Interleaflet patch

Abstract

An implant (210) includes a patch (230), a first anchor (220), and a second anchor (220). The patch is secured against a surface of a first leaflet (14a) of a valve of a heart using the first anchor and against a surface of a second leaflet (14b) of the valve using the second anchor such that the patch bridges a gap (16) between the first leaflet and the second leaflet. The implant may also include an apposition body (736) attached to the patch. The implant may be secured to the first leaflet and the second leaflet such that the mating body extends into the gap. Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 331,771, filed on April 15, 2022, entitled “LEAFLET-BRIDGING PATCH,” and U.S. Provisional Patent Application No. 63 / 373,159, filed on August 22, 2022, entitled “INTER-LEAFLET PATCH,” granted to Sheps et al.

[0003] Each of the above applications is incorporated herein by reference in its entirety. Technical Field

[0004] Some applications of the present invention generally relate to bridging the gap between the leaflets of the tricuspid valve. More specifically, some applications of the present invention relate to transluminal implantation of such a patch across the gap. Background Art

[0005] Native heart valves (i.e., aortic valve, pulmonary valve, tricuspid valve, and mitral valve) play a key role in ensuring the forward flow of adequate blood supply through the cardiovascular system. The effectiveness of these heart valves may be reduced due to congenital malformations, inflammatory processes, infectious conditions, or diseases. Such damage to the valves may lead to serious cardiovascular damage or death. Treatment of such conditions can be accomplished by surgical repair or replacement of the valves during open heart surgery, or by the introduction and implantation of prosthetic devices using transcatheter transvascular techniques in a much less invasive manner than open heart surgery.

[0006] Valvular regurgitation occurs when the native valve fails to close properly and blood flows from the ventricles into the atria during the systolic phase of the heart's contraction. Valvular regurgitation is the most common form of valvular heart disease. Summary of the invention

[0007] Due to the lack of coaptation between the leaflets of the tricuspid valve during ventricular systole, the dilation of the annulus around the tricuspid valve of the subject may cause regurgitation. Some applications of the present application are particularly related to bridging the gap between the two leaflets of the tricuspid valve. For some such applications, this can effectively bicuspidize the tricuspid valve.

[0008] The patch may be transluminally attached to both leaflets such that the patch spans the gap between the leaflets.

[0009] For some applications, a patch of the implant is secured to a first leaflet of the tricuspid valve using a first anchor of the implant, and the patch is also secured to a second leaflet of the tricuspid valve using a second anchor of the implant, such that the patch spans the gap between the first leaflet and the second leaflet. For some applications, the delivery tool is configured to deliver the implant transluminally and implant the implant into the heart. For example, the delivery tool may be adapted to position the patch above the gap between the leaflets, then transluminally implant the anchor through the patch and into the tissue of the leaflets, such that the patch is implanted at the valve.

[0010] For some applications, the patch is secured to the atrial surface of the tricuspid valve.

[0011] For some applications, the patch is secured to the ventricular surface of the leaflet such that during ventricular contraction, the patch is pressed against the ventricular surface of the leaflet. For some such applications, the patch may define a plurality of slots along an edge of the patch to allow chordae tendineae of the heart to be received within the slots, e.g., to further secure the patch and / or avoid interference with the chordae tendineae.

[0012] For some applications, the patch is transluminally attached to all three leaflets of the tricuspid valve. For some applications, such a patch closes or covers the gaps between the three leaflets. For some applications, implanting the patch at the tricuspid valve can arrange the leaflets into more than one orifice through which blood can flow into the ventricle during ventricular diastole. Thus, each of these orifices can serve as a prosthetic valve. For example, three discrete orifices can be created by implanting the patch.

[0013] For some applications, at least one anchor is driven through each leaflet to secure the patch to the valve.

[0014] Thus, according to some applications of the present invention, a method of repairing a heart of a subject is provided.

[0015] For some applications, the method includes transluminally delivering an implant to a heart, the implant including a patch, a first anchor, and a second anchor.

[0016] For some applications, the method includes:

[0017] securing the patch against a surface of a first leaflet of a tricuspid valve of the heart using the first anchor; and / or

[0018] The patch is secured against a surface of a second leaflet of the tricuspid valve using the second anchor such that the patch bridges a gap between the first leaflet and the second leaflet.

[0019] For some applications, securing the patch against the surface of the second leaflet includes:

[0020] actuating the second anchor through the second leaflet so that a cord extends from the second anchor, through the second leaflet and toward the patch, and

[0021] The patch is then advanced over and along the cable toward the second anchor.

[0022] For some applications:

[0023] The implant further comprises an apposition body attached to the patch, and

[0024] Securing the patch against the surface of the second leaflet includes securing the patch so that the apposition body extends into the gap.

[0025] For some applications:

[0026] The patch defines a patch plane, and

[0027] Securing the patch such that the apposition body extends into the gap includes securing the patch such that the apposition body extends orthogonally away from the plane of the patch and into the gap.

[0028] For some applications:

[0029] Delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is in a compressed state, and

[0030] The method further comprises expanding the apposition body within the heart.

[0031] For some applications, expanding the apposition body within the heart includes inflating the apposition body within the heart.

[0032] For some applications:

[0033] delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is constrained in the compressed state, and

[0034] Expanding the apposition body within the heart includes releasing the apposition body to automatically expand within the heart.

[0035] For some applications:

[0036] The mate is a slat, and

[0037] Securing the patch so that the counterpoise extends into the gap includes securing the patch so that the slat extends into the gap.

[0038] For some applications:

[0039] The mate is a spacer, and

[0040] Securing the patch so that the counterpoise extends into the gap includes securing the patch so that the spacer extends into the gap.

[0041] For some applications:

[0042] The dyad is a block, and

[0043] Securing the patch so that the counterbody extends into the gap includes securing the patch so that the block extends into the gap.

[0044] For some applications:

[0045] securing the patch against the surface of the first leaflet comprises driving the first anchor through the first leaflet, and

[0046] Securement of the patch against the surface of the second leaflet includes driving the second anchor through the second leaflet and into tissue of the second leaflet.

[0047] For some applications, the method includes covering the gap with the patch without eliminating the gap.

[0048] For some applications, the method includes covering the gap with a patch to bicuspidize the tricuspid valve.

[0049] For some applications:

[0050] the surface of the first leaflet is an atrial surface of the first leaflet,

[0051] The surface of the second leaflet is an atrial surface of the second leaflet, and

[0052] Securing the patch against the surface of the second leaflet includes securing the patch against the atrial surface of the second leaflet such that the patch bridges a gap between the first leaflet and the second leaflet within the right ventricle of the heart.

[0053] For some applications:

[0054] the surface of the first leaflet is a ventricular surface of the first leaflet,

[0055] The surface of the second leaflet is a ventricular surface of the second leaflet, and

[0056] Secure the patch against the surface of the second leaflet includes secure the patch against the ventricular surface of the second leaflet.

[0057] For some applications:

[0058] The patch defines a plurality of slots along an edge of the patch, and

[0059] Secure the patch against the ventricular surface of the second leaflet includes secure the patch against the ventricular surface of the second leaflet such that chordae of the valve are disposed within slots of the plurality of slots.

[0060] For some applications:

[0061] The first anchor is a first toggle anchor,

[0062] The second anchor is a second toggle anchor, and

[0063] securing the patch against a surface of the first leaflet comprises driving the first toggle anchor through the first leaflet such that the first toggle anchor becomes seated against an opposing surface of the first leaflet, and

[0064] Securing the patch against a surface of the second leaflet includes driving the second toggle anchor through the second leaflet such that the second toggle anchor becomes disposed against an opposing surface of the second leaflet.

[0065] For some applications:

[0066] The first toggle anchor is attached to the patch via a first strap,

[0067] The second toggle anchor is attached to the patch via a second strap,

[0068] actuating the first toggle anchor through the first leaflet comprises actuating the first toggle anchor through the first leaflet such that the first cord extends from the first anchor, through the first leaflet to the patch, and

[0069] Driving the second toggle anchor through the second leaflet includes driving the second toggle anchor through the second leaflet such that the second cord extends from the second anchor, through the second leaflet to the patch.

[0070] For some applications, securing the patch against the surface of the second leaflet includes securing the patch against the surface of the second leaflet such that the patch covers a commissure common to the first leaflet and the second leaflet.

[0071] For some applications, securing the patch against the surface of the second leaflet includes securing the patch against the surface of the second leaflet such that the patch does not contact a third leaflet of the tricuspid valve.

[0072] For some applications, securing the patch against the surface of the second leaflet includes securing the patch against the surface of the second leaflet such that during ventricular systole, a lip of the patch contacts a third leaflet of the tricuspid valve.

[0073] For some applications, securing the patch against the surface of the second leaflet includes securing the patch against the surface of the second leaflet such that the lip of the patch extends into the right ventricle of the heart.

[0074] For some applications, the implant further comprises a third anchor, and the method further comprises:

[0075] The patch is secured against a surface of a third leaflet of the tricuspid valve using the third anchor such that the patch bridges a gap between the first leaflet, the second leaflet, and the third leaflet.

[0076] For some applications, securing the patch against the surface of the third leaflet includes securing the patch against the surface of the third leaflet so that the first leaflet, the second leaflet, and the third leaflet form more than one discrete orifice through which blood can flow into the ventricle during ventricular diastole.

[0077] For some applications, securing the patch against the surface of the third leaflet includes securing the patch against the surface of the third leaflet such that the leaflet forms three discrete orifices at the valve.

[0078] According to some applications of the present invention, there is further provided a device for repairing a heart valve, wherein the heart has atria and ventricles, and the valve is disposed between the atria and ventricles, and the device comprises an implant, which may comprise a flexible patch, a first anchor, and a second anchor.

