Self-locking tissue anchor

Abstract

The invention provides a self-locking tissue anchor. The tissue anchor 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 a non-constrained state in which the tissue coupling portion is not constrained by any external force: (a) the tissue coupling portion is shaped to define (i) an elongated intermediate portion extending from a distal end of the straight anchor shaft portion, and (ii) a forked distal end portion extending from a distal end of the intermediate portion and defining two tines, and (b) a tines passage portion of the tissue anchor passes between the two tines, the tines passage portion defined by at least one of the group consisting of a straight anchor shaft portion and an intermediate portion. Other embodiments are also described.

Description

[0001] This application is a divisional application of the Chinese invention patent application with application date of December 20, 2019, application number 201980085200.2, and name “Self-locking Tissue Anchor” (the application number of the PCT international application corresponding to this application is PCT / US2019 / 068009).

[0002] Cross-reference to related applications

[0003] 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

[0004] The present invention relates generally to tissue anchors and, more particularly, to tissue anchors for implantation in the cardiac region. Background Art

[0005] 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.

[0006] U.S. Patent Application Publication 2003 / 0093096, issued to McGuckin, Jr. et al., describes a clamp device for closing a vascular orifice created by the insertion of a surgical instrument, the surgical instrument including an elongate strand having a central portion and a distal portion extending from the central portion. The tip of the distal portion, remote from the central portion, is shaped to hold tissue encountered thereby. The distal portion has a memory characteristic to cause the distal portion to curl relative to the central portion to hold tissue engaged thereby when the strand is in an unconstrained arrangement.

[0007] U.S. Patent 8,398,672, issued to Kleshinski et al., describes techniques for anchoring a medical implant device within a blood vessel or other body passage. An anchor delivery system houses one or more expandable anchors attached to a medical implant device. The anchors are held 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 an anchor shaft. In one configuration, each anchor is formed as a compressible closed loop that extends outwardly from the anchor shaft and loops back to straddle and extend beyond the anchor shaft. To advance the anchors, 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 anchors to be advanced through the body wall.

[0008] U.S. Patent Application Publication 2002 / 0013571, issued to Goldfarb et al., describes techniques for grasping and optionally repositioning and fixing leaflets to treat cardiac valve regurgitation, particularly mitral regurgitation. Such grasping will generally be atraumatic and provide a number of benefits. For example, atraumatic grasping can allow repositioning of the device relative to the leaflet and repositioning of the leaflet itself without damaging the leaflet. However, in some cases, it may be necessary or desirable to include a grasping that pierces or otherwise permanently affects the leaflet. In some of these cases, the grasping step includes fixation. In one embodiment described with reference to FIGS. 24 and 25, the anchor includes a wire bent into a loop. The wire can be stainless steel, nitinol, or other shape memory wire, polymer, or similar material. A suture is attached to the center of the loop by an adhesive material. The wire has a first end and a second end, where the first end is disposed on top of the loop and the second end is disposed below the loop. This configuration provides support for the loop when the anchor is pulled against the leaflet surface by the suture. The anchor can be used for fixation of the leaflet. The anchor is collapsible when the anchor wire is made of a flexible material so as to be loaded within a needle.

[0009] U.S. Patent Application Publication 2014 / 0275756, granted to Bender et al., describes techniques for compressing, cutting, incising, reconstructing, reshaping, attaching, repositioning, supporting, dislocating, or altering the composition of tissue or anatomical structures to change their positional or force relationships 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 a distal coil is custom formed by features at the end of a delivery member. FIG. 9C' depicts the anchor in a proper position within tissue and includes a proximal tail also formed by the delivery member.

[0010] U.S. Patent Application Publication 2009 / 0112052, granted to Lund et al., describes an implant for placement in the retropubic space of a patient. Figure 8 is a perspective view of the implant anchored to the endopelvic fascia with an anchor, and FIG. 9 is a perspective view of one embodiment of the deployable member or anchor. SUMMARY OF THE INVENTION

[0011] Embodiments of the present invention provide a tissue anchor that can be delivered in an undilated, generally elongated configuration within a deployment tool to a cardiac chamber. The tissue anchor is configured to anchor 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 alters the geometry of a cardiac valve, such as the tricuspid or mitral valve.

[0012] In some embodiments of the present invention, a tissue anchor is provided that includes a wire having a first wire end and a second wire end and is shaped to define a straight anchor shaft portion and a tissue engagement portion that extends from the distal end of the straight anchor shaft portion such that the straight anchor shaft portion is disposed along the wire between the tissue engagement portion and the first wire end. The tissue anchor is configured such that when the tissue engagement portion is in an unconstrained state:

[0013] · The tissue engagement portion is shaped to define a tail end portion including the second end of the wire,

[0014] · The tissue engagement portion of the wire crosses itself at a first loop end longitudinal portion and a second loop end longitudinal portion along the wire to define a loop portion that generally defines a loop portion plane that forms an angle between 75 degrees and 90 degrees with the anchor axis of the straight anchor shaft portion,

[0015] · The first loop end longitudinal portion is closer to the first wire end along the wire than the second loop end longitudinal portion is to the first wire end along the wire, and

[0016] · 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.

[0017] For some applications, 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 loop portion along the anchor shaft axis, mechanical contact between the first loop end longitudinal portion and the second loop end longitudinal portion locks the loop portion and prevents the loop portion from straightening due to the applied tension. Typically, the above pulling is performed using a tether coupled to the tissue anchor.

[0018] In other embodiments of the present invention, a tissue anchor is provided that 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:

[0019] · The tissue coupling portion is shaped to define an elongated intermediate portion extending from the distal end of the straight anchor shaft portion, and a forked distal portion extending from the distal end of the intermediate portion and defining two tines, and

[0020] · A tine passage portion of the tissue anchor passes between the two tines, and the tine passage portion is defined by the straight anchor shaft portion and / or the intermediate portion.

[0021] For some applications, the tissue anchor is configured such that when the tissue coupling portion is in the unconstrained state, the intermediate portion does not mechanically contact itself or either of the two tines. When the proximal end of the straight anchor shaft portion is pulled away from the 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 of the intermediate portion and / or the two tines.

[0022] Thus, according to inventive concept 1 of the present invention, a tissue anchor is provided that includes a wire having only two wire ends,

[0023] wherein the wire is shaped to define:

[0024] a straight anchor shaft portion, and

[0025] a tissue coupling portion that extends from the 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 of only the two wire ends,

[0026] wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state where the tissue coupling portion is not constrained by any external force:

[0027] (a) The tissue coupling portion of the wire is shaped to define a tail end portion that includes only the second wire end of the two wire ends,

[0028] (b) The tissue connection 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, which generally defines a loop portion plane, and the loop portion plane forms an angle between 75 degrees and 90 degrees with the anchor axis of the straight anchor shaft portion.

[0029] (c) The first loop end longitudinal portion is closer to the first wire end along the wire than the second loop end longitudinal portion is along the wire, and

[0030] (d) 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.

[0031] Inventive concept 2. The tissue anchor according to inventive concept 1, wherein the tissue anchor is configured such that when the tissue connection portion of the wire is in an unconstrained state, the anchor axis does not pass through the space surrounded and defined by the loop portion.

[0032] Inventive concept 3. The tissue anchor according to inventive concept 1, wherein the tissue anchor is configured such that when the tissue connection portion of the wire is in an unconstrained state, the wire crosses itself only once along the wire at the first loop end longitudinal portion and the second loop end longitudinal portion.

[0033] Inventive concept 4. The tissue anchor according to inventive concept 1, wherein the tissue anchor is configured such that when the tissue connection portion of the wire is in an unconstrained state, the wire defines only a single loop portion.

[0034] Inventive concept 5. The tissue anchor according to inventive concept 1, wherein the wire is not shaped to define any loop portion near the proximal end of the straight anchor shaft portion.

[0035] Inventive concept 6. The tissue anchor according to inventive concept 1, wherein the tissue anchor is configured such that:

[0036] When the tissue connection portion of the wire is in an unconstrained state, the loop portion is shaped as an open loop portion in which the first loop end longitudinal portion and the second loop end longitudinal portion do not mechanically contact each other, and

[0037] When the proximal end of the straight anchor shaft portion is pulled away from the loop portion plane along the anchor axis, the first loop end longitudinal portion and the second loop end longitudinal portion mechanically contact each other.

