Self-ligating tissue anchor

Abstract

A tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is provided that includes a wire (22, 122, 222, 322, 422, 622) shaped to define a straight anchor shaft portion (26, 276) and a tissue coupling portion (31, 131, 231, 331, 431, 631) extending from the straight anchor shaft portion. The tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state: (a) the tissue coupling portion crosses itself along the metal wire at the first loop end longitudinal portion (40A, 340A, 640A) and the second loop end longitudinal portion (40B, 340B, 640B) to define an annular portion (44, 344, 644) that generally defines an annular portion plane (46, 346), and (b) the first loop end longitudinal portion (40A, 340A, 640A) is disposed along the metal wire. The metal wire is closer to the first proximal wire end (24A) than the second loop end longitudinal portion (40B, 340B, 640B) is to the first proximal wire end (24A) along the metal wire, and (c) the maximum absolute distance (D1) between the first loop end longitudinal portion (40A, 340A, 640A) and the first proximal wire end (24A) is greater than the maximum absolute distance (D2) between the second loop end longitudinal portion (40B, 340B, 640B) and the first proximal wire end (24A). Other embodiments are also described.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 784,670, filed on December 24, 2018, which is assigned to the assignee of the present application and is incorporated herein by reference. Technical Field

[0003] The present invention relates generally to tissue anchors and, more particularly, to tissue anchors for implantation in the cardiac region. Background Art

[0004] Tissue anchors are used to anchor elements such as pacemaker electrode leads or sutures to tissue such as bone or soft tissue. PCT Publication WO 2016 / 087934 to Gilmore et al., the entire contents of which are incorporated herein by reference, describes a tissue anchor comprising a shaft, a tissue coupling element, and a flexible, elongated tension member. The tissue coupling element comprises a metal wire formed into an open-loop coil, and in some applications, the open-loop coil has more than one turn of coil rotation when the tissue anchor is unconstrained, i.e., when expanded from a linear state to a coiled state. The tension member comprises a distal portion fixed to a location on the open-loop coil, a proximal portion having a longitudinal segment extending side by side with at least a portion of the shaft, and a cross-over portion, which (i) is disposed along the tension member between the distal portion and the proximal portion, and (ii) causes at least a portion of the open loop to cross when the tissue anchor is expanded. The tissue anchor is configured to allow relative axial movement between at least a portion of the shaft and a longitudinal segment of the proximal portion of the tension member when the tissue anchor is expanded. For some applications, the head of the tissue anchor is shaped to define a channel in which the proximal portion of the flexible, elongated tension member is slidably disposed. The flexible, elongated tension member includes a locking stop that is axially secured to the proximal or cross portion of the flexible, elongated tension member. The size and shape of the locking stop and the channel are adapted such that the size and shape of the channel prevent the locking stop from moving proximally through the channel. The locking stop limits the total load that can be applied to the open loop by the flexible, elongated tension member, thereby reducing excessive, unnecessary strain on the open loop. The additional load (tension) applied by the flexible, elongated tension member pulls on the entire anchor and does not further increase the load applied to the open loop.

[0005] U.S. Patent Application Publication 2003 / 0093096 to McGuckin, Jr. et al. describes a clamp device for closing a vascular orifice created by insertion of a surgical instrument comprising an elongated strand including a central portion and an end portion extending from the central portion. The tip of the end portion distal to the central portion is shaped to retain tissue encountered thereby. The end portion has a memory property in an attempt to cause the end portion to curl relative to the central portion to retain tissue engaged thereby when the strand is in an unconstrained arrangement.

[0006] U.S. Patent 8,398,672 to Kleshinski et al. describes a technique for anchoring a medical implant device within a blood vessel or other body passage. The anchor delivery system contains one or more expandable anchors connected to the medical implant device. The anchors remain contained in a non-expanded configuration until the medical implant device has been placed at a desired location within the body, and then the anchors are advanced through the body wall where each anchor expands outwardly from the anchor shaft. In one configuration, each anchor is formed as a compressible closed loop that extends outwardly from the anchor shaft and loops rearwardly to span and extend beyond the anchor shaft. To advance the anchor, a drive shaft is connected to a trigger unit that, when activated, causes the drive shaft to drive the anchor shaft in a direction that causes the anchor to be advanced through the body wall.

[0007] U.S. Patent Application Publication 2002 / 0013571 to Goldfarb et al. describes a technique for grasping and optionally repositioning and fixing a valve leaflet to treat heart valve regurgitation, particularly mitral valve regurgitation. Such grasping will generally be non-invasive, providing many benefits. For example, non-destructive grasping can allow the device to be repositioned relative to the valve leaflet and the valve leaflet itself to be repositioned without damaging the valve leaflet. However, in some cases, it may be necessary or desirable to include a grasping that pierces or otherwise permanently affects the valve leaflet. In some of these cases, the grasping step includes fixing. In one embodiment described with reference to FIGS. 24 and 25 , the anchor includes a metal wire bent into a ring. The metal wire can be stainless steel, nitinol or other shape memory metal wire, polymer or similar material. The suture is attached to the center of the ring by an adhesive material. The metal wire has a first end and a second end, wherein the first end is disposed on the top of the ring and the second end is disposed below the ring. This construction provides support for the ring when the anchor is pulled against the surface of the valve leaflet by the suture. The anchor can be used for fixing the valve leaflet. When the anchor wire is constructed of a flexible material, the anchor is foldable for stowage within the needle.

[0008] U.S. Patent Application Publication 2014 / 0275756 to Bender et al. describes techniques for compressing, cutting, incising, reconstructing, reshaping, attaching, repositioning, supporting, dislocating, or changing the composition of a tissue or anatomical structure to change its position or force relationship with other tissues or anatomical structures. In one embodiment described with reference to FIGS. 9C and 9C', an anchor is provided that does not have a preformed coil at its distal end, but rather the distal coil is custom formed by features at the end of a delivery member. FIG. 9C' depicts the anchor in place in the tissue and includes a proximal tail also formed by the delivery member.

[0009] US Patent Application Publication 2009 / 0112052 to Lund et al. describes an implant for placement in the retropubic space of a patient. Figure 8is a perspective view of an implant anchored to the endopelvic fascia, and FIG. 9 is a perspective view of one embodiment of an expandable member or anchor. Summary of the invention

[0010] Embodiments of the present invention provide a tissue anchor that can be delivered to a cardiac chamber in an unexpanded, generally elongated configuration within a deployment tool. The tissue anchor is configured to be anchored to a cardiac tissue wall at a target site, such that once the tissue anchor is deployed, tension can be applied to the tissue anchor, and thus to the cardiac tissue wall, to move the cardiac tissue wall at the target site relative to adjacent cardiac tissue. For some applications, this movement changes the geometry of a cardiac valve, such as a tricuspid valve or a mitral valve.

[0011] In some embodiments of the present invention, a tissue anchor is provided, comprising a wire having a first wire end and a second wire end and being shaped to define a straight anchor shaft portion and a tissue coupling portion, the tissue coupling portion extending from a distal end of the straight anchor shaft portion such that the straight anchor shaft portion is disposed along the wire between the tissue coupling portion and the first wire end. The tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state:

[0012] the tissue coupling portion is shaped to define a trailing end portion comprising the second end of the wire,

[0013] the tissue coupling portion of the wire crosses itself along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion so as to define a loop portion that generally defines a loop portion plane that forms an angle of between 75 degrees and 90 degrees with the anchor shaft axis of the straight anchor shaft portion,

[0014] the first loop end longitudinal portion is located closer to the first wire end along the wire than the second loop end longitudinal portion is located to the first wire end along the wire, and

[0015] The maximum absolute distance between the first loop end longitudinal portion and the first wire end is greater than the maximum absolute distance between the second loop end longitudinal portion and the first wire end.

[0016] For some applications, the tissue anchor is configured such that when the proximal end of the straight anchor shaft portion is pulled along the anchor shaft axis away from the plane of the ring portion, mechanical contact between the first ring end longitudinal portion and the second ring end longitudinal portion locks the ring portion and prevents the ring portion from straightening due to the applied tension. Typically, the pulling is performed using a tether coupled to the tissue anchor.

[0017] In other embodiments of the present invention, a tissue anchor is provided, which includes a straight anchor shaft portion and a tissue coupling portion. The tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state where the tissue coupling portion is not constrained by any external force:

[0018] the tissue coupling portion is shaped to define an elongated intermediate portion extending from a distal end of the straight anchoring shaft portion, and a forked distal portion extending from a distal end of the intermediate portion and defining two tines, and

[0019] The tine passage portion of the tissue anchor passes between two tines, the tine passage portion being defined by the straight anchor shaft portion and / or the intermediate portion.

[0020] For some applications, the tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state, the middle portion is not in mechanical contact with itself or with either of the two tines. When the proximal end of the straight anchor shaft portion is pulled away from a tine plane generally defined by the two tines along the anchor shaft axis of the straight anchor shaft portion, the middle portion is in mechanical contact with at least one of the middle portion and / or the two tines.

[0021] Therefore, according to inventive concept 1 of the present invention, there is provided a tissue anchor comprising a metal wire having only two wire ends,

[0022] Wherein, the metal wire is shaped as defined by:

[0023] A straight anchor shaft portion, and

[0024] a tissue coupling portion extending from a distal end of the straight anchoring shaft portion such that the straight anchoring shaft portion is disposed along the wire between the tissue coupling portion and only a first of the two wire ends,

[0025] Wherein, the tissue anchor is configured such that when the tissue coupling portion of the metal wire is in a non-constrained state where the tissue coupling portion is not constrained by any external force:

[0026] (a) the tissue coupling portion of the wire is shaped to define a trailing end portion including only the second of the two wire ends,

[0027] (b) the tissue coupling portion of the wire crosses itself along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion so as to define a loop portion that generally defines a loop portion plane that forms an angle of between 75 degrees and 90 degrees with the anchor shaft axis of the straight anchor shaft portion,

[0028] (c) the first loop end longitudinal portion is located closer to the first wire end along the wire than the second loop end longitudinal portion is located to the first wire end along the wire, and

[0029] (d) The maximum absolute distance between the longitudinal portion of the first loop end and the first wire end is greater than the maximum absolute distance between the longitudinal portion of the second loop end and the first wire end.

[0030] Inventive Concept 2. The tissue anchor according to Inventive Concept 1, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the anchor shaft axis does not pass through a space surrounded and defined by the annular portion.

[0031] Inventive concept 3. The tissue anchor according to inventive concept 1, wherein the tissue anchor is configured so that when the tissue coupling portion of the metal wire is in an unconstrained state, the metal wire crosses itself only once along the metal wire at the first loop end longitudinal portion and the second loop end longitudinal portion.

[0032] Inventive Concept 4. The tissue anchor according to Inventive Concept 1, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the wire defines only a single loop portion.

[0033] Inventive Concept 5. The tissue anchor according to Inventive Concept 1, wherein the wire is not shaped to define any looped portion proximal to the proximal end of the straight anchor shaft portion.

[0034] Inventive concept 6. The tissue anchor according to inventive concept 1, wherein the tissue anchor is configured such that:

[0035] When the tissue coupling portion of the wire is in an unconstrained state, the loop portion is formed into an open loop portion in which the first loop end longitudinal portion and the second loop end longitudinal portion are not in mechanical contact with each other, and

[0036] When the proximal end of the straight anchor shaft portion is pulled along the anchor shaft axis away from the plane of the ring portion, the first ring end longitudinal portion and the second ring end longitudinal portion are in mechanical contact with each other.

[0037] Inventive Concept 7. The tissue anchor according to Inventive Concept 1, wherein the trailing end portion generally falls within a plane of the annular portion when the tissue coupling portion of the wire is in an unconstrained state.

[0038] Inventive Concept 8. The tissue anchor according to Inventive Concept 1, wherein when the tissue coupling portion of the wire is in an unconstrained state, no portion of the trailing end portion is parallel to the straight anchor shaft portion.

[0039] Inventive Concept 9. The tissue anchor according to Inventive Concept 1, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the trailing end portion is shaped to define at least one straight portion.

[0040] Inventive Concept 10. The tissue anchor according to Inventive Concept 1, further comprising a fabric covering a portion of the metal wire including the first loop end longitudinal portion or the second loop end longitudinal portion.

[0041] Inventive Concept 11. The tissue anchor according to Inventive Concept 1, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the trailing end portion is shaped to define at least one trailing end portion bend.

[0042] Inventive Concept 12. The tissue anchor according to Inventive Concept 1, wherein the proximal end of the straight anchor shaft portion is located at only the first of the two wire ends.