[0079] For some applications, the apparatus further comprises a delivery tool adapted to:

[0080] positioning the patch in the heart, and / or

[0081] The patch is secured against a surface of a first leaflet of the valve using the first anchor and against a surface of a second leaflet of the valve using the second anchor such that the patch bridges a gap between the first leaflet and the second leaflet.

[0082] For some applications:

[0083] The delivery tool further comprises a reference support adapted to apply a reference force to an opposing surface of the first leaflet, and

[0084] The delivery tool is adapted to secure the patch against the surface of the first leaflet by driving the first anchor through the first leaflet while pressing the reference support against the opposing surface of the first leaflet.

[0085] For some applications, the patch is self-expanding such that the patch is suitable for transluminal delivery in a constrained state via the delivery tool and is biased to transition from a contracted state to a deployed state in which the patch is sized to bridge the gap.

[0086] For some applications:

[0087] the surface of the first leaflet is an atrial surface of the first leaflet,

[0088] The surface of the second leaflet is an atrial surface of the second leaflet, and

[0089] The delivery tool is adapted to secure the patch against the atrial surface of the first leaflet and the atrial surface of the second leaflet such that the patch bridges the gap.

[0090] For some applications:

[0091] the surface of the first leaflet is a ventricular surface of the first leaflet,

[0092] The surface of the second leaflet is a ventricular surface of the second leaflet, and

[0093] The delivery tool is adapted to secure the patch against the ventricular surface of the first leaflet and the ventricular surface of the second leaflet such that the patch bridges the gap.

[0094] For some applications:

[0095] The patch defines a plurality of slots along an edge of the patch, and

[0096] The delivery tool is adapted to secure the patch against the ventricular surface of the second leaflet such that chordae of the valve are seated within slots of the plurality of slots.

[0097] For some applications:

[0098] The first anchor is a first toggle anchor,

[0099] The second anchor is a second toggle anchor, and

[0100] The delivery tool is adapted to secure the patch against a surface of the first leaflet by driving the first toggle anchor through the first leaflet such that the first toggle anchor becomes seated against an opposing surface of the first leaflet, and

[0101] The delivery tool is adapted to secure the patch against a surface of the second leaflet by driving the second toggle anchor through the second leaflet such that the second toggle anchor becomes seated against an opposing surface of the second leaflet.

[0102] For some applications:

[0103] The first toggle anchor is attached to the patch via a first strap,

[0104] The second toggle anchor is attached to the patch via a second strap.

[0105] For some applications:

[0106] The gap is a gap between the first lobe, the second lobe and the third lobe,

[0107] The implant further comprises a third anchor,

[0108] The delivery tool is further adapted to secure the patch against a surface of a third leaflet of the valve using the third anchor such that the patch bridges the gap between the first, second, and third leaflets.

[0109] For some applications, the delivery tool is adapted to secure the patch against the surface of the third leaflet such that the first leaflet, the second leaflet, and the third leaflet form more than one discrete orifice through which blood can flow into the ventricle during ventricular diastole.

[0110] For some applications, the delivery tool is adapted to secure the patch against the surface of the third leaflet such that the leaflet forms three discrete orifices at the valve.

[0111] For some applications, the patch comprises a flexible sheet.

[0112] For some applications, the flexible sheet is impermeable.

[0113] For some applications, the flexible sheet is semi-impermeable.

[0114] For some applications, the flexible sheet comprises a fabric.

[0115] For some applications, the flexible sheet comprises a film.

[0116] For some applications, the patch includes a frame adapted to support the flexible sheet.

[0117] For some applications, the frame extends along a perimeter of the flexible sheet.

[0118] For some applications, the delivery tool is suitable for delivering an implant to a heart and comprises:

[0119] Axis, and

[0120] A first channel and a second channel are coupled to the shaft, each of the first channel and the second channel being adapted to receive a respective one of the first anchor and the second anchor during delivery of the implant to the heart.

[0121] For some applications, the delivery tool has a delivery state in which the delivery tool is adapted to deliver the implant to the heart, and wherein:

[0122] The channel is centrally located, and

[0123] The patch wraps around the distal end of the central shaft such that the patch forms a cup-like shape around the channel and the shaft.

[0124] For some applications:

[0125] The delivery tool has a deployed state, wherein the delivery tool is configured to anchor the first anchor and the second anchor to the first leaflet and the second leaflet, and

[0126] The delivery tool is transitionable from the delivery state toward the deployed state by laterally deflecting the first channel and the second channel relative to the axis.

[0127] For some applications, for each of the first and second anchors, the corresponding channel has an axial slit that accommodates a cable extending from the anchor to the patch.

[0128] For some applications:

[0129] The delivery tool is adapted to secure the patch against the surface of the first leaflet and the surface of the second leaflet by:

[0130] positioning the first channel against the first leaflet and positioning the second channel against the second leaflet, and

[0131] Each of the first and second anchors is pushed out of the respective passage and through the respective leaflet.

[0132] For some applications, the apparatus is configured such that, for each of the first and second anchors, ejection of the anchor from the respective channel is facilitated by sliding the respective cable along the respective axial slit.

[0133] According to some applications of the present invention, there is further provided a method for repairing a heart of a subject, the heart having atria, ventricles and valves therebetween.

[0134] The method may include transluminally attaching the first anchor to a first leaflet of the valve while the first anchor is attached to a first cable, and / or transluminally attaching the second anchor to a second leaflet of the valve while the second anchor is attached to a second cable.

[0135] The method may also include transluminally advancing the patch over and along the first and second cables toward the valve as the patch is threaded onto the first and second cables.

[0136] The method may also include subsequently securing the patch to a surface of the first leaflet and a surface of the second leaflet by fastening the patch to first and second straps.

[0137] For some applications, the first and second anchors are attached to the first and second leaflets from the ventricle (eg, advanced through the ventricular surface of the leaflets).

[0138] For some applications, the first and second anchors are attached to the first and second leaflets from the atrium (eg, advanced through an atrial surface of the leaflets).

[0139] For some applications, the valve is a mitral valve, and securing the patch to a surface of the first leaflet and a surface of the second leaflet includes securing the patch to a surface of the first leaflet and a surface of the second leaflet of the mitral valve.

[0140] For some applications, the valve is a tricuspid valve, and securing the patch to a surface of the first leaflet and a surface of the second leaflet includes securing the patch to a surface of the first leaflet and a surface of the second leaflet of the tricuspid valve.

[0141] For some applications, the method further comprises:

[0142] attaching the third anchor transluminally to a third leaflet of the valve when the third anchor is attached to the third cable,

[0143] When the patch is screwed onto the third cord, the patch is advanced transluminally over and along the third cord toward the valve, and

[0144] The patch is secured to the third leaflet by fastening the patch to the third strap.

[0145] For some applications:

[0146] the ventricle is the right ventricle,

[0147] the surface of the first leaflet is a ventricular surface of the first leaflet,

[0148] The surface of the second leaflet is a ventricular surface of the second leaflet, and

[0149] Securing the patch to the surface of the second leaflet includes securing the patch to the surface of the second leaflet such that within the right ventricle, the patch bridges a gap between the first leaflet and the second leaflet.

[0150] For some applications:

[0151] The patch defines a plurality of slots along an edge of the patch, and

[0152] Securing the patch to the surface of the second leaflet includes securing the patch to the surface of the second leaflet such that within the right ventricle, chordae tendineae of the valve are disposed within slots of the plurality of slots.

[0153] According to some applications, there is also provided a method of repairing a valve of a heart of a subject, the method comprising:

[0154] delivering an implant transluminally to a heart, the implant comprising a patch, an apposition body attached to the patch, and an anchor;

[0155] The patch is secured against a surface of a first leaflet of the valve and against a surface of a second leaflet of the valve using at least the anchor such that the apposition body extends between the first leaflet and the second leaflet.

[0156] For some applications:

[0157] The valve is placed between the atrium and the ventricle of the heart,

[0158] Fixing the patch against the surface of the first leaflet and against the surface of the second leaflet so that the apposition body extends between the first leaflet and the second leaflet includes: fixing the patch against the atrial surface of the first leaflet and against the atrial surface of the second leaflet so that the apposition body extends toward the ventricle between the first leaflet and the second leaflet.

[0159] For some applications, the valve is a tricuspid valve, and securing the patch to a surface of the first leaflet of the valve includes securing the patch to a surface of a first leaflet of the tricuspid valve.

[0160] For some applications:

[0161] The patch defines a patch plane, and

[0162] Securing the patch to a surface of the first leaflet and a surface of the second leaflet includes securing the patch so that the apposition extends orthogonally away from the plane of the patch and toward the ventricle downstream of the valve.

[0163] For some applications:

[0164] The mate is a slat, and

[0165] Securing the patch to a surface of the first lobe and a surface of the second lobe includes securing the patch so that the splint extends into a gap between the first lobe and the second lobe.

[0166] For some applications:

[0167] The mate is a spacer, and

[0168] Securing the patch to a surface of the first leaflet and a surface of the second leaflet includes securing the patch so that the spacer extends into a gap between the first leaflet and the second leaflet.

[0169] For some applications:

[0170] The dyad is a block, and

[0171] Securing such a patch to a surface of the first lobe and a surface of the second lobe includes securing the patch so that the block extends into a gap between the first lobe and the second lobe.

[0172] For some applications:

[0173] Delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is in a compressed state, and

[0174] The method further comprises expanding the apposition body within the heart.

[0175] For some applications, expanding the apposition body within the heart includes inflating the apposition body within the heart.

[0176] For some applications:

[0177] delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is constrained in the compressed state, and

[0178] Expanding the apposition body within the heart includes releasing the apposition body to automatically expand within the heart.

