JP2020506007A - Method and system for assisting or repairing a prosthetic heart valve - Google Patents

Abstract

A method for facilitating valve coaptation in a patient, the method comprising: identifying a defective prosthesis in a prosthetic valve implanted in the patient; Implanting a single prosthetic leaflet of the valve assist device, wherein the single valve leaflet moves in conjunction with the defective prosthetic leaf and responds to blood flow through the prosthetic valve. Thus, the defective prosthesis is joined to the functioning prosthesis opposite to the defective prosthesis. In one embodiment, the prosthetic valve is implanted in a heart valve in the patient.

Description

(Cross-reference of related applications)
No. 62 / 570,336 (Attorney Docket No. 49792-704.102), filed Oct. 10, 2017 and No. 62 / 455,427 (Attorney Docket No. 49792). 704.101), claiming priority on filing date February 6, 2017, the entire disclosure of which is incorporated herein by reference.

  The subject matter of this application is related to the subject matter of U.S. Patent Application No. 14 / 901,468 (Attorney Docket No. 49792-702.201), filed December 28, 2015, which is the subject of PCT application PCT / IB2014 / 002155 (Attorney Docket No. 49792-703.601), filed on June 13, 2014 in the United States, which is a provisional patent application Ser. No. 61 / 956,683 (Attorney Docket No. 49792). -703.101), filing date June 14, 2013; No. 61 / 963,330 (Attorney control number 49792-703.102), filing date December 2, 2013; and 61 / 982,307 No. (Attorney Control Number 49792-703.103), which claims the benefit of the filing date of April 21, 2014, the entire disclosure of which is incorporated by reference. It is incorporated herein by reference.

  The present invention relates generally to medical devices and methods. More specifically, the present invention relates to prosthetic devices and methods for improving the function of a protruding heart and other circulation valves.

  Unilateral (primary) or functional (secondary) mitral valvular dysfunction (MVI), such as, but not limited to, prolapse, regurgitation, and eccentricity, can be attributed to individual valve leaflet maljunction and back. A valvular heart disease characterized by the displacement of abnormally thickened mitral leaflets into the left atrium during systole, which can result in valve leakage to pressure. There are various types of MVI that are broadly classified as classical and non-classical. In a non-classical form, MVI has a low risk of complications and can often be kept to a minimum by dietary considerations. In severe cases of classic MVI, complications include mitral regurgitation, infective endocarditis, congestive heart failure, and, in rare circumstances, heart failure that usually results in sudden death. The aortic valve can also suffer from prolapse and the venous circulation valve can suffer from similar symptoms that can lead to chronic venous insufficiency resulting from damaged or "dysfunctional" valves characterized by poor junctions.

  Apparatus for improving valve function in a patient suffering from any of the above identified conditions, and in particular, for improving the junction of heart and venous valves, including both mitral and aortic valves It would be desirable to provide methods and methods. At least some of these objectives will be met by the inventions described hereinafter.

  U.S. Patent Nos. 6,419,695, 6,869,444, and 7,160,322 and U.S. Patent Publications 2012/0197388 and 2013/0023985 all have disclosures relating to the present invention. .

U.S. Patent No. 6,419,695 US Patent No. 6,869,444 US Patent No. 7,160,322 US Patent Publication No. 2012/0197388 US Patent Publication No. 2013/0023985

  Descriptions of prosthetic valve devices and methods of implantation are provided. The present invention generally provides medical devices, systems, and methods that are often used for the treatment of other valvular disorders, including mitral and tricuspid regurgitation.

  The prosthetic valve device consists of a support ring frame, a fastener, or a single cusp sutured to an arcuate structure. The ring frame (hereinafter referred to as the device ring) is radially self-expandable so that it can expand against the atrial wall. The valve device leaflets (hereinafter referred to as the device body) are made from the pericardium or other biological or artificial material and are shaped like natural target leaflets. The device body is sized larger than the target apex such that after implantation, a significant overlap of the device body occurs.

  The invention described herein generally consists of a percutaneous transcatheter delivery system, wherein the joining assist device and the implantable device body can exhibit both a delivery and a working configuration, wherein the delivery configuration comprises: It is small enough to allow delivery to the implantation site via a percutaneous transcatheter.

  The device ring is generally made of a metal (eg, Nitinol), a polymer (eg, polyurethane), or an organic (eg, pericardium). At the treatment site, the device ring is generally secured to the annular base of the target valve by an anchor that can be part of or separate from the device itself.

  The device body generally has an embedding skeleton made of metal, synthetic, or organic, and with a lower step specifically designed to prevent the device body from shrinking out In some embodiments, they are made from synthetic materials (eg, Dacron or polyurethane) or organic materials (eg, pericardium).

  The device body is generally positioned in the direction of the atrioventricular chamber along the blood flow path, such as the cusp of a natural valve, for reciprocating movement between an open and closed configuration.

  During implantation, the device ring should be positioned close to the target valve stoma from the atrial side (eg, via a transseptal approach). After insertion of the device, the cusps of the device body move synchronously with the target leaflets in the bloodstream. In systole after closure of the target valve, the overlap of the device body will be stopped by the opposite cusp edge of the target valve. Thereby, the device overlaps the effective reflux area (ERO) and minimizes or eliminates valve regurgitation.

  The device body is disposed between the natural cusps, thereby providing a surface that is joined to at least one of the natural cusps, to close or reduce the gap caused by the poor attachment of the natural cusps. On the other hand, it effectively replaces the function of the second natural cusp within the area of the valve, which will occlude during systole.

  Among other uses, the joining assist devices, device body implants, and methods described herein create an artificial joining area where at least one of the native mitral leaflets can seal. , May be configured to treat functional and / or degenerative mitral regurgitation (MR). Although the structures and methods herein will be greatly tailored to the application, alternative embodiments include a tricuspid valve, a peripheral vasculature valve, an inferior aorta, or an equivalent heart and / or method. It may be configured for use in other valves of the body.

  In a first specific aspect, the present invention is directed to an anchor configured to be mounted on a natural annulus and an upper surface of the first natural leaflet when the anchor is mounted on the natural annulus. A prosthetic valve joining assist device, including a single valve assisting leaflet configured to be placed over the valve. The single valve leaflet is sufficiently flexible to move in conjunction with the first natural leaflet and to mate with the second natural leaflet in response to blood flow through the valve. In this way, valve escape is reduced and leakage can be minimized.

  In some embodiments of the prosthetic valve joining assist device, the anchor is configured to self-expand to attach to the native annulus. In other embodiments, the anchor may be configured to be sutured to the natural annulus. For anchors that involve both self-expansion and suturing, the anchors may also be configured to completely or partially surround the annulus. Anchors that partially surround the annulus will often have barbs or other tissue penetrating elements that help hold the anchors in place, but the barbs may also be on the completely surrounding anchor. May be included.

  The anchor may be formed from a metal, polymer, or other biocompatible material that has sufficient strength to remain attached to the annulus indefinitely after implantation. The valve assist leaflets are typically a flexible material that can be of the type that is used in the tissue being treated to help stabilize, for example, myocardium and artificial heart valves such as various synthetic polymers. Will be formed from The valve assist cusp may also be reinforced with a metal or polymer reinforcement structure attached over all or a portion of one or both surfaces of the cusp.

  In a second specific aspect of the invention, a method for facilitating valve joining in a patient comprises, for example, using a conventional ultrasound or other imaging technique to identify a protruding valve in the patient. Including the step of identifying. A single prosthetic valve leaflet is implanted over the upper surface of the first natural leaflet of the protruding valve. The single leaflet will move in conjunction with the first natural leaflet and will interface with the second natural leaflet in response to blood flow through the valve. In this way, valve escape is reduced and leakage can be minimized.

