Device and method for at least partially repairing heart valve regurgitation - Patents.com

Abstract

An apparatus for at least partially restoring regurgitation in a heart valve includes at least one subvalvular device including a subvalvular portion defining a longitudinal axis and positioned proximate a subvalvular heart wall adjacent a heart valve. An anchor portion is adjacent to and longitudinally spaced from the subvalvular portion. A connector neck is longitudinally inserted between and attached to the subvalvular portion and the anchor portion. The connector neck longitudinally penetrates a base of the first valve leaflet and at least one of the annulus of the heart valve at a created puncture site. A fastener is selectively connected to the at least one subvalvular device. The fastener penetrates at least one of the first valve leaflet and the second valve leaflet to hold the at least one leaflet in place relative to the at least one subvalvular device.

Description

Detailed Description of the Invention

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims priority to U.S. Provisional Patent Application No. 63 / 300,300, filed January 18, 2022, and U.S. Provisional Patent Application No. 63 / 311,408, filed February 17, 2022, the subject matter of which is incorporated herein by reference in its entirety. [Technical field]

[0002] The present invention relates to apparatus and methods for repairing a heart valve, and more particularly to methods and apparatus for providing a subvalvular device for at least partially repairing regurgitation in a heart valve. [Background technology]

[0003] Functional mitral regurgitation (FMR) and secondary tricuspid regurgitation (STR) are pathologies due to anatomical dilation of the heart geometry due to ischemia, infarction, left-sided heart disease or pulmonary artery high pressure. FMR and STR do not affect the heart valve leaflets or disease of the valve itself, but rather concern ventricular dilation, deformation and / or displacement, which allows blood flow back into the left or right atrium (i.e., regurgitation) by chordae tendineae tethering the leaflets and misaligning the normal leaflet coaptation. Although the causes of regurgitation are different, most medical interventions still revolve around replacing or repairing valves by manipulating the prosthetic valve or leaflets, including leaflet resection, folding and suturing, tools pulling the leaflet tissue together, and artificial chordae tendineae. However, to date, none of these methods have the desired subvalvular therapeutic effect. Summary of the Invention

[0004] In one aspect, alone or in combination with any other aspect, a device for at least partially repairing regurgitation in a heart valve is described. The heart valve includes at least a first valve leaflet and a second valve leaflet. The device includes at least one subvalvular device including a subvalvular portion defining a longitudinal axis and positioned proximate a subvalvular heart wall adjacent the heart valve. An anchor portion is adjacent to and longitudinally spaced from the subvalvular portion. A connector neck is longitudinally inserted between and attached to the subvalvular portion and the anchor portion. The connector neck longitudinally penetrates a base of the first valve leaflet and at least one of the annulus of the heart valve at a created puncture site. A fastener is selectively connected to the at least one subvalvular device. The fastener penetrates at least one of the first valve leaflet and the second valve leaflet to hold the at least one leaflet in place relative to the at least one subvalvular device.

[0005] For a better understanding, reference may be made to the drawings. [Brief description of the drawings]

[0006] [Figure 1] 1 is a schematic partial side view of an apparatus according to one aspect of the present invention; [Diagram 2] 2A to 2C are diagrams illustrating an example operation sequence of the device of FIG. 1. [Diagram 3] 2A to 2C are diagrams illustrating an example operation sequence of the device of FIG. 1. [Figure 4] 2A to 2C are diagrams illustrating an example operation sequence of the device of FIG. 1. [Diagram 5] FIG. 2 is a detailed schematic diagram of the device of FIG. 1. [Figure 6] FIG. 2 is a schematic partial side view of the device of FIG. 1 in a first alternative configuration. [Figure 7] FIG. 2 is a schematic side view of the device of FIG. 1 in a second alternative configuration. [Figure 8] FIG. 8 is a detailed schematic diagram of the device of FIG. [Figure 9] FIG. 8 is a detailed schematic diagram of the device of FIG. [Figure 10]2A to 2C are diagrams illustrating an example operation sequence of the device of FIG. 1. [Figure 11] 2A to 2C are diagrams illustrating an example operation sequence of the device of FIG. 1. [Figure 12] 2A to 2C are diagrams illustrating an example operation sequence of the device of FIG. 1. [Figure 13] FIG. 2 is a schematic side view of the device of FIG. 1 in a third alternative configuration. [Figure 14] 8A to 8C are diagrams illustrating an example operation sequence of the device of FIG. 7. [Figure 15] 8A to 8C are diagrams illustrating an example operation sequence of the device of FIG. 7. [Figure 16] 8A-8C are schematic diagrams illustrating exemplary mounting configurations for the device of FIG. [Figure 17] 8A-8C are schematic diagrams illustrating exemplary mounting configurations for the device of FIG. [Figure 18] 8A-8C are schematic diagrams illustrating exemplary mounting configurations for the device of FIG. [Figure 19] 2 is a schematic side view of an exemplary fixture for use in the apparatus of FIG. 1. [Figure 20] FIG. 2 is a schematic side view of an exemplary arrangement of the devices of FIG. 1. [Figure 21] FIG. 2 is a schematic side view of an exemplary arrangement of the devices of FIG. 1. [Figure 22] FIG. 2 is a side view of parts of the apparatus of FIG. 1 in a first configuration. [Diagram 23] FIG. 23 is a front perspective view of the components of FIG. 22 in an unfolded state. [Figure 24] FIG. 23 is a front perspective view of the components of FIG. 22 in a folded position. [Diagram 25] FIG. 23 is a schematic partial view of the deployment of the components of FIG. 22. [Figure 26] FIG. 23 is a schematic partial view of the deployment of the components of FIG. 22. [Figure 27] FIG. 23 is a schematic side view of the components of FIG. 22 in an installed state. [Figure 28] 2 is a perspective front view of the components of the device of FIG. 1 in a second configuration and in a folded state. [Figure 29]FIG. 29 is a schematic diagram showing the components of FIG. 28 in their deployed state during their installation. [Diagram 30] FIG. 2 is a schematic front perspective view of parts of the apparatus of FIG. 1 in a third configuration. [Diagram 31] FIG. 31 is a schematic diagram showing the state of the part of FIG. 30 when it is in a folded state during its installation. [Diagram 32] 34 and 35 are schematic diagrams illustrating an exemplary operating sequence of parts of the apparatus of FIG. 1 in a fourth configuration. [Diagram 33] 33 is a cross-sectional view taken along line 33-33 in FIG. 32. [Diagram 34] FIG. 33 is a schematic side view of the components of FIG. 32 in an unfolded state. [Diagram 35] 2A-2C are schematic diagrams illustrating an exemplary sequence of operation of parts of the apparatus of FIG. 1 in a fourth configuration. [Diagram 36] FIG. 2 is a schematic front view of parts of the apparatus of FIG. 1 in a fifth configuration. [Figure 37] FIG. 37 is a schematic side view of the components of FIG. 36 when in a deployed state during their installation. [Figure 38] FIG. 2 is a schematic side view of parts of the apparatus of FIG. 1 in a sixth configuration. [Figure 39] FIG. 2 is a schematic side view of parts of the apparatus of FIG. 1 in a seventh configuration. [Diagram 40] FIG. 2 is a schematic side view of parts of the apparatus of FIG. 1 in an eighth configuration. [Diagram 41] 1 is a schematic top perspective view of an apparatus according to an aspect of the present invention in an exemplary environment of use; [Diagram 42] FIG. 42 is a schematic top perspective view of the device of FIG. 41 in a second configuration. [Diagram 43] FIG. 2 is a schematic side view of the device of FIG. 1 in a fourth alternative configuration. [Diagram 44] FIG. 44 is a schematic plan view of the device of FIG. 43 in an exemplary environment of use. [Diagram 45] FIG. 2 is a schematic side view of the device of FIG. 1 in a fifth alternative configuration and a first exemplary environment of use; [Figure 46]FIG. 46 is a schematic side view of the device of FIG. 45 in a second exemplary environment of use. [Figure 47] FIG. 46 is a schematic side view of the device of FIG. 45 in a third exemplary environment of use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0008] As used herein, the term "subject" may be used interchangeably with the term "patient" and is meant to refer to any warm-blooded organism, including, but not limited to, humans, pigs, rats, mice, dogs, goats, sheep, horses, monkeys, apes, rabbits, cows, agricultural livestock, livestock, and the like.

[0009] As used herein, the term "treatment" can refer to therapeutic modulation, prevention, amelioration, alleviation of symptoms of leaflet coaptation problems, and / or reduction of the effects of leaflet coaptation problems. Thus, treatment also includes cases where leaflet coaptation problems or at least symptoms associated therewith are completely inhibited (e.g., prevented from occurring or stopped (e.g., terminated)) such that the subject is no longer subject to leaflet coaptation problems or at least symptoms associated therewith.

[0010] As used herein, the singular forms "a", "one" and "said" may include the plural unless the context clearly dictates otherwise. It will be further understood that as used herein, the terms "comprising" and / or "comprising" may specify the presence of stated features, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups thereof.

[0011] As used herein, the term "and / or" may include any and all combinations of one or more of the associated listed terms.

[0012] As used herein, for example, the phrases “between X and Y” and “between about X and Y” may be interpreted to include X and Y.

[0013] As used herein, for example, the term "between about X and Y" may mean "between about X and about Y."

[0014] As used herein, for example, the term "about X to Y" may mean "about X to about Y."

[0015] It should be understood that when an element is referred to as being "on," "mounted," "connected," "coupled," "in contact," "adjacent" another element, or the like, it may be directly mounted, attached, connected, coupled, in contact with, or adjacent to another element, or intermediate elements may be present. Conversely, when an element is referred to as being, for example, "directly located on," "directly mounted," "directly connected," "directly coupled," "in direct contact," or "directly adjacent" to another element, intermediate elements are not present. Those skilled in the art should understand that references to structures or features of other features set forth as "directly adjacent" may have portions that overlap or underlie the adjacent feature, and that structures or features of other features set forth as "adjacent" may not have portions that overlap or underlie the adjacent feature.