[0179] According to some applications, there is further provided a device for repairing a heart valve, wherein the heart has atria and ventricles, and the valve is disposed between the atria and ventricles, and the device comprises:

[0180] An implant comprising:

[0181] Flexible patch;

[0182] an apposition body attached to the patch;

[0183] a first anchor; and

[0184] a second anchor; and

[0185] A delivery tool suitable for:

[0186] positioning the patch in the heart, and

[0187] The patch is secured against a surface of a first leaflet of the valve using the first anchor and the patch is secured against a surface of a second leaflet of the valve using the second anchor such that the apposition extends between the first leaflet and the second leaflet.

[0188] For some applications, the apposition body has a surface configured to promote adhesion of the first leaflet and the second leaflet thereto.

[0189] For some applications, the implant includes a resilient frame that defines at least a portion of the patch and at least a portion of the apposition body.

[0190] For some applications, the dyad is a block.

[0191] For some applications, the implant includes a sheet that defines a surface of the patch and a surface of the apposition body.

[0192] For some applications, the apposition body includes an elastic frame.

[0193] For some applications, the patch comprises a sheet covering a frame.

[0194] For some applications, the mate defines a hollow portion therein.

[0195] For some applications, the delivery tool is configured to inflate the apposition body with a fluid.

[0196] For some applications, the apposition body is configured to promote fiberization within the hollow portion.

[0197] The present invention is intended to provide some examples, and is not intended to limit the scope of the present invention in any way. For example, any feature included in the examples of the present invention is not required by the claims, unless the claims clearly state these features. In addition, the features, components, steps, concepts, etc. described in the examples of the present invention and elsewhere in the present disclosure can be combined in a variety of ways. The various features and steps described elsewhere in the present disclosure can be included in the examples summarized here. BRIEF DESCRIPTION OF THE DRAWINGS

[0198] Figure 1-4 Schematic illustrations showing various techniques for bridging the gap between the leaflets of the tricuspid valve;

[0199] Figure 5A -B and 6A-C are schematic illustrations of a system including an implant for bridging a gap between leaflets of a tricuspid valve and a delivery tool for delivering and implanting the implant;

[0200] Figure 7 is a schematic illustration of a technique for implanting a patch at the tricuspid valve; and

[0201] Figure 8 is a schematic illustration of a technique for implanting a patch with attached apposition bodies into a tricuspid valve such that the apposition bodies extend into the space between the leaflets. DETAILED DESCRIPTION

[0202] Due to the lack of coaptation between the leaflets of the tricuspid valve during ventricular systole, the dilation of the annulus around the tricuspid valve of the subject may cause regurgitation. Some applications of the present application are particularly related to bridging the gap between the two leaflets of the tricuspid valve. For some such applications, this can effectively bicuspidize the tricuspid valve, for example, by forming a unified leaflet containing the two leaflets.

[0203] For some applications, in order to bridge the gap, a patch of the implant is fixed across the gap. For some such applications, the patch is configured to promote adhesion of the leaflets thereto and / or promote tissue growth between the leaflets and the implant. This can actually advantageously cause the leaflets to fuse together over time, for example, effectively bicuspidizing or partially bicuspidizing the valve.

[0204] Reference now Figure 1 , which is a schematic illustration of a system 100 including an implant 110 for bridging a gap 16 between leaflets of a tricuspid valve 7. Implant 110 includes a patch 130 and a tissue anchor 120 via which the patch can be fixed to leaflets 14a and 14b of valve 7.

[0205] The patch 130 may be transluminally attached to both leaflets 14a and 14b of the valve such that the patch spans the gap 16 between the leaflets.

[0206] For some applications, the patch 130 is secured to the first leaflet 14a of the tricuspid valve using at least one first anchor 120a of the implant, and the patch is also secured to the second leaflet 14b of the tricuspid valve using at least one second anchor 120b of the implant, such that the patch spans the gap 16 between the first leaflet and the second leaflet. In the example shown, the implant 110 includes three first anchors 120a and three second anchors 120b.

[0207] For some applications, and as shown, anchor 120 is a toggle anchor and is anchored by driving the anchor through the leaflet so that it becomes seated against an opposing surface of the leaflet, i.e., the surface opposite to the surface against which patch 130 is seated.

[0208] For some applications, such a toggle anchor is attached to patch 130 via a cable (not visible) such that after anchoring, the cable extends from the anchor, through the leaflet, to the patch.

[0209] For some applications, a delivery tool (not shown) is configured to deliver the implant 110 transluminally and implant the implant into the heart. For example, the delivery tool may be adapted to position the patch above the gap between the leaflets, and then transluminally implant the anchor through the patch and into the tissue of the leaflets so that the patch is implanted at the valve. For some applications, the delivery tool may be adapted to anchor one or more of the first anchors 120a (e.g., when the patch remains in the delivery configuration), then deploy and / or position the patch above the gap 16, and then anchor one or more of the second anchors 120b. For some applications, the delivery tool may be adapted to anchor all of the anchors of the implant 110 before deploying / positioning the patch 130.

[0210] For some applications, and such Figure 1 As shown, implant 110 is implanted so that patch 130 covers commissure 18 common to leaflets 14a and 14b, thereby, for example, blocking blood flow through commissure 18. For some such applications, and as Figure 1As shown, implant 110 is implanted so that patch 130 extends far enough along the corresponding lips of leaflets 14a and 14b so that during ventricular contraction, patch 130 extends to the third leaflet 14c of the valve, for example, so that the lip region 132 of patch 130 is aligned with the lip of leaflet 14c. Thus, for some applications, patch 130 effectively bicuspidizes the tricuspid valve, for example, so that a unified leaflet is formed by leaflet 14a, patch 130, and leaflet 14b. As described above, patch 130 can be configured to promote adhesion of leaflets 14a and 14b thereto and / or promote tissue growth between the leaflets and the implant. This can actually advantageously cause the leaflets to fuse together over time.

[0211] It should be noted that despite implantation of implant 110, gap 16 can remain, for example, as shown. That is, the effect of implanting patch 130 over gap 16 can reduce tricuspid regurgitation without requiring leaflets 14a and 14b to be pulled together so that the gap is completely eliminated. This can advantageously result in less traction / tension on the leaflets compared to techniques where the leaflets are pulled together. This can be particularly advantageous for valves that have large gaps between the leaflets (e.g., due to a particularly large degree of annular dilation).

[0212] Although not shown, for some applications, another anchor (which may be similar to or different from anchor 120) may be used to anchor patch 130 proximate commissures 18, such as to an annular region posterior to the commissures.

[0213] For some applications, and as shown, patch 130 is secured to an upstream (eg, atrial) surface of a leaflet of a tricuspid valve, for example with anchor 120 positioned against a downstream (eg, ventricular) surface of the leaflet.

[0214] Reference now Figure 2 , which is similar to Figure 1 Schematic illustration of a system 200 including an implant 210 for bridging the gap 16 between leaflets 14a and 14b of a tricuspid valve 7. Figure 1 , implant 210 includes a patch 230 and a tissue anchor 220, via which the patch can be fixed to leaflets 14a and 14b of valve 7. For some applications, system 200 can be considered a variation of system 100, for example, patch 230 can be considered a variation of patch 130, and / or anchor 220 can be considered a variation of anchor 120 or be substantially the same as it.

[0215] As shown, the patch 230 can be secured to the ventricular surface of the leaflet such that during ventricular contraction, the patch presses against the ventricular surface of the leaflet. Figure 2An upstream view of valve 7 (eg, from the right atrium 6 of the heart) is shown with patch 230 positioned beneath the valve (ie, within the ventricle). Anchor 220 embodies a toggle anchor and is positioned against the atrial surfaces of leaflets 14a and 14b.

[0216] For some such applications, the patch 230 defines slots 234 along one or more edges of the patch to allow the heart's chordae tendineae to be received within the slots. This can facilitate placement of the patch against the leaflet surface (e.g., while avoiding interference with the chordae tendineae), and / or can further secure the implant in place.

[0217] Reference now Figure 3 , which is a schematic illustration of a system 300 similar to systems 100 and 200 including an implant 310 for bridging the gap 16 between leaflets 14a and 14b of a tricuspid valve 7. Similar to implants 110 and 210, implant 310 includes a patch 330 and a tissue anchor 320 via which the patch can be fixed to leaflets 14a and 14b of valve 7. For some applications, system 300 can be considered a variation of system 200, for example, patch 330 can be considered a variation of patch 230 (e.g., defining a plurality of slots and implantable at the ventricular surface of the leaflets), and / or anchor 320 can be considered a variation of anchor 220 or be substantially the same as it.

[0218] like Figure 3 As shown, the size of patch 330 can be set to extend only partially along the lips of leaflets 14a and 14b, for example, not extending to leaflet 14c. For some applications, this can have a similar effect to patch 230, but may not cause bicuspidization of the valve. For example, patch 330 may not extend along the entire line of apposition between leaflets 14a and 14b. This can be used for applications in which gap 16 does not extend along the entire line of apposition between leaflets. For some applications, implant 310 can be implanted with patch 330 extending to (e.g., covering) commissure 18. For some applications, implant 310 can be implanted with patch 330 not extending to commissure 18.

[0219] For some applications, implant 310 (or variations thereof) may be implanted with patch 330 against the atrial surface of the leaflets rather than against the ventricular surface of the leaflets. For some applications, patch 330 (or variations thereof) may not define a slot. Similarly, patch 130 may be sized to extend only partially along the lip edges of leaflets 14a and 14b.

[0220] Reference now Figure 4, which is a schematic illustration of a system 400 including an implant 410 for reducing tricuspid regurgitation. Implant 410 includes a patch 430 and a tissue anchor 420, via which patch 430 can be fixed to leaflets 14a, 14b, and 14c of valve 7.

