto the annulus of the heart valve.

In some applications, the steps of delivering, placing, pulling, and translating are performed on each of the plurality of spiral implants, wherein the placing includes placing each of the plurality of spiral implants into a different location along the annulus of the heart valve.

In some applications, the pulling includes creating a vacuum that pulls the tissue of the heart valve between the pair of turns.

In some applications, the method includes placing a septum between the helical implant and a vacuum generator that generates the vacuum, thereby preventing fluid from flowing from the heart valve into the vacuum generator during operation of the vacuum generator.

Any of the above methods may be performed on a living animal or mimetic, such as on a cadaver, cadaver heart, mimetic (e.g., mimetic body part, heart, tissue, etc.), or the like.

Drawings

The foregoing discussion will be more readily understood from the following detailed description when taken in conjunction with the accompanying drawings in which:

FIG. 1 is a schematic illustration of a mitral valve of a heart having prolapsed leaflets in need of repair;

FIG. 2 is a schematic side view illustration of placement of a tissue anchor in the mitral valve shown in FIG. 1, according to some applications;

Figures 3A and 3B are schematic side view illustrations and schematic top view illustrations, respectively, of excess tissue placement cutting wires surrounding heart valve leaflets according to some applications;

FIGS. 4A and 4B are schematic side view illustrations and schematic top view illustrations, respectively, of securing a cutting wire around excess tissue to cut it while securing the cutting edges of the tissue together, according to some applications;

FIGS. 5A and 5B are schematic side view illustrations and schematic top view illustrations, respectively, of continuing to tighten the cutting wire and cut excess tissue and continuing to secure the cutting edge while the clamp remains cutting tissue, according to some applications;

FIGS. 6A and 6B are schematic side and top view illustrations, respectively, of continuing to tighten the cutting wire and cut excess tissue and continuing to secure the cutting edge while the clamp continues to hold the cut tissue, according to some applications;

FIGS. 7A and 7B are schematic side view illustrations and schematic top view illustrations, respectively, of a complete disassembly of clamped excess tissue according to some applications;

8A, 8B, 8C, and 8D are schematic side view illustrations, and FIG. 8E is a schematic top view illustration of a stage of sewing a fixed cutting edge and removing a cutting wire according to some applications;

FIG. 9 is a schematic illustration of the mitral valve of FIG. 1 after repair using the method of FIGS. 3A-8E;

FIGS. 10A and 10B are schematic perspective illustrations of examples of control handles for controlling devices useful for implementing the methods of FIGS. 3A-8E, according to some applications;

11A-11D are schematic illustrations of an implantation system for repairing a leaflet of a mitral valve by suturing a portion of the leaflet between a root and a lip of the leaflet and a stage of use thereof, according to some applications;

12A, 12B, and 12C are schematic top or cross-sectional illustrations of stages of repairing a leaflet of a mitral valve by suturing a portion of the leaflet to a root of the leaflet according to some applications;

FIG. 13 is a schematic cross-sectional illustration of a leaflet of a mitral valve being repaired by suturing a portion of the leaflet to a coronary artery surrounding the mitral valve, according to some applications;

14A-14D are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

15A, 15B, and 15C are schematic top view illustrations of stages of repairing leaflets of a mitral valve using an implant according to some applications;

16A-16D are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

17A-17D are schematic top view illustrations of stages of repairing leaflets of a mitral valve using an implant according to some applications;

18A-18C are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

19A-19C are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

FIG. 20 is a schematic, pictorial illustration of a stage of placement of an implant onto a leaflet of a heart valve, thereby repairing the leaflet, in accordance with some applications;

figures 21A to 21D are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use according to some applications;

22A-22C are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

23A-23C are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

24A-24D are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

25A-25C are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

26A-26C are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

27A-27E are schematic cross-sectional illustrations of stages of repairing leaflets of a mitral valve using an anchor implant according to some applications;

fig. 28A-28D are schematic cross-sectional and top view illustrations of stages of repairing leaflets of a mitral valve according to some applications;

fig. 29A and 29B are schematic top view illustrations of stages of repairing leaflets of a mitral valve using an implant according to some applications;

FIGS. 30A and 30B are schematic top view illustrations of stages of repairing leaflets of a mitral valve using an implant according to some applications;

31A-31E are schematic cross-sectional illustrations of stages of repairing leaflets of a mitral valve using an implant according to some applications;

32A-32D are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications;

FIG. 33 is a schematic illustration of a native valve of a heart having prolapsed leaflets in need of repair;

FIG. 34 is a schematic illustration of placement of a retaining device in the native valve shown in FIG. 33, according to some applications;

35A and 35B are schematic illustrations of stages of transitioning the retention device of FIG. 34 from a first operational state to a second operational state, according to some applications;

36A and 36B are schematic illustrations of stages of securing together a section of tissue of a mitral valve using a helical needle according to some applications;

FIG. 37 is a schematic illustration showing the removal of the needle tip of the helical needle of FIGS. 36A and 36B, according to some applications;

FIG. 38 is a schematic illustration of retraction of the helical needle of FIGS. 36A and 36B while continuing to fix a section of tissue of the mitral valve, according to some applications;

39A, 39B and 39C are schematic illustrations of stages of cutting excess tissue between fixed sections of tissue of a mitral valve according to some applications;

FIGS. 40A and 40B are schematic illustrations of clamping and removing cut tissue of a mitral valve according to some applications;

FIG. 41 is a schematic illustration of the mitral valve after repairing the mitral valve of FIG. 33 using the method of FIGS. 34-40B;

FIG. 42 is a schematic illustration of the mitral valve and tricuspid valve of a heart with leaflets that are not properly coaptated and require repair, and a catheter advanced to the mitral valve, according to some applications;

FIG. 43 is a schematic illustration of the catheter of FIG. 42 inserted into a mitral valve in need of repair according to some applications;

fig. 44 is a schematic illustration of the placement of the distal end of the catheter of fig. 42 and 43 adjacent the annulus of the native valve, according to some applications;

45A and 45B are schematic illustrations of placing a spiral implant onto the annulus of a native valve and pulling tissue of the native valve into the space between turns of the spiral implant, according to some applications;

FIG. 46 is a schematic illustration of transformation of the shape of the helical implant of FIGS. 44 and 45, thereby plicating tissue of the annulus, according to some applications; and is also provided with

Fig. 47A and 47B are schematic illustrations of the mitral and tricuspid valves after repair of the mitral and tricuspid valves using a plurality of helical implants and using the method of fig. 43-46, according to some applications.

Detailed Description

The principles of an apparatus and method for repairing leaflets of a heart valve of a subject, and in particular, an apparatus and method for transcatheter or transluminal removal of excess tissue from the leaflets of a heart valve of a subject, may be better understood with reference to the drawings and the following description.

In the following description, various aspects of the present disclosure will be described. For purposes of explanation, specific configurations and details are set forth in order to provide a thorough understanding of the various aspects of the present disclosure. However, it will also be apparent to one skilled in the art that the present disclosure may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified in order not to obscure the present disclosure. In addition, to avoid excessive clutter with excessive numbers and leads on a particular drawing, some elements may not be explicitly identified in each drawing that contains the element.

It is to be understood that the scope of the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.

For the purposes of this application, the term "subject" refers to any mammal, particularly a human.

For the purposes of this application, the term "heart wall" refers to any wall of the heart.

Referring now to the drawings, fig. 1 schematically illustrates excess tissue in the leaflet and its improper closure. Specifically, fig. 1 shows a mitral valve 10 having a first leaflet 12 and a second leaflet 14 surrounded by an annulus 15. The second leaflet 14 has excess tissue 16 such that the leaflets coapt at a point (or edge) 17 with a gap 18 in the valve when the valve is closed.

Fig. 2 is a schematic side view illustration of the placement of a tissue anchor 120 in the mitral valve 10 shown in fig. 1, according to some applications.

As seen in fig. 2, the longitudinal catheter 100 is advanced toward the anatomical site of the subject. In the example shown, the distal portion 106 of the catheter is advanced to a ventricle (e.g., left ventricle) of the heart to be positioned upstream of a heart valve (e.g., mitral valve) having first and second leaflets 12, 14 surrounded by an annulus 15. The leaflets 14 have prolapsed or excess tissue 16. There is a gap 18 at the point (or edge) 17 between the leaflets 12 and 14 where the leaflets should coapt (best seen in fig. 3B). The longitudinal catheter 100 also has an extracorporeal proximal portion 107 (e.g., as shown in fig. 10A-B). The distal portion 106 may be directed to the anatomical site, such as by being actively steerable itself (e.g., by being operatively coupled to the proximal portion 107 by one or more pull wires, such as the steering controller 203 thereof shown in fig. 10A and 10B), or by being passively directed and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). A longitudinal axis 108 extends between the proximal portion 107 and the steerable distal portion 106 of the catheter 100. Catheter 100 is advanced transluminally to the anatomical site, such as through the vena cava, and, if desired, through the septum of the atrium of the heart, using any method known in the art.

In some applications, and as shown, the tissue anchor 120 is advanced to the anatomical site and driven into the tissue of the annulus 15, such as by driving the tool 109. As shown, the drive tool 109 may extend distally from the lumen of the catheter 100, shown here as lumen 154. In some applications, the driving tool 109 is rotatable such that rotation of the driving tool 109 screws a portion of the tissue anchor 120 into the tissue of the annulus 15.

The tissue anchor 120 includes a tissue-engaging element 122 that is inserted into the tissue of the annulus 15, and a head 124 that extends over the tissue at the anatomical site. Wire 110 is coupled to a first device anchor point 126 of head 124 such that tissue anchor 120 anchors the wire, as explained in further detail below. For some applications, and as shown, the first device anchor point 126 defines an aperture, and the wire 110 is reversibly coupled to the aperture by passing through the aperture.

In some applications, and as shown, a tissue anchor is anchored to the side of the excess tissue 16 opposite the lips of the leaflets to facilitate positioning of the wire 110 around the excess tissue, as explained in further detail herein.

For some applications, and as shown, the tissue anchor 120 includes a second device anchor point 128 (see fig. 3B), which will be described in further detail below with respect to fig. 7A-8E.

After anchoring the tissue anchor 120 to the annulus 15, the driving tool 109 may be retracted from the anatomical site, such as through the lumen 154 of the catheter 100.

Figures 3A and 3B are schematic side view illustrations and schematic top view illustrations, respectively, of placement of cutting wires through a catheter of excess tissue surrounding a heart valve leaflet according to steps of some applications.

As seen in fig. 3A and 3B, the wire 110 is advanced distally from the steerable distal portion 106 of the catheter 100 and forms a loop of wire. Here, reference numeral 110 interchangeably refers to a wire and a wire loop formed of a wire.

In some applications, as in the illustrated example, the wire loop 110 may be advanced through the lumen 112 of the catheter 100 to the target anatomical site. In some applications, the wire loop may be advanced to a target location attached to the distal portion 106 of the catheter 100. The wire loop 110 includes a closed distal end 114 that is anchored to a first device anchor point 126 of the tissue anchor 120, as described above.

The fastening element 116 is slidably coupled to the wire loop such that distal sliding of the fastening element 116 over the wire 110 constricts the wire loop and cuts tissue disposed within the wire loop. In other words, as the fastening element 116 moves along the wire 110, the area of the wire loop decreases, which causes the wire to cut tissue engaged by the wire loop. In this way, the wire loop 110 acts as a cutting device for cutting tissue at an anatomical site.

For some applications, the wire loop 110 may be replaced with a different cutting device, mutatis mutandis.

In some applications, the fastening element 116 is functionally associated with the drive element 118 (e.g., for driving movement of the fastening element). In the illustrated example, the drive element 118 is shown as a drive shaft, tube, or channel.

As seen in fig. 3A and 3B, the wire loop 110 is placed around the excess tissue 16 of the leaflets 14 of the heart valve.

For some applications, the excess tissue may be raised prior to placement of the wire loop 110 around the excess tissue 16, for example, using a retaining device and/or according to the methods described below with respect to fig. 34-35B.

Referring now to fig. 4A and 4B, there are a schematic side view illustration and a schematic top view illustration, respectively, of an initial tightening of wire loop 110 around excess tissue 16 to cut it while the edge attachment device holds the cut edges of the tissue together, according to further steps of some applications.

As can be seen, the fastening element 116 of the wire loop 110 is moved forward in the direction of arrow 130, as clearly shown in fig. 4B. As a result, a portion 132 of the excess tissue 16 is cut from the leaflet 14, forming a cutting edge 134 at the leaflet.

The edge attachment means, here shown as a helical needle 140 having a distal needle tip 142, extends distally rotationally from the distal portion 106 of the catheter 100 about the cutting edge 134. As a result, the cutting edges 134 are secured together. The helical needle 140 includes a helical lumen 143 having a suture 144 helically extending therethrough, as described in further detail below. The direction of rotation of the needle 140 is indicated by reference numeral 145. The helical needle 140 grips the cutting edge 134 from above and below as it rotates and in a sense surrounds the cutting edge, thereby securing the cutting edges together. The cutting edges 134 may be pulled together as the helical needle 140 rotates. In some applications, the helical needle may temporarily secure the cutting edges 134 together, and after removal of the helical needle 140, a permanently attached element, such as a suture 144, may maintain attachment of the cutting edges for a long period of time, as described in further detail below.

In some applications, the needle 140 may be advanced through the catheter 100 to the leaflet 14. In some applications, the needle 140 may be advanced through the same lumen as the wire loop 110. In some applications, as in the illustrated example, the needle 140 may be advanced through a dedicated lumen 146 in the catheter 100. In some applications, the helical needle 140 is advanced around the wire 110 such that the linear portion of the wire proximal to the fastening element 116 and the driving element 118 driving the fastening element extend axially through the center of the helix of the helical needle 140. Lumen 146 may be a helical lumen or may be a linear lumen. In the example where lumen 146 is linear, needle 140 automatically turns into a spiral when exposed from the lumen, such as by using a shape memory material for the spiral needle.

In some applications, the helical needle 140 is operably coupled to the fastening element 116, such as described further below with respect to fig. 10A and 10B. In some applications, the tip 142 of the helical needle 140 is maintained at a fixed distance from the fastening element 116 at least during cutting of tissue and securing of the cutting edges 134 together as they are formed. In some applications, advancement of the fastening element 116, as well as additional cutting of the unwanted tissue 16, is operatively coupled to or dependent upon simultaneous advancement of the helical needle 140 to secure the cutting edges 134 together as they are formed by the wire loop 110, such as described further below with respect to fig. 10A and 10B.

In some applications, the fastening element 116 can be advanced distally over the linear portion of the wire 110 only upon subsequent advancement of the helical needle 140. It is hypothesized that for some applications, such operable coupling helps secure the cutting edges 134 together by reducing the likelihood that the cutting edges will move apart from each other (e.g., a distance greater than the lateral diameter of the spiral needle 140) before the needle has engaged (e.g., penetrated) the leaflet.

Although the helical needle 140 is shown as having a cylindrical helical shape, i.e., having a constant transverse diameter along its length, for some applications the transverse diameter of the helical needle may vary along its length, such as being wider at the distal end than at the proximal end, e.g., the helical needle may have a conical helical shape. It is assumed that for some applications, a wider (e.g., flared) distal end may facilitate engagement of cutting edges 134 and/or pull the cutting edges together.

Although the spiral pins 140 are shown with a constant pitch, for some applications, the spiral pins may have a variable pitch.

For some applications, the spiral needle 140 may be replaced with a different edge attachment device, mutatis mutandis. For example, alternative edge attachment means may include clamps, pins, hooks, tissue adhesives, and the like.

A clamp 150 having a clamping end 152 is advanced distally from the distal portion 106 of the catheter 100, generally alongside and to the side of the helical needle 140 and wire loop 110. As will be described in further detail below, the clip 150 is configured to engage with excess tissue 16 (e.g., the cutting portion 132 thereof).

In some applications, and as shown, the clip 150 can be advanced through the catheter 100 to the leaflet 14, such as through the lumen 154. In some applications, the catheter 100 may contain a single lumen such that the wire loop 110, the helical needle 140, and the clip 150 are all advanced through the same lumen to the leaflet 14 or anatomical site.

Referring now to fig. 5A and 5B, which are schematic side view illustrations and schematic top view illustrations, respectively, of the fastener element 116 continuing to slide relative to the wire loop 110 while the clamp 150 holds the cut portion 132 of excess tissue and the helical needle 140 secures the cutting edge 134, and thus the wire loop 110 continuing to cut the excess tissue 16, according to further steps of some applications.

As seen in fig. 5A and 5B, the fastening element 116 continues to advance distally in the direction of arrow 160 to fasten the wire loop 110, thereby continuing to cut excess tissue 16. The helical needle 140 continues to advance rotationally with the fastening element 116 and thus holds the cutting edges 134 together as they are formed. As can be seen, in some applications, the tip 142 of the helical needle 140 remains at a fixed distance relative to the fastening element 116 as the fastening element and helical needle are advanced.

The clamping end 152 of the clip 150 can include jaws (e.g., as shown) and can be actuated (e.g., openable and closable) from an external proximal end of the device and/or system, for example, as described below with reference to fig. 10A-B.

Fig. 4A-4B illustrate the clip 150 advanced from the catheter 100 (e.g., with the clip end 152 in a closed and/or delivery state), while fig. 5A-5B illustrate the clip end 152 having been clipped to the unwanted tissue 16 (e.g., with the clip end having been opened and then closed over the unwanted tissue). It should be noted that while the clamp 150 is shown as having been clamped to the unwanted tissue 16 after the beginning of fastening of the wire loop 110 (and thus cutting of the unwanted tissue), for some applications the clamp may be clamped to the unwanted tissue prior to beginning of cutting the unwanted tissue (e.g., prior to any wire loop tightening).

During additional tightening of the wire loop 110 and additional cutting of the excess tissue, the clamping end 152 of the clamp 150 continues to hold the cut portion 132 of the excess tissue 16 of the leaflet 14. In some applications, the clamp 150 holds the cut tissue aside, as shown in fig. 5A-B, for example, to ensure that the cut tissue does not interfere with the operation of the wire loop 110 and the helical needle 140. In some applications, as cutting excess tissue advances, the clip 150 may be advanced further distally from the catheter 100, as seen by comparing fig. 4A and 5A.

Turning now to fig. 6A and 6B, which illustrate additional steps according to some applications, it can be seen that the fastening element 116 continues to fasten the wire loop 110 around the excess tissue 16 and cut the excess tissue, thereby extending the cutting edge 134. The helical needle 140 continues to advance and, in some applications, the tip 142 is maintained a fixed distance from the fastening element 116 and secures the cutting edges 134 together as they are formed. At the same time, the clamp 150 continues to hold the cut portion 132 of the excess tissue 16.

Referring now to fig. 7A and 7B, which are schematic side view illustrations and schematic top view illustrations, respectively, of the completion of the cutting of excess tissue 16 by the wire loop 110 while the helical needle 140 secures the cutting edges 134 together along their entire length, and the complete removal of the excess tissue held by the clamp 150 from the leaflet 14, according to further steps of some applications.

As seen in fig. 7A and 7B, the fastening element 116 of the wire loop 110 has been pushed distally to a degree sufficient that the remaining tissue 16 has been completely removed from the leaflet 14 and is now held stationary only by the clamping end 152 of the clamp 150. For some applications, at this stage, the wire loop 110 has a minimal area, e.g., substantially represented by a longitudinal wire (or two parallel longitudinal wire lengths). For some applications, at this stage, the fastening element 116 engages the tissue anchor 120.

After cutting of the excess tissue 16 is completed, the helical needle 140 may continue to be rotationally advanced to secure the entire cutting edge 134 together. For some applications, and as shown, at this stage, the helical needle 140 is operably uncoupled from the fastening element 116 such that the tip 142 of the helical needle may no longer be at the same fixed distance from the fastening element, e.g., such that the fastening element remains stationary during advancement of the helical needle. For some applications, and as shown, the helical needle 140 may be rotationally advanced to extend beyond the fastening element 116. The tip 142 of the helical needle 140 is anchored in place, such as by being anchored to the tissue anchor 120 (e.g., to its second device anchor point 128), or by being directly anchored to the tissue of the annulus 15, e.g., as described in further detail below.

In some applications, the clip 150, with the fully detached excess tissue 16 clamped thereto, may be removed from the anatomical site at this stage, for example, through the lumen 154 of the catheter 100.

In some applications, the clamp 150 may continue to clamp the detached excess tissue 16 at the anatomical site until the wire loop 110 and the helical needle 140 are removed from the anatomical site, as described in further detail herein. For some applications, the clip 150 and excess tissue 16 may be removed through the lumen 154. For some applications, the clip 150 and excess tissue 16 may be removed by withdrawing the catheter 100, e.g., the clip and/or excess tissue remain exposed from the catheter.

Referring now to fig. 8A, 8B, 8C and 8D, which are schematic side view illustrations, and with reference to fig. 8E, which are schematic top view illustrations of suturing the fixed cutting edge 134 and the stage of removing the wire loop 110 and the helical needle 140 according to additional steps of some applications.

As seen in fig. 8A, the suture 144 extends helically through the helical lumen 143 of the helical needle 140 and is secured to the tip 142 of the helical needle at a needle anchor point 174. It should be understood that throughout this application, although the term "suture" may be applied to components that are the same as or similar in material and/or structure to a surgical suture, the scope of the term encompasses the use of other materials and/or structures.

Once the tip 142 of the helical needle 140 has been anchored in place (e.g., to the tissue anchor 120, such as to its second device anchor point 128), the tip of the helical needle is detached from the body (i.e., the remainder) of the helical needle and the helical needle 140 is rotationally retracted (e.g., unscrewed) from the tissue, e.g., around the drive element 118 (fig. 8B) in which the wire 110 is disposed.

In some applications, the tip 142 of the helical needle 140 may be disassembled using a push wire extending through the lumen 143 of the helical needle, such as described below with respect to fig. 37.

In some applications, the needle tip 142 may be anchored directly to the tissue of the annulus 15 and not to the tissue anchor 120. Such examples may be utilized, for example, when the tissue anchor 120 is to be subsequently retracted from the anatomical site, as explained in further detail herein.

As seen in fig. 8B, the body of the helical needle 140 is rotationally retracted in the direction indicated by arrow 176, leaving the tip 142 of the helical needle and the suture 144 in place.

Turning to fig. 8C, it can be seen that the wire loop 110 is detached from the first device anchor point 126 of the tissue anchor 120 and retracted through the suture 144 in the direction of arrow 178. In some applications, the wire loop 110 is retracted with the helical needle 140, or at a fixed distance from the helical needle. In some applications, the wire loop 110 may be retracted independently of the helical needle 140. In some applications, the wire loop 110 may be fully retracted before the helical needle 140 begins to retract. During retraction of the wire loops, if the suture 144 remains loose enough to pass the wire loops, the wire loops 110 may also be retracted after the helical needle 140 is retracted.

For applications where the wire loop 110 is initially attached by passing through an eyelet defined by the first device anchor point 126, the wire loop may be detached by not passing through (e.g., untangling), for example, by releasing one proximal end of the wire and pulling the other end of the wire proximally.

As seen in fig. 8D and 8E, which are corresponding plan side and plan top views illustrations of the stages of suturing and retraction after the helical needle 140 is further retracted into the catheter 100, for example, into the lumen through which it is advanced to the anatomical site. Similarly, the wire loop may have been retracted into the catheter, for example into a lumen through which the wire loop is advanced to the anatomical site. After retraction of the wire loop, the suture 144 may be secured (e.g., by pulling proximally) to further secure the cutting edge 134. Retraction of the needle 140 may continue until the needle is fully retracted, and then the catheter 100 may be removed from the anatomical site, leaving the suture 144 securing the cutting edges 134 together.

In some applications, the clip 150 remains at the anatomical site with the cut excess tissue 16 (fig. 7B) clamped thereto during retraction of the needle 140 and tightening of the suture 144, as shown in fig. 8D and 8E. In some applications, the clamp 150 and cutting excess tissue 16 may be removed from the anatomical site after retraction of the wire loop 110 and the helical needle 140.

In some applications, the tissue anchor 120 may remain anchored in the annulus 15 of the heart valve, also after the procedure is completed and the catheter 100 is removed from the heart valve. In some applications, after the leaflets 14 heal, the tissue anchor 120 can be removed from the heart valve, e.g., in a separate procedure that can involve decoupling the anchor 120 from the sutures 144 (e.g., by decoupling the sutures from the distal needle tips 142, or by decoupling the distal needle tips from the anchor 120).

In some applications, for example, as in the example where distal needle tip 142 is anchored directly to the tissue of annulus 15, tissue anchor 120 may be removed from the anatomical site along with wire 110 by detaching the tissue anchor from the tissue of annulus 15 while retaining the wire attached to the tissue anchor, and then retracting the wire with the tissue anchor. In some applications, after removing the tissue anchor 120, the distal needle tip 142, rather than the tissue anchor 120, will continue to hold the suture 144 securing the cutting edge 134.

Reference is now made to fig. 9, which is a schematic top view illustration of the mitral valve after repair using the method of fig. 3A-8E. As can be seen, the excess tissue has been removed from the valve leaflet She Yichu so that the leaflets 12 and 14 now better coapt, i.e., better close the valve, at reference numeral 17. Sutures 144 extend along the leaflets 14, holding the cutting edges 134 together and by the tissue anchors 120 retained in the annulus 15 of the valve.

Reference is now made to fig. 10A and 10B, which are schematic illustrations of examples of control handles for controlling devices useful for implementing the techniques described with reference to fig. 3A-8E, according to some applications.

As shown, for some applications, the proximal portion 107 of the longitudinal catheter 100 includes a control handle, such as control handle 200A (fig. 10A) or control handle 200B (fig. 10B). Although control handles 200a and 200b are shown as separate examples, one or more features of each example may be substituted for and/or combined with one or more features of the other example. Control handles 200a and 200b may be manipulated by a user, such as a surgeon, and may be used to control and manipulate one or more of the elements of the systems discussed above, including catheter 100, wire loop 110, fastening element 116, tissue anchor 120, helical needle 140, tip 142 of the helical needle, clip 150, and/or suture 144 (fig. 3A-8E). Control handles 200a and 200b may be mechanically coupled to the system elements that they control and may form a user interface for mechanical interaction with the system.

Alternatively or additionally, control handles 200a and 200b may include a user interface for computerized control elements for the operation of one or more control system elements. For the purposes of this application, the term "computerized control element" and the equivalent term "computerized controller" refer to a computing circuit or element for controlling the operation of mechanical and/or electrical components of a system. The computerized control element includes a processing unit functionally associated with a non-tangible computer-readable storage medium. The storage medium stores instructions that, when executed by the processing unit, perform actions that control the operation of mechanical and/or electrical components of the system. For example, the instructions may include instructions to advance one or more components of the system, or to retract one or more components of the system. The computerized control element may be functionally associated with or may contain a user interface for accepting user input, which may be used to trigger execution of specific instructions stored in the storage medium.

For the purposes of this application, the term "user interface" refers to any mechanical or electrical device with which a user interacts to control the system, either by directly, e.g., a mechanical control system or components thereof, or by providing input to computerized control elements of any component of the control system. As such, the user interface may comprise a handle, knob, or button for moving one or more mechanical components of the system, a computer interface for providing input to computerized control elements of one or more components of the control system, such as a keyboard, mouse, screen, etc., or any other mechanism of a user operating system, such as a surgeon.

It should be noted that control handles 200a and 200b are the extracorporeal control portion of catheter 100 and may be shaped and configured differently than shown. For example, it is possible that the extracorporeal control portion is not a configuration of a handle shaped for gripping.

The following description relates to a unified control handle that controls all system elements. However, it should be understood that control of system elements may be distributed among a plurality of different control handles or other user interfaces, as appropriate for the particular embodiment of the system and the environment in which the system is employed.

Each of the control handles 200a and 200b may contain a catheter controller 202, shown here as a rotatable engagement element, for advancing and retracting the catheter 100 (fig. 3A-8E), controlling the advancement of the catheter when the rotatable engagement element is rotated in one direction and controlling the retraction of the catheter when the rotatable engagement element is rotated in the opposite direction. Although the illustrated example shows catheter controller 202 as a wheel, it should be understood that any other catheter controller may be used, such as a slide controller, a touchpad controller, and the like. Alternatively or additionally, advancement and retraction of catheter 100 may be accomplished by axially moving the catheter as a whole, such as by pushing and pulling a control handle.

Each of the control handles 200a and 200b may contain one or more catheter steering controls 203, shown here as rotatable engagement elements, for steering the catheter 100 (fig. 3A-8E). For example, rotation of the catheter steering controller 203 in one direction may control steering of the catheter in a first direction, and rotation in an opposite direction may control steering of the catheter in a second opposite direction. For example, the catheter steering controller 203 may be operably coupled to the distal portion 106 of the catheter 100 by one or more pull wires. Although the illustrated example shows the catheter steering controller 203 as wheels to facilitate steering of the catheter in two directions, it should be understood that additional catheter steering controllers may be used to steer the catheter in additional directions. It should also be appreciated that any other catheter controller may be used, such as a slider controller, a touchpad controller, a joystick controller, and the like.

Each of the control handles 200a and 200b may include a wire loop controller 204 for distally advancing the wire loop 110 (fig. 3A-8C) from the catheter, and optionally also for retracting the wire loop. In the example shown, the wire loop controller 204 is shown as a rotatable engagement element that controls advancement of the wire 110 when rotated in one direction and controls retraction of the wire when rotated in the opposite direction. Although the illustrated example shows wire loop controller 204 as a wheel, it should be understood that any other wire loop controller may be used, such as a slide controller, a touchpad controller, and the like.

In some applications, the wire loop controller 204 may include or be functionally associated with a wire removal button 206 adapted to control removal of the wire 110 from the tissue anchor (fig. 8C). Wire detachment button 206 may be a depressible button, or any other suitable type of button or interface with which a user may interact. In some applications, the wire removal button 206 may be implemented as part of the wire loop controller 204, such as when depression of the wire loop controller 204 causes the wire 110 to be removed from the tissue anchor 120, and rotation of the wire loop controller controls advancement and retraction of the wire.

Each of the control handles 200a and 200B may include a fastening element controller 208 for sliding the fastening element 116 distally over the wire loop 110 (fig. 3A-7B), and/or to and from the catheter. In some applications, the fastening element controller 208 is functionally associated with the drive element 118 (fig. 3A-7B) and controls advancement of the fastening element 116 by controlling advancement of the drive element. In the example shown, the fastener element controller 208 is shown as a rotatable engagement element that induces advancement of the fastener element 116 when rotated in one direction, and in some applications, retraction of the fastener element when rotated in the opposite direction. While the illustrated example shows the fastening element controller 208 as a rotatable engagement element, it should be understood that any other fastening element controller may be used, such as a slide controller, a touchpad controller, and the like.

Each of the control handles 200a and 200b may contain a tissue anchor controller 210 that may be functionally coupled to the anchor driving tool 109 for driving the tissue anchor 120 (fig. 3A-8E) to an anatomical site and anchoring the tissue anchor in the annulus 15 (fig. 3A-8E). In the illustrated example, the tissue anchor controller 210 is shown as a rotatable engagement element that rotates the anchor tool 109 in a first direction (e.g., screws the tissue anchor 120 into the anatomical site) when rotated in one direction and rotates the anchor tool 109 in a second, opposite direction (e.g., releases the tissue anchor 120 from the anatomical site) when rotated in an opposite direction. However, any other type of tissue anchor and/or tissue anchor driver may be used, such as dart-like tissue anchor, which is inserted axially into tissue.

In some applications, each of control handles 200a and 200b may contain a needle controller 212 for distally advancing or distally advancing a spiral needle 140 (fig. 3A-8E) to or from a catheter, and for retracting the spiral needle. In the example shown, the needle controller 212 is shown as a rotatable engagement element that controls advancement of the needle 140 when rotated in one direction and retraction of the needle when rotated in the opposite direction. Although the illustrated example shows needle controller 212 as a wheel, it should be understood that any other needle controller may be used, such as a slide controller, a touchpad controller, and the like.

In some applications, the needle controller 212 may include or be functionally associated with a tip removal button 214 adapted to control removal of the needle tip 142 (fig. 3A-8E) from the remainder of the needle 140. Tip removal button 214 may be a depressible button, or any other suitable type of button or interface with which a user may interact. In some applications, the tip removal button 214 may be implemented as part of the needle controller 212, for example, when rotation of the needle controller controls the advancement and retraction of the needle 140, and depression of the needle controller 212 causes the needle tip 142 to be removed from the remainder of the needle.

In some applications, control handles 200a and 200B may contain clamp controller 216 for distally advancing clamp 150 (fig. 4A-7B) to or from a catheter, and for retracting the clamp. In the example shown, the clamp controller 216 is shown as a rotatable engagement element that controls advancement of the clamp 150 when rotated in one direction and that controls retraction of the clamp when rotated in the opposite direction. While the illustrated example shows the clamp controller 216 as a wheel, it should be understood that any other clamp controller may be used, such as a slide controller, a touchpad controller, and the like.

In some applications, the clamp controller 216 may contain, or may be functionally associated with, a clamp actuator 218 adapted to control the opening and closing of the clamp end 152 (fig. 4A-7B). The clamp actuator 218 may be a depressible button, or any other suitable type of button, lever, or interface with which a user may interact. In some applications, the clamp actuator 218 may be implemented as part of the clamp controller 216, such as when rotation of the clamp controller controls advancement and retraction of the clamp, depression of the clamp controller 216 causes the clamp end 152 to open, and release of the clamp controller 216 causes the clamp end 152 to close.

In some applications, each of the control handles 200a and 200b may include a unified engagement element that, when actuated, consistently controls movement of the clamp controller 216 and the helical needle 140, for example, at a fixed distance from each other.

In the example shown in fig. 10A, control handle 200A includes a unified engagement element in the form of a rotatable engagement element 220 that is different from fastening element controller 208 and needle controller 212. Advancement of the fastening element 116 and the helical needle 140 is controlled consistently when the rotatable engagement element 220 is rotated in one direction, for example at a fixed distance from each other. In some applications where it is desirable for the fastening element 116 and the helical needle 140 to retract in unison, retraction of the fastening element and the helical needle may be controlled in unison when the rotatable engagement element 220 is rotated in opposite directions.