[0016] For ease of description, the specification may use spatially relative terms such as "lower," "below," "lower side," "upper," "upper," "proximal," "distal," and the like to describe the relationship of one element or feature to another element or feature as shown in the figures. It should be noted that the spatially relative terms may include different orientations in the use or operation of the device other than the orientation depicted in the figures. For example, if the device in the figures were inverted, elements described as being "lower" or "below" other elements or features would be oriented so as to be "above" the other elements or features.

[0017] As used herein, the term "at least one of X and Y" may be interpreted to include X, Y, or a combination of X and Y. For example, if an element is described as having at least one of X and Y, the element may include X, Y, or a combination of X and Y at a particular time, and the selection may change from time to time. Conversely, the term "at least one of X" may be interpreted to include one or more Xs.

[0018] Although the terms "first", "second", etc. may be used herein to describe various elements, it should be understood that these elements are not limited to these terms. These terms are used only to distinguish one element from another. Thus, a "first" element discussed below may be called a "second" element without departing from the teachings of the present invention. The order of operations (or steps) is not limited to the order shown in the claims or drawings unless specifically and explicitly stated otherwise.

[0019] Throughout the present invention, various aspects of the present invention can be presented in a range format. As will be understood, the description of the range format is merely for convenience and brevity of description, and should not be construed as strictly limiting the scope of the present invention. Thus, the description of a range should be considered as specifically disclosing all possible subranges and each numerical value within that range. For example, the description of a range of about 1 to about 6 should be considered as having specifically disclosed subranges, such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., and single and partial numbers within that range, such as 1, 1.1, 2, 2.8, 3, 3.2, 4, 4.7, 4.9, 5, 5.5, and 6. The breadth of the range is not limited.

[0020] The present invention is intended to include, consist of, or consist essentially of the following features in any combination:

[0021] 1 illustrates at least a portion of a device 100 for at least partially repairing regurgitation in a heart valve 102. The heart valve 102 includes at least a first valve leaflet 104 and a second valve leaflet 106, each supported by a valve annulus 108. The heart valve 102 is located within a heart 110, which has an outer wall 112 including myocardium 114. The heart valve 102, the first valve leaflet 104 and the second valve leaflet 106, the valve annulus 108, and the myocardium 114 all include and are referred to together as "cardiac tissue" (e.g., along with other patient tissue as known to those skilled in the art). For example, the cardiac tissue may further include papillary muscles 116 and chordae tendineae 118. For ease of explanation, a bileaflet valve (e.g., mitral valve) 102 is referenced in the following description and shown in many of the figures, however, it is contemplated that the device 100 may be used in a trileaflet valve (e.g., tricuspid valve) or any other desired patient tissue environment, whether or not associated with cardiac tissue. One skilled in the art can readily configure the device 100 and associated structure for any desired environment.

[0022] The apparatus 100 can be used to at least partially repair regurgitation of a heart valve 102. The apparatus 100 includes at least one subvalvular device 120 defining a longitudinal axis A. The subvalvular device 120 can be essentially similar to any of those shown and described in U.S. Patent No. 10,537,432, issued on January 21, 2020, U.S. Patent No. 11,241,313, issued on February 8, 2022, and / or co-pending U.S. patent application Ser. No. 17 / 396,987, filed on August 9, 2021 (collectively, the "432 Family"), all of which are entitled "Apparatuses and Methods for At Least Partially Supporting a Valve Leaflet of a Regurgitant Heart Valve," the entire contents of which are incorporated herein by reference for all purposes.

[0023] The subvalvular device 120 includes a subvalvular portion 122 including an upper subvalvular surface 124 longitudinally spaced from an opposing lower subvalvular surface 126. When the subvalvular device 102 is attached to the heart valve 102, the upper subvalvular surface 124 is configured to remain selectively adjacent (e.g., in contact with) the underside of the first valve leaflet 104. A subvalvular peripheral wall 128 extends longitudinally between the upper subvalvular surface 124 and the lower subvalvular surface 126 and is integrally formed contiguous with the upper subvalvular surface 124 and the lower subvalvular surface 126. When the subvalvular device 120 is attached to the heart valve 102, at least a portion of the subvalvular portion 122 (e.g., the subvalvular peripheral wall 128) is positioned adjacent to, and optionally in contact with, a subvalvular heart wall 130 adjacent (e.g., located below) the heart valve 102.

[0024] In particular, when the subvalvular peripheral wall 128 contacts the subvalvular heart wall 130, the subvalvular portion 122 can be used to "support" or "hold" the first leaflet 104 from below against and support the subvalvular heart wall 130 during at least a portion of a cardiac cycle. If present, such support from the subvalvular portion 122 tends to reduce regurgitation of the heart valve 102 by pushing the first leaflet 104 into apposition with the second leaflet 106. However, it is contemplated that the subvalvular device 120 or structure thereof may alternatively be configured (e.g., via size, loop strength, location and / or any other factor) to provide the anchor portions described below with any potential influence on the positioning of the first leaflet 104 associated with and / or limited to a given portion of the cardiac cycle. Although "first" and "second" valve leaflets have been referred to herein, for ease of explanation, it should be understood that these are arbitrary names and that any leaflet of any type of cardiac valve 102 may be associated with any portion of device 100 in accordance with the description herein.

[0025] An anchor portion 132 is adjacent to and longitudinally spaced from the upper subvalvular surface 124. The anchor portion 132 has a lower anchor surface 134 longitudinally spaced from an opposing upper anchor surface 136. The lower anchor surface 134 is configured to remain selectively adjacent (e.g., in contact with) an upper side of the first valve leaflet 104 when the subvalvular device 102 is attached to the heart valve 102. Anchor peripheral wall 138 extends longitudinally between the upper anchor surface 136 and the lower anchor surface 134.

[0026] It is noted that the upper support and anchor surfaces 124, 136, the lower support and anchor surfaces 126, 134, and the subvalve and anchor peripheral walls 128, 138 are described herein as distinct from one another. However, one skilled in the art will appreciate that either the subvalve portion 122 or the anchor portion 132 may be configured such that their surfaces and walls are not clearly delineated from one another, and that adjacent structures may "flow" or be shaped such that they do not clearly define a clear boundary between them. One skilled in the art can readily determine whether a particular structure actually performs the function of a name element and will mark the structure accordingly.

[0027] The subvalvular device 120 further includes a connector neck 140 that is inserted longitudinally between the upper subvalvular surface 124 and the lower anchor surface 134 and is attached to both the upper subvalvular surface 124 and the lower anchor surface 134. The connector neck 140 longitudinally penetrates at least one of the base of the first valve leaflet 104 and the annulus 108 of the heart valve 102 at a prepared puncture site. As used herein, a "prepared puncture site" refers to an area of ​​heart tissue where an opening is created naturally or artificially before or during installation of the subvalvular device 120. For purposes of the following discussion, native valve coaptation is not considered a "prepared puncture site." The "432 Family" disclosure provides additional exemplary details regarding the subvalvular device 120 and its placement in the position shown in the figures.

[0028] The subvalve portion 122, the anchor portion 132, and / or the connector neck 140 may each be formed at least in part from at least one of braided strands of a first configuration, braided strands of a second configuration, an airbag, a plurality of longitudinally extending struts, a plurality of laterally extending struts, and / or any other material. It is contemplated that at least one of the subvalve portion 122, the anchor portion 132, and the connector neck 140 may be made from a first material (e.g., a plurality of struts cut from a tubular base) and at least another of the subvalve portion 122, the anchor portion 132, and / or the connector neck 140 may be made from a second material (e.g., braided strands of a first configuration). For reasons described below, at least one of the subvalvular portion 122 and the anchor portion 132 is desirably formed of a mesh or other material that resists tearing or ripping after puncture, and can also provide sufficient structural integrity to resist tension forces without inhibiting significant deformation of the heart valve 102 while maintaining an attachment position.

[0029] The subvalvular portion 122, anchor portion 132, and connector neck 140 may collectively seal a single contiguous interior volume (e.g., used as different diameter portions of a single balloon, mesh, and / or tubular structure) or may be broken down into separate structures that are attached together to form the subvalvular device 120. For example, the subvalvular portion 122 and anchor portion 132 may be at least one of a balloon and mesh structure, respectively, and the connector neck 140 may be a hollow tube (hollow tube) or solid rod that attaches the subvalvular portion 122 and anchor portion 132 to one another. In most use environments, the connector neck 140 will be significantly smaller than either of the subvalvular portion 122 and anchor portion 132, e.g., by having an average cross-sectional area that is at least a fraction of the size of the average cross-sectional area of ​​at least one of the subvalvular portion 122 and anchor portion 132.

[0030] 4, a fastener 442 may be selectively connected to the subvalvular device 120, for example, to a selected one of the subvalvular portion 122 and the anchor portion 132. The fastener 442 may at least partially penetrate selected cardiac tissue to maintain at least one leaflet 104 and 106 in a predetermined position relative to at least another cardiac tissue and the subvalvular device 100. For example, the fastener 442 may penetrate at least one of the first leaflet 104 and the second leaflet 106 to hold at least one leaflet 104 and 106 in a predetermined position relative to the subvalvular portion 122 and at least one of the anchor portion 132. This holding may be via nailing, tensioning, compressing, and / or any other desired mechanism for a particular use environment. A number of exemplary aspects and configurations of various apparatus 100, including exemplary subvalvular devices 120 and fasteners 442, are described below with reference to the drawings.