[0221] like Figure 4 As shown in , the patch 430 can be transluminally attached to all three leaflets 14a, 14b, and 14c of the tricuspid valve 7 so that the patch 430 spans the gaps between all three leaflets.

[0222] For some applications, the patch 430 closes or covers the gaps between the leaflets. For some applications, implanting the patch 430 at the tricuspid valve 7 can arrange the leaflets into more than one orifice through which blood can flow into the ventricle during ventricular diastole. Thus, each of these orifices can be used as a false valve. In the example shown, three discrete orifices 20i, 20ii, and 20iii have been created by implanting the patch 430.

[0223] For some applications, patch 430 can be secured to the leaflets using anchors 420, e.g., as described above with reference to anchors 120, 220, and 320 (e.g., anchor 420 can be considered a variation of these anchors, e.g., the anchor can be a toggle anchor). For some applications, for each leaflet, patch 430 is secured to each of first leaflet 14a, second leaflet 14b, and third leaflet 14c using at least one anchor 420 of the implant, such that the patch spans gap 16 between the leaflets. In the example shown, multiple anchors are implanted at each leaflet.

[0224] As shown, the patch 430 can be secured to the ventricular surface of the leaflet such that during ventricular contraction, the patch 430 presses against the ventricular surface of the leaflet. Figure 2 and 3 , Figure 4 An upstream view of valve 7 (eg, from the right atrium 6 of the heart) is shown with patch 430 positioned beneath the valve (ie, within the ventricle). Anchor 420 is embodied as a toggle anchor and is positioned against the atrial surfaces of leaflets 14a, 14b, and 14c.

[0225] For some such applications, and as referenced above Figure 2As described, the patch 430 defines slots along one or more edges of the patch 430 to allow the chordae tendineae of the heart to be received within these slots. This can facilitate placement of the patch 430 against the leaflet surface (e.g., while avoiding interference with the chordae tendineae), and / or can further secure the implant in place. In the particular example shown, the patch 430 is generally shaped as a circular flower with the slots disposed between the petals of the flower. Furthermore, in the particular example shown, the patch 430 has nine such petals and nine slots therebetween.

[0226] For some applications, implant 410 (or variations thereof) may be implanted with patch 430 resting against the atrial surface of the leaflets rather than against the ventricular surface of the leaflets.For some applications, patch 430 (or variations thereof) may not define a slot.

[0227] Similar to the above description, patch 430 can be configured to promote leaflets 14a, 14b and 14c to adhere thereto and / or promote tissue growth between the leaflets and the implant. This can actually advantageously cause the central portion of the leaflets to fuse together over time.

[0228] Reference now Figure 5A -B and 6A-C, which are schematic illustrations of a system 500 including an implant 510 for bridging a gap 516 between leaflets of a tricuspid valve 7, and a delivery tool 550 for delivering and implanting the implant. Figure 1-4 , implant 510 includes a patch 530 and a tissue anchor 520, via which the patch can be fixed to the leaflets of the valve. As described below, a delivery tool 550 is generally adapted to implant the patch 530 against a surface of the leaflets (e.g., a ventricular surface). For some applications, and as described above, the patch 530 can define a plurality of slots for accommodating chordae tendineae of the ventricle.

[0229] Figures 5A-6C Patch 530 is shown to be similar to patch 430 to some extent, for example, a patch that can be fixed to all three leaflets of the tricuspid valve and / or a patch that resembles a circular flower. Patch 530 can be considered a variation of patch 430, but with twelve petals and slots instead of nine. However, it should be understood that for some applications, patch 530 can represent and / or can be considered a variation of any of patches 130, 230, 330, and / or 430. Similarly, tool 550 or a variation thereof can be used to implant any of patches 130, 230, 330, and / or 430, mutatis mutandis.

[0230] For some applications, and as shown, anchor 520 is a lasso anchor and is anchored by driving the anchor through the leaflet so that the lasso anchor becomes seated against an opposing surface of the leaflet, i.e., a leaflet surface opposite to the surface against which patch 530 is seated (e.g., an atrial surface).

[0231] For some applications, such a toggle anchor is attached to patch 530 via a cable 524 such that after anchoring, the cable extends from the anchor, through the leaflet, to the patch.

[0232] Delivery tool 550 includes a central shaft 554 to which is attached a plurality of channels 552. Each of channels 552 is generally adapted to receive an anchor 520 during delivery of the implant to the heart. Figure 5A The delivery tool 550 is shown in a delivery state, wherein the channel 552 is positioned medially (e.g., relatively close to the shaft 554) so ​​that the distal region of the tool can be delivered to the heart, for example, via an outer sheath. As shown, in the delivery state, the patch 530 can be wrapped around the distal end of the delivery tool so that the patch forms a cup-like shape around the channel 552. Each channel 552 can have an axial slit 556 (e.g., facing laterally) that accommodates a cable 524 extending from an anchor 520 to connect the anchor to the patch 530.

[0233] The delivery tool 550 carrying the implant 510 can be advanced into the right atrium 6 ( Fig. 6A ). At this stage, the delivery tool 550 can be transformed into a partially open state, for example, as shown. Alternatively, the delivery tool 550 can remain in the delivery state at this stage.

[0234] The delivery tool 550 is then advanced into the right ventricle so that the open end of each channel 552 faces upstream toward the leaflet 14 ( Figure 6B ). At this stage, and if Fig. 6A and 6B 554, the delivery tool can be transformed to a deployed state in which the open end of the channel 552 is positioned more laterally (e.g., radially outward) from the shaft 554. For example, in the deployed state of the delivery tool, the channel can extend obliquely to the shaft 554, such as extending proximally and outwardly from the distal portion of the shaft ( Figure 5B ). For some applications, tool 550 may include a mechanical linkage that transitions the tool from a delivery state to a deployed state by causing the channel to deviate laterally from the axis.

[0235] Figure 5B Also shown is the tool 550 in its deployed state. For some applications, and as Figure 5BAs shown in , in this state, the tip of the anchor 520 can be exposed from the channel 552 so that the tip of the anchor can protrude slightly into the leaflet and thereby be tightly attached to the leaflet. This can be used to facilitate positioning and / or stabilization of the delivery tool relative to the leaflet before and / or during deployment of the anchor. For some applications, the tip of the anchor 520 can be exposed in this manner even in the delivery state. For some applications, the tip of the anchor 520 is exposed only when the channel is positioned at the valve (e.g., with the open end facing the leaflet), such as as part of or after transitioning to the deployed state.

[0236] At this stage, the patch 530 may remain wrapped around the passageway, for example in the ventricle, downstream of the valve and anchor.

[0237] For some applications, anchor 520 is then pushed out of its passage 552 and through the leaflets so that at least one anchor is driven through each of leaflets 14a, 14b, and 14c. This can be facilitated by sliding cable 524 along axial slit 556 until it extends to the open end of the passage. As described above, and as shown, anchor 520 can be a toggle anchor and can be pushed out of passage 552, through the leaflets, and into the right atrium so that the cable extends through the leaflets, thereby connecting the anchor to the patch.

[0238] For some applications, delivery tool 550 is then withdrawn from the heart through valve 7, through right atrium 6, for example after returning to its delivery state. For some applications, withdrawing the delivery tool allows the central portion of patch 530 to move to align with the plane of the leaflet. Figure 6C As shown in FIG. 5 , implanted implant 510 thus bridges gap 516 between leaflets 14a , 14b , and 14c .

[0239] Reference now Figure 7 , which is a schematic illustration of an alternative technique for implanting a patch across a valve 7.

[0240] For some applications, the plurality of anchors 620 are first anchored (eg, driven) into the leaflets of the valve prior to implanting the patch. For some applications, this may be accomplished using the method described above with reference to Fig. 6A -C can be implemented mutatis mutandis by the devices and / or techniques described in -C. However, other devices and / or techniques may be used alternatively or in addition. Once the anchor 620 has been anchored, a cable 624 attached to the anchor is extended from the anchor, through the right atrium 6, and out of the heart (e.g., out of the subject), for example, via a catheter 654. For some applications, and as shown, the anchor 620 is placed on the upstream (i.e., atrial) surface of the leaflet 14, and the cable 624 extends from the anchor, through the leaflet, into the ventricle, turns upstream through the gap 616 between the leaflets, and the cable extends from here through the atrium and out of the heart.

[0241] Next, a patch (e.g., a patch similar to any of patches 130, 230, 330, 430, and / or 530) is lowered onto the cable 624 such that the patch slides over and along the cable, thereby following the path of the cable until the patch is seated against the surface of the leaflet. In the example shown, the patch will slide through the gap 616 and press against the downstream (i.e., ventricular) surface of the leaflet. The patch may then be secured in place using stops (e.g., locks or crimps), e.g., one stop for each cable 624. The cable 624 may then be trimmed (e.g., just proximal to the stops).

[0242] Reference now Figure 8 , which is a schematic illustration of a system 700 including an implant 710 for reducing regurgitation between leaflets of a heart valve, such as the tricuspid valve 7. In addition to including a patch 730 (which may be considered a variation of any of the patches mentioned above) and a tissue anchor 720 by which the patch can be secured to the leaflets 14a and 14b of the valve, the implant 710 further includes an apposition body 736 attached to the patch and adapted to extend from the patch (e.g., toward the ventricle) between the leaflets after the patch is secured to the leaflets. Positioning the apposition body 736 between the leaflets (e.g., in the gap 716 between the leaflets) can advantageously cause the leaflets 14a and 14b to apposition around the apposition body, thereby advantageously reducing the need to pull the leaflets toward each other. This can enhance the advantageous effects of implanting a patch that bridges the gap between the leaflets described above.