[0043] Inventive Concept 13. The tissue anchor according to any one of Inventive Concepts 1 to 11, wherein the proximal end of the straight anchor shaft portion is located at only a first of the two wire ends.

[0044] Inventive concept 14. A tissue anchor according to any one of inventive concepts 1 to 12, wherein the tissue anchor is configured such that when the tissue connecting portion of the metal wire is in an unconstrained state, the tissue connecting portion of the metal wire is shaped to define a first loop end bend portion, and the first loop end longitudinal portion is positioned along the first loop end bend portion.

[0045] Inventive concept 15. The tissue anchor according to inventive concept 14, wherein the tissue anchor is configured so that when the proximal end of the straight anchor shaft portion is pulled away from the plane of the ring portion along the anchor shaft axis, the metal wire at the second ring end longitudinal portion snaps into the first ring end longitudinal portion at the first ring end curved portion of the metal wire.

[0046] Inventive concept 16. A tissue anchor according to inventive concept 14, wherein the tissue anchor is configured so that when the tissue connecting portion of the metal wire is in an unconstrained state, the radius of curvature of the inner curved surface of the curved portion of the first loop end is equal to between 80% and 120% of the radius of the metal wire along the longitudinal portion of the second loop end.

[0047] Inventive Concept 17. The tissue anchor according to Inventive Concept 14, wherein the first loop end curved portion extends directly from the distal end of the straight anchor shaft portion.

[0048] Inventive concept 18. A tissue anchor according to any one of Inventive Concepts 1 to 12, wherein the tissue anchor is configured such that when the tissue connecting portion of the metal wire is in an unconstrained state, the tissue connecting portion of the metal wire is shaped to define a first loop end straight portion, and the first loop end longitudinal portion is positioned along the first loop end straight portion.

[0049] Inventive concept 19. The tissue anchor according to inventive concept 18, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the tissue coupling portion of the wire is shaped to define a second loop end straight portion along which the second loop end longitudinal portion is positioned.

[0050] Inventive Concept 20. The tissue anchor according to any one of Inventive Concepts 1 to 12, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the looped portion includes only one turn.

[0051] Inventive Concept 21. The tissue anchor according to any one of Inventive Concepts 1 to 12, further comprising an anchor head coupled to and supporting the straight anchor shaft portion of the wire.

[0052] Inventive Concept 22. A system comprising the tissue anchor according to any one of Inventive Concepts 1 to 12, wherein the system further comprises a tether secured to the tissue anchor.

[0053] Inventive concept 23. The system of inventive concept 22, wherein the tissue anchor is a first tissue anchor, and wherein the system further comprises a second tissue anchor that is separate and distinct from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by a tether.

[0054] According to inventive concept 24 of the present invention, there is also provided a method, comprising:

[0055] delivering a tissue anchor to a cardiac chamber within a deployment tool, the tissue anchor comprising a wire having only two wire ends, the wire being shaped to define a straight anchor shaft portion and a tissue coupling portion in an unexpanded generally elongated configuration within the deployment tool, the tissue coupling portion extending from a distal end of the straight anchor shaft portion such that the straight anchor shaft portion is disposed along the wire between the tissue coupling portion and a first of the only two wire ends;

[0056] delivering a tissue coupling portion of the wire in an unexpanded generally elongated configuration from a first side of the heart tissue wall through the heart tissue wall to a second distal side of the heart tissue wall; and

[0057] Release the organization anchor from the deployment tool, allowing:

[0058] (a) the straight anchor shaft portion of the wire is at least partially disposed within the cardiac tissue wall,

[0059] (b) a tissue coupling portion of the wire is disposed outside of a second distal side of the heart tissue wall, the tissue coupling portion being shaped to define a trailing end portion including only a second of the two wire ends,

[0060] (c) the tissue coupling portion of the wire crosses itself along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion so as to define an annular portion anchoring the tissue anchor to the cardiac tissue wall, the annular portion generally defining an annular portion plane forming an angle between 75 degrees and 90 degrees with the anchor shaft axis of the straight anchor shaft portion,

[0061] (d) the first loop end longitudinal portion is located closer to the first wire end along the metal wire than the second loop end longitudinal portion is located to the first wire end along the metal wire, and

[0062] (e) The maximum absolute distance between the longitudinal portion of the first loop end and the first wire end is greater than the maximum absolute distance between the longitudinal portion of the second loop end and the first wire end.

[0063] Inventive concept 25. The method according to inventive concept 24, wherein the proximal end of the straight anchor shaft portion is at a first of only two wire ends.

[0064] Inventive concept 26. The method of inventive concept 24, further comprising, after releasing the tissue anchor from the deployment tool, applying tension to the tissue anchor by pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the plane of the annular portion.

[0065] Inventive concept 27. The method according to inventive concept 26,

[0066] wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the annular portion is formed into an open loop portion in which the first loop end longitudinal portion and the second loop end longitudinal portion are not in mechanical contact with each other, and

[0067] Therein, the proximal end of the straight anchor shaft portion is pulled away from the plane of the ring portion along the anchor shaft axis so that the first ring end longitudinal portion and the second ring end longitudinal portion are in mechanical contact with each other.

[0068] Inventive concept 28. The method according to inventive concept 26,

[0069] wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tissue coupling portion of the wire is shaped to define a first loop end bend along which the first loop end longitudinal portion is positioned, and

[0070] The proximal end of the straight anchor shaft portion is pulled away from the plane of the ring portion along the anchor shaft axis, and the metal wire at the second ring end longitudinal portion can be snapped into the first ring end longitudinal portion at the first ring end curved portion of the metal wire.

[0071] Inventive concept 29. A method according to inventive concept 28, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool so that the inner curved surface of the first loop end curved portion has a radius of curvature equal to between 80% and 120% of the radius of the metal wire along the longitudinal portion of the second loop end.

[0072] Inventive concept 30. The method according to inventive concept 28, wherein the first loop end curved portion extends directly from the distal end of the straight anchor shaft portion.

[0073] Inventive concept 31. The method of inventive concept 26, wherein pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the plane of the annular portion tightly draws the annular portion against the second distal side of the heart tissue wall.

[0074] Inventive concept 32. The method of inventive concept 26, wherein pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the plane of the annular portion comprises pulling a tether secured to the tissue anchor.

[0075] Inventive concept 33. The method of inventive concept 32, wherein the tissue anchor is a first tissue anchor, and wherein the method further comprises implanting a second tissue anchor that is separate and distinct from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by a tether.

[0076] Inventive concept 34. A method according to inventive concept 24, wherein the heart tissue wall is a myocardial tissue wall, and wherein delivering the tissue connecting portion of the metal wire in an unexpanded generally slender structure through the heart tissue wall includes delivering the tissue connecting portion of the metal wire through the myocardial tissue wall into the pericardial cavity between the epicardium and the pericardial wall layer, generally next to and against the pericardial wall layer without penetrating the pericardial wall layer.

[0077] Inventive concept 35. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the anchor shaft axis does not pass through a space surrounded and defined by the annular portion.

[0078] Inventive concept 36. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the wire crosses over itself only once along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion.

[0079] Inventive concept 37. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the wire defines only a single loop portion.

[0080] Inventive concept 38. The method according to inventive concept 24, wherein the wire is not shaped to define any looped portion proximate the proximal end of the straight anchor shaft portion.

[0081] Inventive concept 39. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tissue coupling portion of the wire is shaped to define a first loop end straight portion along which the first loop end longitudinal portion is positioned.

[0082] Inventive concept 40. The method of inventive concept 39, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tissue coupling portion of the wire is shaped to define a second loop end straight portion along which the second loop end longitudinal portion is positioned.

[0083] Inventive concept 41. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the trailing end portion falls generally into a plane of the annular portion.

[0084] Inventive concept 42. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that no portion of the trailing end portion is parallel to the straight anchor shaft portion.

[0085] Inventive concept 43. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the trailing end portion is shaped to define at least one straight portion.

[0086] Inventive concept 44. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the trailing end portion is shaped to define at least one trailing end portion bend.

[0087] Inventive concept 45. The method according to inventive concept 24, wherein the tissue anchor further comprises a fabric covering a portion of the metal wire including the first loop end longitudinal portion or the second loop end longitudinal portion.

[0088] Inventive concept 46. The method of inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the looped portion includes only one turn.

[0089] Inventive Concept 47. The method according to Inventive Concept 24, wherein the tissue anchor further comprises an anchor head coupled to and supporting the straight anchor shaft portion of the wire.

[0090] According to inventive concept 48 of the present invention, there is also provided a tissue anchor comprising a metal wire having only two wire ends,

[0091] Wherein, the metal wire is shaped as defined by:

[0092] A straight anchor shaft portion, and

[0093] a tissue coupling portion extending from a distal end of the straight anchoring shaft portion such that the straight anchoring shaft portion is disposed along the wire between the tissue coupling portion and only a first of the two wire ends,

[0094] Wherein, the tissue anchor is configured such that when the tissue coupling portion of the metal wire is in a non-constrained state where the tissue coupling portion is not constrained by any external force:

[0095] (a) the tissue coupling portion of the wire is shaped to define a tail portion including only the second of the two wire ends, and

[0096] (b) the tissue coupling portion of the wire crosses itself along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion to define a loop portion that generally defines a loop portion plane that forms an angle of between 75 degrees and 90 degrees with the anchor shaft axis of the straight anchor shaft portion, and

[0097] Wherein, the tissue anchor is configured such that when the proximal end of the straight anchor shaft portion is pulled away from the plane of the ring portion along the anchor shaft axis, mechanical contact between the first ring end longitudinal portion and the second ring end longitudinal portion locks the ring portion and prevents the ring portion from straightening due to tension applied to the straight anchor shaft portion.

[0098] Inventive concept 49. The tissue anchor of inventive concept 48, wherein the proximal end of the straight anchor shaft portion is located at only the first of the two wire ends.

[0099] Inventive concept 50. The tissue anchor according to inventive concept 48, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the anchor shaft axis does not pass through a space surrounded and defined by the annular portion.

[0100] Inventive concept 51. The tissue anchor according to inventive concept 48, wherein the tissue anchor is configured such that:

[0101] When the tissue coupling portion of the wire is in an unconstrained state, the loop portion is formed into an open loop portion in which the first loop end longitudinal portion and the second loop end longitudinal portion are not in mechanical contact with each other, and

[0102] When the proximal end of the straight anchor shaft portion is pulled along the anchor shaft axis away from the plane of the ring portion, the first ring end longitudinal portion and the second ring end longitudinal portion are in mechanical contact with each other.

[0103] Inventive concept 52. The tissue anchor of inventive concept 48, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the wire crosses over itself only once along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion.

[0104] Inventive concept 53. The tissue anchor of inventive concept 48, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the wire defines only a single looped portion.

[0105] Inventive concept 54. The tissue anchor of inventive concept 48, wherein the wire is not shaped to define any looped portion proximate the proximal end of the straight anchor shaft portion.

[0106] Inventive concept 55. The tissue anchor of inventive concept 48, wherein the trailing end portion generally falls within the plane of the loop portion when the tissue coupling portion of the wire is in an unconstrained state.

[0107] Inventive concept 56. The tissue anchor of inventive concept 48, wherein no portion of the trailing end portion is parallel to the straight anchor shaft portion when the tissue coupling portion of the wire is in an unconstrained state.

[0108] Inventive concept 57. The tissue anchor according to inventive concept 48, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the trailing end portion is shaped to define at least one straight portion.

[0109] Inventive concept 58. The tissue anchor of inventive concept 48, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the trailing end portion is shaped to define at least one trailing end portion bend.

[0110] Inventive concept 59. A tissue anchor according to any one of inventive concepts 48 to 58, wherein the tissue anchor is configured such that when the tissue connecting portion of the metal wire is in an unconstrained state, the tissue connecting portion of the metal wire is shaped to define a first loop end bend portion, and the first loop end longitudinal portion is positioned along the first loop end bend portion.

[0111] Inventive concept 60. A tissue anchor according to inventive concept 59, wherein the tissue anchor is configured so that when the proximal end of the straight anchor shaft portion is pulled away from the plane of the ring portion along the anchor shaft axis, the metal wire at the second ring end longitudinal portion is snapped into the first ring end longitudinal portion at the first ring end curved portion of the metal wire, thereby locking the ring portion.

[0112] Inventive concept 61. A tissue anchor according to inventive concept 59, wherein the tissue anchor is configured so that when the tissue connecting portion of the metal wire is in an unconstrained state, the radius of curvature of the inner curved surface of the curved portion of the first loop end is equal to between 80% and 120% of the radius of the metal wire along the longitudinal portion of the second loop end.