In the example shown in fig. 10B, control handle 200B includes a coupling element 222 that is functionally associated with fastening element controller 208 and needle controller 212. In a first operational state of the coupling element 222, such as when slid to the distal portion of the slot in which the coupling element is located, the fastening element controller 208 and the needle controller 212 become operably coupled (e.g., locked) to one another to form a unified engagement element such that rotation of either the fastening element controller or the needle controller consistently controls movement of both the fastening element 116 and the helical needle 140, and/or at a fixed distance from one another. In a second operational state of the coupling element 222, for example when slid to the proximal portion of the slot in which the coupling element is located, the fastening element control 208 and the needle control 212 become uncoupled. In this second operating state, actuation of the fastening element controller 208 controls only movement of the fastening element 116, and actuation of the needle controller 212 controls only movement of the helical needle 140.

The following description relates to additional implants and implantation methods for repairing flail leaflets (flail leaflets) of a heart valve. The methods and implants discussed herein are shown with respect to repair of leaflets of a mitral valve. However, the methods and implants are equally applicable and useful for treatment of the leaflets of the tricuspid valve.

The same reference numerals will be used hereinafter when referring to the anatomical or mechanical structures mentioned in relation to fig. 1-10B.

Referring now to fig. 11A-11D, these are schematic illustrations of stages of use of a system 300 for repairing a second leaflet 14 of a mitral valve 10 by suturing a portion of the leaflet between the root and the lip of the leaflet, according to some applications. Fig. 11A is a top view illustration showing at least some stages of a technique for repairing a leaflet using system 300. In the example shown in fig. 11A, the second leaflet 14 includes excess tissue 16, e.g., such that prolapse and/or suboptimal apposition with the first leaflet 12 (e.g., along a portion of the edge 17).

As seen at stage I, the longitudinal catheter 302 is advanced toward the anatomy of the subject. The longitudinal conduit 302 is substantially similar to the longitudinal conduit 100 described above with respect to fig. 2-10B. In the example shown, the distal portion 306 of the catheter is advanced to a ventricle (e.g., left ventricle) of the heart to be positioned upstream of a heart valve (e.g., mitral valve 10). The longitudinal catheter 302 also has an extracorporeal proximal portion (e.g., as shown in fig. 10A-B). The distal portion 306 may be directed to the anatomical site, such as by being actively steerable itself (e.g., by being operatively coupled to a proximal portion thereof by one or more pull wires, such as steering controller 203 thereof shown in fig. 10A and 10B), or by being passively directed and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). A longitudinal axis 308 extends between the proximal portion of the catheter 302 and the steerable distal portion 306. Catheter 302 is advanced transluminally to the anatomical site, such as through the vena cava, and, if desired, through the septum of the atrium of the heart, using any method known in the art.

The mount 310 is advanced to the heart of the subject, e.g., the ventricle upstream of the valve to be treated. In some applications, as in the illustrated example, the mount 310 may be advanced through the lumen of the catheter 302 to the target anatomical site and distally from the steerable distal portion 306 of the catheter 302. In some applications, the mount may be advanced to a target location attached to the distal portion 306 of the catheter 302.

In some applications, as in the example shown in fig. 11A, the mount 310 has a crescent-shaped cross-section perpendicular to its longitudinal axis. The crescent shape defines a concave leaflet-facing surface 314, thereby defining a cavity 316 extending longitudinally along at least a portion of the mount 310. The mount 310 may have opposing surfaces 312 oriented away from the leaflet. The surface 312 may be convex (e.g., defined by a crescent shape).

It should be noted that the mount 310 may alternatively have a different cross-sectional shape. However, in some applications, in each case, the opposing surface 312 is shaped substantially as an arc 317 (e.g., a circular arc), which if extrapolated into a complete circle (indicated by dashed line 318; fig. 11B-11D) would extend around the leaflet-facing surface 314 with a space 319 between the arc and the leaflet-facing surface. This is shown in fig. 11B, where the leaflet-facing surface 314 of the crescent-shaped mount 310 is concave, in fig. 11C the cross-sectional shape of the mount 310' (i.e., a variant of mount 310) is a circular section (e.g., a semicircle), where the leaflet-facing surface 314 is substantially flat, and in fig. 11D the cross-sectional shape of the mount 310 "(i.e., a variant of mount 310) is substantially convex, where the leaflet-facing surface 314 is convex.

The mount 310 is positioned with the surface 314 facing the leaflet 14, e.g., in contact with the leaflet (stage I). It should be appreciated that in such positioning, a portion of the leaflet 14 may be disposed within the space 319 and may be disposed within the mounting member cavity 316. As seen in stages I and II, a helical needle 320 having a distal needle tip 322 is then rotationally advanced distally from the distal portion 306 of the catheter 302, helically around the mount 310. The spiral needle 320 may be similar or identical to the spiral needle 140 described above with respect to fig. 4A and 4B. Rotation of the helical needle 320 may be performed while the mount 310 remains stationary relative to the leaflet 14. The spiral needle 320 includes a spiral lumen having a suture 324 extending helically therethrough, as described in further detail below. As best seen in the enlarged portion of phase II, as the helical needle 320 rotates, a portion of the tissue of the second leaflet 14 (e.g., the portion disposed within the space 319) between the annulus 15 and the lips 14a of the leaflets is captured by the helical needle.

In some applications, the helical needle 320 is stabilized or guided by the mount 310 during rotation of the helical needle. More specifically, during rotation of the helical needle 320, the helical needle engages the mount 310 along an arc 317. For some applications, mount 310 is configured such that the angle corresponding to arc 317 of opposing surface 312 is greater than 180 degrees, and thus the arc contacts needle 320 through more than half of each rotation. This further stabilizes helical needle 320 (e.g., the needle cannot be advanced closer to surface 314 than surface 312).

It should be noted that a mount similar to mount 310 may be used in a similar manner to stabilize or guide helical needle 140 during performance of the method described above with respect to fig. 4A-9.

In the example shown in fig. 11A, the mount 310 and the spiral needle 320 are advanced along the width of the leaflet 14, substantially parallel to the annulus and/or the lips of the leaflet. However, in some applications, the mount and spiral needle may be advanced in other directions or orientations, mutatis mutandis.

In some applications, the needle 320 may be advanced through the same lumen as the mount 310. In some applications, as in the illustrated example, the needle 320 may be advanced through a dedicated lumen 304 in the catheter 302. Lumen 304 may be a helical lumen or may be a linear lumen. In instances where lumen 304 is linear, needle 320 may automatically become helical upon exposure from the lumen, such as by using a shape memory material for the helical needle.

Although the helical needle 320 is shown as having a cylindrical helical shape, i.e., having a constant transverse diameter along its length, for some applications the transverse diameter of the helical needle may vary along its length, such as being wider at the distal end than at the proximal end, e.g., the helical needle may have a conical helical shape.

Although the spiral pins 320 are shown as having a constant pitch, for some applications, the spiral pins may have a variable pitch.

As seen at stage III, the helical needle 320 continues to advance rotationally toward the distal end of the mount 310. At this stage, the pointed end 322 of the helical needle 320 is detached from the body (i.e., the remainder) of the helical needle 320, but remains attached to the suture 324, preventing the suture from sliding out of the tissue.

Turning to stage IV, it can be seen that the helical needle 320 is rotationally retracted (e.g., unscrewed) from the tissue in the direction indicated by arrow 326, e.g., around the mount 310, leaving the suture 324 in place. The mount 310 is retracted linearly from the tissue in the direction indicated by arrow 328. In some applications, the mount 310 is retracted with the helical needle 320, or at a fixed distance from the helical needle. In some applications, during retraction of the mount, mount 310 may be retracted after helical needle 320 is retracted if suture 324 remains loose enough to pass the mount. In some applications, the mount 310 may be retracted before the helical needle 320 is retracted.

Retraction of the helical needle 320 and the mount 310 may, for example, be into the catheter 302, for example, into a corresponding lumen from which the helical needle and the mount advance to the anatomical site.

Stage V illustrates suture 324 passing through leaflet 14 after helical needle 320, mount 310, and catheter 302 are completely removed.

After the mount 310 and helical needle 320 are fully retracted, the suture 324 may be tensioned (e.g., by pulling proximally), as shown at stage VI. After the suture 324 is tensioned, the second locking element 330 may be locked to the suture to secure the suture in its tensioned state, and the proximal end of the suture may be cut.

As seen in the enlarged portion of stage VI, after suture 324 is tensioned, the tissue of second leaflet 14 captured by spiral needle 320 folds. As a result, the length of the second leaflet 14 from the annulus 15 to the lip 14a is shortened relative to the initial length shown at stage I, thereby improving coaptation between the leaflets 14 and 12.

For some applications, the suture 324 may be sufficiently tensioned so as to crease or shorten tissue along the longitudinal direction of the suture. For some such applications, the helical needle 320 is selected to have a relatively large spacing, which creates a greater distance between the locations of the suture passing through the tissue, and thus enhances the plication of the tissue between such locations upon subsequent tensioning of the suture. That is, a relatively small pitch may be selected to facilitate retraction in a direction transverse to the axis of the helical needle, while a relatively large pitch may be selected to facilitate retraction in a direction along or parallel to the axis of the helical needle. For some applications, such techniques may be used, mutatis mutandis, to constrict or fold the annulus.

Referring now to fig. 12A, 12B and 12C, these are schematic top or cross-sectional illustrations of stages of repairing a second leaflet 14 of a mitral valve 10 by suturing a portion of the leaflet to the root of the leaflet, according to some applications. The method shown in fig. 12A, 12B, and 12C is similar to the method shown in fig. 11A, with fig. 12A, 12B, and 12C generally corresponding to stages III, IV, and VI of fig. 11A.

As seen in fig. 12A, the longitudinal catheter 302 has been advanced toward the anatomical site at the root of the second leaflet 14, substantially as described above with respect to stage I of fig. 11A. The mount 310 has been advanced distally from the catheter 302, and the helical needle 320 has been extended distally from the catheter 302 rotationally about the mount 310 in the direction of arrow 332, substantially as described above with respect to stages I, II and III of fig. 11A. However, in the example shown in fig. 12A, the mount 310 has been positioned along the root 333 of the leaflet 14 such that the spiral needle 320 engages both the leaflet 14 and the atrial wall 334 of the ventricle upstream of the valve 10. For example, and as shown, the needle 320, as it advances helically, may enter the atrial wall 334 and exit the leaflet 14. In this way, the spiral needle has captured the tissue of the leaflet therein at the root 333 of the leaflet abutting the atrial wall 334.

As seen in fig. 12B, after the needle 320 is rotationally advanced to the edge of the mount 310, the tip 322 of the helical needle 320 is detached from the body (i.e., the remainder) of the helical needle 320, but remains attached to the suture 324, preventing the suture from sliding out of the tissue.

The helical needle 320 is then rotationally retracted (e.g., unscrewed) from the tissue, with the necessary modifications, e.g., around the mount 310, leaving the suture 324 in place, e.g., as described with reference to stage IV of fig. 11. The mount 310 may be retracted linearly from the tissue in the direction indicated by arrow 336. In some applications, the mount 310 is retracted with the helical needle 320, or at a fixed distance from the helical needle. In some applications, during retraction of the mount, mount 310 may be retracted after helical needle 320 is retracted if suture 324 remains loose enough to pass the mount. In some applications, the mount 310 may be retracted before the helical needle 320 is retracted.

Figure 12B shows that the suture 324 remains threaded through the root of the leaflet 14 after the needle 320 and mount 310 are withdrawn. Fig. 12C shows suture 324 that has been tensioned (e.g., by pulling proximally), tension has been locked in the suture using a second locking element 330 locked onto the suture, and a proximal portion of the suture has been cut.

As seen in fig. 12C, after the suture 324 is tensioned, the tissue of the second leaflet 14 adjacent the heart wall folds, which is captured by the helical needle 320. As a result, the second leaflet 14 is effectively shortened (along the root-to-tip axis) relative to the initial length shown in the enlarged portion of fig. 12B, and thus the lip 14a of the second leaflet 14 properly coapts with the lip 12a of the first leaflet 12.

Referring now additionally to fig. 13, a schematic cross-sectional illustration of a leaflet 14 of a mitral valve 10 being repaired by suturing a portion of the leaflet to a coronary artery 340 surrounding the mitral valve, according to some applications.

As seen in fig. 13, the process of fig. 12A-12C may be performed by introducing a catheter into the anatomical site through a coronary artery 340 surrounding the mitral valve. In some applications, the helical needle and suture 324 will extend through an entry point in the wall of the coronary artery 340, through the leaflet 14 adjacent the root, and back into the coronary artery through an exit point in the wall of the coronary artery. After the suture 324 is tensioned, a portion of the leaflet 14 adjacent its root engages the heart wall through which the coronary artery 340 extends, as shown in fig. 13. As a result, the leaflet 14 is effectively shortened (along the root-to-tip axis), and thus the lip 14a of the second leaflet 14 properly coapts with the lip 12a of the first leaflet 12. For some applications, mount 310 (or similar mount) is used to facilitate such techniques. For some applications, such techniques are performed without the use of mounts.

Reference is now made to fig. 33, which is another schematic illustration of excess tissue in the leaflets of a native valve and its incorrect closure. The reference numerals used in fig. 33 correspond to those used in fig. 1 and throughout the specification. Fig. 33 shows a native valve 10 (described herein as a mitral valve, but applicable to other valves) having first and second leaflets 12, 14 surrounded by an annulus 15. The second leaflet 14 has excess tissue 16 such that when the valve is closed, a gap 18 exists in the valve. The length of the second leaflet 14 extending from the lip 14a to the annulus 15 is indicated by reference numeral 801, while the width of the leaflet in a direction perpendicular to the length 801 is indicated by reference numeral 802.

Fig. 34 is a schematic illustration of placement of a retaining device 810 in the native valve 10 shown in fig. 33, according to some applications.

As seen in fig. 34, the longitudinal catheter 800 is advanced toward the anatomy of the subject. The longitudinal catheter 800 is substantially similar to the longitudinal catheter 100 described above with respect to fig. 2-10B. In the example shown, the distal portion 806 of the catheter is advanced to a ventricle (e.g., left ventricle) of the heart to be positioned upstream of a heart valve (e.g., mitral valve 10). The longitudinal catheter 800 also has an extracorporeal proximal portion (e.g., as shown in fig. 10A-B). The distal portion 806 may be directed to the anatomical site, such as by being actively steerable itself (e.g., by being operatively coupled to a proximal portion thereof, such as the steering controller 203 thereof shown in fig. 10A and 10B, by one or more pull wires), or by being passively directed and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). A longitudinal axis 808 extends between the proximal portion of the catheter 800 and the steerable distal portion 806. Catheter 800 is advanced transluminally to the anatomical site, such as through the vena cava, and, if desired, through the septum of the atrium of the heart, using any method known in the art.

In some applications, and as shown, a retaining device 810 comprising a first beam 812, a second beam 814, and a third beam 816 is advanced distally from the steerable distal portion 806 of the catheter 800. The catheter 800 positions the retention device 10 on the second leaflet 14 of the mitral valve 10 such that the first and third beams 812, 816 are disposed on one side of the leaflet, here shown as the upstream side of the leaflet, and the second beam 814 is disposed on the opposite side of the leaflet, here shown as the downstream side of the leaflet. In some applications, the catheter positions the first beam 812 and the third beam 816 at lateral edges of the excess tissue 16 of the leaflet 14 such that all of the excess tissue is positioned between the beams 812 and 816.

For some applications, the catheter 800 positions the retention device 810 on the second leaflet 14 when the retention device is in the first operating state to define a first distance G1 between the beams 412 and 416. In this first operational state, beams 812, 814, and 816 may be substantially in a single plane.

For some applications, beams 812, 814, and 816 may be fixedly attached to one another and move as a unit relative to catheter 800. In this way, the beam may be advanced from catheter 800 as a single unit.

For some other applications, beams 812, 814, and 816 may be moved independently of one another relative to catheter 800, and may each be individually advanced from catheter 800.

For some applications, beams 812, 814, and 816 may all be advanced from a single lumen in catheter 800. For some applications, at least two of beams 812, 814, and 816 may be advanced from two different lumens in catheter 800, or each of the beams may be advanced from a dedicated lumen in the catheter.

For some applications, retaining device 810, and in particular beams 812, 814, and/or 816, may be flexible and/or resilient. For example, in some applications, the retaining device 810 and/or the beams thereof may be formed of a resilient metal or shape memory material.

Reference is now made to fig. 35A and 35B, which are schematic illustrations of stages of transitioning the retention device 810 from the first operational state to the second operational state, according to some applications.

In some applications, and as shown, catheter 800 is used to transition retaining device 810 from the first operational state shown in fig. 34 to the second operational state shown in fig. 35B by moving first beam 812 and third beam 816 toward each other in the direction of arrow 818 while moving second beam 814 away from the plane formed by beams 812 and 816, and away from perpendicular to the plane formed by the beams for some applications, shown here as being in an upward direction indicated by arrow 820.

In some applications, the second beam 814 flexes or deforms during the transition of the retention device 810 from the first operating state to the second operating state. The curved beam 814 includes a transition section 824a that in some applications turns the remainder of the beam 824b at an obtuse angle. In some such applications, the remaining portion 824b is substantially parallel to the beams 812 and 816.

In some applications, in the second operational state of the holding device 810, there is a second distance G2 between the first beam 812 and the second beam 816, the distance G2 being less than the distance G1. In some applications, the distance G2 is no greater than twice the width of the second beam 814. For example, the distance G2 may be substantially equal to the width of the second beam, or may be less than the width of the second beam.

In some applications, in the second operational state of the holding device 810, the second beam 814 is disposed outside of the plane defined by the first beam 812 and the third beam 816.

As seen in fig. 35B, after the retention device 810 is transitioned to the second operational state, the excess tissue 16 forms a bulge 830 that is retained between the first beam 812 and the third beam 816 and is supported from the downstream side of the leaflet by the second beam 814. In the illustrated embodiment, the projections 830 extend toward the upstream side of the leaflets 14 and into the ventricle.

Reference is now made to fig. 36A and 36B, which are schematic illustrations of stages of securing together segments of tissue of the mitral valve 10 using a helical needle 840 according to some applications.

As seen, the attachment means, here shown as a helical needle 840 having a distal needle tip 842, extends distally rotationally from the distal portion 806 of the catheter 800. The spiral needle 840 may be similar or identical to the spiral needle 140 described above with respect to fig. 4A and 4B. The spiral needle 840 includes a spiral lumen 843 having a suture 844 extending helically therethrough, as described in further detail below.

For some applications, the spiral needle 840 rotates while advancing along the length 801 toward the annulus 15, substantially perpendicular to the lips of the leaflets. However, in some applications, the mount and spiral needle may be advanced in other directions or orientations, mutatis mutandis.

For some applications, the spiral needle 840 rotates around the first beam 812 and the third beam 816 and under the second beam 814 to attach two sections of the leaflet. A first of the two sections may include a portion of the base of the protrusion 830 above the first beam 812, a portion of the leaflet 14 to the side of the first beam, and tissue of the leaflet engaged by the first beam. Similarly, a second of the two sections may include a portion of the base of the boss 830 above the third beam 816, a portion of the leaflet 14 to the side of the third beam, and tissue of the leaflet engaged by the third beam. The direction of rotation of the needle 840 is indicated by reference numeral 845.

In some applications, the spiral needle 840 may temporarily secure two sections of the leaflet 14 together, and after removal of the spiral needle 840, a permanent attachment element, such as a suture 844, may subsequently maintain attachment of the two sections for a long period of time, as described in further detail below.

In some applications, the needle 840 may be advanced through the catheter 800 to the leaflet 14. In some applications, needle 840 may be advanced through the same lumen as retaining device 810. In some applications, the needle 140 may be advanced through a dedicated lumen in the catheter 800, similar to the lumen 146 of fig. 4A and 4B. The dedicated lumen may be a helical lumen or may be a linear lumen. In the example where the dedicated lumen is linear, the needle 840 automatically becomes helical upon exposure from the lumen, such as by using a shape memory material for the helical needle.

Although the spiral needle 840 is shown as having a cylindrical spiral shape, i.e., having a constant transverse diameter along its length, for some applications the transverse diameter of the spiral needle may vary along its length, such as being wider at the distal end than at the proximal end, e.g., the spiral needle may have a conical spiral shape.

Although the spiral needle 840 is shown with a constant pitch, for some applications, the spiral needle may have a variable pitch.

For some applications, the spiral needle 840 may be replaced with a different edge attachment device, mutatis mutandis. For example, alternative attachment means for attaching two sections of tissue may include clamps, pins, hooks, tissue adhesives, and the like.

For some applications, during rotation thereof, the helical needle 840 may be guided or stabilized by a mount similar to mount 310 of fig. 11A-11D, and in a manner similar to that described with respect to fig. 11A-11D.

Referring now to fig. 37, a schematic illustration of a needle tip 842 detached from a spiral needle 840 according to some applications. As seen in fig. 37, after rotating the needle 840 to secure the desired section of the leaflet 14, shown here as extending from the lip 14a to the section of the annulus 15, the tip 842 of the spiral needle is detached from the body (i.e., the remainder) of the spiral needle 840, but remains attached to the suture 844, preventing the suture from sliding out of the tissue.

For some applications, removal of needle tip 842 from the remainder of spiral needle 840 is performed by pushing wire 846. Push wire 846 extends through lumen 843 of spiral needle 840 and is configured to push detachable needle tip 842 distally relative to the remainder of spiral needle 840, thereby detaching the needle tip from the needle body.

It should be noted that a push wire similar to push wire 846 may be used in a similar manner to detach needle tip 142 from the remainder of helical needle 140 during performance of the method described above with respect to fig. 4A-9, or to detach needle tip 322 from the remainder of helical needle 320 during performance of the method described above with respect to fig. 11A-13.

Turning now to fig. 38, the figure is a schematic illustration of a section of a spiral needle 840 retracted while continuing to secure the leaflet 14, according to some applications. It can be seen that the helical needle 840 is rotationally retracted (e.g., unscrewed) from the tissue in the direction indicated by arrow 848, leaving the suture 844 in place, and the needle tip 842 anchors the suture directly to the tissue of the boss 830.

For some applications, and as shown, first beam 812 and/or third beam 816 may be proximally retracted from boss 830 prior to retraction of helical needle 840. For some such applications, the second beam 814 remains distally extending from the catheter 800 and supports the boss 830, as shown in fig. 38.

For some applications, beams 812 and 816 may be retracted linearly from tissue in the direction indicated by arrow 850. In some applications, beams 812 and 816 retract simultaneously with the helical needle 840 and/or at a fixed distance from the helical needle. In some applications, during retraction of the beams, beams 812 and 816 may be retracted after helical needle 840 is retracted if suture 844 remains loose enough to pass the beams. In some applications, beams 812 and 816 may be retracted prior to retraction of helical needle 840.

Retraction of the spiral needle 840 and beams 812 and 816 may, for example, be into the catheter 800, such as into the respective lumens from which the spiral needle and beams advance into the heart valve.

After the helical needle 840 and beams 812 and 816 are fully retracted, the suture 844 may be tensioned (e.g., by pulling proximally). After the suture 844 is tensioned, the second locking element 882 may be locked to the suture to secure the suture in its tensioned state, and the proximal end of the suture may be cut, substantially as described above with respect to fig. 11A.

After the suture 844 is tensioned, the tissue of the second leaflet 14 captured by the helical needle 840 folds. As a result, the effective width of the second leaflet 14 (indicated by 802 in fig. 33) is shortened relative to the initial width, thereby improving apposition between the leaflets 14 and 12. However, for some applications, it is desirable to reduce the amount of residual tissue remaining in the bulge 830, for example by resecting some tissue from the bulge, as described herein with respect to fig. 39A-41.

Reference is now made to fig. 39A, 39B and 39C, which are schematic illustrations of stages of cutting of excess tissue 16 between the fixed sections of the projections 830 of the leaflets 14 according to some applications.

As can be seen, in some applications, after the helical needle 840 is fully retracted, and in some applications, also after the beams 812 and 816 are retracted, the cutting device 860 is advanced distally to the end of the boss 830, between the two fixed sections of tissue.

In the application shown in fig. 39A-39C, the cutting device 860 includes a longitudinal rod 862 having one or more (e.g., one, a pair, three, etc.) blades 864 attached to a sharpened edge 865 at its distal end. The blade 864 is pivotable about an axis 866 relative to a longitudinal axis of the rod 862 between a first operational state suitable for storage and delivery and a second operational state suitable for cutting. In the first storage operating state shown in box I of fig. 39A, the blade 864 is disposed substantially parallel to the longitudinal axis of the rod 862, and in the second cutting operating state shown in box II of fig. 39A, the blade is substantially perpendicular to the longitudinal axis of the rod, with the sharpened edge 865 pointing in a proximal direction. The cutting device 860 may be actuated (e.g., transitionable between operational states) from an external proximal end of the device and/or system, for example, as described above with reference to fig. 10A-10B.

For some applications, the cutting device 860 may extend distally from the distal end 870 of the second beam 814. In such applications, the second beam 814 includes a lumen 872 that houses a cutting device 860 therein, wherein the cutting device is in the first operating state until the cutting device is needed. As the helical needle 840 is retracted, the second beam 814 may be advanced further distally from the catheter 800, as seen by comparing fig. 38 and 39A, such that the distal end 870 extends distally from the boss 830. At this stage, the cutting device 860 may be advanced distally from the second beam 814 and may transition from the storage operational state to the cutting operational state such that the sharpened edge 865 of the blade 864 is directed toward the protrusion 830.

However, it should be appreciated that the cutting device 860 may be any suitable cutting device and may be advanced adjacent to the protrusion 830 independently of the beam 814 or the retaining device 810. For example, the cutting device may comprise a cutting wire or wire loop that may be advanced through catheter 800, e.g., through a dedicated lumen or lumen advanced through by helical needle 840, to the mitral valve, substantially as described above with respect to fig. 4A-9.

Turning to fig. 39B, it can be seen that the second beam 814 with the cutting device 860 extending distally therefrom is retracted proximally into the catheter 800 in the direction of arrow 876. During retraction of the second beam 814, the sharp edge 865 of the blade 864 cuts through the tissue of the boss 830 between the boss sections secured by the suture 844. As a result, cut tissue 878 extends over cutting device 860 and cutting edge 880 is formed in protrusions 830 between the suture sections.

Turning to fig. 39C, it can be seen that cutting device 860 and second beam 814 are moved further proximally such that cut tissue 878 is further removed from boss 830 and cutting edge 880 extends. Proximal movement of the second beam 814 and the cutting device 860 may be caused by further retraction of the beam 814 into the catheter 800, and/or by proximal retraction of the catheter 800 with the beam 814 and the cutting device 860 away from the leaflet 14. Fig. 39C shows two types of movement. As seen in fig. 39C, the cut tissue 878 is almost completely detached from the boss 830.

Reference is now made to fig. 40A and 40B, which are schematic illustrations of clamping and removing cut tissue 878 from the mitral valve 10, according to some applications. As seen in fig. 40A, a clamp having a distal clamping end is advanced distally from catheter 800 and engaged with the cut tissue just before or after the cut tissue 878 is completely removed from the remainder of boss 830. In the illustrated embodiment, the cutting device 860 acts as a clamp by transitioning at least partially back toward the storage operational orientation such that the blade 864 clamps a portion (e.g., an end) of the cut tissue 878.

However, any other type of clamp may be used, such as the clamp 150 described above with respect to fig. 4A-9. The clip may be advanced distally from catheter 800 as described with respect to fig. 4A-9, for example, through a dedicated lumen or through the same lumen as retaining device 810 or spiral needle 840. The clamp may be advanced distally from the catheter in a closed and/or delivery state and may be operated to clamp cut tissue 878, substantially as described. The clamping end of the clip may comprise a jaw and may be actuated (e.g., openable and closable) from an external proximal end of the device and/or system, for example, as described below with reference to fig. 10A-10B.

As seen in fig. 40B, the second beam 814 with the cut tissue 878 clamped thereon is removed from the heart chamber adjacent the mitral valve 10. In some applications where the clip is separate from the second beam 814, the second beam, cutting device, and clip are removed from the mitral valve.

For some applications, the beam 814 containing the cutting device 860 and the cut tissue 878 clamped thereto (or the second beam, the cutting device, and another clamp of the cut tissue clamped thereto) may be removed by its retraction into one or more lumens of the catheter 800. For some applications, the beam 814 and the cut tissue 878 may be removed by withdrawing the catheter 800, e.g., where the beam 814 and/or the cut tissue 878 remain exposed from the catheter.

It should be appreciated that for some applications (e.g., applications where the cutting device and clamp are independent of the second beam 814), the second beam 814 may be retracted from the mitral valve 10 along with the first and third beams, e.g., during retraction of the spiral needle 840.

It should be appreciated that for some applications where beams 812, 814, and 816 are not longitudinally movable relative to one another, and/or are not separately retractable from one another from the mitral valve (e.g., are axially fixed relative to one another), beams 812 and 816 may be retracted with beam 814 during cutting of excess tissue from boss 830. For such applications, tensioning of the suture 844 may be performed after cutting the excess tissue, such that the suture remains sufficiently loose to allow the beams 812 and 816 to retract during cutting.

Referring now to fig. 41, which is a schematic top view illustration of the mitral valve after repairing the mitral valve 10 using the method of fig. 34-40B. As can be seen, excess tissue has been removed from the bulge formed by the valve leaflets, so that the leaflets 12 and 14 now coapt better, i.e. close the valve better, at reference numeral 17. Sutures 844 extend along leaflet 14 from lip 14a toward annulus 15, substantially perpendicular to the lip, and hold cutting edges 880 together. The suture is held by a needle tip 842, which is held near tissue at one of the raised attachment sections, and a locking element 882, which is placed onto the end of the suture 844, substantially as described above with respect to fig. 11A to 13.

It should be appreciated that the method described above with respect to fig. 33-41 is substantially similar to the method described above with respect to fig. 1-9 in that both methods include the steps of cutting tissue from the leaflet and securing the cut edge of the tissue. In the method of fig. 1-9, tissue is cut to form a cutting edge, which is then secured. In contrast, in the method of fig. 33-41, the tissue is initially fixed, and then the cutting edges (already fixed to each other) are formed by resecting the tissue.

Reference is now made to fig. 14A-14D, which are schematic illustrations of an implant 350 for repairing leaflets of a heart valve and stages of its use, according to some applications.

Implant 350 includes a frame 351 that includes a first leaflet engaging end 352a and a second leaflet engaging end 352b. The first leaflet engaging end 352a and the second leaflet engaging end 352b are interconnected by a middle portion of the frame. The intermediate portion includes a generally U-shaped central portion 354 having first and second arm portions 356a and 356b extending from respective ends of the central portion 354 to respective leaflet-engaging ends 352a and 352b of the arm portions.

Implant 350 further includes at least one tether 360 extending away from leaflet engaging ends 352a and 352b. In some applications, one tether 360 extends away from each of the leaflet-engaging ends, e.g., each tether is fixedly attached to a corresponding one of the leaflet-engaging ends. In some applications, as in the illustrated example, the hollow lumen 358 extends through the entire length of the frame 351, from the first leaflet engaging end 352a, through the first arm portion 356a, the central portion 354, and the second arm portion 356b, to the second leaflet engaging end 352b. In such examples, a single tether 360 may extend through the entire lumen 358 and protrude beyond the leaflet engaging ends 352a and 352b, e.g., as shown.

In some applications, the length of the frame 351 is formed as a unitary structure.

The frame 351 may be a flexible and/or resilient device. For example, in some applications, the frame 351 may be formed of a resilient metal or shape memory material.

In some applications, the frame 351 is generally planar. Alternatively, and as shown, arm portion 356 may be curved out of plane, such as around a leaflet.

In some applications, in a first operational state of implant 350, i.e., a rest state in which no force is applied to the implant, arm portions 356a and 356b extend outwardly from the ends of central portion 354. In the rest state, the distance d1 between the ends of the arm portions 356a and 356b connected to the leaflet engaging ends 352a and 352b, respectively, is greater than the distance d2 between the ends of the arm portions engaging the central portion 354. In the resting state shown in fig. 14A, leaflet engaging ends 352a and 352b are angled inwardly with respect to arm portions 356a and 356b such that a distance d3 less than d1 extends between the ends of leaflet engaging ends 352a and 352 b.

When a force is applied to the leaflet engaging ends 352a and 352b, pushing them toward each other, the arm portions 356a and 356b pivot about the central portion 354 to decrease the distance d2 and bring the leaflet engaging ends 352a and 352b closer to each other, as explained in further detail below.

Turning to fig. 14B, the first leaflet 12 has excess tissue 16B such that a gap 18B is formed between the lips 12a and 14a of the leaflets 12 and 14.

As seen in fig. 14B, when the implant is in a resting state, the implant 350 is delivered transluminally to the heart chamber adjacent the mitral valve 10, e.g., to the heart chamber upstream of the mitral valve. In some applications, the implant is delivered through at least one longitudinal catheter similar to catheter 100 described above, which is configured to be advanced transluminally toward the heart. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

As seen in fig. 14C, the catheter is adapted to be steerable so that the first leaflet engaging end 352a engages the lip 12a of the leaflet 12 at a first position along the lip and the second leaflet engaging end 352b engages the lip 12a at a second position along the lip. In this arrangement, the central portion 354 and arm portions 356a and 356b are disposed on the downstream side of the mitral valve 10 with excess tissue 16b on and/or between the central and arm portions. The leaflet engaging ends 352a and 352b extend past and around the lip 12a and may engage with the upstream surface of the leaflet 12.

In some applications, as in the example shown, the implant 350 engages the leaflet 12 such that the arm sections of the U-shaped central portion 354 are substantially perpendicular to the lip 12a.

Turning to fig. 14D, it can be seen that the tensioning of tether 360 applies a force to leaflet engaging ends 352a and 352b, pulling them and arm portions 356a and 356b toward one another. As a result, implant 350 transitions to the second operational state. Movement of the arm portions 356a and 356b toward each other causes the excess tissue 16b to be sandwiched between the arms, e.g., forming protrusions 361 in the downstream surface of the leaflet 12. The tension in the tether 360 is secured by locking members 362 that slide onto both ends of the tether to secure the tether in its tensioned state. Tensioning of the tether 360 and locking in tension therein may be performed by the catheter, mutatis mutandis, e.g., in response to human manipulation of the control handle, e.g., similar to the catheter described above with respect to the catheter 100 and its control handle.

As seen in fig. 14D, the lips 12a of the leaflets have shortened due to the formation of the projections in the leaflets 12, such that the leaflets 12 and 14 properly coapt along their entire lengths, and the gap 18b has closed.