  In some embodiments of the method for promoting valve conjugation of the present invention, the native valve may be a heart valve, such as a mitral or aortic valve. In other embodiments, the natural valve may be a venous valve, typically a peripheral venous valve.

  The step of implanting may include implanting a single prosthetic leaflet in an open surgical procedure, but more typically, a single prosthetic leaflet, as illustrated in detail below. It may involve advancing into the blood vessel, transseptally or transapically.

  When introduced into a blood vessel, transseptally, or transapically, the step of implanting typically involves self-expanding an anchor coupled to a single prosthetic leaflet within the native annulus. The anchor may be expanded to completely surround the annulus or may be expanded to partially surround the annulus. In both cases, particularly when the anchor partially surrounds the annulus, the anchor may pierce the natural annulus as the anchor expands to help secure the anchor to the annulus, one or more barbs or Other tissue penetrating elements may be included. Alternatively, in some cases, the step of implanting may include suturing an anchor coupled to the single leaflet to the native annulus.

  In a third specific aspect of the present invention, a method for delivering a prosthetic valve joining assist device to a native valve site comprises an anchor and a single prosthetic valve leaflet constrained within the delivery device. Providing a bonding assist device. The delivery device is advanced to the native valve site and the prosthetic valve joining assist device is deployed from the delivery device to the native valve site. The prosthetic valve joining assist device has an anchor that expands within the natural annulus to position a single prosthetic valve leaflet over the top surface of the natural leaflet. The single leaflet will move in conjunction with the first natural leaflet and will interface with the second natural leaflet in response to blood flow through the valve. In this way, valve escape is reduced and leakage can be minimized.

  In some embodiments of the method for delivering a prosthetic valve joining assist device, the native valve may be a heart valve, such as a mitral or aortic valve. In other embodiments, the natural valve may be a venous valve, typically a peripheral venous valve.

  The advancing step may include advancing a single prosthetic leaflet intravascularly, transseptally, or transapically, as exemplified in detail below.

  The deploying step typically involves constraining the prosthetic valve joining assist device such that the anchor self-expands within the native annulus and holds a single prosthetic leaflet in place over the first native leaflet. Will be included. The anchor may self-expand to completely surround the annulus. Alternatively, the anchor may self-expand to partially surround the annulus. In any case, particularly in the case of partial expansion, the anchor may include one or more barbs that penetrate the natural annulus as the anchor self-expands.

The drawings in this application use the following reference numbers.

FIG. 1 illustrates a first embodiment of a prosthetic prosthesis device constructed in accordance with the principles of the present invention.

2A and 2B illustrate a prosthetic apposition device implanted in the mitral valve position of the mitral valve as seen from the left atrium during mid-diastole (FIG. 2A) and mid-systole (FIG. 2B). . 2A and 2B illustrate a prosthetic apposition device implanted in the mitral valve position of the mitral valve as seen from the left atrium during mid-diastole (FIG. 2A) and mid-systole (FIG. 2B). .

FIG. 3 illustrates from a side view a prosthetic assist device implanted within the mitral valve, as seen from the left atrium during mid-diastole.

FIG. 4 is a perspective view of a prototype of a pair of mitral valve assist devices fabricated from a polymer.

FIGS. 5A and 5B are perspective views of a reinforced polymeric prosthetic prosthesis device obtained from the left atrium of a pig during simulated mid systole (FIG. 5A) and mid diastole (FIG. 5B). FIGS. 5A and 5B are perspective views of a reinforced polymeric prosthetic prosthesis device obtained from the left atrium of a pig during simulated mid systole (FIG. 5A) and mid diastole (FIG. 5B).

FIG. 6A illustrates a strap for attaching the cusp assist device to the mitral annulus.

FIG. 6B illustrates the apical assist device of FIG. 6A compressed into a catheter for transdermal delivery.

FIG. 7A illustrates the distal portion of a valve assist device configured within a delivery catheter for delivery.

FIG. 7B illustrates the tip assist device of FIG. 7A in its deployed configuration.

FIG. 8 illustrates a device strap with a median anchor element and a lateral anchor element on the anchor strap.

FIGS. 9, 10A, 10B, and 11 illustrate alternative device strap designs. FIGS. 9, 10A, 10B, and 11 illustrate alternative device strap designs. FIGS. 9, 10A, 10B, and 11 illustrate alternative device strap designs. FIGS. 9, 10A, 10B, and 11 illustrate alternative device strap designs.

FIG. 12 is a perspective view of an alternative mitral valve assist device as seen from the left atrium after deployment into the pig heart.

FIG. 13 is a perspective view, similar to that shown in FIG. 11, of a further alternative mitral valve assist device shown in a deployed state.

FIGS. 14, 15, and 16 depict aspects of a deployment system that includes yet another alternative apical assist device and guide catheter. FIGS. 14, 15, and 16 depict aspects of a deployment system that includes yet another alternative apical assist device and guide catheter. FIGS. 14, 15, and 16 depict aspects of a deployment system that includes yet another alternative apical assist device and guide catheter.

FIG. 17A illustrates a side cross-sectional view of the anchoring portion of the mitral valve assist device after the assist device has been released from the delivery catheter, but prior to activation of the anchor.

FIG. 17B illustrates the device of FIG. 17A after deployment of the anchor.

FIG. 18 is a cross-sectional view illustrated in a fully deployed configuration of the mooring portion useful with the embodiment of FIGS. 14-17A and 17B.

FIGS. 19A, 19B, 19C, and 19D illustrate a delivery system that includes another alternative mitral valve assist device and a delivery catheter that is visualized at various stages during the delivery cycle. FIGS. 19A, 19B, 19C, and 19D illustrate a delivery system that includes another alternative mitral valve assist device and a delivery catheter that is visualized at various stages during the delivery cycle. FIGS. 19A, 19B, 19C, and 19D illustrate a delivery system that includes another alternative mitral valve assist device and a delivery catheter that is visualized at various stages during the delivery cycle. FIGS. 19A, 19B, 19C, and 19D illustrate a delivery system that includes another alternative mitral valve assist device and a delivery catheter that is visualized at various stages during the delivery cycle.

FIG. 20 illustrates a mitral valve assist device similar to that of FIG. 19, but carried on three coupled delivery catheters.

FIGS. 21A, 21B, 21C, and 21D illustrate an alternative embodiment of a coupling element that terminates in an anchoring mechanism used to attach a mitral valve assist device to the myocardium. FIGS. 21A, 21B, 21C, and 21D illustrate an alternative embodiment of a coupling element that terminates in an anchoring mechanism used to attach a mitral valve assist device to the myocardium. FIGS. 21A, 21B, 21C, and 21D illustrate an alternative embodiment of a coupling element that terminates in an anchoring mechanism used to attach a mitral valve assist device to the myocardium. FIGS. 21A, 21B, 21C, and 21D illustrate an alternative embodiment of a coupling element that terminates in an anchoring mechanism used to attach a mitral valve assist device to the myocardium.

FIG. 22 illustrates a device formed from a molding having a peripheral stiffener.

Figures 23A and 23B show a cross section of the screw anchor system. Figures 23A and 23B show a cross section of the screw anchor system.

Figures 23C and 23D illustrate the delivery and operative configuration of the screw anchor element of Figures 23A and 23B, respectively. Figures 23C and 23D illustrate the delivery and operative configuration of the screw anchor element of Figures 23A and 23B, respectively.

FIG. 24 illustrates one embodiment of a steerable delivery catheter for a coupling element.

FIG. 25 illustrates a steerable delivery catheter delivering a device to a target area via an intravascular transseptal approach from the inferior aorta.

FIG. 26 shows a steerable delivery catheter delivering a device to a target area via an intravascular artery delivery approach.

FIG. 27 shows a steerable delivery catheter delivering a device to a target area via a transapical approach.