[0113] Inventive concept 62. The tissue anchor according to inventive concept 59, wherein the first loop end bend portion extends directly from the distal end of the straight anchor shaft portion.

[0114] Inventive concept 63. A tissue anchor according to any one of inventive concepts 48 to 58, wherein the tissue anchor is configured such that when the tissue connecting portion of the metal wire is in an unconstrained state, the tissue connecting portion of the metal wire is shaped to define a first loop end straight portion, and the first loop end longitudinal portion is positioned along the first loop end straight portion.

[0115] Inventive concept 64. A tissue anchor according to inventive concept 63, wherein the tissue anchor is configured such that when the tissue coupling portion of the metal wire is in an unconstrained state, the tissue coupling portion of the metal wire is shaped to define a second loop end straight portion, and the second loop end longitudinal portion is positioned along the second loop end straight portion.

[0116] Inventive Concept 65. The tissue anchor according to any one of Inventive Concepts 48 to 58, further comprising a fabric covering a portion of the metal wire including the first loop end longitudinal portion or the second loop end longitudinal portion.

[0117] Inventive Concept 66. The tissue anchor according to any one of Inventive Concepts 48 to 58, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the looped portion includes only one turn.

[0118] Inventive Concept 67. The tissue anchor according to any one of Inventive Concepts 48 to 58, further comprising an anchor head coupled to and supporting the straight anchor shaft portion of the wire.

[0119] Inventive Concept 68. A system comprising the tissue anchor according to any one of Inventive Concepts 48 to 58, wherein the system further comprises a tether secured to the tissue anchor.

[0120] Inventive concept 69. The system of inventive concept 68, wherein the tissue anchor is a first tissue anchor, and wherein the system further comprises a second tissue anchor that is separate and distinct from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by a tether.

[0121] According to inventive concept 70 of the present invention, there is further provided a method, comprising:

[0122] delivering a tissue anchor to a cardiac chamber within a deployment tool, the tissue anchor comprising a wire having only two wire ends, the wire being shaped to define a straight anchor shaft portion and a tissue coupling portion in an unexpanded generally elongated configuration within the deployment tool, the tissue coupling portion extending from a distal end of the straight anchor shaft portion such that the straight anchor shaft portion is disposed along the wire between the tissue coupling portion and a first of the only two wire ends;

[0123] delivering a tissue coupling portion of the wire in an unexpanded generally elongated configuration from a first side of a cardiac tissue wall through the cardiac tissue wall to a second distal side of the cardiac tissue wall;

[0124] Release the organization anchor from the deployment tool, so that:

[0125] (a) the straight anchor shaft portion of the wire is at least partially disposed within the cardiac tissue wall,

[0126] (b) a tissue coupling portion of the wire is disposed outside of a second distal side of the heart tissue wall, the tissue coupling portion being shaped to define a trailing end portion including only a second of the two wire ends,

[0127] (c) the tissue coupling portion of the wire crosses itself along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion to define a loop portion, such that the loop portion anchors the tissue anchor to the cardiac tissue wall and the loop portion generally defines a loop portion plane that forms an angle of between 75 degrees and 90 degrees with the anchor shaft axis of the straight anchor shaft portion; and

[0128] After the tissue anchor is released from the deployment tool, tension is applied to the tissue anchor by pulling the proximal end of the straight anchor shaft portion away from the plane of the ring portion along the anchor shaft axis, so that mechanical contact between the first ring end longitudinal portion and the second ring end longitudinal portion locks the ring portion and prevents the ring portion from straightening due to the tension applied to the straight anchor shaft portion.

[0129] Inventive concept 71. The method of inventive concept 70, wherein the proximal end of the straight anchor shaft portion is located at only a first of the two wire ends.

[0130] Inventive concept 72. The method according to inventive concept 70,

[0131] wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the annular portion is formed into an open loop portion in which the first loop end longitudinal portion and the second loop end longitudinal portion are not in mechanical contact with each other, and

[0132] Therein, the proximal end of the straight anchor shaft portion is pulled away from the plane of the ring portion along the anchor shaft axis so that the first ring end longitudinal portion and the second ring end longitudinal portion are in mechanical contact with each other.

[0133] Inventive concept 73. The method according to inventive concept 70,

[0134] wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tissue coupling portion of the wire is shaped to define a first loop end bend along which the first loop end longitudinal portion is positioned, and

[0135] Therein, pulling the proximal end of the straight anchor shaft portion away from the plane of the ring portion along the anchor shaft axis can snap the metal wire at the second ring end longitudinal portion into the first ring end longitudinal portion at the first ring end curved portion of the metal wire, thereby locking the ring portion.

[0136] Inventive concept 74. A method according to inventive concept 73, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool so that the inner curved surface of the curved portion of the first ring end has a radius of curvature equal to between 80% and 120% of the radius of the metal wire along the longitudinal portion of the second ring end.

[0137] Inventive concept 75. The method according to inventive concept 73, wherein the first loop end curved portion extends directly from the distal end of the straight anchor shaft portion.

[0138] Inventive concept 76. The method according to inventive concept 70, wherein pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the plane of the annular portion tightly draws the annular portion against the second distal side of the heart tissue wall.

[0139] Inventive concept 77. The method according to inventive concept 70, wherein pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the plane of the annular portion comprises pulling a tether secured to the tissue anchor.

[0140] Inventive concept 78. The method of inventive concept 77, wherein the tissue anchor is a first tissue anchor, and wherein the method further comprises implanting a second tissue anchor that is separate and distinct from the first tissue anchor, and wherein the second tissue anchor is coupled to the first tissue anchor by a tether.

[0141] Inventive concept 79. A method according to inventive concept 70, wherein the heart tissue wall is a myocardial tissue wall, and wherein delivering the tissue connecting portion of the metal wire in an unexpanded generally slender structure through the heart tissue wall includes delivering the tissue connecting portion of the metal wire through the myocardial tissue wall into the pericardial cavity between the epicardium and the pericardial wall layer, generally next to and against the pericardial wall layer without penetrating the pericardial wall layer.

[0142] Inventive concept 80. The method according to inventive concept 70, wherein the tissue anchor further comprises an anchor head coupled to and supporting the straight anchor shaft portion of the wire.

[0143] According to inventive concept 81 of the present invention, there is further provided a tissue anchor, comprising:

[0144] a straight anchor shaft portion; and

[0145] Tissue connection part,

[0146] Wherein, the tissue anchor is configured such that when the tissue coupling portion is in a non-constrained state where the tissue coupling portion is not constrained by any external force:

[0147] (a) the tissue coupling portion is shaped to define (i) an elongated intermediate portion extending from a distal end of a straight anchoring shaft portion, and (ii) a forked distal portion extending from a distal end of the intermediate portion and defining two tines, and

[0148] (b) A tine passing portion of the tissue anchor passes between the two tines, the tine passing portion being defined by at least one of the group consisting of: a straight anchor shaft portion and a middle portion.

[0149] Inventive concept 82. The tissue anchor of inventive concept 81, wherein the tine pass-through portion is defined by a straight anchor shaft portion.

[0150] Inventive concept 83. The tissue anchor of inventive concept 81, wherein the tine pass-through portion is defined by the intermediate portion.

[0151] Inventive concept 84. The tissue anchor of inventive concept 81, wherein the tissue anchor is configured such that when the tissue coupling portion is in the unconstrained state, only one tine-passing portion of the tissue anchor passes between two tines.

[0152] Inventive concept 85. The tissue anchor of inventive concept 81, wherein the tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state, the two tines generally define a tine plane that forms an angle between 60 and 90 degrees with the shaft axis of the straight shaft portion.

[0153] Inventive concept 86. The tissue anchor of inventive concept 81, wherein the tissue anchor is configured such that when the tissue coupling portion is in the unconstrained state, the intermediate portion is at least partially curved.

[0154] Inventive concept 87. The tissue anchor of inventive concept 81, further comprising a fabric at least partially covering the tissue coupling element.

[0155] Inventive concept 88. The tissue anchor of any one of inventive concepts 81 to 87, wherein the tissue anchor comprises a single wire shaped to define a straight anchor shaft portion and a tissue coupling portion.

[0156] Inventive concept 89. The tissue anchor according to inventive concept 88, wherein the proximal end of the straight anchor shaft portion coincides with the proximal end of the metal wire.

[0157] Inventive concept 90. The tissue anchor according to any one of inventive concepts 81 to 87,

[0158] wherein the tissue anchor comprises two metal wires shaped so as to together define a straight anchor shaft portion and a tissue coupling portion, and

[0159] Wherein, the tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state, the two metal wires:

[0160] along at least a portion of the straight anchor shaft portion and along at least a portion of the intermediate portion extend alongside one another, and

[0161] The two wires are separated from each other along the forked distal end portion such that the two wires define two tines, respectively.

[0162] Inventive concept 91. The tissue anchor of inventive concept 90, wherein the two wires are secured to one another at least partially along the straight anchor shaft portion and at least partially along the intermediate portion.

[0163] Inventive concept 92. The tissue anchor according to inventive concept 90, wherein a proximal end of the straight anchor shaft portion coincides with a proximal end of at least one of the two wires.

[0164] Inventive concept 93. The tissue anchor according to any one of inventive concepts 81 to 87, wherein the tissue anchor is configured such that:

[0165] When the tissue coupling portion is in the unconstrained state, the intermediate portion is not in mechanical contact with itself or with either of the two tines, and

[0166] When the proximal end of the straight anchor shaft portion is pulled away from a tine plane generally defined by the two tines along the anchor shaft axis of the straight anchor shaft portion, the intermediate portion mechanically contacts at least one element selected from the group consisting of: the intermediate portion and at least one of the two tines.

[0167] Inventive concept 94. A tissue anchor according to inventive concept 93, wherein the tissue anchor is configured so that when the proximal end of the straight anchor shaft portion is pulled away from the tine plane along the anchor shaft axis, the middle portion mechanically contacts the tissue coupling portion at the junction where the tissue coupling portion bifurcates into two tines.

[0168] Inventive Concept 95. The tissue anchor according to any one of Inventive Concepts 81 to 87, further comprising an anchor head coupled to and supporting the straight anchor shaft portion.

[0169] Inventive Concept 96. A system comprising the tissue anchor according to any one of Inventive Concepts 81 to 87, the system further comprising a tether secured to the tissue anchor.

[0170] Inventive concept 97. The system of inventive concept 96, wherein the tissue anchor is a first tissue anchor, and wherein the system further comprises a second tissue anchor that is separate and distinct from the first tissue anchor, and wherein the second tissue anchor is coupled to the first tissue anchor by a tether.

[0171] According to inventive concept 98 of the present invention, there is also provided a method, comprising:

[0172] delivering a tissue anchor within a deployment tool to a cardiac chamber, the tissue anchor comprising a straight anchor shaft portion and a tissue coupling portion, the tissue coupling portion being an unexpanded generally elongated configuration within the deployment tool;

[0173] delivering the tissue coupling portion in the unexpanded generally elongated configuration from a first side of the heart tissue wall through the heart tissue wall to a second, more distal side of the heart tissue wall; and

[0174] Release the organization anchor from the deployment tool, so that:

[0175] (a) the straight anchor shaft portion is at least partially disposed within the cardiac tissue wall,

[0176] (b) a tissue coupling portion disposed on the exterior of the second distal side of the cardiac tissue wall, the tissue coupling portion being formed as (i) an elongated middle portion extending from the distal end of the straight anchoring shaft portion, and (ii) a forked distal portion extending from the distal end of the middle portion and defining two tines, and

[0177] (c) A tine passing portion of the tissue anchor passes between the two tines, the tine passing portion being defined by at least one of the group consisting of: a straight anchor shaft portion and an intermediate portion.

[0178] Inventive concept 99. The method of inventive concept 98, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tine passage portion is defined by the straight anchor shaft portion.

[0179] Inventive concept 100. The method of inventive concept 98, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tine passage portion is defined by the intermediate portion.

[0180] Inventive concept 101. The method of inventive concept 98, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that only one tine-passing portion of the tissue anchor passes between two tines.

[0181] Inventive concept 102. The method of inventive concept 98, wherein the tissue anchor comprises a single wire shaped to define a straight anchor shaft portion and a tissue coupling portion.

[0182] Inventive concept 103. The method according to inventive concept 102, wherein the proximal end of the straight anchor shaft portion coincides with the proximal end of the wire.

[0183] Inventive concept 104. The method according to inventive concept 98,

[0184] wherein the tissue anchor comprises two metal wires shaped so as to together define a straight anchor shaft portion and a tissue coupling portion, and

[0185] Wherein, releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the two wires:

[0186] along at least a portion of the straight anchor shaft portion and along at least a portion of the intermediate portion extend alongside one another, and

[0187] The forked distal end portion is separated from each other so that the two metal wires define two tines respectively.