15A, 15B, and 15C, which are schematic top view illustrations of stages of repairing leaflets of a heart valve using another implant 370 according to some applications.

Implant 370 includes a first leaflet-engaging clip 372a and a second leaflet-engaging clip 372b. Each of the clips 372a and 372b includes a first surface 374 adapted to engage an upstream surface of the lip of the valve leaflet and a second surface 376 adapted to engage a downstream surface of the lip of the valve leaflet, the first and second surfaces being connected by a hinge portion 378. The first leaflet engaging clip 372a and the second leaflet engaging clip 372b are connected to one another by one or more tethers 380 extending between the first surfaces 374. In the example shown, the implant 370 includes a pair of tethers 380. Each of the clips 372a and 372b has a first operative state, which is an open state in which the surfaces 374 and 376 are angled with respect to one another about the hinge 378, and a second operative state, which is a closed state in which the surfaces 374 and 376 are substantially parallel to one another.

In the example shown, the implant 370 is used to repair the first leaflet 12 of the mitral valve 10. As seen in fig. 15A, the first leaflet 12 has excess tissue 16b such that a gap 18b is formed between the lips 12a and 14a of the leaflets 12 and 14.

Implant 370 is delivered transluminally to the heart chamber adjacent mitral valve 10, for example, to the heart chamber upstream of the mitral valve. In some applications, the implant is delivered through at least one elongate catheter 390 configured to be transluminally advanced toward the heart chamber. As described above with respect to catheter 100, longitudinal catheter 390 has a proximal portion and a steerable distal portion with a longitudinal axis therebetween. At least one clip installation tool 392 to which at least one of the clips 372a and 372b is attached is advanced distally from the catheter 390 with the attached clip in an open state.

The conduit 390 and/or the tool 392 are adapted to be steerable so as to bring the clip installation tool 392 to the lips 12a of the leaflets for the clip installation tool to clamp a clip mounted thereon to the lips of the leaflets by transitioning from an open state to a closed state. In fig. 15A, a first leaflet engaging clip 372a has been clamped to the lip 12a at a first position adjacent the end of the excess tissue 16 b. As can be seen, the surface 374 of the clip presses against the upstream surface of the leaflet 12, while the surface 376 presses against the downstream surface of the leaflet. The clip installation tool 392 is prepared to clamp the clip 372b mounted thereon to the lip 12a in the open position.

Turning to fig. 15B, it can be seen that the catheter 390 and clip installation tool 392 have been used to clamp the second leaflet engaging clip 372B to the lips 12a of the leaflet 12 at a second position along the lips such that excess tissue 16B extends between the first clip and the second clip. In this arrangement, the tether 380 extends over the excess tissue 16B, as best seen in fig. 15B.

After attaching the second clip 372B to the lips of the leaflet, the clip installation tool 392 can be retracted into the catheter 390 and optionally removed from the subject as seen in fig. 15B. The tether 380 continues to extend through the conduit 390, for example, to the exterior of its control handle or conduit, for access by a human operator.

In some applications, a single clip installation tool 392 may be used to deliver and place both clips 372a and 372b, e.g., one after the other. In some applications, a separate clip installation tool is used for delivery and placement of each of the clips 372a and 372 b.

Turning to fig. 15C, it can be seen that tensioning of the tether 380 pulls the leaflet engaging clips 372a and 372b toward each other. Movement of the clips 372a and 372b toward each other causes the excess tissue 16b to fold the region 394 of the lip 12a of the leaflet 12 disposed therebetween. In some applications, tension in the tether 380 may be secured by a locking member 396 that slides over the tether 380 to secure the tether in its tensioned state. Although fig. 15C shows each tether 380 having a corresponding locking member 396, for some applications a single locking member may be used to lock multiple (e.g., all) tethers 380.

Tensioning of the tether 380 and locking in tension therein may be performed by the catheter, mutatis mutandis, e.g., in response to human manipulation of the control handle, e.g., similar to the catheter described above with respect to the catheter 100 and its control handle.

As seen in fig. 15C, the lips 12a of the leaflets have shortened due to the folds of the region 394 of the leaflets 12, such that the leaflets 12 and 14 properly coapt along their entire lengths, and the gap 18b has closed.

Reference is now made to fig. 16A-16D, which are schematic illustrations of an implant for repairing leaflets of a heart valve and stages of its use, according to some applications.

Fig. 16A is a schematic perspective illustration of an implant 400. As seen, implant 400 includes a penetrating member 402 and a fixation member 404. Lancing element 402 includes a base 406 from which a lancing tip 408 extends. In some applications, as the illustrated example, the fixation element 404 includes a housing 410 adapted to receive and secure the piercing tip 408 therein. As shown, the fixation element 404 may define a hollow 414 adapted to receive the piercing tip 408, may be substantially cylindrical, and/or may terminate at a wall portion 412. However, in some applications, the fixation elements may have different structures. The fixation element may be formed of a biocompatible elastomer adapted to receive and grip the piercing tip 408 upon implantation, as explained herein.

Turning to fig. 16B, the first leaflet 12 has excess tissue 16B such that a gap 18B is formed between the lips 12a and 14a of the leaflets 12 and 14.

As seen in fig. 16B, when the penetrating element 402 is separated from the fixation element 404, the implant 400 may be transluminally delivered to a heart chamber adjacent the mitral valve 10 (e.g., to a heart chamber upstream of the mitral valve). Alternatively, in some applications, implant 400 may be delivered while piercing tip 408 is secured within fixation element 404. In such examples, the penetrating member and the fixation member separate and recombine during implantation of implant 400.

In some applications, implant 400 is delivered through at least one longitudinal catheter, e.g., similar to catheter 100 described above, configured to be transluminally advanced toward the heart. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

As seen in fig. 16C, the catheter is adapted to be steerable so as to create a folded (or pleated) region 416 of the leaflet 12 by folding the leaflet. The catheter is then configured to insert the penetrating tip 408 of the penetrating element 402 through at least two layers of the leaflet at the fold region 416. The catheter is further configured to secure at least one fold of the fold region by connecting the fixation element 404 to the puncture tip 408, thereby securing the puncture tip within the hollow of the fixation element 404. When the penetrating tip 408 is secured with the fixation element 404, both the penetrating element 402 and the fixation element 404 are on the same side of the leaflet 12, as shown in fig. 16C as the upstream side of the leaflet.

Folding the leaflets, puncturing the fold area using the puncturing element 402, and securing the puncturing tip 408 of the puncturing element can be performed by the catheter, mutatis mutandis, e.g., in response to human manipulation of the control handle, e.g., similar to the catheter 100 and its control handle described above.

As a result of folding and securing the leaflets, at least two layers of tissue are disposed between the piercing element 402 and the securing element 404, with two or more layers of tissue forming at least one bulge along the lip 12 a. Thus, the lip 12a is shortened such that the leaflets 12 and 14 properly coapt along their entire length and the gap 18b has closed.

In some applications, such as the one shown in fig. 16C, the fold region 416, as well as the penetrating element 402 and the fixation element 404, are oriented toward the upstream side of the valve. However, in some applications, such as the application shown in fig. 16D, the fold region 416, the penetrating element 402, and the fixation element 404 are oriented toward the downstream side of the valve.

Reference is now made to fig. 17A, 17B, 17C, and 17D, which are schematic top view illustrations of stages of repairing leaflets of a mitral valve using a tether implant that includes one or more tethers 420, according to some applications.

In the example shown, the tether implant is used to repair the second leaflet 14 of the mitral valve 10. As seen in fig. 17A, prolapse 16 exists in a second fan (i.e., P2) of leaflet 14, depicted by separations 422a and 422b between the second fan and adjacent fans (i.e., P1 and P3).

The tether 420 of the tether implant is delivered transluminally to the heart chamber adjacent the mitral valve 10, for example, to the heart chamber upstream of the mitral valve. In some applications, the implant is delivered through at least one longitudinal catheter 424 configured to be transluminally advanced toward the heart chamber. As described above with respect to catheter 100, longitudinal catheter 424 has a proximal portion and a steerable distal portion, and a longitudinal axis therebetween.

The catheter 424 is adapted to be steerable so as to guide the tether 420 of the tether implant to the leaflet 14 and to pass the distal end 421a of the tether 420 through the separation 422a into the ventricle, alongside the downstream surface of the leaflet 14, and back through the separation 422b into the atrium (fig. 17A).

Turning to fig. 17B, a grasping tool 426, such as a snare, is distally advanced from the catheter 424 and is adapted to grasp the distal end 421a of the tether 420 of the tether implant. As seen in fig. 17C, the grasping tool 426 has pulled the distal end 421a of the tether 420 back to the catheter 424. As a result, the tether 420 of the tether implant is now fanned around the center of the second leaflet 14.

Turning to fig. 17D, the tensioning of the tether 420 then causes the prolapse 16 to be compressed. The tension in the tether 420 is then secured by locking members 428 that slide onto the ends 421a and 421b of the tether to secure the tether in its tensioned state.

Tensioning of the tether 420 and locking in tension therein may be performed by the catheter 422, mutatis mutandis, e.g., in response to human manipulation of the control handle, e.g., similar to the catheter described above with respect to the catheter 100 and its control handle.

As seen in fig. 17D, the lips 14a of the leaflets have been shortened due to the formation of folds in the leaflets 14, such that the leaflets 12 and 14 properly coapt along their entire lengths.

In some applications, the tether implant may contain more than one tether 420. In such examples, each tether 420 of the tether implant passes through the separate portions 422b and 422a and is tensioned as described herein, e.g., such that the tethers 420 of the tether implant extend parallel to each other and to the lips 14a of the second leaflet.

Reference is now made to fig. 18A-18C, which are schematic illustrations of an implant 450 for repairing leaflets of a heart valve and stages of its use, according to some applications.

As seen in fig. 18A, implant 450 includes a base portion 452 from which a plurality of beams extend, here shown as five beams 454a, 454b, 454c, 454d and 454e, each of which has an end 456 remote from base portion 452. Beams 454a, 454b, 454c, 454d, and 454e may be substantially parallel to each other and/or may be substantially perpendicular to base portion 452. Although five beams are shown, implant 450 may comprise any number of beams and typically comprises at least three beams.

Implant 450 may be a flexible and/or resilient device. For example, in some applications, the implant 450 may be formed of a resilient or shape memory material (e.g., nitinol, spring steel, or cobalt chrome).

In some applications, in a first operational state of the implant 450, i.e., the open state, the ends 456 of a first subset of the plurality of beams are not in the same plane as the ends 456 of a second subset of the plurality of beams. In some applications, the beams in the first subset alternate with the beams in the second subset. For example, in the example shown in fig. 18A, the first subset includes a second beam 454b and a fourth beam 454d, with ends 456 disposed in a lower plane than the ends of the first beam 454a, the third beam 454c, and the fifth beam 454 e.

In a second, closed, operational state of the implant 450, the base portion 452 and the ends 456 of all of the beams 454a, 454b, 454c, 454d, and 454e may be disposed in a single plane (e.g., as shown). In some applications, the ends of beams 454a, 454b, 454c, 454d, and 454e move toward a single plane during the transition from the open state to the closed state. In the example shown, the ends reach a single plane, and in some applications, the ends may even pass each other and continue to move through the single plane relative to each other.

Turning now to fig. 18B, the first leaflet 12 of the mitral valve 10 has excess tissue 16B such that a gap 18B is formed between the lips 12a and 14a of the leaflets 12 and 14.

As seen in fig. 18B, in the first open operational state, the implant 450 is delivered transluminally to the heart chamber adjacent the mitral valve 10, e.g., to the heart chamber upstream of the mitral valve.

In some applications, the implant 450 is delivered through at least one longitudinal catheter similar to the catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

As seen in fig. 18C, the catheter is adapted to be steerable so as to slide the implant 450 onto the leaflet 12. This may be accomplished, for example, in such a way that beams 454a, 454b, 454c, 454d, and 454e are substantially perpendicular to the leaflet's lip 12a, and the base portion 452 extends along the leaflet's lip, e.g., as shown. The implant 450 is placed onto the leaflets 12 in the open state such that the beams of one of the subsets are disposed upstream of the leaflets and the beams of the other of the subsets are disposed downstream of the leaflets. In the example shown, the beams 454a, 454c, and 454e of the second subset are disposed upstream of the leaflet 12, and the beams 454b and 454d of the second subset are disposed downstream of the leaflet. Due to the finger-like nature of the beam 454, it can slide between the chordae without becoming entangled.

The catheter is then configured to transition the implant 450 to a second closed operational state, wherein the beam 454 is moved toward a single plane, e.g., by removing the constraint, and thereby allowing the implant to responsively (e.g., elastically or resiliently) move to its closed operational state. As seen in the enlarged cross-sectional portion of fig. 18C, when the implant 450 is in the second state, the leaflets 12 follow a tortuous path between the beams 454a and 454e, traveling under and over alternating beams.

Placing the implant on the leaflet and transitioning the implant from the first operating state to the second operating state may be performed by the catheter, mutatis mutandis, e.g., in response to human manipulation of the control handle, e.g., similar to the catheter 100 and its control handle described above.

In some applications, the catheter may be configured to change the placement of the implant 450 by applying a force to the implant 450 or a portion thereof, such as when transitioning from an open state to a closed state. The applied force actively changes or deforms the shape of the implant.

In some applications, the catheter may be configured to alter the placement of the implant 450 by removing the constraint, constraining the implant 450 in a particular state. Removal of the constraint is particularly useful when the implant is formed of a resilient or elastic material, such as a shape memory material.

As the leaflets 12 follow a tortuous path above and below the beam of the implant 450, excess tissue 16b is consumed by the tortuous path and the effective length of the lips 12a of the leaflets 12 is shortened, thereby reducing prolapse and/or regurgitation.

Although the illustrated example shows the beams alternating between the first subset and the second subset in the open state (i.e., neither subset contains two adjacent beams), in some applications the beams may be divided into two subsets in other ways.

It should be noted that while the illustrated example shows the outermost beams 454a and 454e disposed on the upstream surface of the leaflet 12, the arrangement of the implant 450 may also be reversed such that the outermost beams are disposed against the downstream surface of the leaflet.

Reference is now made to fig. 19A-19C, which are schematic illustrations of an implant 460 for repairing leaflets of a heart valve and stages of its use, according to some applications.

Turning to fig. 19A, implant 460 includes a first U-shaped portion 462 that includes a base portion 464 from which two beams 466 and 468 extend. Implant 460 includes a second U-shaped portion 472 that includes a base portion 474 from which two beams 476 and 478 extend. Beams 466 and 468 may be substantially perpendicular to base portion 464, and/or substantially parallel to each other. Similarly, beams 476 and 478 are substantially perpendicular to base portion 474 and substantially parallel to one another. In some applications, the U-shaped portions 462 and 472 may be substantially identical to one another.

Beams 468 and 476 are joined to one another and held together within a longitudinally extending cylindrical joining element 480 to form a unified center beam. Beams 468 and 476 are pivotable about the longitudinal axis of the beams within cylindrical engagement element 480. Thus, the first and second U-shaped portions 462, 472 may rotate or pivot relative to one another.

Implant 460 may be a flexible and/or resilient device. For example, in some applications, implant 460 may be formed of a resilient metal or shape memory material.

In some applications, in the first operational state of implant 460 shown in fig. 19A, U-shaped portions 462 and 472 are positioned such that there is a first distance between beams 466 and 478 indicated by H1 in fig. 19B. In this state, the U-shaped portions 462 and 472 may be disposed substantially in a single plane.

In the second operational state of the implant 460, the U-shaped portions 462 and 472 are rotated toward each other such that the unified center beam is disposed in a different plane than the edge beams 466 and 478. In the second operating state, a second distance, indicated by H2 in fig. 19C, exists between its beams 466 and 478. Distance H2 may be less than distance H1.

As seen in fig. 19B, the first leaflet 12 has excess tissue 16B such that a gap 18B is formed between the lips 12a and 14a of the leaflets 12 and 14. In the first planar operational state, the implant 460 is delivered transluminally to the heart chamber adjacent the mitral valve 10, for example, to the heart chamber upstream of the mitral valve.

In some applications, the implant 460 is delivered through at least one longitudinal catheter similar to the catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

As seen in fig. 19C, the catheter is adapted to be steerable so as to slide the implant 460 onto the leaflet 12, e.g., such that the beams 466 and 478 and the unified center beam are substantially perpendicular to the leaflet's lip 12a, and the base portions 464 and 474 extend along the leaflet's lip. The implant 460 is placed onto the leaflet 12 such that the edge beams 466 and 478 engage one surface of the leaflet or are positioned adjacent one surface of the leaflet and the central unified beam comprising the central beams 468 and 476, which is encased in the cylindrical engagement element 480, engages the opposite surface of the leaflet or is positioned adjacent the opposite surface of the leaflet. In the example shown, the edge beams are disposed near or on the upstream surface of the leaflet 12 and the central uniform beam is disposed near or on the downstream surface of the leaflet.

The catheter is then configured to transition the implant 460 to a second angled operational state in which the U-shaped portions 462 and 472 are angled relative to one another. As seen in the enlarged portion of fig. 19C, in this orientation, edge beams 466 and 478 are disposed in different planes than the unified center beam, here shown as lower planes. In this orientation, the leaflets 12 follow a tortuous path between the beams 466 and 478, passing over the central unified beam.

In some applications, the catheter may be configured to change the arrangement of the implant 460 by applying a force to the implant 460 or a portion thereof, such as when transitioning from the first state to the second state. The applied force actively changes or deforms the shape of the implant.

In some applications, the catheter may be configured to change the placement of the implant 460 by removing the constraint, constraining the implant 460 in a particular state. Removal of the constraint is particularly useful when the implant is formed of a resilient or elastic material, such as a shape memory material.

Since the leaflets 12 follow a tortuous path above and below the beam of the implant 460, the excess tissue 16b serves to complete the tortuous path and the effective length of the lips 12a of the leaflets 12 is shortened. Thus, the leaflets 12 and 14 properly coapt during ventricular systole. As seen in the enlarged portion of fig. 19C, for some applications, the implant 460 (e.g., base portions 464 and 474 thereof) may abut the leaflet 14 during ventricular systole.

It should be noted that while the illustrated example shows edge beams 466 and 478 being disposed on the upstream surface of leaflet 12 and the center beam being disposed against the downstream surface of the leaflet, the arrangement of implant 460 may also be reversed such that the edge beams are disposed against the downstream surface of the leaflet and the center beam is disposed against the upstream surface of the leaflet.

Referring now to fig. 20, a schematic, pictorial illustration of a stage of placement of an implant 500 onto a leaflet of a heart valve, thereby repairing the leaflet, in accordance with some applications.

Implant 500 is formed from a length of flexible and/or resilient material. For example, in some applications, implant 500 may be formed from a resilient metal or shape memory material. In some applications, implant 500 is integrally formed, for example, from a single piece of raw material.

In some applications, implant 500 is substantially reflectively symmetric about axis of symmetry 501, and its operation may proceed symmetrically on both sides thereof, as explained below.

Implant 500 is shaped to define a first beam 502 that terminates at one of its free ends 503 and at the other of its first bends 504. The second beam 506 extends from the bend 504 to a second bend 508. The generally U-shaped portion 510 extends from the second bend 508 to a third bend 512. The U-shaped portion 510 may include a pair of longitudinal beams 510a separated by a curved base portion 510 b. The third beam 514 extends from the third bend 512 to the fourth bend 516, and the fourth beam 518 extends from the fourth bend 516 to the second free end 519.

As seen in stage I of fig. 20, in a first operational state of implant 500, the implant may be planar. In this operating state, each of the bends 504, 508, 512, and 516 may be substantially 180 degree bent (constrained by the material) such that the beams 502, 506, 514, and 518 and the beam 510a of the U-shaped portion 510 may be substantially parallel to one another. In this arrangement, the bends 504, 508, 512, and 516 and the base portion 510b of the U-shaped portion 510 may be in a single plane.

Turning to phase II, it can be seen that beams 506 and 514 pivot upward about bends 508 and 512, respectively, as indicated by arrow 520. Such pivoting causes bends 504 and 516 to lie in different planes than bends 508 and 512, resulting in a second operational state of implant 500. In this operational state, beams 502, 506, 514, and 518 are in different planes than U-shaped portion 510, or in multiple different planes (e.g., when beams 506 and 514 are not pivoted to the same degree of angle relative to U-shaped portion 510). The second operating state may also be considered an open operating state.

As seen at stage III, implant 500 is delivered transluminally to a heart chamber adjacent a heart valve, such as a mitral valve, for example, to a heart chamber upstream of the mitral valve. As shown in stage III, implant 500 is delivered in the second open operational state. However, in some applications, the order of phases II and III may be reversed such that implant 500 is delivered to the heart chamber in a first planar operating state shown at phase I and transitions to a second operating state shown at phase II when in the heart chamber.

Implant 500 is adapted for placement onto leaflets 522 of a heart valve, such as leaflets with excess tissue 526. For example, as described above, the heart valve may be a mitral valve, or may be a tricuspid valve. The leaflet 522 may be any leaflet of a heart valve, such as the anterior or posterior leaflet of a mitral valve, or any of the leaflets of a tricuspid valve.

In some applications, implant 500 is delivered through at least one longitudinal catheter similar to catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The catheter is adapted to be steerable so as to slide the implant 500 onto the leaflet 522 in the direction of arrow 528, e.g., such that the beams 502, 506, 514, and 518 and the longitudinal beam 510a of the U-shaped portion 510 are substantially perpendicular to the leaflet's lips 522a. In this arrangement, bends 508 and 512 are adjacent lip 522a, and base portion 510b of U-shaped portion 510 is remote from the lip. In some applications, the implant is placed adjacent to the unwanted tissue 526.

Implant 500 is placed onto leaflet 522 in the second open operational state such that U-shaped portion 510 engages or is disposed adjacent the downstream surface of the leaflet and beams 502, 506, 514, and 518 are disposed over the upstream surface of the leaflet.

Turning to stage IV, it can be seen that the catheter is configured to transition the implant 500 back to the first planar operating state by pivoting the beams 506 and 514 downward about the bends 508 and 512, respectively, as indicated by arrow 530. The pivoting of beams 506 and 514 at stage IV is opposite to the pivoting direction at stage II. After beams 506 and 514 are pivoted, beams 502, 506, 514, and 518 engage or are positioned adjacent to the upstream surface of leaflet 522, as shown at stage V. As shown, the leaflets 522 may be sandwiched between the beam 506 and one of the beams 510a, and between the beam 514 and the other of the beams 510 a.

At stage VI, the conduit is configured to pivot beam 506 about bend 508 and pivot beam 514 about bend 512 such that beams 506 and 514 rotate about beam 510a, e.g., do not substantially deflect with respect to beam 510 a. As seen in stages VI and VII, this causes the tissue of leaflet 522 to wrap around beams 510a, 502, 506, 514 and 518. In this way, when implant 500 is in the fully folded third operating state, leaflets 522 follow the tortuous path between beams 502 and 518, as shown in the cross-sectional portion of stage VII.

For some applications, and as shown, beams 506 and 514 may swivel up to 180 degrees about beam 510 a. As such, after it is turned around beam 510a, beams 502, 506, 514, and 518 may lie in substantially the same plane as U-shaped portion 510 and be disposed within the footprint of the U-shaped portion, i.e., centered with respect to beam 510 a.

In stage VII, implant 500 may be considered in a third operational state, which may also be referred to as a fully folded operational state. For clarity, the third operational state of implant 500 is also shown in stage VIII of fig. 20.

Placing the implant on the leaflet and switching the implant between its operational states may be performed by the catheter, mutatis mutandis, e.g. in response to a human operation of the control handle, e.g. similar to the catheter described above in relation to the catheter 100 and its control handle.

In some applications, the catheter may be configured to alter the placement of the implant 500 by applying a force to the implant 500 or a portion thereof, such as when transitioning from one stage to another stage of fig. 20. The applied force actively changes or deforms the shape of the implant.

In some applications, the catheter may be configured to alter the placement of the implant 500 by removing the constraint, constraining the implant 500 in a particular stage or placement. Removal of the constraint is particularly useful when the implant is formed of a resilient or elastic material, such as a shape memory material.

Since the leaflets 522 follow a tortuous path above and below the beam of the implant 500, excess tissue 526 is used to complete the tortuous path and the effective length of the lips 522a of the leaflets 522 is shortened.

It should be noted that in some applications, beams 502 and 518 and bends 504 and 516 may be omitted, with the free ends of the implants being at the ends of beams 506 and 514.

It should be noted that while the illustrated example shows the U-shaped portion 510 being placed onto the downstream surface of the leaflet 522 at stage III, with the beams 502, 506, 514, and 518 disposed above the upstream surface of the leaflet, the arrangement of the implant 500 may also be reversed such that the beams are disposed against the downstream surface of the leaflet and the U-shaped portion above the upstream surface of the leaflet. In such an example, at stage IV, the U-shaped portion will pivot relative to the beam when on the leaflet to reach the first operational state of the implant.

Reference is now made to fig. 21A-21D, which are schematic illustrations of an implant 540 for repairing leaflets of a heart valve and stages of its use, according to some applications.

As seen in fig. 21A, implant 540 includes a tubular body 542 with a pair of clips 544 mounted thereon. In some applications, each of the clips 544 is substantially U-shaped and has a first elongated portion 546 disposed on or near an outer surface of the tubular body 542 and a second elongated portion 547 disposed on or near an inner surface of the tubular body 542. Within each clip 544, the elongated portions 546 and 547 are connected to one another by end portions 548, typically such that the portions 546 and 547 are substantially parallel to one another, e.g., such that the clip is generally similar to a hair clip for hair styling. The resilient element 550 (e.g., a resilient strap) couples the clips 544 to one another (e.g., couples the second elongate portion 547 of one clip to the second elongate portion of the other clip) in a manner that pulls the clips toward one another. The resilient element 550 may be disposed inside the tubular body 542, for example, as shown. In some applications, the resilient element 550 is disposed adjacent to an end portion 548 of the clip 544, as shown, for example.

As seen in fig. 21B, in a first operational state of the implant 540, the clip 544 is disposed on a first side of the tubular body 542, shown as the upper side of the tubular body in fig. 21B. The clips 544 may be centered on the upper side of the tubular body closer to each other or may be slightly spaced apart from each other.

According to some applications, the implant 540 is used to repair the leaflets 12 of the mitral valve 10. As seen in fig. 21B, the first leaflet 12 has excess tissue 16B such that a gap 18B is formed between the lips 12a and 14a of the leaflets 12 and 14.

Implant 540 is delivered transluminally to the heart chamber adjacent mitral valve 10, for example, to the heart chamber upstream of the mitral valve. In some applications, implant 540 may be delivered in a first operational state, for example, as shown in fig. 21B.

In some applications, implant 540 is delivered through at least one longitudinal catheter similar to catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

The catheter is adapted to be steerable so as to slide the implant 540 onto the leaflet 12 in the direction of arrow 552, e.g., such that the tubular body 542 and the first and second elongate portions 546, 547 of the clip 544 are substantially perpendicular to the leaflet's lips 12a. In some applications, the implant is placed adjacent to the unwanted tissue 16 b.

The implant 540 is placed onto the leaflet 12 in the first operational state such that the tubular body 542 engages or is disposed adjacent to the downstream surface of the leaflet and the first (outer) elongate portion 546 of the clip 544 is disposed over the upstream surface of the leaflet. For some applications, the leaflet 12 is held by the implant 540 such that the lip 12a of the leaflet is adjacent to or engages with the base portion 548 of the clip 544, as shown in the inset of fig. 21C. In this arrangement, three beams of the implant 540 engage the leaflet 12, the tubular body 542 serves as one beam, and the elongated portions 546 of two clips 544 serve as the other two beams.

The catheter is then configured to rotate the clip 544 about the tubular body 542 in the direction of arrow 554 in the illustration of fig. 21C, against the force applied by the resilient element 550. Such rotation transitions the implant 540 to a second operational state wherein the clip 544 engages an opposite side of the tubular body 542 from the first operational state, shown as the underside of the tubular body in the upper insert view of fig. 21D. Rotation of the clips 544 about the tubular body 542 causes tissue of the leaflets 12 to wrap about the tubular body. Thus, when the implant 540 is in the second operational state, the leaflets 12 follow a tortuous path between the clips 544 surrounding the tubular body 542, as shown in the upper inset of fig. 21D.

In some applications, the catheter may be configured to change the arrangement of the implant 540 by applying a force to the implant 540 or a portion thereof, such as when transitioning from the first state to the second state. The applied force actively changes or deforms the shape of the implant.

In some applications, the catheter may be configured to change the placement of the implant 540 by removing the constraint, constraining the implant 540 in a particular state.

Since the leaflet 12 follows a tortuous path around the tubular body 542 of the implant 540, the excess tissue 16b serves to complete the tortuous path and the effective length of the lip 12a of the leaflet 12 is shortened.

As seen in the lower illustration of fig. 21D, in some applications, the tubular body 542 of the implant 540 may be removed from the mitral valve after repairing the leaflet 12. In such examples, the protrusions 558 on the upstream side of the leaflets formed by tissue surrounding the leaflets 12 of the tubular body 542 are maintained by the clips 544 even when the tubular body is removed.

It should be noted that while the illustrated example shows the tubular body 542 being placed onto the downstream surface of the leaflet 12, with the beam 546 of the clip 544 disposed over the upstream surface of the leaflet, the placement of the implant 540 may also be reversed. In an inverted arrangement, the implant 540 will be placed onto the leaflet 12 in the second operational state such that the clips 544 are disposed against the bottom side of the tubular body 542, the elongated portions 546 of the clips 544 are disposed against the downstream surface of the leaflet, and the tubular body 542 is disposed over the upstream surface of the leaflet. In such examples, the catheter is adapted to rotate the clamp 544 upward relative to the tubular body 542, transitioning the implant from the second operational state to the first operational state. In such examples, the projections 558 will be formed on the downstream side of the leaflet.

Reference is now made to fig. 22A-22C, which are schematic illustrations of an implant 560 for repairing leaflets of a heart valve and stages of its use, according to some applications.

Turning to fig. 22A, implant 560 includes a tubular core 562, such as a mandrel and a retaining clip 564. In some applications, the retaining clip 564 is substantially U-shaped and has first and second elongated portions 566 connected to one another by an end portion 568, generally such that the elongated portions 566 are substantially parallel to one another, e.g., such that the clip is generally similar to a hair clip for hairstyling. Turning to fig. 21B, in some applications, an implant 560 is used to repair the leaflets 12 of the mitral valve 10. As can be seen, the first leaflet 12 has excess tissue 16b such that a gap 18b is formed between the lips 12a and 14a of the leaflets 12 and 14.

The tubular core 562 and the retaining clip 564 of the implant 560 are delivered transluminally to the heart chamber adjacent the mitral valve 10, for example, to the heart chamber upstream of the mitral valve. In some applications, the components of implant 560 are delivered through at least one longitudinal catheter similar to catheter 100 described above, which is configured to be transluminally advanced toward the heart. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween. In some applications, a first catheter is used to deliver tubular core 562 and a second catheter is used to deliver fixation clip 564.

The catheter that manipulates the tubular core 562 is adapted to be steerable so as to slide the tubular core under the leaflet 12, e.g., from the leaflet's lip toward the root in the direction of arrow 572, e.g., so that the tubular core 562 is substantially perpendicular to the leaflet's lip 12a. In some applications, the implant is placed adjacent to the unwanted tissue 16 b. As a result, excess tissue 16b resides on tubular core 562, as shown in inset I of FIG. 22C. The catheter-actuated retaining clip 564 (which may be the same catheter as that of the actuated core 562, or a different catheter), or another catheter or tool, is then configured to wrap the tissue of the leaflet 12 around the tubular core 562 such that the downstream surface of the leaflet engages the outer surface of the core. The catheter-operated fixation clip 564 then pushes the clip from the root of the leaflet toward its lips in the direction indicated by arrow 574 such that the elongate portion 566 of the clip 564 engages the upstream surface of the leaflet 12 with the end portion 568 being proximal to the end of the tubular core, distal to the lips 12a. Thus, the retaining clip 564 secures tissue around the tubular core 562 and the tissue of the leaflet 12 forms a bulge 578 around the core, as shown in inset II of fig. 22C. The sizing and mechanical structure of core 562 and clip 564 are designed and configured to ensure a fit therebetween that ensures that core 562 remains in place, wrapped with tissue, to form protrusion 578.

The placement of the tubular core and securing of the clip to the leaflet may be performed by the catheter, mutatis mutandis, e.g. in response to a human manipulation of the control handle, e.g. similar to the catheter described above with respect to the catheter 100 and its control handle.

Since the leaflet 12 is secured around the tubular core 562 of the implant 560, the excess tissue 16b is used to form the bulge 578 and the effective length of the lip 12a of the leaflet 12 is shortened.

As seen in inset III of fig. 22C, in some applications, tubular core 562 of implant 560 may be removed from the mitral valve after repairing leaflet 12. In such examples, the protrusions 578 on the upstream side of the leaflets formed by the tissue surrounding the leaflets 12 of the tubular core 562 are maintained by the retaining clip 564 even when the tubular core has been removed.

It should be noted that although the illustrated example shows a tubular core 562 being placed onto the downstream surface of the leaflet 12 at illustration I, with the retaining clips 564 engaging the upstream surface of the leaflet 12 to retain the tissue of the leaflet around the core, the placement of the implant 560 can also be reversed. In an inverted arrangement, the tubular wick 562 would be placed onto the upstream surface of the leaflet 12 with the tissue wrapped around the wick from the underside such that the upstream surface of the leaflet engages the exterior of the tubular wick. The retaining clip 564 is then placed over the tubular core 562 to engage the downstream surface of the leaflet. In such examples, the protrusions 578 will be formed on the downstream side of the leaflet.

Reference is now made to fig. 23A-23C, which are schematic illustrations of an implant 560 for repairing leaflets of a heart valve and stages of its use, according to some applications.

In the example of fig. 23A-23C, the tip 569 of the elongate portion 566 of the retention clip 564 may be sharpened so as to be able to penetrate tissue, as explained below.

As discussed above with respect to fig. 22A-22C, tubular core 562 and retaining clip 564 of implant 560 are delivered transluminally to a heart chamber adjacent mitral valve 10, for example, to a heart chamber upstream of the mitral valve. In some applications where the tip 569 is sharpened, the tip may be secured by a suitable end element, such as an elastomeric end element, during delivery of the retaining clip 564 to the heart chamber.