[0031] FIG. 5 illustrates an exemplary fastener 442 in detail. The fastener 442 includes at least one of a suture (i.e., an elongated loop of suture material), a pledget, a clip, a staple, a leg, a barb, a screw, any other desired fastener structure, or any combination thereof. As shown in FIG. 5, the fastener 442 may include a fastener anchor 544 for selectively penetrating and contacting any desired anchor structure (e.g., at least one cardiac tissue and / or the subvalvular portion 122, the anchor portion 132, or both of the at least one subvalvular device 120). The fastener 442 further includes a fastener head 546 for selectively joining, directly or indirectly, at least one cardiac tissue, e.g., at least one of the first valve leaflet 104 and the second valve leaflet 106.

[0032] 5, the fastener 442 may include a flexible covering 548 on at least a portion of the outer surface of the fastener 442 (e.g., the fastener head 546, as shown) that is used to cushion, promote or prevent tissue ingrowth, and / or for any other purpose. For example, the flexible covering 548 (if present) may include one or more of polyester, polytetrafluoroethylene ("PTFE"), expanded polytetrafluoroethylene ("ePTFE"), fabric, foam, allograft tissue, autograft tissue, cadaveric tissue, artificial or natural material membrane, any other flexible material, or any combination thereof. One skilled in the art can readily position the fastener head 546 according to the needs of the particular environment in which the device 100 is to be used.

[0033] The fastener anchor 544 may include any desired structure capable of contributing to the joining of at least one cardiac tissue and / or a portion of the subvalvular device 120. For example, the fastener anchor 544 may include one or more barbs, hooks, screws, adhesives, magnets, sutures, nails, clips, pins, any other fastening device, or any combination thereof. In the exemplary environment of use shown in the figures, the fastener anchor 544 at least partially penetrates and optionally completely penetrates at least one of the cardiac tissue and at least one portion of the subvalvular device 120. This may be achieved by providing the fastener anchor 544 with at least one elongated leg 550, as shown in FIG. 5, having a first leg end 552 and a second leg end 554, respectively, separated by a leg body 556. The first leg end 552 is attached (directly or indirectly) to a fastener head 546. The leg body 556 penetrates, optionally completely, through at least one of the cardiac tissue and a portion of the subvalvular device 120 to directly or indirectly connect these structures. For example, as shown in FIG. 5 , the leg body 556 penetrates, optionally completely, through at least one leaflet, here the first valve leaflet 104, and penetrates, optionally completely, through a wall 558 of the subvalvular portion 122 and / or the anchor portion 132 to connect at least one leaflet to the subvalvular device 120.

[0034] Thus, second leg end 554 may be located inside wall 558 or may be at least partially embedded in wall 558. (As used herein, "inside" may refer to a target structure that is any wall of cardiac tissue and / or any side of a portion of the subvalvular device 120.) Once the second leg end 554 is within or "through" (on the inside of) the wall 558, the second leg end 554 may spread or pull along a predetermined direction relative to the first leg end 552 to resist disengagement from the target structure, which may be cardiac tissue, at least a portion of the subvalvular device 120, or any other desired component of the apparatus 100 or a patient's heart. This spreading spreads legs 550 in a "nail" shape, which resists pulling when fastener head 546 is under tension. In many of the drawings, multiple legs 550 are provided on the fastener 542 to enhance the nail-like effect created by the second leg ends 554 being spread apart from one another, thereby helping to hold the fastener anchor 544 in place within the target structure.

[0035] Such spreading of the second leg end 554 can be accomplished in any desired manner. For example, other structures may be provided to bend the leg body 556 or fastener anchor 544 to effect the spreading action. It is contemplated that the second leg end 554 is spread or displaced relative to the first leg end 552 by at least one of a shape memory material and a resilient bias to the spread position. In the latter case, the leg body 556 may be produced in a bent or pre-spread configuration, elastically deforms (non-plastically deforms) under pressure for insertion into the heart under constrained conditions, and then returns to the bent, spread configuration when released from a constrainer (e.g., catheter) and placed in the desired relationship with the wall 558.

[0036] 1-4 show a schematic sequence of a method for at least partially repairing regurgitation of a heart valve 102 having a flail subtype in which the first valve leaflet 104 is separated from the chordae tendineae 118 and at least partially dangling. With reference to FIG. 1, a subvalvular device 120 is constructed, with at least a portion of the subvalvular portion 122 adjacent to a subvalvular heart wall 130 adjacent to the heart valve 102. The connector neck 140 penetrates longitudinally at least one of the base of the first valve leaflet 104 and the annulus 108 of the heart valve 102 at the prepared puncture site. The subvalvular device 120 can reach the position shown in FIG. 1 in any desired manner, for example by inserting the subvalvular device 120 into a folded state by a septal approach and into the heart 110 via a long catheter (schematically indicated at 260 in FIG. 2). Once the subvalvular device 120 has been advanced to a desired location adjacent a heart valve 192, the subvalvular device 120 may be deployed from the collapsed state to the deployed state. Further information regarding suitable ways to position the subvalvular device 120 in any of the relevant figure locations may be found in the "432 Family" disclosure or may be provided by one of ordinary skill in the art for a particular environment of use.

[0037] A fastener 442 may be provided and inserted into the heart 110. For example, as shown in the sequence of Figures 3-4, the fastener 442 may be folded into a folded state for insertion into the heart 110 via a long catheter 260 (which may be the same or different from the long catheter provided for insertion and deployment of the subvalvular device 120). Once adjacent to the subvalvular device 120, the fastener 442 may be deployed from a folded state to an deployed state.

[0038] Before, during or after the fastener 442 is deployed from the folded state, the fastener 442 may be selectively connected directly or indirectly to at least one subvalvular device 120. This connection may include selectively connecting the fastener 442 to either the subvalvular portion 122 and the anchor portion 132, for example, in the order shown, optionally by the fastener anchor 544 at least partially penetrating at least a portion of the subvalvular device 120. For example, the fastener anchor 544 may be joined to a net forming at least a portion of the at least one subvalvular device 120. That is, the leg body 556 may extend through an opening in a mesh, and the second leg end 554 may then be spread outward such that the leg body 556 cannot be easily pulled back through the opening and protrudes significantly.

[0039] The fastener 442 may be or may alternatively be fastened to at least one of the cardiac tissue. For example, as particularly shown in FIG. 4, the fastener 442 is connected to at least one of the first valve leaflet 104 and the second valve leaflet 106 (here connected to the first valve leaflet 104). Such fastening to the cardiac tissue may include selectively joining the fastener head 546 to the cardiac tissue. Referring again to FIG. 4, the fastener legs 550 extend through the first valve leaflet 104, but the fastener head 546 is considered to be pinned to the subvalvular portion 122 to "join" the first valve leaflet because the fastener legs 550 extend through the first valve leaflet 104 but the fastener head 546 is too large to penetrate the punctured tissue behind the legs 550. 4, the leg body 556 penetrates cardiac tissue (here, the first valve leaflet 104) and a wall 558 of the subvalvular device 120 to connect the first valve leaflet 104 to the at least one subvalvular device 120, here to the subvalvular portion 122. The second leg end 554 then expands inwardly of the wall 558 relative to the first leg end 556 to prevent the fastener 442 from detaching from the at least one subvalvular device 120.

[0040] The first leaflet 104 can then be held in place relative to the at least one subvalvular device 120 via the fasteners 442. In a use environment as shown diagrammatically in Figures 1-4, the first leaflet 104 is "pinned" to the subvalvular device 120 by one or more fasteners 442 in lieu of attachment of a replacement chordae to replace a ruptured or lost natural chordae 118. Thus, the first leaflet 104 is supported by the subvalvular device 120 for desired coaptation with the second leaflet 106 by use of the apparatus 100.

[0041] 1-4 and the associated description above, one of ordinary skill in the art can readily deduce and develop various methods of attaching one or more appropriately structured subvalvular devices 120 and / or fasteners 442 to any desired cardiac tissue to resolve or repair any of a variety of undesirable cardiac 110 conditions. The attachment sequence of many of the exemplary embodiments in the following exemplary embodiments of apparatus 100 will not be described in detail, but can be readily determined by one of ordinary skill in the art, particularly following the methods described in some detail herein.

[0042] Some of the configurations in Figures 6 to 47 are similar to those in Figures 1 to 5. Therefore, in Figures 6 to 47, the same reference numerals are used for configurations that are the same as or similar to those described with reference to Figures 1 to 5. Elements and operations common to the embodiment described above do not overlap with the parts, forms, arrangements and configurations described below, and are incorporated below by appropriate reference.

[0043] Turning now to Figure 6, a "low profile" configuration of the subvalvular device 120 is shown. In the configuration of Figure 6, the upper subvalvular surface 124 and the lower subvalvular surface 126 are both convex. The subvalvular peripheral wall 128 serves as the "lower edge" of the somewhat disc-shaped subvalvular portion 122. Thus, the subvalvular peripheral wall 128 is located longitudinally below the first valve leaflet relative to both the upper subvalvular surface 124 and the lower subvalvular surface 126.

[0044] Turning now to Figure 7, an alternative configuration of fastener 442 is shown diagrammatically. In the fastener 442 of Figure 6, the fastener anchor 544 is directly connected to the fastener head 546. In contrast, the fastener 442 of Figure 7 has the fastener anchor 544 spaced apart from the fastener head 546 with a flexible tether 762 mechanically interposed therebetween. The tether 762 may be thread, suture, fabric tape, or any other elongated flexible material that can be used to securely attach the fastener anchor 544 and the fastener head 546 and is adapted to withstand tension between the fastener anchor 544 and the fastener head 546 when the fastener 442 is attached to the heart 110.