[0188] Inventive concept 105. The method according to inventive concept 104, wherein the two metal wires are fixed to each other at least partially along the straight anchor shaft portion and at least partially along the middle portion.

[0189] Inventive concept 106. The method according to inventive concept 104, wherein a proximal end of the straight anchor shaft portion coincides with a proximal end of at least one of the two wires.

[0190] Inventive concept 107. The method of inventive concept 98, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the two tines generally define a tine plane that forms an angle between 60 and 90 degrees with the anchor shaft axis of the straight anchor shaft portion.

[0191] Inventive concept 108. The method of inventive concept 98, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the intermediate portion is at least partially bent.

[0192] Inventive concept 109. The method of inventive concept 98, further comprising, after releasing the tissue anchor from the deployment tool, applying tension to the tissue anchor by pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis of the straight anchor shaft portion away from a tine plane generally defined by the two tines.

[0193] Inventive concept 110. The method according to inventive concept 109,

[0194] wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the intermediate portion is not in mechanical contact with itself or with either of the two tines, and

[0195] wherein pulling the proximal end of the straight anchor shaft portion away from the tine plane causes the intermediate portion to be in mechanical contact with at least one element selected from the group consisting of: the intermediate portion and at least one of the two tines.

[0196] Inventive concept 111. The method of inventive concept 110, wherein the proximal end of the straight anchoring shaft portion is pulled away from the tine plane so that the intermediate portion is in mechanical contact with the tissue coupling portion at a junction where the tissue coupling portion bifurcates into two tines.

[0197] Inventive concept 112. The method of inventive concept 109, wherein pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the tine plane tightly draws the tine against the second distal side of the heart tissue wall.

[0198] Inventive concept 113. The method of inventive concept 109, wherein pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the tine plane comprises pulling a tether secured to the tissue anchor.

[0199] Inventive concept 114. The method of inventive concept 113, wherein the tissue anchor is a first tissue anchor, and wherein the method further comprises implanting a second tissue anchor that is separate and distinct from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by a tether.

[0200] Inventive concept 115. A method according to inventive concept 98, wherein the cardiac tissue wall is a myocardial tissue wall, and wherein delivering the tissue connection portion in an unexpanded, generally elongated structure through the cardiac tissue wall includes delivering the tissue connection portion through the myocardial tissue wall into the pericardial cavity between the epicardium and the pericardial wall layer, generally next to and against the pericardial wall layer without penetrating the pericardial wall layer.

[0201] Inventive concept 116. The method of inventive concept 98, wherein the tissue anchor further comprises a fabric at least partially covering the tissue coupling element.

[0202] Inventive concept 117. The method of inventive concept 98, wherein the tissue anchor further comprises an anchor head coupled to and supporting the straight anchor shaft portion.

[0203] According to inventive concept 118 of the present invention, there is also provided a tissue anchor comprising a metal wire having only two wire ends,

[0204] Wherein, the metal wire is shaped as defined by:

[0205] a straight anchor shaft portion having (i) a proximal end at a first of only two wire ends and (ii) a distal end, and

[0206] a tissue coupling portion extending from a distal end of the straight anchor shaft portion, and

[0207] Wherein, the tissue anchor is configured such that when the tissue coupling portion of the metal wire is in a non-constrained state where the tissue coupling portion is not constrained by any external force:

[0208] (a) the tissue coupling portion of the wire is shaped to define a trailing end portion including only the second of the two wire ends,

[0209] (b) the tissue coupling portion of the wire crosses itself along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion so as to define a loop portion that generally defines a loop portion plane that forms an angle of between 75 degrees and 90 degrees with the anchor shaft axis of the straight anchor shaft portion,

[0210] (c) the first loop end longitudinal portion is located closer to the first wire end along the wire than the second loop end longitudinal portion is located to the first wire end along the wire, and

[0211] (d) The maximum absolute distance between the longitudinal portion of the first loop end and the first wire end is greater than the maximum absolute distance between the longitudinal portion of the second loop end and the first wire end.

[0212] Inventive concept 119. The tissue anchor according to inventive concept 118, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the anchor shaft axis does not pass through the space surrounded and defined by the annular portion.

[0213] Inventive concept 120. The tissue anchor according to inventive concept 118, wherein the tissue anchor is configured such that:

[0214] When the tissue coupling portion of the wire is in an unconstrained state, the loop portion is formed as an open loop portion, wherein the first loop end longitudinal portion and the second loop end longitudinal portion are not in mechanical contact with each other, and

[0215] When the proximal end of the straight anchor shaft portion is pulled along the anchor shaft axis away from the plane of the ring portion, the first ring end longitudinal portion and the second ring end longitudinal portion are in mechanical contact with each other.

[0216] Inventive concept 121. The tissue anchor of inventive concept 118, wherein the trailing end portion generally falls within the plane of the loop portion when the tissue coupling portion of the wire is in an unconstrained state.

[0217] Inventive concept 122. The tissue anchor according to inventive concept 118, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the trailing end portion is shaped to define at least one straight portion.

[0218] Inventive concept 123. The tissue anchor of inventive concept 118, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the trailing end portion is shaped to define at least one trailing end portion bend.

[0219] Inventive concept 124. A tissue anchor according to any one of inventive concepts 118 to 123, wherein the tissue anchor is configured such that when the tissue connecting portion of the metal wire is in the unconstrained state, the tissue connecting portion of the metal wire is shaped to define a first loop end bend portion, and the first loop end longitudinal portion is positioned along the first loop end bend portion.

[0220] Inventive concept 125. A tissue anchor according to inventive concept 124, wherein the tissue anchor is configured so that when the proximal end of the straight anchor shaft portion is pulled away from the plane of the ring portion along the anchor shaft axis, the metal wire at the second ring end longitudinal portion snaps into the first ring end longitudinal portion at the first ring end curved portion of the metal wire.

[0221] Inventive concept 126. A tissue anchor according to inventive concept 124, wherein the tissue anchor is configured so that when the tissue connecting portion of the metal wire is in an unconstrained state, the radius of curvature of the inner curved surface of the curved portion of the first loop end is equal to between 80% and 120% of the radius of the metal wire along the longitudinal portion of the second loop end.

[0222] Inventive concept 127. The tissue anchor according to inventive concept 124, wherein the first loop end curved portion extends directly from the distal end of the straight anchor shaft portion.

[0223] Inventive concept 128. The tissue anchor according to any one of inventive concepts 118 to 123, further comprising a fabric covering a portion of the metal wire including the first loop end longitudinal portion or the second loop end longitudinal portion.

[0224] Inventive concept 129. The tissue anchor of any one of inventive concepts 118 to 123, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the looped portion includes only one turn.

[0225] Inventive Concept 130. The tissue anchor according to any one of Inventive Concepts 118 to 123, further comprising an anchor head coupled to and supporting the straight anchor shaft portion of the wire.

[0226] Inventive Concept 131. A system comprising the tissue anchor of any one of Inventive Concepts 118 to 123, wherein the system further comprises a tether coupled to the tissue anchor.

[0227] The present invention will be more fully understood from the following detailed description of embodiments of the present invention in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0228] Figure 1A is a schematic diagram of a tissue anchor configured to be anchored to a cardiac tissue wall according to an application of the present invention;

[0229] Figure 1B to Figure 1C According to the application of the present invention Figure 1A Schematic diagram of two views of a metal wire of a tissue anchor;

[0230] Figure 1D is a schematic diagram of a system including a tissue anchor and a tether according to an application of the present invention;

[0231] Figure 2A is a schematic diagram of another tissue anchor configured to be anchored to a cardiac tissue wall according to an application of the present invention;

[0232] Figure 2B According to the application of the present invention Figure 2A Schematic diagram of the metal wire of the tissue anchor;

[0233] Figure 3A is a schematic diagram of yet another tissue anchor configured to be anchored to a cardiac tissue wall according to an application of the present invention;

[0234] Figure 3B According to the application of the present invention Figure 3A Schematic diagram of the metal wire of the tissue anchor;

[0235] Figure 3C is a schematic diagram of another tissue anchor configured to be anchored to a cardiac tissue wall according to an application of the present invention;

[0236] Figure 4A is a schematic diagram of yet another tissue anchor according to the application of the present invention, the tissue anchor being configured to be anchored to a cardiac tissue wall;

[0237] Figure 4B According to the application of the present invention Figure 4A Schematic diagram of the metal wire of the tissue anchor;

[0238] Figure 5A is a schematic diagram of another tissue anchor configured to be anchored to a cardiac tissue wall according to an application of the present invention;

[0239] Figure 5B According to the application of the present invention Figure 5A Schematic diagram of the metal wire of the tissue anchor;

[0240] Fig. 6A and Figure 6B is a schematic diagram of a metal wire configured as a tissue anchor anchored to a cardiac tissue wall according to a corresponding application of the present invention;

[0241] Figure 7 is a schematic diagram of a metal wire configured as another tissue anchor anchored to a cardiac tissue wall according to an application of the present invention;

[0242] Figure 8 is deployed through the myocardial tissue wall according to the application of the present invention FIG. 2A to FIG. 2B Schematic diagram of the tissue anchor method;

[0243] Fig. 9A and Fig. 9B are schematic diagrams of additional tissue anchors configured to be anchored to a cardiac tissue wall according to respective applications of the present invention; and

[0244] Fig.10 is a schematic diagram of another tissue anchor configured to be anchored to a cardiac tissue wall in accordance with an application of the present invention. DETAILED DESCRIPTION

[0245] Figure 1A Schematic diagram of a tissue anchor 20 according to an application of the present invention, the tissue anchor being configured to be anchored to a cardiac tissue wall. The tissue anchor 20 comprises a metal wire 22 having only two wire ends: a first wire end 24A and a second wire end 24B. The metal wire 22 is shaped to define:

[0246] a straight anchor shaft portion 26 having (i) a proximal end 28 and (ii) a distal end 30, and

[0247] A tissue coupling portion 31 extending from the distal end 30 of the straight anchor shaft portion 26 such that the straight anchor shaft portion 26 is disposed along the wire 22 between the tissue coupling portion 31 and the first wire end 24A.

[0248] Typically, the tissue anchor 20 also includes an anchor head 33, which is connected to and supports the straight anchor shaft portion 26. Optionally, the anchor head 33 includes one or more collars 34, such as a distal collar 34A and a proximal collar 34B, as shown. Alternatively, the anchor head 33 includes only a single collar 34 or does not include any collars 34. Optionally, the anchor head 33 also includes a sealing element 36, which is sized and shaped to be inserted into the incision through the heart tissue wall together with the anchor head 33. When the implantation of the expandable tissue anchor 20 is completed, the sealing element 36 is retained in the incision together with at least a portion of the anchor head 33. The sealing element 36 is configured to promote hemostasis to provide a seal of the incision. For some applications, the sealing element 36 includes a metal or a polymer, such as a bioabsorbable polymer, which decomposes after healing and hemostasis occur. For some applications, sealing element 36 implements the techniques described in PCT Publication WO 2019 / 089262 filed on February 9, 2018 and / or U.S. Provisional Application 62 / 628,457, both of which are assigned to the assignee of the present application and are incorporated herein by reference.

[0249] For some applications, such as Figure 1A (and some other figures), the proximal end 28 of the straight anchor shaft portion 26 is located at the first wire end 24A. Alternatively, the proximal end 28 of the straight anchor shaft portion 26 does not coincide with the first wire end 24A, for example, as described below with reference to Figure 3C The description of tissue anchor 270 is as follows, mutatis mutandis.

