Device and method for at least partially repairing heart valve regurgitation

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 heart valves, 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 conditions resulting from anatomical dilation of the heart's geometry due to ischemia, infarction, left-sided heart disease, or pulmonary artery hypertension. FMR and STR do not affect disease of the heart valve leaflets or the valve itself, but rather involve ventricular dilation, deformation, and / or displacement, which causes the chordae tendineae to tether the leaflets and distort normal leaflet coaptation, allowing blood flow back into the left or right atrium (i.e., regurgitation). Although the causes of regurgitation vary, many medical interventions still revolve around replacing or repairing valves through manipulation of prosthetic valves or leaflets, including leaflet resection, folding and suturing, tools to pull leaflet tissue together, and artificial chordae tendineae. However, to date, none of these methods have achieved 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 near a subvalvular heart wall adjacent the heart valve. An anchor portion is adjacent to the subvalvular portion and longitudinally spaced from the subvalvular portion. A connector neck is inserted longitudinally 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 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 explanation of the drawings]

[0006] [Figure 1] 1 is a schematic partial side view of an apparatus according to one aspect of the present invention; [Figure 2] 2A to 2C are diagrams illustrating an example operation sequence of the device of FIG. 1. [Figure 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. [Figure 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. 7. [Figure 9] FIG. 8 is a detailed schematic diagram of the device of FIG. 7. [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 and 8B are diagrams illustrating an example operation sequence of the device of FIG. 7. [Figure 15] 8A and 8B are diagrams illustrating an example operation sequence of the device of FIG. 7. [Figure 16] 8A and 8B are schematic diagrams illustrating exemplary mounting configurations for the device of FIG. 7. [Figure 17] 8A and 8B are schematic diagrams illustrating exemplary mounting configurations for the device of FIG. 7. [Figure 18] 8A and 8B are schematic diagrams illustrating exemplary mounting configurations for the device of FIG. 7. [Figure 19] FIG. 2 is a schematic side view of an exemplary fixture for use with the apparatus of FIG. 1. [Figure 20] 2 is a schematic side view of an exemplary arrangement of the devices of FIG. 1. [Figure 21] 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 the components of the apparatus of FIG. 1 in a first configuration. [Figure 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. [Figure 25] 23 is a partial schematic view of the deployment of the components of FIG. 22. FIG. [Figure 26] 23 is a partial schematic view of the deployment of the components of FIG. 22. FIG. [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]29 is a diagram showing the components of FIG. 28 in a deployed state during their installation. FIG. [Figure 30] FIG. 2 is a schematic front perspective view of components of the apparatus of FIG. 1 in a third configuration. [Figure 31] 30 is a diagram showing a state where the part of FIG. 30 is in a folded state during its installation period. [Figure 32] 34 and 35 are diagrams illustrating an exemplary sequence of operation of the components of the apparatus of FIG. 1 in a fourth configuration. [Figure 33] FIG. 33 is a cross-sectional view taken along line 33-33 in FIG. [Figure 34] FIG. 33 is a schematic side view of the components of FIG. 32 in an unfolded state. [Figure 35] 1. FIG. 4 is a schematic diagram illustrating an exemplary sequence of operation of parts of the apparatus of FIG. 1 in a fourth configuration. [Figure 36] FIG. 2 is a schematic front view of components 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 their deployed state during their installation. [Figure 38] FIG. 10 is a schematic side view of components of the apparatus of FIG. 1 in a sixth configuration. [Figure 39] FIG. 10 is a schematic side view of components of the apparatus of FIG. 1 in a seventh configuration. [Figure 40] FIG. 10 is a schematic side view of components of the apparatus of FIG. 1 in an eighth configuration. [Figure 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; [Figure 42] FIG. 42 is a schematic top perspective view of the device of FIG. 41 in a second configuration. [Figure 43] FIG. 2 is a schematic side view of the device of FIG. 1 in a fourth alternative configuration. [Figure 44] FIG. 44 is a schematic plan view of the device of FIG. 43 in an exemplary environment of use. [Figure 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 INVENTION

[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 intended to refer to any warm-blooded organism, including, but not limited to, humans, pigs, rats, mice, dogs, goats, sheep, horses, monkeys, apes, rabbits, cattle, 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 cohesion problems, and / or reduction of the effects of leaflet cohesion problems. Thus, treatment also includes cases where the leaflet cohesion problem or at least a symptom associated therewith is completely inhibited (e.g., prevented from occurring or stopped (e.g., terminated)), such that the subject is no longer subject to the leaflet cohesion problem or at least a symptom associated therewith.