[0038] Inventive concept 7. The tissue anchor according to inventive concept 1, wherein when the tissue connection portion of the wire is in an unconstrained state, the tail end portion generally falls into the loop portion plane.

[0039] 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 tail end portion is parallel to the straight anchor shaft portion.

[0040] 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 tail end portion is shaped to define at least one straight portion.

[0041] Inventive Concept 10. The tissue anchor according to Inventive Concept 1, further comprising a fabric that covers a portion of the wire including the first loop end longitudinal portion or the second loop end longitudinal portion.

[0042] 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 tail end portion is shaped to define at least one tail end portion bent portion.

[0043] 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 wire end of the two wire ends.

[0044] 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 the first wire end of the two wire ends.

[0045] Inventive Concept 14. 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 tissue coupling portion of the wire is shaped to define a first loop end bent portion, and the first loop end longitudinal portion is positioned along the first loop end bent portion.

[0046] Inventive Concept 15. The tissue anchor according to Inventive Concept 14, 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 annular portion along the anchor shaft axis, the wire is snapped into the first loop end longitudinal portion at the first loop end bent portion of the wire at the second loop end longitudinal portion.

[0047] Inventive Concept 16. The tissue anchor according to Inventive Concept 14, wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state, the radius of curvature of the inner curved surface of the first loop end bent portion is between 80% and 120% of the radius of the wire along the second loop end longitudinal portion.

[0048] Inventive Concept 17. The tissue anchor according to Inventive Concept 14, wherein the first loop end bent portion extends directly from the distal end of the straight anchor shaft portion.

[0049] Inventive Concept 18. The tissue anchor according to any one of Inventive Concepts 1 to 12, wherein the tissue anchor is configured such that when the tissue engaging portion of the wire is in an unconstrained state, the tissue engaging portion of the wire is shaped to define a first loop end straight portion, and a first loop end longitudinal portion is positioned along the first loop end straight portion.

[0050] Inventive Concept 19. The tissue anchor according to Inventive Concept 18, wherein the tissue anchor is configured such that when the tissue engaging portion of the wire is in an unconstrained state, the tissue engaging portion of the wire is shaped to define a second loop end straight portion, and a second loop end longitudinal portion is positioned along the second loop end straight portion.

[0051] 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 engaging portion of the wire is in an unconstrained state, the loop portion comprises only one turn.

[0052] Inventive Concept 21. The tissue anchor according to any one of Inventive Concepts 1 to 12, further comprising an anchor head that is coupled to and supports the straight anchor shaft portion of the wire.

[0053] 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 that is secured to the tissue anchor.

[0054] Inventive Concept 23. The system according to 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.

[0055] According to Inventive Concept 24 of the present invention, there is further provided a method, comprising:

[0056] Delivering a tissue anchor within a deployment tool to a heart chamber, 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 engaging portion that is in an undilated, generally elongated configuration within the deployment tool, the tissue engaging portion extending distally 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 engaging portion and a first one of the only two wire ends;

[0057] Delivering the tissue engaging portion of the wire in the undilated, generally elongated configuration from a first side of a heart tissue wall through the heart tissue wall to a second, distal side of the heart tissue wall; and

[0058] Releasing the tissue anchor from the deployment tool such that:

[0059] (a) The straight anchor shaft portion of the wire is at least partially disposed within the heart tissue wall,

[0060] (b) The tissue connection portion of the wire is disposed outside the second distal side of the heart tissue wall, and the tissue connection portion is shaped to define a tail end portion including only the second wire end of the two wire ends.

[0061] (c) The tissue connection portion of the wire crosses itself at the first loop end longitudinal portion and the second loop end longitudinal portion along the wire so as to define an annular portion for anchoring the tissue anchor to the heart tissue wall, and the annular portion generally defines an annular portion plane forming an angle between 75 degrees and 90 degrees with the anchor axis of the straight anchor shaft portion.

[0062] (d) The first loop end longitudinal portion is closer to the first wire end along the wire than the second loop end longitudinal portion is along the wire, and

[0063] (e) 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.

[0064] Inventive Concept 25. The method according to Inventive Concept 24, wherein the proximal end of the straight anchor shaft portion is at the first wire end of the two wire ends.

[0065] Inventive Concept 26. The method according to 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 away from the annular portion plane along the anchor axis.

[0066] Inventive Concept 27. The method according to Inventive Concept 26,

[0067] wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the annular portion is shaped as 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

[0068] wherein pulling the proximal end of the straight anchor shaft portion away from the annular portion plane along the anchor axis causes the first loop end longitudinal portion and the second loop end longitudinal portion to be in mechanical contact with each other.

[0069] Inventive Concept 28. The method according to Inventive Concept 26,

[0070] wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the tissue connection portion of the wire is shaped to define a first loop end bending portion, and the first loop end longitudinal portion is positioned along the first loop end bending portion, and

[0071] Wherein, pulling the proximal end of the straight anchor shaft portion away from the plane of the annular portion along the anchor shaft axis can snap the wire into the first loop end longitudinal portion at the second loop end longitudinal portion and at the bent portion of the first loop end of the wire.

[0072] Inventive concept 29. The method according to inventive concept 28, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the inner curved surface of the first loop end bent portion has a radius of curvature between 80% and 120% of the radius of the wire along the second loop end longitudinal portion.

[0073] Inventive concept 30. The method according to inventive concept 28, wherein the first loop end bent portion extends directly from the distal end of the straight anchor shaft portion.

[0074] Inventive concept 31. The method according to inventive concept 26, wherein pulling the proximal end of the straight anchor shaft portion away from the plane of the annular portion along the anchor shaft axis can tightly pull the annular portion against the second distal side of the heart tissue wall.

[0075] Inventive concept 32. The method according to inventive concept 26, wherein pulling the proximal end of the straight anchor shaft portion away from the plane of the annular portion along the anchor shaft axis includes pulling a tether fixed to the tissue anchor.

[0076] Inventive concept 33. The method according to inventive concept 32, wherein the tissue anchor is a first tissue anchor, and wherein the method further includes implanting a second tissue anchor that is separate and different from the first tissue anchor, and the second tissue anchor is connected to the first tissue anchor by a tether.

[0077] Inventive concept 34. The method according to inventive concept 24, wherein the heart tissue wall is a myocardial tissue wall, and wherein delivering the tissue connection portion of the wire in an undilated generally elongated configuration through the heart tissue wall includes delivering the tissue connection portion of the wire through the myocardial tissue wall into the pericardial cavity between the epicardium and the parietal pericardium layer, generally next to and against the parietal pericardium layer without penetrating the parietal pericardium layer.

[0078] Inventive concept 35. The method according to inventive concept 24, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the anchor shaft axis does not pass through the space surrounded and defined by the annular portion.

[0079] Inventive concept 36. The method according to inventive concept 24, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the wire crosses itself only once at the first loop end longitudinal portion and the second loop end longitudinal portion.

[0080] Inventive Concept 37. The method according to 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.

[0081] Inventive Concept 38. The method according to inventive concept 24, wherein the wire is not shaped to define any loop portion proximate the proximal end of the straight anchor shaft portion.

[0082] Inventive Concept 39. The method according to 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 attachment portion of the wire is shaped to define a first loop end straight portion along which a first loop end longitudinal portion is positioned.

[0083] Inventive Concept 40. The method according to 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 attachment portion of the wire is shaped to define a second loop end straight portion along which a second loop end longitudinal portion is positioned.

[0084] Inventive Concept 41. The method according to inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tail end portion generally falls within the plane of the loop portion.

[0085] Inventive Concept 42. The method according to 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 tail end portion is parallel to the straight anchor shaft portion.

[0086] Inventive Concept 43. The method according to inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tail end portion is shaped to define at least one straight portion.

[0087] Inventive Concept 44. The method according to inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the tail end portion is shaped to define at least one tail end portion bend.

[0088] Inventive Concept 45. The method according to inventive concept 24, wherein the tissue anchor further comprises a fabric that covers a portion of the wire including the first loop end longitudinal portion or the second loop end longitudinal portion.