[0250] Still reference Figure 1A , and additionally refer to Figure 1B to Figure 1C , which is a schematic diagram of two views of a metal wire 22 according to the application of the present invention. Although as mentioned above, the metal wire 22 is generally connected to the anchor head 25, for the sake of clarity, Figure 1B to Figure 1C The anchor head 25 is not shown. Figures 1A to 1C (and Figure 1D , as described below) shows the tissue coupling portion 31 in an unconstrained state, wherein the tissue coupling portion 31 is not constrained by any external force. (Note that the straight anchor shaft portion 26 can be configured to be straight simply because it is constrained by the anchor head 33, or, alternatively, even if it is not constrained by the anchor head 33)

[0251] Tissue anchor 20 is configured such that when tissue coupling portion 31 is in an unconstrained state, e.g. Figures 1A to 1C As shown:

[0252] The tissue coupling portion 31 of the metal wire 22 is shaped to define a tail portion 32 including the second wire end 24B,

[0253] The tissue coupling portion 31 of the wire 22 crosses itself along the wire 22 at the first loop end longitudinal portion 40A and the second loop end longitudinal portion 40B to define an annular portion 44 that generally defines an annular portion plane 46 that forms an angle α (alpha) between 75 and 90 degrees (e.g., 90 degrees) with the anchor shaft axis 48 of the straight anchor shaft portion 26,

[0254] the first loop-end longitudinal portion 40A is located closer along the wire 22 to the first wire end 24A (and thus generally closer to the proximal end 28 of the straight anchor shaft portion 26) than the second loop-end longitudinal portion 40B is located along the wire 22 to the first wire end 24A (and thus generally closer to the proximal end 28 of the straight anchor shaft portion 26), and

[0255] ·The maximum absolute distance D1 between the first loop end longitudinal portion 40A and the first wire end 24A is greater than the maximum absolute distance D2 between the second loop end longitudinal portion 40B and the first wire end 24A (thus, in addition, the maximum absolute distance between the first loop end longitudinal portion 40A and the proximal end 28 of the straight anchor shaft portion 26 is generally greater than the maximum absolute distance between the second loop end longitudinal portion 40B and the proximal end 28 of the straight anchor shaft portion 26).

[0256] As referenced below Figure 8 As described, tissue anchor 20 is delivered to a cardiac chamber within a deployment tool. Tissue coupling portion 31 is delivered in an unexpanded, generally elongated configuration within a deployment tool through a cardiac tissue wall from a first side of the wall to a second side of the wall, such as described below with reference to Figure 8 The tissue coupling portion 31 is also configured to expand on the second side of the heart tissue wall when deployed, for example as described below with reference to Figure 8 Descriptive.

[0257] The tissue anchor 20 is configured such that when the proximal end 28 of the straight anchor shaft portion 26 is pulled away from the ring portion plane 46 along the anchor shaft axis 48, the mechanical contact between the first ring end longitudinal portion 40A and the second ring end longitudinal portion 40B locks the ring portion 44 and prevents the ring portion 44 from straightening due to the applied tension. Typically, the above-mentioned pulling is performed using a tether 52 coupled to the tissue anchor 20 (e.g., the anchor head 33), as described below. (The mechanical contact between the first ring end longitudinal portion 40A and the second ring end longitudinal portion 40B can be direct, or via a reference FIG. 6A to FIG. 6B Coating or fabric 560 described below)

[0258] Typically, the tissue anchor 20 is configured such that when the tissue coupling portion 31 of the wire 22 is in an unconstrained state, the anchor shaft axis 48 does not pass through the space 54 surrounded and defined by the annular portion 44, for example Figures 1A to 1C shown.

[0259] Typically, the tissue anchor 20 is configured such that when the tissue coupling portion 31 of the wire 22 is in the unconstrained state, the loop portion 44 includes only one turn, e.g. Figures 1A to 1C Alternatively, the annular portion 44 includes more than one turn (configuration not shown).

[0260] For some applications, tissue anchor 20 is configured such that when tissue coupling portion 31 of wire 22 is in an unconstrained state, wire 22 crosses itself only once along wire 22 at first loop end longitudinal portion 40A and second loop end longitudinal portion 40B.

[0261] For some applications, tissue anchor 20 is configured such that wire 22 defines only a single loop portion 44 when tissue coupling portion 31 of wire 22 is in an unconstrained state.

[0262] For some applications, when tissue coupling portion 31 of wire 22 is in an unconstrained state, trailing end portion 32 generally falls within loop portion plane 46, e.g. Figures 1A to 1C as shown, and thus may aid in anchoring.

[0263] For some applications, when tissue coupling portion 31 of wire 22 is in the unconstrained state, no portion of trailing end portion 32 is parallel to straight anchoring shaft portion 26 .

[0264] For some applications, such as Figures 1A to 1C As shown, the tissue anchor 20 is configured such that when the tissue coupling portion 31 of the metal wire 22 is in an unconstrained state, the metal wire 22 is shaped to define a first loop end curved portion 50, along which the first loop end longitudinal portion 40A is positioned. Alternatively, the tissue anchor 20 is configured such that when the tissue coupling portion 31 of the metal wire 22 is in an unconstrained state, the metal wire 22 is shaped to define a first loop end straight portion, along which the first loop end longitudinal portion 40A is positioned (e.g., metal wire 622, hereinafter referred to as Figure 7 In this case, the metal wire 22 may optionally be shaped to define a second loop end bend along which the second loop end longitudinal portion 40B is positioned (a configuration not shown), or the metal wire 22 may not be shaped to define a second loop end bend (e.g., metal wire 622, hereinafter referred to as Figure 7 to describe it).

[0265] For some applications, wire 22 is not shaped to define any looped portion proximate proximal end 28 of straight anchor shaft portion 26 .

[0266] For some applications, a system 10 is provided that includes a tissue anchor 20 and a tether 52 secured to the tissue anchor 20, such as secured to the anchor head 33, such as secured to the distal collar 34A of the anchor head 33. Thus, the tether 52 is generally indirectly coupled to the straight anchor shaft portion 26 via the anchor head 33. For some applications, the system 10 also includes a second tissue anchor 38 that is separate and distinct from the tissue anchor 20. Generally, the second tissue anchor 38 is coupleable to or coupled to the tissue anchor 20 via the tether 52. For some applications, the second tissue anchor 38 includes a bracket 39, as shown. Alternatively, the second tissue anchor 38 includes another type of tissue anchor, such as a helical tissue anchor, as known in the art; another tissue anchor that is the same or similar to the tissue anchor 20; a tissue anchor known in the art; or any tissue anchor described in patent application publications and / or patents, which are incorporated herein by reference.

[0267] For some applications, when tissue coupling portion 31 of wire 22 is in an unconstrained state, loop portion 44 is formed as an open loop portion, wherein first loop end longitudinal portion 40A and second loop end longitudinal portion 40B are not in mechanical contact with each other (direct contact, or contact via a contact as described below). FIG. 6A to FIG. 6B (In these applications, the loop portion 44 is considered an "open loop portion" in the sense that the wire 22 bends back toward itself and passes through itself to define the space 54, even though the first loop end longitudinal portion 40A and the second loop end longitudinal portion 40B are not in mechanical contact with each other.) For these applications, the tissue anchor 20 is configured such that when the proximal end 28 of the straight anchor shaft portion 26 is pulled away from the loop portion plane 46 along the anchor shaft axis 48, the first loop end longitudinal portion 40A and the second loop end longitudinal portion 40B are in mechanical contact with each other (either directly or via a contact as described below). FIG. 6A to FIG. 6B Coating or fabric 560 described).

[0268] For other applications, when the tissue coupling portion 31 of the wire 22 is in an unconstrained state (i.e., even before the proximal end 28 of the straight anchor shaft portion 26 is pulled away from the ring portion plane 46 along the anchor shaft axis 48), the ring portion 44 is formed as a closed loop portion, wherein the first loop end longitudinal portion 40A and the second loop end longitudinal portion 40B are in mechanical contact with each other (direct contact, or via the contact referred to below). FIG. 6A to FIG. 6B Coating or fabric 560 described).

[0269] As used in this application, including in the claims, the term "annular portion" includes within its scope both open and closed loop portions.

[0270] Reference now Figure 1D , which is a schematic diagram of a system 60 including a tissue anchor 70 and a tether 52 according to an application of the present invention. Except as described below, the system 60 is the same as the system 10, and the tissue anchor 70 is the same as that described above with reference to FIG. Figures 1A to 1C The tissue anchor 20 described is identical and like reference numerals refer to like parts.

[0271] Reference to above Figure 1A Unlike the tissue anchor 20 described above, the tether 52 is coupled to the tissue anchor 70 by being directly coupled to the straight anchor shaft portion 26. The tissue anchor 70 does not include an anchor head 33. Therefore, the tether 52 is generally coupled directly to the straight anchor shaft portion 26. For some applications, such as the system 60, the system 10 also includes a second tissue anchor 38 that is separate and distinct from the tissue anchor 70. Generally, the second tissue anchor 38 is couplable or coupled to the tissue anchor 70 via the tether 52.

[0272] Reference now Figure 2A, which is a schematic diagram of a tissue anchor 120 configured to be anchored to a cardiac tissue wall in accordance with an application of the present invention. Figure 2B , which is a schematic diagram of a metal wire 122 of a tissue anchor 120 according to an application of the present invention. Except as described below, the tissue anchor 120 is the same as that described above with reference to Figures 1A to 1C The tissue anchor 120 is similar to the tissue anchor 20 described above, and like reference numerals refer to like parts. The tissue anchor 120 may also implement the features of the tissue anchor 70, as described above with reference to FIG. Figure 1D Descriptive.

[0273] When the tissue coupling portion 131 of the wire 122 is in an unconstrained state, the trailing end portion 132 of the tissue coupling portion 131 of the wire 122 is shaped to define at least one first loop end bend 154. For some applications, the distance between the anchor shaft axis 48 and the point on the first loop end bend 154 that is farthest from the anchor shaft axis 48 is equal to between 40% and 150%, such as between 60% and 100%, of the distance between the anchor shaft axis 48 and the point on the annular portion 44 that is farthest from the anchor shaft axis 48. This arrangement can add balance to the anchoring provided by the tissue anchor 120.

[0274] Reference now Figure 3A , which is a schematic diagram of a tissue anchor 220 configured to be anchored to a cardiac tissue wall in accordance with an application of the present invention. Figure 3B , which is a schematic diagram of a metal wire 222 of a tissue anchor 220 according to an application of the present invention. Except as described below, the tissue anchor 220 is the same as the above reference Figures 1A to 1C The tissue anchor 220 is identical to the tissue anchor 20 described above, and like reference numerals refer to like parts. The tissue anchor 220 may also implement features of the tissue anchor 70, as described above with reference to FIG. Figure 1D Descriptive.

[0275] When the tissue coupling portion 231 of the metal wire 222 is in an unconstrained state, the tail portion 232 of the tissue coupling portion 231 of the metal wire 222 is shaped to define at least one straight portion 256. The straight portion 256 generally extends to the second wire end 24B. For some applications, the distance between the anchor shaft axis 48 and the point on the straight portion 256 (e.g., the second wire end 24B) farthest from the anchor shaft axis 48 is equal to between 40% and 150%, such as between 60% and 100%, of the distance between the anchor shaft axis 48 and the point on the annular portion 44 farthest from the anchor shaft axis 48. This arrangement can increase the balance of the anchoring provided by the tissue anchor 220.

[0276] Reference now Figure 3C , which is a schematic diagram of a tissue anchor 270 configured to be anchored to a cardiac tissue wall in accordance with an application of the present invention. Except as described below, the tissue anchor 270 is similar to the tissue anchor 270 described above with reference to FIG. FIG. 3A to FIG. 3BThe described tissue anchor 220 is identical, and like reference numerals refer to like parts. The features of tissue anchor 270 may be implemented mutatis mutandis by any of the tissue anchors described herein.

[0277] In this configuration, the proximal end 28 of the straight anchor shaft portion 276 of the metal wire 222 of the tissue anchor 270 does not coincide with the first wire end 24A; instead, the first wire end 24A is proximal to the proximal end 28 of the straight anchor shaft portion 276 along the metal wire 222. For example, the metal wire 222 can be at least partially bent (e.g., bent away from the anchor shaft axis 48) between the first wire end 24A and the proximal end 28 of the straight anchor shaft portion 276, as shown in FIG. Figure 3C As shown, and / or one or more acute angles may be defined between the first wire end 24A and the proximal end 28 of the straight anchor shaft portion 276 (configuration not shown).

[0278] Reference now Figure 4A , which is a schematic diagram of a tissue anchor 320 configured to be anchored to a cardiac tissue wall in accordance with an application of the present invention. Figure 4B , which is a schematic diagram of a metal wire 322 of a tissue anchor 320 according to an application of the present invention. Except as described below, the tissue anchor 320 is the same as that described above with reference to Figures 1A to 1C The tissue anchor 320 is similar to the tissue anchor 20 described above, and like reference numerals refer to like parts. The tissue anchor 320 may also implement the features of the tissue anchor 70, as described above with reference to FIG. Figure 1D Descriptive.