[0243] It should be noted that while patch 730 is shown as a variation of patch 130 described above, it should be understood that for some applications, patch 730 may represent and / or may be considered to be a variation of any of patches 230, 330, 430 and / or 530, for example, patch 730 may define a plurality of slots, and / or may be anchored to the three leaflets of the tricuspid valve of the heart, as described with reference to patch 430.

[0244] In some embodiments, the apposition body 736 can reduce the atrial-directed forces experienced by the leaflets 14a and 14b and / or patch 730 during ventricular contraction of the heart. For example, when the leaflets are urged to apposition with the apposition body 736, at least some of the atrial-directed forces experienced by the valve can be deflected laterally.

[0245] As shown, the mate 736 may extend orthogonally away from the patch 730 such that when the patch is secured to the leaflets 14a and 14b, the mate extends from the leaflets and toward (e.g., into) the ventricle downstream of the valve so that the lip edges of the leaflets mate (e.g., seal) around the mate.

[0246] For some applications, implant 710 includes an elastic frame that defines at least a portion of apposition body 736. For some applications, the elastic frame defines at least a portion of patch 730 and at least a portion of the apposition body. For some applications, the frame is covered by a sheet material such as a fabric or a membrane. This sheet material may belong only to the apposition body, or may belong to both the apposition body and the patch.

[0247] For some applications, the apposition body 736 is a slat that extends away from the patch (e.g., such that the slat and the apposition body together define a T-shape). The slat can be flat (e.g., rectangular or another substantially two-dimensional shape) or can be curved. The slat can include a resilient frame (which can be a grid or grille, or can extend only around the periphery of the slat). One or both sides of the frame can be covered by a sheet. For such applications, the contact (e.g., frictional contact) experienced by the leaflets 14a and 14b when appositioned against the slat can be sufficient to reduce or eliminate regurgitation from the ventricle to the atrium 6.

[0248] In some embodiments, the apposition body 736 is delivered to the heart in a compressed state (eg, when constrained in a compressed state within a catheter of a delivery tool). For some applications, the apposition body is biased to automatically expand once deployed within the heart from the delivery tool.

[0249] For some applications, the apposition body 736 is a block (e.g., a three-dimensional protrusion) that can be hull-shaped and / or spherical. Such a block can be advantageous for valves with large gaps between the leaflets (e.g., due to a particularly large degree of annular dilation) - for example, by filling the gap, thereby allowing the leaflets to apposition around the apposition body, rather than the leaflets having to extend to meet each other.

[0250] For some applications, the mass includes at least a portion of a frame that automatically expands the mass when deployed in the heart. Alternatively, for some applications, the delivery tool is adapted to expand the apposition body by inflating the apposition body in the heart, such as by filling a hollow portion defined by the apposition body with a fluid.

[0251] For some embodiments, the counter-body is non-expandable.

[0252] For some applications, the apposition body 736 includes a permeable sheet (e.g., fabric) surrounding the hollow portion (e.g., by being supported by a frame). For some such applications, the sheet allows blood to enter the hollow portion. For some such applications, the apposition body (e.g., sheet) is configured to promote fibrosis within the hollow portion.

[0253] For some applications, patch 730 and / or apposition body 736 (e.g., apposition body surfaces against which leaflets 14a and 14b abut) are configured to promote adhesion of leaflets 14a and 14b thereto and / or promote tissue growth between the leaflets and the implant. This can advantageously cause the leaflets to fuse together over time, for example, effectively bicuspidizing or partially bicuspidizing the valve.

[0254] For some applications, implant 730 comprises a sheet material that limits the surface of patch and the surface of apposition body, for example, the sheet material provides a single surface that extends continuously above patch and apposition body. For some applications, whole implant 710 is coated with a continuous coating of polymer. For some applications, patch 730 and apposition body 736 (for example, whole implant 710) are molded as a single integral article.

[0255] For some applications, anchor 720 may be considered a variation of any of the anchors described above, such as a toggle anchor, a wadding anchor, a spiral anchor, or any other tissue anchor known in the art.

[0256] Reference again Figure 1-8 Patches 130, 230, 330, 430, 530, and / or 730 may include a flexible sheet, such as a sheet of fabric and / or membrane. For some applications, the sheet may be impermeable, such as so that once the patch is implanted, the patch acts as a barrier at the gap. For some applications, the sheet may be semi-permeable, such as so that the patch only partially closes the gap. For some applications, the flexible sheet is supported by a frame. For some applications, such a frame may extend along the periphery of the valve, such as Figure 2-4 However, it should be understood that such a frame may be configured to support the patch (eg, a flexible sheet thereof) in any other configuration, such as including cross braces and / or a lattice structure.

[0257] For some applications, the patch (e.g., its frame) can be self-expanding such that the patch can transition from a patch delivery state, in which the patch is constrained within a delivery vehicle (e.g., within a catheter), to a deployed state, in which the patch assumes a more expanded configuration (e.g., by the frame pushing the sheet outward).

[0258] Reference again Figure 1-8For some applications, any anchor described herein (e.g., any of anchors 120, 220, 320, 420, 520, 620, or 720) can be a wadding anchor, for example, as described in U.S. Patent Application Publication 2019 / 0254677 to Cahalane, which is incorporated herein by reference in its entirety. For some applications, any anchor described herein (e.g., any of anchors 120, 220, 320, 420, 520, 620, or 720) can be a variation of or substantially the same as any leaflet anchor described in PCT Publication WO 2022 / 101817, which is incorporated herein by reference in its entirety.

[0259] Reference again Figure 1-8 For some applications, during implantation of an implant at a valve (eg, during driving an anchor of the implant through a leaflet), a reference force is applied to the leaflet to facilitate driving the anchor through the leaflet, eg, to prevent the leaflet from moving away from the anchor.

[0260] For some applications, such a reference force is achieved by positioning the reference support against an opposing surface of the leaflet. For example, in applications where the anchor is driven into the leaflet from the atrium, positioning the reference support against the ventricular surface of the leaflet can prevent the leaflet from moving away from the anchor and into the ventricle during the anchoring of the anchor into the leaflet. For some applications, the reference support is expandable and / or deflectable, e.g., adapted to conform to the leaflet surface against which it is pressed, so as to provide sufficient force.

[0261] For some applications, a reference support may be provided in a manner similar to that described in International Patent Application No. PCT / IB2021 / 060436 to Tennenbaum et al., filed on November 11, 2021, and published as WO 2022 / 101817, incorporated herein by reference. For example, and as described in the aforementioned application, the reference support may be embodied as a scaffold-like element, similar to the "downstream support" described by Tennenbaum et al.

[0262] For applications where the anchor is deployed through the leaflets from the ventricle (and into the atrium), a reference support may not be required because the chordae tendineae may provide sufficient resistance to prevent the leaflets from moving toward the atrium. However, a reference support may still be provided.

[0263] For some applications, the patch may be shaped regularly or irregularly in any manner, such as a circular flower-shaped patch 430 having multiple petals extending outwardly from a central circular area having a central origin, a rectangular or square patch 130 or a segmented or centipede-shaped patch 230 to better facilitate coverage of the gap 16 and / or facilitate anchoring, adhesion or connection with the leaflets.

[0264] Any systems, devices, equipment, etc. described herein may be sterilized (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure that they are safe for use on patients, and any methods described herein may include sterilizing (e.g., using heat, radiation, ethylene oxide, hydrogen peroxide, etc.) the associated systems, devices, equipment, etc. as one of the method steps.

[0265] Example Application (Some non-limiting examples of the concepts herein are listed below):

[0266] Example 1. A device for repairing a heart valve, wherein the heart has atria and ventricles, and the valve is disposed between the atria and ventricles, the device comprising:

[0267] An implant comprising:

[0268] Flexible patch;

[0269] a first anchor; and

[0270] a second anchor; and

[0271] A delivery tool suitable for:

[0272] positioning the patch in the heart, and

[0273] The patch is secured against a surface of a first leaflet of the valve using the first anchor and against a surface of a second leaflet of the valve using the second anchor such that the patch bridges a gap between the first leaflet and the second leaflet.

[0274] Example 2. The apparatus of Example 1, wherein the delivery tool is adapted to secure the patch against the surface of the first leaflet and the surface of the second leaflet such that the patch bridges the gap without eliminating the gap.

[0275] Example 3. The apparatus of any one of examples 1-2, wherein:

[0276] The valve is a tricuspid valve, and

[0277] The delivery tool is adapted to secure the patch against the surface of the first leaflet and the surface of the second leaflet such that the tricuspid valve is bicuspidized.

[0278] Example 4. An apparatus according to any one of Examples 1-3, wherein the delivery tool is suitable for fixing the patch against the surface of the first leaflet and the surface of the second leaflet so that the patch covers the common commissure of the first leaflet and the second leaflet.

[0279] Example 5. The device of any one of examples 1-4, wherein the device is sterilized.

[0280] Example 6. The device of any of Examples 1-5, wherein the patch is configured to promote adhesion of the first leaflet and the second leaflet to the patch.

[0281] Example 7. The apparatus of any one of examples 1-6, wherein:

[0282] The delivery tool further comprises a reference support adapted to apply a reference force to an opposing surface of the first leaflet, and

[0283] The delivery tool is adapted to secure the patch against the surface of the first leaflet by driving the first anchor through the first leaflet while pressing the reference support against the opposing surface of the first leaflet.

[0284] Example 8. The apparatus of any of Examples 1-7, wherein the implant further comprises an apposition body attached to the patch, and wherein the delivery tool is adapted to secure the patch such that the apposition body extends into the gap.

[0285] Example 9. A device according to Example 8, wherein the mate has a surface configured to promote adhesion of the first leaflet and the second leaflet thereto.