[0089] Inventive Concept 46. The method according to inventive concept 24, wherein releasing the tissue anchor from the deployment tool comprises releasing the tissue anchor from the deployment tool such that the loop portion comprises only one turn.

[0090] Inventive concept 47. The method according to inventive concept 24, wherein the tissue anchor further comprises an anchor head that is coupled to and supports a straight anchor shaft portion of the wire.

[0091] According to inventive concept 48 of the present invention, there is also provided a tissue anchor comprising a wire having only two wire ends,

[0092] wherein the wire is shaped to define:

[0093] a straight anchor shaft portion, and

[0094] a tissue coupling portion that extends 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 wire end of the only two wire ends,

[0095] wherein the tissue anchor is configured such that when the tissue coupling portion of the wire is in an unconstrained state in which the tissue coupling portion is not subjected to any external force:

[0096] (a) the tissue coupling portion of the wire is shaped to define a tail end portion including a second wire end of the only two wire ends, and

[0097] (b) the tissue coupling portion of the wire crosses itself at a first loop end longitudinal portion and a second loop end longitudinal portion along the wire so as to define a loop portion that generally defines a loop portion plane, and the loop portion plane forms an angle between 75 degrees and 90 degrees with an anchor axis of the straight anchor shaft portion, and

[0098] wherein the tissue anchor is configured such that when the proximal end of the straight anchor shaft portion is pulled away from the loop portion plane along the anchor axis, mechanical contact between the first loop end longitudinal portion and the second loop end longitudinal portion locks the loop portion and prevents the loop portion from straightening due to the tension applied to the straight anchor shaft portion.

[0099] Inventive concept 49. The tissue anchor according to inventive concept 48, wherein the proximal end of the straight anchor shaft portion is located at the first wire end of the only two wire ends.

[0100] 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 axis does not pass through a space surrounded and defined by the loop portion.

[0101] Inventive concept 51. The tissue anchor according to inventive concept 48, wherein the tissue anchor is configured such that:

[0102] when the tissue coupling portion of the wire is in an unconstrained state, the loop portion is shaped as 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

[0103] When the proximal end of the straight anchor shaft portion is pulled away from the plane of the annular portion along the axis of the anchor shaft, the first annular end longitudinal portion and the second annular end longitudinal portion are in mechanical contact with each other.

[0104] Inventive concept 52. 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 wire crosses itself only once along the wire at the first annular end longitudinal portion and the second annular end longitudinal portion.

[0105] Inventive concept 53. 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 wire defines only a single annular portion.

[0106] Inventive concept 54. The tissue anchor according to inventive concept 48, wherein the wire is not shaped to define any annular portion near the proximal end of the straight anchor shaft portion.

[0107] Inventive concept 55. The tissue anchor according to inventive concept 48, wherein when the tissue coupling portion of the wire is in an unconstrained state, the tail end portion generally falls within the plane of the annular portion.

[0108] Inventive concept 56. The tissue anchor according to inventive concept 48, wherein when the tissue coupling portion of the wire is in an unconstrained state, no portion of the tail end portion is parallel to the straight anchor shaft portion.

[0109] 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 tail end portion is shaped to define at least one straight portion.

[0110] Inventive concept 58. 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 tail end portion is shaped to define at least one tail end portion bent portion.

[0111] Inventive concept 59. 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 tissue coupling portion of the wire is shaped to define a first annular end bent portion, and the first annular end longitudinal portion is positioned along the first annular end bent portion.

[0112] Inventive Concept 60. The tissue anchor according to Inventive Concept 59, 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 annular portion along the anchor shaft axis, the metal wire is snapped into the first annular end longitudinal portion at the bent portion of the first annular end of the metal wire at the second annular end longitudinal portion, thereby locking the annular portion.

[0113] Inventive Concept 61. The tissue anchor according to Inventive Concept 59, wherein the tissue anchor is configured such that when the tissue connection portion of the metal wire is in an unconstrained state, the radius of curvature of the inner curved surface of the first annular end bent portion is equal to between 80% and 120% of the radius of the metal wire along the second annular end longitudinal portion.

[0114] Inventive Concept 62. The tissue anchor according to Inventive Concept 59, wherein the first annular end bent portion extends directly from the distal end of the straight anchor shaft portion.

[0115] Inventive Concept 63. The tissue anchor according to any one of Inventive Concepts 48 to 58, wherein the tissue anchor is configured such that when the tissue connection portion of the metal wire is in an unconstrained state, the tissue connection portion of the metal wire is shaped to define a first annular end straight portion, and the first annular end longitudinal portion is positioned along the first annular end straight portion.

[0116] Inventive Concept 64. The tissue anchor according to Inventive Concept 63, wherein the tissue anchor is configured such that when the tissue connection portion of the metal wire is in an unconstrained state, the tissue connection portion of the metal wire is shaped to define a second annular end straight portion, and the second annular end longitudinal portion is positioned along the second annular end straight portion.

[0117] Inventive Concept 65. The tissue anchor according to any one of Inventive Concepts 48 to 58, further comprising a fabric that covers a part of the metal wire including the first annular end longitudinal portion or the second annular end longitudinal portion.

[0118] 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 connection portion of the metal wire is in an unconstrained state, the annular portion includes only one turn.

[0119] Inventive Concept 67. The tissue anchor according to any one of Inventive Concepts 48 to 58, further comprising an anchor head that is coupled to and supports the straight anchor shaft portion of the metal wire.

[0120] Inventive Concept 68. A system including the tissue anchor according to any one of Inventive Concepts 48 to 58, wherein the system further comprises a tether fixed to the tissue anchor.

[0121] Inventive Concept 69. The system according to Inventive Concept 68, wherein the tissue anchor is a first tissue anchor, and wherein the system further comprises a second tissue anchor, the second tissue anchor being separate and different from the first tissue anchor, and the second tissue anchor being coupled to the first tissue anchor by a tether.

[0122] According to Inventive Concept 70 of the present invention, there is further provided a method, comprising:

[0123] delivering a tissue anchor within a deployment tool to a cardiac chamber, 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 undilated 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 the first of the only two wire ends;

[0124] delivering the tissue coupling portion of the wire in the undilated 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;

[0125] releasing the tissue anchor from the deployment tool such that:

[0126] (a) the straight anchor shaft portion of the wire is at least partially disposed within the cardiac tissue wall,

[0127] (b) the tissue coupling portion of the wire is disposed external to the second distal side of the cardiac tissue wall, the tissue coupling portion being shaped to define a tail end portion including the second of the only two wire ends,

[0128] (c) the tissue coupling portion of the wire crosses itself at a first loop end longitudinal portion and a second loop end longitudinal portion along the wire so as 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 forming an angle between 75 degrees and 90 degrees with an anchor axis of the straight anchor shaft portion; and

[0129] after releasing the tissue anchor from the deployment tool, applying tension to the tissue anchor by pulling a proximal end of the straight anchor shaft portion away from the loop portion plane along the anchor axis such that mechanical contact between the first loop end longitudinal portion and the second loop end longitudinal portion locks the loop portion and prevents the loop portion from straightening due to the tension applied to the straight anchor shaft portion.

[0130] Inventive Concept 71. The method according to Inventive Concept 70, wherein the proximal end of the straight anchor shaft portion is at the first of the only two wire ends.

[0131] Inventive Concept 72. The method according to Inventive Concept 70,

[0132] Wherein, releasing the tissue anchor from the deployment tool includes 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

[0133] Wherein, pulling the proximal end of the straight anchor shaft portion away from the plane of the annular portion along the anchor shaft axis causes the first loop-end longitudinal portion and the second loop-end longitudinal portion to be in mechanical contact with each other.

[0134] Inventive concept 73. The method according to inventive concept 70,

[0135] Wherein, releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the tissue coupling portion of the wire is formed to define a first loop-end bending portion along which the first loop-end longitudinal portion is positioned, and

[0136] Wherein, pulling the proximal end of the straight anchor shaft portion away from the plane of the annular portion along the anchor shaft axis can snap the wire into the first loop-end longitudinal portion at the first loop-end bending portion of the second loop-end longitudinal portion, thereby locking the annular portion.

[0137] Inventive concept 74. The method according to inventive concept 73, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the inner bending surface of the first loop-end bending portion has a radius of curvature between 80% and 120% of the radius of the wire along the second loop-end longitudinal portion.