[0279] When the tissue coupling portion 331 of the metal wire 322 is in a non-constrained state, for example FIG. 4A to FIG. 4B As shown:

[0280] The tissue coupling portion 331 of the metal wire 322 is shaped to define a tail portion 332 including the second wire end 24B,

[0281] the tissue coupling portion 331 of the wire 22 crosses itself along the wire 322 at the first loop end longitudinal portion 340A and the second loop end longitudinal portion 340B to define an annular portion 344 that generally defines an annular portion plane 346 that forms an angle of between 75 and 90 degrees (e.g., 90 degrees) with the anchor shaft axis 48 of the straight anchor shaft portion 26,

[0282] the first loop end longitudinal portion 340A is closer to the first wire end 24A along the metal line 322 than the second loop end longitudinal portion 340B is to the first wire end 24A along the metal line 322, and

[0283] The maximum absolute distance D1 between the first loop end longitudinal portion 340A and the first wire end 24A is greater than the maximum absolute distance D2 between the second loop end longitudinal portion 340B and the first wire end 24A.

[0284] When the tissue coupling portion 331 of the wire 322 is in an unconstrained state, the wire 322 is shaped to define a first loop end curved portion 350 along which the first loop end longitudinal portion 340A is located. The tissue anchor 320 is configured so that when the proximal end 28 of the straight anchor shaft portion 26 is pulled away from the loop portion plane 46 along the anchor shaft axis 48, the wire 322 snaps at the second loop end longitudinal portion 340B into the first loop end longitudinal portion 340A at the first loop end curved portion 350 of the wire 22. This snap locks the loop portion 344 and prevents the loop portion 344 from straightening.

[0285] For some applications, tissue anchor 320 is configured such that when tissue coupling portion 331 of wire 322 is in an unconstrained state, the radius of curvature r of inner curved surface 358 of first loop end curved portion 350 is C Equal to between 80% and 120% (eg, between 90% and 110%, such as 100%) of the radius of wire 322 along second loop end longitudinal portion 340B. For some applications, first loop end curved portion 350 extends directly from distal end 30 of straight anchor shaft portion 26 .

[0286] Typically, when the wire 322 is snapped into the first loop-end longitudinal portion 340A at the first loop-end bend 350 of the wire 22, the inner curved surface 358 of the first loop-end bend 350 surrounds at least 180 degrees of the wire 322 at the first loop-end longitudinal portion 340A. For example, as described below, the inner curved surface 358 may surround 180 degrees, or slightly more, e.g. FIG. 4A to FIG. 4B as shown, or at least 200 degrees, e.g. FIG. 5A to FIG. 5B shown. FIG. 4A to FIG. 4B , FIG. 5A to FIG. 5B and FIG. 6A to FIG. 6B The construction shown in can be realized FIG. 4A to FIG. 4B and FIG. 6A to FIG. 6B The lesser degree of enclosure shown in FIG. 5A to FIG. 5B The greater degree of enclosure shown in .

[0287] For some applications, when tissue coupling portion 331 of wire 322 is in an unconstrained state, trailing end portion 332 is shaped to define at least one straight portion 356. Straight portion 356 generally extends to second wire end 24B.

[0288] Reference now Figure 5A , which is a schematic diagram of a tissue anchor 420 configured to be anchored to a cardiac tissue wall in accordance with an application of the present invention. Figure 5B , which is a schematic diagram of a metal wire 422 of a tissue anchor 420 according to an application of the present invention. Except as described below, the tissue anchor 420 is the same as the above reference FIG. 4A to FIG. 4B The tissue anchor 420 is similar to the tissue anchor 320 described above, and like reference numerals refer to like parts. The tissue anchor 420 may also implement the features of the tissue anchor 70, as described above with reference to FIG. Figure 1D Descriptive.

[0289] The trailing end portion 432 of the tissue coupling portion 431 of the wire 422 is shaped to define at least one trailing end portion bend 454 when the tissue coupling portion 431 of the wire 422 is in an unconstrained state.

[0290] Reference now Fig. 6A and Figure 6B , which are schematic diagrams of metal wires 322 configured to be anchored to the heart tissue wall according to respective applications of the present invention, respectively. Except as described below, the tissue anchors 520A and 520B are the same as those described above with reference to FIG. 4A to FIG. 4B The described tissue anchor 320 is identical and like reference numerals refer to like parts. The features of tissue anchors 520A and 520B may also be implemented mutatis mutandis in conjunction with the other tissue anchors described herein.

[0291] Tissue anchors 520A and 520B further include fabric 560 that covers the longitudinal portion 340A of wire 322 including the first loop end (tissue anchor 520A, such as Fig. 6A ) or the second loop end longitudinal portion 340B (tissue anchor 520B, as shown Figure 6B The fabric 560 can help prevent corrosion of the metal of the wire 322 when the second loop end longitudinal portion 340B moves back and forth relative to the first loop end curved portion 350 (e.g., in the hook defined by the first loop end curved portion 350).

[0292] Reference now Figure 7 , which is a schematic diagram of a wire 622 of a tissue anchor 620 configured to be anchored to a cardiac tissue wall in accordance with an application of the present invention. Except as described below, the tissue anchor 620 is similar to the above-referenced Figures 1A to 1C The tissue anchor 620 is identical to the tissue anchor 20 described above, and like reference numerals refer to like parts. Figure 1D The features of the tissue anchor 70 described above, or any other tissue anchor described herein, may be used mutatis mutandis; for example, the tissue anchor 620 may include the anchor head 33. Although the tail portion 432 of the tissue coupling portion 631 of the wire 622 is shown as being shaped to define at least one tail portion bend 454, or the tail portion 432 does not define any tail portion bend, for example Figures 1A to 1D , FIG. 3A to FIG. 3C , FIG. 4A to FIG. 4B and FIG. 6A to FIG. 6B shown.

[0293] Tissue anchor 620 is configured such that tissue coupling portion 631 of wire 622 is in an unconstrained state, (a) tissue coupling portion 631 of wire 622 crosses itself along wire 622 at first loop-end longitudinal portion 640A and second loop-end longitudinal portion 640B to define loop portion 644, and (b) tissue coupling portion 631 is shaped to define:

[0294] a first ring end straight portion 623A along which the first ring end longitudinal portion 640A is located, and / or

[0295] • A second ring end straight portion 623B along which the second ring end longitudinal portion 640B is located.

[0296] It should be noted that the metal wire 622 of the ring portion 644 is located at the bottom of the ring portion 644 when viewed from above the ring portion plane (ie, from the side of the ring portion plane opposite to the first wire end 24A). Figure 7 623A is shown as looping from the first loop end straight portion 623A to the second loop end straight portion 623B in the clockwise direction. The metal wire 622 can also be looped in the counterclockwise direction. Similarly, when viewed from above the plane of the loop portion, Figures 1A to 1D , FIG. 2A to FIG. 2B , FIG. 3A to FIG. 3C , FIG. 4A to FIG. 4B , FIG. 5A to FIG. 5B and FIG. 6A to FIG. 6B The wires of the looped portion of the tissue anchor are shown looping in a counterclockwise direction from a first loop end straight portion to a second loop end straight portion; the wires may also be looped in a clockwise direction.

[0297] Reference now Figure 8 , which is a schematic diagram of a method of deploying a tissue anchor 120 through a myocardial tissue wall 160 according to an application of the present invention. Figure 8 , tissue anchor 120 is shown deployed through a myocardial tissue wall, but tissue anchor 120 may also be deployed through other cardiac tissue walls, such as the atrial septum at or away from the fossa ovalis, or through other non-cardiac tissue walls. Indeed, the tissue anchors described herein may be deployed in any number of body locations where it is desirable to anchor into or behind tissue in order to move such tissue relative to adjacent tissue. Although Figure 8 Deployment of tissue anchor 120 is shown, but other tissue anchors described herein may be similarly deployed.

[0298] The tissue anchor 120 is delivered to a target site, such as a cardiac chamber, within a deployment tool, wherein the tissue coupling portion 131 is in an unexpanded generally elongated configuration within the deployment tool. The deployment tool may include a hollow needle. The cardiac chamber may be the right atrium 164 (as shown), the right ventricle 166 (not shown configuration), the left atrium (not shown configuration), or the left ventricle (not shown configuration). The tissue coupling portion 131 of the wire 122 is delivered from a first side of the cardiac tissue wall through the cardiac tissue wall to a second distal side of the cardiac tissue wall in an unexpanded generally elongated configuration. In one application, the hollow needle is used to pierce a first side of the myocardial tissue wall 160 and the visceral pericardium 182 (which is a portion of the epicardium), avoiding the vascular system, such as the right coronary artery (RCA) 178. For some applications, the deployment tool is then directed further, beyond the second distal side of the heart tissue wall, into the pericardial cavity 180 between the epicardium 182 and the parietal pericardium 184, being careful to avoid puncturing the parietal pericardium 184 and the fibrous pericardium 186. Figure 8 The execution of these steps of the method is not shown in the drawings, but these steps can be performed using the techniques described in PCT Publication WO 2018 / 035378 to Tobis et al., which is incorporated herein by reference. Fig. 6A To Figure 6C and combined here.

[0299] like Figure 8 As shown, the tissue anchor 120 is released from the deployment tool so that the straight anchor shaft portion 26 of the wire 122 is at least partially disposed within the heart tissue wall and the tissue coupling portion 131 of the wire 122 is outside the second distal side of the heart tissue wall (optionally within the pericardial cavity 180, as shown in FIG. Figure 8 ) expands and assumes the shape described above, thereby anchoring the tissue anchor 120 to the myocardial tissue wall 160.

[0300] Once the tissue anchor 120 has been anchored to the myocardial tissue wall 160 at the target site, tension is applied to the tissue anchor 120 by pulling the proximal end 28 of the straight anchor shaft portion 26 away from the annular portion plane 46 along the anchor shaft axis 48, pulling the expanded tissue coupling portion 131 (including its annular portion 44) tightly against the second distal side of the myocardial tissue wall 160 at the target site (usually via the epicardium 182). Tension is thus applied to the tissue coupling portion 131 and thus to the myocardial tissue wall 160, thereby moving the myocardial tissue wall 160 at the target site relative to the adjacent cardiac tissue. For some applications, this movement may have the benefit of changing the geometry of a nearby heart valve, such as the tricuspid or mitral valve. Typically, the tension is applied using a tether 52.

[0301] Reference now Fig. 9A and Fig. 9B , which are schematic diagrams of tissue anchors 720A and 720B configured to be anchored to a cardiac tissue wall according to respective applications of the present invention.

[0302] Also refer to Fig.10 , which is a schematic diagram of a tissue anchor 820 configured to anchor to a cardiac tissue wall, in accordance with an application of the present invention.

[0303] Tissue anchors 720A, 720B, and 820 each include:

[0304] Straight anchor shaft portions 726A, 726B and 826; and

[0305] • Tissue connecting portions 731A, 731B and 831.

[0306] Tissue anchors 720A, 720B, and 820 are configured such that when tissue coupling portions 731A, 731B, and 831 are in respective non-constrained states where the tissue coupling portions are not constrained by any external force, as shown in FIG. FIG. 9A to FIG. 9B and Fig.10 As shown:

[0307] the tissue coupling portions 731A, 731B and 831 are shaped to define (i) an elongated intermediate portion 735A, 735B and 835 extending from the distal ends 730A, 730B and 830 of the straight anchor shaft portions 726A, 726B and 826, respectively, and (ii) a bifurcated distal portion 737A, 737B and 837 extending from the distal ends 741A, 741B and 841 of the intermediate portions 735A, 735B and 835, respectively, and defining two tines 743A, 743B and 843, respectively,

[0308] The corresponding tine passing portions 745A, 745B and 845B of the tissue anchors 720A, 720B and 820 pass between two tines 743A, 743B and 843, respectively.

[0309] For some applications, for example Fig. 9A and Fig.10 In the illustrated tissue anchors 720A and 820, the tine passage portions 745A and 845 are defined by straight anchor shaft portions 726A and 826, respectively. For other applications, for example Fig. 9B In the illustrated tissue anchor 720B, the tine passage portion 745B is defined by the middle portion 735B. Alternatively, the tine passage portion is defined in part by the straight anchor shaft and in part by the middle portion (configuration not shown). The tissue anchor 820 may alternatively be configured such that the tine passage portion 845 is defined by the middle portion 835, similar to Fig. 9B Configuration shown (configuration not shown).

[0310] For some applications, each tissue anchor is configured such that when the tissue coupling portion is in the unconstrained state, only one tine-passing portion of the tissue anchor passes between two tines, such as FIG. 9A to FIG. 9B and Fig.10 shown.

[0311] For some applications, each tissue anchor is configured such that when the tissue coupling portion is in the unconstrained state, the two tines generally define a tine plane 747 that is aligned with the straight anchor shaft portion (at Fig. 9A Anchor shaft axis 749 (noted for tissue anchor 720A, but also applicable to tissue anchors 720B and 820) forms an angle between 60 degrees and 90 degrees (eg, between 75 degrees and 90 degrees).