The catheter that manipulates the tubular core 562 is adapted to be steerable so as to place the tubular core against the upstream surface of the leaflet 12 at the region containing the excess tissue 16 b. In some applications, the ends of tubular wick 562 engage with or are adjacent to the lips 12a of leaflet 12, and the wick is substantially perpendicular to the lips.

The catheter (e.g., the catheter that manipulates core 562, the catheter that manipulates or is adapted to manipulate retaining clip 564, or another catheter) is configured to wrap the tissue of leaflet 12 around tubular core 562 such that the upstream surface of the leaflet engages the outer surface of the core, as seen in illustration I of fig. 23C. The catheter of the retaining clip 564 is then manipulated to push the retaining clip from the root of the leaflet toward its lip in the direction indicated by arrow 574 so that the tip 569 penetrates the tissue of the leaflet 12. As a result, the end portion 568 of the clip 564 seats against the upstream side of the leaflet, near the end of the tubular core distal from the lip 12a, and the elongate portion 566 engages the downstream surface of the leaflet 12. Thus, the elongated portion 566 of the retaining clip 564 secures tissue around the tubular core 562, and the tissue of the leaflet 12 forms a bulge 578 around the core, as shown in insert II of fig. 23C. The dimensions and mechanical structure of tubular core 562 and retaining clip 564 are designed and configured to ensure a fit therebetween that ensures that core 562 remains in place, wrapped by tissue, to form protuberance 578.

In some applications, the catheter may be configured to secure the tip 569 of the fixation clip 564 after the sharpened tip penetrates the tissue of the leaflet 12, for example, using an elastomeric end element.

As seen in inset III of fig. 23C, in some applications, tubular core 562 of implant 560 may be removed from the mitral valve after repairing leaflet 12. In such examples, the protrusions 578 on the downstream side of the leaflets formed by the tissue surrounding the leaflets 12 of the tubular core 562 are maintained by the retaining clip 564 even when the tubular core has been removed.

Reference is now made to fig. 24A-24D, which are schematic illustrations of an implant 600 for repairing leaflets of a heart valve and stages of its use, according to some applications.

Implant 600 includes a core member 602 including a first plate 604a and a second plate 604b connected by a neck portion 606. Plates 604a and 604b have a larger diameter or larger cross-section than neck portion 606 such that a notch 608 is formed around neck portion 606 between plates 604a and 604b.

In the example shown, the first plate 604a and the second plate 604b are substantially the same size. However, in some applications, the first and second plates need not be the same size, so long as both plates have a larger cross-section than the neck portion 606.

In the example shown, the first plate 604a and the second plate 604b are substantially parallel to each other. However, in some applications, the two plates may be angled with respect to each other.

In the example shown, the first plate 604a and the second plate 604b are circular, and the neck portion 606 is cylindrical and has a circular cross-section. However, the plate and neck portions may have other shapes or other cross-sections. Additionally, the plates 604 need not have the same cross-sectional shape as the neck portion 606 or each other.

Implant 600 includes fixation element 612, which includes a faceplate 614 having a recess or hollow formed therein. The groove includes a generally circular region 616 and a linear region 618.

Retaining element 612 is sized to receive core element 602 therein. In this way, the thickness of retaining element 612 is less than the height of recess 608 such that panel 614 may be received within recess 608. Additionally, the cross-section of the circular region 616 is greater than the diameter of at least one of the first plate 604a and the second plate 604b to allow the at least one of the plates to pass through the circular region 616 of the groove. Furthermore, the width WLR of the linear region 618 of the groove is greater than the diameter of the neck portion 606.

In fig. 24A, implant 600 is shown in a first operational state in which core member 602 is separated from fixation member 612.

As explained in further detail below, in the second operational state of implant 600, first plate 604a is disposed on one side of faceplate 614, second plate 604b is disposed on a second, opposite side of faceplate 614, and neck portion 606 extends through linear region 618 of fixation element 612. In a sense, the second operational state of implant 600 is similar to a button or rivet held within a button ring.

The transition from the first operational state to the second operational state of implant 600 is accomplished in two steps. First, first plate 604a or second plate 604b is inserted into circular region 616 of fixation element 612 such that panel 614 is vertically aligned with and surrounds neck portion 606, and neck portion 606 is substantially centered within circular region 616. Core member 602 is then moved relative to fixation member 612 such that neck portion 606 slides into linear region 618 while plates 604a and 604b are outside of panel 614 and disposed on opposite sides thereof.

It should be noted that although circular region 616 is shown as having a circular shape, in instances where plates 604a and 604b have different shapes or cross-sections, the shape of circular region 616 may be modified to match the shape of plates 604a and/or 604 b. The primary requirement is that when the plates are parallel to the panel 614, at least one of the plates 604a and 604b can extend through the region 616, and neither plate 604a and 604b can extend through the linear region 618.

Turning to fig. 24B, the first leaflet 12 has excess tissue 16B such that a gap 18B is formed between the lips 12a and 14a of the leaflets 12 and 14.

Core element 602 and fixation element 612 of implant 600 are delivered transluminally to the heart chamber adjacent mitral valve 10, for example, to the heart chamber upstream of the mitral valve. In some applications, core element 602 and fixation element 612 of implant 600 are delivered through at least one longitudinal catheter similar to catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween. In some applications, a first catheter is used to deliver core element 602 and a second catheter is used to deliver fixation element 612.

The catheter of the manipulation core element 602 is adapted to be steerable so as to slide the core element from the lip of the leaflet toward the root in the direction of arrow 622 below the leaflet 12. As a result, the excess tissue 16b remains on the core member 602. In some applications, the core element 602 is held under the leaflet 12 such that one of its plates, e.g., the first plate 604a, engages the downstream surface of the leaflet.

The catheter that manipulates fixation element 612 is then configured to place fixation element 612 against the upstream surface of leaflet 12 such that first plate 604a of core element 602 aligns with and extends into circular region 616 of the fixation element's groove. Because the tissue of leaflet 12 is disposed between core element 602 and fixation element 612, when first plate 604a extends into circular region 616, at least some of the excess tissue 16b disposed above first plate 604 wraps around the first plate and is also pushed into circular region 616, as seen in the enlarged portion of fig. 24C.

As seen in fig. 24D, the catheter that manipulates the core element 602 pushes the core element relative to the fixation element 612 away from the lips 12a of the leaflet 12 in the direction indicated by reference numeral 624. In some applications, core element 602 is pushed until tissue surrounding neck portion 606 engages an end of linear region 618 distal from circular region 616. Movement of core member 602 relative to fixation member 612 causes neck portion 606 to slide along linear region 618 of fixation member 612, which is wrapped in excess tissue 16b of leaflet 12. At the same time, plates 604a and 604b extend above and below face plate 614 around linear region 618 and ensure that core element 602 remains secured to fixation element 612. Thus, the tissue of the leaflet 12 forms a bulge around the plate 604a and neck portion 606 of the core element 602.

As mentioned above, the core element 602 and fixation element 612 are sized and configured to ensure a fit therebetween that secures the organized core element 602 within fixation element 612.

The placement of core member 602 and fixation member 612 on the leaflets and relative movement therebetween can be performed by the catheter, mutatis mutandis, e.g., in response to human manipulation of the control handle, e.g., similar to the catheter described above with respect to catheter 100 and its control handle.

Since the tissue of the leaflet 12 is fixed around the core element 602 of the implant 600, the excess tissue 16b is used to form the bulge and the effective length of the lip 12a of the leaflet 12 is shortened.

It should be noted that while the illustrated example shows movement of the core element 602 away from the lip 12a of the leaflet, in order to engage the core element with the linear region 618 of the fixation element 612, the mechanical locking of the core element to the fixation element may be achieved by pushing the fixation element relative to the core element toward the lip 12a in a direction opposite to arrow 624. In such examples, the core element 602 would initially be placed in a position that is desired to be its final position under the leaflet.

It should be noted that although the illustrated example shows the core element 602 being placed onto the downstream surface of the leaflet 12 and the fixation element 612 engaging the upstream surface of the leaflet to retain the tissue of the leaflet around the core, the arrangement of the implant 600 may also be reversed. In an inverted arrangement, the core element 602 is placed onto the upstream surface of the leaflet 12, with the tissue wrapped around the second plate 604b of the core element such that the upstream surface of the leaflet engages the second plate. Fixation element 612 is then placed under core element 602 to engage the downstream surface of the leaflet. In such examples, the protrusions will form on the downstream side of the leaflet.

Reference is now made to fig. 25A-25C, which are schematic illustrations of a clip implant 630 for repairing leaflets of a heart valve and stages of its use, according to some applications.

The clip implant 630 includes a central portion 632 that includes a strip of flexible material that forms a substantially U-shape. The longitudinal bars 634 extend from a corner of one end of the central portion 632 and are connected to each other by horizontal bars 635. Similarly, longitudinal bars 636 extend from corners of opposite ends of the central portion 632 and are connected to one another by horizontal bars 637 that are substantially parallel to the horizontal bars 635. The longitudinal bars 634 together with the horizontal bars 635 form a first frame, and the longitudinal bars 636 together with the horizontal bars 637 form a second frame. In some applications, cushioning elements 638 are disposed on horizontal bars 635 and 637.

The clip implant 630, or at least the frame thereof, is resilient and has a predetermined preload that pushes to maintain the horizontal bars 635 and 637 at a predetermined distance D from each other. When the horizontal strips 635 and 637 are pulled apart from each other, such as by applying a force thereto, and then released, the preload in the clip implant pushes the horizontal strips 635 and 637 back toward each other to regain the predetermined distance between the two strips.

As seen in fig. 25B, the second leaflet 14 has prolapsed or has flails such that the lips 14a of the second leaflet 14 prolapse into the ventricle and do not properly coapt with the lips 12a of the first leaflet. The second leaflet 14 includes an intermediate region 640 extending between the lip 14a and the root of the leaflet 14, or the annulus 15 adjacent the leaflet 14.

The clip implant 630 is delivered transluminally to the heart chamber adjacent the mitral valve 10, for example, to the heart chamber upstream of the mitral valve. In some applications, the implant 630 is delivered through at least one longitudinal catheter similar to the catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

A catheter, such as a catheter for delivering the implant 630 or another catheter, is configured to fold the second leaflet 14 downward such that the lips 14a of the leaflet 14 engage the downstream surface of the leaflet. The intermediate region 640 is then presented at the fold of the leaflet.

Then, as shown in fig. 25C, the catheter is configured to place the clip implant 630 onto the fold of the leaflet 14 to constrain the lips of the leaflet in the folded position. In some applications, the clip implant 630 is placed such that the longitudinal strips 634 and 636 are positioned substantially perpendicular to the lips 14a, the horizontal strips 635 and 637 are positioned substantially parallel to the lips, and the U-shaped portion 632 engages the upstream surface of the leaflet 14 at its fold. The cushioning element 638 is adapted to ensure that the horizontal bars 635 and 637 do not rupture the tissue of the leaflet 14 when the leaflet is held within the clip implant 630.

In some applications, in order to mount clip implant 630 to the folded leaflets, the catheter must push horizontal strips 635 and 637 to insert tissue into the clip and then release the horizontal strips to preload the clip implant, closing the gaps between the horizontal strips and securing the tissue therein. In some applications, the distance D existing between the horizontal bars 635 and 637 is selected to be substantially equal to the thickness of the two layers of the leaflet 14, or slightly less, in the resting state of the clip implant, for example, when no force is applied thereto, to ensure that the horizontal bars 635 and 637 hold the leaflet in the folded position.

As seen in fig. 25C, particularly in its cross-sectional portion, the folded leaflet 14 and the constraining lip 14a present a middle region 640 of the leaflet 14 in the folded position as an alternative coaptation surface for coaptation of the lip 12a of the first leaflet 12. Thus, as seen in fig. 25C, after folding and constraining the lips 14a, the lips 12a of the leaflets 12 may properly coapt against the intermediate region 640, thereby repairing or improving the function of the mitral valve 10. In some applications, the material of the strap 632 may form part of an alternative apposition surface.

Reference is now made to fig. 26A-26C, which are schematic illustrations of a pin implant 650 and stages of its use for repairing leaflets of a heart valve, according to some applications.

The pin implant 650 is formed from a generally planar U-shaped piece of resilient material such as a resilient metal. The U-shaped member includes a base portion 652 and a pair of arm portions 654 extending from the base portion. At or near the base portion 652, there is a base distance Db between the arm portions 654. An end portion 656 extends from an end of each of the arm portions 654, which end portions are turned inwardly toward each other such that an end distance De, which is less than the base distance Db, exists between the end portions 656.

The pin implant 650 is formed of a resilient material having a predetermined preload that maintains the end portions 656 at an end distance De from each other in the at rest state of the pin implant. When the end portions 656 are pulled apart from each other, for example by applying a force thereto, and then released, the preload in the pin implant pushes the end portions 656 back toward each other to regain the end distance De.

In fig. 26B, the state of the mitral valve 10 is similar to that described with respect to fig. 25B, with the second leaflet 14 flail such that the lips 14a of the second leaflet 14 prolapse into the ventricle and do not properly coapt with the lips 12a of the first leaflet. Similarly, the second leaflet 14 includes an intermediate region 640 extending between the lip 14a and the root of the leaflet 14, or the annulus 15 adjacent the leaflet 14.

The pin implant 650 is used to repair the leaflet 14 in a manner similar to that described above with respect to the clip implant 630 of fig. 25A-25C. The pin implant is also adapted to secure the leaflet 14 in a folded position such that the intermediate region 640 presents to the lip 12a of the first leaflet 12 for apposition therewith.

As can be seen, the pin implant 650 is delivered transluminally to the heart chamber adjacent the mitral valve 10, for example, to the heart chamber upstream of the mitral valve. In some applications, the pin implant 650 is delivered through at least one longitudinal catheter similar to the catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

A catheter, such as a catheter for delivering a pin implant 650 or another catheter, is configured to fold the second leaflet 14 downward such that the lips 14a of the leaflet 14 engage the downstream surface of the leaflet. The intermediate region 640 is then presented at the fold of the leaflet.

Then, as shown in fig. 25C, the catheter is configured to place the pin implant 650 onto the fold of the leaflet 14 to constrain the lips of the leaflet in the folded position. In some applications, the pin implant 650 is placed such that the arms 654 are disposed substantially perpendicular to the lips 14a and the U-shaped portion 652 engages with the upstream surface of the leaflet 14 at its fold. The end portions 656 are adapted to penetrate into the tissue of the leaflet 14 to secure the pin implant 650 to the leaflet.

In some applications, to mount the pin implant 650 to the folded leaflet, the catheter must push the arms 654 apart to insert tissue into the pin implant, and then release the arms to preload the pin implant, thereby closing the gap between the end portions 656 and securing the tissue therein. In some applications, the end distance De that exists in the resting state of the pin implant 650, e.g., when no force is applied thereto, is selected to be substantially equal to the thickness of the two layers of the leaflet 14, or slightly less, to ensure that the end portion 656 holds the leaflet in the folded position.

As seen in fig. 26C, a plurality of pin implants 650, here shown as three pin implants 650a, 650b, and 650C, are used to constrain the lip 14a of the second leaflet 14. In some applications, the pin implants 650a, 650b, and 650c may be delivered to the mitral valve and placed onto the folded leaflets 14 in sequence. In other words, a catheter may be used to deliver and place pin implant 650a, then the same catheter may be used to deliver and place pin implant 650b, and finally the same catheter may be used to deliver and place pin implant 650c. In some applications, multiple catheters may be used to deliver the pin implants 650a, 650b, and 650c to the mitral valve substantially simultaneously, and to place the pin implants onto the folded leaflet substantially simultaneously.

As seen in fig. 26C, particularly in its cross-sectional portion, the folded leaflet 14 and the constraining lip 14a present a middle region 640 of the leaflet 14 in the folded position as an alternative coaptation surface for coaptation of the lip 12a of the first leaflet 12. Thus, as seen in fig. 26C, after folding and constraining the lips 14a, the lips 12a of the leaflets 12 may properly coapt against the intermediate region 640, thereby repairing or improving the function of the mitral valve 10.

Reference is now made to fig. 27A-27E, which are schematic cross-sectional illustrations of stages of repairing a second leaflet 14 of a mitral valve 10 using a constraint implant 660 according to some applications.

As seen in fig. 27A, the first leaflet 12 or second leaflet 14 has prolapsed or has flails such that the lip 14a of the second leaflet 14 prolapses into the ventricle and does not properly coapt with the lip 12a of the first leaflet. The second leaflet 14 includes an intermediate region 640 extending between the lip 14a and the root of the leaflet 14, or the annulus 15 adjacent the leaflet 14.

Turning to fig. 27B, it can be seen that constraint implant 660 includes a tissue anchor comprising a tissue-engaging element 662 and a head 664. The constraint implant 660 is delivered transluminally to a heart chamber adjacent the mitral valve 10, for example, to a heart chamber upstream of the mitral valve. As seen, the implant 660 is delivered by a longitudinal catheter 680, for example, similar to the catheter 100 described above, configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween. In some applications, the catheter 680 is engaged with the head 664 of the implant 660 during delivery thereof.

A catheter, such as catheter 680 for delivering implant 660 or another catheter, is configured to fold down second leaflet 14 such that lips 14a of leaflet 14 engage heart wall 672 of the heart chamber downstream of the mitral valve. The intermediate region 640 is then presented at the fold of the leaflet.

Then, as shown in fig. 27C, the catheter 680 is configured to anchor the lips 14a of the second leaflet 14 to the heart wall 672 using the constraining implant 660 to constrain the lips of the leaflets in the folded position. In some applications, the catheter 680 may contain a driving tool, which may extend distally from the lumen of the catheter 680. In some applications, the driving tool is rotatable such that rotation of the driving tool screws a portion of the implant 660 into tissue of the heart wall 672.

As seen in fig. 27D, particularly in its cross-sectional portion, the folded leaflet 14 and the constraining lip 14a present a middle region 640 of the leaflet 14 in the folded position as an alternative coaptation surface for coaptation of the lip 12a of the first leaflet 12. Thus, as seen in fig. 27D, after folding and constraining the lip 14a, the first leaflet 12 may properly coapt against the middle region 640, thereby repairing or improving the function of the mitral valve 10.

Turning to fig. 27E, in some applications, after constraining the lip 14a to the heart wall 672, a secondary implant 690 defining a manual coaptation surface 692 may be mounted over the constrained leaflet 14. The manual coaptation surface 692 forms an alternative coaptation surface for coaptation of the lip 12a of the first leaflet 12. Thus, as seen in fig. 27D, after folding and constraining the lip 14a, the leaflets 12 can properly coapt against the intermediate region 640, thereby repairing or improving the function of the mitral valve 10.

In some applications, the secondary implant 690 may be transluminally delivered to the heart chamber downstream of the mitral valve 10 through the catheter 680 (e.g., after delivery and implantation of the implant 660) or through another catheter. In some applications, the secondary implant 690 may be formed from a shape memory material or wire mesh. In some applications, the secondary implant 690 may be delivered to the heart chamber in a compressed form. In such examples, the secondary implant 690 is decompressed or inflated after its delivery and/or after its implantation over the constrained leaflet.

Reference is now made to fig. 28A, 28B, 28C and 28D, which are schematic cross-sectional and top view illustrations of stages of repair of a leaflet 14 of a mitral valve 10 using a restraining sliver implant 700 of a plurality of restraining leaflets 14a, according to some applications.

As seen in fig. 28A, the first leaflet 12 or second leaflet 14 has prolapsed or has flails such that the lip 14a of the second leaflet 14 prolapses into the ventricle and does not properly coapt with the lip 12a of the first leaflet. The second leaflet 14 includes an intermediate region 640 extending between the lip 14a and the root of the leaflet 14, or the annulus 15 adjacent the leaflet 14.

The constrained tampon implant 700 includes a flexible longitudinal portion 702, and a first end portion 704a and a second end portion 704b, respectively. The end portions 704a and 704b are arranged or can be arranged in a direction perpendicular to the longitudinal axis of the longitudinal portion 702.

The restraining-tampon implant 700 is delivered transluminally to a heart chamber adjacent the mitral valve 10, for example, to the heart chamber upstream of the mitral valve. As seen, implant 700 is delivered by a longitudinal catheter 680, for example, similar to catheter 100 described above, configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween. In some applications, during delivery to the heart chamber, catheter 680 constrains tampon implant 700 to be placed within the lumen of catheter 680.

As seen in fig. 28A, catheter 680 begins to implant a restraining silver implant 700 by inserting the implant into and through heart wall 672 at a first location upstream of mitral valve 10. As such, the first end portion 704a engages the outer surface 672a of the heart wall upstream of the mitral valve 10, and a portion of the flexible longitudinal portion 702 adjacent the first end portion 704a extends through the heart wall 672 into the heart chamber. After insertion of the implant into the heart wall, the end portion 704a is disposed at an angle relative to the longitudinal portion 702, such as vertically, to prevent the end portion 704a from sliding into the heart chamber through tissue of the heart wall 672.

A catheter, such as catheter 680 for delivering implant 700 or another catheter, is configured to fold down second leaflet 14 such that lips 14a of leaflet 14 engage heart wall 672 of the heart chamber downstream of the mitral valve. The intermediate region 640 of the leaflet then appears at the fold of the leaflet.

Catheter 680 is then configured to anchor the lips 14a of the second leaflet 14 to the heart wall 672 by inserting the second end portion 704B of the restraining silver implant 700 into and through the lips 14a and heart wall 672 at a second location downstream of the mitral valve 10, as shown in fig. 28B. This constrains the lips 14a of the leaflets 14 in the folded position. In this arrangement, the flexible longitudinal portion 702 of the constrained tampon implant 700 extends against and engages the upstream surface of the leaflet 14, and in particular the intermediate region 640. Additionally, the second end portion 704b is disposed at an angle relative to the longitudinal portion 702, such as vertically, to prevent the second end portion from sliding into the heart chamber through tissue of the heart wall 672. The catheter 680 may then be removed from the heart chamber.

As seen in fig. 28C and 28D, the folded leaflet 14 and constraining lip 14a present a middle region 640 of the leaflet 14 in the folded position as an alternative coaptation surface for coaptation of the lip 12a of the second leaflet 12. As shown in fig. 28D, because each implant 700 is relatively narrow, in some applications, multiple constraining tampon implants 700 are implanted at different locations along leaflet 14, constraining lips at multiple locations.

After folding and constraining the lip 14a, the leaflet 12 may properly coapt against the middle region 640 and the longitudinal portion 702, thereby repairing or improving the function of the mitral valve 10, as best seen in fig. 28D.

Reference is now made to fig. 29A and 29B, which are schematic top view illustrations of stages of repairing a leaflet 14 of a mitral valve 10 using a leaflet-engaging surface implant 710, according to some applications.

As seen in fig. 29A, the second leaflet 14 has prolapsed or has flails such that the lips 14a of the second leaflet 14 prolapse into the ventricle and do not properly coapt with the lips 12a of the first leaflet.

Leaflet-engaging surface implant 710 includes a flexible leaflet-engaging surface 712 and a tether 714. The flexible leaflet engaging surface 712 may be formed from fabric, silicone, polymer, biological tissue, such as pericardium, and/or any other biocompatible material. In some applications, the flexible leaflet engaging surface 712 may be substantially inelastic, or not elastic to the human eye. Leaflet-engaging surface implant 710 is delivered transluminally to the heart chamber adjacent mitral valve 10, for example, to the heart chamber upstream of the mitral valve. As seen, the implant 710 is delivered through a longitudinal catheter 720, e.g., similar to the catheter 100 described above, configured to be advanced transluminally toward the heart. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween. In some applications, the tether 714 is long enough such that the end of the tether extends from the proximal end of the catheter 720 and is steerable by the medical provider who implants the implant 710.

As seen in fig. 29A, the leaflet-engaging surface 712 is attached to the surface of the second leaflet 14 using tethers 714, for example, by suturing the leaflet-engaging surface to the leaflet. In some applications, it is desirable to shorten the length of the leaflet for repair thereof, with at least one length of the tether extending along the desired shortening direction. For example, in the example shown, the leaflet 14 will be repaired by shortening the distance between the leaflet's lip 14a and root. Thus, in the illustrated example, two lengths of the tether extend in a desired shortening direction between the root of the leaflet and the lip, with the connection length of the tether extending substantially along the lip of the leaflet therebetween.

As seen in fig. 29B, the tether 714 is tensioned in the foreshortening direction (e.g., between the lips and the root of the leaflet 14), such as by pulling both ends of the tether 714 proximally, thereby deforming the leaflet at least along its dimension between the root and the lips. After the tether 714 is tensioned, the end of the tether may be cut and the locking element 716 slid onto the cut end of the tether to secure the tether in its tensioned state.

As seen in fig. 29B, after shortening of the leaflet 14, the leaflet 12 may properly coapt with the leaflet 14. In this way, the shortening of the leaflets restores or improves the functioning of the mitral valve 10.

Reference is now made to fig. 30A and 30B, which are schematic top view illustrations of stages of repairing a second leaflet 14 of a mitral valve 10 using a leaflet coaptation surface implant 730, according to some applications.

As seen in fig. 30A, the second leaflet 14 has prolapsed or has flails such that the lips 14a of the second leaflet 14 prolapse into the ventricle and do not properly coapt with the lips 12a of the first leaflet.

The leaflet-engaging surface implant 730 includes a resilient leaflet-engaging surface 732 and a tether 734. The elastomeric leaflet engaging surface 732 may be formed from an elastomeric cloth, an elastomeric polymer, or another biocompatible material. The leaflet engaging surface implant 730 is transluminally delivered to the heart chamber adjacent the mitral valve 10, substantially as described above with respect to fig. 29A.

As seen in fig. 29A, the elastomeric leaflet engaging surface 732 stretches in at least one dimension thereof. In the example shown, the direction of stretch of the elastic leaflet engaging surface 732 is indicated by arrow 736. In some applications, more than one catheter advanced into the heart chamber may be used to stretch the elastic leaflet engaging surface 732 within the heart chamber.

Upon stretching, the elastic leaflet-engaging surface 732 is attached to the surface of the second leaflet 14 using a tether 734, for example, by suturing the leaflet-engaging surface to the leaflet. In some applications, the stretched elastic leaflet-engaging surface 732 is attached to the leaflet from all sides of the surface. In some applications, when the elastic leaflet-engaging surface 732 is attached to the leaflet 14, the stretched dimension of the surface is disposed along the dimension of the leaflet that should be shortened. For example, in the example shown, the leaflet 14 is too long in the direction extending between the root of the leaflet and the lip so that shortening of the leaflet can restore its function. In this way, the resilient leaflet engaging surface 732 is placed over the leaflet such that its stretched dimension, indicated by arrow 736, extends between the root and the lip of the leaflet 14.

As seen in fig. 30B, after the elastic leaflet-engaging surface 732 is attached to the leaflet 14 by the tether 734, the stretching of the leaflet-engaging surface is released. As a result, the resilient leaflet engaging surface 732 contracts in the direction indicated by arrow 738, the leaflet attached to the surface deforms, at least along the dimension between its root and lip.

As seen in fig. 30B, after shortening of the leaflet 14, the leaflet 12 may properly coapt with the leaflet 14. In this way, the shortening of the leaflets restores or improves the functioning of the mitral valve 10.

Reference is now made to fig. 31A, 31B, 31C, 31D and 31E, which are schematic cross-sectional illustrations of stages of repair of the second leaflet 14 of the mitral valve 10 using a tampon implant delivered through the coronary artery 750 adjacent the leaflet, according to some applications.

As seen in fig. 31A, the first leaflet 12 or second leaflet 14 has prolapsed or has flails such that the lip 14a of the second leaflet 14 prolapses into the ventricle and does not properly coapt with the lip 12a of the first leaflet.

Guidewire 742 is transluminally delivered through coronary artery 750 and wall 752 of the coronary artery to a heart chamber adjacent mitral valve 10, for example, to a heart chamber upstream of the mitral valve. Guidewire 742 may be delivered through the coronary artery and into the heart chamber via a longitudinal catheter similar to catheter 100 described above, which is configured to be transluminally advanced through the coronary artery toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

As can be seen, the end 742a of the guidewire 742 passes through the leaflet from its upstream side to its downstream side at a first location 754 of the leaflet 14 near the root of the leaflet. Then, an end 742a of the guidewire 742 passes through the leaflet from the downstream side to the upstream side of the leaflet 14 at a second location 756 of the leaflet between the first location 754 and the lip 14 a. As a result, the cross-section of leaflet 14, indicated by reference numeral 758, is flanked by guide wires 742. The guidewire may be threaded into and through the leaflet via a catheter.

Turning to fig. 31B, a tampon delivery system 744 is advanced transluminally over a guidewire 742, e.g., through a catheter and through a coronary artery 750. Once the tampon delivery system 744 is positioned within the leaflet, the guidewire 742 is removed from the leaflet and coronary artery 750, for example, through the catheter, leaving the tampon delivery system in place for delivery of the tampon.

Turning to fig. 31C, a tampon comprising a longitudinal portion 745 and two end portions 746 and 748 is advanced transluminally, e.g., through a catheter, by a tampon delivery system 744. The first and second end portions 746, 748 are generally parallel to the longitudinal portion 745 during tampon delivery and generally perpendicular to the longitudinal portion 745 after tampon implantation, as seen in fig. 31C and 31D.

In fig. 31C, the pledget is advanced until first end 746 extends from the leaflet at second location 756 and rests against the upstream surface of leaflet 14. The tampon delivery system 744 is retracted into the catheter until the distal end of the tampon delivery system is positioned adjacent the first location 754 at the upstream side of the leaflet 14. Thus, the tampon and in particular its longitudinal portion 745 remains the only object of tissue extending through the leaflet 14.

Turning to fig. 31D, the tampon delivery system 744 is further retracted exposing the second end portion 748 such that the second end portion engages the upstream surface of the leaflet 14 adjacent the first location 754. The longitudinal portion 745 may be tensioned between the end portions 746 and 748. Tensioning of the longitudinal portion 745 reduces the distance between the first and second locations 754, 756, thereby wrinkling and effectively shortening the leaflet 14 at the cross-section 758 between the root and lips of the leaflet.

When the pledget is implanted in the leaflet, the second end portion 748 is generally perpendicular to the longitudinal portion 745 and is wide enough to prevent retraction of the pledget from the leaflet 14 toward the second location 756. The two end portions 746 and 748 maintain tension in the longitudinal portion 745, thereby maintaining a reduced length between the root and lip of the leaflet 14.

As seen in fig. 31E, after the tampon is fully implanted, the tampon delivery system 744 is retracted from wall 752 and coronary artery 750, e.g., through the catheter. As the leaflet 14 is shortened by forming the bulge at the cross-section 758, the lips 12a of the leaflet 12 may properly coapt against the lips 14a of the leaflet 14, thereby repairing or improving the function of the mitral valve 10, as best seen in fig. 31E.

Reference is now made to fig. 32A-32D, which are schematic illustrations of a flail reducing clip implant 770 and stages of its use for repairing leaflets of a heart valve, according to some applications.

The clip implant 770 includes a clip portion 772 having an integrally formed bent end 774 and a second end 775. The bent end 774 is substantially parallel to the remainder of the clip portion 772. The wire finger 778 is attached to the second end 745.

As seen in fig. 32B, some of the chordae 780 that hold the second leaflet 14 have broken or snapped off and as a result, the second leaflet 14 has flails such that the lips 14a of the second leaflet 14 prolapse into the ventricle. Thus, there is regurgitation from the left ventricle into the left atrium, as indicated by arrow 782.

As seen in fig. 32C and 32D, in the first planar operational state, implant 770 is transluminally delivered to a heart chamber adjacent mitral valve 10, e.g., to a heart chamber upstream of the mitral valve.

In some applications, the implant 770 is delivered through at least one longitudinal catheter similar to the catheter 100 described above, which is configured to be transluminally advanced toward the heart chamber. As described above, the longitudinal catheter has a proximal portion and a steerable distal portion and a longitudinal axis therebetween.

As can be seen, the catheter is adapted to be steerable so as to slide the implant 770 onto the leaflet 14 such that the lip 14a seats within the curve 776 with the curved end 774 of the implant engaging the upstream surface of the leaflet and the clip portion 772 engaging the downstream surface of the leaflet. The catheter is further adapted to arrange the wire fingers 778 of the implant 770 such that the distal ends thereof are disposed at points 784 where the roots of the leaflets 14 engage with or twist into the heart wall 672. It should be noted that the length of the wire fingers 778 and the entire clip implant 770 are set and configured to facilitate positioning of the clip implant as described herein.

Placement of the implant 770 as shown in fig. 32C and 32D in this manner provides a physical limit to the movement of the leaflets, preventing them from flail. Thus, as seen in fig. 32C, the lips 14a of the leaflet 14 with the implant 770 thereon are properly coaptated with the lips 12a of the leaflet 12. Additionally, because the wire portion 778 may pivot at the end 775 relative to the clip portion 772, blood flow from the atrium through the mitral valve 10 into the ventricle is not interrupted.

Reference is now made to fig. 42, 43, 44, 45A-B, 46 and 47A-B, which are schematic illustrations of a system for use with a valve of a subject's heart, according to some applications. Fig. 42 shows the mitral valve 10 and tricuspid valve 20 of the heart, both having leaflets that are not properly coaptated and require repair, and the catheter 900 is advanced to the mitral valve, according to some applications. The reference numerals used in fig. 42 correspond to those used in fig. 1 and throughout the specification. Fig. 42 shows a mitral valve 10 having a first leaflet 12 and a second leaflet 14 surrounded by an annulus 15. The first and second leaflets do not coapt properly such that when the valve is closed, a gap 18 exists in the valve.

For some applications, the tricuspid valve 20 in the same heart as the mitral valve 10 may also need to be repaired in a similar manner. In the application shown in fig. 42, tricuspid valve 20 includes leaflets 22, 23, and 24 surrounded by an annulus 25. The leaflets of the tricuspid valve 20 do not properly coapt against each other such that when the valve is closed, there are one or more gaps 28 in the valve.