[0045] Attachment of tether-type fasteners 442 to the first valve leaflet 104 and the subvalvular portion 122 is shown diagrammatically in the larger context of the heart 110 in the schematic diagram of Figure 8 and Figure 8. Flexible tether 762 may have a tether length that is predetermined (e.g., via pre-operative imaging) before the fasteners 442 are positioned in contact with cardiac tissue (e.g., at least one of the first valve leaflet 104 and the second valve leaflet 106) and / or at least one subvalvular device 120. Conversely, the tether length may be determined after at least a portion of the fasteners 442 have already been positioned in contact with at least one of (1) the cardiac tissue (e.g., at least one of the first valve leaflet 104 and the second valve leaflet 106) and (2) the at least one subvalvular device 120 (e.g., the subvalvular portion 122). Determining and / or adjusting the length of the tether 762 can be accomplished in any desired manner, including, but not limited to, pulling the fastener head 546 along the tether 762 at different distances from the fastener anchor 544 and then locking the fastener head 546 once a desired tether length is achieved. The tether 762 can function as a pseudo chordae tendineae, allowing a predetermined amount of movement of the first valve leaflet 104 relative to the subvalvular device 120 during the cardiac cycle, for example in the arrangement of FIG.

[0046] 10-12 show schematics of an exemplary use of apparatus 100 to address mitral regurgitation, where a first valve leaflet 104 is too short to be repaired by direct connection to the subvalvular device 120. In FIG. 11, a long catheter 260 is inserted into the heart 110 after the aorta and used to attach the fastener 442 from the underside of the second valve leaflet 106, through the leaflet and into the subvalvular portion 122.

[0047] FIG. 13 shows a schematic of the device 100 with the fastener 442 penetrating both the first and second leaflets 104, 106 simultaneously to hold both the first and second leaflets 104, 106 in place relative to each other and to the subvalvular device 120. The bi-leaflet arrangement of FIG. 13 is useful, for example, when tethering of the first leaflet 104 is significant and the annulus 108 is sufficiently expanded to cause conventional clips to have difficulty or to twist the heart valve 102 too much. Here, the subvalvular portion 122 is positioned below the first leaflet 104 to hold or support it toward the second leaflet 106. The fastener 442 can then be advanced back up the aorta (as in FIGS. 10-12) to maintain the first and second leaflets 104, 106 in place relative to the subvalvular device. The repair shown in FIG. 13 is therefore functionally equivalent to known "edge-to-edge" repair techniques.

[0048] 14-15 are schematic diagrams illustrating an exemplary attachment sequence of a fastener 442 having a tether 762 and a clip 1464 for joining and maintaining the second valve leaflet 106 to the subvalvular portion 122. As shown in FIG. 14, the fastener head 546 includes a clip 1464 for selectively gripping a free edge of at least one of the first valve leaflet 104 and the second valve leaflet 106 (here, the second valve leaflet 106). The clip 1464 can be operated by a wire (not shown) or other user-operable mechanism that extends through the elongate catheter 260 into the heart 110 and is ultimately deployed after gripping the free edge of the desired valve leaflet. The fastener anchor 544 can be deployed and secured to the subvalvular device 120 similar to the deployment described previously or in any other desired manner. In FIG. 15, the fastener 442 is shown to include a tether 762 for providing a limited usable movement space between the second valve leaflet 106 and the subvalvular device 120 .

[0049] 16-18, various attachment configurations of fastener 442 including tether 762, which may have a fixed length or may be adjusted in situ as described above, are shown. In FIGS. 16-18, the fastener 442 is used to apply tension across a heart chamber via the attachment of the fastener head 546 to cardiac tissue spaced from the subvalvular device 120. For example, in FIG. 16, the fastener head 546 is selectively attached to myocardium 114 in the same cardiac cavity as the anchor portion 132, and the fastener anchor 544 is selectively attached to, and optionally penetrates, the subvalvular portion 122. As such, the fastener head 546 may include one or more legs 550 that splay similarly to the legs 550 of the fastener anchor 544, which are attached to the subvalvular device 120. (Any desired configuration may include, but is not limited to, attaching fastener head 546 to cardiac tissue using one or more barbs, hooks, screws, adhesives, magnets, sutures, nails, clips, pins, any other fastening device, or any combination thereof.) When arranged as shown in FIG. 16, the fastener 442 applies tension to press myocardium 114 against the subvalvular portion 122, responsively changing the shape of the annulus 108. As shown in FIG. 16, the fastener anchor 544 may selectively penetrate and contact the subvalvular portion 122 by passing through at least one of the first leaflet 104 and the second leaflet 106 (here, passing through the first leaflet 104).

[0050] 17, the fastener head 546 is shown to selectively interface with the annulus 108 located in the same heart chamber as the anchor portion 132, where the fastener anchor 544 (and / or at least a portion of the tether 762) extends through at least one of the first valve leaflet 104 and the second valve leaflet 106 to selectively penetrate and contact anchor portion 132. The fastener 442 applies tension to urge the annulus 108 toward the anchor portion 132, responsively changing the shape of the annulus 108.

[0051] As shown in FIG. 18, the fastener head 546 can selectively join myocardium 114 in the same heart cavity where the subvalvular portion 122 is located and the fastener anchor 544 extends to selectively penetrate and contact the subvalvular portion 122. The fastener 442 can apply tension (e.g., via the tether 762) to compress the myocardium 114 against the subvalvular portion 122, responsively changing the shape of the annulus. The structure of FIG. 18, like the structures shown in FIGS. 16-17, can include at least a portion of the fastener 442 penetrating / piercing at least one of the first and second leaflets 104, 106, to "pin" them to form a desired spatial relationship with remaining heart tissue and / or the subvalvular device 120.

[0052] 19 illustrates an apparatus 1966 for at least partially repairing a patient's heart valve 102. An elongate sheath 1968 has a proximal sheath end 1970 and a distal sheath end 1972 spaced longitudinally by a sheath body 1974, each of which defines a sheath lumen. A fastener mounted catheter 1976 has a proximal catheter end 1978 and a distal catheter end 1980 spaced longitudinally by a catheter body 1982, each of which defines a catheter lumen. The catheter body 1982 may be selectively inserted into the proximal sheath end 1970 and threaded through the sheath lumen. Although the distal sheath end 1972 is shown as being advanced into the opening of the heart valve 102 and further partially advanced into the opening of the heart valve 102, it is contemplated that the distal sheath end 1972 may instead be retained in a heart cavity away from the valve opening while the catheter 1976 is advanced out of the distal sheath end 1972 distally through the valve opening, as described and shown above.

[0053] The catheter 1976 includes a fastener release feature 1984 at the distal catheter end 1980. Fasteners 442 are disposed within the catheter lumen and / or by the fastener release feature 1984, allowing one of skill in the art to appropriately configure device 1966 for a particular environment of use.

[0054] A gripping tool 1986 is connected to the distal sheath end 1972 and at least one of the catheter body 1982. The gripping tool 1986 is configured to selectively grip at least one valve leaflet 104, 106 while the catheter 1976 extends through a valve opening. The gripping tool 1986 has jaw members 1988 that are laterally rotatable about a pivot point 1990 relative to the catheter body 1982 ("laterally" as used herein refers to directions toward and away from a central longitudinal axis defined by the catheter lumen). The pivot point 1990 may be located at the distal-most end of the jaw members 1988 and is used to open the gripping tool 1986 "backwards" as shown in FIG. Alternatively, the pivot point 1990 may be located at the proximal most end of jaw member 1988 such that the gripper 1986 opens downwardly toward the distal catheter end 1980 .

[0055] When the at least one valve leaflet 104, 106 is grasped by a grasping tool 1986, the catheter 1976 may be configured to make a pigtail turn such that the fastener release feature 1984 contacts the at least one valve leaflet 104, 106 from its underside, as shown in FIG. 19. In other words, when the grasping tool 1986 is connected to the distal sheath end 1972, the catheter body 1982 may extend from the distal sheath end 1972 to position the distal catheter end 1980 substantially perpendicular to the orientation of the sheath body 1974, as shown in FIG. 19. Also, the pigtail turn may be located distal to the grasping tool 1986, as shown in FIG.

[0056] 20-21, an example arrangement of the subvalvular device 120 is shown. At least one of the subvalvular portion 122 and the anchor portion 132 includes a separately provided covering 2092 attached to its outer surface. "Outer surface" is used herein to refer to the area of ​​the subvalvular portion 122 and / or the anchor portion 132 that is exposed to the environmental space. For example, the "outer surface" of the subvalvular device 122 may include both the upper subvalvular surface 124, the lower subvalvular surface 126, and the subvalvular peripheral wall 128, and the "outer surface" of the anchor portion 132 may include both the upper anchor surface 134, the lower anchor surface 136, and the anchor peripheral wall 138. The covering 2092 is attached to at least one of the inside (as a "liner") and outside (as a "cover") of the outer surface of the subvalvular portion 122 and / or the anchor portion 132. For example, in FIG. 20, the subvalve portion 122 is shown having the exterior of its outer surface at least partially “covered” by the covering material 2092 .

[0057] The covering material 2092 may be connected to the subvalvular device 122 at the connector neck 140 and selectively contact an outer surface of at least one of the subvalvular portion 122 and the anchor portion 132. This is, for example, the case shown in Figures 20-21. In Figure 20, the covering material 2092 is essentially attached to an outer surface of at least a portion of the subvalvular portion 122, and the fasteners 442 pass through the covering material 2092 while selectively connecting to the subvalvular device 122.

[0058] In contrast, in the exemplary arrangement of FIG. 21 , at least a portion of the covering 2092 is spaced from at least a portion of the outer side of the outer surface of the subvalvular portion 122 and has an intermediate volume therebetween during at least a portion of a use cycle of the device 100. That is, the covering 2092 can "stiffen" or "expand" in a parachute-like manner during a portion of a cardiac cycle under hemodynamic forces from blood flow within the heart 119. In the arrangement of FIG. 21 , the fasteners 442 may be connected to the subvalvular device 122 by connecting directly to the covering 2092. Thus, the parachute-like action of the covering 2092 allows the attached valve leaflets 104, 106 to move a limited amount relative to the subvalvular portion 122 during a cardiac cycle, even in the absence of a tether 762.