[0010] As used herein, the singular forms "a," "one," and "said" may include the plural forms unless the context clearly dictates otherwise. It will be further understood that as used herein, the terms "comprise" 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] When an element is referred to as being "on," "mounted," "connected," "coupled," "contacting," "adjacent," or the like, it should be understood that it may be directly mounted on, attached to, connected to, coupled to, contacting, or adjacent to another element, or that intermediate elements may be present. Conversely, when an element is referred to as being, for example, "directly located on," "directly mounted on," "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, this specification may use spatially relative terms such as "lower," "below," "lower side," "upper," "superior," "proximal," and "distal" to describe the relationship of one element or feature to another element or feature as shown in the figures. It should be noted that spatially relative terms may include different orientations in 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 "below" 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, that element may include X, Y, or a combination of X and Y at a particular time, and that 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 referred to as 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 stated otherwise.

[0019] Throughout this invention, various aspects of the invention can be presented in a range format. It should be understood that the description of a range format is merely for convenience and brevity and should not be construed as strictly limiting the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all possible subranges and each numerical value within that range. For example, a description of a range of about 1 to about 6 should be considered to have specifically disclosed subranges, such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as 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 a range is not intended to be limiting.

[0020] The present invention may 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 leaflet 104 and a second 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 that includes myocardium 114. The heart valve 102, the first leaflet 104 and the second leaflet 106, the valve annulus 108, and the myocardium 114 all comprise 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 conjunction with 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 related structure for any desired environment of use.

[0022] The apparatus 100 can be used to at least partially repair regurgitation in 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 January 21, 2020, U.S. Patent No. 11,241,313, issued February 8, 2022, and / or co-pending U.S. patent application Ser. No. 17 / 396,987, filed 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 to (e.g., in contact with) the underside of the first valve leaflet 104. A subvalvular peripheral wall 128 extends longitudinally between the upper and lower subvalvular surfaces 124 and 126 and is integrally formed continuously with the upper and lower subvalvular surfaces 124 and 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 to (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 valve leaflet 104 from below against and support the subvalvular heart wall 130 during at least a portion of the cardiac cycle. If present, such support from the subvalvular portion 122 tends to reduce regurgitation of the heart valve 102 by pushing the first valve leaflet 104 into apposition with the second valve leaflet 106. However, it is contemplated that the subvalvular device 120 or its structure 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 valve 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] Anchor portion 132 is adjacent to and longitudinally spaced from upper subvalvular surface 124. Anchor portion 132 has a lower anchor surface 134 longitudinally spaced from an opposing upper anchor surface 136. Lower anchor surface 134 is configured to rest selectively adjacent (e.g., in contact with) an upper side of first valve leaflet 104 when subvalvular device 102 is attached to the heart valve 102. Anchor peripheral wall 138 extends longitudinally between upper anchor surface 136 and lower anchor surface 134.

[0026] It should be noted that the upper support and anchor surfaces 124, 136, the lower support and anchor surfaces 126, 134, and the subvalvular and anchor peripheral walls 128, 138 are described herein as distinct from one another. However, one skilled in the art will understand that either the subvalvular portion 122 or the anchor portion 132 may be configured such that their surfaces and walls are not clearly delineated from one another, that adjacent structures may "flow," or may be shaped such that no clear boundary is defined 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 longitudinally inserted between the upper subvalvular surface 124 and the lower anchor surface 134 and 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 created puncture site. As used herein, a "created puncture site" refers to an area of ​​cardiac tissue where an opening is created, either 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 "created puncture site." The "432 Family" disclosure provides additional exemplary details regarding the subvalvular device 120 and its placement in the positions shown in the drawings.