[0138] Inventive concept 75. The method according to inventive concept 73, wherein the first loop-end bending portion extends directly from the distal end of the straight anchor shaft portion.

[0139] Inventive concept 76. The method according to inventive concept 70, wherein pulling the proximal end of the straight anchor shaft portion away from the plane of the annular portion along the anchor shaft axis can tightly pull the annular portion against the second distal side of the heart tissue wall.

[0140] Inventive concept 77. The method according to inventive concept 70, wherein pulling the proximal end of the straight anchor shaft portion away from the plane of the annular portion along the anchor shaft axis includes pulling a tether fixed to the tissue anchor.

[0141] Inventive concept 78. The method according to inventive concept 77, wherein the tissue anchor is a first tissue anchor, and wherein the method further includes implanting a second tissue anchor that is separate and different from the first tissue anchor, and the second tissue anchor is connected to the first tissue anchor by a tether.

[0142] Inventive concept 79. The method according to inventive concept 70, wherein the heart tissue wall is a myocardial tissue wall, and wherein delivering the tissue coupling portion of the wire in an undilated, generally elongated configuration through the heart tissue wall includes delivering the tissue coupling portion of the wire through the myocardial tissue wall into the pericardial cavity between the epicardium and the parietal pericardium, generally alongside and against the parietal pericardium without penetrating the parietal pericardium.

[0143] Inventive concept 80. The method according to inventive concept 70, wherein the tissue anchor further includes an anchor head that is coupled to and supports the straight anchor shaft portion of the wire.

[0144] According to inventive concept 81 of the present invention, there is further provided a tissue anchor, comprising:

[0145] A straight anchor shaft portion; and

[0146] A tissue coupling portion,

[0147] wherein the tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state in which the tissue coupling portion is not subject to any external force:

[0148] (a) the tissue coupling portion is shaped to define (i) an elongated intermediate portion extending from the distal end of the straight anchor shaft portion, and (ii) a forked distal portion extending from the distal end of the intermediate portion and defining two tines, and

[0149] (b) a tine passage portion of the tissue anchor passes between the two tines, the tine passage portion being defined by at least one of the group consisting of: the straight anchor shaft portion and the intermediate portion.

[0150] Inventive concept 82. The tissue anchor according to inventive concept 81, wherein the tine passage portion is defined by the straight anchor shaft portion.

[0151] Inventive concept 83. The tissue anchor according to inventive concept 81, wherein the tine passage portion is defined by the intermediate portion.

[0152] Inventive concept 84. The tissue anchor according to inventive concept 81, wherein the tissue anchor is configured such that when the tissue coupling portion is in the unconstrained state, only one tine passage portion of the tissue anchor passes between the two tines.

[0153] Inventive concept 85. The tissue anchor according to inventive concept 81, wherein the tissue anchor is configured such that when the tissue coupling portion is in the unconstrained state, the two tines generally define a tine plane that forms an angle between 60 degrees and 90 degrees with the anchor axis of the straight anchor shaft portion.

[0154] Inventive Concept 86. The tissue anchor according to Inventive Concept 81, wherein the tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state, the intermediate portion is at least partially bent.

[0155] Inventive Concept 87. The tissue anchor according to Inventive Concept 81, further comprising a fabric that at least partially covers the tissue coupling element.

[0156] Inventive Concept 88. The tissue anchor according to any one of Inventive Concepts 81 to 87, wherein the tissue anchor comprises a single wire formed to define a straight anchor shaft portion and a tissue coupling portion.

[0157] 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 wire.

[0158] Inventive Concept 90. The tissue anchor according to any one of Inventive Concepts 81 to 87,

[0159] wherein the tissue anchor comprises two wires that are formed together to define a straight anchor shaft portion and a tissue coupling portion, and

[0160] wherein the tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state, the two wires:

[0161] extend side by side with each other along at least a portion of the straight anchor shaft portion and along at least a portion of the intermediate portion, and

[0162] are separated from each other along the forked distal portion such that the two wires respectively define two tines.

[0163] Inventive Concept 91. The tissue anchor according to Inventive Concept 90, wherein the two wires are at least partially fixed to each other along the straight anchor shaft portion and at least partially along the intermediate portion.

[0164] Inventive Concept 92. The tissue anchor according to Inventive Concept 90, wherein the proximal end of the straight anchor shaft portion coincides with the proximal end of at least one of the two wires.

[0165] Inventive Concept 93. The tissue anchor according to any one of Inventive Concepts 81 to 87, wherein the tissue anchor is configured such that:

[0166] when the tissue coupling portion is in an unconstrained state, the intermediate portion does not mechanically contact itself or any one of the two tines, and

[0167] When the proximal end of the straight anchor shaft portion is pulled away from the cusp plane generally defined by the two cusps along the anchor axis of the straight anchor shaft portion, the intermediate portion makes mechanical contact with at least one element selected from the group consisting of: the intermediate portion and at least one of the two cusps.

[0168] Inventive Concept 94. The tissue anchor according to Inventive Concept 93, wherein the tissue anchor is configured such that when the proximal end of the straight anchor shaft portion is pulled away from the cusp plane along the anchor axis, the intermediate portion makes mechanical contact with the tissue connection portion at the junction where the tissue connection portion bifurcates into two cusps.

[0169] Inventive Concept 95. The tissue anchor according to any one of Inventive Concepts 81 to 87, further comprising an anchor head that is coupled to and supports the straight anchor shaft portion.

[0170] Inventive Concept 96. A system comprising a tissue anchor according to any one of Inventive Concepts 81 to 87, the system further comprising a tether fixed to the tissue anchor.

[0171] Inventive Concept 97. The system according to 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 different from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by a tether.

[0172] According to Inventive Concept 98 of the present invention, there is also provided a method, comprising:

[0173] Delivering a tissue anchor into a heart chamber within a deployment tool, the tissue anchor comprising a straight anchor shaft portion and a tissue connection portion, the tissue connection portion being in an undilated generally elongated configuration within the deployment tool;

[0174] Delivering the tissue connection portion in the undilated generally elongated configuration from a first side of the heart tissue wall through the heart tissue wall to a more second distal side of the heart tissue wall; and

[0175] Releasing the tissue anchor from the deployment tool such that:

[0176] (a) The straight anchor shaft portion is at least partially disposed within the heart tissue wall,

[0177] (b) The tissue connection portion is disposed outside the second distal side of the heart tissue wall, the tissue connection portion being shaped as (i) an elongated intermediate portion extending from the distal end of the straight anchor shaft portion,

[0178] And (ii) a forked distal portion extending from the distal end of the intermediate portion and defining two cusps,

[0179] And

[0180] (c) The cusp passage portion of the tissue anchor passes partially between two cusps, and the cusp passage portion is defined by at least one of the following group: a straight anchor shaft portion and an intermediate portion.

[0181] Inventive concept 99. The method according to inventive concept 98, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the cusp passage portion is defined by the straight anchor shaft portion.

[0182] Inventive concept 100. The method according to inventive concept 98, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the cusp passage portion is defined by the intermediate portion.

[0183] Inventive concept 101. The method according to inventive concept 98, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that only one cusp passage portion of the tissue anchor passes between two cusps.

[0184] Inventive concept 102. The method according to inventive concept 98, wherein the tissue anchor includes a single wire formed to define a straight anchor shaft portion and a tissue connection portion.

[0185] 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.

[0186] Inventive concept 104. The method according to inventive concept 98,

[0187] wherein the tissue anchor includes two wires formed to together define a straight anchor shaft portion and a tissue connection portion, and

[0188] wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the two wires:

[0189] extend side by side with each other along at least a portion of the straight anchor shaft portion and along at least a portion of the intermediate portion, and

[0190] are separated from each other along the forked distal portion such that the two wires respectively define two cusps.

[0191] Inventive concept 105. The method according to inventive concept 104, wherein the two wires are fixed to each other at least partially along the straight anchor shaft portion and at least partially along the intermediate portion.

[0192] Inventive concept 106. The method according to inventive concept 104, wherein the proximal end of the straight anchor shaft portion coincides with the proximal end of at least one of the two wires.