[0059] 22-40 show various exemplary configurations, arrangements and conditions of exemplary fasteners 442 that can be used with the device 100. Some of the fasteners 442 shown in FIGS. 22-40 include a shape memory tube 2294 (e.g., hypotube) and have a number of slits 2294 that define at least one of the fastener anchor 544 and the fastener head 546. The slits 2294 can be formed, for example, by laser cutting. The arrangement of the elongate catheter 260 is optional and can employ any desired deployment scheme. For example, the fasteners 442 of FIGS. 22-27 (including features of shape memory material) can be loaded onto an introducer and deployed by retraction of the cover catheter 260. The fastener 442 may also have a cavity (as shown in FIGS. 22-30) to allow passage of a needle, wire, or any other puncture device, thereby aiding in puncturing the first leaflet 104 or second leaflet 106 when the fastener 442 is delivered to the subvalvular device 120. As another example, the fastener 442 of FIGS. 32-35 may include a pull wire for deploying a pivot toggle fastener anchor 544. The fasteners 442 of FIGS. 22-40 include a fastener head 546 and a fastener anchor 544, which are substantially similar in structure to each other and may be used to "sandwich" the attached structure (e.g., at least a portion of the cardiac tissue and / or subvalvular device 120). One of ordinary skill in the art can readily provide one or more fasteners 442 for use in a particular use environment of the present invention, and each fastener may be one of the designs shown in the figures or any other design.

[0060] 41-42 show an example configuration of an apparatus 100 including a plurality of subvalvular devices 120 (here, a first subvalvular device and a second subvalvular device 120), each located at a manufacturing puncture site in a different valve leaflet 104, 106 of the heart valve 102. Bridging members 2298 extend between and connect to the first and second subvalvular devices 120, and responsively apply tension between the first and second subvalvular devices 120 to hold each valve leaflet 104, 106 in place relative to the other valve leaflets 106, 104. The bridging members 2298 may be substantially rigid or flexible.

[0061] In the embodiment of Figure 41, the bridging member 2298 connects the subvalvular portions 122 of the first and second subvalvular devices 120 and extends across an underside of the heart valve 102. Conversely, the embodiment of Figure 42 shows the bridging member 2298 connecting the anchor portions 132 of the first and second subvalvular devices 120 and extending across an upper side of the heart valve 102.

[0062] 43-44, the anchor portion 132 may be a first anchor portion 132, and the subvalvular device 120 may include a second anchor portion 132' adjacent and longitudinally spaced from the lower subvalvular surface 126. When the subvalvular device 120 of FIGS. 43-44 is not adjacent the subvalvular heart wall 130 (i.e., in the "rest position" shown in FIG. 43), the second anchor portion 132' is longitudinally spaced from the first anchor portion 132, with at least a portion of the subvalvular portion 122 therebetween. Conversely, when the subvalvular device 120 of FIG. 43 is shown in the attached configuration of FIG. 44, the first anchor portion 132 and the second anchor portion 132' are both positioned above the first valve leaflet 104 and connector necks 140, 140' extend through at least one of the first valve leaflet 104 and the annulus 108 to hold the subvalvular portion 122 in place below the first valve leaflet 104 with two anchor contact points.

[0063] 45-47 show a situation similar to that of FIGS. 16-18 in which the tether 762 of the fastener 442 spans at least a portion of a heart chamber to assist in reshaping the annulus 108, for example, under tension between the subvalvular device 120 and cardiac tissue attached to the fastener head 546. However, in the arrangement of FIGS. 45-47, the fastener 442 is selectively connected to a selected one of the subvalvular portion 122 and the anchor portion 132, and the flexible tether 762 extends through at least a portion of at least one of the anchor portion 132 and the subvalvular portion 122. By passing the tether 762 through at least one of the anchor portion 132 and the subvalvular portion 122, the tether 762 can be used to position and support the anchor portion 132 and / or the subvalvular portion 122 in a desired manner and orientation to properly support the valve leaflets and provide an annuloplasty effect.

[0064] In Figure 45, the fastener anchor 544 is joined to the anchor portion 132 with the tether 762 extending through the interior volumes of both the anchor portion 132 and the subvalvular portion 122 of the subvalvular device 120 to the fastener head 546 joined to the valve annulus. Figure 46 similarly shows the fastener anchor 544 joined to the anchor portion 132 with the tether 762 extending through the interior volumes of both the anchor portion 132 and the subvalvular portion 122 of the subvalvular device 120 to the fastener head 546 joined to the myocardium 114 of the heart wall 112 in the same heart cavity as the subvalvular portion 122. In contrast, FIG. 47 shows the fastener anchor 544 attached to the anchor portion 132, with the tether 762 extending from the anchor portion 132 of the subvalvular device 120, optionally through an interior volume of the anchor portion 132, to the fastener head 546 which attaches to the myocardium 114 of the heart wall 112 in the same heart cavity as the anchor portion 132. Although not shown in FIGS. 45-47, it is contemplated that the tether 442 or any other structure of the fastener 442 may extend through or otherwise attach to the first leaflet 104 and / or second leaflet 106 in the illustrated arrangements, as desired. Upon reading the present invention, one of skill in the art may readily provide a suitable device 100 having a tether 762 extending through any desired natural or artificial structure required in a particular environment of use.

[0065] In summary, as will be appreciated by one of ordinary skill in the art, exemplary embodiment 1 includes a method of at least partially repairing regurgitation in a heart valve, the heart valve including at least first and second valve leaflets, the method comprising: providing at least one subvalve device defining a longitudinal axis, said subvalve device comprising: a subvalvular portion located near a subvalvular heart wall adjacent to a heart valve; an anchor portion adjacent to and spaced longitudinally from the subvalvular portion; a connector neck longitudinally interposed between the subvalvular portion and the anchor portion and attached to both the subvalvular portion and the anchor portion; deploying the subvalvular device, with at least a portion of the subvalvular portion adjacent to a subvalvular heart wall adjacent to the heart valve, and with the connector neck longitudinally penetrating at least one of a base of the first valve leaflet and an annulus of the heart valve at a created puncture site; Providing a fastener; selectively connecting the fastener to the at least one subvalve device; connecting the fastener to at least one of a first valve leaflet and a second valve leaflet; and holding the at least one leaflet in place relative to the at least one subvalvular device via the fastener.

[0066] Exemplary embodiment 2 is a method according to exemplary embodiment 1, wherein the subvalve portion includes an upper subvalve surface adjacent to a first leaflet and spaced longitudinally from an opposing lower subvalve surface, and a subvalve peripheral wall extending longitudinally between the upper subvalve surface and the lower subvalve surface and integrally and continuously formed with both the upper subvalve surface and the lower subvalve surface; the anchor portion is adjacent to and spaced longitudinally from the upper valve subsurface, the anchor portion including a lower anchor surface spaced longitudinally from an opposing upper anchor surface and adjacent the first leaflet, and a circumferential anchor wall extending longitudinally between the upper and lower anchor surfaces; the connector neck is longitudinally inserted between the upper valve subsurface and the lower anchor surface and is attached to both the upper valve subsurface and the lower anchor surface; Deploying a subvalvular device such that at least a portion of the subvalvular portion is adjacent to a subvalvular heart wall adjacent to the heart valve includes positioning at least a portion of the subvalvular peripheral wall adjacent to the subvalvular heart wall adjacent to the heart valve.

[0067] Example embodiment 3 is a method according to example embodiment 1, wherein selectively connecting the fastener to the at least one subvalvular device includes selectively connecting the fastener to a selected one of the subvalvular portion and the anchor portion.

[0068] Exemplary embodiment 4 is the method according to exemplary embodiment 1, inserting the subvalvular device in a collapsed state into the heart via a long catheter; and deploying the subvalvular device from a collapsed state to a deployed state adjacent to the heart valve.

[0069] Exemplary embodiment 5 is the method according to exemplary embodiment 1, inserting the fastener in a folded state into the heart via a long catheter; and deploying the fastener from a folded state to a deployed state adjacent to the subvalvular device.

[0070] Exemplary embodiment 6 is a method according to exemplary embodiment 1, wherein connecting the fastener to at least one of the first leaflet and the second leaflet includes penetrating the fastener into at least one of the first leaflet and the second leaflet.

[0071] Exemplary embodiment 7 is a method according to exemplary embodiment 1, wherein connecting the fastener to at least one of the first leaflet and the second leaflet includes penetrating the fastener through both the first leaflet and the second leaflet to connect the first leaflet and the second leaflet.

[0072] Example embodiment 8 is a method according to example embodiment 1, wherein connecting the fastener to at least one of the first leaflet and the second leaflet includes clamping at least a portion of the fastener to a free edge of at least one of the first leaflet and the second leaflet.

[0073] Exemplary embodiment 9 is the method according to exemplary embodiment 1, wherein the fastener includes a fastener head and a fastener anchor; selectively connecting the fastener to a selected one of the subvalvular portion and the anchor portion includes disposing the fastener anchor to selectively penetrate and contact at least a portion of the subvalvular device; Connecting the fastener to at least one of the first and second valve leaflets includes selectively joining the fastener head to at least one of the first and second valve leaflets.

[0074] Exemplary embodiment 10 is the method of exemplary embodiment 9, wherein the fastener anchor includes at least one elongated leg, the at least one elongated leg having a first leg end and a second leg end separated by a leg body, the first leg end being attached to the fastener head; Holding the at least one leaflet in place relative to at least a portion of the subvalvular device via the fastener comprises: penetrating the leg body through at least one of the first and second valve leaflets and a wall of the at least one subvalvular device to connect at least one of the first and second valve leaflets to the at least one subvalvular device; and deploying the second leg end inwardly of the wall relative to the first leg end to prevent it from moving away from the at least one subvalvular device.