FIG. 28 shows a mitral valve having flexible stiffeners present within the circumference of the mitral valve assist device body to minimize upward displacement of the mitral valve assist device during mitral valve closure 3 illustrates an auxiliary device.

FIG. 29 illustrates a cross-sectional view of a heart having a tip assist or repair device installed therein to assist or repair a defective artificial tip, according to many embodiments.

FIG. 30 illustrates a cross-sectional view of a heart with a cusp assist device installed therein to assist a previously installed prosthetic annulus, according to many embodiments.

31A, 31B, 31C, and 31D show a back perspective view, a front perspective view, and a side view, respectively, of a point assist device, according to many embodiments. 31A, 31B, 31C, and 31D show a back perspective view, a front perspective view, and a side view, respectively, of a point assist device, according to many embodiments. 31A, 31B, 31C, and 31D show a back perspective view, a front perspective view, and a side view, respectively, of a point assist device, according to many embodiments. 31A, 31B, 31C, and 31D show a back perspective view, a front perspective view, and a side view, respectively, of a point assist device, according to many embodiments.

FIGS. 32A and 32B show top views of a mitral valve and an annulus with a cusp fixation device and a cusp assist device attached thereto, according to many embodiments. FIGS. 32A and 32B show top views of a mitral valve and an annulus with a cusp fixation device and a cusp assist device attached thereto, according to many embodiments.

33A and 33B show top views of a mitral valve and an annulus with a cusp fixation device and a cusp assist device attached thereto, according to many embodiments. 33A and 33B show top views of a mitral valve and an annulus with a cusp fixation device and a cusp assist device attached thereto, according to many embodiments.

FIG. 34 illustrates a perspective view of a point assist or repair device, according to many embodiments.

FIG. 35 illustrates a cross section of a mitral valve with a semi-flexible cusp assist device installed therethrough, according to many embodiments.

FIG. 36 illustrates a cusp for a cusp assist device, according to many embodiments.

FIGS. 37, 38, 39, and 40 show top views of a mitral valve with a cusp assist device attached, according to many embodiments. FIGS. 37, 38, 39, and 40 show top views of a mitral valve with a cusp assist device attached, according to many embodiments. FIGS. 37, 38, 39, and 40 show top views of a mitral valve with a cusp assist device attached, according to many embodiments. FIGS. 37, 38, 39, and 40 show top views of a mitral valve with a cusp assist device attached, according to many embodiments.

  FIG. 1 improves the function of the device ring 101 and the native (eg, mitral valve) leaflet, which serves as an anchor for attachment to tissue near or at the mitral or other annulus. 7 depicts a surgically and / or percutaneously deliverable artificial apex assist device 100 having a device body or artificial apex 102 for performing the operation. The apex material is selected from any of a synthetic biocompatible polymer such as Dacron or polyurethane or a treated natural fixation material such as pericardium or / and other materials known in the art for use in implantable valves. You may. The device ring is generally made of a metal (eg, Nitinol) or a polymer such as polyurethane. In some embodiments, the cusp is sutured to the ring when the cusp is comprised of a natural fixation material. When the cusps are comprised of a polymeric material, they may be attached to the device ring through suturing, molding, or use of an adhesive. Alternatively, the device ring may be penetrated. The flexible cusps 102 interface with the natural cusps.

  FIG. 2A depicts the device in mitral valve position, as seen from the left atrium during mid-diastole. The device ring 201 interfaces with the left annulus around the anterior mitral valve leaflet 204 and the left ventricle 205 can be seen through the open valve. The device leaflet 202 sits opposite the posterior leaflet 203 and over the anterior mitral leaflet 204. FIG. 2B depicts the device during mid systole.

  FIG. 3 illustrates the device in a mitral valve position during mid diastole from a side view. The device ring 301 in the left atrium 306 holds the device body or cusp 302 opposite the posterior mitral leaflet 303 and across the anterior mitral leaflet 304, which extends into the left ventricle 305. And is captured at the overlap 307 between the two mitral leaflets. Chordae and papillary muscles 308 inhibit the natural apex. Atrial septum 309 and ventricular septum 310 are also shown.

  FIG. 4 shows two mock-up variants of a mitral valve assist device fabricated from a polymer. As depicted, device body 402 is attached to polymer ring 401. Alternatively, device ring 401 and device body 402 may be molded as a complete device. As shown, the device body is made in two different sizes to accommodate different sized native mitral valves.

  FIG. 5A shows a middle diastole of a mitral valve assist device comprising a device ring 401 and a device body 402 sutured into the left mitral valve annulus above the mitral leaflet 504 of the pig heart. FIG. 4 shows a top view from the left atrium in between. The mitral valve assist device is oriented so that the device body sits over the anterior mitral valve leaflet 503 opposite the anterior mitral valve leaflet. Left ventricle 505 is visible through the release valve. FIG. 5B shows the same valve during metaphase.

  FIG. 6A illustrates a device strap 611 that provides an alternative for attaching the cusp assist device to the mitral annulus. This arrangement does not require that the valve ring be sutured to the annulus, thereby facilitating a simpler percutaneous means of attaching the cusp assist device. The device strap 611 comprises a median or intermediate anchor 622 and two side anchors 623. Anchors are “barbed” structures designed to puncture heart tissue and lock the device strap in place. FIG. 6B depicts an apical assist device 600 configured for transdermal delivery with an anchor strap 611. The device main body 602 is wound around a device strap 611 folded in half by a median anchor 622. A mitral valve assist device is at the distal end of the delivery catheter that can be constrained within the delivery catheter 613 and attached to or separated from the guide catheter 612. Once attached, removal means are provided, such as the use of an electrolysable joint as is known in the art for releasing an arterial stent. The strap may be made of Nichirol or other suitable resilient material. In response to delivery to the atrium, the device 600 is pushed from within the delivery catheter 613 and the guide catheter 612 forces the median anchor 622 into the mitral annulus tissue. The delivery catheter is then moved proximally to release the lateral anchor 623 and valve body 602. As the lateral anchors expand upon release, they bury themselves in the ring tissue.

  FIG. 7A illustrates the distal portion of the valve assist device 700 as configured in a delivery catheter 713 for delivery. The device strap 713 is bent during delivery at its midpoint between two sharp projections with a median anchor 722. As the device is pushed into the myocardium 721 and released from the delivery catheter 713, the sharp protrusion 722 of the median anchor expands to lock the median anchor into the myocardium 721 and the lateral sharp protrusion 723 Puncture myocardium. FIG. 7B illustrates the apex assist device 700 in its deployed configuration.

  FIG. 8 illustrates one version of a device strap in which a median anchor element 822 and a lateral anchor element 823 are provided on an anchor strap 811. The device strap of FIG. 8 is short enough not to require a curved shape that matches the hoop.

  Figures 9, 10A, 10B, and 11 represent alternative designs for device straps. FIG. 9 includes a device strap fabricated from wire (such as Nichirol or similar material capable of withstanding high strain). A median anchor element 922 is provided on an anchor strap 911 on a spring element 927. When in the delivery configuration, the side anchors 923 are pulled together against each other and the spring element 927 is compressed to open the intermediate anchor element. During delivery, the open median anchor is pushed against the myocardium, and the delivery catheter is then pulled back to release the lateral anchor 923, which in turn closes the median anchor element, thereby Allows the tissue to be grasped. In response to release from the delivery catheter, the lateral anchors 923 additionally swing toward a position that penetrates into the myocardial tissue.

  10A and 10B depict an alternative device strap 1011 in a delivered configuration as in FIG. 10A and a deliverable configuration as in FIG. 10B. The device strap 1011 includes a hinge element 1028 at the center of the median anchor element 1022. The hinge element in some embodiments is deployed such that, in response to the transition from the deployable configuration of FIG. 10B to the deployed configuration of FIG. 10A, the strap is locked with the median anchor in the gripped configuration. A locking mechanism so as to be locked in the configuration. In some embodiments, a spring is used to urge the device strap into the deployed configuration in response to release from the delivery catheter. In other embodiments, the device strap 1011 is manipulated and locked into the deployed configuration in response to release from the delivery catheter.