[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 fabricated from a first material (e.g., a plurality of struts cut from a tubular base), and at least one other of the subvalve portion 122, the anchor portion 132, and / or the connector neck 140 may be fabricated from a second material (e.g., braided strands of a first configuration). For reasons explained below, it is desirable that at least one of the subvalvular portion 122 and the anchor portion 132 be formed from a mesh or other material that resists tearing or ripping after puncture, and that 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 can collectively seal a single contiguous interior volume (e.g., used as different diameter portions of a single balloon, mesh, and / or tubular structure), or can 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 can be at least one of a balloon and a mesh structure, respectively, and the connector neck 140 can be a 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 the subvalvular portion 122 or the 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 the anchor portion 132.

[0030] 4 , a fastener 442 may be selectively connected to the subvalvular device 120, e.g., selectively connected to a selected one of the subvalvular portion 122 and the anchor portion 132. The fastener 442 at least partially penetrates selected cardiac tissue to maintain at least one leaflet 104, 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 valve leaflet 104 and the second valve leaflet 106 to hold at least one leaflet 104, 106 in a predetermined position relative to at least one of the subvalvular portion 122 and the anchor portion 132. This holding may be achieved via nailing, tensioning, compressing, and / or any other desired mechanism for a particular use environment. Many 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 may include at least one of a suture (i.e., an elongated loop of suture material), a pledget, a clip, a staple, legs, barbs, 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., 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 configure 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 the fastener head 546. The leg body 556 penetrates, and optionally completely penetrates, at least one of 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, and optionally completely penetrates, at least one leaflet (here, the first valve leaflet 104) and 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 at least partially embedded in wall 558. (As used herein, "inside" may refer to a target structure on any side of any wall of cardiac tissue and / or a portion of the subvalvular device 120.) Once second leg end 554 is within or "through" (on the inside of) wall 558, second leg end 554 may expand or pull along a predetermined direction relative to 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 expansion causes legs 550 to expand in a "nail" shape, thereby resisting pulling when fastener head 546 is under tension. In many of the figures, multiple legs 550 are provided on fastener 542 to enhance the nail-like effect created by second leg ends 554 being spread apart, thereby helping to hold fastener anchor 544 in place within the target structure.

[0035] This 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 cause the spreading. It is contemplated that the second leg end 554 may be 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 deform (non-plastically deform) under pressure for insertion into the heart under constrained conditions, and then return to the bent, spread configuration when released from a constraining device (e.g., a catheter) and placed in a desired relationship with the wall 558.

[0036] 1-4 schematically illustrate a sequence of a method for at least partially repairing regurgitation in 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. Referring to FIG. 1 , a subvalvular device 120 is configured, 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 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. The subvalvular device 120 can be positioned as shown in FIG. 1 in any desired manner, for example, by inserting the subvalvular device 120 into a collapsed state using a transseptal approach and into the heart 110 via a long catheter (schematically designated 260 in FIG. 2 ). Once the subvalvular device 120 has been advanced to a desired position adjacent the heart valve 192, the subvalvular device 120 may be deployed from the collapsed state to the deployed state. Further information regarding suitable methods for positioning the subvalvular device 120 in any of the relevant drawing positions can be found in the "432 Family" disclosure or may be provided by one skilled in the art for a particular use environment.

[0037] A fastener 442 is 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 collapsed state for insertion into the heart 110 via an elongate catheter 260 (which may be the same as or different from the elongate 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 the collapsed state to an expanded state.

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

[0039] The fastener 442 may be, or alternatively may be, fastened to at least one 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 cardiac tissue may include selectively joining the fastener head 546 to 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, connecting the first valve leaflet 104 to the at least one subvalvular device 120, here connecting the subvalvular portion 122. The second leg end 554 then expands inwardly of the wall 558 relative to the first leg end 556, preventing 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 the use environment shown schematically 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 replacement chordae to replace 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 through use of the apparatus 100.