[0075] Example embodiment 11 is a method according to example embodiment 10, wherein spreading the second leg end inwardly of the wall relative to the first leg end to prevent it from moving away from the at least one subvalvular device includes spreading the second leg end through at least one of the following: the second leg end being formed from a shape memory material, and the second leg end being elastically biased toward an expanded position.

[0076] Example embodiment 12 is a method according to example embodiment 9, wherein positioning the fastener anchor to selectively penetrate and contact at least a portion of the selected one of the subvalvular portion and the anchor portion includes joining a mesh forming at least a portion of the at least one subvalvular device to the fastener anchor.

[0077] Example embodiment 13 is a method according to example embodiment 9, including spacing the fastener anchor away from the fastener head using a flexible tether mechanically inserted between the fastener anchor and the fastener head.

[0078] Exemplary embodiment 14 is a method according to exemplary embodiment 13, comprising predetermining a tether length of the flexible tether before the fastener is positioned in contact with at least one of the first and second valve leaflets and the at least one subvalvular device.

[0079] Exemplary embodiment 15 is a method according to exemplary embodiment 13, comprising determining a tether length of the flexible tether after the fastener is positioned to contact (1) the first and second valve leaflets and (2) a selected one of the at least one subvalvular device.

[0080] Exemplary embodiment 16 is the method of exemplary embodiment 1, wherein connecting the fastener to at least one of the first valve leaflet and the second valve leaflet comprises: providing an apparatus for attaching the fasteners associated with the subvalvular device to a patient's heart valve, the apparatus comprising: an elongate sheath having a proximal sheath end and a distal sheath end spaced longitudinally by a sheath body defining a sheath lumen; a fastener attached catheter having a proximal catheter end and a distal catheter end spaced longitudinally by a catheter body defining a catheter lumen, the distal catheter end including a fastener release feature; a gripping tool connected to at least one of the distal sheath end and the catheter body; selectively inserting the catheter body into the proximal sheath end and through the sheath lumen; advancing the sheath lumen through a patient's vascular system to configure the distal sheath end adjacent a heart valve; extending the distal catheter end from the distal sheath end; extending the catheter body through the valve opening such that the distal catheter end is on an opposite side of the valve opening from the proximal catheter end; utilizing the grasping tool to selectively grasp at least one valve leaflet while the catheter is extending through the valve opening; guiding at least the end of the distal catheter through a pigtail turn as the catheter extends through the valve opening and the at least one valve leaflet is grasped by the grasping tool; and positioning the fastener release feature so as to contact at least one valve leaflet interposed between the distal catheter end and the sheath body.

[0081] As can be appreciated by one of ordinary skill in the art, exemplary embodiment 17 includes an apparatus for at least partially supporting regurgitation in a heart valve, the heart valve including at least a first valve leaflet and a second valve leaflet, the apparatus comprising: The valve includes at least a first subvalvular device and a second subvalvular device, each subvalvular device defining a longitudinal axis, each subvalvular device associated with a corresponding first or second valve leaflet, each subvalvular device comprising: a subvalvular portion including an upper subvalvular surface longitudinally spaced from an opposing lower subvalvular surface and adjacent a leaflet, and a subvalvular peripheral wall longitudinally extending between said upper and lower subvalvular surfaces and integrally and continuously formed with both said upper and lower subvalvular surfaces, at least a portion of said subvalvular peripheral wall contacting a subvalvular heart wall adjacent said heart valve; an anchor portion adjacent to and spaced longitudinally from the upper valve subsurface, the anchor portion including a lower anchor surface spaced longitudinally from an opposing upper anchor surface adjacent the leaflet, and a peripheral anchor wall extending longitudinally between the upper and lower anchor surfaces; a connector neck longitudinally inserted between and attached to the upper subvalve surface and the lower anchor surface, the connector neck longitudinally penetrating at least one of the base of the corresponding leaflet and the annulus of the heart valve at a produced puncture site; and a bridging member extending between and connected to the first and second subvalvular devices, the bridging member responsively applying tension between the first and second subvalvular devices to hold each valve leaflet in position relative to the other valve leaflets.

[0082] As one of ordinary skill in the art can appreciate, exemplary embodiment 17 includes an apparatus for at least partially repairing regurgitation in a heart valve, the heart valve including at least a first valve leaflet and a second valve leaflet mounted in a valve annulus, the heart valve being located in a heart having an outer wall including myocardium, the heart valve, the first valve leaflet and the second valve leaflet, the valve annulus, and the myocardium all including cardiac tissue, the apparatus including at least one subvalvular device defining a longitudinal axis and a fastener; The subvalve device comprises: a subvalvular portion located near a subvalvular heart wall adjacent to the heart valve; an anchor portion adjacent to and longitudinally spaced from the subvalvular portion; a connector neck inserted longitudinally between and attached to the subvalvular portion and the anchor portion, the connector neck longitudinally penetrating at least one of a base of the first valve leaflet and an annulus of the heart valve at a produced puncture site; The fasteners are selectively connected to the at least one subvalvular device, and the fasteners at least partially penetrate selected cardiac tissue to hold the first and second leaflets in place relative to the annulus.

[0083] Exemplary embodiment 18 is the device of exemplary embodiment 17, wherein the subvalvular portion includes an upper subvalvular surface adjacent a first leaflet and spaced longitudinally from an opposing lower subvalvular surface, and a subvalvular peripheral wall extending longitudinally between the upper and lower subvalvular surfaces and integrally and continuously formed with both the upper and lower subvalvular surfaces, at least a portion of which is adjacent a subvalvular heart wall adjacent the heart valve; the anchor portion is adjacent to and longitudinally spaced from the upper valve subsurface, the anchor portion including a lower anchor surface longitudinally spaced from an opposing upper anchor surface, the lower anchor surface adjacent the first leaflet, and a circumferential anchor wall extending longitudinally between the upper and lower anchor surfaces; The connector neck is inserted longitudinally between the upper valve subsurface and the lower anchor surface and is attached to both the upper valve subsurface and the lower anchor surface.

[0084] Example embodiment 19 is the device of example embodiment 17, wherein the fastener is selectively connected to a selected one of the subvalvular portion and the anchor portion.

[0085] Exemplary embodiment 20 is the device of exemplary embodiment 17, wherein both the subvalvular portion and the anchor portion are formed, at least in part, by at least one of braided strands of a first configuration, braided strands of a second configuration, a balloon, a plurality of longitudinally extending struts, and a plurality of laterally extending struts.

[0086] Example embodiment 21 is the device of example embodiment 17, wherein the subvalvular portion, the anchor portion, and the connector neck together seal a single continuous interior volume.

[0087] Exemplary embodiment 22 is a device described in exemplary embodiment 18, wherein the upper subvalve surface and the lower subvalve surface are both convex in shape, and the subvalve peripheral wall is located vertically below the corresponding first valve leaflet relative to the upper subvalve surface and the lower subvalve surface.

[0088] Example embodiment 23 is the device described in example embodiment 17, wherein the fastener penetrates both the first leaflet and the second leaflet to hold both the first leaflet and the second leaflet in a predetermined position relative to each other and relative to the annulus.

[0089] Exemplary embodiment 24 is an apparatus described in exemplary embodiment 18, wherein the anchor portion is a first anchor portion, and the subvalvular device includes a second anchor portion adjacent to and longitudinally spaced from the upper subvalvular surface, the second anchor portion including a lower second anchor surface longitudinally spaced from the opposing upper second anchor surface and adjacent a first leaflet, and a second anchor peripheral wall extending longitudinally between the upper second anchor surface and the lower second anchor surface.

[0090] Example embodiment 25 is an apparatus described in example embodiment 24, wherein when the subvalvular device is not in contact with the subvalvular heart wall, the second anchor portion is spaced apart from the first anchor portion and at least a portion of the subvalvular portion is vertically interposed therebetween.

[0091] Exemplary embodiment 26 is the device of exemplary embodiment 17, wherein the fastener comprises at least one of a suture, a pledget, a clip, a staple, and a leg.

[0092] Example embodiment 27 is the device of example embodiment 17, wherein the fastener includes a flexible cover on at least a portion of an exterior fastener surface.

[0093] Example embodiment 28 is a device described in example embodiment 17, wherein the fastener includes a fastener anchor for selectively penetrating and contacting the at least one subvalvular device and a fastener head for selectively attaching to at least a selected portion of the cardiac tissue.

[0094] Example embodiment 29 is the device of example embodiment 28, wherein the fastener includes a shape memory tube having a plurality of slits that define at least one of the fastener anchor and the fastener head.

[0095] Exemplary embodiment 30 is the device of exemplary embodiment 28, wherein the fastener head includes a clip for selectively gripping a free edge of at least one of the first valve leaflet and the second valve leaflet.

[0096] Example embodiment 31 is a device described in example embodiment 28, wherein the fastener anchor includes at least one long leg having a first leg end and a second leg end separated by a leg body, the first leg end being attached to the fastener head, the leg body penetrating a wall of at least one subvalvular device to connect at least a selected portion of cardiac tissue to the at least one subvalvular device, and the second leg end expanding relative to the first leg end inside the wall to resist moving away from the inside of the wall.

[0097] Example embodiment 32 is a device described in example embodiment 31, wherein the second leg end expands inwardly of the wall relative to the first leg end via at least one of being formed from a shape memory material and being elastically biased toward the expanded position.

[0098] Example embodiment 33 is the apparatus of example embodiment 28, wherein the fastener anchor is connected directly to the fastener head.