  FIG. 11 is an image of a prototype mitral valve assist device 1100. The device main body 1102 is processed from Dacron felt, and the device strap 1111 is processed from stainless steel wire. In the images, the intermediate anchors 1122 are bent 90 ° laterally from their delivery configuration for visibility. The device straps 1111 held in place between the Dacron layers are glued as shown. In alternative embodiments, the layers may be treated by suturing, solvent welding, heat welding, ultrasonic welding, or other suitable means.

  In FIG. 12, an alternative mitral valve assist device 1200 is shown as seen from the left atrium after deployment. In this embodiment, the device strap consists of a stainless steel wire similar to that of FIG. In this configuration, the lateral anchors comprise a pair of anchors on each end of the anchor strap 1211 and a pair of median anchors 1222 oriented downward, all of which are hooked into the myocardial tissue 1221. . In this embodiment, the device main body 1202 is attached to the device strap 1211 by winding a part of the device main body around the device strap and locking it in place using a suture. The lateral anchors 1223 are compressed together to minimize their effect on suppressing the movement of the affected myocardial tissue.

  In FIG. 13, another alternative mitral valve assist device, similar to that shown in FIG. 11, is shown in a deployed state. The mitral valve assist device 1300 differs from that of FIG. 12 in that there is only one median anchor 1322 and the lateral anchor 1323 has been widened to increase their hook into the myocardium. different.

  14-16 depict aspects of yet another alternative apical assist device 1400 and deployment system provided within a guide catheter 1412. FIG. FIG. 14 illustrates the mitral valve assist device 1400 in a delivery configuration within a delivery catheter 1413 affixed to the distal end of a guide catheter 1412 incorporating a delivery system. The valve body 1402 is pleated to facilitate loading within the delivery catheter 1413. The guide catheter and delivery system 1412 is attached to a central section or device strap 1411. FIG. 15 depicts the mitral valve assist device 1400 during deployment after release from the delivery catheter 1413. FIG. 15 depicts the device strap 1411 in its expanded deployment configuration, after release from the delivery catheter, with the valve body 1402 also open. The device strap is still attached to the guide catheter and delivery system 1412 and is viewed from the side. FIG. 16 illustrates the central mooring portion and mooring features of the device strap 1411. This section of the device strap is used to attach the mitral valve assist device 1400 to the guide catheter during delivery and to anchor the mitral valve assist device to the myocardium during deployment. The anchor portion of the device strap includes an anchor port 1414 and a guide catheter attachment feature 1415.

  FIG. 17A illustrates a side cross-sectional view of the anchoring portion of the mitral valve assist device 1400 as it is configured after the assist device has been released from the delivery catheter and the device body has been opened, but prior to activation of the anchor. I do. The anchoring portion of the auxiliary device consists of a device strap 1411 as described above, and the activatable anchor mechanism comprises the following features: a nail guide drive 1418, one or more anchor nails 1417, It comprises a nail guiding section 1419 and an anchor nail driving section 1416. The illustrated section includes a section where the anchor nail passes through the guide. All of these may be provided in a guide catheter 1420 attached to a device strap 1411 at a guide catheter mounting feature 1415. As shown, the guide catheter has been manipulated to direct the mechanism toward the myocardium 1721 near or at the mitral valve annulus. FIG. 17B illustrates the device after deployment of the anchor. The deployment of the anchor after proper alignment as depicted in FIG. 17 is achieved as follows. Anchor guide nail drive 1418 and anchor nail drive 1416 are simultaneously pushed out of guide catheter 1420 and into myocardial tissue until guide nail 1419 is seated against device strap 1411. Anchor nail drive 1416 is then pushed distally, pushing the anchor nail forward through nail guide 1419 and into the myocardium. The anchor nail is deformed as it passes through the nail guide, thereby locking the anchor nail in myocardial tissue.

  A cross section of an embodiment of a mooring portion similar to that of FIGS. 14 to 17A and 17B is illustrated in FIG. 18 in a fully expanded configuration. In this embodiment, only one drive is required to operate both the guide nail and the anchor nail. The mechanism relies on the increased force required to actuate the anchor nail against the penetration of the myocardium with the anchor assembly. During deployment, the anchor assembly, consisting of nail guide 1819 and anchor nail 1817, is pushed into the myocardium until the anchor assembly seats itself against the upper surface of device strap 1811. At this point, the sharp projection of the anchor nail is straight and contained within the straight portion of the nail guide. In response to seating, and thus the penetration of the myocardium, the actuation force is increased and the anchor nail 1817 is pushed through the nail guide, thereby deforming the distal end of the anchor nail as shown in FIG. Let it. The section shown in FIG. 18 has been rotated off the section incorporating the mounting location for the delivery catheter.

  FIGS. 19A to 19D illustrate another alternative mitral valve assist device and delivery system provided in a delivery catheter, visualized at various stages during the delivery cycle. FIG. 19A illustrates the distal end of the delivery system with the mitral valve assist device body 1902 wrapped around a set of delivery coupling elements (not visible) and partially pushed out of the delivery catheter 1913. Illustrated. In FIG. 19B, the mitral valve assist device body 1902 has been pushed completely out of the delivery catheter 1913 and has been partially expanded. In FIG. 19C, the illustrated mitral valve assist device 1900 is fully expanded and tethered to the coupling element 1924. The mitral valve assist device 1900 is now oriented 90 ° with respect to the delivery catheter, and the delivery coupling element 1924 is visible. In FIG. 19D, the mitral valve assist device 1900 pulls the delivery catheter against the mitral valve assist device or pushes the coupling element further out of the delivery catheter, and then the coupling element delivered from the delivery catheter Has been rotated by 90 ° by equalizing the length. In this manner, the orientation of the mitral valve assist device may be adjusted through an angular range to better facilitate alignment with the mitral valve annulus prior to attachment to the home position.

  FIG. 20 illustrates a mitral valve assist device similar to that of FIG. 19, but carried on three coupled delivery catheters 2024, which then uses an anchor attachment tool (not shown). Thus, it is attached to the anchor location 2029 via the mooring element in place.

  19 and 20 may be affixed in place by a number of different means. These include, but are not limited to, any of the following: The device may be properly placed within the mitral valve, followed by placement of the mitral annuloplasty zone (not shown). The annuloplasty band is then affixed in place to lock the mitral valve assist device between the annuloplasty band and the mitral valve wall. One such band that can be used in the present scheme is Edwards Lifesciences Corp. Valtech Cardioband available from (Irvine, CA). Alternatively, an anchoring element may be delivered via the second delivery catheter and used to anchor the attachment edge of the mitral valve assist device to the myocardium. Anchor elements include, but are not limited to, a helical anchor, including a cap, described in Rosenman, US Pat. No. 6,478,776, and Gross US Pat. Helical anchors as described in U.S. Pat. No. 725, expandable nail anchors as described herein, and staple anchors as described in Morales U.S. Pat. No. 6,986,775. May be any of

  In an alternative embodiment, the coupling element may be terminated within the anchoring mechanism, which is then used to attach the mitral valve assist device to the myocardium. FIG. 21 illustrates such a device. FIG. 21C is shown after the mitral valve assist device 2100 has been delivered from within the delivery catheter 2113, wherein the device body is unfolded and the steerable coupling element 2130 is in a plane parallel to the longitudinal axis of the delivery catheter. Being operated against. During deployment, the coupling location of the device will be aligned with or near the mitral valve annulus and they will be steered relative to the myocardium. In such a configuration, the terminal mooring mechanism may comprise any of the mooring means described herein above.