[0041] 1-4 and the associated description above, one skilled in the art can readily deduce and develop various methods for 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 conditions 110. The attachment sequence for many of the following exemplary embodiments of apparatus 100 will not be described in detail, but can be readily determined by one skilled in the art, particularly following the methods described in some detail herein.

[0042] Some of the configurations in Figures 6 to 47 are the same as 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 that are common to the previously described embodiments 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 positioned 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 schematically. 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 firmly attach the fastener anchor 544 and the fastener head 546 and that 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 schematically in Figure 8 and in the larger context of the heart 110 in the schematic diagram of Figure 8. Flexible tether 762 may have a tether length that is predetermined (e.g., via pre-operative imaging) before the fasteners 442 are placed 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 has already been placed in contact with at least one of (1) the cardiac tissue (e.g., 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 the desired tether length is achieved. The tether 762 can function as a pseudochordae 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 schematically illustrate an exemplary use of apparatus 100 to address mitral valve regurgitation, where the 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 schematically illustrates the device 100 with the fastener 442, which simultaneously penetrates both the first and second leaflets 104, 106 to hold them in place relative to each other and 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 dilated that conventional clips have difficulty or significantly twist the heart valve 102. 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 after 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 schematically illustrate an exemplary attachment sequence of a fastener 442 having a tether 762 and a clip 1464 for coapting and maintaining the second valve leaflet 106 relative to the subvalvular portion 122. As shown in FIG. 14 , the fastener head 546 includes a clip 1464 for selectively grasping the 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 grasping 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 fasteners 442 including tethers 762 (which may have a fixed length or be adjustable in situ, as described above) are shown. In FIGS. 16-18, the fasteners 442 are used to apply tension across a cardiac chamber via attachment of the fastener heads 546 to cardiac tissue spaced from the subvalvular device 120. For example, in FIG. 16, the fastener heads 546 selectively attach to myocardium 114 in the same cardiac chamber as the anchor portions 132, and the fastener anchors 544 selectively attach to, and optionally penetrate and contact, the subvalvular portion 122. To that end, the fastener heads 546 may include one or more legs 550 that expand similarly to the legs 550 of the fastener anchors 544, and the legs 550 are attached to the subvalvular device 120. (Any desired configuration includes, but is not limited to, joining fastener head 546 to cardiac tissue using one or more barbs, hooks, screws, adhesive, 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 penetrate at least one of the first leaflet 104 and the second leaflet 106 (here, penetrating the first leaflet 104) and selectively penetrate and contact the subvalvular portion 122.

[0050] 17, the fastener head 546 is shown to selectively join with the valve 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 push the valve annulus 108 toward the anchor portion 132, causing the shape of the valve annulus 108 to responsively change.

[0051] As shown in FIG. 18 , the fastener head 546 can selectively join myocardium 114 in the same heart cavity as the subvalvular portion 122, and the fastener anchor 544 can extend 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. Similar to the structures shown in FIGS. 16-17 , the structure of FIG. 18 can include at least a portion of the fastener 442 penetrating / piercing at least one of the first and second leaflets 104, 106, "pinning" them to form a desired spatial relationship with the remaining heart tissue and / or the subvalvular device 120.

[0052] 19 illustrates a device 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 defining 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 defining a catheter lumen. The catheter body 1982 is selectively insertable into the proximal sheath end 1970 and threadable 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 as being 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 spaced from the valve opening while the catheter 1976 is advanced distally out of the distal sheath end 1972 through the valve opening, as described and shown.

[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 skilled in the art to appropriately configure the device 1966 for a particular environment of use.

[0054] A grasping tool 1986 is connected to the distal sheath end 1972 and at least one of the catheter body 1982. The grasping tool 1986 is configured to selectively grasp at least one valve leaflet 104, 106 while the catheter 1976 is extending through a valve opening. The grasping tool 1986 has jaw members 1988 that are laterally rotatable relative to the catheter body 1982 about a pivot point 1990 ("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 grasping tool 1986 "backwards," as shown in FIG. 19 . Alternatively, the pivot point 1990 may be located at the proximal most end of jaw member 1988 so that the gripping tool 1986 opens downwardly toward the distal catheter end 1980 .