[0286] Example 10. The apparatus of Example 8 wherein the implant comprises a resilient frame defining at least a portion of the patch and at least a portion of the apposition body.

[0287] Example 11. An apparatus according to Example 8, wherein the mate is a block.

[0288] Example 12. An apparatus according to Example 8, wherein the apposition body includes an elastic frame.

[0289] Example 13. The apparatus of Example 12, wherein the patch comprises a sheet covering a frame.

[0290] Example 14. The apparatus of Example 8 wherein the implant comprises a sheet defining a surface of the patch and a surface of the apposition body.

[0291] Example 15. An apparatus according to Example 8, wherein the mate defines a hollow portion therein.

[0292] Example 16. The apparatus of Example 15, wherein the delivery tool is configured to inflate the apposition body with a liquid.

[0293] Example 17. The apparatus of Example 15, wherein the mate is configured to promote fiberization within the hollow portion.

[0294] Example 18. A device according to any of Examples 1-17, wherein the patch is self-expanding such that the patch is suitable for transluminal delivery in a constrained state via the delivery tool and is biased to transition from the constrained state to a deployed state, in which the patch is sized to bridge the gap.

[0295] Example 19. The apparatus of any one of examples 1-18, wherein:

[0296] the surface of the first leaflet is an atrial surface of the first leaflet,

[0297] The surface of the second leaflet is an atrial surface of the second leaflet, and

[0298] The delivery tool is adapted to secure the patch against the atrial surface of the first leaflet and the atrial surface of the second leaflet such that the patch bridges the gap.

[0299] Example 20. The apparatus of any one of examples 1-19, wherein:

[0300] the surface of the first leaflet is a ventricular surface of the first leaflet,

[0301] The surface of the second leaflet is a ventricular surface of the second leaflet, and

[0302] The delivery tool is adapted to secure the patch against the ventricular surface of the first leaflet and the ventricular surface of the second leaflet such that the patch bridges the gap.

[0303] Example 21. The apparatus of Example 20, wherein:

[0304] The patch defines a plurality of slots along an edge of the patch, and

[0305] The delivery tool is adapted to secure the patch against the ventricular surface of the second leaflet such that chordae of the valve are seated within slots of the plurality of slots.

[0306] Example 22. The apparatus of any one of examples 1-21, wherein:

[0307] The first anchor is a first toggle anchor,

[0308] The second anchor is a second toggle anchor, and

[0309] The delivery tool is adapted to secure the patch against a surface of the first leaflet by driving the first toggle anchor through the first leaflet such that the first toggle anchor becomes seated against an opposing surface of the first leaflet, and

[0310] The delivery tool is adapted to secure the patch against a surface of the second leaflet by driving the second toggle anchor through the second leaflet such that the second toggle anchor becomes seated against an opposing surface of the second leaflet.

[0311] Example 23. The apparatus of Example 22, wherein:

[0312] The first toggle anchor is attached to the patch via a first strap, and

[0313] The second toggle anchor is attached to the patch via a second strap.

[0314] Example 24. The apparatus of any one of examples 1-23, wherein:

[0315] The gap is a gap between the first leaflet, the second leaflet and the third leaflet of the valve,

[0316] The implant further comprises a third anchor, and

[0317] The delivery tool is further adapted to secure the patch against a surface of the third leaflet using the third anchor such that the patch bridges the gap between the first leaflet, the second leaflet, and the third leaflet.

[0318] Example 25. An apparatus according to Example 24, wherein the delivery tool is suitable for fixing the patch against the surface of the third leaflet so that the first leaflet, the second leaflet and the third leaflet form more than one discrete orifice, and blood can flow into the ventricle through the discrete orifices during ventricular diastole.

[0319] Example 26. The apparatus of Example 25 wherein the delivery tool is adapted to secure the patch against the surface of the third leaflet such that the leaflet forms three discrete orifices at the valve.

[0320] Example 27. The device of any of Examples 1-26, wherein the patch comprises a flexible sheet.

[0321] Example 28. The apparatus of Example 27, wherein the flexible sheet is impermeable.

[0322] Example 29. The device of Example 27, wherein the flexible sheet is semi-impermeable.

[0323] Example 30. The apparatus of Example 27, wherein the flexible sheet comprises fabric.

[0324] Example 31. The apparatus of Example 27, wherein the flexible sheet comprises a film.

[0325] Example 32. The apparatus of Example 27, wherein the patch comprises a frame adapted to support the flexible sheet.

[0326] Example 33. An apparatus according to Example 32, wherein the frame extends along a periphery of the flexible sheet.

[0327] Example 34. The apparatus of any of Examples 1-33, wherein the delivery tool is adapted to deliver the implant to the heart and comprises:

[0328] Axis, and

[0329] A first channel and a second channel are coupled to the shaft, each of the first channel and the second channel being adapted to receive a respective one of the first anchor and the second anchor during delivery of the implant to the heart.

[0330] Example 35. The apparatus of Example 34, wherein the delivery tool has a delivery state in which the delivery tool is adapted to deliver the implant to the heart, and wherein:

[0331] The channel is centrally located, and

[0332] The patch wraps around the distal end of the shaft such that the patch forms a cup-like shape around the channel and the shaft.

[0333] Example 36. The apparatus of example 35, wherein:

[0334] The delivery tool has a deployed state, wherein the delivery tool is configured to anchor the first anchor and the second anchor to the first leaflet and the second leaflet, and

[0335] The delivery tool is transitionable from the delivery state toward the deployed state by laterally deflecting the first channel and the second channel relative to the axis.

[0336] Example 37. The apparatus of Example 35 wherein, for each of the first and second anchors, the respective channel has an axial slit that accommodates a tether extending from the anchor to the patch.

[0337] Example 38. The apparatus of Example 37, wherein:

[0338] The delivery tool is adapted to secure the patch against the surface of the first leaflet and the surface of the second leaflet by:

[0339] positioning the first channel against the first leaflet and positioning the second channel against the second leaflet, and

[0340] Each of the first anchor and the second anchor is pushed out of the respective passage and through the respective leaflet.

[0341] Example 39. The apparatus of Example 38, wherein the apparatus is configured such that, for each of the first and second anchors, ejection of the anchor from the respective channel is facilitated by sliding the respective strap along the respective axial slit.

[0342] Example 40. A device for repairing a heart valve, wherein the heart has atria and ventricles, and the valve is disposed between the atria and ventricles, the device comprising:

[0343] An implant comprising:

[0344] Flexible patch;

[0345] an apposition body attached to the patch;

[0346] a first anchor; and

[0347] a second anchor; and

[0348] A delivery tool suitable for:

[0349] positioning the patch in the heart, and

[0350] The patch is secured against a surface of a first leaflet of the valve using the first anchor and the patch is secured against a surface of a second leaflet of the valve using the second anchor such that the apposition extends between the first leaflet and the second leaflet.

[0351] Example 41. The device of Example 40, wherein the device is sterilized.

[0352] Example 42. An apparatus according to any of Examples 40-41, wherein the mate has a surface configured to promote adhesion of the first leaflet and the second leaflet thereto.

[0353] Example 43. The apparatus of any of Examples 40-42, wherein the implant includes a resilient frame that defines at least a portion of the patch and at least a portion of the apposition body.

[0354] Example 44. An apparatus according to any of Examples 40-43, wherein the duo is a block.

[0355] Example 45. The apparatus of any of Examples 40-44, wherein the implant comprises a sheet defining a surface of the patch and a surface of the apposition body.

[0356] Example 46. An apparatus according to any of Examples 40-45, wherein the duo comprises an elastic frame.

[0357] Example 47. An apparatus as described in Example 46, wherein the patch comprises a sheet covering a frame.

[0358] Example 48. An apparatus according to any of Examples 40-47, wherein the mate defines a hollow portion therein.

[0359] Example 49. The apparatus of Example 48, wherein the delivery tool is configured to inflate the apposition body with a liquid.

[0360] Example 50. The apparatus of Example 48, wherein the mate is configured to promote fiberization within the hollow portion.

[0361] Example 51. A method of repairing a heart of a subject, the method comprising:

[0362] delivering an implant transluminally to the heart, the implant comprising a patch, a first anchor, and a second anchor;

[0363] securing the patch against a surface of a first leaflet of a tricuspid valve of the heart using the first anchor; and

[0364] The patch is secured against a surface of a second leaflet of the tricuspid valve using the second anchor such that the patch bridges a gap between the first leaflet and the second leaflet.

[0365] Example 52. The method of example 51, wherein securing the patch against a surface of the second leaflet comprises:

[0366] actuating the second anchor through the second leaflet so that a cord extends from the second anchor, through the second leaflet and toward the patch, and

[0367] The patch is then advanced over and along the cable toward the second anchor.

[0368] Example 53. The method according to any one of examples 51-52, wherein:

[0369] The implant further comprises an apposition body attached to the patch, and

[0370] Securing the patch against the surface of the second leaflet includes securing the patch so that the apposition body extends into the gap.

[0371] Example 54. The method of Example 53, wherein:

[0372] The patch defines a patch plane, and

[0373] Securing the patch so that the apposition body extends into the gap includes securing the patch so that the apposition body extends orthogonally away from the plane of the patch and into the gap.

[0374] Example 55. The method according to Example 53, wherein:

[0375] delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is in a compressed state, and

[0376] The method further includes expanding the apposition body within the heart.

[0377] Example 56. The method of Example 55, wherein expanding the apposition body within the heart comprises inflating the apposition body within the heart.

[0378] Example 57. The method according to Example 55, wherein:

[0379] delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is constrained in the compressed state, and

[0380] Expanding the apposition body within the heart includes releasing the apposition body to automatically expand within the heart.