  A peripheral stiffener 2230 may be molded into the device body 2202 when the device body comprises a molding as shown in FIG. In addition to peripheral stiffeners 2230, bending stiffeners 2231 may be incorporated into the device body. Alternatively, the flexural stiffener may be provided along a longitudinal section of the device body. Such stiffeners in some embodiments will be sandwiched between the proximal and distal surfaces of the device body. The mitral valve assist device 2200 comprises a device body 2202 and a device strap 2211 with an anchor element 2238 deployed by an anchor driver 2225. After the helical anchor screw 2239 has been affixed into the myocardial tissue, the guide sheath 2232 and guide lock 2233 are removed, allowing for retrieval of the anchor element drive 2225.

  FIGS. 23A and 23B show a cross section of a screw anchor system 2342 comprising a screw anchor element 2334, screw anchor guide elements 2333 and 2332, and a screw anchor drive 2335. FIG. 23A shows the screw anchor drive 2335 located in, but not engaged with, the anchor drive slot 2338, and FIG. 23B shows the drive element engaged with the drive slot. Certain guidance systems consisting of a guidance element lock 2333 and a guidance element sheath 2332 facilitate alignment and engagement of the drive with the drive slot. These guide elements are removed along the lumen across the length of the drive element, through the screw drive anchor 2335, removing the guide lock 2333, and thus releasing the guide sheath 2332, allowing the guide and drive elements to After the mooring element has been deployed, it is removed from the assembly by allowing it to be removed from the mooring element. FIGS. 23C and 23D illustrate the delivery and operative configuration of the screw anchor element 2334, respectively, and the helical screw element 2339 uses a screw anchor drive 2335 as described above in FIGS. 23A and 23B. Be expanded.

  FIG. 24 depicts one embodiment of a steerable delivery catheter for a coupling element. Steering is accomplished by pulling the steering wire 2441, causing the catheter 2425 to flex. Alternative catheter steering systems known to those skilled in the art may also be employed.

  FIGS. 25-27 depict the delivery of a tip assist device as described herein using three different approaches. FIG. 25 shows a steerable delivery catheter delivering a device to a target area via an intravascular transseptal approach delivered from the inferior aorta. As shown, the distal end of delivery catheter 2513 has been passed through the septum between the left and right atrium. Thereafter, the mitral valve assist device is delivered from the delivery catheter, and the mitral valve assist device body is then positioned over the posterior mitral valve leaflet 2503 and between the anterior mitral valve leaflet and the posterior mitral valve leaflet. Orientation. A device strap 2511 is aligned with the left annulus around the posterior mitral valve leaflet 2504. A screw anchor system 2542 is then used to attach the mitral valve assist device in place. Delivery catheter 2513 as depicted in FIG. 25 is a steerable catheter as is known in the art. FIG. 26 depicts an intravascular artery delivery approach, and FIG. 27 depicts a transapical approach.

  FIG. 28 shows a flexible stiffening element 2831 provided around the mitral valve assist device body 2802 to minimize upward displacement of the mitral valve assist device during mitral valve closure. 3 illustrates a mitral valve assist device. The device body 2802 may be made of fibers, polymer sheets, or tissue, and the stiffening mechanism may be sutured in place as shown. In some cases, a biasing material for coating the stiffening element may be employed. The stiffening element may consist of a polymeric material, a superelastic material, or a combination of such materials.

  Referring to FIG. 29, a tip assist or repair device 2900 may be used to assist or repair a malfunctioning artificial tip FPL. A percutaneously delivered prosthetic mitral valve PMV, delivered over a native mitral valve NMV, may be repaired by attaching a cusp assist or repair device 2900 to the prosthetic valve support structure via a connector 2901. One such repair is illustrated in FIG. Such connectors 2901 may include anchors or anchor elements 622, 722, 822, 922, 923, 1122, 1222, 1223, 1322, 1323, 2238, 2334, 2332, 2333, 2235, and 2542, to name a few. It may be selected from any of those described herein. The tip assist or repair device 2900 may be similar to any of the artificial tip assist devices described herein, such as the device 100. For example, the tip assist or repair device 2900 may provide a surface to which a functioning artificial tip can join.

  Referring to FIG. 30, a cusp assist or repair device 3000 assists or repairs a malfunctioning natural cusp via attachment of the cusp assist or repair device 3000 to a prosthetic valve annulus APR previously installed in the heart. May be used for One such repair where a percutaneously delivered prosthetic annulus APR has been used to improve the performance of the mitral valve MV is illustrated in FIG. One cusp of the mitral valve MV may be further supported by attaching the cusp assist or repair device 3000 to the supporting prosthetic annulus APR via the connector 3001. Such connectors 3001 may include anchors or anchor elements 622, 722, 822, 922, 923, 1122, 1222, 1223, 1322, 1323, 2238, 2334, 2332, 2333, 2235, and 2542, to name a few. It may be selected from any of those described herein. The tip assist or repair device 3000 may be similar to any of the artificial tip assist devices described herein, such as device 100. For example, the tip assist or repair device 3000 may provide a surface to which a functioning natural tip can join.

  FIGS. 29 and 30 additionally show cardiac atria such as right atrium RA, left atrium LA, pulmonary valve PV, tricuspid valve TV, mitral valve MV, chordae CT, right ventricle RV, left ventricle LV, and diaphragm ST. Shows various natural anatomical features.

  31A through 31D illustrate features of a tip assist device 3100 that may include a direction sensitive stiffener, ie, two direction sensitive edge stiffeners 3105 and one direction sensitive central stiffener 3110. When the stiffeners 3105, 3110 are bent in an elastic direction 3121 as shown in FIG. 31C (such as when a force is applied in the direction indicated by arrow 3103), the directional stiffeners 3105, 3110 are The spaces or slices 3120 are open, providing the device with a curved section 3101 and thus from the multiple slices or spaces 3115 between the multiple raised sections 3120 such that stiffness is provided by the apex membrane portion of the device. It may be similar to that described herein above, except that it may be possible. In contrast, when the cusp is bent in a rigid direction 3125 (such as when a force is applied in the direction indicated by arrow 3123), the space is closed and the ascending section is added, as shown in FIG. 31D. Provides a stiffness.

  FIGS. 32A and 32B show attachment to a mitral valve annulus MVA of a mitral valve MV that has been repaired using a cusp anchoring device such as a mitral valve clip MC or suture (as shown in FIGS. 32A and 32B). Illustrated is a cusp assist device 3200, shown. In some cases, when the mitral valve clip MC or such a device is used, the improvement of the junction, and thus the reduction of regurgitation, may not be sufficient and / or over time and the mitral valve clip MC The improvement resulting from use may be reduced. In such a case, the cusp assist device 3200 may be used in conjunction with the mitral valve clip MC. In the configuration shown, the tip assist device 3200 may be mounted perpendicular to the junction axis of the tip by a connector 3201. FIG. 32A illustrates the valve MV in diastole when the cusp assist device is folded down to allow blood flow through the valve MV. FIG. 32B shows a mitral valve in systole in which the cusp assist device 3200 may be pushed upwards to stop the natural cusps from moving further upwards, thereby providing a shelf to improve the joint. The MV is illustrated.

  FIGS. 33A and 33B show a cusp assist device 3300 that has been previously treated with a cusp fixation device, in this case a mitral valve clip MC, configured to be attached to the mitral annulus MVA parallel to the junction axis. FIG. 18 illustrates another embodiment of a cusp assist device 3300 for use in a closed native mitral valve MV. As shown, the joining device 3300 may include two cusps 3301 such that one cusp is on each side of the cusp anchoring device. In some embodiments, the cusp assist device 3300 includes only one cusp 3301 for treating half of the joint. FIG. 33A illustrates the valve MV during diastole, and FIG. 33B illustrates the valve MV during systole.