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

[0056] 20-21 , an exemplary 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. The term "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 ambient environment. For example, the "outer surface" of the subvalvular device 122 may include 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 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 anchor portion 132. For example, in FIG. 20, the subvalvular 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 the outer surface of at least a portion of the subvalvular portion 122, and the fasteners 442 selectively penetrate the covering material 2092 while being connected 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 apparatus 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 illustrate various exemplary configurations, arrangements, and conditions of exemplary fasteners 442 usable with the device 100. Some of the fasteners 442 illustrated in FIGS. 22-40 include a shape-memory tube 2294 (e.g., hypotube) with a plurality of slits 2294 defining at least one of the fastener anchor 544 and the fastener head 546. The slits 2294 may be formed, for example, by laser cutting. The arrangement of the elongate catheter 260 is optional, and any desired deployment scheme may be employed. For example, the fasteners 442 of FIGS. 22-27 (including shape-memory material features) may be loaded onto an introducer and deployed by retraction of the cover catheter 260. The fasteners 442 may also have cavities (as shown in FIGS. 22-30 ) for passage of a needle, wire, or any other puncture device to aid in puncturing the first leaflet 104 or second leaflet 106 when delivering the fasteners 442 to the subvalvular device 120. As another example, the fasteners 442 of FIGS. 32-35 may include pull wires for deploying pivot-toggle fastener anchors 544. The fasteners 442 of FIGS. 22-40 include fastener heads 546 and fastener anchors 544 that are substantially similar in structure and can be used to "sandwich" attached structures (e.g., cardiac tissue and / or at least a portion of the subvalvular device 120). One skilled in the art can readily provide one or more fasteners 442 for use in a particular environment of use of the present invention, and each fastener may be one of the designs shown in the figures or any other design.

[0060] 41-42 illustrate an exemplary configuration of an apparatus 100 including multiple subvalvular devices 120 (here, a first subvalvular device and a second subvalvular device 120), each positioned at a manufacturing puncture site in a different valve leaflet 104, 106 of the heart valve 102. A bridging member 2298 extends between and connects the first and second subvalvular devices 120 and responsively applies 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 member 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 the 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 the top 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 spaced from the first anchor portion 132, longitudinally sandwiching 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 illustrate 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 valve 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 provide proper support for the valve leaflets and an annuloplasty effect.

[0064] 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, which is joined to the valve annulus. FIG. 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, which is joined to the myocardium 114 of the heart wall 112 in the same heart cavity as the subvalvular portion 122. In contrast, Figure 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 the 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 Figures 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 this disclosure, one skilled in the art will readily be able to provide a suitable device 100 having a tether 762 extending through any desired natural or artificial structure required in a particular use environment.

[0065] In summary, as will be appreciated by those skilled in the art, exemplary embodiment 1 includes a method for 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 subvalvular device defining a longitudinal axis, said subvalvular device comprising: a subvalvular portion located near the subvalvular heart wall adjacent to the heart valve; an anchor portion adjacent to and longitudinally spaced from the subvalvular portion; a connector neck longitudinally inserted 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 the subvalvular heart wall adjacent to the heart valve, and with the connector neck longitudinally penetrating at least one of the base of the first valve leaflet and the annulus of the heart valve at the created puncture site; Providing a fastener; selectively connecting the fastener to the at least one subvalvular 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 the method of exemplary embodiment 1, wherein the subvalvular portion includes an upper subvalvular surface adjacent to the 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; the anchor portion is adjacent to and spaced longitudinally from the upper valve inferior surface, the anchor portion including a lower anchor surface spaced longitudinally from an opposing upper anchor surface and adjacent the first leaflet, and a peripheral anchor wall extending longitudinally between the upper and lower anchor surfaces; the connector neck is inserted longitudinally between the upper valve lower surface and the lower anchor surface and is attached to both the upper valve lower surface 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 collapsed state to an expanded 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] Exemplary embodiment 8 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 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 the selected one of the subvalvular portion and the anchor portion includes positioning 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 separating from the at least one subvalvular device.

