133 results about "Heart Valve Leaflet" patented technology

Devices, systems and methods supplement, repair, or replace a native heart valve. The devices, systems, and methods employ an implant that, in use, extends adjacent a valve annulus. The implant includes a mobile neoleaflet element that occupies the space of at least a portion of one native valve leaflet. The implant mimics the one-way valve function of a native leaflet, to resist or prevent retrograde flow. The implant restores normal coaptation of the leaflets to resist retrograde flow, thereby resisting eversion and / or prolapse, which, in turn, reduces regurgitation.

Disclosed are methods and devices for determining valve leaflet orientation. A catheter is provided with a conformable, radiopaque target. The target is deployed within a valve, such as the mitral valve. The conformable target conforms to the coaptation axis in response to closing of the valve leaflets. That coaptation axis may then be visualized, and utilized to determine information about valve operation, or to assist in placement of devices in the vicinity of the valve.

The various aspects of the invention pertain to devices and related methods for treating heart conditions, including, for example, dilatation, valve incompetencies, including mitral valve leakage, and other similar heart failure conditions. The devices and related methods of the present invention operate to assist in the apposition of heart valve leaflets to improve valve function. According to one aspect of the invention, a method improves the function of a valve of a heart by placing an elongate member transverse a heart chamber so that each end of the elongate member extends through a wall of the heart, and placing first and second anchoring members external the chamber. The first and second anchoring members are attached to first and second ends of the elongate member to fix the elongate member in a position across the chamber so as to reposition papillary muscles within the chamber. Also described herein is a method for placing a splint assembly transverse a heart chamber by advancing an elongate member through vasculature structure and into the heart chamber.

A novel approach to mitral or tricuspid valve repair involves the performance of an edge-to-edge fastening / securing of opposing heart valve leaflets through a catheter entering the heart. Thus, a device is introduced including a leaflet fastener applicator through a cardiac catheter or other suitable catheter. The leaflet fastener applicator and cardiac catheter can be formed into a kit. A gripper can be used to hold the heart valve leaflets while they are fastened.

A process and system for compressing bioprosthetic tissue for use in medical implants. The process involves placing the tissue between two compressive surfaces and applying a force to reduce any nonuniformity of thickness in the tissue, while at the same time reduce the overall thickness. One particularly useful application is the compression of bioprosthetic sheet during the preparation of heart valve leaflets. Bovine pericardium may be compressed to reduce its thickness by about 50%, and then formed into heart valve leaflets. The thinned leaflets have substantially the same absolute strength as those made from uncompressed tissue, and are particular desirable for use in minimally invasive valves which must be compressed into a small profile. The thin tissue enables a reduction in the overall size of the minimally invasive heart valve for delivery. For instance, rolled MIS valves may be reduced in size to as small as 20 mm in diameter. Desirably, a cross-linking step is combined with the compression step to fix the reduced thickness of the tissue. One apparatus may include porous compression substrates through which a cross-linking solution may diffuse so as to perform the fixation and compression simultaneously.

Tissue shaping methods and devices are provided for reinforcing and / or remodeling heart valves. In certain embodiments, magnetic tissue shaping devices are implanted in tissue adjacent heart valve leaflets. The devices are mutually attractive or repulsive so as to remodel the heart tissue and improve heart valve function. In certain other embodiments, one or more tissue shaping devices including shape memory material are implanted in a patient's body within or on tissue adjacent a heart valve leaflet. The shape memory material can be activated within the patient in a less invasive or non-invasive manner, such as by applying energy percutaneously or external to the patient's body. The shape memory tissue shaping devices are implanted in a first configuration and then activated to remember a second configuration that displaces tissue so as to remodel the heart valve geometry and improve heart valve function. In certain other embodiments, a brace is crimped to the base of a heart valve leaflet to support the leaflet and improve valve closure.

A valve prosthesis is adapted to operate in conjunction with native heart valve leaflets. The prosthesis includes an annulus and a skirt extending from the annulus. The skirt may be configured to be positioned through a native heart valve annulus, and the skirt may be movable between an open configuration permitting blood flow through the skirt and a closed configuration blocking blood flow through the skirt in cooperation with opening and closing of the native heart valve leaflets.