  FIG. 34 shows a cusp assist device 3400 similar to that shown in 33B with a direction sensitive central stiffener 3403 and two cusps, a first cusp 3401a and a second cusp 3401b. 1 illustrates an embodiment. The direction-sensitive central stiffener 3403 may be similar to other direction-sensitive stiffeners described herein, and vice versa (eg, this may include multiple slices or one side on one side). (It may have space, promote bending in one direction and withstand bending in the other opposite direction).

  FIG. 35 illustrates a cross section of a mitral valve with a semi-flexible cusp assist device 3500 placed over the posterior mitral valve leaflet (PML) to join the anterior mitral valve leaflet (AML). The cusp assist device 3500 is anchored along the mitral valve annulus and can be anchored by any of the methods described elsewhere herein. Dashed line 3501 represents the level of natural and / or desired bending of the top of the natural cusp, described herein as the bending level when the valve is closed. In the mitral valve, this level will be at or near the maximum atrial level of the annulus.

  Such a cusp assist device may consist of pericardium, artificial tissue, or other synthetic material (ie, Dacron). The apex assist device 3500 includes a more rigid perimeter 3530. Perimeter 3530 may be stiffened by a seam applied to the rim. In some embodiments, the stiffener may be provided in a seam applied to an edge, such as a nitinol wire. In some embodiments, the tip assist device 3500 may consist of two layers and a seam around the perimeter 3530 used to attach the two layers. FIG. 36 illustrates such a cusp 3600 consisting of two layers of pericardium stitched together at a stiffened perimeter 3630.

  FIGS. 37-40 illustrate an embodiment of a cusp assist device that improves junction (as indicated by junction area CA) by placing a patch or barrier at or near the mitral valve bending level. I do. Typically, these devices will be set up so that they limit the movement of the natural cusp to levels at or below the bending level. Such a device may be used in combination with or independently of the device of FIG. 36 or other cusp assist devices described herein. Such devices may be attached by screws, staples, sutures, or any other suitable means, including any of those described herein above.

  FIG. 37 illustrates a cusp assist device 3700 consisting of a rectangular sheet 3710 placed just below the mitral valve bending level. Such a device would limit the movement of natural and / or other mitral valve assist devices to the level of their installation. As shown, the attachments 3720 of the tip assist device 3700 are at four corners. This will improve the joint of the valve by pushing a better joint and covering the area of poor joint.

  The embodiments of FIGS. 38 and 39 illustrate alternative joining devices 3800 and 3900, respectively, comprising a volume filling component. The volume filling components as illustrated herein are the spindle beads 3850 of FIG. 38 and the spherical beads 3950 of FIG. Such a volume filling component is anchored on anchors 3840 and 3940 by means as described elsewhere herein. In some embodiments, the volume filling components are resilient balloons that are in situ inflated; in other embodiments, they may be self-expanding. The bonding device 3800 may further include a sheet 3810 and an attachment 3820, as in the device 3700 illustrated in FIG. The bonding device 3900 may further include an attachment 3920, as in the device 3700 illustrated in FIG.

  FIG. 40 illustrates an embodiment where a cusp 3600, such as that described in FIG. 36, is used in combination with a cusp assist device 3700, such as that described in FIG.

  Although the cusp assist devices described herein are generally described in the context of a mitral valve, they can be used to enhance the performance of any in the circulatory system.

  While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The following claims define the scope of the invention, and methods and structures within the scope of these claims and their equivalents are intended to be covered thereby.