[0193] Inventive Concept 107. The method according to Inventive Concept 98, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the two tines generally define a tine plane that forms an angle between 60 degrees and 90 degrees with the anchor axis of the straight anchor shaft portion.

[0194] Inventive Concept 108. The method according to Inventive Concept 98, wherein releasing the tissue anchor from the deployment tool includes releasing the tissue anchor from the deployment tool such that the intermediate portion is at least partially bent.

[0195] Inventive Concept 109. The method according to 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 axis of the straight anchor shaft portion away from the tine plane generally defined by the two tines.

[0196] Inventive Concept 110. The method according to Inventive Concept 109,

[0197] wherein releasing the tissue anchor from the deployment tool includes 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

[0198] 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.

[0199] Inventive Concept 111. The method according to Inventive Concept 110, 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 the tissue coupling portion at the junction where the tissue coupling portion bifurcates into two tines.

[0200] Inventive Concept 112. The method according to Inventive Concept 109, wherein pulling the proximal end of the straight anchor shaft portion along the anchor axis away from the tine plane can tightly pull the tines against the second distal side of the heart tissue wall.

[0201] Inventive Concept 113. The method according to Inventive Concept 109, wherein pulling the proximal end of the straight anchor shaft portion along the anchor axis away from the tine plane includes pulling a tether fixed to the tissue anchor.

[0202] Inventive Concept 114. The method according to 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 different from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by a tether.

[0203] Inventive Concept 115. A method according to Inventive Concept 98, wherein the heart tissue wall is a myocardial tissue wall, and wherein delivering the tissue connection portion in an undilated, generally elongated configuration through the heart tissue wall includes delivering the tissue connection portion through the myocardial tissue wall into the pericardial cavity between the epicardium and the parietal pericardium, generally beside and against the parietal pericardium without penetrating the parietal pericardium.

[0204] Inventive Concept 116. A method according to Inventive Concept 98, wherein the tissue anchor further includes a fabric that at least partially covers the tissue connection element.

[0205] Inventive Concept 117. A method according to Inventive Concept 98, wherein the tissue anchor further includes an anchor head that is coupled to and supports the straight anchor shaft portion.

[0206] According to Inventive Concept 118 of the present invention, there is also provided a tissue anchor that includes a wire having only two wire ends.

[0207] wherein the wire is shaped to define:

[0208] a straight anchor shaft portion having (i) a proximal end at the first wire end of only two wire ends and (ii) a distal end, and

[0209] a tissue connection portion that extends from the distal end of the straight anchor shaft portion, and

[0210] wherein the tissue anchor is configured such that when the tissue connection portion of the wire is in an unconstrained state where the tissue connection portion is not constrained by any external force:

[0211] (a) the tissue connection portion of the wire is shaped to define a tail end portion that includes the second wire end of only two wire ends,

[0212] (b) the tissue connection portion of the wire crosses itself at the first loop end longitudinal portion and the second loop end longitudinal portion along the wire so as to define a loop portion that generally defines a loop portion plane, the loop portion plane forming an angle between 75 degrees and 90 degrees with the anchor axis of the straight anchor shaft portion,

[0213] (c) the first loop end longitudinal portion is closer to the first wire end along the wire than the second loop end longitudinal portion is along the wire, and

[0214] (d) 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.

[0215] Inventive Concept 119. The tissue anchor according to Inventive Concept 118, wherein the tissue anchor is configured such that when the tissue engaging portion of the wire is in an unconstrained state, the anchor axis does not pass through the space surrounded and defined by the annular portion.

[0216] Inventive Concept 120. The tissue anchor according to Inventive Concept 118, wherein the tissue anchor is configured such that:

[0217] when the tissue engaging portion of the wire is in an unconstrained state, the annular portion is formed as an open annular portion, wherein the first annular end longitudinal portion and the second annular end longitudinal portion do not mechanically contact each other, and

[0218] when the proximal end of the straight anchor shaft portion is pulled away from the plane of the annular portion along the anchor axis, the first annular end longitudinal portion and the second annular end longitudinal portion mechanically contact each other.

[0219] Inventive Concept 121. The tissue anchor according to Inventive Concept 118, wherein when the tissue engaging portion of the wire is in an unconstrained state, the tail end portion generally falls within the plane of the annular portion.

[0220] Inventive Concept 122. The tissue anchor according to Inventive Concept 118, wherein the tissue anchor is configured such that when the tissue engaging portion of the wire is in an unconstrained state, the tail end portion is formed to define at least one straight portion.

[0221] Inventive Concept 123. The tissue anchor according to Inventive Concept 118, wherein the tissue anchor is configured such that when the tissue engaging portion of the wire is in an unconstrained state, the tail end portion is formed to define at least one tail end portion bending portion.

[0222] Inventive Concept 124. The tissue anchor according to any one of Inventive Concepts 118 to 123, wherein the tissue anchor is configured such that when the tissue engaging portion of the wire is in the unconstrained state, the tissue engaging portion of the wire is formed to define a first annular end bending portion, and the first annular end longitudinal portion is positioned along the first annular end bending portion.

[0223] Inventive Concept 125. The tissue anchor according to Inventive Concept 124, 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 annular portion along the anchor axis, the wire snaps into the first annular end longitudinal portion at the first annular end bending portion of the wire at the second annular end longitudinal portion.

[0224] Inventive Concept 126. The tissue anchor according to Inventive Concept 124, wherein the tissue anchor is configured such that when the tissue engaging portion of the wire is in an unconstrained state, the radius of curvature of the inner bending surface of the first annular end bending portion is between 80% and 120% of the radius of the wire along the second annular end longitudinal portion.

[0225] Inventive Concept 127. The tissue anchor according to Inventive Concept 124, wherein the first loop end bending portion extends directly from the distal end of the straight anchor shaft portion.

[0226] Inventive Concept 128. The tissue anchor according to any one of Inventive Concepts 118 to 123, further comprising a fabric that covers a part of the wire including the first loop end longitudinal portion or the second loop end longitudinal portion.

[0227] Inventive Concept 129. The tissue anchor according to 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 annular portion includes only one turn.

[0228] Inventive Concept 130. The tissue anchor according to any one of Inventive Concepts 118 to 123, further comprising an anchor head that is coupled to and supports the straight anchor shaft portion of the wire.

[0229] Inventive Concept 131. A system comprising a tissue anchor according to any one of Inventive Concepts 118 to 123, wherein the system further comprises a tether coupled to the tissue anchor.

[0230] The present invention will be more fully understood from the following detailed description of embodiments of the invention in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0231] Figure 1A is a schematic view of a tissue anchor configured to be anchored to a heart tissue wall according to an application of the present invention;

[0232] Figures 1B to 1C is according to an application of the present invention Figure 1A schematic views of two views of the wire of the tissue anchor;

[0233] Figure 1D is a schematic view of a system including a tissue anchor and a tether according to an application of the present invention;

[0234] Figure 2A is a schematic view of another tissue anchor configured to be anchored to a heart tissue wall according to an application of the present invention;

[0235] Figure 2B is according to an application of the present invention Figure 2A schematic view of the wire of the tissue anchor;

[0236] Figure 3A is a schematic view of yet another tissue anchor configured to be anchored to a heart tissue wall according to an application of the present invention;

[0237] Figure 3B is according to an application of the present inventionFigure 3A Schematic diagram of the wire of the tissue anchor

[0238] Figure 3C Schematic diagram of another tissue anchor configured to anchor to the heart tissue wall according to the application of the present invention

[0239] Figure 4A Schematic diagram of yet another tissue anchor according to the application of the present invention, the tissue anchor being configured to anchor to the heart tissue wall

[0240] Figure 4B is according to the application of the present invention Figure 4A Schematic diagram of the wire of the tissue anchor

[0241] Figure 5A Schematic diagram of another tissue anchor configured to anchor to the heart tissue wall according to the application of the present invention

[0242] Figure 5B is according to the application of the present invention Figure 5A Schematic diagram of the wire of the tissue anchor

[0243] Figure 6A and Figure 6B Schematic diagram of the wire of the tissue anchor configured to anchor to the heart tissue wall according to the corresponding application of the present invention

[0244] Figure 7 Schematic diagram of the wire of another tissue anchor configured to anchor to the heart tissue wall according to the application of the present invention

[0245] Figure 8 is the method of deploying the tissue anchor through the myocardial tissue wall according to the application of the present invention Figures 2A to 2B Schematic diagram of the method

[0246] Figure 9A and Figure 9B are respectively schematic diagrams of additional tissue anchors configured to anchor to the heart tissue wall according to the corresponding applications of the present invention; and

[0247] Figure 10 Schematic diagram of another tissue anchor configured to anchor to the heart tissue wall according to the application of the present invention Detailed Description

[0248] Figure 1A Schematic diagram of the tissue anchor 20 according to the application of the present invention, the tissue anchor being configured to anchor to the heart tissue wall. The tissue anchor 20 includes a wire 22 having only two wire ends: a first wire end 24A and a second wire end 24B. The wire 22 is shaped to define:

[0249] · A straight anchor shaft portion 26 having (i) a proximal end 28 and (ii) a distal end 30, and

[0250] · The tissue coupling portion 31 extends from the distal end 30 of the straight anchor shaft portion 26 such that the straight anchor shaft portion 26 is disposed between the tissue coupling portion 31 and the first wire end 24A along the wire 22.