[0381] Example 58. The method of Example 53, wherein:

[0382] The mate is a lath, and

[0383] Securing the patch so that the counterpoise extends into the gap includes securing the patch so that the splint extends into the gap.

[0384] Example 59. The method of Example 53, wherein:

[0385] The mate is a spacer, and

[0386] Securing the patch so that the apposition body extends into the gap includes securing the patch so that the spacer extends into the gap.

[0387] Example 60. The method of example 53, wherein:

[0388] The dyad is a block, and

[0389] Securing the patch so that the apposition body extends into the gap includes securing the patch so that the block extends into the gap.

[0390] Example 61. The method according to any one of examples 51-60, wherein:

[0391] securing the patch against the surface of the first leaflet comprises driving the first anchor through the first leaflet, and

[0392] Securement of the patch against the surface of the second leaflet includes driving the second anchor through the second leaflet and into tissue of the second leaflet.

[0393] Example 62. A method according to any one of Examples 51-61, wherein the method includes covering the gap with the patch without eliminating the gap.

[0394] Example 63. A method according to any of Examples 51-62, wherein the method includes covering the gap with the patch so that the tricuspid valve is bicuspidized.

[0395] Example 64. The method according to any one of examples 51-63, wherein:

[0396] the surface of the first leaflet is an atrial surface of the first leaflet,

[0397] The surface of the second leaflet is an atrial surface of the second leaflet, and

[0398] Securing the patch against the surface of the second leaflet includes securing the patch against the atrial surface of the second leaflet such that the patch bridges a gap between the first leaflet and the second leaflet within the right ventricle of the heart.

[0399] Example 65. The method of any one of examples 51-64, wherein:

[0400] the surface of the first leaflet is a ventricular surface of the first leaflet,

[0401] The surface of the second leaflet is a ventricular surface of the second leaflet, and

[0402] Secure the patch against the surface of the second leaflet includes secure the patch against the ventricular surface of the second leaflet.

[0403] Example 66. The method of Example 65, wherein:

[0404] The patch defines a plurality of slots along an edge of the patch, and

[0405] Secure the patch against the ventricular surface of the second leaflet includes secure the patch against the ventricular surface of the second leaflet such that chordae of the tricuspid valve are seated within slots of the plurality of slots.

[0406] Example 67. The method of any one of examples 51-66, wherein:

[0407] The first anchor is a first toggle anchor,

[0408] The second anchor is a second toggle anchor, and

[0409] securing the patch against a surface of the first leaflet comprises driving the first toggle anchor through the first leaflet such that the first toggle anchor becomes seated against an opposing surface of the first leaflet, and

[0410] Securing the patch against a surface of the second leaflet includes driving the second toggle anchor through the second leaflet such that the second toggle anchor becomes seated against an opposing surface of the second leaflet.

[0411] Example 68. The method of Example 67, wherein:

[0412] The first toggle anchor is attached to the patch via a first strap,

[0413] The second toggle anchor is attached to the patch via a second strap,

[0414] actuating the first toggle anchor through the first leaflet comprises actuating the first toggle anchor through the first leaflet such that the first cord extends from the first anchor, through the first leaflet to the patch, and

[0415] Actuating the second toggle anchor through the second leaflet includes actuating the second toggle anchor through the second leaflet such that the second cord extends from the second anchor, through the second leaflet to the patch.

[0416] Example 69. A method according to any of Examples 51-68, wherein securing the patch against the surface of the second leaflet includes securing the patch against the surface of the second leaflet so that the patch covers a commissure common to the first leaflet and the second leaflet.

[0417] Example 70. The method of Example 69 wherein securing the patch against the surface of the second leaflet comprises securing the patch against the surface of the second leaflet such that the patch does not contact a third leaflet of the tricuspid valve.

[0418] Example 71. A method according to Example 69, wherein securing the patch against the surface of the second leaflet includes securing the patch against the surface of the second leaflet so that during ventricular contraction, a lip edge of the patch contacts the third leaflet of the tricuspid valve.

[0419] Example 72. The method of Example 71, wherein securing the patch against the surface of the second leaflet includes securing the patch against the surface of the second leaflet such that the lip of the patch extends into the right ventricle of the heart.

[0420] Example 73. The method according to any one of examples 51-72, wherein:

[0421] The implant further comprises a third anchor, and

[0422] The method additionally includes securing the patch against a surface of a third leaflet of the tricuspid valve using the third anchor such that the patch bridges a gap between the first leaflet, the second leaflet, and the third leaflet.

[0423] Example 74. A method according to Example 73, wherein securing the patch against the surface of the third leaflet includes securing the patch against the surface of the third leaflet so that the first leaflet, the second leaflet and the third leaflet form more than one discrete orifice through which blood can flow into the right ventricle of the heart during ventricular diastole.

[0424] Example 75. The method of Example 74 wherein securing the patch against the surface of the third leaflet comprises securing the patch against the surface of the third leaflet such that the leaflet forms three discrete orifices at the valve.

[0425] Example 76. The method according to Example 51, further comprising:

[0426] The implant is sterilized prior to delivery of the implant to the heart.

[0427] Example 77. A method for repairing a heart of a subject, the heart having an atrium, a ventricle, and a valve therebetween, the method comprising, starting from the ventricle:

[0428] attaching the first anchor transluminally to a first leaflet of the valve while the first anchor is attached to the first cable,

[0429] attaching the second anchor transluminally to a second leaflet of the valve while the second anchor is attached to the second cable,

[0430] while the patch is threaded onto the first and second cables, transluminally advancing the patch over and along the first and second cables toward the valve, and

[0431] The patch is then secured to a surface of the first leaflet and a surface of the second leaflet by fastening the patch to the first and second straps.

[0432] Example 78. A method according to Example 77, wherein the valve is a mitral valve, and wherein securing the patch to a surface of a first leaflet and a surface of a second leaflet includes securing the patch to a surface of a first leaflet and a surface of a second leaflet of the mitral valve.

[0433] Example 79. A method according to any of Examples 77-78, wherein the valve is a tricuspid valve, and wherein securing the patch to a surface of a first leaflet and a surface of a second leaflet includes securing the patch to a surface of a first leaflet and a surface of a second leaflet of the tricuspid valve.

[0434] Example 80. The method according to any one of examples 77-79, wherein the method further comprises:

[0435] attaching the third anchor transluminally to a third leaflet of the valve when the third anchor is attached to the third cable,

[0436] When the patch is screwed onto the third cord, the patch is advanced transluminally over and along the third cord toward the valve, and

[0437] The patch is secured to the third leaflet by fastening the patch to the third strap.

[0438] Example 81. The method according to any one of examples 77-80, wherein:

[0439] the ventricle is the right ventricle,

[0440] the surface of the first leaflet is a ventricular surface of the first leaflet,

[0441] The surface of the second leaflet is a ventricular surface of the second leaflet, and

[0442] Securing the patch to the surface of the second leaflet includes securing the patch to the surface of the second leaflet such that the patch bridges a gap between the first leaflet and the second leaflet within the right ventricle.

[0443] Example 82. The method of Example 81, wherein:

[0444] The patch defines a plurality of slots along an edge of the patch, and

[0445] Securing the patch to the surface of the second leaflet includes securing the patch to the surface of the second leaflet such that within the right ventricle, chordae tendineae of the valve are seated within slots of the plurality of slots.

[0446] Example 83. The method of Example 77, further comprising sterilizing the first anchor, the second anchor, the first tie, the second tie, and the patch before delivering the first anchor, the second anchor, the first tie, the second tie, and the patch to the heart of the subject.

[0447] Example 84. A method of repairing a valve of a subject's heart, the method comprising:

[0448] delivering an implant transluminally to the heart, the implant comprising a patch, an apposition body attached to the patch, and an anchor; and

[0449] The patch is secured against a surface of a first leaflet of the valve and against a surface of a second leaflet of the valve using at least the anchor such that the apposition body extends between the first leaflet and the second leaflet.

[0450] Example 85. The method of Example 84, wherein:

[0451] The valve is positioned between the atria and ventricles of the heart, and

[0452] Fixing the patch against the surface of the first leaflet and against the surface of the second leaflet so that the apposition body extends between the first leaflet and the second leaflet includes: fixing the patch against the atrial surface of the first leaflet and against the atrial surface of the second leaflet so that the apposition body extends toward the ventricle between the first leaflet and the second leaflet.

[0453] Example 86. A method according to any of Examples 84-85, wherein the valve is a tricuspid valve, and wherein securing the patch to a surface of a first leaflet of the valve includes securing the patch to a surface of the first leaflet of the tricuspid valve.

[0454] Example 87. The method of any one of examples 84-86, wherein:

[0455] The patch defines a patch plane, and

[0456] Securing the patch to a surface of the first leaflet and a surface of the second leaflet includes securing the patch so that the apposition body extends orthogonally away from the plane of the patch and toward the ventricle downstream of the valve.

[0457] Example 88. The method of any one of examples 84-87, wherein:

[0458] The mate is a slat, and

[0459] Securing the patch to a surface of the first lobe and a surface of the second lobe includes securing the patch such that the splint extends into a gap between the first lobe and the second lobe.

[0460] Example 89. The method of any one of examples 84-87, wherein:

[0461] The mate is a spacer, and

[0462] Securing the patch to a surface of the first leaflet and a surface of the second leaflet includes securing the patch such that the spacer extends into a gap between the first leaflet and the second leaflet.

[0463] Example 90. The method of any one of examples 84-87, wherein:

[0464] The dyad is a block, and

[0465] Securing such a patch to a surface of the first leaflet and a surface of the second leaflet includes securing the patch such that the block extends into a gap between the first leaflet and the second leaflet.