The deploying step typically involves constraining the prosthetic valve joining assist device such that the anchor self-expands within the native annulus and holds a single prosthetic leaflet in place over the first native leaflet. Will be included. The anchor may self-expand to completely surround the annulus. Alternatively, the anchor may self-expand to partially surround the annulus. In any case, particularly in the case of partial expansion, the anchor may include one or more barbs that penetrate the natural annulus as the anchor self-expands.
The present invention provides, for example, the following.
(Item 1)
A method for promoting valve conjugation in a patient, the method comprising:
Identifying a defective artificial cusp in a prosthetic valve implanted in the patient;
Implanting a single prosthetic valve prosthesis of the valve assist device over the top surface of the defective prosthetic device;
Including
The single valve leaflet moves in conjunction with the defective prosthesis and responds to blood flow through the prosthetic valve to a functioning leaflet opposite the defective leaflet. How to join.
(Item 2)
2. A method for promoting valve conjugation according to item 1, wherein the prosthetic valve is implanted into a heart valve in the patient.
(Item 3)
3. The method for promoting valve conjugation according to item 2, wherein the heart valve is a mitral valve or an aortic valve.
(Item 4)
2. The method for promoting valve conjugation according to item 1, wherein the prosthetic valve is implanted into a venous valve in the patient.
(Item 5)
19. The method for promoting valve conjugation according to item 1, wherein implanting comprises implanting the single prosthetic leaflet in an open surgical procedure.
(Item 6)
19. The method for promoting valve conjugation according to item 1, wherein implanting comprises advancing the single prosthetic leaflet into a blood vessel.
(Item 7)
2. The method for promoting valve conjugation according to item 1, wherein implanting comprises advancing the single prosthetic leaflet in the transseptal.
(Item 8)
19. The method for promoting valve conjugation according to item 1, wherein implanting comprises advancing the single prosthetic leaflet transapically.
(Item 9)
2. The method for promoting valve joining according to item 1, wherein implanting comprises self-expanding an anchor coupled to the single leaflet within the prosthetic valve.
(Item 10)
10. The method for promoting valve conjugation according to item 9, wherein the anchor is expanded to completely surround the prosthetic valve.
(Item 11)
11. The method for promoting valve conjugation according to item 10, wherein the anchor is expanded to partially surround the prosthetic valve.
(Item 12)
11. The method for promoting valve joining according to item 10, wherein the anchor comprises one or more barbs piercing the prosthetic valve as the anchor expands.
(Item 13)
2. The method for promoting valve conjugation according to item 1, wherein implanting comprises suturing an anchor coupled to the single prosthetic leaflet to the prosthetic valve.
(Item 14)
14. The method for promoting valve joining according to item 13, wherein the anchor is sutured completely around the prosthetic valve.
(Item 15)
2. The method for promoting valve joining according to item 1, wherein the anchor is sutured to partially surround the prosthetic valve.
(Item 16)
2. The method for promoting valve joining according to item 1, wherein the valve assist device comprises a stiffening element.
(Item 17)
2. The method for promoting valve joining according to item 1, wherein the stiffening element is direction sensitive.
(Item 18)
A method for promoting valve conjugation in a patient, the method comprising:
Identifying a prosthetic annulus positioned adjacent a protruding leaflet within the patient's natural valve;
Implanting a single prosthetic valve leaflet of the valve assist device over the upper surface of the protruding leaflet;
Including
The single valve assist leaflet moves in conjunction with the protruding leaflet and, in response to blood flow through the natural valve, mates with a second leaflet opposite the prosthetic leaflet. how to.
(Item 19)
19. The method for promoting valve conjugation according to item 18, wherein the natural valve is a heart valve.
(Item 20)
20. The method for promoting valve coaptation according to item 19, wherein the heart valve is a mitral valve or an aortic valve.
(Item 21)
19. The method for promoting valve conjugation according to item 18, wherein the natural valve is a venous valve.
(Item 22)
19. The method for promoting valve joining according to item 18, wherein implanting comprises implanting the single prosthetic leaflet in an open surgical procedure.
(Item 23)
19. The method for promoting valve conjugation according to item 18, wherein implanting comprises advancing the single prosthetic leaflet into a blood vessel.
(Item 24)
19. The method for promoting valve conjugation according to item 18, wherein implanting comprises advancing the single prosthetic leaflet in the transseptal.
(Item 25)
19. The method for promoting valve conjugation according to item 18, wherein implanting comprises advancing the single prosthetic leaflet transapically.
(Item 26)
19. The valve of claim 18, wherein implanting comprises self-expanding an anchor coupled to the single leaflet within the native valve, thereby coupling the anchor to the prosthetic annulus. A method for promoting bonding.
(Item 27)
29. The method for promoting valve conjugation according to item 26, wherein the anchor is expanded to completely surround the prosthetic annulus.
(Item 28)
27. The method for promoting valve joining according to item 26, wherein the anchor is expanded to partially surround the prosthetic annulus.
(Item 29)
27. The method for promoting valve joining according to item 26, wherein the anchor comprises one or more barbs piercing the prosthetic annulus as the anchor expands.
(Item 30)
19. The method for promoting valve joining according to item 18, wherein implanting includes suturing an anchor coupled to the single prosthetic leaflet to the prosthetic annulus.
(Item 31)
31. The method for promoting valve joining according to item 30, wherein the anchor is sutured completely surrounding the prosthetic annulus.
(Item 32)
19. The method for promoting valve joining according to item 18, wherein the anchor is sutured to partially surround the prosthetic annulus.
(Item 33)
19. The method for facilitating valve joining according to item 18, wherein the valve assist device comprises a stiffening element.
(Item 34)
34. The method for promoting a valve joint according to claim 33, wherein the stiffening element is direction sensitive.
(Item 35)
A method for delivering a prosthetic valve joining assist device to a native valve site, said method comprising:
Providing the prosthetic valve joining assist device having an anchor and a single prosthetic valve assist leaflet constrained within the delivery device;
Advancing the delivery device to the natural valve site, the natural valve site having a prosthetic valve implanted therein;
Deploying the prosthetic valve joining assist device from the delivery device to the natural valve site, the valve prosthetic valve joining assist device comprising: Having a connector coupled to said prosthetic valve for positioning
Including
The single valve leaflet moves in conjunction with the defective prosthesis and responds to blood flow through the prosthetic valve to a functioning leaflet opposite the defective leaflet. How to join.
(Item 36)
36. A method for delivering a prosthetic valve joining assist device according to item 35, wherein the natural valve is a heart valve.
(Item 37)
36. The method for delivering a prosthetic valve joining assist device according to item 35, wherein the heart valve is a mitral valve or an aortic valve.
(Item 38)
36. The method for delivering a prosthetic valve joining assist device according to item 35, wherein the natural valve is a venous valve.
(Item 39)
36. A method for delivering a valve prosthesis joining aid according to item 35, wherein the single valve leaflet is advanced into a blood vessel.
(Item 40)
36. A method for delivering a prosthetic valve joining aid according to item 35, wherein the single prosthetic leaflet is advanced with a transseptal.
(Item 41)
36. A method for delivering a valve prosthesis joining aid according to item 35, wherein the single valve leaflet is advanced transapically.
(Item 42)
The deploying may include removing the prosthetic valve joining assist device from restraint such that the connector self-expands within the prosthetic valve and holds the single prosthetic leaflet in place over the defective prosthetic leaflet. 36. A method for delivering a prosthetic valve joining assist device according to item 35, comprising releasing.
(Item 43)
43. A method for delivering a prosthetic valve joining assist device according to item 42, wherein the connector self-expands completely surrounding the prosthetic valve.
(Item 44)
43. The method for delivering a prosthetic valve joining assist device according to item 42, wherein the connector self-expands to partially surround the prosthetic valve.
(Item 45)
43. A method for delivering a prosthetic valve joining assist device according to item 42, wherein the connector includes one or more barbs piercing the prosthetic valve as the connector self-expands.
(Item 46)
39. A method for delivering a prosthetic valve joining assist device according to item 38, wherein the valve assist device comprises a stiffening element.
(Item 47)
49. A method for delivering a prosthetic valve joining assist device according to item 46, wherein the stiffening element is direction sensitive.
(Item 48)
A method for delivering a prosthetic valve joining assist device to a native valve site, said method comprising:
Providing the prosthetic valve joining assist device having an anchor and a single prosthetic valve assist leaflet constrained within the delivery device;
Advancing the delivery device to the natural valve site, the natural valve site having a prosthetic annulus implanted therein; and
Deploying the valve prosthesis assist device from the delivery device to the natural valve site, wherein the valve prosthesis assist device places the single valve prosthesis over a top surface of a first natural valve leaflet. Having a connector coupled to the prosthetic annulus,
Including
The method wherein the single leaflet moves in conjunction with the first natural leaflet and mates with a second natural leaflet in response to blood flow through the valve.
(Item 49)
49. A method for delivering a prosthetic valve joining assist device according to item 48, wherein the natural valve is a heart valve.
(Item 50)
49. A method for delivering a prosthetic valve joining assist device according to item 48, wherein the heart valve is a mitral valve or an aortic valve.
(Item 51)
49. The method for delivering a prosthetic valve joining assist device according to item 48, wherein the natural valve is a venous valve.
(Item 52)
49. A method for delivering a valve prosthesis joining aid according to item 48, wherein the single valve leaflet is advanced into a blood vessel.
(Item 53)
49. A method for delivering a prosthetic valve joining assist device according to item 48, wherein the single prosthetic leaflet is advanced with a transseptal.
(Item 54)
49. A method for delivering a prosthetic valve joining assist device according to item 48, wherein the single prosthetic leaflet is advanced transapically.
(Item 55)
Deploying constrains the prosthetic valve joining assist device such that the connector self-expands within the prosthetic annulus and holds the single prosthetic leaflet in place over the first natural leaflet. 49. A method for delivering a prosthetic valve joining assist device according to item 48, comprising releasing from the device.
(Item 56)
56. A method for delivering a prosthetic valve joining assist device according to item 55, wherein the connector self-expands completely surrounding the prosthetic annulus.
(Item 57)
57. A method for delivering a prosthetic valve joining assist device according to item 56, wherein the connector self-expands to partially surround the prosthetic annulus.
(Item 58)
58. A method for delivering a prosthetic valve joining assist device according to item 57, wherein the connector includes one or more barbs piercing the prosthetic annulus as the connector self-expands.
(Item 59)
49. A method for delivering a prosthetic valve joining assist device according to item 48, wherein the valve assisting device comprises a stiffening element.
(Item 60)
60. A method for delivering a prosthetic valve joining assist device according to item 59, wherein the stiffening element is direction sensitive.

Claims (60)