[0251] Generally, the tissue anchor 20 further includes an anchor head 33 that is coupled 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 no collars 34. Optionally, the anchor head 33 further includes a sealing element 36 sized and shaped to be inserted through the incision in the heart tissue wall together with the anchor head 33. At the completion of the implantation of the expandable tissue anchor 20, the sealing element 36 remains 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 for the incision. For some applications, the sealing element 36 includes a metal or a polymer, such as a bioabsorbable polymer, that decomposes after healing and hemostasis have occurred. For some applications, the 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 incorporated herein by reference.

[0252] For some applications, such as Figure 1A (and some other figures) shown, 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 the tissue anchor 270, with necessary modifications.

[0253] Still referring to Figure 1A , and additionally referring to Figures 1B to 1C , which is a schematic illustration of two views of the wire 22 for an application in accordance with the present invention. Although as described above, the wire 22 is generally coupled to the anchor head 25, for clarity of illustration, Figures 1B to 1C the anchor head 25 is not shown in Figures 1A to 1C (and Figure 1D , as described below) shows the tissue coupling portion 31 in an unconstrained state, where the tissue coupling portion 31 is not constrained by any external force. (Note that the straight anchor shaft portion 26 may be configured to be straight only because it is constrained by the anchor head 33, or alternatively, even if it is not constrained by the anchor head 33)

[0254] The tissue anchor 20 is configured such that when the tissue coupling portion 31 is in an unconstrained state, such as Figures 1A to 1C shown:

[0255] · The tissue connection portion 31 of the wire 22 is formed to define a tail portion 32 including the second wire end 24B,

[0256] · The tissue connection 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 so as to define an annular portion 44, and the annular portion generally defines an annular portion plane 46 that forms an angle α (alpha) between 75 degrees and 90 degrees (e.g., 90 degrees) with the anchor axis 48 of the straight anchor shaft portion 26.

[0257] · The first loop end longitudinal portion 40A is closer to the first wire end 24A along the wire 22 (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 along the wire 22 from the first wire end 24A, and

[0258] · 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, additionally, generally 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 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).

[0259] As described below with reference to Figure 8 The tissue anchor 20 is delivered to the heart chamber within the deployment tool. The tissue connection portion 31 is delivered through the heart tissue wall from the first side of the wall to the second side within the deployment tool in an undilated generally elongated configuration, e.g., as described below with reference to Figure 8 described. The tissue connection portion 31 is also configured to expand on the second side of the heart tissue wall upon deployment, e.g., as described below with reference to Figure 8 described.

[0260] 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 annular portion plane 46 along the anchor axis 48, the mechanical contact between the first loop end longitudinal portion 40A and the second loop end longitudinal portion 40B locks the annular portion 44 and prevents the annular portion 44 from straightening due to the applied tension. Typically, the above 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 loop end longitudinal portion 40A and the second loop end longitudinal portion 40B can be direct, or via a coating or fabric 560 described below in Figures 6A to 6B described below)

[0261] Typically, the tissue anchor 20 is configured such that when the tissue engaging portion 31 of the wire 22 is in an unconstrained state, the anchor axis 48 does not pass through the space 54 surrounded and defined by the annular portion 44, such as Figures 1A to 1C shown.

[0262] Typically, the tissue anchor 20 is configured such that when the tissue engaging portion 31 of the wire 22 is in an unconstrained state, the annular portion 44 includes only one turn, such as Figures 1A to 1C shown. Alternatively, the annular portion 44 includes more than one turn (configurations not shown).

[0263] For some applications, the tissue anchor 20 is configured such that when the tissue engaging portion 31 of the wire 22 is in an unconstrained state, the wire 22 crosses itself only once along the wire 22 at the first loop end longitudinal portion 40A and the second loop end longitudinal portion 40B.

[0264] For some applications, the tissue anchor 20 is configured such that when the tissue engaging portion 31 of the wire 22 is in an unconstrained state, the wire 22 defines only a single annular portion 44.

[0265] For some applications, when the tissue engaging portion 31 of the wire 22 is in an unconstrained state, the tail end portion 32 generally falls within the plane 46 of the annular portion, such as Figures 1A to 1C shown, and thus may contribute to the anchoring.

[0266] For some applications, when the tissue engaging portion 31 of the wire 22 is in an unconstrained state, no portion of the tail end portion 32 is parallel to the straight anchor shaft portion 26.

[0267] For some applications, such as Figures 1A to 1C shown, the tissue anchor 20 is configured such that when the tissue engaging portion 31 of the wire 22 is in an unconstrained state, the 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 engaging portion 31 of the wire 22 is in an unconstrained state, the wire 22 is shaped to define a first loop end straight portion along which the first loop end longitudinal portion 40A is positioned (such as wire 622, described below with reference to Figure 7 it); in this case, the wire 22 may optionally be shaped to define a second loop end curved portion along which the second loop end longitudinal portion 40B is positioned (configurations not shown), or the wire 22 may not be shaped to define a second loop end curved portion (such as wire 622, described below with reference to Figure 7 it).

[0268] For some applications, wire 22 is not shaped to define any looped portion proximate proximal end 28 of straight anchor shaft portion 26 .

[0269] 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.

[0270] 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). Figures 6A to 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). Figures 6A to 6B Coating or fabric 560 described).

[0271] 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). Figures 6A to 6B Coating or fabric 560 described).

[0272] As used in this application, including in the claims, the term "annular portion" includes within its scope both open and closed loop portions.

[0273] Reference now Figure 1D, which is a schematic view 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, system 60 is the same as system 10, tissue anchor 70 is the same as tissue anchor 20 described above with reference to Figures 1A to 1C and the same reference numerals represent the same components.

[0274] Different from the tissue anchor 20 described above with reference to Figure 1A , 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. Thus, the tether 52 is generally directly coupled to the straight anchor shaft portion 26. For some applications, such as system 60, system 10 also includes a second tissue anchor 38 that is separate and different from the tissue anchor 70. Generally, the second tissue anchor 38 can be coupled to or is coupled to the tissue anchor 70 by the tether 52.

[0275] Now refer to Figure 2A , which is a schematic view of a tissue anchor 120 configured to be anchored to a heart tissue wall according to an application of the present invention. Also refer to Figure 2B , which is a schematic view of the wire 122 of the tissue anchor 120 according to an application of the present invention. Except as described below, tissue anchor 120 is the same as tissue anchor 20 described above with reference to Figures 1A to 1C and the same reference numerals represent the same components. Tissue anchor 120 can also implement the features of tissue anchor 70, as described above with reference to Figure 1D .

[0276] When the tissue coupling portion 131 of the wire 122 is in an unconstrained state, the distal end portion 132 of the tissue coupling portion 131 of the wire 122 is shaped to define at least one first loop end bending portion 154. For some applications, the distance between the anchor shaft axis 48 and the point on the first loop end bending portion 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 provide increased balance for the anchoring of the tissue anchor 120.

[0277] Now refer to Figure 3A , which is a schematic view of a tissue anchor 220 configured to be anchored to a heart tissue wall according to an application of the present invention. Also refer to Figure 3B , which is a schematic view of the wire 222 of the tissue anchor 220 according to an application of the present invention. Except as described below, tissue anchor 220 is the same as tissue anchor 20 described above with reference to Figures 1A to 1C and the same reference numerals represent the same components. Tissue anchor 220 can also implement the features of tissue anchor 70, as described above with reference to Figure 1D .