[0075] Example embodiment 11 is a method according to example embodiment 10, wherein expanding 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 expanding 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 to contact at least one of the first valve leaflet and the second valve leaflet 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 valve leaflet and the second valve leaflet 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 longitudinally spaced apart by a sheath body defining a sheath lumen; a fastener-mounted 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 the 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 by grasping the at least one valve leaflet with the grasping tool as the catheter extends through the valve opening; and positioning the fastener release feature to contact at least one valve leaflet interposed between the distal catheter end and the sheath body.

[0081] As will be appreciated by those skilled in the art, exemplary embodiment 17 includes a device 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 device comprising: 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 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 contacting a subvalvular heart wall adjacent the heart valve; an anchor portion adjacent to and spaced longitudinally from the upper subvalvular surface, the anchor portion including a lower anchor surface spaced longitudinally from an opposing upper anchor surface and adjacent the leaflet, and a peripheral anchor wall extending longitudinally between the upper and lower anchor surfaces; a connector neck inserted longitudinally 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 the created puncture site; and a bridging member extending between and connecting 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 will be understood by one skilled in the art, 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 subvalvular device a subvalvular portion located near the subvalvular heart wall adjacent 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 the base of the first valve leaflet and the annulus of the heart valve at the created 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 valve 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 to the 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 to a subvalvular heart wall adjacent to 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 longitudinally extending 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 described in 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 transversely extending struts.

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

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

[0088] Exemplary embodiment 23 is the device described in exemplary 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 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 to the first leaflet, and a second anchor peripheral wall extending longitudinally between the upper second anchor surface and the lower second anchor surface.

[0090] Exemplary embodiment 25 is an apparatus described in exemplary 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 longitudinally 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] Exemplary embodiment 27 is the device of exemplary embodiment 17, wherein the fastener includes a flexible cover on at least a portion of the outer fastener surface.

[0093] Exemplary embodiment 28 is a device described in exemplary 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 joining 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] Exemplary embodiment 31 is a device described in exemplary 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 the 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 by at least one of being formed from a shape memory material and being elastically biased toward the expanded position.

[0098] Exemplary embodiment 33 is the device of exemplary embodiment 28, wherein the fastener anchor is directly connected 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, with a flexible tether mechanically interposed therebetween.

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

[0101] Exemplary embodiment 36 is a device described in exemplary 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] Exemplary embodiment 38 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 anchor portion, the fastener anchor selectively penetrates and contacts the subvalvular portion, and the fastener applies tension to press the myocardium against the subvalvular portion and responsively change the shape of the valve annulus.

[0104] Exemplary embodiment 39 is a device described in exemplary 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 valve leaflet and the second valve leaflet 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 and 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 its 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 a 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] Exemplary embodiment 44 is the device of exemplary embodiment 42, wherein the covering material is attached substantially to the 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] Exemplary embodiment 45 is a device of exemplary embodiment 42, wherein during at least a portion of the device's use cycle, 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 subvalvular portion so as to have an intermediate volume therebetween, and the fastener is connected to the subvalvular device by being directly connected to the covering material.

[0111] As will be appreciated by those skilled 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 a proximal sheath end and a distal sheath end spaced longitudinally by a sheath body defining a sheath lumen; a zippered catheter having proximal and distal catheter ends longitudinally spaced 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; When the at least one valve leaflet is grasped by the grasping tool, the catheter is configured to make a pigtail turn and configure the fastener release feature to contact the at least one valve leaflet.

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

[0113] Exemplary embodiment 48 is the device described in exemplary 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 distal-most end of the jaw member.

[0114] Exemplary embodiment 49 is the device described in exemplary 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, and the distal catheter end can be configured substantially perpendicular to the sheath body.