[0312] For some applications, tissue anchors 720A, 720B, and 820 are configured such that intermediate portions 735A, 735B, and 835 are at least partially curved when tissue coupling portions 731A, 731B, and 831A are in an unconstrained state.

[0313] For some applications, tissue anchors 720A, 720B, and 820 also include a fabric that at least partially covers the tissue coupling element, such as reference FIG. 6A to FIG. 6B Regarding fabric 560 described.

[0314] refer to FIG. 9A to FIG. 9B For some applications, each of the tissue anchors 720A and 720B includes a single wire 722 that is shaped to define a straight anchoring shaft portion 726A, 726B and a tissue coupling portion 731A, 731B. For some of these applications, the proximal end 728 of the straight anchoring shaft portion 726A, 726B coincides with the proximal end 724 of the wire 722. Alternatively, the proximal end 728 of the straight anchoring shaft portion 726A, 726B does not coincide with the proximal end 724 of the wire 722, such as described above with reference to Figure 3C As described with respect to tissue anchor 270 , mutatis mutandis.

[0315] refer to Fig.10 For some applications, tissue anchor 820 includes two wires 822A and 822B that are shaped to together define a straight anchor shaft portion 826 and a tissue coupling portion 831. Tissue anchor 820 is configured such that when tissue coupling portion 831 is in an unconstrained state, such as Fig.10 As shown, two metal lines 822A and 822B:

[0316] extending alongside (i.e., directly adjacent) one another along at least a portion of the straight anchor shaft portion 826 and along at least a portion of the intermediate portion 835, and

[0317] Separated from each other along the forked distal portion 837 , such that the two wires 822A and 822B define two tines 843 , respectively.

[0318] Typically, but not necessarily, the two wires 822A and 822B are secured to one another at least partially along the straight anchor shaft portion 826 and at least partially along the intermediate portion 835 .

[0319] For some applications, the proximal end 828 of the straight anchor shaft portion 826 coincides with the proximal end 824A and / or 824B of at least one of the two wires 822A and 822B, for example, with the two proximal ends 724A and 724B. Fig.10 Alternatively, the proximal end 828 of the straight anchor shaft portion 826 does not coincide with the proximal end 824A and / or 824B of at least one of the two metal wires 822A and 822B, for example, as described above with reference to Figure 3C As described with respect to tissue anchor 270 , mutatis mutandis.

[0320] Reference again FIG. 9A to FIG. 9B and Fig.10 For some applications, tissue anchors 720A, 720B, and 820 are configured such that:

[0321] When tissue coupling portions 731A, 731B, and 831 are in an unconstrained state, intermediate portions 735A, 735B, and 835 are not in mechanical contact (either directly or via a coating or the optional fabric described above) with themselves or with either of the two tines 743A, 743B, and 843, respectively, and

[0322] When the proximal ends 728, 828 of the straight anchor shaft portions 726A, 726B and 826, respectively, are pulled away from the tine plane 747 along the anchor shaft axis 749, the intermediate portions 735A, 735B and 835, respectively, are in mechanical contact with at least one element selected from the group consisting of: the intermediate portions 735A, 735B and 835 (i.e., different longitudinal portions of the intermediate portions) and at least one of the two tines 743A, 743B and 843 (either directly or via a coating or the above-mentioned optional fabric).

[0323] For some of these applications, the tissue anchors 720A, 720B and 820 are configured so that when the proximal ends 728, 828 of the straight anchor shaft portions 726A, 726B and 826, respectively, are pulled away from the tine plane 747 along the anchor shaft axis 749, the intermediate portions 735A, 735B and 835, respectively, mechanically contact the tissue connecting portions 731A, 731B and 831, respectively, at the junction 751A, 751B and 851 where the tissue connecting portion bifurcates into two tines.

[0324] Still reference FIG. 9A to FIG. 9B and Fig.10 Typically, each of the tissue anchors 720A, 720B, and 820 further includes an anchor head that is coupled to and supports the straight anchor shaft portion. The anchor head can implement the above reference Figure 1A Alternatively, the tissue anchor does not include an anchor head, such as the one described above with reference to Figure 1D A tissue anchor system may be provided that includes one of the tissue anchors 720A, 720B, and 820 and a tether, and optionally, a second tissue anchor, such as described above with reference to Figure 1A and Figure 1D Descriptive.

[0325] For some applications, tissue anchors 720A, 720B, and 820 are generally as described above with reference to Figure 8 The tissue anchor 20 is deployed as described above, mutatis mutandis. The tissue anchor is delivered to the cardiac chamber within the deployment tool, wherein the tissue coupling portion is in an unexpanded, generally elongated configuration. The tissue coupling portion is delivered in the unexpanded, generally elongated configuration from a first side of the cardiac tissue wall through the cardiac tissue wall to a second, distal side of the cardiac tissue wall. The tissue anchor is released from the deployment tool such that the straight anchor shaft portion of the wire is at least partially disposed within the cardiac tissue wall and the tissue coupling portion is disposed outside of the second, distal side of the cardiac tissue wall (optionally within the pericardial cavity 180, as shown in FIG. 1 ). Figure 8 As shown), and the tine passing portion of the tissue anchor passes between the two tines.

[0326] Typically, after the tissue anchor is released from the deployment tool, tension is applied to the tissue anchor by pulling the proximal end of the straight anchor shaft portion away from a tine plane generally defined by the two tines along the anchor shaft axis of the straight anchor shaft portion.

[0327] For some applications, the tissue anchor is released from the deployment tool such that the middle portion is not in mechanical contact with itself or with either of the two tines (either directly, or via the coating or optional fabric described above). The proximal end of the straight anchor shaft portion is pulled away from the plane of the tines so that the middle portion is in mechanical contact with at least one element selected from the group consisting of: the middle portion and at least one of the two tines. For example, pulling the proximal end of the straight anchor shaft portion away from the plane of the tines can cause the middle portion to be in mechanical contact with the tissue coupling portion at the junction where the tissue coupling portion bifurcates into the two tines.

[0328] Typically, pulling the proximal end of the straight anchor shaft portion along the anchor shaft axis away from the tine plane can tightly draw the tines against a second distal side of the heart tissue wall (typically via the epicardium 182).

[0329] For some applications, the cardiac tissue wall is a myocardial tissue wall, and the tissue attachment portion is delivered in an unexpanded generally elongated configuration through the myocardial tissue wall into the pericardial cavity between the epicardium and the pericardial wall, generally along and against the pericardial wall without penetrating the pericardial wall.

[0330] The scope of the present invention includes embodiments described in the following applications, which are assigned to the assignee of the present application and are incorporated herein by reference. For some applications, techniques and apparatus described in one or more of the following applications are combined with the techniques and apparatus described herein: U.S. Patent 8,475,525 to Maisano et al.; U.S. Patent 8,961,596 to Maisano et al.; U.S. Patent 8,961,594 to Maisano et al.; PCT Publication WO 2011 / 089601; U.S. Patent 9,241,702 to Maisano et al.; U.S. Provisional Application 61 / 750,427 filed January 9, 2013; U.S. Provisional Application 61 / 783,224 filed March 14, 2013; U.S. Provisional Application 61 / 897,491 filed October 30, 2013; U.S. Provisional Application 61 / 897,509 filed October 30, 2013; U.S. Patent 9,307,980 to Gilmore et al.; PCT Publication WO 2014 / 108903; PCT publication WO 2014 / 141239; U.S. Provisional Application 62 / 014,397 filed June 19, 2014; PCT publication WO 2015 / 063580; U.S. Patent Application Publication 2015 / 0119936; U.S. Provisional Application 62 / 086,269 filed December 2, 2014; U.S. Provisional Application 62 / 131,636 filed March 11, 2015; U.S. Provisional Application 62 / 167,660 filed May 28, 2015; PCT publication WO 2015 / 193728; PCT publication WO 2016 / 087934; U.S. Patent Application Publication 2016 / 0235533; U.S. Patent Application Publication 2016 / 0242762; PCT publication WO 2016 / 189391; U.S. Patent Application Publication No. 2016 / 0262741; U.S. Provisional Application No. 62 / 376,685 filed on August 18, 2016; U.S. Provisional Application No. 62 / 456,206 filed on February 8, 2017; U.S. Provisional Application No. 62 / 456,202 filed on February 8, 2017; U.S. Provisional Application No. 62 / 465,410 filed on March 1, 2017; U.S. Provisional Application No. 62 / 465,400 filed on March 1, 2017; U.S. Provisional Application No. 62 / 516,894 filed on June 8, 2017; U.S. Provisional Application No. 62 / 530,372 filed on June 10, 2017; PCT Publication No. WO 2018 / 035378; U.S. Provisional Application 62 / 570,226 filed October 10, 2017; U.S. Provisional Application 62 / 579,281 filed October 31, 2017;U.S. Provisional Application 62 / 596,658, filed December 8, 2017; PCT Publication WO 2018 / 148364; U.S. Patent Application Publication 2018 / 0221148; U.S. Provisional Application 62 / 628,457, filed February 9, 2018; PCT Publication WO 2018 / 160456; U.S. Patent Application Publication 2018 / 0249993; International Application PCT / US18 / 036609, filed June 8, 2018; U.S. Patent Application Publication 2018 / 0353297; PCT Publication WO 2019 / 013994; International Application PCT / US2018 / 045523, filed August 7, 2018; PCT Publication WO 2019 / 074815; PCT Publication WO 2019 / 089262; and PCT Publication WO 2019 / 157116. ;

[0331] The patents and patent application publications incorporated by reference in this application for patent shall be considered an integral part of this application, except that to the extent any term is defined in these incorporated patent and patent application publications in a manner that conflicts with a definition explicitly or implicitly made in this specification, only the definition in this specification shall prevail.

[0332] Those skilled in the art will appreciate that the present invention is not limited to the contents specifically shown and described above. On the contrary, the scope of the present invention includes the combination and sub-combination of the various features described above, and changes and modifications thereof that are not in the prior art that those skilled in the art will think of when reading the above description.

Claims

1. A tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) comprising a metal wire (22, 122, 222, 322, 422, 622) having only two wire ends (24A, 24B), in, The metal wire (22, 122, 222, 322, 422, 622) is shaped to define: a straight anchor shaft portion (26, 276), and a tissue coupling portion (31, 131, 231, 331, 431, 631) extending from the distal end (30) of the straight anchoring shaft portion (26, 276) such that the straight anchoring shaft portion (26, 276) is disposed along the metal wire (22, 122, 222, 322, 422, 622) between the tissue coupling portion (31, 131, 231, 331, 431, 631) and the first wire end (24A) of the only two wire ends (24A, 24B), Wherein, the tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue connecting portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in a non-constrained state in which the tissue connecting portion (31, 131, 231, 331, 431, 631) is not constrained by any external force: (a) the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is shaped to define a tail portion (32, 132, 232, 332, 432) including the second wire end (24B) of the only two wire ends (24A, 24B), Characterized in that the tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is further configured so that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in a non-constrained state: (b) the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) crosses itself along the metal wire (22, 122, 222, 322, 422, 622) at a first loop end longitudinal portion (40A, 340A, 640A) and a second loop end longitudinal portion (40B, 340B, 640B) so as to define an annular portion (44, 344, 644), the annular portion defining an annular portion plane (46) forming an angle (α) between 75 and 90 degrees with an anchor shaft axis (48) of the straight anchor shaft portion (26, 276), (c) the first loop end longitudinal portion (40A, 340A, 640A) is closer to the first wire end (24A) along the metal wire (22, 122, 222, 322, 422, 622) than the second loop end longitudinal portion (40B, 340B, 640B) is closer to the first wire end (24A) along the metal wire (22, 122, 222, 322, 422, 622), (d) the maximum absolute distance (D1) between the first loop end longitudinal portion (40A, 340A, 640A) and the first wire end (24A) is greater than the maximum absolute distance (42) between the second loop end longitudinal portion (40B, 340B, 640B) and the first wire end (24A), (e) The metal wire (22, 122, 222, 322, 422, 622) defines only a single annular portion (44, 344, 644).

2. The tissue anchor according to claim 1, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the anchor shaft axis (48) does not pass through the space (54) surrounded and defined by the annular portion (44, 344, 644).

3. The tissue anchor according to claim 1, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured so that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the metal wire (22, 122, 222, 322, 422, 622) crosses itself only once along the metal wire (22, 122, 222, 322, 422, 622) at the first loop end longitudinal portion (40A, 340A, 640A) and the second loop end longitudinal portion (40B, 340B, 640B).