As seen in fig. 42, the longitudinal catheter 900 is advanced toward the anatomy of the subject. The longitudinal catheter 900 is substantially similar to the longitudinal catheter 100 described above with respect to fig. 2-10B. In the example shown, the distal portion 906 of the catheter is advanced to a ventricle (e.g., left ventricle) of the heart to be positioned upstream of a heart valve (e.g., mitral valve 10). The longitudinal catheter 900 also has an extracorporeal proximal portion (e.g., as shown in fig. 10A-B). The distal portion 906 can be directed to the anatomical site, such as by being actively steerable itself (e.g., by being operably coupled to a proximal portion by one or more pull wires, such as a steering controller thereof, such as steering controller 203 shown in fig. 10A and 10B, or the like), or by being passively directed and/or steered (e.g., by extending over or through another steerable element, such as an actively steerable catheter). A longitudinal axis 908 extends between the proximal portion of the catheter 900 and the steerable distal portion 906. Catheter 900 is advanced transluminally to the anatomical site, such as through the vena cava, and, if desired, through the septum of the atrium of the heart, using any method known in the art.

Turning now additionally to fig. 43 and 44, it can be seen that the distal end 906 of the catheter 900 is partially cut away to define an implant deployment port 909. A helical implant 910 is disposed within the catheter 900 near its distal end 906. The helical implant 910 defines a pair of turns, designated by reference numeral 912, each turn defining a respective space 914, wherein the size of the spaces 914 depends on the pitch of the turns 912 in the helical implant. In a first operational state of the helical implant 910, as shown in fig. 44, the turn 912 has a first pitch P1. As explained in further detail below with respect to fig. 46, in the second operational state of the helical implant 910, the pair of turns have a second pitch P2, which is less than the first pitch.

The helical implant 912 is advanced to the distal end 906 of the catheter 900 in any suitable manner. For some applications, the helical implant 910 may be rotationally advanced (e.g., screwed, etc.) through the catheter.

For some applications, in addition to the central lumen 918, the catheter 900 may also include a spiral channel 916 extending through a wall 917 of the catheter, as shown in fig. 44. For such applications, the helical implant 910 may be rotationally advanced to the distal end 906 through the helical channel 916. For some applications, the pitch of the helical channels 916 is equal to the first pitch P1, and the configuration of the helical channels may help maintain the pitch of the helical implant 910 during advancement of the helical implant.

For some applications in which multiple helical implants 910 are to be used, each helical implant 910 may be advanced individually (e.g., one at a time) through the helical channel 916, such as by pushing a wire or other advancement tool, as explained in further detail below.

For other applications, multiple helical implants 910 may be placed into the helical channel 916 one after the other. Pushing force may be applied to the proximal most side of the helical implant, for example by pushing a wire or tool. The proximal implant pushes the next implant distally and each other implant pushes the next implant distally so that the pushing force applied to the proximal implant pushes all implants in the channel 916 forward one after the other.

For some applications, the helical implant 910 may be pushed linearly along the longitudinal axis of the catheter to the distal end 906.

For some applications, the helical implant 910 is flexible and/or resilient. For some applications, the helical implant 910 comprises a resilient metal. For some applications, the helical implant 910 includes a shape memory material.

Fig. 45A and 45B illustrate that, according to some applications, a spiral implant 910 is placed onto the annulus 15 of the mitral valve 10, and the tissue of the mitral valve (e.g., its annulus) is pulled into the space 914 between turns 912 of the spiral implant.

As seen in fig. 45A, when the implant 910 is in the first operational state, the implant is advanced to the distal end 906 of the catheter 900 such that the first turn 912a of the helical implant is in the implant deployment port 909. In this state, the turn 912a engages the tissue of the annulus 15 of the mitral valve 10. For example, by pulling tissue toward and/or into access port 909, tissue of the annulus is pulled into space 914a of turn 912 a. This may be accomplished, for example, by applying suction 920 (e.g., vacuum) via catheter 900, such as by activating pump 921 functionally associated with the proximal portion of catheter 900.

Turning to fig. 45B, it can be seen that the catheter 900 has been retracted in a proximal direction while the helical implant 910 remains attached to the annulus 15 such that the second turn 912B is disposed in the implant deployment inlet 909. In this state, the turn 912b engages the tissue of the annulus 15 of the mitral valve 10. The tissue of the annulus is pulled into the space 914b of the curve 912b, for example, by using a vacuum pump 921. For some applications, septum 922 is disposed within catheter 900 between implant deployment port 909 and pump 921 so as to inhibit or restrict fluid flow from the distal end of the catheter to the proximal end thereof, at least in the absence of aspiration. Septum 922 may include a slit 923 that is generally closed, preventing blood from flowing proximally into catheter 900 when not desired. When pump 921 applies suction, additional force increases the pressure gradient across membrane 922, causing the slit to open and allow flow in the proximal direction through the catheter. It should be appreciated that other arrangements of septum 922 (with or without slits) or other types of valve members may also be used to achieve such behavior.

Fig. 46 illustrates that the shape of the helical implant 910 is changed from a first operational state to a second operational state, thereby plicating tissue of the annulus 15, according to some applications.

In some applications, and as shown, catheter 900 transitions helical implant 910 from the first operational state shown in fig. 45A and 45B to the second operational state shown in fig. 46 by moving turns 912 toward each other in the direction of arrows 924. As a result, the tissue of the annulus 15 disposed within the space 914 folds therein. For some applications, this is achieved by the implant 910 being biased to assume the second operational state (e.g., due to elasticity and/or shape memory). For some applications, this is accomplished by constraining the implant 910 in a first operational state (and optionally for previous advancement of the implant) during pulling of tissue into the space 914, for example by positioning the implant within the channel 916 with the pitch P1, and then being released to responsively move toward a second operational state.

For some applications, after placement of the helical implant 910, the catheter 900 may be moved to another location along the annulus 15 for placement of a second helical implant 910', as shown in fig. 46.

After placement of the desired number of helical implants 910, the catheter 900 may be retracted from the heart chamber or anatomical site, for example, by pulling the catheter in a proximal direction, or using any other method known in the art.

Turning now to fig. 47A and 47B, the mitral valve is shown after repairing the mitral valve 10 using a plurality of spiral implants 910, each positioned over and creasing the annulus, according to the steps of fig. 44-46. As seen in fig. 47A, four helical implants 910 are placed alongside the catheter. After placement of the helical catheter, the gap between the leaflets 12 and 14 has been eliminated and the leaflets properly coapt.

Fig. 47B shows the repaired mitral valve 10 as well as the tricuspid valve 20, which has been repaired using five helical implants 910. Using the steps described herein with respect to fig. 44-46, each of the spiral implants 910 is applied to the annulus 25 of the tricuspid valve 20.

For some applications, the helical implant 910 may be replaced with at least one helical needle implant that is driven through tissue of the annulus, e.g., similar to the helical needle described herein, except that it remains implanted in the heart. After being driven through the tissue, the helical needle implant axially contracts (e.g., due to shape memory) and thereby clamps or folds the tissue in a manner similar to that described herein.

It should be noted that although the various examples shown herein are for mitral valve 10, and only for one leaflet thereof, the implants and methods disclosed herein are similarly used to repair another leaflet of the mitral valve, as well as to repair other valves (e.g., tricuspid valve) and leaflets thereof.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve, the system comprising at least one longitudinal catheter configured to transluminally advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween. In some applications, the system includes a longitudinal mount distally advanceable from the longitudinal catheter, the mount having a first curved surface and a second curved surface.

In some applications, the system includes a helical needle defining a helical lumen, the helical needle configured to be advanced distally from the longitudinal catheter and to extend axially and rotationally about the first surface of the longitudinal mount and through tissue of the leaflet, pulling the tissue against the second surface of the longitudinal mount.

In some applications, the at least one longitudinal conduit is adapted to: (i) Advancing the mount of tissue adjacent the leaflet through a lumen in an advancement direction; (ii) The spiral needle and the suture are advanced transluminally around the mount along and through the leaflet, thereby pulling tissue of the leaflet against the second surface of the mount; (iii) securing the distal end of the suture; (iv) Removing the mount and the spiral needle from the heart valve while maintaining the suture helically through the tissue of the leaflet; and (v) tensioning the suture, thereby deforming the tissue of the leaflet disposed within the suture.

For example, some such examples are illustrated in figures 11 through 13, which are described in detail above.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve, the system comprising at least one longitudinal catheter configured to transluminally advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween. The system may further comprise an implant comprising: a first leaflet engaging portion and a second leaflet engaging portion, the first and second leaflet engaging portions adapted to engage the lips of the leaflet; and at least one tether extending between the first leaflet-engaging portion and the second leaflet-engaging portion.

In some applications, the at least one conduit is adapted to: (i) Delivering the implant transluminally to the heart chamber adjacent the heart valve; (ii) Engaging the first leaflet engaging portion to a first position on the lip of the leaflet; (iii) Engaging the second leaflet-engaging portion to a second position on the lip of the leaflet; and (iv) pulling the first leaflet-engaging portion and the second leaflet-engaging portion toward each other by tensioning the at least one tether between the first leaflet-engaging portion and the second leaflet-engaging portion.

An example embodiment is shown in fig. 14, where the leaflet attachment portion is the end of the implant 350 and the tether extends through the implant. Another example embodiment is shown in fig. 15, wherein the leaflet engaging portions are leaflet engaging clips connected by a plurality of tethers.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve: and a lip adapted to coapt with at least one other leaflet of the valve, the system comprising at least one longitudinal catheter configured to transluminally advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis and a penetrating implant therebetween.

In some applications, the penetrating implant comprises: (i) A piercing element comprising a base from which a piercing tip extends; and (ii) a securing element adapted to secure the piercing tip of the piercing element.

In some applications, the at least one conduit is adapted to: (i) Delivering the penetrating implant transluminally to the heart chamber; (ii) Creating a folded region of the leaflet by folding the leaflet; (iii) Inserting the penetrating tip of the penetrating element through at least two layers of the leaflet at the fold region; and (iv) securing the at least one fold at the fold region by connecting the securing element to the piercing tip of the piercing element such that the base of the piercing element and the securing element are on the same side of the leaflet with the at least two layers disposed therebetween.

An example embodiment of such a system is shown in fig. 16.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the valve, the small She Baohan first and second notches, the system comprising at least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis and a tether implant therebetween.

In some applications, the tether implant comprises: (i) a tether having a proximal end and a distal end; and (ii) at least one locking element adapted to secure at least one end of the tether.

In some applications, the at least one conduit is adapted to: (i) transluminally delivering the tether to the heart chamber; (ii) Passing the distal end of the tether from a first side of the leaflet through the first notch in the leaflet to a second side of the leaflet; (iii) Passing the distal end of the tether from the second side of the leaflet further through the second notch in the leaflet to the first side of the leaflet; (iv) Tensioning the tether through the first and second notches to pull the first and second notches toward each other; and (v) securing the proximal and distal ends of the tether using the at least one locking element to maintain tension in the tether.

An example embodiment of such a system is shown in fig. 17.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve: and a lip adapted to coapt with at least one other leaflet of the valve, the system comprising at least one longitudinal catheter configured to transluminally advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion, and a longitudinal axis and an implant therebetween.

In some applications, the implant includes a first beam, a second beam, and a third beam, and has a first operational state and a second operational state.

In some applications, the at least one conduit is adapted to: (i) transluminally delivering the implant to the heart chamber; (ii) Placing the implant onto the leaflet in the first operational state; and (iii) transitioning the implant from the first operational state toward the second operational state, thereby causing the leaflet to follow a tortuous path between the first beam and the third beam.

An example embodiment of such a system is shown in fig. 18, wherein the first beam, the second beam and the third beam are implemented as three of the beams 454. An example embodiment is also shown in fig. 19, wherein the first, second and third beams are implemented as beam 466, central unified beam and beam 478, respectively. Also illustrated in fig. 20 is an example embodiment in which a first beam is implemented as sections 502 and/or 506, a second beam is implemented as beam 510a, and a third beam is implemented as sections 514 and/or 518. An example embodiment is also shown in fig. 21, wherein the first and third beams are implemented by the elongated portion 546 of the clip 544 and the second beam is implemented by the tubular body 542.

In some applications, the implant comprises: (i) a core; and (ii) a fixation element adapted to fix tissue around the core.

In some applications, the at least one conduit is adapted to: (i) transluminally delivering the implant to the heart chamber; (ii) Positioning a portion of the leaflet about the core by placing the core against a first surface of the leaflet; and (iii) securing the portion of the leaflet extending around the core from a second opposing surface of the leaflet using the securing element, thereby deforming the region of the leaflet.

An example embodiment is shown in fig. 22 and 23, wherein the core is a mandrel or tubular core 562 and the fixation element is a clip 564. An example embodiment is also shown in fig. 24, where the core is a rivet or core element 602 and the securing element is a faceplate 612.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip, the system comprising at least one longitudinal catheter configured to transluminal advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween and a constraint implant.

In some applications, the at least one longitudinal conduit is adapted to: (i) Delivering the constraint implant transluminally to the heart chamber; and (ii) constraining the lip using the constraining implant so as to present the intermediate region as an alternative apposition surface to the at least one other leaflet.

Example embodiments of such systems are shown in fig. 25, 26, 27A-27D and 28.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip, the system comprising at least one longitudinal catheter configured to transluminally advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion, and a longitudinal axis and an implant therebetween.

In some applications, the implant comprises: (i) a constraining element; and (ii) a manual apposition element.

In some applications, the at least one longitudinal conduit is adapted to: (i) Transluminally delivering the constraining element and the artificial apposition element to the heart chamber; (ii) Constraining the lip using the constraining implant so as to present the intermediate region; and (iii) mounting the artificial apposition element onto the intermediate region of the leaflet so as to present an artificial apposition surface for apposition with the at least one other leaflet.

An example embodiment is shown in fig. 27E.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve: a lip adapted to coapt with at least one other leaflet of the valve, the system comprising at least one longitudinal catheter configured to transluminal advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion, and a longitudinal axis and a leaflet-engaging surface implant therebetween.

In some applications, the leaflet-engaging surface implant comprises: (i) a flexible leaflet-engaging surface; and (ii) a tether.

In some applications, the at least one longitudinal conduit is adapted to: (i) Delivering the leaflet-engaging surface implant transluminally to the heart chamber; (ii) Attaching the leaflet-engaging surface to a surface of the leaflet using the tether; and (iii) deforming the leaflet engaging surface when attached to the leaflet, thereby deforming or shortening the leaflet along at least one dimension thereof.

An example embodiment is shown in fig. 29 and 30.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root portion of the leaflet being adjacent a coronary artery, the system comprising at least one longitudinal conduit configured to transluminally advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal conduit having a proximal portion and a steerable distal portion and a longitudinal axis and an implant therebetween.

In some applications, the implant comprises: (i) A guidewire having a first end and a second end; and (ii) first and second tampons adapted to be attached to respective first and second ends of the guidewire.

In some applications, the at least one longitudinal conduit is adapted to: (i) Delivering the guidewire and the first and second tampons transluminally through the coronary artery to the heart chamber; (ii) Puncturing the first end of the guidewire through two locations in the leaflet, thereby forming a fold in the leaflet, the two locations and the fold being between the root of the leaflet and the lip of the leaflet; and (iii) deploying the first and second tampons at the first and second ends of the guidewire while tensioning the guidewire to maintain the fold in the leaflet and reduce the length of the leaflet from the root to the lip.

An example embodiment is shown in fig. 31.

According to some applications, the teachings herein include a system for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root portion of the leaflet being attached to a heart wall, the system comprising at least one longitudinal conduit configured to transluminal advance toward a heart chamber of the subject adjacent the heart valve, the longitudinal conduit having a proximal portion and a steerable distal portion, and a longitudinal axis and clip implant therebetween.

In some applications, the clip implant comprises: a clip portion defining a bend; and a wire finger attached to the clip portion.

In some applications, the at least one longitudinal conduit is adapted to: (i) Delivering the clip implant transluminally to the heart chamber; (ii) The clip implant is mounted to the leaflet such that the curve engages the lip of the leaflet and the wire fingers extend to a point of contact between the root of the leaflet and the heart wall such that the clip implant mechanically constrains the leaflet flails.

An example embodiment of this type is shown in fig. 32.

For the purposes of this specification and the claims that follow, the term "substantially" is defined as "at least 95%" of the relevant amount. For example, "substantially perpendicular" means at least 95% perpendicular, or having an angle in the range of 85 ° to 95 °.

It should be understood that the use of "and/or" is defined inclusively, such that the term "a and/or b" should be read to include the set: "a and b", "a or b", "a", "b".

The invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and sub-combinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description. In addition, the techniques, methods, operations, steps, etc., described or suggested herein may be performed on living animals or non-living mimics, such as on cadavers, cadaveric hearts, mimics (e.g., with a body part, tissue, etc., being simulated), etc.

Although the operations of some of the disclosed examples are described in a particular order for ease of presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth above. For example, in some cases, operations or steps described in sequence may be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. In addition, the present specification sometimes uses terms such as "provide" or "implement" to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations corresponding to these terms may vary depending on the particular implementation and are discernible by one of ordinary skill in the art.

Example application(some non-limiting examples of the concepts herein are listed below):

example 1. A system for use with a subject, the system comprising: (A) A longitudinal catheter configured to be advanced transluminally toward an anatomical site of the subject, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; (B) A wire distally advanceable from the longitudinal catheter, the wire forming a wire loop having a closed distal end and a fastening element slidably coupled to the wire such that distal sliding of the fastening element over the wire constricts the wire loop and cuts tissue disposed within the wire loop, thereby forming a cut tissue and a cutting edge at the anatomical site; (C) A helical needle defining a helical lumen, the helical needle configured to be advanced distally from the longitudinal catheter and to extend rotationally through the cutting edges at the anatomical site and to secure the cutting edges together; and (D) a suture extending through the helical lumen of the helical needle, wherein the helical needle and the suture are configured to extend along the cutting edge of the anatomical site to suture the cutting edge during distal sliding of the fastening element.

Example 2 the system of example 1, further comprising a tissue anchor configured to anchor to tissue at the anatomical site, wherein at least one of the wire loop and the helical needle is attachable to the tissue anchor.

Example 3 the system of example 2, wherein the helical needle comprises a needle body terminating in a detachable distal tip configured to be attached to the tissue anchor and detached from the needle body.

Example 4. The system of example 3, wherein a distal end of the suture is attached to the detachable distal tip of the helical needle.

Example 5 the system of example 4, wherein after detaching the detachable distal tip of the helical needle from the needle body, the needle body is threadably retracted away from the detachable distal tip while sliding over and along the suture.

Example 6 the system of example 3, further comprising a push wire extending through the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

Example 7 the system of any one of examples 1-6, wherein the wire and the helical needle are adapted to be removed from the anatomical site after cutting the tissue disposed within the wire loop while leaving the suture in the anatomical site to suture the cutting edge.

Example 8 the system of any one of examples 1-7, further comprising a clamp having a distal clamping end, the clamp being distally advanceable from the longitudinal catheter to engage the cut tissue prior to the cut tissue being completely detached from the anatomical site.

Example 9. The system of example 8, wherein the clamp is adapted to be removed from the anatomical site, the cut tissue clamped to the clamp after the wire and the helical needle are removed from the anatomical site.

Example 10 the system of example 8 or example 9, wherein the clamp is configured to advance through the longitudinal catheter alongside the helical needle.

Example 11 the system of any one of examples 1-10, wherein the helical needle follows the fastening element at a fixed distance from the fastening element at least during distal sliding of the fastening element.

Example 12 the system of any one of examples 1-11, wherein the anatomical site comprises a heart valve and the cut tissue comprises a portion of a leaflet of the heart valve.

Example 13 the system of any one of examples 1-12, wherein the helical needle and the suture are configured to rotationally extend through the cutting edge at the anatomical site as the cutting edge is formed.

Example 14 the system of any one of examples 1-13, wherein in at least a first state of the system, the fastening element is operably coupled to the helical needle such that the fastening element is distally advanceable over the wire only upon subsequent advancement of the helical needle.

Example 15 the system of example 14, further comprising a user interface enabling a user to control the system, the user interface including a unified engagement element that, when actuated, consistently controls movement of the fastening element and the helical needle.

Example 16 the system of example 15, wherein the unified engagement element, when actuated, controls movement of the fastening element and the helical needle at a fixed distance from each other.

Example 17 the system of example 15 or example 16, wherein the user interface comprises: (i) A first engagement element that controls movement of the fastening element when actuated; (ii) And a second engagement element that controls movement of the helical needle when actuated.

Example 18 the system of example 17, wherein the unified engagement element includes a third engagement element different from the first engagement element and the second engagement element.

Example 19 the system of example 17, wherein: (i) The user interface further includes a coupling element functionally associated with the first engagement element and the second engagement element; (ii) In a first operating state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the fastening element and the helical needle or movement at a fixed distance from each other; and (iii) in a second operational state of the coupling element, the first and second engagement elements are uncoupled such that actuation of the first engagement element controls only movement of the fastening element and actuation of the second engagement element controls only movement of the helical needle.

Example 20 the system of any one of examples 1-19, wherein at least one of the wire and the helical needle is adapted to be (i) advanced to the anatomical site through the longitudinal catheter, or (ii) removed from the anatomical site through the longitudinal catheter.

Example 21 the system of any one of examples 1-20, further comprising a longitudinal mount adapted to be advanced distally from the longitudinal catheter such that the helical needle is adapted to rotate about the longitudinal mount and be stabilized or guided by the longitudinal mount during rotation of the helical needle.

Example 22 the system of any one of examples 1-21, further comprising a tissue engagement tool comprising a first beam, a second beam, and a third beam, the first beam, the second beam, and the third beam being distally advanceable from the longitudinal conduit, the tissue engagement tool adapted to (i) position the first beam and the third beam on a first side of the tissue, and to (ii) position the second beam on an opposite side of the tissue; and (ii) forming a bump in the tissue by moving the second beam relative to the first beam and the third beam, wherein the wire loop is adapted to constrain the bump on the first side of the tissue.

Example 23. A system for use with a subject, the system comprising: (A) A cutting device that is advanceable and steerable toward an anatomical site of the subject, wherein movement of the cutting device at the anatomical site causes cutting of tissue engaged by the cutting device, thereby forming a cutting edge at the anatomical site; and (B) an edge attachment device configured to at least temporarily secure the cutting edge at the anatomical site, wherein in at least a first state of the system the edge attachment device is operably coupled to the cutting device such that the cutting device can be advanced distally at the anatomical site only upon subsequent advancement of the edge attachment device to secure the cutting edges to one another upon formation of the cutting edge.

Example 24 the system of example 23, wherein in the first state of the system, the edge attachment device is operably coupled to the cutting device such that the cutting device is distally advanceable only when the edge attachment device is subsequently advanced a fixed distance from the cutting device.

Example 25 the system of example 23 or example 24, further comprising a user interface enabling a user to control the system, the user interface including a unified engagement element that, when actuated, consistently controls movement of the cutting device and the edge attachment device.

Example 26 the system of example 25, wherein the unified engagement element, when actuated, controls movement of the cutting device and the edge attachment device at a fixed distance from each other.

Example 27 the system of example 25 or example 26, wherein the user interface comprises: (A) A first engagement element that, when actuated, controls movement of the cutting device; and (B) a second engagement element that, when actuated, controls movement of the edge attachment device.

Example 28 the system of example 27, wherein the unified engagement element includes a third engagement element different from the first engagement element and the second engagement element.

Example 29 the system of example 27, wherein: (i) The user interface further includes a coupling element functionally associated with the first engagement element and the second engagement element; (ii) In a first operating state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the cutting device and the edge attachment device; and (iii) in a second operational state of the coupling element, the first and second engagement elements are uncoupled such that actuation of the first engagement element controls only movement of the cutting device and actuation of the second engagement element controls only movement of the edge attachment device.

Example 30. A system for use with a subject, the system comprising: (A) A cutting device that is advanceable and steerable toward an anatomical site of the subject, wherein movement of the cutting device at the anatomical site causes cutting of tissue engaged by the cutting device, thereby forming a cutting edge at the anatomical site; (B) An edge attachment device configured to at least temporarily secure the cutting edge at the anatomical site as the cutting edge is formed; and (C) a user interface enabling a user to control the system, the user interface comprising a unified engagement element that, when actuated, consistently controls movement of the cutting device and the edge attachment device.

Example 31 the system of example 30, wherein the unified engagement element, when actuated, controls movement of the cutting device and the edge attachment device at a fixed distance from each other.

Example 32 the system of example 30 or example 31, wherein the user interface comprises: (A) A first engagement element that, when actuated, controls movement of the cutting device; and (B) a second engagement element that, when actuated, controls movement of the edge attachment device.

Example 33 the system of example 32, wherein the unified engagement element includes a third engagement element different from the first engagement element and the second engagement element.

Example 34. The system of example 32, wherein: (i) The user interface further includes a coupling element functionally associated with the first engagement element and the second engagement element; (ii) In a first operating state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the cutting device and the edge attachment device; and (iii) in a second operational state of the coupling element, the first and second engagement elements are uncoupled such that actuation of the first engagement element controls only movement of the cutting device and actuation of the second engagement element controls only movement of the edge attachment device.

Example 35 the system of any one of examples 23-34, further comprising a longitudinal catheter configured to be advanced transluminally toward the anatomical site of the subject, the longitudinal catheter having a proximal portion and a steerable distal portion, wherein the cutting device and the edge attachment device are adapted to be advanced and steerable distally from the longitudinal catheter to the anatomical site.

Example 36 the system of example 35, wherein the cutting device and the edge attachment device are adapted to be advanced through the longitudinal catheter to the anatomical site.

Example 37 the system of any one of examples 23-36, wherein the cutting device and the edge attachment device are adapted to be removed from the anatomical site after cutting the tissue and securing the cutting edges together.

Example 38 the system of any one of examples 23-37, further comprising a permanent edge attachment device adapted to permanently attach the cutting edge at the anatomical site.

Example 39 the system of example 38, wherein the edge attachment device is adapted to temporarily secure the cutting edge at the anatomical site and the permanent edge attachment device is adapted to permanently attach the cutting edge.

Example 40 the system of example 39, wherein the edge attachment device comprises a needle and the permanent edge attachment device comprises a suture extending through a lumen of the needle.

Example 41 the system of example 40, wherein the needle is a helical needle and the lumen is a helical lumen.

Example 42 the system of any one of examples 23-41, wherein the cutting device comprises a wire forming a wire loop having a closed distal end and a fastening element slidably coupled to the wire such that distal sliding of the fastening element over the wire contracts the wire loop and cuts the tissue disposed within the wire loop.

Example 43 the system of any one of examples 23-42, further comprising a clamp having a distal clamping end, the clamp being advanceable to the anatomical site to engage the cut tissue prior to the cut tissue cut by the cutting device being completely removed from the anatomical site.

Example 44 the system of example 43, wherein the clamp is adapted to be removed from the anatomical site, the cut tissue clamped to the clamp after at least one of the cutting device and the edge attachment device is removed from the anatomical site.

Example 45 the system of any one of examples 23-44, further comprising a tissue anchor configured to anchor to tissue at the anatomical site to anchor at least one of the cutting device and the edge attachment device.

Example 46 the system of any of examples 23-45, wherein the anatomical site comprises a heart valve and the tissue engaged and thereby cut by the cutting device comprises a portion of a leaflet of the heart valve.

Example 47. A method of removing tissue from an anatomical site of a subject, the method comprising: (A) Transluminally advancing a longitudinal catheter toward the anatomical site, the longitudinal catheter having a proximal portion and a steerable distal portion; (B) Distally advancing a wire loop from the longitudinal catheter, the wire loop having a closed distal end, a proximal end, and a fastening element slidably coupled to the wire loop; (C) Distally advancing a helical needle from the longitudinal catheter, the helical needle comprising a helical lumen and a suture extending through the helical lumen; (D) Placing the wire loop around tissue at the anatomical site; (E) Sliding the fastening element distally relative to the wire loop, thereby cutting the tissue disposed within the wire loop and forming a cut tissue and a cut edge at the anatomical site; and (F) advancing the helical needle and the suture along the cutting edge during distal sliding of the fastening element to secure the cutting edges to one another.

Example 48 the method of example 47, further comprising advancing a tissue anchor through the longitudinal catheter to the anatomical site and anchoring the tissue anchor to tissue at the anatomical site.

Example 49 the method of example 48, further comprising, after the advancing of the helical needle: (i) Anchoring a detachable distal tip of the helical needle to the tissue anchor, the detachable distal tip having a distal end of the suture attached thereto; (ii) Detaching the detachable distal tip of the helical needle from the body of the helical needle; and (iii) helically retracting the body of the helical needle from the detachable distal tip as it slides over the suture, thereby removing the helical needle from the anatomical site while leaving the suture in the anatomical site, thereby securing the cutting edge.

Example 50. The method of example 49, wherein the removing comprises pushing the removable distal tip of the helical needle distally relative to the needle body using a push wire extending through the helical needle, thereby removing the removable distal tip from the needle body.

Example 51 the method of any one of examples 47-50, further comprising, after cutting the tissue, removing the wire loop from the anatomical site.

Example 52 the method of any one of examples 47 to 51, further comprising: (i) Advancing a clamp having a distal clamping end to the anatomical site and clamping the cut tissue into the distal clamping end of the clamp prior to completion of cutting the tissue disposed within the wire loop; and (ii) removing the clamp and the cutting clamp tissue from the anatomical site.

Example 53 the method of example 52, wherein advancement of the clip through the longitudinal catheter, and wherein the clip is positioned alongside the helical needle during advancement of the clip.

Example 54 the method of any one of examples 47-53, wherein the helical needle is maintained at a fixed distance from the fastening element during sliding of the fastening element and advancement of the helical needle.

Example 55 the method of any one of examples 47-54, wherein the anatomical site comprises a heart valve and the tissue disposed within the wireform loop comprises a portion of a leaflet of the heart valve.

Example 56 the method of any one of examples 47-55, wherein advancement of the helical needle and suture occurs while the cutting edge is formed.

Example 57 the method of any one of examples 47-56, wherein distal sliding of the fastening element relative to the wire loop is operably coupled to advancement of the helical needle such that the fastening element is distally advanceable relative to the wire loop only upon subsequent advancement of the helical needle.

Example 58 the method of any one of examples 47-57, further comprising controlling (i) sliding of the fastening element relative to the wire loop and (ii) advancement of the helical needle by a user actuating a unified engagement element of a user interface to consistently control movement of the fastening element and the helical needle.

Example 59 the method of example 58, wherein controlling sliding of the fastening element relative to the wire loop and advancement of the helical needle by user actuation of the uniform engagement element includes controlling movement of the fastening element and the helical needle at a fixed distance from each other.

Example 60. The method of example 58 or example 59, wherein the user interface comprises: (A) A first engagement element that controls movement of the fastening element when actuated; (B) A second engagement element that when actuated controls movement of the helical needle; (C) A coupling element functionally associated with the first and second engagement elements such that (i) in a first operational state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the fastening element and the helical needle, and (ii) in a second operational state of the coupling element, the first and second engagement elements are uncoupled such that actuation of the first engagement element controls movement of only the fastening element, and actuation of the second engagement element controls movement of only the helical needle, wherein (1) the method further comprises ensuring that the coupling element of the user interface is in the first operational state before the fastening element is slid distally relative to the wire and before the helical needle is advanced.

Example 61 the method of any one of examples 47-60, wherein at least one of advancement of the wire loop and advancement of the helical needle is through the longitudinal catheter.

Example 62. A method of removing tissue from a valve leaflet She Yichu of a heart valve of a subject, the method comprising: (A) Cutting tissue from the valve leaflet with a loop of wire to form a cutting edge; and (B) securing the cutting edges together as they are formed, and before the tissue is completely removed from the valve leaflet She Caxie.

Example 63. The method of example 62, wherein the securing the cutting edges together comprises advancing a helical needle through the cutting edges.

Example 64 the method of example 62 or example 63, further comprising, prior to the resecting, advancing the wire loop to the heart valve by transluminal longitudinal catheter.

Example 65 the method of example 63, wherein advancing the spiral needle comprises advancing the spiral needle a fixed distance relative to a fastening element of the wire loop.

Example 66 the method of any one of examples 63-65, wherein the spiral needle comprises a spiral lumen and has a suture extending through the spiral lumen, the method further comprising removing the spiral needle from the heart valve while attaching the suture to the cutting edge.

Example 67 a method of removing tissue from an anatomical site of a subject, the method comprising: (A) Cutting tissue engaged by the cutting device at the anatomical site using a cutting device disposed at the anatomical site, thereby forming cut tissue and a cutting edge; and (B) securing the cutting edges together with an edge attachment device at least temporarily while the cutting edges are formed and before the cut tissue is completely removed from the anatomical site, wherein (i) the cutting is operatively coupled to the secured together cutting edges such that the cutting device is only able to cut tissue at the anatomical site when subsequently advanced by the edge attachment device to secure the cutting edges to one another during formation of the cutting edges by the cutting device.

Example 68 the method of example 67, wherein the cutting is operably coupled to the fixed together cutting edges such that the cutting device is capable of cutting tissue at the anatomical site only when the edge attachment device is subsequently advanced to a fixed distance from the cutting device.

Example 69. The method of example 67 or example 68, further comprising controlling the cutting and the securing together by a user actuating a unified engagement element of a user interface to consistently control movement of the cutting device and the edge attachment device.

Example 70 the method of example 69, wherein controlling the cutting and the securing together by the user actuating the unified engagement element includes controlling movement of the cutting device and the edge attachment device at a fixed distance from each other.

Example 71 the method of example 69 or example 70, wherein the user interface comprises: (A) A first engagement element that, when actuated, controls movement of the cutting device; (B) A second engagement element that when actuated controls movement of the edge attachment device; and (C) a coupling element functionally associated with the first and second engagement elements such that (i) in a first operational state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the cutting device and the edge attachment device; and (ii) in a second operational state of the coupling element, the first and second coupling elements are uncoupled such that actuation of the first coupling element controls only movement of the cutting device and actuation of the second coupling element controls only movement of the edge attachment device, wherein (1) the method further comprises, prior to the cutting and prior to the securing together, ensuring that the coupling element of the user interface is in the first operational state.

Example 72. A method of removing tissue from an anatomical site of a subject, the method comprising: (A) Cutting tissue engaged by the cutting device at the anatomical site using a cutting device disposed at the anatomical site, thereby forming cut tissue and a cutting edge; (B) At least temporarily securing the cutting edges together with an edge attachment device while the cutting edges are formed and before the cutting tissue is completely removed from the anatomical site; and (C) controlling the cutting and the securing together by a user actuating a unified engagement element of a user interface to consistently control movement of the cutting device and the edge attachment device.