[0278] When the tissue connection portion 231 of the wire 222 is in an unconstrained state, the distal end portion 232 of the tissue connection portion 231 of the 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 axis 48 and the point on the straight portion 256 (such as the second wire end 24B) that is farthest from the anchor axis 48 is equal to 40% to 150% of the distance between the anchor axis 48 and the point on the annular portion 44 that is farthest from the anchor axis 48, for example, between 60% and 100%. Such an arrangement can provide increased balance for the anchoring of the tissue anchor 220.

[0279] Now refer to Figure 3C , which is a schematic view of a tissue anchor 270 configured to be anchored to a heart tissue wall for an application according to the present invention. Except as described below, the tissue anchor 270 is the same as the tissue anchor 220 described above with reference to Figures 3A to 3B , and the same reference numerals represent the same components. Any tissue anchor described herein can implement the features of the tissue anchor 270, with necessary modifications.

[0280] In this configuration, the proximal end 28 of the straight anchor shaft portion 276 of the wire 222 of the tissue anchor 270 does not coincide with the first wire end 24A; rather, the first wire end 24A is along the wire 222 close to the proximal end 28 of the straight anchor shaft portion 276. For example, the wire 222 can be at least partially bent (e.g., bent away from the anchor axis 48) between the first wire end 24A and the proximal end 28 of the straight anchor shaft portion 276, as Figure 3C shown, and / or one or more acute angles (configurations not shown) can be defined between the first wire end 24A and the proximal end 28 of the straight anchor shaft portion 276.

[0281] Now refer to Figure 4A , which is a schematic view of a tissue anchor 320 configured to be anchored to a heart tissue wall for an application according to the present invention. Also refer to Figure 4B , which is a schematic view of the wire 322 of the tissue anchor 320 for an application according to the present invention. Except as described below, the tissue anchor 320 is the same as the tissue anchor 20 described above with reference to Figures 1A to 1C , and the same reference numerals represent the same components. The tissue anchor 320 can also implement the features of the tissue anchor 70, as described above with reference to Figure 1D .

[0282] When the tissue connection portion 331 of the wire 322 is in an unconstrained state, for example Figures 4A to 4B shown:

[0283] · The tissue connection portion 331 of the wire 322 is shaped to define a distal end portion 332 including the second wire end 24B,

[0284] · The tissue connection 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 so as to define a loop portion 344, which generally defines a loop portion plane 346 that forms an angle between 75 degrees and 90 degrees (e.g., 90 degrees) with the anchor axis 48 of the straight anchor shaft portion 26.

[0285] · The first loop end longitudinal portion 340A is closer to the first wire end 24A along the wire 322 than the second loop end longitudinal portion 340B is along the wire 322 from the first wire end 24A, and

[0286] · 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.

[0287] When the tissue connection portion 331 of the wire 322 is in an unconstrained state, the wire 322 is shaped to define a first loop end bending portion 350 along which the first loop end longitudinal portion 340A is positioned. The tissue anchor 320 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 axis 48, the wire 322 snaps into the first loop end longitudinal portion 340A at the first loop end bending portion 350 of the wire 22 at the second loop end longitudinal portion 340B. This snap locks the loop portion 344 and prevents the loop portion 344 from straightening.

[0288] For some applications, the tissue anchor 320 is configured such that when the tissue connection portion 331 of the wire 322 is in an unconstrained state, the radius of curvature r of the inner bending surface 358 of the first loop end bending portion 350 C is between 80% and 120% (e.g., between 90% and 110%, e.g., 100%) of the radius of the wire 322 along the second loop end longitudinal portion 340B. For some applications, the first loop end bending portion 350 extends directly from the distal end 30 of the straight anchor shaft portion 26.

[0289] Typically, when the wire 322 snaps into the first loop end longitudinal portion 340A at the first loop end bending portion 350 of the wire 22, the inner bending surface 358 of the first loop end bending portion 350 surrounds the wire 322 at the first loop end longitudinal portion 340A by at least 180 degrees. For example, as described below, the inner bending surface 358 can surround 180 degrees, or slightly more, e.g., Figures 4A to 4B as shown, or at least 200 degrees, e.g., Figures 5A to 5B as shown. Figures 4A to 4B 、 Figures 5A to 5B and Figures 6A to 6BThe configuration shown can achieve Figures 4A to 4B and Figures 6A to 6B a lesser degree of enclosure as shown in Figures 5A to 5B or a greater degree of enclosure as shown in

[0290] For some applications, when the tissue connection portion 331 of the wire 322 is in an unconstrained state, the tail end portion 332 is shaped to define at least one straight portion 356. The straight portion 356 generally extends to the second wire end 24B.

[0291] Now refer to Figure 5A , which is a schematic view of a tissue anchor 420 configured to be anchored to a heart tissue wall for an application according to the present invention. Also refer to Figure 5B , which is a schematic view of the wire 422 of the tissue anchor 420 for an application according to the present invention. Except as described below, the tissue anchor 420 is the same as the tissue anchor 320 described above with reference to Figures 4A to 4B , and like reference numerals denote like parts. The tissue anchor 420 can also implement the features of the tissue anchor 70, as described above with reference to Figure 1D .

[0292] When the tissue connection portion 431 of the wire 422 is in an unconstrained state, the tail end portion 432 of the tissue connection portion 431 of the wire 422 is shaped to define at least one tail end portion bending portion 454.

[0293] Now refer to Figure 6A and Figure 6B , which are schematic views of the wire 322 of tissue anchors 520A and 520B configured to be anchored to a heart tissue wall for respective applications according to the present invention. Except as described below, the tissue anchors 520A and 520B are the same as the tissue anchor 320 described above with reference to Figures 4A to 4B , and like reference numerals denote like parts. The features of the tissue anchors 520A and 520B can also be implemented in combination with other tissue anchors described herein with necessary modifications.

[0294] The tissue anchors 520A and 520B further include a fabric 560 that covers a portion of the wire 322 including the first loop end longitudinal portion 340A (for the tissue anchor 520A, as shown in Figure 6A ) or the second loop end longitudinal portion 340B (for the tissue anchor 520B, as shown in Figure 6B ). The fabric 560 can help prevent corrosion of the metal of the wire 322 in the case where the second loop end longitudinal portion 340B moves back and forth relative to the first loop end bending portion 350 (e.g., in the hook defined by the first loop end bending portion 350).

[0295] Now refer to Figure 7, which is a schematic view of a wire 622 of a tissue anchor 620 configured to be anchored to a heart tissue wall for an application in accordance with the present invention. Except as described below, the tissue anchor 620 is the same as the tissue anchor 20 described above with reference to Figures 1A to 1C and like reference numerals denote like components. The tissue anchor 620 may also implement the features of the tissue anchor 70 described above with reference to Figure 1D or any other tissue anchor described herein, with necessary modifications; for example, the tissue anchor 620 may include an anchor head 33. Although the distal end portion 432 of the tissue engagement portion 631 of the wire 622 is shown as being shaped to define at least one distal end portion bend 454, or the distal end portion 432 does not define any distal end portion bend, such as Figures 1A to 1D , Figures 3A to 3C , Figures 4A to 4B and Figures 6A to 6B as shown.

[0296] The tissue anchor 620 is configured such that the tissue engagement portion 631 of the wire 622 is in an unconstrained state, (a) the tissue engagement portion 631 of the wire 622 crosses itself along the wire 622 at a first loop end longitudinal portion 640A and a second loop end longitudinal portion 640B to define a loop portion 644, and (b) the tissue engagement portion 631 is shaped to define:

[0297] · a first loop end straight portion 623A along which the first loop end longitudinal portion 640A is positioned, and / or

[0298] · a second loop end straight portion 623B along which the second loop end longitudinal portion 640B is positioned.