[0099] Exemplary embodiment 34 is the device of exemplary embodiment 28, wherein the fastener anchor is spaced from the fastener head and has a flexible tether mechanically interposed therebetween.

[0100] Example embodiment 35 is a device described in example embodiment 34, wherein the flexible tether has a tether length, the tether length being predetermined before the fastener contacts the selected portion of the cardiac tissue and the at least one subvalvular device.

[0101] Example embodiment 36 is a device described in example embodiment 34, wherein the flexible tether has a tether length, and the tether length is determined after the fastener has already been positioned to contact (1) the selected portion of the cardiac tissue and (2) at least a selected one of the at least one subvalvular device.

[0102] Example embodiment 37 is a device described in example embodiment 34, wherein the fastener is selectively connected to a selected one of the subvalvular portion and the anchor portion, and the flexible tether extends through at least a portion of at least one of the anchor portion and the subvalvular portion.

[0103] Example embodiment 38 is a device described in example embodiment 28, wherein the fastener head is selectively attached to myocardium located in the same heart cavity as the anchor portion, the fastener anchor selectively penetrates and contacts the subvalvular portion, and the fastener applies tension to compress the myocardium against the subvalvular portion to responsively change the shape of the valve annulus.

[0104] Example embodiment 39 is a device described in example embodiment 38, wherein the fastener tether penetrates at least one of the first valve leaflet and the second valve leaflet, and the fastener anchor penetrates and contacts the subvalvular portion.

[0105] Exemplary embodiment 40 is the device described in exemplary embodiment 28, wherein the fastener head, when positioned with the anchor portion, selectively attaches to the valve annulus in the same heart chamber, the fastener anchor extends beyond at least one of the first and second valve leaflets to selectively penetrate and contact the anchor portion, and the fastener applies tension to compress the valve annulus toward the anchor portion and responsively change the shape of the valve annulus.

[0106] Exemplary embodiment 41 is a device described in exemplary embodiment 28, wherein the fastener head is selectively attached to myocardium located in the same heart cavity as the subvalvular portion, the fastener anchor extends to selectively penetrate and contact the subvalvular portion, and the fastener applies tension to press the myocardium against the subvalvular portion to responsively change the shape of the valve annulus.

[0107] Exemplary embodiment 42 is a device described in exemplary embodiment 17, wherein at least one of the subvalvular portion and the anchor portion includes a separately provided covering material attached to the outer surface on at least one of the inside of the outer surface and the outside of the outer surface.

[0108] Example embodiment 43 is the device described in example embodiment 42, wherein the covering material is connected to the subvalvular device at the connector neck and selectively contacts the outer surface of at least one of the subvalvular portion and the anchor portion.

[0109] Example embodiment 44 is the apparatus of example embodiment 42, wherein the covering material is attached substantially to an outer surface of at least a portion of the subvalvular portion, and the fastener selectively penetrates the covering material while being connected to the subvalvular device.

[0110] Example embodiment 45 is a device of example embodiment 42, wherein during at least a portion of a use cycle of the device, at least a portion of the covering material is spaced from at least a portion of the outer side of the outer surface of the subvalve portion so as to have an intermediate volume therebetween, and the fastener is connected to the subvalve device by being directly connected to the covering material.

[0111] As will be appreciated by one of ordinary skill in the art, exemplary embodiment 46 includes an apparatus for at least partially repairing a patient's heart valve, the heart valve including a valve annulus and at least two valve leaflets that collectively define a valve opening, the heart valve having an associated subvalvular device, the subvalvular device including a subvalvular portion, an anchor portion, and a fastener, the apparatus comprising: an elongate sheath having proximal and distal sheath ends longitudinally spaced apart by a sheath body defining a sheath lumen; a zippered catheter having proximal and distal catheter ends spaced longitudinally apart by a catheter body defining a catheter lumen, the catheter body being selectively insertable into the proximal sheath end and capable of passing through the sheath lumen, the catheter including a zipper release feature at the distal catheter end; a grasping tool connected to at least one of the distal sheath end and the catheter body, the grasping tool configured to selectively grasp at least one valve leaflet as the catheter extends through the valve opening; The catheter is configured to make a pigtail turn and configure the fastener release feature to contact the at least one valve leaflet when the at least one valve leaflet is grasped by the grasping tool.

[0112] Example embodiment 47 is the apparatus of example embodiment 46, wherein the pigtail turn is located distal to the gripping fixture.

[0113] Example embodiment 48 is the device described in example embodiment 46, wherein the gripping tool includes a jaw member that is operable to pivot laterally relative to the catheter body about a pivot point located at a distal-most end of the jaw member.

[0114] Example embodiment 49 is the device described in example embodiment 46, wherein the gripping tool includes a jaw member that is operable to pivot laterally relative to the catheter body about a pivot point located at the proximal-most end of the jaw.

[0115] Exemplary embodiment 50 is the device described in exemplary embodiment 46, wherein when the gripping tool is connected to the distal sheath end, the catheter body extends from the distal sheath end, configuring the distal catheter end substantially perpendicular to the sheath body.

[0116] As can be appreciated by one of ordinary skill in the art, exemplary embodiment 51 includes a method of at least partially repairing regurgitation in a heart valve, the heart valve including a valve annulus and at least first and second valve leaflets, the method comprising: providing a subvalvular device for attachment to a patient's heart valve, said subvalvular device including a subvalvular portion, an anchor portion and a fastener; 1. An apparatus for attaching the fasteners associated with the subvalvular device to a patient's heart valve, comprising: an elongate sheath having a proximal sheath end and a distal sheath end spaced longitudinally by a sheath body defining a sheath lumen; a fastener attached catheter having proximal and distal catheter ends spaced longitudinally by a catheter body defining a catheter lumen, the distal catheter end including a fastener release feature; a gripping tool connected to at least one of the distal sheath end and the catheter body; selectively inserting the catheter body into the proximal sheath end and through the sheath lumen; advancing the sheath through a patient's vascular system to configure the distal sheath end adjacent a heart valve; extending the distal catheter end from the distal sheath end; extending the catheter body through the valve opening such that the distal catheter end is on an opposite side of the valve opening from the proximal catheter end; utilizing the grasping tool to selectively grasp at least one valve leaflet as the catheter extends through the valve opening; The catheter extends through the valve orifice and the at least one valve leaflet is grasped by the grasping tool to guide at least the end of the distal catheter to bend at a pigtail. guiding at least the end of the distal catheter through a pigtail turn as the catheter extends through the valve opening and the at least one valve leaflet is grasped by the grasping tool; and configuring the fastener release feature to contact at least one valve leaflet interposed between the distal catheter end and the sheath body.

[0117] Exemplary embodiment 52 is the method of exemplary embodiment 51, wherein selectively grasping at least one valve leaflet while the catheter is extending through the valve opening includes: pivoting the jaw members laterally relative to the catheter body about a pivot point; maintaining at least a portion of the valve leaflets in compression between the jaw members and a selected one of the catheter body and the sheath body.

[0118] Exemplary embodiment 53 is the method of exemplary embodiment 51, wherein guiding at least the distal catheter end at a pigtail turn comprises: When the gripping tool is connected to the distal sheath end, the catheter body can extend from the distal sheath end to configure the distal catheter end substantially perpendicular to the sheath body.

[0119] Exemplary embodiment 54 is the method of exemplary embodiment 51, wherein guiding at least the distal catheter end at a pigtail turn includes: When the gripping tool is connected to the catheter body, rotating the catheter body distal to the gripping tool to configure the distal catheter end substantially perpendicular to the sheath body.

[0120] As can be appreciated by one of ordinary skill in the art, exemplary embodiment 55 includes an apparatus for at least partially supporting regurgitation in a heart valve, the heart valve including at least a first valve leaflet and a second valve leaflet, the apparatus including: The valve includes at least a first subvalvular device and a second subvalvular device, each subvalvular device defining a longitudinal axis, each subvalvular device associated with a corresponding first or second valve leaflet, each subvalvular device comprising: a subvalvular portion including an upper subvalvular surface longitudinally spaced from an opposing lower subvalvular surface and adjacent a leaflet, and a subvalvular peripheral wall longitudinally extending between said upper and lower subvalvular surfaces and integrally and continuously formed with both said upper and lower subvalvular surfaces, at least a portion of said subvalvular peripheral wall contacting a subvalvular heart wall adjacent said heart valve; an anchor portion adjacent to and spaced longitudinally from the upper valve subsurface, the anchor portion including a lower anchor surface spaced longitudinally from an opposing upper anchor surface adjacent the leaflet, and a peripheral anchor wall extending longitudinally between the upper and lower anchor surfaces; a connector neck longitudinally inserted between and attached to the upper subvalve surface and the lower anchor surface, the connector neck longitudinally penetrating at least one of the base of the corresponding leaflet and the annulus of the heart valve at a produced puncture site; and a bridging member extending between and connected to the first and second subvalvular devices, the bridging member responsively applying tension between the first and second subvalvular devices to hold each valve leaflet in position relative to the other valve leaflets.

[0121] Exemplary embodiment 56 is a device described in exemplary embodiment 55, wherein both the subvalvular portion and the anchor portion are formed, at least in part, by at least one of braided strands of a first configuration, braided strands of a second configuration, a balloon, a plurality of longitudinally extending struts, and a plurality of laterally extending struts.

[0122] Example embodiment 57 is the device of example embodiment 55, wherein the subvalvular portion, the anchor portion, and the connector neck together seal a single continuous interior volume.

[0123] Example 58: The device of Example 55, wherein the upper subvalve surface and the lower subvalve surface are both convex, and the subvalve peripheral wall is located vertically below the corresponding valve leaflets relative to the upper subvalve surface and the lower subvalve surface.