Example 73 the method of example 72, wherein controlling the cutting and the securing together includes actuating the unified engagement element to control movement of the cutting device and the edge attachment device at a fixed distance from each other.

Example 74 the method of example 72 or example 73, wherein the user interface comprises: (A) A first engagement element that, when actuated, controls movement of the cutting device; (B) A second engagement element that when actuated controls movement of the edge attachment device; and (C) a coupling element functionally associated with the first and second engagement elements such that (i) in a first operational state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the cutting device and the edge attachment device; and (ii) in a second operational state of the coupling element, the first and second coupling elements are uncoupled such that actuation of the first coupling element controls only movement of the cutting device and actuation of the second coupling element controls only movement of the edge attachment device, wherein (1) the method further comprises, prior to the cutting and prior to the securing together, ensuring that the coupling element of the user interface is in the first operational state.

Example 75 the method of any one of examples 67 to 74, further comprising: (i) Transluminally advancing a longitudinal catheter toward the anatomical site, the longitudinal catheter having a proximal portion and a steerable distal portion; and (ii) advancing and steering the cutting device and the edge attachment device distally from the longitudinal catheter to the anatomical site.

Example 76. The method of example 75, wherein the advancing and steering of the cutting device and the edge attachment device is through the longitudinal catheter.

Example 77 the method of any one of examples 67-76, further comprising removing the cutting device and the edge attachment device from the anatomical site after the cutting and the securing together.

Example 78 the method of any one of examples 67 to 77, wherein the securing together comprises temporarily securing the cutting edges together at the anatomical site by the edge attachment device, the method further comprising permanently attaching the cutting edges at the anatomical site.

Example 79 the method of example 78, wherein the temporarily securing together comprises advancing a needle through the cutting edge to hold the needle together, and the permanently attaching comprises extending a suture through the needle.

Example 80. The method of example 79, wherein the needle is a helical needle.

Example 81 the method of any of examples 67-80, wherein the cutting device comprises a wire loop having a closed distal end and a fastening element slidably coupled to the wire loop, wherein cutting the tissue comprises the fastening element sliding distally relative to the wire loop, the wire loop contracting the wire loop and cutting tissue disposed within the wire loop.

Example 82 the method of any one of examples 67-81, further comprising engaging the cut tissue with a clamp having a distal clamping end advanced to the anatomical site prior to the cut tissue being completely removed from the anatomical site.

Example 83 the method of example 82, further comprising removing the clamp from the anatomical site, the cut tissue clamped to the clamp after at least one of the cutting device and the edge attachment device is removed from the anatomical site.

Example 84 the method of any one of examples 67-83, further comprising anchoring a tissue anchor to tissue at the anatomical site, and anchoring at least one of the cutting device and the edge attachment device to the anatomical site.

Example 85 the method of any one of examples 67 to 84, wherein the anatomical site comprises a heart valve and the cut tissue comprises a portion of a leaflet of the heart valve.

Example 86 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; (B) A longitudinal mount distally advanceable from the longitudinal guide tube, the mount having a first curved surface and a second surface; (C) A helical needle defining a helical lumen, the helical needle configured to be advanced distally from the longitudinal catheter and to extend axially and rotationally about the first curved surface of the longitudinal mount and through tissue of the leaflet, pulling the tissue against the second surface of the longitudinal mount; and (D) a suture extending through the lumen of the helical needle, wherein the at least one longitudinal catheter is adapted to: (i) Advancing the mount of tissue adjacent the leaflet through a lumen in an advancement direction; (ii) The spiral needle and the suture are advanced transluminally around the mount along and through the leaflet, thereby pulling tissue of the leaflet against the second surface of the mount; (iii) securing the distal end of the suture; (iv) Removing the mount and the spiral needle from the heart valve while maintaining the suture helically through the tissue of the leaflet; and (v) tensioning the suture, thereby deforming the tissue of the leaflet disposed within the suture.

Example 87 the system of example 86, further comprising at least one locking element configured to be applied to the suture by the at least one longitudinal catheter after tensioning the suture to secure the suture in its tensioned state.

Example 88 the system of example 87, wherein the helical needle comprises a needle body that terminates in a detachable distal tip, and wherein the distal end of the suture is attached to the detachable distal tip of the helical needle.

Example 89 the system of example 88, further comprising a push wire extending through the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

Example 90 the system of example 88, wherein the longitudinal catheter is adapted to move the helical needle by retracting the needle body helically away from the detachable distal tip while sliding over and along the suture after the detachable distal tip of the helical needle is detached from the needle body.

Example 91 the system of any of examples 86-90, further comprising a user interface that enables a user to control the movement of the longitudinal catheter and its operation.

The system of any one of examples 86-91, wherein at least one of the mount and the helical needle is adapted to be advanced to or removed from the heart chamber through the longitudinal catheter.

Example 93 the system of example 92, wherein the mount and the helical needle are adapted to be advanced through a single lumen of the longitudinal catheter.

Example 94 the system of example 92, wherein the longitudinal catheter includes at least two lumens, and each of the mount and the helical needle is adapted to be advanced through a different lumen of the at least two lumens of the longitudinal catheter.

Example 95 the system of any one of examples 86 to 94, wherein: (i) The mount has a crescent-shaped cross-section in a direction perpendicular to a longitudinal axis of the mount, the crescent-shaped shape defining an outer curved surface as the first curved surface and an inner curved surface defining a cavity as the second curved surface, and (ii) the helical needle is adapted to pull tissue into the cavity during rotation thereof.

The system of any one of examples 86 to 94, wherein: (i) the first curved surface is an arc of a first circle having a first radius and the second curved surface is an arc of a second circle having a second radius, (ii) the second radius is not less than the first radius, and (iii) a gap exists between the mount and the spiral needle along at least a portion of the mount when the mount is defined by the spiral needle.

Example 97 the system of any of examples 86-96, wherein the helical needle comprises a shape memory material.

Example 98. A method of deforming a leaflet of a heart valve of a subject, the leaflet extending between a root attached to a heart wall and a lip adapted to coapt with at least one other leaflet, the method comprising: (A) Transluminally advancing a longitudinal catheter toward the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion; (B) Distally advancing a longitudinal mount from the longitudinal catheter, the longitudinal mount having a first curved surface and a second curved surface; (C) Advancing a spiral needle distally along and through the leaflet from the longitudinal catheter around the first curved surface of the mount, thereby pulling tissue of the leaflet against the second surface of the mount, the spiral needle including a spiral lumen and a suture extending through the spiral lumen; (D) After advancement of the helical needle, securing the distal end of the suture adjacent the leaflet; (E) Removing the mount and the spiral needle from the heart valve while maintaining the suture helically through the tissue of the leaflet; and (F) tensioning the suture, thereby deforming the tissue disposed within the suture.

Example 99 the method of example 98, wherein securing the distal end of the suture includes sliding a locking element onto the distal end of the suture to secure the distal end of the suture.

Example 100 the method of example 98 or example 99, further comprising, after tensioning the suture, sliding another locking element over the suture to secure the suture in its tensioned state.

Example 101 the method of any one of examples 98-100, further comprising, after advancing the helical needle, detaching a detachable distal tip of the helical needle from a body of the helical needle, wherein removing the helical needle comprises helically retracting the body of the helical needle from the detachable distal tip as it slides over the suture.

Example 102 the method of any one of examples 98-101, wherein at least one of advancement of the longitudinal mount, advancement of the helical needle, and removal of the longitudinal mount and the helical needle is performed through the longitudinal catheter.

Example 103. The method of example 102, wherein the advancing of the longitudinal mount and the advancing of the helical needle are performed through a single lumen of the longitudinal catheter.

Example 104. The method of example 102, wherein advancement of the mount is through a first lumen of the longitudinal catheter and advancement of the helical needle is through a second lumen of the longitudinal catheter, the first lumen being different than the second lumen.

Example 105 the method of any one of examples 98 to 104, wherein: (i) The mount has a crescent-shaped cross-section in a direction perpendicular to a longitudinal axis of the mount, the crescent-shaped shape defining an outer curved surface as the first curved surface and an inner curved surface defining a cavity as the second curved surface, and (ii) advancement of the spiral needle includes pulling tissue of the leaflet into the cavity during rotation of the spiral needle.

Example 106 the method of any one of examples 98 to 104, wherein: (i) The first curved surface is an arc of a first circle having a first radius and the second curved surface is an arc of a second circle having a second radius that is not less than the first radius, and (ii) advancement of the spiral needle includes pulling tissue of the leaflet into a gap between the mount and the spiral needle during rotation of the spiral needle.

Example 107 the method of any one of examples 98-106, wherein advancing the mount comprises advancing the mount along the leaflet in a direction substantially perpendicular to the lip of the leaflet, thereby deforming the tissue of the leaflet disposed within the suture to shorten a width of the leaflet.

The method of any one of examples 98-106, wherein advancing the mount comprises advancing the mount along the leaflet in a direction substantially parallel to the lip of the leaflet or the root of the leaflet, thereby deforming the tissue of the leaflet disposed within the suture to shorten a length of the leaflet between the root and the lip.

The method of any one of examples 98-106, wherein advancing the mount comprises advancing the mount along the root of the leaflet, wherein advancing the helical needle around the mount pulls tissue of the root of the leaflet, abutting the heart wall around the heart valve, such that the tissue disposed within the suture deforms to shorten a length of the leaflet along the root of the leaflet.

Example 110 the method of any one of examples 98-106, wherein the advancing of the longitudinal catheter is through a coronary artery surrounding the leaflet, wherein the advancing of the spiral needle around the mount includes advancing the spiral needle through a wall of the coronary artery and through the leaflet adjacent the root of the leaflet such that the tissue disposed within the suture is deformed to shorten a length of the leaflet along the root of the leaflet.

Example 111 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) an implant, the implant comprising: (i) A first leaflet engaging portion and a second leaflet engaging portion, the first and second leaflet engaging portions adapted to engage the lips of the leaflet; and (ii) at least one tether extending between the first leaflet-engaging portion and the second leaflet-engaging portion; wherein the at least one longitudinal conduit is adapted to: (1) Delivering the implant transluminally to the heart chamber adjacent the heart valve; (2) Engaging the first leaflet engaging portion to a first position on the lip of the leaflet; (3) Engaging the second leaflet-engaging portion to a second position on the lip of the leaflet; and (4) pulling the first leaflet-engaging portion and the second leaflet-engaging portion toward each other by tensioning the at least one tether between the first leaflet-engaging portion and the second leaflet-engaging portion.

Example 112 the system of example 111, further comprising at least one locking element, wherein the catheter is further adapted to slide the at least one locking element onto at least one end of the at least one tether after tensioning thereof to maintain tension in the at least one tether.

Example 113 the system of example 111 or example 112, wherein the implant comprises a unitary frame having as its ends a first leaflet-engaging portion and a second leaflet-engaging portion, the unitary frame further comprising: (i) a central portion; and (ii) first and second arm portions connecting the central portion to each of the first and second leaflet-engaging portions, respectively, wherein (1) the at least one tether comprises a single tether and (2) a hollow lumen extends through the unitary frame and the tether extends through the hollow lumen and from the first and second leaflet-engaging portions.

Example 114 the system of example 113, wherein the unitary frame has a stationary state, wherein: (i) A first distance between ends of the first and second arm portions connected to the first and second leaflet-engaging portions, respectively, is greater than a second distance between ends of the first and second arm portions engaged with the central portion; and (ii) a third distance between edges of the first leaflet-engaging portion and the second leaflet-engaging portion is less than the first distance.

Example 115 the system of example 114, wherein the first arm portion and the second arm portion are adapted to pivot relative to the central portion to reduce the second distance and the third distance when a force pushing toward each other is applied to the leaflet-engaging portions when the unitary frame is in the resting state.

The system of any one of examples 113-115, wherein the unitary frame is substantially planar.

The system of any one of examples 113-116, wherein the unitary frame is at least one of a flexible frame and a resilient frame.

The system of any one of examples 113-117, wherein the unitary frame is formed of a shape memory material.

The system of any one of examples 114-118, wherein (i) the longitudinal conduit is adapted to engage the first leaflet-engaging portion and the second leaflet-engaging portion to the lips of the leaflet when the unitary frame is in the resting state of the unitary frame, and (ii) tensioning of the tether transitions the unitary frame from the resting state to a second operational state in which edges of the first leaflet-engaging portion and the second leaflet-engaging portion draw toward one another relative to their positioning in the resting state.

The system of any one of examples 113-119, wherein the catheter is adapted to engage the first and second leaflet-engaging portions with the leaflet by placing the first and second arm portions and the central portion against a downstream surface of the leaflet such that the first and second leaflet-engaging portions extend above the lip of the leaflet to an upstream surface thereof.

Example 121 the system of example 120, wherein the catheter is adapted to deform a portion of the lip of the leaflet between the first leaflet-engaging portion and the second leaflet-engaging portion by tensioning of the tether and create a bulge in the downstream surface of the leaflet.

Example 122 the system of example 121, wherein after the protrusion is generated, the first arm portion and the second arm portion are adapted to be substantially perpendicular to the lip of the leaflet.

Example 123 the system of example 111 or example 112, wherein the first leaflet-engaging portion and the second leaflet-engaging portion comprise a first clip and a second clip, and the conduit is adapted to engage the first leaflet-engaging portion and the second leaflet-engaging portion to the lip of the leaflet by clamping the first clip and the second clip to the lip at the first location and the second location, respectively, along the lip.

Example 124 the system of example 123, wherein the catheter is adapted to join the first leaflet-engaging portion and the second leaflet-engaging portion to the lip in a direction substantially perpendicular to the lip of the leaflet.

Example 125 the system of example 123 or example 124, wherein the at least one tether comprises a plurality of tethers, each tether connecting the first leaflet-engaging portion and the second leaflet-engaging portion to each other, and wherein the conduit is adapted to tension each tether of the plurality of tethers.

Example 126. A method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the heart valve, the method comprising: (i) Delivering, transluminally, an implant to a heart chamber adjacent the heart valve, the implant comprising a first leaflet commissure portion, a second leaflet commissure portion, and at least one tether extending between the first leaflet commissure portion and the second leaflet commissure portion; (ii) Engaging the first leaflet engaging portion with a first location on the lip of the leaflet; (iii) Engaging the second leaflet engaging portion with a second location on the lip of the leaflet; and (iv) pulling the first leaflet-engaging portion and the second leaflet-engaging portion toward each other by tensioning the at least one tether between the first leaflet-engaging portion and the second leaflet-engaging portion.

Example 127 the method of example 126, further comprising securing the at least one tether after tensioning thereof to maintain the first leaflet-engaging portion and the second leaflet-engaging portion drawn toward each other.

Example 128 the method of example 126 or example 127, wherein the implant comprises a unitary frame having as its ends a first leaflet-engaging portion and a second leaflet-engaging portion, the unitary frame further comprising: (a) a central portion; and (B) first and second arm portions connecting the central portion to each of the first and second leaflet-engaging portions, respectively, (i) wherein the at least one tether comprises a single tether, (ii) a hollow lumen extends through the integral frame, and the tether extends through the hollow lumen and from the first and second leaflet-engaging portions, and (iii) tensioning of the tether reduces a distance between ends of the first and second leaflet-engaging portions, thereby deforming the leaflet and creating a bulge in a downstream surface of the leaflet.

Example 129 the method of example 128, wherein the coaptation of the first leaflet coaptation portion and the second leaflet coaptation portion comprises placing the first arm portion and the second arm portion and the central portion against the downstream surface of the leaflet such that the first leaflet coaptation portion and the second leaflet coaptation portion extend above the lip of the leaflet to an upstream surface thereof.

Example 130. The method of example 126 or example 127, wherein the first leaflet-engaging portion and the second leaflet-engaging portion comprise a first clip and a second clip, the engaging of the first leaflet-engaging portion comprising clamping the first clip to the lip of the leaflet at a first location and clamping the second clip to the lip at a second location.

Example 131 the method of example 130, wherein the clamping of the first clip and the second clip is to a direction substantially perpendicular to the lip of the leaflet.

Example 132 the method of example 130 or example 131, wherein the at least one tether comprises a plurality of tethers, each tether connecting the first leaflet-engaging portion and the second leaflet-engaging portion to each other, and wherein the tensioning comprises tensioning each tether of the plurality of tethers.

Example 133 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) a penetrating implant comprising: (i) A piercing element, the piercing base, a piercing tip extending from the base; and (ii) a securing element adapted to secure the piercing tip of the piercing element; the at least one conduit is adapted to: (1) Delivering the penetrating implant transluminally to the heart chamber; (2) Creating a folded region of the leaflet by folding the leaflet; (3) Inserting the penetrating tip of the penetrating element through at least two layers of the leaflet at the fold region; and (4) securing at least one fold at the fold region by connecting the securing element to the piercing tip of the piercing element such that the base of the piercing element and the securing element are on the same side of the leaflet with the at least two layers disposed therebetween.

Example 134 the system of example 133, wherein the fixation element comprises a cylindrical housing defining a hollow adapted to receive the piercing tip.

Example 135 the system of example 133, wherein the fixation element comprises an elastomer.

The system of any of examples 133-135, wherein the at least one longitudinal catheter is adapted to (i) transluminally deliver the piercing implant to the heart chamber while the piercing tip is secured by the securing element, and (ii) separate the piercing element or the piercing tip from the securing element prior to insertion of the piercing tip of the piercing element.

The system of any one of examples 133-135, wherein the at least one longitudinal catheter is adapted to transluminally deliver the penetrating implant to the heart chamber upon separation of the penetrating member from the fixation member.

Example 138 a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the heart valve, the method comprising: (A) Delivering transluminally a penetrating implant to a heart chamber adjacent the heart valve, the penetrating implant comprising: a piercing element having a base from which a piercing tip extends; and a fixation element adapted to fix the piercing tip of the piercing element; (B) Creating a folded region of the leaflet by folding the leaflet into at least one fold; (C) Inserting the penetrating tip of the penetrating element through at least two layers of the leaflet at the fold region; and (D) securing the at least one fold at the fold region by connecting the securing element to the piercing tip of the piercing element, wherein after the securing, the base of the piercing element and the securing element are on the same side of the leaflet with the at least two layers disposed therebetween.

Example 139 the method of example 138, wherein the fixation element comprises a cylindrical housing defining a hollow, and wherein the securing comprises inserting the piercing tip into the hollow.

Example 140. The method of example 138, wherein the fixation element comprises an elastomer, and wherein the fixing comprises piercing the piercing tip into the elastomer.

The method of any one of examples 138 to 140, wherein: (i) The transluminal delivery comprises transluminal delivery of the penetrating implant to the heart chamber while the penetrating tip is secured by the securing element, and (ii) the method further comprises, after the transluminal delivery and prior to the inserting, separating the penetrating element or the penetrating tip from the securing element.

The method of any one of examples 138-140, wherein the transluminal delivery comprises transluminal delivery of the penetrating implant to the heart chamber when the penetrating member is separated from the fixation member.

The method of any one of examples 138-142, wherein the creating the fold region comprises creating a fold region disposed at an upstream side of the heart valve, and wherein after the securing, the base of the penetrating element and the securing element are on an upstream side of the leaflet.

The method of any one of examples 138-142, wherein the creating a fold region comprises creating the fold region disposed at a downstream side of the heart valve, and wherein after the securing, the base of the penetrating element and the securing element are on a downstream side of the leaflet.

Example 145 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) a tether implant, the tether implant comprising: (i) a tether having a proximal end and a distal end; and (ii) at least one locking element adapted to secure at least one end of the tether; the at least one longitudinal conduit is adapted to: (1) transluminally delivering the tether to the heart chamber; (2) Wrapping the tether around the flail or turnup portion of the leaflet by advancing the distal end of the tether along a first surface of the leaflet to a transition point at which the distal end of the tether is transitioned to a second surface of the leaflet, the second surface being opposite the first surface, and advancing the distal end of the tether along the second surface of the leaflet such that the tether forms a closed loop around the flail or turnup portion of the leaflet; (3) Tensioning the tether around the flail or turnup portion; and (4) securing the proximal end and the distal end of the tether using the at least one locking element to maintain tension in the tether.

Example 146 the system of example 145, further comprising a grasping tool extending distally from the at least one longitudinal conduit and adapted to grasp the distal end of the tether during passage of the distal end by the conduit.

Example 147 the system of example 145 or example 146, wherein the tether implant comprises: a plurality of tethers, each tether having a corresponding proximal end and a corresponding distal end; and a plurality of locking elements adapted to secure at least one end of each of the plurality of tethers, and wherein the catheter is adapted to deliver, wrap, tension, and secure each of the plurality of tethers.

Example 148 a method for repairing a roll-over, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the heart valve; and flail or turnup portions, the method comprising: (A) Delivering a tether transluminally to a heart chamber adjacent the heart valve, the tether having a proximal end and a distal end; (B) Wrapping the tether around the flail or turnup portion by: (i) Advancing the distal end of the tether along a first surface of the leaflet to a transition point; (ii) At the transition point, transitioning the distal end of the tether to a second surface of the leaflet, the second surface opposite the first surface; (iii) Advancing the distal end of the tether along the second surface of the leaflet to form the tether into a closed loop around the flail or turnup portion of the leaflet; (iv) Tensioning the tether wrapped around the flail or turnup portion; and (v) after the tensioning, securing the proximal end and the distal end of the tether using at least one locking element to maintain tension in the tether.

Example 149. The method of example 148, wherein the wrapping comprises grasping the distal end of the tether using a grasping tool extending distally from the at least one longitudinal catheter.

Example 150. The method of example 148 or example 149, wherein the steps of transluminal delivery, wrapping, tensioning, and securing are performed for each tether of the plurality of tethers.

Example 151 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) an implant comprising a first beam, a second beam, and a third beam, and having a first operational state and a second operational state, wherein the at least one longitudinal conduit is adapted to: (i) transluminally delivering the implant to the heart chamber; (ii) Placing the implant onto the leaflet in the first operational state; and (iii) transitioning the implant from the first operational state toward the second operational state, thereby causing the leaflet to follow a tortuous path between the first beam and the third beam.

Example 152 the system of example 151, wherein at least two of the first beam, the second beam, and the third beam are substantially parallel to one another in at least one of the first operational state and the second operational state.

Example 153 the system of example 151 or example 152, wherein the implant is at least one of a flexible implant and a resilient implant.

The system of any one of examples 151-153, wherein the implant comprises a resilient metal.

Example 155 the system of any of examples 151-153, wherein the implant comprises a shape memory material.

The system of any one of examples 151-153, wherein the implant comprises an elastic component.

The system of any one of examples 151-156, wherein the longitudinal catheter is adapted to place the implant onto the leaflet in the first operational state by placing the implant such that the lip of the leaflet engages with a portion of the implant and the first, second, and third beams are substantially perpendicular to the lip of the leaflet.

The system of any one of examples 151-157, wherein the longitudinal catheter is adapted to place the implant on the leaflet in the first operational state such that two of the first, second, and third beams are disposed on or near one side of the leaflet and the remaining ones of the first and third beams are disposed on or near the opposite side of the leaflet.

Example 159 the system of any one of examples 151 to 158, wherein: (i) The implant includes a base from which extends a plurality of beams including the first, second, and third beams, each beam of the plurality of beams having an end remote from the base, the first, second, and third beams being substantially parallel to one another; (ii) In the first operating state, the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams; and (iii) in the second operational state, the base and the ends of the first, second, and third beams are in a single plane.

Example 160 the system of example 159, wherein: (i) the plurality of beams comprises at least five beams; (ii) A first subset of the plurality of beams comprises one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams comprises the other two of the first beam, the second beam, and the third beam, the first subset and the second subset of the plurality of beams being mutually exclusive; (iii) In the first operating state, the plane is defined by the ends and the base of all beams in the second subset, and the ends of all beams in the first subset are disposed outside the plane; and (iv) in the second operational state, the base and the ends of the beams in the first and second subsets are in the single plane.

Example 161 the system of example 160, wherein in the first operational state, the ends of all beams in the first subset are disposed in a second plane, the second plane being angled with respect to the plane.

The system of any one of examples 159-161, wherein in at least one of the first operational state and the second operational state, the first beam, the second beam, and the third beam are substantially perpendicular to the base.

The system of any one of examples 159-162, wherein the longitudinal conduit is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that the base extends along the lip of the leaflet, thereby placing the implant onto the leaflet.

The system of any one of examples 151-158, wherein the implant comprises: (A) First and second U-shaped portions, each U-shaped portion comprising a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other; and (B) an engagement element that holds the second beam of each of the first and second U-shaped portions together to form a unified beam, wherein (i) the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion, (ii) the second beams of the first and second U-shaped portions are pivotable relative to the engagement element about respective longitudinal axes of the second beam such that the first and second U-shaped portions are pivotable relative to one another.

Example 165 the system of example 164, wherein the first U-shaped portion and the second U-shaped portion are identical to each other.

Example 166. The system of example 164 or example 165, wherein the engagement element comprises a longitudinally extending cylinder.

The system of any one of examples 164-166, wherein in the first operational state the first U-shaped portion and the second U-shaped portion are substantially in a single plane, and in the second operational state the unified beam is disposed outside of a plane formed by the first beams of the first U-shaped portion and the second U-shaped portion.

The system of any one of examples 164-167, wherein in the first operational state a first distance exists between the first beam of the first U-shaped portion and the second U-shaped portion, and in the second operational state a second distance exists between the first beam of the first U-shaped portion and the second U-shaped portion, the second distance being less than the first distance.

The system of any one of examples 164-168, wherein the longitudinal conduit is adapted to rotate the first U-shaped portion and the second U-shaped portion relative to one another, thereby transitioning the implant from the first operational state to the second operational state.

The system of any one of examples 164-169, wherein the longitudinal conduit is adapted to slide the implant onto the lips of the leaflet when the implant is in the first operating state such that (i) the base of the first and second U-shaped portions extend along the lips of the leaflet, (ii) the unified beam is disposed on or near one side of the leaflet, and (iii) the first beams of the first and second U-shaped portions are disposed on or near the opposite side of the leaflet, thereby placing the implant onto the leaflet.

The system of any one of examples 151-158, wherein the implant comprises: (A) A central U-shaped portion comprising a pair of central beams and a connecting section; and (B) first and second side portions, each side portion including at least one beam and being connected to one of the center beams by a respective one of first and second bends, wherein (i) the at least one beam of each of the first and second side portions is substantially parallel to at least one of the center beams, and (ii) the first and second bends facilitate movement of the respective first and second side portions relative to the pair of center beams in at least two directions.

Example 172 the system of example 171, wherein (i) in the first operational state the central U-shaped portion is in the first plane and each of the first side portion and the second side portion is in a plane different from the first plane and disposed outside of the central U-shaped portion, and (ii) in the second operational state the central U-shaped portion and the first side portion and the second side portion are in the first plane, wherein the first side portion and the second side portion are disposed within the central U-shaped portion.

Example 173 the system of example 171 or example 172, wherein the implant is formed from a single length of flexible or resilient material.

The system of any one of examples 171-173, wherein each of the first side portion and the second side portion includes a pair of side rails connected to one another by an additional bend, the pair of side rails being substantially parallel to one another.

Example 175 the system of any of examples 171-174, wherein the implant is laterally symmetrical about a central longitudinal axis of the central U-shaped portion.

The system of any one of examples 171-175, wherein (i) in the first operational state, a first distance exists between the first side portion and the second side portion, and (ii) in the second operational state, a second distance exists between the first side portion and the second side portion, the second distance being less than the first distance.

The system of any one of examples 172 to 176, wherein: (i) The implant has an intermediate operational state, wherein the first and second side portions are in the first plane and are disposed outside the central U-shaped portion, and (ii) for transitioning the implant from the first operational state to the second operational state, the catheter is adapted to (1) transition the implant from the first operational state to the intermediate operational state by pivoting the first and second side portions relative to the central U-shaped portion in a first direction to place the first and second side portions into the first plane, and (2) further transition the implant from the intermediate operational state to the second operational state by rotating the first and second side portions relative to the central U-shaped portion in a second direction to move the first and second side portions into the interior of the central U-shaped portion.

Example 178 the system of example 177, wherein the first direction is about an axis perpendicular to a longitudinal axis of the center beam and the second direction is about an axis parallel to the longitudinal axis of the center beam.

The system of any of examples 171-178, wherein the longitudinal conduit is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that (i) the first and second bends engage the lip of the leaflet and the connection section of the U-shaped portion is distal to the lip of the leaflet, wherein the U-shaped portion is disposed on or near one side of the leaflet and (ii) the first and second side portions are disposed on or near the opposite side of the leaflet, thereby placing the implant onto the leaflet.

The system of any one of examples 171-179, wherein the longitudinal catheter is adapted to transluminally deliver the implant to the heart chamber when the implant is in the first operational state.

The system of any one of examples 172-179, wherein (i) the longitudinal conduit is adapted to transluminally deliver the implant to the heart chamber when the implant is in a ready-to-operate state, wherein the first side portion and the second side portion are in the first plane and outside the central U-shaped portion, and (ii) the longitudinal conduit is further adapted to transition the implant from the ready-to-operate state to the first operating state by pivoting the first side portion and the second side portion relative to the U-shaped portion about an axis perpendicular to a longitudinal axis of the central beam prior to placement of the implant on the leaflet.

The system of any one of examples 151-158, wherein the implant comprises: (A) A tubular body disposed along a central longitudinal axis; (B) A first substantially U-shaped clip and a second substantially U-shaped clip, each substantially U-shaped clip having: a first elongate portion disposed on or adjacent an outer surface of the tubular body; and a second elongate portion disposed on or near an inner surface of the tubular body, the first and second elongate portions being connected by an end portion; and (C) a resilient element holding together the second elongated portions of the first and second clips, wherein (i) in the first operational state the clips are disposed on a first side of the tubular body, and (ii) in the second operational state the clips are disposed on a second side of the tubular body, the second side being opposite the first side.

The system of example 183, wherein the longitudinal conduit is adapted to slide the implant onto the lip of the leaflet when the implant is in the first operating state such that (i) the end portion engages with the lip of the leaflet, wherein the tubular body of the first and second clips and the second elongated portion are disposed on or near one side of the leaflet, and (ii) the first elongated portions of the first and second clips are disposed on or near an opposite side of the leaflet, thereby placing the implant onto the leaflet.

Example 184 the system of example 182 or example 183, wherein the longitudinal catheter is adapted to transluminally deliver the implant to the heart chamber when the implant is in the first operational state.

Example 185 the system of example 182 or example 183, wherein (i) the longitudinal catheter is adapted to transluminally deliver the implant to the heart chamber when the U-shaped clip is separated from the tubular body, and (ii) the longitudinal catheter is further adapted to place the first clip and the second clip onto the tubular body prior to or during placement of the implant onto the leaflet.

The system of any of examples 182-185, wherein the longitudinal catheter is adapted to transition the implant from the first operational state to the second operational state by pulling the first clip and the second clip apart from each other around the circumference of the tubular body and against the force of the resilient element.

Example 187 a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the heart valve, the method comprising: (i) Delivering transluminally an implant having a first operational state and a second operational state to a heart chamber adjacent the heart valve, the implant comprising a first beam, a second beam, and a third beam; (ii) Placing the implant onto the leaflet in the first operational state; and (iii) causing the leaflet to follow a tortuous path between the first beam and the third beam by transitioning the implant from the first operational state toward the second operational state when the implant is on the leaflet.

Example 188 the method of example 187, wherein the placing of the implant comprises placing the implant such that the lips of the leaflet engage a portion of the implant and the first, second, and third beams are substantially perpendicular to the lips of the leaflet.

The method of example 187 or example 188, wherein the placing of the implant comprises placing the implant onto the leaflet in the first operational state such that (i) two of the first, second, and third beams are disposed on or near one side of the leaflet, and (ii) the remaining ones of the first and third beams are disposed on or near the opposite side of the leaflet.

The method of any one of examples 187 to 189, wherein: (i) The implant includes a base from which extends a plurality of beams including the first, second, and third beams, each beam of the plurality of beams having an end remote from the base, the first, second, and third beams being substantially parallel to one another; (ii) Placement of the implant in the first operational state includes placing the implant such that the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams; (iii) In the second operational state, the base and the ends of the first, second, and third beams are in a single plane; and (iv) the transition of the implant from the first operational state toward the second operational state includes moving the ends of the first, second, and third beams relative to one another such that the ends of the first, second, and third beams are in the single plane.

Example 191 the method of example 190, wherein: (i) the plurality of beams comprises at least five beams; (ii) A first subset of the plurality of beams comprises one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams comprises the other two of the first beam, the second beam, and the third beam, the first subset and the second subset of the plurality of beams being mutually exclusive; (iii) Placement of the implant in the first operational state includes placing the implant such that the plane is defined by the ends of all beams in the second subset and the base, and the ends of all beams in the first subset are disposed outside the plane; and (iv) the conversion of the implant comprises moving the ends of all of the beams in the first subset such that in the second operational state the base and the ends of the beams in the first and second subsets are in the single plane.

Example 192. The method of example 191, wherein the placement of the implant in the first operational state includes placing the implant such that the ends of all beams in the first subset are disposed in a second plane, the second plane being angled with respect to the plane.

The method of any one of examples 190-192, wherein the placing of the implant comprises placing the implant while the first beam, the second beam, and the third beam are substantially perpendicular to the base.

The method of any of examples 190-193, wherein placing the implant onto the leaflet comprises sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that the base extends along the lip of the leaflet, wherein one of the first, second, and third beams is on one side of the leaflet and the other two of the first, second, and third beams are on the opposite side of the leaflet.

The method of any one of examples 187-189, wherein the implant comprises: (A) First and second U-shaped portions, each U-shaped portion comprising a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other; and (B) an engagement element that holds the second beam of each of the first and second U-shaped portions together to form a unified beam, wherein (i) the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion, (ii) the second beams of the first and second U-shaped portions are pivotable relative to the engagement element about respective longitudinal axes of the second beam such that the first and second U-shaped portions are pivotable relative to one another, and (iii) placement of the implant in the first operating state includes placement of the implant such that the first beams of the first and second U-shaped portions are at a first distance from one another.

The method of example 196, wherein (i) placement of the implant in the first operational state comprises placing the implant onto the leaflet while the first and second U-shaped portions are in a single plane, and (ii) the transitioning comprises pivoting the first and second U-shaped portions relative to one another to position the unified beam movement outside of a plane formed by the first beams of the first and second U-shaped portions.