A method for promoting valve conjugation in a patient, the method comprising:
Identifying a defective artificial cusp in a prosthetic valve implanted in the patient;
Implanting a single valve prosthesis of the valve assist device over the top surface of the defective prosthesis;
The single valve leaflet moves in conjunction with the defective prosthesis and responds to blood flow through the prosthetic valve to a functioning leaflet opposite the defective leaflet. How to join.   2. The method of claim 1 wherein the prosthetic valve is implanted into a heart valve within the patient.   3. The method for promoting valve coaptation according to claim 2, wherein the heart valve is a mitral or aortic valve.   2. The method for promoting valve conjugation according to claim 1, wherein the prosthetic valve is implanted into a venous valve in the patient.   2. The method for promoting valve conjugation according to claim 1, wherein implanting comprises implanting the single prosthetic leaflet in an open surgical procedure.   2. The method for promoting valve conjugation according to claim 1, wherein implanting comprises advancing the single prosthetic leaflet into a blood vessel.   2. The method for promoting valve conjugation according to claim 1, wherein implanting comprises advancing the single prosthetic leaflet in the transseptal.   2. The method for promoting valve conjugation according to claim 1, wherein implanting comprises advancing the single prosthetic leaflet transapically.   The method for promoting valve joining according to claim 1, wherein implanting comprises self-expanding an anchor coupled to the single leaflet within the prosthetic valve.   10. The method for promoting valve conjugation according to claim 9, wherein the anchor is expanded to completely surround the prosthetic valve.   The method for promoting valve joining according to claim 10, wherein the anchor is expanded to partially surround the prosthetic valve.   The method for promoting valve joining according to claim 10, wherein the anchor includes one or more barbs that penetrate the prosthetic valve as the anchor expands.   The method for promoting valve joining according to claim 1, wherein implanting comprises suturing an anchor coupled to the single valve leaflet to the valve prosthesis.   14. The method for promoting valve joining according to claim 13, wherein the anchor is sutured completely surrounding the prosthetic valve.   The method for promoting valve joining according to claim 1, wherein an anchor is sutured to partially surround the prosthetic valve.   The method for promoting valve joining according to claim 1, wherein the valve assist device comprises a stiffening element.   The method for facilitating valve joining according to claim 1, wherein the stiffening element is direction sensitive. A method for promoting valve conjugation in a patient, the method comprising:
Identifying a prosthetic annulus positioned adjacent a protruding leaflet within the patient's natural valve;
Implanting a single prosthetic valve prosthesis of the valve assist device over the upper surface of the protruding cusp;
The single valve assist leaflet moves in conjunction with the protruding leaflet and, in response to blood flow through the natural valve, mates with a second leaflet opposite the prosthetic leaflet. how to.   19. The method for facilitating valve coaptation according to claim 18, wherein the natural valve is a heart valve.   20. The method for promoting valve coaptation according to claim 19, wherein the heart valve is a mitral or aortic valve.   19. The method for promoting valve conjugation according to claim 18, wherein the natural valve is a venous valve.   19. The method for promoting valve conjugation according to claim 18, wherein implanting comprises implanting the single leaflet in an open surgical procedure.   19. The method for promoting valve conjugation according to claim 18, wherein implanting comprises advancing the single prosthetic leaflet into a blood vessel.   19. The method for promoting valve conjugation according to claim 18, wherein implanting comprises advancing the single prosthetic leaflet transseptally.   19. The method for promoting valve conjugation according to claim 18, wherein implanting comprises advancing the single prosthetic leaflet transapically.   19. The implant of claim 18, wherein implanting comprises self-expanding an anchor coupled to the single leaflet within the native valve, thereby coupling the anchor to the prosthetic annulus. A method for promoting valve joining.   27. The method for promoting valve joining according to claim 26, wherein the anchor is expanded to completely surround the prosthetic annulus.   27. The method for promoting valve joining according to claim 26, wherein an anchor is expanded to partially surround the prosthetic annulus.   27. The method for promoting valve joining according to claim 26, wherein the anchor comprises one or more barbs that penetrate the prosthetic annulus as the anchor expands.   19. The method for promoting valve joining according to claim 18, wherein implanting comprises suturing an anchor coupled to the single leaflet to the prosthetic annulus.   31. The method for promoting valve joining according to claim 30, wherein an anchor is sutured completely surrounding the prosthetic annulus.   19. The method for promoting valve joining according to claim 18, wherein an anchor is sutured to partially surround the prosthetic annulus.   19. The method for facilitating valve joining according to claim 18, wherein the valve assist device comprises a stiffening element.   34. The method for promoting a valve joint according to claim 33, wherein the stiffening element is direction sensitive. A method for delivering a prosthetic valve joining assist device to a native valve site, said method comprising:
Providing the prosthetic valve joining assist device having an anchor and a single prosthetic valve assist leaflet constrained within the delivery device;
Advancing the delivery device to the native valve site, wherein the native valve site has a prosthetic valve implanted therein; and
Deploying the prosthetic valve joining assist device from the delivery device to the natural valve site, the valve prosthetic joint assisting device comprising: Having a connector that couples to the prosthetic valve to position the valve.
The single valve leaflet moves in conjunction with the defective prosthesis and responds to blood flow through the prosthetic valve to a functioning leaflet opposite the defective leaflet. How to join.   36. The method for delivering a prosthetic valve joining assist device of claim 35, wherein the native valve is a heart valve.   36. The method for delivering a prosthetic valve joining assist device of claim 35, wherein the heart valve is a mitral or aortic valve.   36. The method for delivering a prosthetic valve joining assist device of claim 35, wherein the natural valve is a venous valve.   36. The method for delivering a prosthetic valve joining assist device of claim 35, wherein the single prosthetic leaflet is advanced into a blood vessel.   36. The method for delivering a prosthetic valve joining assist device of claim 35, wherein the single prosthetic leaflet is advanced trans-septally.   36. The method for delivering a prosthetic valve joining assist device of claim 35, wherein the single prosthetic leaflet is advanced transapically.   The deploying may include removing the prosthetic valve joining assist device from restraint such that the connector self-expands within the prosthetic valve and holds the single prosthetic leaflet in place over the defective prosthetic leaflet. 36. The method for delivering a prosthetic valve joining assist device of claim 35, comprising releasing.   43. The method for delivering a prosthetic valve joining assist device of claim 42, wherein the connector self-expands completely surrounding the prosthetic valve.   43. The method for delivering a prosthetic valve joining assist device of claim 42, wherein the connector self-expands to partially surround the prosthetic valve.   43. The method for delivering a prosthetic valve joining assist device of claim 42, wherein the connector includes one or more barbs that penetrate the prosthetic valve as the connector self-expands.   39. The method for delivering a prosthetic valve joining assist device according to claim 38, wherein the valve assist device comprises a stiffening element.   50. The method for delivering a prosthetic valve joining assist device of claim 46, wherein the stiffening element is direction sensitive. A method for delivering a prosthetic valve joining assist device to a native valve site, said method comprising:
Providing the prosthetic valve joining assist device having an anchor and a single prosthetic valve assist leaflet constrained within the delivery device;
Advancing the delivery device to the natural valve site, the natural valve site having a prosthetic annulus implanted therein; and
Deploying the valve prosthesis assist device from the delivery device to the natural valve site, wherein the valve prosthesis assist device places the single valve prosthesis over a top surface of a first natural valve leaflet. Having a connector coupled to the prosthetic annulus.
The method wherein the single leaflet moves in conjunction with the first natural leaflet and mates with a second natural leaflet in response to blood flow through the valve.   49. The method for delivering a prosthetic valve joining assist device of claim 48, wherein the natural valve is a heart valve.   49. The method for delivering a prosthetic valve joining assist device of claim 48, wherein the heart valve is a mitral or aortic valve.   49. The method for delivering a prosthetic valve joining assist device of claim 48, wherein the natural valve is a venous valve.   49. The method for delivering a prosthetic valve joining assist device of claim 48, wherein the single prosthetic leaflet is advanced into a blood vessel.   49. The method for delivering a prosthetic valve joining assist device of claim 48, wherein the single prosthetic leaflet is advanced at the transseptal.   50. The method for delivering a prosthetic valve joining assist device of claim 48, wherein the single prosthetic leaflet is advanced transapically.   Deploying constrains the prosthetic valve joining assist device such that the connector self-expands within the prosthetic annulus and holds the single prosthetic leaflet in place over the first natural leaflet. 49. A method for delivering a prosthetic valve joining assist device according to claim 48, comprising releasing from the valve.   56. The method for delivering a prosthetic valve joining assist device of claim 55, wherein the connector self-expands completely surrounding the prosthetic annulus.   57. The method for delivering a prosthetic valve joining assist device of claim 56, wherein the connector self-expands to partially surround the prosthetic annulus.   58. The method for delivering a prosthetic valve joining assist device of claim 57, wherein the connector includes one or more barbs that pierce the prosthetic annulus as the connector self-expands.   49. The method for delivering a prosthetic valve joining assist device of claim 48, wherein the valve assist device comprises a stiffening element.   60. The method for delivering a prosthetic valve joining assist device of claim 59, wherein the stiffening element is direction sensitive.