4. The tissue anchor according to claim 1, wherein: The wire (22, 122, 222, 322, 422, 622) is not shaped to define any looped portion proximate the proximal end (28) of the straight anchor shaft portion (26, 276).

5. The tissue anchor according to claim 1, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that: When the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the annular portion (44, 344, 644) is formed as an open loop portion in which the first loop end longitudinal portion (40A, 340A, 640A) and the second loop end longitudinal portion (40B, 340B, 640B) are not in mechanical contact with each other, and When the proximal end (28) of the straight anchor shaft portion (26, 276) is pulled away from the ring portion plane (46) along the anchor shaft axis (48), the first ring end longitudinal portion (40A, 340A, 640A) and the second ring end longitudinal portion (40B, 340B, 640B) are in mechanical contact with each other.

6. The tissue anchor according to claim 1, wherein: When the tissue coupling portion (31, 131, 231, 331, 431, 631) of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the trailing end portion (32, 132, 232, 332, 432) falls into the annular portion plane (46).

7. The tissue anchor according to claim 1, wherein: When the tissue coupling portion (31, 131, 231, 331, 431, 631) of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, no portion of the trailing end portion (32, 132, 232, 332, 432) is parallel to the straight anchoring shaft portion (26, 276).

8. The tissue anchor according to claim 1, wherein: The tissue anchor (220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue coupling portion of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the trailing end portion (32, 232, 332, 432) is shaped to define at least one straight portion (256, 356).

9. The tissue anchor of claim 1, further comprising a fabric (560) covering a portion of the wire (322) including the first loop end longitudinal portion (40A, 340A, 640A) or the second loop end longitudinal portion (40B, 340B, 640B).

10. The tissue anchor of claim 1, wherein: The tissue anchor (120, 420, 620) is configured such that when the tissue coupling portion of the wire (122, 422, 622) is in an unconstrained state, the trailing end portion (132, 432) is shaped to define at least one trailing end portion bend (454).

11. The tissue anchor according to claim 1, wherein: The proximal end (28) of the straight anchor shaft portion (26, 276) is located at the first wire end (24A) of the only two wire ends (24A, 24B).

12. The tissue anchor according to any one of claims 1 to 10, wherein: The proximal end (28) of the straight anchor shaft portion (26, 276) is located at the first wire end (24A) of the only two wire ends (24A, 24B).

13. The tissue anchor according to any one of claims 1 to 11, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B) is configured such that when the tissue coupling portion (31, 131, 231, 331, 431) of the metal wire (22, 122, 222, 322, 422) is in an unconstrained state, the tissue coupling portion (31, 131, 231, 331, 431) of the metal wire (22, 122, 222, 322, 422) is shaped to define a first loop end curved portion (50, 350), and the first loop end longitudinal portion (40A, 340A) is positioned along the first loop end curved portion.

14. The tissue anchor of claim 13, wherein: The tissue anchor (320, 420, 520A, 520B) is configured such that when the proximal end (28) of the straight anchor shaft portion (26) is pulled away from the ring portion plane (46) along the anchor shaft axis (48), the metal wire (322, 422) snaps into the first loop end longitudinal portion (40A, 340A) at the first loop end curved portion (350) of the metal wire (322, 422) at the second loop end longitudinal portion (40B, 340B).

15. The tissue anchor of claim 13, wherein: The tissue anchor (320, 420, 520A, 520B) is configured such that when the tissue coupling portion (331, 431) of the metal wire (322, 422) is in an unconstrained state, the radius of curvature of the inner curved surface (358) of the first loop end curved portion (350) is equal to between 80% and 120% of the radius of the metal wire (322, 422) along the second loop end longitudinal portion (340B).

16. The tissue anchor of claim 13, wherein: The first loop end bend portion (50, 350) extends directly from the distal end (30) of the straight anchor shaft portion (26, 276).

17. The tissue anchor according to any one of claims 1 to 11, wherein: The tissue anchor (620) is configured such that when the tissue coupling portion (631) of the wire (622) is in an unconstrained state, the tissue coupling portion (631) of the wire (622) is shaped to define a first loop end straight portion (623A), and the first loop end longitudinal portion (640A) is positioned along the first loop end straight portion.

18. The tissue anchor of claim 17, wherein: The tissue anchor (620) is configured such that when the tissue coupling portion (631) of the metal wire (622) is in an unconstrained state, the tissue coupling portion (631) of the metal wire (622) is shaped to define a second loop end straight portion (623B), and the second loop end longitudinal portion (640B) is positioned along the second loop end straight portion.

19. The tissue anchor according to any one of claims 1 to 11, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the loop portion (44, 344, 644) includes only one turn.

20. The tissue anchor according to any one of claims 1 to 11, further comprising an anchor head (33) coupled to and supporting the straight anchor shaft portion (26, 276) of the wire (22, 122, 222, 322, 422, 622).

21. A system (10) comprising a tissue anchor according to any one of claims 1 to 11, wherein: The system (10) also includes a tether (52) secured to the tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620).

22. The system of claim 21, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is a first tissue anchor, and wherein the system (10) further comprises a second tissue anchor (38) that is separate and distinct from the first tissue anchor and that is coupled to the first tissue anchor via the tether (52).

23. A tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) comprising a metal wire (22, 122, 222, 322, 422, 622) having only two wire ends (24A, 24B), in, The metal wire (22, 122, 222, 322, 422, 622) is shaped to define: a straight anchor shaft portion (26, 276), and a tissue coupling portion (31, 131, 231, 331, 431, 631) extending from the distal end (30) of the straight anchoring shaft portion (26, 276) such that the straight anchoring shaft portion (26, 276) is disposed along the metal wire (22, 122, 222, 322, 422, 622) between the tissue coupling portion (31, 131, 231, 331, 431, 631) and the first wire end (24A) of the only two wire ends (24A, 24B), Wherein, the tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue connecting portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in a non-constrained state in which the tissue connecting portion (31, 131, 231, 331, 431, 631) is not constrained by any external force: (a) the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is shaped to define a tail portion (32, 132, 232, 332, 432) including the second wire end (24B) of the only two wire ends (24A, 24B), Characterized in that the tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is further configured so that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in a non-constrained state: (b) the tissue coupling portion (31, 131, 231, 331, 431, 631) of the wire (22, 122, 222, 322, 422, 622) crosses itself along the wire (22, 122, 222, 322, 422, 622) at a first loop end longitudinal portion (40A, 340A, 640A) and a second loop end longitudinal portion (40B, 340B, 640B) to define an annular portion (44, 344, 644), the annular portion defining an annular portion plane (46) forming an angle (α) between 75 and 90 degrees with an anchor shaft axis (48) of the straight anchor shaft portion (26, 276), and wherein the tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the proximal end (28) of the straight anchor shaft portion (26, 276) is pulled away from the annular portion plane (46) along the anchor shaft axis (48), mechanical contact between the first ring end longitudinal portion (40A, 340A, 640A) and the second ring end longitudinal portion (40B, 340B, 640B) locks the annular portion (44, 344, 644) and prevents the annular portion (44, 344, 644) from straightening due to tension applied to the straight anchor shaft portion (26, 276).

24. The tissue anchor of claim 23, wherein: The proximal end (28) of the straight anchor shaft portion (26, 276) is located at the first wire end (24A) of the only two wire ends (24A, 24B).

25. The tissue anchor of claim 23, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the anchor shaft axis (48) does not pass through the space (54) surrounded and defined by the annular portion (44, 344, 644).

26. The tissue anchor of claim 23, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that: When the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the annular portion (44, 344, 644) is formed as an open loop portion in which the first loop end longitudinal portion (40A, 340A, 640A) and the second loop end longitudinal portion (40B, 340B, 640B) are not in mechanical contact with each other, and When the proximal end (28) of the straight anchor shaft portion (26, 276) is pulled away from the ring portion plane (46) along the anchor shaft axis (48), the first ring end longitudinal portion (40A, 340A, 640A) and the second ring end longitudinal portion (40B, 340B, 640B) are in mechanical contact with each other.

27. The tissue anchor of claim 23, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured so that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the metal wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the metal wire (22, 122, 222, 322, 422, 622) crosses itself only once along the metal wire (22, 122, 222, 322, 422, 622) at the first loop end longitudinal portion (40A, 340A, 640A) and the second loop end longitudinal portion (40B, 340B, 640B).

28. The tissue anchor of claim 23, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the wire (22, 122, 222, 322, 422, 622) defines only a single loop portion (44, 344, 644).

29. The tissue anchor of claim 23, wherein: The wire (22, 122, 222, 322, 422, 622) is shaped to define any looped portion proximal to the proximal end (28) of the straight anchor shaft portion (26, 276).

30. The tissue anchor of claim 23, wherein: When the tissue coupling portion of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the trailing end portion (32, 132, 232, 332, 432) falls into the annular portion plane (46).

31. The tissue anchor of claim 23, wherein: When the tissue coupling portion of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, no portion of the trailing end portion (32, 132, 232, 332, 432) is parallel to the straight anchoring shaft portion (26, 276).

32. The tissue anchor of claim 23, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue coupling portion of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the trailing end portion (32, 132, 232, 332, 432) is shaped to define at least one straight portion (256, 356).

33. The tissue anchor of claim 23, wherein: The tissue anchor (120, 420, 620) is configured such that when the tissue coupling portion of the wire (122, 422, 622) is in an unconstrained state, the trailing end portion (132, 432) is shaped to define at least one trailing end portion bend (454).

34. The tissue anchor of any one of claims 23 to 33, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B) is configured such that when the tissue coupling portion (31, 131, 231, 331, 431) of the metal wire (22, 122, 222, 322, 422) is in an unconstrained state, the tissue coupling portion (31, 131, 231, 331, 431) of the metal wire (22, 122, 222, 322, 422) is shaped to define a first loop end curved portion (50, 350), and the first loop end longitudinal portion (40A, 340A) is positioned along the first loop end curved portion.

35. The tissue anchor of claim 34, wherein: The tissue anchor (320, 420, 520A, 520B) is configured such that when the proximal end (28) of the straight anchor shaft portion (26) is pulled away from the ring portion plane (46) along the anchor shaft axis (48), the metal wire (322, 422) snaps into the first ring end longitudinal portion (40A, 340A) at the first ring end curved portion (350) of the metal wire (322, 422) at the second ring end longitudinal portion (40B, 340B), thereby locking the ring portion (344).

36. The tissue anchor of claim 34, wherein: The tissue anchor (320, 420, 520A, 520B) is configured such that when the tissue coupling portion (331, 431) of the metal wire (322, 422) is in an unconstrained state, the radius of curvature of the inner curved surface (358) of the first loop end curved portion (350) is equal to between 80% and 120% of the radius of the metal wire (322, 422) along the second loop end longitudinal portion (340B).

37. The tissue anchor of claim 34, wherein: The first loop end bend portion (50, 350) extends directly from the distal end (30) of the straight anchor shaft portion (26, 276).

38. The tissue anchor of any one of claims 23 to 33, wherein: The tissue anchor (620) is configured such that when the tissue coupling portion (631) of the wire (622) is in an unconstrained state, the tissue coupling portion (631) of the wire (622) is shaped to define a first loop end straight portion (623A), and the first loop end longitudinal portion (640A) is positioned along the first loop end straight portion.

39. The tissue anchor of claim 38, wherein: The tissue anchor (620) is configured such that when the tissue coupling portion (631) of the metal wire (622) is in an unconstrained state, the tissue coupling portion (631) of the metal wire (622) is shaped to define a second loop end straight portion (623B), and the second loop end longitudinal portion (640B) is positioned along the second loop end straight portion.

40. The tissue anchor of any one of claims 23 to 33, further comprising a fabric (560) covering a portion of the wire (322) including the first loop end longitudinal portion (40A, 340A, 640A) or the second loop end longitudinal portion (40B, 340B, 640B).

41. The tissue anchor of any one of claims 23 to 33, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is configured such that when the tissue coupling portion (31, 131, 231, 331, 431, 631) of the wire (22, 122, 222, 322, 422, 622) is in an unconstrained state, the loop portion includes only one turn.

42. The tissue anchor of any one of claims 23 to 33, further comprising an anchor head (33) coupled to and supporting the straight anchor shaft portion (26, 276) of the wire (22, 122, 222, 322, 422, 622).

43. A system (10) comprising a tissue anchor according to any one of claims 23 to 33, wherein: The system (10) also includes a tether (52) secured to the tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620).

44. The system of claim 43, wherein: The tissue anchor (20, 70, 120, 220, 270, 320, 420, 520A, 520B, 620) is a first tissue anchor, and wherein the system (10) further comprises a second tissue anchor (38) separate and distinct from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by the tether (52).

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