[0124] Exemplary embodiment 58 is a device described in exemplary embodiment 55, wherein the upper subvalve surface and the lower subvalve surface are both convex in shape, and the subvalve peripheral wall is located vertically below the corresponding first valve leaflet relative to the upper subvalve surface and the lower subvalve surface.

[0125] Example embodiment 59 is a device described in example embodiment 58, wherein at least one of the subvalvular portion and the anchor portion includes a separately provided covering material attached to the wall on at least one of the inside and outside of the wall.

[0126] Example embodiment 60 is the device described in example embodiment 59, wherein the covering material is connected to the subvalvular device at the connector neck and selectively contacts the outside of the wall of at least one of the subvalvular portion and the anchor portion.

[0127] Exemplary embodiment 61 is the apparatus of exemplary embodiment 55, wherein the bridging member is substantially rigid.

[0128] Exemplary embodiment 62 is the device of exemplary embodiment 55, wherein the bridging member is flexible.

[0129] Exemplary embodiment 63 is the apparatus of exemplary embodiment 55, wherein the bridging member connects the subvalvular portions of the first and second subvalvular devices to each other and extends across the underside of the heart valve.

[0130] Exemplary embodiment 64 is the apparatus of exemplary embodiment 55, wherein the bridging member connects the anchor portions of the first subvalvular device and the second subvalvular device and extends across the upper side of the heart valve.

[0131] Although each aspect of the present invention has been specifically shown and described with reference to the above exemplary embodiments, those skilled in the art will understand that various additional aspects can be envisioned. For example, the specific methods for using the above described devices are merely exemplary, and those skilled in the art can easily determine any number of tools, step sequences, or other devices / options for placing the above described devices or parts thereof in substantially similar positions as shown herein. To maintain clarity in the drawings, some of the overlapping parts shown are not specifically numbered, but those skilled in the art will recognize the element numbers to be associated with the unnumbered parts based on the numbered parts. Any of the described structures and parts may be integrally formed as a single unitary or integral part, or may be composed of separate sub-parts, and any of these structures may relate to any suitable raw material or customized parts and / or any suitable material or combination of materials, although the materials selected should be biocompatible for many applications. Any of the described structures and parts may be disposable or may be used repeatedly as required by the particular environment of use. Any component may be provided with a user-perceivable marking to indicate the material, configuration, at least one dimension, etc. associated with that component, potentially aiding the user in selecting one component for a particular use environment from an array of similar components. The "predetermined" state may be determined at any time up until the engineered structure actually reaches that state, and may be performed immediately prior to the structure reaching the predetermined state. The term "substantially" as used herein does not necessarily indicate perfect quality, and may include relatively minor non-quality items when a particular -a "substantially" quality. Although some parts described herein are shown to have particular geometric shapes, all structures of the present invention may have any suitable shape, size, configuration, relative relationship, cross-sectional area, or any other physical characteristic required for a particular application.Each aspect and configuration discussed herein is described with all options discussed with respect to all other aspects and configurations, so that any structure or feature described with reference to one aspect or configuration may be provided in other aspects or configurations alone or in combination with other structures or features, and devices or methods incorporating any of these features should be understood to be within the scope of the invention as determined by the following claims and any equivalents thereof.

[0132] Other aspects, objects and advantages can be obtained from the accompanying drawings, the invention, and the appended claims.

Claims

1. 1. A device for at least partially repairing regurgitation in a heart valve, comprising: the heart valve includes at least a first valve leaflet and a second valve leaflet; The apparatus includes at least one subvalve device defining a longitudinal axis and a fastener; The subvalve device comprises: a subvalvular portion located near a subvalvular heart wall adjacent to the heart valve; an anchor portion adjacent to and longitudinally spaced from the subvalvular portion; a connector neck inserted longitudinally between the subvalvular portion and the anchor portion and attached to both the subvalvular portion and the anchor portion, the connector neck longitudinally penetrating a base of the first valve leaflet and at least one of the annulus of the heart valve at a produced puncture site; The device, characterized in that the fastener is selectively connected to the at least one subvalvular device, the fastener passing through at least one of the first valve leaflet and the second valve leaflet to hold the at least one leaflet in a predetermined position relative to the at least one subvalvular device.

2. the subvalvular portion includes an upper subvalvular surface longitudinally spaced from an opposing lower subvalvular surface adjacent a first leaflet, and a subvalvular peripheral wall longitudinally extending between the upper and lower subvalvular surfaces and integrally and continuously formed with both the upper and lower subvalvular surfaces, at least a portion of the subvalvular peripheral wall being located adjacent a subvalvular heart wall adjacent the heart valve; the anchor portion is adjacent to and longitudinally spaced from the upper valve subsurface, the anchor portion including a lower anchor surface longitudinally spaced from an opposing upper anchor surface and adjacent the first leaflet, and a circumferential anchor wall extending longitudinally between the upper anchor surface and the lower anchor surface; 2. The device of claim 1, wherein the connector neck is longitudinally interposed between the upper valve subsurface and the lower anchor surface and is attached to both the upper valve subsurface and the lower anchor surface.

3. 2. The apparatus of claim 1, wherein the fastener is selectively connected to a selected one of the subvalvular portion and the anchor portion, the fastener passing through at least one of the first and second valve leaflets to hold the at least one leaflet in a predetermined position relative to the at least one subvalvular device.

4. 10. The device of claim 1, wherein both the subvalvular portion and the anchor portion are formed, at least in part, by at least one of braided strands of a first configuration, braided strands of a second configuration, a balloon, a plurality of longitudinally extending struts, and a plurality of transversely extending struts.

5. 10. The device of claim 1, wherein the subvalve portion, the anchor portion and the connector neck together seal a single continuous interior volume.

6. 3. The device of claim 2, wherein the upper subvalve surface and the lower subvalve surface are both convex, and the subvalve peripheral wall is located longitudinally below the first valve leaflet relative to the upper subvalve surface and the lower subvalve surface.

7. 2. The apparatus of claim 1, wherein the fastener penetrates both the first leaflet and the second leaflet to hold both the first leaflet and the second leaflet in position relative to each other and to the subvalvular device.

8. 3. The apparatus of claim 2, wherein the anchor portion is a first anchor portion, and the subvalvular device includes a second anchor portion adjacent to and longitudinally spaced from the upper subvalvular surface, the second anchor portion including a lower second anchor surface longitudinally spaced from an opposing upper second anchor surface and adjacent a first leaflet, and a second anchor peripheral wall extending longitudinally between the upper second anchor surface and the lower second anchor surface.

9. 9. The apparatus of claim 8, wherein the second anchor portion is spaced apart from the first anchor portion and at least a portion of the subvalvular portion is longitudinally interposed between the first anchor portion and the second anchor portion when the subvalvular device is not adjacent to the subvalvular heart wall.

10. The device of claim 1 , wherein the fastener comprises at least one of a suture, a pledget, a clip, a staple, and a leg.

11. 10. The device of claim 1, wherein the fastener includes a flexible covering on at least a portion of an exterior fastener surface.

12. 2. The apparatus of claim 1, wherein the fastener includes a fastener anchor for selectively penetrating and contacting the at least one subvalvular device and a fastener head for selectively joining at least one of the first valve leaflet and the second valve leaflet.

13. 13. The apparatus of claim 12, wherein the fastener comprises a shape memory tube having a plurality of slits defining at least one of the fastener anchor and the fastener head.

14. 13. The device of claim 12, wherein the fastener head includes a clip for selectively gripping a free edge of at least one of the first valve leaflet and the second valve leaflet.

15. 13. The apparatus of claim 12, wherein the fastener anchor includes at least one elongated leg having a first leg end and a second leg end separated by a leg body, the first leg end attached to the fastener head, the leg body penetrating the at least one of the first and second valve leaflets and a wall of the at least one subvalvular device to connect the at least one of the first and second valve leaflets to the at least one subvalvular device, and the second leg end expanding relative to the first leg end inside the wall to prevent disengagement from the at least one subvalvular device.

16. 16. The device of claim 15, wherein the second leg end splays inside the wall relative to the first leg end by at least one of being formed from a shape memory material and being resiliently biased toward the splayed position.

17. The apparatus of claim 12 , wherein the fastener anchor is directly connected to the fastener head.

18. 13. The device of claim 12, wherein the fastener anchor is spaced from the fastener head, and a flexible tether is mechanically interposed between the fastener anchor and the fastener head.

19. 20. The apparatus of claim 18, wherein the flexible tether has a predetermined tether length before the fastener is positioned to contact at least one of the first and second valve leaflets and at least one subvalvular device.

20. 20. The apparatus of claim 18, wherein the flexible tether has a tether length that is determined after the fastener has already been positioned to contact at least a selected one of (1) the first valve leaflet, the second valve leaflet, and (2) the at least one subvalvular device.

21. 20. The device of claim 18, wherein the fastener is selectively connected to a selected one of the subvalvular portion and the anchor portion, and the flexible tether extends through at least a portion of at least one of the anchor portion and the subvalvular portion.

22. 2. The device of claim 1, wherein at least one of the subvalvular portion and the anchor portion includes a separately provided covering attached to its outer surface on at least one of an inner side of the outer surface and an outer side of the outer surface.

23. 23. The apparatus of claim 22, wherein the covering is connected to the subvalvular device at the connector neck and selectively contacts an outer surface of at least one of the subvalvular portion and the anchor portion.

24. 23. The apparatus of claim 22, wherein the covering is attached to substantially an outer surface of at least a portion of the subvalvular portion, and the fastener selectively penetrates the covering while being connected to the subvalvular device.

25. The device of claim 22, wherein during at least a portion of a use cycle of the device, at least a portion of the covering material is spaced from at least a portion of an outer side of the outer surface of the subvalve portion so as to have an intermediate volume therebetween, and the fastener is connected to the subvalve device by being directly connected to the covering material.

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