[0116] As will be appreciated by those skilled in the art, exemplary embodiment 51 includes a method for 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-mounted 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 grasping 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 the 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, thereby guiding 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 by grasping the at least one valve leaflet with the grasping tool as the catheter extends through the valve opening; 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 comprises: 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 through 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, configuring 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 comprises: When the gripping tool is connected to the catheter body, the catheter body is rotated distal to the gripping tool to configure the distal catheter end substantially perpendicular to the sheath body.

[0120] As can be appreciated by one skilled in the art, exemplary embodiment 55 includes a device 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 device comprising: 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 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 contacting a subvalvular heart wall adjacent the heart valve; an anchor portion adjacent to and spaced longitudinally from the upper subvalvular surface, the anchor portion including a lower anchor surface spaced longitudinally from an opposing upper anchor surface and adjacent the leaflet, and a peripheral anchor wall extending longitudinally between the upper and lower anchor surfaces; a connector neck inserted longitudinally 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 the created puncture site; and a bridging member extending between and connecting 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 transversely extending struts.

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

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

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

[0125] Exemplary embodiment 59 is a device described in exemplary 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] Exemplary embodiment 60 is a device described in exemplary 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] While 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 are contemplated. For example, the specific methods for using the above-described devices are merely exemplary, and those skilled in the art can readily determine any number of tools, step sequences, or other devices / options for placing the above-described devices or components thereof in substantially similar locations to those shown herein. To maintain clarity in the drawings, some of the overlapping components shown are not specifically numbered, but those skilled in the art will recognize the element numbers that should be associated with the unnumbered components based on the numbered components. Any of the described structures and components may be integrally formed as a single, unitary or integral part, or may be composed of separate subcomponents. Any of these structures may be constructed from any suitable raw material or customized components and / or any suitable material or combination of materials, although the selected materials should be biocompatible for many applications. Any of the described structures and components may be disposable or may be reused repeatedly as required by the particular environment of use. Any component can be provided with user-perceivable markings to indicate the material, configuration, at least one dimension, etc. associated with the component, potentially assisting the user in selecting a 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 occur immediately before the structure reaches the predetermined state. The term "substantially," as used herein, does not necessarily imply perfect quality and may include relatively minor non-quality items when a particular "substantially" quality is present. While some parts described herein are shown as having specific 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, and 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. 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 restoring 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 subvalvular device defining a longitudinal axis and a fastener; The subvalvular device a subvalvular portion located near the subvalvular heart wall adjacent 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 at least one of the base of the first valve leaflet and the annulus of the heart valve at the prepared puncture site; 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 place relative to the at least one subvalvular device; 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.

2. the subvalvular portion includes an upper subvalvular surface longitudinally spaced from an opposing lower subvalvular surface and adjacent to 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 near a subvalvular heart wall adjacent the heart valve; the anchor portion is adjacent to the upper valve inferior surface and spaced longitudinally from the upper valve inferior surface, the anchor portion including a lower anchor surface spaced longitudinally from an opposing upper anchor surface and adjacent to the first leaflet, and a peripheral 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 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.

3. 3. The device of claim 1, wherein the fastener is selectively connected to a selected one of the subvalvular portion and the anchor portion, and the fastener penetrates 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.

4. 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 the first leaflet, and a second anchor peripheral wall extending longitudinally between the upper second anchor surface and the lower second anchor surface.

5. 5. The device of any one of claims 1, 2 and 4, wherein the fastener includes a flexible covering on at least a portion of an outer fastener surface.

6. 6. The device of claim 5, 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 being attached to the fastener head, the leg body penetrating the at least one of the first valve leaflet and the second valve leaflet and a wall of the at least one subvalvular device to connect the at least one of the first valve leaflet and the second valve leaflet 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.

7. 6. The device according to claim 5, wherein the fastener anchor is spaced apart from the fastener head, and a flexible tether is mechanically interposed between the fastener anchor and the fastener head.

8. 8. The device of claim 7, wherein the flexible tether has a tether length that is predetermined before the fastener is positioned to contact at least one of the first valve leaflet and the second valve leaflet and at least one subvalvular device, and / or 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.

9. 8. The device of claim 7, 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.

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