The method of any one of examples 195-196, wherein the converting includes pivoting the first U-shaped portion and the second U-shaped portion relative to each other to form a second distance between the first beams of the first U-shaped portion and the second U-shaped portion, the second distance being less than the first distance.

The method of any one of examples 195-197, wherein the placing of the implant comprises sliding the implant onto the lips of the leaflet when the implant is in the first operating state such that (i) the base of the first and second U-shaped portions extend along the lips of the leaflet, (ii) the unified beam is disposed on or near one side of the leaflet, and (iii) the first beams of the first and second U-shaped portions are disposed on or near the opposite side of the leaflet.

The method of any one of examples 187-189, wherein the implant comprises: (A) A central U-shaped portion comprising a pair of central beams and a connecting section; and (B) first and second side portions, each side portion including at least one beam and being connected to one of the center beams by a respective one of first and second bends, wherein (i) the at least one beam of each of the first and second side portions is substantially parallel to the at least one of the center beams, (ii) the first and second bends facilitate movement of the respective first and second side portions relative to the pair of center beams in at least two directions, (iii) placement of the implant in the first operational state is included in the central U-shaped portion in the first plane, and each of the first and second side portions is in a plane different from the first plane, and placement of the implant on the leaflet when disposed outside the central U-shaped portion; and (iv) wherein said converting comprises moving said first side portion and said second side portion into said first plane within said central U-shaped portion.

Example 200. The method of example 199, wherein (i) placement of the implant in the first operational state comprises placing the implant onto the leaflet while there is a first distance between the first side portion and the second side portion, and (ii) transitioning of the implant comprises reducing a distance between the first side portion and the second side portion to a second distance that is less than the first distance.

The method of any one of examples 199-200, wherein (i) the implant has an intermediate operational state, wherein the first side portion and the second side portion are in the first plane and disposed outside of the central U-shaped portion, and (ii) wherein transitioning the implant from the first operational state toward the second operational state comprises: (A) Transitioning the implant from the first operative state to the intermediate operative state by pivoting the first side portion and the second side portion in a first direction relative to the central U-shaped portion to place the first side portion and the second side portion into the first plane; and (B) transitioning the implant from the intermediate operating state to the second operating state by rotating the first and second side portions in a second direction relative to the central U-shaped portion to move the first and second side portions into the interior of the central U-shaped portion.

Example 202. The method of example 201, wherein (i) the pivoting in the first direction comprises pivoting about an axis perpendicular to a longitudinal axis of the center beam, and (ii) the rotating in the second direction comprises rotating about an axis parallel to the longitudinal axis of the center beam.

The method of any one of examples 199-202, wherein placing the implant comprises sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that (i) the first and second bends engage with the lip of the leaflet, and (ii) the connection section of the U-shaped portion is distal to the lip of the leaflet, wherein (a) the U-shaped portion is disposed on or near one side of the leaflet, and (b) the first and second side portions are disposed on or near the opposite side of the leaflet.

The method of any one of examples 199-203, wherein the transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the implant is in the first operational state.

The method of any one of examples 199-203, wherein (i) the transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the implant is in a ready-to-operate state, wherein the first side portion and the second side portion are in the first plane and outside of the central U-shaped portion, and (ii) the method further comprises transitioning the implant from the ready-to-operate state toward the first operating state prior to placement of the implant.

Example 206 the method of example 205, wherein the transition of the implant from the ready state includes pivoting the first side portion and the second side portion relative to the U-shaped portion about an axis perpendicular to a longitudinal axis of the center beam.

The method of any one of examples 187-189, wherein the implant comprises: (A) A tubular body disposed along a central longitudinal axis; (B) A first substantially U-shaped clip and a second substantially U-shaped clip, each substantially U-shaped clip having: (i) A first elongate portion disposed on or adjacent an outer surface of the tubular body; and (ii) a second elongate portion disposed on or near an inner surface of the tubular body, the first and second elongate portions being connected by an end portion; and (C) a resilient element that holds the second elongated portions of the first and second clips together, wherein (1) in the first operational state the clips are disposed on a first side of the tubular body and in the second operational state the clips are disposed on a second side of the tubular body opposite the first side, and (2) placement of the implant includes sliding the implant onto the lips of the leaflet when the implant is in the first operational state such that the end portions engage with the lips of the leaflet, wherein the tubular body and the second elongated portions of the first and second clips are disposed on or near one side of the leaflet and the first elongated portions of the first and second clips are disposed on or near an opposite side of the leaflet.

Example 208 the method of example 207, wherein the transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the implant is in the first operational state.

Example 209 the method of example 207, wherein: (i) The transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the U-shaped clip is separated from the tubular body, and (ii) the method further comprises sliding the first clip and the second clip onto the tubular body to form the first operational state prior to or during placement of the implant.

Example 210 the method of any one of examples 207-209, wherein the transitioning of the implant includes pulling the first clip and the second clip apart from one another around the circumference of the tubular body and against the force of the resilient element.

Example 211 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) an implant comprising: (i) a core; and (ii) a fixation element adapted to fix tissue around the core; the at least one longitudinal conduit is adapted to: (1) transluminally delivering the implant to the heart chamber; (2) Positioning a portion of the leaflet about the core by placing the core against a first surface of the leaflet; and (3) securing the portion of the leaflet extending around the core from a second opposing surface of the leaflet using the securing element, thereby deforming an area of the leaflet.

Example 212 the system of example 211, wherein the core and the fixation element are configured and arranged to cooperate with one another to retain the core and the fixation element in their implanted position on the leaflet.

The system of any one of examples 211-212, wherein the at least one longitudinal conduit comprises: (A) A first catheter adapted to transluminally deliver the core; and (B) a second catheter adapted to transluminally deliver the fixation element.

Example 214. The system of example 211 or example 213, wherein (i) the core comprises a tubular core, and (ii) the fixation element comprises a fixation clip having a first longitudinal portion and a second longitudinal portion connected by an end portion.

Example 215 the system of example 214, wherein the longitudinal conduit is adapted to position the portion of the leaflet around the tubular core when a longitudinal axis of the tubular core is substantially perpendicular to the lip of the leaflet.

Example 216 the system of example 214 or example 215, wherein the catheter is adapted to secure the portion of the leaflet around the tubular core by the fixation clip when the first and second longitudinal portions of the fixation clip are substantially perpendicular to the lip of the leaflet.

The system of any one of examples 214-216, wherein the catheter is adapted to place the fixation clip such that the end portion thereof is distal from the lip of the leaflet, thereby securing the portion of the leaflet extending around the core.

The system of any one of examples 214-217, wherein the catheter is adapted to puncture the tissue of the leaflet through which the fixation clip passes when fixing the portion of the leaflet extending around the core.

The system of any one of examples 214-218, wherein once the fixation element is fixed, the catheter is further adapted to remove the core from the heart valve such that the leaflet remains fixed only by the fixation element.

The system of any one of examples 211 to 213, wherein: (i) The core includes first and second plates having a neck portion therebetween, the plates having a larger diameter than the neck portion such that a recess is formed between the plates around the neck portion; and (ii) the securing element comprises a panel having a recess formed therein, the recess having a panel receiving region and a neck receiving region, the panel receiving region adapted to receive one of the first and second panels of the core and the neck receiving region adapted to receive the neck of the core, wherein the first panel extends on one side of the panel and the second panel extends on an opposite side of the panel.

Example 221 the system of example 220, wherein the first plate and the second plate are substantially the same size.

Example 222. The system of example 220 or example 221, wherein the first and the second plates are substantially parallel to each other.

The system of any one of examples 220-222, wherein (i) the plate-receiving region is sized to allow at least one of the first plate and the second plate to pass therethrough, and (ii) the neck-receiving region is sized to limit the first plate and the second plate to pass therethrough.

The system of any one of examples 220-223, wherein a thickness of the panel is less than a height of the recess of the core.

The system of any one of examples 220-224, wherein (i) the catheter is adapted to position the portion of the leaflet around the core by placing the first plate against the first surface of the leaflet, and (ii) the catheter is adapted to secure the portion of the leaflet extending around the core by: (a) Inserting the first plate on which the portion of the leaflet is disposed into the plate-receiving region of the panel, and (b) moving the panel relative to the core such that the neck portion of the core slides into the neck-receiving portion while the first and second plates remain outside the panel on opposite sides thereof, thereby securing the portion of the leaflet surrounding the inclusion.

Example 226 a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; and a lip adapted to coapt with at least one other leaflet of the heart valve, the method comprising: (A) Delivering, transluminally, an implant to a heart chamber adjacent the heart valve, the implant comprising a core and a fixation element adapted to fix tissue around the core; (B) Positioning a portion of the leaflet about the core by placing the core against a first surface of the leaflet; and (C) securing the portion of the leaflet extending around the core from a second opposing surface of the leaflet using the securing element, thereby causing deformation of the portion of the leaflet.

Example 227. The method of example 226, wherein the transluminal delivery comprises (i) transluminally delivering the core to a first heart chamber adjacent the first surface of the leaflet using a first catheter, and (ii) transluminally delivering the fixation element to a second heart chamber adjacent the second opposing surface of the leaflet using a second catheter.

The method of example 226 or example 227, wherein (i) the core comprises a tubular core, (ii) the fixation element comprises a fixation clip having a first longitudinal portion and a second longitudinal portion connected by an end portion, (iii) the positioning comprises positioning the portion of the leaflet around the tubular core when a longitudinal axis of the tubular core is substantially perpendicular to the lip of the leaflet, and (iv) the securing comprises securing the portion of the leaflet around the tubular core when the first longitudinal portion and the second longitudinal portion of the fixation clip are substantially perpendicular to the lip of the leaflet.

Example 229. The method of example 228, wherein after the securing, the end portion of the securing clip is distal to the lip of the leaflet.

The method of any one of examples 228-229, wherein the securing comprises puncturing the tissue of the leaflet with the securing clip.

The method of any one of examples 228-230, further comprising, after the securing, removing the core from the heart valve such that the leaflets remain secured only by the securing element.

Example 232 the method of example 226 or example 227, wherein: (i) The core includes first and second plates having a neck portion therebetween, the plates having a larger diameter than the neck portion such that a recess is formed between the plates around the neck portion; (ii) The fixation element includes a panel having a recess formed therein, the recess having a plate receiving area adapted to receive one of the first and second plates of the core and a neck receiving area adapted to receive the neck portion of the core, wherein the first plate extends on one side of the panel and the second plate extends on an opposite side of the panel; and (iii) the positioning includes positioning a portion of the leaflet about the core by placing the first plate against the first surface of the leaflet.

Example 233 the method of example 232, wherein the securing comprises: (i) Inserting the first plate on which the portion of the leaflet is disposed into the plate-receiving region of the panel, and (ii) moving the panel relative to the core such that the neck portion of the core slides into the neck-receiving portion while the first plate and the second plate remain outside the panel on opposite sides thereof, thereby securing the portion of the leaflet surrounding the inclusion.

Example 234 a system for use with a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the heart valve; and an intermediate region extending between the root and the lip, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) a constraining implant, wherein the at least one longitudinal conduit is adapted to: (i) Delivering the constraint implant transluminally to the heart chamber; and (ii) constraining the lip using the constraining implant so as to present the intermediate region as an alternative apposition surface to the at least one other leaflet.

Example 235 the system of example 234, wherein the catheter is adapted to fold the leaflet to present the middle region thereof prior to use of the constraint implant.

Example 236 the system of example 234 or example 235, wherein the alternate apposition surface comprises at least a portion of a fixation element.

The system of any one of examples 234-235, wherein the conduit is adapted to constrain the lip of the leaflet to a downstream surface of the leaflet.

The system of any one of examples 234-237, wherein (i) the constraining element comprises a U-clip, and (ii) the catheter is adapted to constrain the lip by folding the lip toward the downstream surface of the leaflet and securing the fold using the U-clip.

The system of any one of examples 234-237, wherein (i) the constraining element comprises a plurality of U-shaped pins, and (ii) the catheter is adapted to constrain the lip by folding the lip toward the downstream surface of the leaflet and by positioning the U-shaped pins at a plurality of positions along the fold.

The system of any one of examples 234-236, wherein the catheter is adapted to constrain the lips of the leaflet to a heart wall downstream of the heart valve.

Example 241 the system of example 240, wherein the constraining element comprises at least one tissue anchor and the catheter is adapted to anchor the lip of the leaflet to the heart wall using the at least one tissue anchor.

The system of example 242, wherein (i) the constraining element comprises at least one pledget having a first end portion and a second end portion connected by a longitudinal portion, the first and second end portions having a larger cross-section than the longitudinal portion, and (ii) the catheter is adapted to constrain the lip of the at least one pledget at the fold by anchoring the first end of the at least one pledget to a first location in the heart wall upstream of the heart valve and anchoring the second end of the at least one pledget to a second location in the heart wall downstream of the heart valve by anchoring the second end of the at least one pledget to the lip of the leaflet, (iii) such that the longitudinal portion of the at least one pledget extends along a surface of the leaflet from the first location to the second location.

Example 243 the system of example 242, wherein said catheter is adapted to anchor said first end and said second end of said at least one pledget into the coronary sinus adjacent to said heart wall.

Example 244 the system of example 242, wherein the barrel is adapted to anchor the first end and the second end of the at least one pledget into a coronary artery within the heart wall.

Example 245. A method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip, the method comprising: (A) Transluminally delivering a constraining element to the heart chamber adjacent the heart valve; and (B) presenting the intermediate region as an alternative apposition surface for apposition with the at least one other leaflet by constraining the lip using the constraining element.

Example 246 the method of example 245, wherein presenting the intermediate region as the alternate apposition surface comprises presenting at least a portion of the constraining element as the alternate apposition surface.

The method of any one of examples 245-246, wherein the constraining comprises folding the leaflet to present the middle region.

The method of any one of examples 245-247, wherein (i) the constraining element comprises a generally U-shaped clip, and (ii) the constraining comprises folding the lip of the leaflet toward a downstream surface of the leaflet and securing the fold using the U-shaped clip.

The method of any one of examples 245-247, wherein (i) the constraining element comprises a plurality of U-shaped pins, and (ii) the constraining comprises folding the lips of the leaflet toward the downstream surface of the leaflet, and securing the fold at a plurality of positions along the fold using the U-shaped pins.

Example 250 the method of any one of examples 245-247, wherein the constraining comprises constraining the lips of the leaflet to a heart wall downstream of the heart valve.

Example 251. The method of example 250, wherein the constraining element comprises at least one tissue anchor, and the constraining comprises anchoring the lip of the leaflet to the heart wall.

Example 252. The method of example 250, wherein: (i) The constraining element comprises at least one tampon having a first end portion and a second end portion connected by a longitudinal portion, the first and second end portions having a larger cross section than the longitudinal portion; and (ii) the constraint comprises: (a) Anchoring the first end of the at least one pledget to a first location in the heart wall upstream of the heart valve; and (b) anchoring the second end of the at least one pledget to a second location in the heart wall downstream of the heart valve by the lip of the leaflet such that the longitudinal portion of the at least one pledget extends along an upstream surface of the leaflet from the first location to the second location.

Example 253. The method of example 252, wherein the first end and the second end of the at least one pledget are anchored in a coronary sinus adjacent the heart wall.

Example 254 the method of example 252, wherein the first end and the second end of the at least one pledget are anchored in a coronary artery within the heart wall.

Example 255 a system for use with a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) an implant, the implant comprising: (i) a constraining element; and (ii) a manual apposition element, wherein the at least one longitudinal catheter is adapted to: (1) Transluminally delivering the constraining element and the artificial apposition element to the heart chamber; (2) Constraining the lip using the constraining implant so as to present the intermediate region; and (3) mounting the artificial apposition element onto the intermediate region of the leaflet so as to present an artificial apposition surface for apposition with the at least one other leaflet.

Example 256 the system of example 255, wherein prior to use of the constraint implant, the catheter is adapted to fold the leaflet to present the middle region thereof.

Example 257 the system of any one of examples 255-256, wherein the catheter is adapted to constrain the lips of the leaflet to a heart wall downstream of the heart valve.

The system of any one of examples 255-257, wherein the constraining element comprises at least one tissue anchor, and the catheter is adapted to anchor the lip of the leaflet to the heart wall using the at least one tissue anchor.

The system of any one of examples 255-258, wherein the artificial apposition element comprises a shape memory material.

The system of any one of examples 255-259, wherein the artificial apposition element comprises a wire mesh.

The system of any one of examples 255-260, wherein the catheter is adapted to (i) transluminally deliver the artificial apposition element to the heart chamber in a compressed form, and (ii) allow the artificial apposition element to decompress after delivery or installation thereof.

The system of any one of examples 255-261, wherein the at least one conduit comprises: (i) A first catheter adapted to transluminally deliver the constraining element; and (ii) a second catheter adapted to transluminally deliver the artificial apposition element.

Example 263 a method for repairing a roll-over, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve; and an intermediate region extending between the root and the lip, the method comprising: (A) Transluminally delivering a constraining element and a prosthetic coaptation element to the heart chamber adjacent the heart valve; (B) Presenting the intermediate region of the leaflet by constraining the lip of the leaflet using the constraining element; and (C) presenting a manual coaptation surface for coaptation with the at least one other leaflet by mounting the manual coaptation element onto the middle region of the leaflet.

Example 264 the method of example 263, further comprising, prior to constraining the lip of the leaflet, folding the leaflet to present the middle region thereof.

Example 265 the method of any one of examples 263-264, wherein the constraining comprises constraining the lip of the leaflet to a heart wall downstream of the heart valve.

Example 266 the method of any of examples 263-265, wherein (i) the constraining element comprises at least one tissue anchor, and (ii) the constraining comprises anchoring the lip of the leaflet to the heart wall using the at least one tissue anchor.

Example 267 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) a leaflet-engaging surface implant, the leaflet-engaging surface implant comprising: (i) a flexible leaflet-engaging surface; and (ii) a tether; wherein the at least one longitudinal conduit is adapted to: (1) Delivering the leaflet-engaging surface implant transluminally to the heart chamber; (2) Attaching the leaflet-engaging surface to a surface of the leaflet using the tether; and (3) deforming the leaflet engaging surface when attached to the leaflet, thereby deforming or shortening the leaflet along at least one dimension thereof.

The system of example 267, wherein (i) the leaflet-engaging surface is inelastic, (ii) the conduit is adapted to deform the leaflet-engaging surface by tensioning the tether that attaches the leaflet-engaging surface to the surface of the leaflet, and (iii) the conduit is further adapted to fix tension in the tether to maintain the leaflet in a deformed or shortened orientation.

The system of example 269, wherein (i) the leaflet engaging surface is elastic, (ii) the conduit is further adapted to stretch the leaflet engaging surface prior to its attachment to the surface of the leaflet and attach the leaflet engaging surface to the surface of the leaflet in a stretched position, and (iii) the conduit is adapted to deform the leaflet engaging surface after attachment to the surface of the leaflet by releasing the stretching of the leaflet engaging surface.

Example 270 the system of example 269, wherein the at least one conduit comprises at least two conduits adapted to hold opposite sides of the leaflet-engaging surface for stretching the leaflet-engaging surface.

Example 271. A method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the method comprising: (A) Delivering transluminally a leaflet-engaging surface implant to the heart chamber adjacent the heart valve, the leaflet-engaging surface implant comprising a tether and a leaflet-engaging surface; (B) Attaching the leaflet-engaging surface to a surface of the leaflet using the tether; and (C) deforming the leaflet-engaging surface when attached to the leaflet, thereby deforming or shortening the leaflet along at least one dimension thereof.

Example 272 the method of example 271, wherein: (i) the leaflet-engaging surface is inelastic, (ii) the deforming of the leaflet-engaging surface includes tensioning the tether that attaches the leaflet-engaging surface to the surface of the leaflet, and (iii) the method further includes fixing the tension in the tether to maintain the leaflet in a deformed or shortened orientation.

Example 273 the method of example 271, wherein (i) the leaflet-engaging surface is elastic, (ii) the method further comprises stretching the leaflet-engaging surface prior to its attachment to the surface of the leaflet, (iii) the attachment comprises attaching the leaflet-engaging surface to the surface of the leaflet in the stretched position, and (iv) the deforming comprises releasing the stretching of the leaflet-engaging surface after the attachment.

Example 274. The method of example 273, wherein the stretching comprises pulling opposite sides of the leaflet-engaging surface away from each other using two conduits.

Example 275. A system for use with a leaflet of a heart valve of a subject, a root of the leaflet being adjacent a coronary artery, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) an implant comprising a pledget comprising a longitudinal portion terminating at both ends thereof in a first end portion and a second end portion, wherein the at least one longitudinal conduit is adapted to: (i) Transluminal delivery of the tampon to the heart chamber through the coronary artery; (ii) Piercing through two of the leaflets, thereby forming a fold in the leaflet, the two locations and the fold being between the root of the leaflet and the lip of the leaflet; and (iii) deploying the tampon, wherein after deployment of the tampon, the first end portion and the second end portion are perpendicular to the longitudinal portion and engage with a surface of the leaflet, thereby maintaining tension in the longitudinal portion and folding in the leaflet and reducing a length of the leaflet from the root to the lip.

Example 276 the system of example 275, further comprising: (A) A guidewire having a first end and a second end; and (B) a tampon delivery system, wherein the barrel is further adapted to: (i) Transluminally delivering the guidewire and the tampon delivery system to the heart chamber through the coronary artery; (ii) Penetrating through the two locations in the leaflet using the guidewire; (iii) Advancing the tampon delivery system over the guidewire to extend between the two locations; and (iv) deploying the tampon by the tampon delivery system.

Example 277 a method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root of the leaflet being adjacent a coronary artery, the method comprising: (A) Delivering a guidewire having a first end and a second end, a tampon delivery system, and a tampon comprising a longitudinal portion and first and second end portions transluminally through the coronary artery to a heart chamber adjacent the heart valve; (B) Puncturing the first end of the guidewire through two locations in the leaflet, thereby forming a fold in the leaflet, the two locations and the fold being between the root of the leaflet and the lip of the leaflet; (C) Advancing the tampon delivery system over the guidewire, positioned through the two of the leaflets; and (D) deploying the tampon such that the first end portion and the second end portion engage the surface of the leaflet at the two locations and the longitudinal portion extends between the two locations and tightens the longitudinal portion to maintain the fold in the leaflet and reduce the length of the leaflet from the root to the lip.

Example 278 a system for use with a leaflet of a heart valve of a subject, a root portion of the leaflet attached to a heart wall, the system comprising: (A) At least one longitudinal catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) a clip implant comprising a polymer having: a clip portion defining a bend; and a wire finger attached to the clip portion, wherein the at least one longitudinal conduit is adapted to: (i) Delivering the clip implant transluminally to the heart chamber; and (ii) mounting the clip implant onto the leaflet such that the curve engages the lip of the leaflet and the wire fingers extend to a point of contact between the root of the leaflet and the heart wall such that the clip implant mechanically constrains the leaflet flails.

Example 279 the system of example 278, wherein (i) the wire finger is substantially U-shaped and includes two longitudinal portions connected by an end portion, and (ii) the catheter is adapted to mount the clip implant such that the end portion is disposed at the contact point.

Example 280. The system of example 278 or example 279, wherein the catheter is adapted to mount the clip implant such that the wire portion is disposed against or adjacent to a downstream surface of the leaflet.

Example 281. A method for repairing a roll-up, prolapse, or flail of a leaflet of a heart valve of a subject, the leaflet having: a root attached to an annulus of the heart valve; a lip adapted to coapt with at least one other leaflet of the valve, the root portion of the leaflet being attached to a heart wall, the method comprising: (A) Transluminally delivering to a heart chamber adjacent the heart valve by a clip implant, the clip implant comprising a polymer having: a clip portion defining a bend; and a wire finger attached to the clip portion; and (B) mounting the clip implant onto the leaflet such that the curve engages the lip of the leaflet and the wire fingers extend to a point of contact between the root of the leaflet and the heart wall such that the clip implant mechanically constrains the leaflet flails.

Example 282. The method of example 281, wherein the installing comprises installing the clip implant such that the wire portion is disposed against or adjacent to a downstream surface of the leaflet.

Example 283. A system for use with leaflets of a heart valve of a subject, the system comprising: (A) A catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) a device comprising a first beam, a second beam, and a third beam, and having a first operational state and a second operational state, wherein the catheter is adapted to: (i) transluminally delivering the device to the heart chamber; (ii) Positioning the device at the leaflet in the first operational state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet; and (iii) transitioning the device from the first operational state to the second operational state while the first and third beams remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet.

Example 284 the system of example 283, wherein the device is an implant.

Example 285 the system of example 284, wherein at least two of the first beam, the second beam, and the third beam are substantially parallel to one another in at least one of the first operational state and the second operational state.

Example 286 the system of example 284 or example 285, wherein the implant is at least one of a flexible implant and a resilient implant.

The system of any one of examples 284 to 286, wherein the implant comprises a resilient metal.

The system of any one of examples 284 to 286, wherein the implant comprises a shape memory material.

The system of any one of examples 289-286, wherein the implant comprises an elastic component.

The system of any one of examples 284-289, wherein the catheter is adapted to position the implant on the leaflet in the first operational state by positioning the implant such that the first, second, and third beams are substantially perpendicular to a lip of the leaflet.

The system of any one of examples 284 to 290, wherein: (i) The implant includes a base from which extends a plurality of beams including the first, second, and third beams, each beam of the plurality of beams having an end remote from the base, the first, second, and third beams being substantially parallel to one another; (ii) In the first operating state, the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams; and (iii) in the second operational state, the base and the ends of the first, second, and third beams are in a single plane.

Example 292 the system of example 291, wherein: (i) the plurality of beams comprises at least five beams; (ii) A first subset of the plurality of beams comprises one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams comprises the other two of the first beam, the second beam, and the third beam, the first subset and the second subset of the plurality of beams being mutually exclusive; (iii) In the first operating state, the plane is defined by the ends and the base of all beams in the second subset, and the ends of all beams in the first subset are disposed outside the plane; and (iv) in the second operational state, the base and the ends of the beams in the first and second subsets are in the single plane.

Example 293 the system of example 292, wherein in the first operational state, the ends of all beams in the first subset are disposed in a second plane, the second plane being angled with respect to the plane.

The system of any one of examples 291-293, wherein in at least one of the first operational state and the second operational state, the first beam, the second beam, and the third beam are substantially perpendicular to the base.

The system of any one of examples 291-294, wherein the catheter is adapted to slide the implant onto a lip of the leaflet when the implant is in the first operating state such that the base extends along the lip of the leaflet, thereby positioning the implant on the leaflet.

The system of any one of examples 296, 284 to 290, wherein the implant comprises: (A) First and second U-shaped portions, each U-shaped portion comprising a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other; and (B) an engagement element that holds the second beam of each of the first and second U-shaped portions together to form a unified beam, wherein (i) the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion, and (ii) the second beams of the first and second U-shaped portions are pivotable relative to the engagement element about respective longitudinal axes of the second beam such that the first and second U-shaped portions are pivotable relative to one another.

Example 297 the system of example 296, wherein the first U-shaped portion and the second U-shaped portion are identical to each other.

Example 298 the system of example 296 or example 297, wherein the engagement element comprises a longitudinally extending cylinder.

The system of any one of examples 296-298, wherein (i) in the first operational state the first U-shaped portion and the second U-shaped portion are substantially in a single plane, and (ii) in the second operational state the unified beam is disposed outside of a plane formed by the first beams of the first U-shaped portion and the second U-shaped portion.

Example 300 the system of any one of examples 296-299, wherein (i) in the first operational state, a first distance exists between the first beam of the first and second U-shaped portions, and (ii) in the second operational state, a second distance exists between the first beam of the first and second U-shaped portions, the second distance being less than the first distance.

Example 301 the system of any of examples 296-300, wherein the catheter is adapted to rotate the first U-shaped portion and the second U-shaped portion relative to one another, thereby transitioning the implant from the first operational state to the second operational state.

The system of any one of examples 296-301, wherein (i) the unified beam comprises a second beam of the implant, and (ii) the first beams of the first and second U-shaped portions comprise the first and third beams of the implant, respectively.

The system of any one of examples 284 to 290, wherein the implant comprises: (A) A central U-shaped portion comprising a pair of central beams and a connecting section; and (B) first and second side portions, each side portion including at least one beam and being connected to one of the center beams by a respective one of first and second bends, wherein (i) the at least one beam of each of the first and second side portions is substantially parallel to at least one of the center beams, and (ii) the first and second bends facilitate movement of the respective first and second side portions relative to the pair of center beams in at least two directions.

Example 304 the system of example 303, wherein (i) in the first operational state the central U-shaped portion is in the first plane and each of the first and second side portions is in a plane different from the first plane and disposed outside of the central U-shaped portion, and (ii) in the second operational state the central U-shaped portion and the first and second side portions are in the first plane, wherein the first and second side portions are disposed within the central U-shaped portion.

Example 305 the system of example 303 or example 304, wherein the implant is formed from a single length of flexible or resilient material.

Example 306 the system of any one of examples 303-305, wherein each of the first side portion and the second side portion includes a pair of side rails connected to one another by an additional bend, the pair of side rails being substantially parallel to one another.

The system of any one of examples 303-306, wherein the implant is laterally symmetrical about a central longitudinal axis of the central U-shaped portion.

The system of any one of examples 303-307, wherein (i) in the first operational state a first distance exists between the first side portion and the second side portion, and (ii) in the second operational state a second distance exists between the first side portion and the second side portion, the second distance being less than the first distance.

The system of any one of examples 304-308, wherein (i) the implant has an intermediate operational state with the first and second side portions in the first plane and disposed outside of the central U-shaped portion, and (ii) the conduit is adapted to (a) transition the implant from the first operational state to the second operational state by pivoting the first and second side portions in a first direction relative to the central U-shaped portion to the intermediate operational state to place the first and second side portions into the first plane, and (b) further transition the implant from the intermediate operational state to the second operational state by rotating the first and second side portions in a second direction relative to the central U-shaped portion to move the first and second side portions into the inner portion of the central U-shaped portion.

Example 310 the system of example 309, wherein the first direction is about an axis perpendicular to a longitudinal axis of the center beam and the second direction is about an axis parallel to the longitudinal axis of the center beam.

Example 311 the system of any one of examples 303 to 310, wherein the U-shaped portion includes the second beam and the first side portion and the second side portion include the first beam and the third beam, respectively.

Example 312 the system of any one of examples 303-311, wherein the catheter is adapted to slide the implant onto a lip of the leaflet when the implant is in the first operating state such that the first and second bends engage the lip of the leaflet and the connection section of the U-shaped portion is distal to the lip of the leaflet, thereby positioning the implant on the leaflet.

Example 313 the system of any one of examples 303-312, wherein the catheter is adapted to transluminally deliver the implant to the heart chamber when the implant is in the first operational state.

The system of any one of examples 304-312, wherein (i) the catheter is adapted to transluminally deliver the implant to the heart chamber when the implant is in a ready-to-operate state, wherein the first side portion and the second side portion are in the first plane and outside the central U-shaped portion, and (ii) the catheter is further adapted to transition the implant from the ready-to-operate state to the first operating state by pivoting the first side portion and the second side portion relative to the central U-shaped portion about the axis perpendicular to a longitudinal axis of the central beam prior to placement of the implant on the leaflet.

The system of any one of examples 284 to 290, wherein the implant comprises: (A) A tubular body disposed along a central longitudinal axis; (B) A first substantially U-shaped clip and a second substantially U-shaped clip, each substantially U-shaped clip having: a first elongate portion disposed on or adjacent an outer surface of the tubular body; and a second elongate portion disposed on or near an inner surface of the tubular body, the first and second elongate portions being connected by an end portion; and (C) a resilient element holding together the second elongated portions of the first and second clips, wherein (i) in the first operational state the clips are disposed on a first side of the tubular body, and (ii) in the second operational state the clips are disposed on a second side of the tubular body, the second side being opposite the first side.

Example 316 the system of example 315, wherein (i) the catheter is adapted to slide the implant onto a lip of the leaflet when the implant is in the first operating state such that the end portion engages the lip of the leaflet, thereby placing the implant onto the leaflet, and (ii) the tubular bodies and the second elongated portions of the first and second clips form the second beam of the implant, and the first elongated portions of the first and second clips form the first and third beams of the implant.

Example 317 the system of example 315 or example 316, wherein the catheter is adapted to transluminally deliver the implant to the heart chamber when the implant is in the first operational state.

Example 318 the system of example 315 or example 316, wherein (i) the catheter is adapted to transluminally deliver the implant to the heart chamber when the U-shaped clip is separated from the tubular body, and (ii) wherein the catheter is further adapted to place the first clip and the second clip onto the tubular body prior to or during placement of the implant onto the leaflet.

The system of any one of examples 315-318, wherein the catheter is adapted to transition the implant from the first operational state to the second operational state by pulling the first clip and the second clip apart from each other around the circumference of the tubular body and against the force of the resilient element.

Example 320 the system of example 283, wherein: (i) The catheter is adapted to form a bulge in the leaflet by transitioning the device from the first operational state toward the second operational state while the first beam and the third beam remain on a first side of the leaflet and the second beam remain on the second opposite side of the leaflet, and (ii) the system further comprises an attachment device transluminally deliverable through the catheter and configured to at least temporarily secure two sections of the leaflet at the bulge.

Example 321. The system of example 320, wherein the catheter is further adapted to hold the two sections of the leaflet together to retain the projection by moving the first beam and the third beam toward each other.

Example 322 the system of example 320 or example 321, wherein the attachment device is configured to secure the two sections together when the two sections are held together.

Example 323, the system of any of examples 320-322, wherein the attachment device comprises a helical needle defining a helical lumen, the helical needle configured to be advanced distally from the catheter and to extend rotationally through the two sections at the protuberance and secure the two sections at the protuberance together.

Example 324 the system of example 323, further comprising a suture extending through the lumen of the helical needle, wherein the suture is attached to a detachable needle tip of the helical needle and configured to secure the two sections at the boss after removal of the helical needle from the heart chamber.

Example 325 the system of example 324, further comprising a push wire extending through the lumen of the spiral needle and configured to push the detachable needle tip of the spiral needle distally relative to a needle body, thereby detaching the detachable needle tip from the needle body.

The system of any one of examples 320-325, further comprising a cutting device configured to cut tissue through the leaflet, wherein the catheter is further adapted to: (i) transluminally delivering the cutting device to the heart chamber; and (ii) operating the cutting device to cut a portion of the leaflet disposed between the two sections at the projection, thereby forming a cutting edge.