Devices, systems and methods retain a native heart valve leaflet to prevent retrograde flow. The devices, systems, and methods employ an implant that, in use, rests adjacent a valve annulus and includes a retaining structure that is sized and shaped to overlay at least a portion of one or more native valve leaflets. The retaining structure retains the leaflet or leaflets it overlays, to resist leaflet eversion and / or prolapse. In this way, the implant prevents or reduces regurgitation. The implant does not interfere significantly with the opening of and blood flow through the leaflets during periods of antegrade flow.

Disclosed are methods and devices for determining valve leaflet orientation. A catheter is provided with a conformable, radiopaque target. The target is deployed within a valve, such as the mitral valve. The conformable target conforms to the coaptation axis in response to closing of the valve leaflets. That coaptation axis may then be visualized, and utilized to determine information about valve operation, or to assist in placement of devices in the vicinity of the valve.

A heart valve and tissue repair device for independently, selectively and sequentially grasping heart valve leaflets and independently, selectively and sequentially applying one or more fasteners thereto is disclosed. The device includes a leaflet engaging tip having one or more graspers capable of individually and sequentially grasping leaflets, and one or more deployable fasteners capable of fastening the leaflets. An actuation system for the device individually and selectively controls the graspers and deploys the one or more fasteners. Vacuum pressure from an external vacuum source can be used to grasp the leaflets via a selector system that controls the actuation system so as to individually and sequentially apply vacuum force to the graspers.

The invention is an apparatus, system, and method for repairing heart valves. A suture line is secured to a papillary muscle, and then passed through a portion of a heart valve leaflet. A reference element is provided at a desired distance from a plane defined by the heart valve annulus. The suture line is secured to the heart valve leaflet at a position adjacent the reference element. The reference element may part of a device configured for placement on or in a heart valve annulus. The reference element may be slidingly secured to the device so that the distance of the reference element from the main body of the device can be varied by a surgeon or other user. The reference element may be a line of suture, which may be pre-installed during manufacture of the device or may be installed by the surgeon or other user.

According to one aspect, heart valve leaflet removal apparatus of the present invention comprises a pair of cooperating cutting elements, a holder and members for manipulating the cutting elements. The cooperating cutting elements are adapted for cutting and removing leaflets from an aortic valve in a patient's heart, one of the cutting elements is rotatably coupled the other of the pair of cutting elements. The holder is coupled to one of the cutting elements and is adapted to receive the cut leaflets and the cutting elements and holder are configured for delivery to the valve leaflets through an aortotomy formed in a patient's aorta. In one variation, the pair of cooperating cutting elements and holder have a radial dimension and are radially collapsible. Replacement valve delivery apparatus also is provided.

A computational technique to construct a 3-D valve leaflet geometry. The invention pertains to methodology to construct a 3-D heart valve leaflet geometry using finite element analysis (FEA) to simulate the manual assembly process or, in other words, provide a virtual assembly process as an input to a subsequent simulated valve testing step. The simulated valves may be subjected to simulated cyclic valve opening and closings and the stress levels induced therein monitored. Simulated valve designs with lower principal stresses can then be selected for prototyping. Proposed valves can be subjected to cyclic fatigue stress testing under simulated physiologic conditions to study valve durability.

Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve. One apparatus for testing the leaflets includes a frame for securing the arcuate cusp of the leaflet while the straight coapting edge remains free, to simulate the actual leaflet mounting configuration within the heart valve prosthesis. The frame may include a lower portion having a recess for the leaflet and plurality of receptor holes around the peripheral edge of the recess, and an upper portion having a plurality of needles which extend downward through the leaflet and into the receptor holes and secure the edges of the leaflet.

A heart valve and tissue repair device for independently, selectively and sequentially grasping heart valve leaflets and independently, selectively and sequentially applying one or more fasteners thereto is disclosed. The device includes a leaflet engaging tip having one or more graspers capable of individually and sequentially grasping leaflets, and one or more deployable fasteners capable of fastening the leaflets. An actuation system for the device individually and selectively controls the graspers and deploys the one or more fasteners. Vacuum pressure from an external vacuum source can be used to grasp the leaflets via a selector system that controls the actuation system so as to individually and sequentially apply vacuum force to the graspers.