[0466] Example 91. The method of any one of examples 84-90, wherein:

[0467] delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is in a compressed state, and

[0468] The method further includes expanding the apposition body within the heart.

[0469] Example 92. The method of Example 91, wherein expanding the apposition body within the heart comprises inflating the apposition body within the heart.

[0470] Example 93. The method of Example 91, wherein:

[0471] delivering the implant transluminally to the heart comprises delivering the implant transluminally to the heart while the apposition body is constrained in a compressed state, and

[0472] Expanding the apposition body within the heart includes releasing the apposition body to automatically expand within the heart.

[0473] Example 94. The method of any of Examples 84-93, further comprising sterilizing the implant prior to delivering the implant to the heart.

[0474] The present invention is not limited to the examples specifically shown and described above. On the contrary, the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as variations and modifications thereof that are not in the prior art, which will occur to those skilled in the art after reading the above description. In addition, the treatment techniques, methods, steps, etc. described or proposed herein or in the references introduced herein may be performed on living animals or on non-living simulations, such as on corpses, corpse hearts, simulations (e.g., with simulated body parts, tissues, etc.), etc.

Claims

1. A device for repairing a heart valve, wherein the heart has an atrium and a ventricle, and the valve is arranged between the atrium and the ventricle, and the device include: An implant comprising: Flexible patch; a first anchor; and a second anchor; and A delivery tool suitable for: positioning the patch in the heart, and The patch is secured against a surface of a first leaflet of the valve using the first anchor and against a surface of a second leaflet of the valve using the second anchor such that the patch bridges a gap between the first leaflet and the second leaflet.

2. The apparatus of claim 1, wherein the delivery tool is adapted to secure the patch against the surface of the first leaflet and the surface of the second leaflet such that the patch bridges the gap without eliminating the gap.

3. The device according to any one of claims 1 to 2, in: The valve is a tricuspid valve, and The delivery tool is adapted to secure the patch against the surface of the first leaflet and the surface of the second leaflet such that the tricuspid valve is bicuspidized.

4. The device according to any one of claims 1-3, wherein the delivery tool is suitable for fixing the patch against the surface of the first leaflet and the surface of the second leaflet so that the patch covers the common commissure of the first leaflet and the second leaflet.

5. The device according to any one of claims 1 to 4, wherein the device is sterilized.

6. The device of any one of claims 1-5, wherein the patch is configured to promote adhesion of the first leaflet and the second leaflet to the patch.

7. The device according to any one of claims 1 to 6, in: The delivery tool further comprises a reference support adapted to apply a reference force to an opposing surface of the first leaflet, and The delivery tool is adapted to secure the patch against the surface of the first leaflet by driving the first anchor through the first leaflet while pressing the reference support against the opposing surface of the first leaflet.

8. The apparatus according to any one of claims 1-7, wherein the implant further comprises an apposition body attached to the patch, and wherein the delivery tool is adapted to secure the patch such that the apposition body extends into the gap.

9. The apparatus of claim 8, wherein the apposition body has a surface configured to promote adhesion of the first leaflet and the second leaflet thereto.

10. The apparatus of claim 8, wherein the implant includes a resilient frame defining at least a portion of the patch and at least a portion of the apposition body. The apparatus according to claim 8 , wherein the mate is a block.

12. The apparatus of claim 8, wherein the apposition body comprises an elastic frame.

13. The device of claim 12, wherein the patch comprises a sheet covering a frame.

14. The apparatus of claim 8, wherein the implant comprises a sheet defining a surface of the patch and a surface of the apposition body.

15. The apparatus of claim 8, wherein the mate defines a hollow portion therein.

16. The apparatus of claim 15, wherein the delivery tool is configured to inflate the apposition body with a liquid.

17. The apparatus of claim 15, wherein the apposition body is configured to promote fiberization within the hollow portion.

18. The device according to any one of claims 1-17, wherein the patch is self-expanding so that the patch is suitable for transluminal delivery in a constrained state via the delivery tool and is biased to transition from the constrained state to a deployed state, in which the size of the patch is set to bridge the gap.

19. The device according to any one of claims 1 to 18, in: the surface of the first leaflet is an atrial surface of the first leaflet, The surface of the second leaflet is an atrial surface of the second leaflet, and The delivery tool is adapted to secure the patch against the atrial surface of the first leaflet and the atrial surface of the second leaflet such that the patch bridges the gap.

20. The device according to any one of claims 1 to 19, in: the surface of the first leaflet is a ventricular surface of the first leaflet, The surface of the second leaflet is a ventricular surface of the second leaflet, and The delivery tool is adapted to secure the patch against the ventricular surface of the first leaflet and the ventricular surface of the second leaflet such that the patch bridges the gap.

21. The device according to claim 20, in: The patch defines a plurality of slots along an edge of the patch, and The delivery tool is adapted to secure the patch against the ventricular surface of the second leaflet such that chordae of the valve are seated within slots of the plurality of slots.

22. The device according to any one of claims 1 to 21, in: The first anchor is a first toggle anchor, The second anchor is a second toggle anchor, and The delivery tool is adapted to secure the patch against a surface of the first leaflet by driving the first toggle anchor through the first leaflet such that the first toggle anchor becomes seated against an opposing surface of the first leaflet, and The delivery tool is adapted to secure the patch against a surface of the second leaflet by driving the second toggle anchor through the second leaflet such that the second toggle anchor becomes seated against an opposing surface of the second leaflet.

23. The device according to claim 22, in: The first toggle anchor is attached to the patch via a first strap, and The second toggle anchor is attached to the patch via a second strap.

24. The device according to any one of claims 1 to 23, in: The gap is a gap between the first leaflet, the second leaflet and the third leaflet of the valve, The implant further comprises a third anchor, and The delivery tool is further adapted to secure the patch against a surface of the third leaflet using the third anchor such that the patch bridges the gap between the first leaflet, the second leaflet, and the third leaflet.

25. The apparatus of claim 24, wherein the delivery tool is adapted to secure the patch against the surface of the third leaflet such that the first leaflet, the second leaflet, and the third leaflet form more than one discrete orifice through which blood can flow into the ventricle during ventricular diastole.

26. The apparatus of claim 25, wherein the delivery tool is adapted to secure the patch against the surface of the third leaflet such that the leaflet forms three discrete orifices at the valve.

27. The device of any one of claims 1-26, wherein the patch comprises a flexible sheet.

28. The apparatus of claim 27, wherein the flexible sheet is impermeable.

29. The device of claim 27, wherein the flexible sheet is semi-impermeable.

30. The apparatus of claim 27, wherein the flexible sheet comprises fabric.

31. The apparatus of claim 27, wherein the flexible sheet comprises a film.

32. The apparatus of claim 27, wherein the patch comprises a frame adapted to support the flexible sheet.

33. The apparatus of claim 32, wherein the frame extends along a periphery of the flexible sheet.

34. The apparatus of any one of claims 1-33, wherein the delivery tool is adapted to deliver the implant to the heart and include: Axis, and A first channel and a second channel are coupled to the shaft, each of the first channel and the second channel being adapted to receive a respective one of the first anchor and the second anchor during delivery of the implant to the heart.

35. The apparatus of claim 34, wherein the delivery tool has a delivery state in which the delivery tool is adapted to deliver the implant to the heart, and in: The channel is centrally located, and The patch wraps around the distal end of the shaft such that the patch forms a cup-like shape around the channel and the shaft.

36. The device according to claim 35, in: The delivery tool has a deployed state, wherein the delivery tool is configured to anchor the first anchor and the second anchor to the first leaflet and the second leaflet, and The delivery tool is transitionable from the delivery state toward the deployed state by laterally deflecting the first channel and the second channel relative to the axis.

37. The apparatus of claim 35, wherein for each of the first and second anchors, the respective channel has an axial slit that accommodates a cable extending from the anchor to the patch.

38. The apparatus according to claim 37, in: The delivery tool is adapted to secure the patch against the surface of the first leaflet and the surface of the second leaflet by: positioning the first channel against the first leaflet and positioning the second channel against the second leaflet, and Each of the first and second anchors is pushed out of the respective passage and through the respective leaflet.

39. The apparatus of claim 38, wherein the apparatus is configured such that, for each of the first and second anchors, ejection of the anchor from the respective channel is facilitated by sliding a respective cable along a respective axial slit.

40. A device for repairing a heart valve, the heart having atria and ventricles, the valve being arranged between the atria and ventricles, the device include: An implant comprising: Flexible patch; an apposition body attached to the patch; a first anchor; and a second anchor; and A delivery tool suitable for: positioning the patch in the heart, and The patch is secured against a surface of a first leaflet of the valve using the first anchor and the patch is secured against a surface of a second leaflet of the valve using the second anchor such that the apposition extends between the first leaflet and the second leaflet.

41. The device of claim 40, wherein the device is sterilized.

42. The apparatus of any one of claims 40-41, wherein the apposition body has a surface configured to promote adhesion of the first leaflet and the second leaflet thereto.

43. The apparatus of any one of claims 40-42, wherein the implant comprises a resilient frame defining at least a portion of the patch and at least a portion of the apposition body.

44. The apparatus of any one of claims 40-43, wherein the dyad is a block.

45. The apparatus of any one of claims 40-44, wherein the implant comprises a sheet defining a surface of the patch and a surface of the apposition body.

46. ​​The apparatus of any one of claims 40-45, wherein the apposition body comprises an elastic frame.

47. The apparatus of claim 46, wherein the patch comprises a sheet covering a frame.

48. The apparatus of any one of claims 40-47, wherein the apposition body defines a hollow portion therein.

49. The apparatus of claim 48, wherein the delivery tool is configured to inflate the apposition body with a liquid.

50. The apparatus of claim 48, wherein the apposition body is configured to promote fiberization within the hollow portion.

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