Example 327 the system of example 326, wherein the cutting edge is at least temporarily secured by the attachment device.

The system of example 326 or 327, wherein (i) the cutting device is adapted to extend distally from the second beam of the device, and (ii) after the device transitions from the first operational state to the second operational state, and after the two sections are secured together, the catheter is further adapted to pull the device proximally such that during the pulling of the device, the cutting device cuts the tissue of the leaflet between the two sections at the protrusion.

The system of any one of examples 326-328, wherein (i) the cutting device is further configured to clamp the cut tissue prior to its complete cutting, and (ii) the catheter is further adapted to transluminally remove the cutting device and the cut tissue clamped by the cutting device from the heart chamber.

Example 330. A method for repairing leaflets of a heart valve of a subject, the method comprising: (i) Delivering transluminally a device to a heart chamber adjacent the heart valve, the device comprising a first beam, a second beam, and a third beam and having a first operational state and a second operational state; (ii) Positioning the device at the leaflet in the first operational state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet; and (iii) transitioning the device from the first operational state to the second operational state while the first and third beams remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet.

Example 331. The method of example 330, wherein (i) the device comprises an implant, (ii) the transluminal delivery comprises transluminal delivery of the implant, (iii) the positioning comprises positioning the implant, and (iv) the transforming comprises transforming the implant.

Example 332 the method of example 331, wherein positioning the implant comprises positioning the implant such that the first beam, the second beam, and the third beam are substantially perpendicular to the lips of the leaflet.

Example 333 the method of any one of examples 331-332, wherein: (i) The implant includes a base from which extends a plurality of beams including the first, second, and third beams, each beam of the plurality of beams having an end remote from the base, the first, second, and third beams being substantially parallel to one another; (ii) Positioning the implant in the first operational state includes positioning the implant such that the end of one of the first, second, and third beams is disposed outside a plane defined by the base and the end of the other two of the first, second, and third beams, one of the first, second, and third beams being disposed between the other two of the first, second, and third beams; (iii) In the second operational state, the base and the ends of the first, second, and third beams are in a single plane; and (iv) the transition of the implant from the first operational state toward the second operational state includes moving the ends of the first, second, and third beams relative to one another such that the ends of the first, second, and third beams are in the single plane.

Example 334 the method of example 333, wherein: (i) the plurality of beams comprises at least five beams; (ii) A first subset of the plurality of beams comprises one of the first beam, the second beam, and the third beam, and a second subset of the plurality of beams comprises the other two of the first beam, the second beam, and the third beam, the first subset and the second subset of the plurality of beams being mutually exclusive; (iii) Positioning of the implant in the first operational state includes positioning the implant such that the plane is defined by the ends of all beams in the second subset and the base, and the ends of all beams in the first subset are disposed outside the plane; and (iv) the conversion of the implant comprises moving the ends of all of the beams in the first subset such that in the second operational state the base and the ends of the beams in the first and second subsets are in the single plane.

The method of example 335, wherein positioning the implant in the first operational state comprises positioning the implant such that the ends of all beams in the first subset are disposed in a second plane, the second plane being angled with respect to the plane.

Example 336 the method of any one of examples 333-335, wherein positioning the implant comprises positioning the implant when the first beam, the second beam, and the third beam are substantially perpendicular to the base.

Example 337 the system of any of examples 333-336, wherein positioning the implant on the leaflet comprises sliding the implant onto the lip of the leaflet when the implant is in the first operational state such that the base extends along the lip of the leaflet.

The method of any one of examples 331-332, wherein the implant comprises: (A) First and second U-shaped portions, each U-shaped portion comprising a base and first and second beams extending substantially perpendicularly from the base and substantially parallel to each other; and (B) an engagement element that holds the second beam of each of the first and second U-shaped portions together to form a unified beam, wherein (i) the unified beam is a central beam disposed between the first beam of the first U-shaped portion and the first beam of the second U-shaped portion, (ii) the second beams of the first and second U-shaped portions are pivotable relative to the engagement element about respective longitudinal axes of the second beam such that the first and second U-shaped portions are pivotable relative to one another, and (iii) positioning of the implant in the first operating state includes positioning the implant such that the first beams of the first and second U-shaped portions are at a first distance from one another.

The method of example 339, wherein (i) positioning the implant in the first operational state comprises positioning the implant on the leaflet while the first and second U-shaped portions are in a single plane, and (ii) the translating comprises pivoting the first and second U-shaped portions relative to each other to position the unified beam movement outside of a plane formed by the first beams of the first and second U-shaped portions.

Example 340 the method of any one of examples 338-339, wherein the converting includes pivoting the first U-shaped portion and the second U-shaped portion relative to each other to form a second distance between the first beams of the first U-shaped portion and the second U-shaped portion, the second distance being less than the first distance.

The method of any one of examples 338-340, wherein positioning the implant comprises sliding the implant onto the lips of the leaflet when the implant is in the first operating state such that (i) the base of the first and second U-shaped portions extend along the lips of the leaflet, (ii) the unified beam acts as the second beam and is located on the second opposing side of the leaflet, and (iii) the first beams of the first and second U-shaped portions act as the first and third beams of the device and are disposed on the first side of the leaflet.

The method of any one of examples 331-332, wherein the implant comprises: (A) A central U-shaped portion comprising a pair of central beams and a connecting section; and (B) first and second side portions, each side portion including at least one beam and being connected to one of the center beams by a respective one of first and second bends, wherein (i) the at least one beam of each of the first and second side portions is substantially parallel to at least one of the center beams, (ii) the first and second bends facilitate movement of the respective first and second side portions relative to the pair of center beams in at least two directions, (iii) positioning of the implant in the first operational state includes positioning the implant at the upper leaflet (1) the central U-shaped portion in the first plane, and (2) each of the first and second side portions in a plane different from the first plane, and when disposed outside the central U-shaped portion; and (iv) the converting includes moving the first side portion and the second side portion into the first plane within the central U-shaped portion.

Example 343 the method of example 342, wherein (i) positioning the implant in the first operational state comprises positioning the implant on the leaflet while a first distance exists between the first side portion and the second side portion, and (ii) transitioning the implant comprises reducing a distance between the first side portion and the second side portion to a second distance that is less than the first distance.

The method of any one of examples 342-343, wherein (i) the implant has an intermediate operational state, wherein the first side portion and the second side portion are in the first plane and disposed outside of the central U-shaped portion, and (ii) the transition of the implant from the first operational state toward the second operational state comprises: (A) Transitioning the implant from the first operative state to the intermediate operative state by pivoting the first side portion and the second side portion in a first direction relative to the central U-shaped portion to place the first side portion and the second side portion into the first plane; and (B) transitioning the implant from the intermediate operating state to the second operating state by rotating the first and second side portions in a second direction relative to the central U-shaped portion to move the first and second side portions into the interior of the central U-shaped portion.

Example 345 the method of example 344, wherein (i) the pivoting in the first direction comprises pivoting about an axis perpendicular to a longitudinal axis of the center beam, and (ii) the rotating in the second direction comprises rotating about an axis parallel to the longitudinal axis of the center beam.

The method of any one of examples 342-345, wherein positioning the implant comprises sliding the implant onto the lip of the leaflet when the implant is in the first operating state such that (i) the first and second curves engage with the lip of the leaflet and (ii) the connection section of the U-shaped portion is distal to the lip of the leaflet.

Example 347 the method of any of examples 342-346, wherein the transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the implant is in the first operational state.

The method of any one of examples 342-346, wherein (i) the transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the implant is in a ready-to-operate state, wherein the first side portion and the second side portion are in the first plane and outside of the central U-shaped portion, and (ii) the method further comprises transitioning the implant from the ready-to-operate state toward the first operating state prior to placement of the implant.

Example 349 the method of example 348, wherein transitioning the implant from the ready-to-operate state includes pivoting the first side portion and the second side portion relative to the U-shaped portion about an axis perpendicular to a longitudinal axis of the center beam.

The method of any one of examples 331-332, wherein the implant comprises: (A) A tubular body disposed along a central longitudinal axis; (B) A first substantially U-shaped clip and a second substantially U-shaped clip, each substantially U-shaped clip having: a first elongate portion disposed on or adjacent an outer surface of the tubular body; and a second elongate portion disposed on or near an inner surface of the tubular body, the first and second elongate portions being connected by an end portion; and (C) a resilient element that holds the second elongated portions of the first and second clips together, wherein (i) in the first operational state the clips are disposed on a first side of the tubular body and (ii) in the second operational state the clips are disposed on a second side of the tubular body opposite the first side, and (ii) positioning of the implant includes sliding the implant onto the lips of the leaflet when the implant is in the first operational state such that the end portions engage with the lips of the leaflet, wherein the tubular bodies and the second elongated portions of the first and second clips function as the second beam and the first elongated portions of the first and second clips function as the first and third beams.

Example 351 the method of example 350, wherein the transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the implant is in the first operational state.

Example 352. The method of example 350, wherein: (i) The transluminal delivery comprises transluminal delivery of the implant to the heart chamber when the U-shaped clip is separated from the tubular body, and (ii) the method further comprises sliding the first clip and the second clip onto the tubular body to form the first operational state prior to or during positioning of the implant.

Example 353 the method of any one of examples 350-352, wherein the transitioning of the implant includes pulling the first clip and the second clip apart from one another around a perimeter of the tubular body and against a force of the resilient element.

Example 354 the method of example 330, wherein: (i) The transition of the device from the first operational state toward the second operational state includes forming a protrusion in the leaflet when the first beam and the third beam remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet, and (ii) the method further includes at least temporarily securing two sections of the leaflet at the protrusion using an attachment device.

Example 355 the method of example 354, further comprising holding the two sections of the leaflet together to retain the projection by moving the first beam and the third beam toward each other.

Example 356. The method of example 354 or example 355, wherein the at least temporarily securing is performed while the two sections of the leaflet are held together.

Example 357 the method of any one of examples 354-356, further comprising transluminally delivering the attachment device to the heart chamber adjacent the heart valve.

Example 358 the method of any one of examples 354-357, wherein: (i) The attachment means comprises a helical needle defining a helical lumen, and (ii) the at least temporarily securing comprises rotationally advancing the helical needle to extend through the two sections at the protuberance and secure the two sections together.

Example 359. The method of example 358, wherein (i) a suture extends through the helical lumen of the helical needle, (ii) the suture is attached to a detachable needle tip of the helical needle, and (iii) the method further comprises, after the helical needle is rotationally advanced: (A) Anchoring the detachable needle tip of the spiral needle to tissue of the leaflet; (B) Detaching the detachable tip of the helical needle from the body of the helical needle; and (C) helically retracting the body of the helical needle from the detachable needle tip as the helical needle is slid over the suture, thereby removing the helical needle from the anatomical site while securing the suture to the two sections at the protrusion.

Example 360 the method of example 359, wherein the removing of the detachable needle tip comprises pushing the detachable needle tip of the helical needle distally relative to the body of the helical needle using a pushing wire extending through the lumen of the helical needle.

Example 361 the method of any one of examples 354 to 360, further comprising: (a) transluminally delivering a cutting device to the heart chamber; and (B) cutting a portion of the leaflet disposed between the two sections at the bulge using the cutting device, thereby forming a cutting edge.

Example 362 the method of example 361, wherein the at least temporarily securing includes at least temporarily securing the cutting edge.

Example 363 the method of example 361 or example 362, wherein (i) transluminal delivery of the cutting device comprises advancing the cutting device distally from the second beam of the device, and (ii) the cutting comprises pulling the device proximally such that during pulling of the device, the cutting device cuts the tissue of the leaflet between the two sections at the projections.

Example 364 the method of any one of examples 361-363, further comprising: (A) Clamping the cut tissue into a clamping end of a clamping device prior to completion of cutting the tissue between the two sections; and (B) removing the clamping device and the cut tissue clamped to the clamping device from the heart chamber.

Example 365. The method of example 364, further comprising distally advancing the clamping device from the second beam of the device prior to clamping.

Example 366. The method of example 365, wherein (i) the cutting device is used as the gripping device, and (ii) advancement of the cutting device comprises advancement of the gripping device.

Example 367 a system for use with leaflets of a heart valve of a subject, the system comprising: (A) A catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; (B) A cutting device distally advanceable from the catheter, adapted to cut tissue through the leaflets of the heart valve, thereby forming cut tissue and a cutting edge at the heart valve; (C) A helical needle defining a helical lumen, the helical needle configured to be advanced distally from the catheter and to extend rotationally through and secure together two tissue sections of the leaflet; and (D) a suture extending through the helical lumen of the helical needle, wherein the helical needle and the suture are configured to extend along the two tissue sections of the leaflet to suture the two tissue sections to one another.

Example 368 the system of example 367, wherein: (i) The cutting device includes a wire forming a wire loop having a closed distal end and a fastening element slidably coupled to the wire such that distal sliding of the fastening element over the wire contracts the wire loop and cuts the tissue disposed within the wire loop, thereby forming the cut tissue and the cutting edge, and (ii) the helical needle and the suture are configured to secure the cutting edge together.

Example 369 the system of example 367 or example 368, wherein the helical needle comprises a needle body terminating in a detachable distal tip configured to be anchored to tissue at the heart valve and detached from the needle body.

Example 370 the system of example 369, wherein a distal end of the suture is attached to the detachable distal tip of the helical needle.

Example 371 the system of example 370, wherein after detaching the detachable distal tip of the helical needle from the needle body, the needle body is adapted to be retracted helically away from the detachable distal tip while sliding over and along the suture.

Example 372 the system of any one of examples 369-371, further comprising a push wire extending through the helical lumen of the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

The system of any one of examples 367-372, wherein the cutting device and the helical needle are adapted to be removed from the heart chamber after cutting the tissue by the cutting device while leaving the suture in the leaflet of the heart valve, thereby securing the two tissue sections.

The system of any one of examples 374-373, further comprising a clamp having a distal clamping end, the clamp being distally advanceable from the catheter to engage the cut tissue before the cut tissue is completely removed from the small She Caxie.

Example 375 the system of example 374, wherein the clamp is adapted to be removed from the heart chamber, the cut tissue being clamped to the clamp during or after the cutting device and the helical needle are removed from the heart chamber.

Example 376 the system of example 374 or example 375, wherein the clamp is configured to be advanced through the catheter alongside the helical needle.

Example 377 the system of example 374 or example 375, wherein the cutting device is used as the clamp.

The system of any one of examples 367-377, further comprising a retention device comprising a first beam, a second beam, and a third beam, and having a first operational state and a second operational state, the retention device being distally advanceable from the catheter, wherein the catheter is adapted to: (a) transluminally delivering the fixation device to the heart chamber; (B) Positioning the retaining device at the leaflet in the first operational state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet; and (C) transitioning the retaining device from the first operational state to the second operational state when the first and third beams remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet.

Example 379 the system of example 378, wherein (i) the cutting device is adapted to advance distally from the second beam of the retaining device, and (ii) after the retaining device transitions from the first operational state to the second operational state, and after the two tissue sections are secured together, the catheter is further adapted to pull the retaining device proximally such that during the pulling of the retaining device, the cutting device cuts the tissue of the leaflet between the two sections at a bulge.

Example 380 the system of example 378 or example 379, wherein: (i) The catheter is adapted to form the bulge in the leaflet by transitioning the retaining device from the first operational state to the second operational state, and (ii) the helical needle and the suture are adapted to secure the two tissue sections of the leaflet at the bulge.

Example 381 the system of example 380, wherein the catheter is further adapted to hold the two sections of the leaflet together to retain the projection by moving the first beam and the third beam toward each other.

Example 382 the system of example 380 or example 381, wherein the helical needle is configured to secure the two tissue sections together when the two tissue sections are held together.

Example 383 a method for repairing a leaflet of a heart valve of a subject, the method comprising: (A) Securing together two sections of tissue of the leaflets of the heart valve; and (B) resecting tissue from between the two sections of tissue of the leaflet with a cutting device to form a cutting edge.

Example 384 the method of example 383, wherein (i) the resecting occurs prior to the securing, and (ii) the securing comprises securing the cutting edge while the cutting edge is formed and prior to the tissue being completely removed from the small She Caxie.

Example 385 the method of example 384, wherein the resecting is performed using a cutting wire that forms a wire loop distally advanceable from the catheter and comprising distally sliding a fastening element over the cutting wire to retract the wire loop and cut tissue disposed within the wire loop, thereby forming the cutting edge.

Example 386 the method of example 383, wherein (i) the securing occurs prior to the resecting and (ii) the resecting comprises resecting the tissue from between securing two sections to form an exposed cutting edge.

The method of example 387, further comprising: (A) Delivering transluminally a device to a heart chamber adjacent the heart valve, the device comprising a first beam, a second beam, and a third beam and having a first operational state and a second operational state; (B) Positioning the device at the leaflet in the first operational state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet; and (C) transitioning the device from the first operational state to the second operational state when the first beam and the third beam remain on the first side of the leaflet and the second beam remains on the second opposite side of the leaflet, thereby forming a bulge in the leaflet, wherein securing the two sections together comprises securing the two sections together at the bulge.

The method of any one of examples 383-387, wherein the securing the two sections together includes advancing a spiral needle through the two sections.

Example 389 the method of any one of examples 383-388, further comprising, prior to the resecting, advancing the cutting device to the heart valve by transluminal catheter.

Example 390 the method of any one of examples 383-389, wherein (i) the spiral needle includes a spiral lumen and has a suture extending through the spiral lumen, (ii) the method further comprises removing the spiral needle from the heart valve while attaching the suture to the two sections.

Example 391, a system for use with a heart valve of a subject, the system comprising: (A) A catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween; and (B) a screw implant defining a pair of turns, wherein in a first operational state of the screw implant, the pair of turns have a first pitch, and in a second operational state of the screw implant, the pair of turns have a second pitch, the second pitch being less than the first pitch, wherein the catheter is adapted to: (i) Delivering the helical implant transluminally to the heart chamber; (ii) Placing the helical implant in the first operational state onto tissue of the heart valve; (iii) Pulling the tissue between the pair of turns while the helical implant remains in the first operating state; and (iv) switching the helical implant from the first operational state toward the second operational state while the tissue remains between the pair of turns, thereby crimping the tissue.

Example 392 the system of example 391, wherein the catheter is adapted to place the spiral implant in the first operational state onto an annulus of the heart valve.

The system of example 391 or example 392, wherein (i) the helical implant comprises a plurality of helical implants, and (ii) the catheter is adapted to transluminally deliver, place, pull, and transition each helical implant of the plurality of helical implants at tissue in different locations along the annulus of the heart valve.

The system of any one of examples 391-393, further comprising a vacuum generator functionally associated with the catheter, and wherein the vacuum generator is configured to generate a vacuum that pulls the tissue of the heart valve between the pair of turns.

Example 395 the system of any one of examples 391-394, wherein the helical implant is at least one of a flexible implant and a resilient implant.

Example 396 the system of any one of examples 391 to 395, wherein the helical implant comprises a resilient metal.

The system of any one of examples 391 to 396, wherein the helical implant comprises a shape memory material.

The system of any one of examples 394-397, further comprising a septum disposed between the distal end of the catheter and the vacuum generator, the septum adapted to prevent fluid flow into the proximal end of the catheter during operation of the vacuum generator.

Example 399 the system of any one of examples 391-398, wherein the distal end of the catheter is partially resected to define an implant deployment portal such that during placement of the spiral implant, a distal portion of the implant is disposed within the implant deployment portal and in contact with tissue of the heart valve and a proximal portion of the spiral implant is separated from the tissue of the heart valve by the catheter.

Example 400. A method for repairing leaflets of a heart valve of a subject, the method comprising: (A) Delivering a spiral implant transluminally to a heart chamber adjacent the heart valve, the spiral implant defining a pair of turns, wherein in a first operational state of the spiral implant, the pair of turns have a first pitch, and in a second operational state of the spiral implant, the pair of turns have a second pitch, the second pitch being less than the first pitch; (B) Placing the helical implant in the first operational state onto tissue of the heart valve; (C) Pulling the tissue between the pair of turns while the helical implant remains in the first operating state; and (D) transitioning the helical implant from the first operational state to the second operational state while the tissue remains between the pair of turns, thereby crimping the tissue.

Example 401 the method of example 400, wherein the placing comprises placing the spiral implant in the first operational state onto an annulus of the heart valve.

Example 402 the method of example 400 or example 401, wherein (i) the steps of delivering, placing, pulling, and translating are performed on each of the plurality of spiral implants, and (ii) the placing comprises placing each of the plurality of spiral implants into a different location along the annulus of the heart valve.

Example 403, the method of any one of examples 400 to 402, wherein the pulling comprises generating a vacuum that pulls the tissue of the heart valve between the pair of turns.

Example 404 the method of example 403, further comprising placing a septum between the helical implant and a vacuum generator that generates the vacuum, thereby preventing fluid from flowing from the heart valve into the vacuum generator during operation of the vacuum generator.

Claims

1. A system for use with a subject, the system comprising:

a longitudinal catheter configured to be advanced transluminally toward an anatomical site of the subject, the longitudinal catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween;

A wire distally advanceable from the longitudinal catheter, the wire forming a wire loop having a closed distal end and a fastening element slidably coupled to the wire such that distal sliding of the fastening element over the wire constricts the wire loop and cuts tissue disposed within the wire loop, thereby forming a cut tissue and a cutting edge at the anatomical site;

a helical needle defining a helical lumen, the helical needle configured to be advanced distally from the longitudinal catheter and to extend rotationally through the cutting edges at the anatomical site and to secure the cutting edges together; and

a suture extending through the lumen of the helical needle,

wherein the helical needle and the suture are configured to extend along the cutting edge of the anatomical portion to suture the cutting edge during distal sliding of the fastening element.

2. The system of claim 1, further comprising a tissue anchor configured to anchor to tissue at the anatomical site, wherein at least one of the wire loop and the helical needle is attachable to the tissue anchor.

3. The system of claim 2, wherein the helical needle comprises a needle body terminating in a detachable distal tip configured to be attached to the tissue anchor and detached from the needle body.

4. The system of claim 3, wherein a distal end of the suture is attached to the detachable distal tip of the helical needle.

5. The system of claim 4, wherein after detaching the detachable distal tip of the helical needle from the needle body, the needle body is helically retractable away from the detachable distal tip while sliding over and along the suture.

6. The system of claim 3, further comprising a push wire extending through the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

7. The system of any one of claims 1-6, wherein the wire and the helical needle are adapted to be removed from the anatomical site after cutting the tissue disposed within the wire loop while leaving the suture in the anatomical site to suture the cutting edge.

8. The system of any one of claims 1-7, further comprising a clamp having a distal clamping end, the clamp being distally advanceable from the longitudinal catheter to engage the cut tissue before the cut tissue is completely removed from the anatomical site.

9. The system of claim 8, wherein the clamp is adapted to be removed from the anatomical site, the cut tissue being clamped to the clamp after the wire and the helical needle are removed from the anatomical site.

10. The system of claim 8 or claim 9, wherein the clamp is configured to advance through the longitudinal catheter alongside the helical needle.

11. The system of any one of claims 1 to 10, wherein the helical needle follows the fastening element at a fixed distance from the fastening element at least during distal sliding of the fastening element.

12. The system of any one of claims 1 to 11, wherein the anatomical site comprises a heart valve and the cut tissue comprises a portion of a leaflet of the heart valve.

13. The system of any one of claims 1-12, wherein the helical needle and the suture are configured to rotationally extend through the cutting edge at the anatomical site as the cutting edge is formed.

14. The system of any one of claims 1 to 13, wherein in at least a first state of the system, the fastening element is operably coupled to the helical needle such that the fastening element is distally advanceable over the wire only upon subsequent advancement of the helical needle.

15. The system of claim 14, further comprising a user interface enabling a user to control the system, the user interface including a unified engagement element that when actuated consistently controls movement of the fastening element and the helical needle.

16. The system of claim 15, wherein the unified engagement element, when actuated, controls movement of the fastening element and the helical needle at a fixed distance from each other.

17. The system of claim 15 or claim 16, wherein the user interface comprises:

a first engagement element that controls movement of the fastening element when actuated; and

a second engagement element that when actuated controls movement of the helical needle.

18. The system of claim 17, wherein the unified engagement element comprises a third engagement element different from the first engagement element and the second engagement element.

19. The system of claim 17, wherein:

the user interface further includes a coupling element functionally associated with the first engagement element and the second engagement element;

in a first operating state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the fastening element and the helical needle or movement at a fixed distance from each other; and is also provided with

In a second operating state of the coupling element, the first and second coupling elements are uncoupled such that actuation of the first coupling element controls only movement of the fastening element and actuation of the second coupling element controls only movement of the helical needle.

20. The system of any one of claims 1 to 19, wherein at least one of the wire and the helical needle is adapted to be advanced to or removed from the anatomical site through the longitudinal catheter.

21. The system of any one of claims 1 to 20, further comprising a longitudinal mount adapted to be advanced distally from the longitudinal catheter such that the helical needle is adapted to rotate about the longitudinal mount and be stabilized or guided by the longitudinal mount during rotation of the helical needle.

22. The system of any one of claims 1 to 21, further comprising a tissue engagement tool comprising a first beam, a second beam, and a third beam, the first beam, the second beam, and the third beam being distally advanceable from the longitudinal catheter, the tissue engagement tool being adapted to:

positioning the first beam and the third beam on a first side of the tissue and positioning the second beam on an opposite side of the tissue; and is also provided with

Forming a protrusion in the tissue by moving the second beam relative to the first beam and the third beam,

wherein the wire loop is adapted to constrain the protrusion on the first side of the tissue.

23. A system for use with a subject, the system comprising:

a cutting device that is advanceable and steerable toward an anatomical site of the subject, wherein movement of the cutting device at the anatomical site causes cutting of tissue engaged by the cutting device, thereby forming a cutting edge at the anatomical site; and

an edge attachment device configured to at least temporarily secure the cutting edge at the anatomical site,

Wherein in at least a first state of the system, the edge attachment device is operably coupled to the cutting device such that the cutting device is distally advanceable at the anatomical site only upon subsequent advancement of the edge attachment device to secure the cutting edges to one another upon formation of the cutting edges.

24. The system of claim 23, wherein in the first state of the system, the edge attachment device is operably coupled to the cutting device such that the cutting device is distally advanceable only when the edge attachment device is subsequently advanced a fixed distance from the cutting device.

25. The system of claim 23 or claim 24, further comprising a user interface enabling a user to control the system, the user interface including a unified engagement element that, when actuated, consistently controls movement of the cutting device and the edge attachment device.

26. The system of claim 25, wherein the unified engagement element, when actuated, controls movement of the cutting device and the edge attachment device at a fixed distance from each other.

27. The system of claim 25 or claim 26, wherein the user interface comprises:

a first engagement element that, when actuated, controls movement of the cutting device; and

a second engagement element that when actuated controls movement of the edge attachment device.

28. The system of claim 27, wherein the unified engagement element comprises a third engagement element different from the first engagement element and the second engagement element.

29. The system according to claim 27, wherein:

in a first operating state of the coupling element, the first and second engagement elements are coupled to form the unified engagement element such that actuation of one of the first and second engagement elements consistently controls movement of the cutting device and the edge attachment device; and is also provided with

In a second operating state of the coupling element, the first and second coupling elements are uncoupled such that actuation of the first coupling element controls only movement of the cutting device and actuation of the second coupling element controls only movement of the edge attachment device.

30. A system for use with a subject, the system comprising:

a cutting device that is advanceable and steerable toward an anatomical site of the subject, wherein movement of the cutting device at the anatomical site causes cutting of tissue engaged by the cutting device, thereby forming a cutting edge at the anatomical site;

an edge attachment device configured to at least temporarily secure the cutting edge at the anatomical site as the cutting edge is formed; and

a user interface enabling a user to control the system, the user interface comprising a unified engagement element that when actuated consistently controls movement of the cutting device and the edge attachment device.

31. The system of claim 30, wherein the unified engagement element, when actuated, controls movement of the cutting device and the edge attachment device at a fixed distance from each other.

32. The system of claim 30 or claim 31, wherein the user interface comprises:

33. The system of claim 32, wherein the unified engagement element comprises a third engagement element different from the first engagement element and the second engagement element.

34. The system according to claim 32, wherein:

35. The system of any one of claims 23 to 34, further comprising a longitudinal catheter configured to be advanced transluminally toward the anatomical site of the subject, the longitudinal catheter having a proximal portion and a steerable distal portion, wherein the cutting device and the edge attachment device are adapted to be advanced and steerable distally from the longitudinal catheter to the anatomical site.

36. The system of claim 35, wherein the cutting device and the edge attachment device are adapted to be advanced through the longitudinal catheter to the anatomical site.

37. The system according to any one of claims 23 to 36, wherein the cutting device and the edge attachment device are adapted to be removed from the anatomical site after cutting the tissue and securing the cutting edges together.

38. The system of any one of claims 23 to 37, further comprising a permanent edge attachment device adapted to permanently attach the cutting edge at the anatomical site.

39. The system of claim 38, wherein the edge attachment device is adapted to temporarily secure the cutting edge at the anatomical site and the permanent edge attachment device is adapted to permanently attach the cutting edge.

40. The system of claim 39, wherein the edge attachment device comprises a needle and the permanent edge attachment device comprises a suture extending through a lumen of the needle.

41. The system of claim 40, wherein the needle is a helical needle and the lumen is a helical lumen.

42. The system of any one of claims 23 to 41, wherein the cutting device comprises a wire forming a wire loop having a closed distal end and a fastening element slidably coupled to the wire such that distal sliding of the fastening element over the wire constricts the wire loop and cuts the tissue disposed within the wire loop.

43. The system of any one of claims 23 to 42, further comprising a clamp having a distal clamping end, the clamp being advanceable to the anatomical site to engage the cut tissue prior to the cut tissue cut by the cutting device being completely removed from the anatomical site.

44. The system of claim 43, wherein the clamp is adapted to be removed from the anatomical site, the cut tissue being clamped to the clamp after at least one of the cutting device and the edge attachment device is removed from the anatomical site.

45. The system of any one of claims 23 to 44, further comprising a tissue anchor configured to anchor to tissue at the anatomical site to anchor at least one of the cutting device and the edge attachment device.

46. The system of any one of claims 23-45, wherein the anatomical site comprises a heart valve and the tissue engaged and cut thereby by the cutting device comprises a portion of a leaflet of the heart valve.

47. A system for use with leaflets of a heart valve of a subject, the system comprising:

a catheter configured to be transluminally advanced toward a heart chamber of the subject adjacent the heart valve, the catheter having a proximal portion and a steerable distal portion and a longitudinal axis therebetween;

a cutting device distally advanceable from the catheter, adapted to cut tissue through the leaflets of the heart valve, thereby forming cut tissue and a cutting edge at the heart valve;

a helical needle defining a helical lumen, the helical needle configured to be advanced distally from the catheter and to extend rotationally through and secure together two tissue sections of the leaflet; and

A suture extending through the lumen of the helical needle,

wherein the spiral needle and the suture are configured to extend along the two tissue sections of the leaflet to suture the two tissue sections to one another.

48. The system of claim 47, wherein:

the cutting device includes a wire forming a wire loop having a closed distal end and a fastening element slidably coupled to the wire such that distal sliding of the fastening element over the wire contracts the wire loop and cuts the tissue disposed within the wire loop, thereby forming the cut tissue and the cutting edge, and

the helical needle and the suture are configured to secure the cutting edge together.

49. The system of claim 47 or claim 48, wherein the spiral needle comprises a needle body terminating in a detachable distal tip configured to be anchored to tissue at the heart valve and detached from the needle body.

50. The system of claim 49, wherein a distal end of the suture is attached to the detachable distal tip of the helical needle.

51. The system of claim 50, wherein after detaching the detachable distal tip of the helical needle from the needle body, the needle body is adapted to be retracted helically away from the detachable distal tip while sliding over and along the suture.

52. The system of any one of claims 49-51, further comprising a push wire extending through the lumen of the helical needle and configured to push the detachable distal tip of the helical needle distally relative to the needle body, thereby detaching the detachable distal tip from the needle body.

53. The system of any one of claims 47-52, wherein the cutting device and the helical needle are adapted to be removed from the heart chamber after cutting the tissue by the cutting device while leaving the suture in the leaflets of the heart valve, thereby securing the two tissue sections.

54. The system of any one of claims 47-53, further comprising a clamp having a distal clamping end, the clamp being distally advanceable from the catheter to engage the cut tissue before the cut tissue is completely from the small She Caxie.

55. The system of claim 54, wherein the clamp is adapted to be removed from the heart chamber, the cut tissue being clamped to the clamp during or after the cutting device and the helical needle are removed from the heart chamber.

56. The system of claim 54 or claim 55, wherein the clamp is configured to be advanced through the catheter alongside the helical needle.

57. The system of claim 54 or claim 55, wherein the cutting device is used as the clamp.

58. The system of any one of claims 47-57, further comprising a retaining device comprising a first beam, a second beam, and a third beam, and having a first operational state and a second operational state, the securing device being distally advanceable from the catheter, wherein the catheter is adapted to:

delivering the fixation device transluminally to the heart chamber;

positioning the retaining device at the leaflet in the first operational state, wherein the first beam and the third beam are on a first side of the leaflet and the second beam is on a second, opposite side of the leaflet; and is also provided with

The retaining device is transitioned from the first operating state to the second operating state when the first beam and the third beam are retained on the first side of the leaflet and the second beam is retained on the second, opposite side of the leaflet.

59. The system of claim 58, wherein the cutting device is adapted to advance distally from the second beam of the retaining device, and wherein after the retaining device transitions from the first operational state to the second operational state, and after the two tissue sections are secured together, the catheter is further adapted to pull the retaining device proximally such that during the pulling of the retaining device, the cutting device cuts the tissue of the leaflet between the two sections at a bulge.

60. The system of claim 58 or claim 59, wherein:

the catheter is adapted to form the bulge in the leaflet by switching the retaining device from the first operating state to the second operating state, and

the spiral needle and the suture are adapted to secure the two tissue sections of the leaflet at the bulge.

61. The system of claim 60, wherein the catheter is further adapted to hold the two sections of the leaflet together to retain the projection by moving the first beam and the third beam toward each other.

62. The system of claim 60 or claim 61, wherein the helical needle is configured to secure the two tissue sections together when the two tissue sections are held together.