Devices, systems and methods retain a native heart valve leaflet to prevent retrograde flow. The devices, systems, and methods employ an implant that, in use, rests adjacent a valve annulus and includes a retaining structure that is sized and shaped to overlay at least a portion of one or more native valve leaflets. The retaining structure retains the leaflet or leaflets it overlays, to resist leaflet eversion and / or prolapse. In this way, the implant prevents or reduces regurgitation. The implant does not interfere significantly with the opening of and blood flow through the leaflets during periods of antegrade flow.

Methods and devices for repairing a cardiac valve. A minimally invasive procedure includes creating an access in the apex region of the heart through which one or more instruments may be inserted. The device can implant artificial heart valve chordae tendineae into cardiac valve leaflet tissues to restore proper leaflet function and prevent reperfusion. The device punctures the apex of the heart and travels through the ventricle. The tip of the device rests on the defective valve and punctures the valve leaflet. A suture or a suture / guide wire combination is inserted, securing the top of the leaflet to the apex of the heart. A resilient element or shock absorber mechanism adjacent to the outside of the apex of the heart minimizes the linear travel of the device in response to the beating of the heart or opening / closing of the valve.

A valve prosthesis is adapted to operate in conjunction with native heart valve leaflets. The prosthesis includes an annulus and a skirt extending from the annulus. The skirt may be configured to be positioned through a native heart valve annulus, and the skirt may be movable between an open configuration permitting blood flow through the skirt and a closed configuration blocking blood flow through the skirt in cooperation with opening and closing of the native heart valve leaflets.

A clip used to repair the tissue of a heart valve leaflet may include a shaft having a barb and a plurality of legs connected to the shaft. The plurality of legs may extend away from the barb in a first condition, and may extend towards the barb in a use condition. The clips may be delivered to the heart valve leaflet and applied to the same in a minimally invasive procedure using a transcatheter device. The device may be used to apply a single clip to the leaflet tissue or multiple clips.

The invention provides a heart valve leaflet capture device (250) comprising a cardiac catheter probe having a proximal end for manipulating the device (250) and a distal end terminating in a transvalve element (256). The transvalve element (256) is configured to pass through a heart valve generally parallel to a longitudinal axis of the catheter and includes two or three leaflet gripping elements (252). The leaflet gripping elements (252) are individually movable by operation of an associated actuating mechanism (260) between a radially retracted position, in which they are withdrawn with respect to the transvalve element (256), and a capture position, in which they diverge outwardly at an acute angle from the transvalve element (256). In the capture position, each leaflet gripping element (252) defines a convergent capture zone that is directed towards the edges of a target valve leaflet and in which the target valve leaflet may be captured.

The invention relates to a system for testing heart valve leaflets. The system includes a leaflet support assembly with a support post for receiving and supporting a leaflet to be tested, the post being disposed in a target region of the support assembly. The system also has a transmitter assembly that includes a light source and is configured and arranged to direct light from the light source onto the target region. The system further includes a receiver assembly that has an image sensor configured and arranged to sense an image of the target region and generate image information indicative of the sensed image, such as leaflet droop.

An apparatus for gathering of tissue of a heart valve leaflet comprises an elongated member and a grasping assembly movable in the elongated member between a retracted position and an extended position. The grasping assembly includes an actuating arm having a proximal end and a distal end. The grasping assembly is attached to the distal end of the activating arm. The grasping assembly is operable to gather and clamp the tissue of the heart valve leaflet such that clamped tissue has a gathered configuration.

The invention relates to a system for repairing a heart valve comprising a catheter, said catheter comprising an engagement member, the engagement member having at its distal end a hook capable of engaging with the surface of a prolapsed heart valve leaflet; and a fastener capable of deploying a fastening means to said leaflet.

The various aspects of the invention pertain to devices and related methods for treating heart conditions, including, for example, dilatation, valve incompetencies, including mitral valve leakage, and other similar heart failure conditions. The devices and related methods of the present invention operate to assist in the apposition of heart valve leaflets to improve valve function. According to one aspect of the invention, a method improves the function of a valve of a heart by placing an elongate member transverse a heart chamber so that each end of the elongate member extends through a wall of the heart, and placing first and second anchoring members external the chamber. The first and second anchoring members are attached to first and second ends of the elongate member to fix the elongate member in a position across the chamber so as to reposition papillary muscles within the chamber. Also described herein is a method for placing a splint assembly transverse a heart chamber by advancing an elongate member through vasculature structure and into the heart chamber.