[0299] It should be noted that when viewed from above the plane of the loop portion (i.e., from the side of the plane of the loop portion opposite the first wire end 24A), the wire 622 of the loop portion 644 is shown in Figure 7 as looping from the first loop end straight portion 623A in a clockwise direction to the second loop end straight portion 623B. The wire 622 may also loop in a counterclockwise direction. Similarly, when viewed from above the plane of the loop portion, Figures 1A to 1D , Figures 2A to 2B , Figures 3A to 3C , Figures 4A to 4B , Figures 5A to 5B and Figures 6A to 6B the wires of the loop portions of the tissue anchors shown as looping from the first loop end straight portion to the second loop end straight portion in a counterclockwise direction; these wires may also loop in a clockwise direction.

[0300] Now referring to Figure 8, which is a schematic illustration of a method of deploying tissue anchor 120 through myocardial tissue wall 160 according to an application of the present invention. Although in Figure 8 , tissue anchor 120 is shown as being deployed through the myocardial tissue wall, tissue anchor 120 can also be deployed through other cardiac tissue walls, such as the atrial septum at or not at the fossa ovalis, or through other non-cardiac tissue walls. In fact, the tissue anchors described herein can be deployed in any number of body locations where it is desired to anchor into or behind tissue in order to move such tissue relative to adjacent tissue. Although Figure 8 the deployment of tissue anchor 120 is shown, other tissue anchors described herein can be deployed similarly.

[0301] Tissue anchor 120 is delivered to a target site, such as a cardiac chamber, within a deployment tool, where tissue coupling portion 131 is in an undilated generally elongated configuration within the deployment tool. The deployment tool can include a hollow needle. The cardiac chamber can be the right atrium 164 (as shown), the right ventricle 166 (a configuration not shown), the left atrium (a configuration not shown), or the left ventricle (a configuration not shown). The tissue coupling portion 131 of wire 122 is delivered through the cardiac tissue wall from a first side of the cardiac tissue wall to a second distal side of the cardiac tissue wall in an undilated generally elongated configuration. In one application, a hollow needle is used to pierce the first side of myocardial tissue wall 160 and the visceral pericardium 182 (which is part of the epicardium), avoiding the vasculature, such as the right coronary artery (RCA) 178. For some applications, the deployment tool is then further guided beyond the second distal side of the cardiac tissue wall and into the pericardial cavity 180 between the visceral pericardium 182 and the parietal pericardium 184, carefully avoiding piercing the parietal pericardium 184 and the fibrous pericardium 186. Although the performance of these steps of the method is not shown in Figure 8 , these steps can be performed using the techniques described in PCT Publication WO 2018 / 035378 to Tobis et al., which patent is incorporated herein by reference in its Figure 6A entirety through FIG. 6C.

[0302] As Figure 8 shown, tissue anchor 120 is released from the deployment tool such that the straight anchor shaft portion 26 of wire 122 is at least partially disposed within the cardiac tissue wall and the tissue coupling portion 131 of wire 122 expands outside the second distal side of the cardiac tissue wall (optionally within the pericardial cavity 180, as Figure 8 shown) and assumes the shape described above, thereby anchoring tissue anchor 120 to myocardial tissue wall 160.

[0303] 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 plane 46 of the annular portion 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). Thus, tension is 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 heart tissue. For some applications, this movement can have the benefit of altering the geometry of nearby heart valves, such as the tricuspid or mitral valves. Typically, a tether 52 is used to apply the tension.

[0304] Now refer to Figure 9A and Figure 9B , which are schematic views of tissue anchors 720A and 720B configured to be anchored to a heart tissue wall for respective applications of the present invention.

[0305] Also refer to Figure 10 , which is a schematic view of a tissue anchor 820 configured to be anchored to a heart tissue wall for an application of the present invention.

[0306] The tissue anchors 720A, 720B, and 820 each include:

[0307] · Straight anchor shaft portions 726A, 726B, and 826; and

[0308] · Tissue coupling portions 731A, 731B, and 831.

[0309] The tissue anchors 720A, 720B, and 820 are configured such that when the tissue coupling portions 731A, 731B, and 831 are in their respective unconstrained states where the tissue coupling portions are not subject to any external forces, as Figures 9A to 9B and Figure 10 shown:

[0310] · The tissue coupling portions 731A, 731B, and 831 are shaped to respectively define (i) elongated intermediate portions 735A, 735B, and 835 extending from the distal ends 730A, 730B, and 830 of the straight anchor shaft portions 726A, 726B, and 826, and (ii) bifurcated distal portions 737A, 737B, and 837 extending from the distal ends 741A, 741B, and 841 of the intermediate portions 735A, 735B, and 835, and respectively define two tines 743A, 743B, and 843.

[0311] · The respective cusp portions of tissue anchors 720A, 720B, and 820 pass between two cusps 743A, 743B, and 843 through portions 745A, 745B, and 845B, respectively.

[0312] For some applications, such as tissue anchors 720A and 820 shown respectively as Figure 9A and Figure 10 The cusp through portions 745A and 845 are defined by straight anchor shaft portions 726A and 826, respectively. For other applications, such as Figure 9B the tissue anchor 720B shown, the cusp through portion 745B is defined by an intermediate portion 735B. Alternatively, the cusp through portion is defined partly by a straight anchor shaft and partly by an intermediate portion (a configuration not shown). The tissue anchor 820 may alternatively be shaped such that the cusp through portion 845 is defined by an intermediate portion 835, similar to Figure 9B the configuration shown (a configuration not shown).

[0313] For some applications, each tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state, only one cusp through portion of the tissue anchor passes between two cusps, as shown in Figures 9A to 9B and Figure 10 shown.

[0314] For some applications, each tissue anchor is configured such that when the tissue coupling portion is in an unconstrained state, two cusps generally define a cusp plane 747 that forms an angle between 60 degrees and 90 degrees (e.g., between 75 degrees and 90 degrees) with the anchor axis 749 of the straight anchor shaft portion (labeled for tissue anchor 720A in Figure 9A but equally applicable to tissue anchors 720B and 820).

[0315] For some applications, tissue anchors 720A, 720B, and 820 are configured such that when the tissue coupling portions 731A, 731B, and 831A are in an unconstrained state, the intermediate portions 735A, 735B, and 835 are at least partially bent.

[0316] For some applications, tissue anchors 720A, 720B, and 820 further include a fabric that at least partially covers the tissue coupling element, such as described with reference to Figures 6A to 6B fabric 560.

[0317] Refer to Figures 9A to 9B。For some applications, each of tissue anchors 720A and 720B includes a single metal wire 722, which is shaped to define straight anchor shaft portions 726A, 726B and tissue coupling portions 731A, 731B. For some of these applications, the proximal ends 728 of the straight anchor shaft portions 726A, 726B coincide with the proximal end 724 of the metal wire 722. Alternatively, the proximal ends 728 of the straight anchor shaft portions 726A, 726B do not coincide with the proximal end 724 of the metal wire 722, such as described above with reference to Figure 3C tissue anchor 270, with necessary modifications.

[0318] Reference Figure 10 。For some applications, tissue anchor 820 includes two metal wires 822A and 822B, which 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 the tissue coupling portion 831 is in an unconstrained state, as Figure 10 shown, the two metal wires 822A and 822B:

[0319] · extend side by side (i.e., directly adjacent) to each other along at least a portion of the straight anchor shaft portion 826 and along at least a portion of the intermediate portion 835, and

[0320] · separate from each other along the forked distal portion 837 such that the two metal wires 822A and 822B respectively define two prongs 843.

[0321] Typically, but not necessarily, the two metal wires 822A and 822B are fixed to each other at least partially along the straight anchor shaft portion 826 and at least partially along the intermediate portion 835.

[0322] 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 metal wires 822A and 822B, such as coincides with the two proximal ends 724A and 724B, as Figure 10 shown. 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, such as described above with reference to Figure 3C tissue anchor 270, with necessary modifications.

[0323] Referring again to Figures 9A to 9B and Figure 10 , for some applications, tissue anchors 720A, 720B and 820 are configured such that:

[0324] · When the tissue attachment portions 731A, 731B, and 831 are in an unconstrained state, the intermediate portions 735A, 735B, and 835 are not in mechanical contact (direct contact, or via a coating or the optional fabric described above) with themselves or with any one of the two cusp teeth 743A, 743B, and 843, respectively, and

[0325] · When the proximal ends 728, 828 of the straight anchor shaft portions 726A, 726B, and 826 are pulled away from the cusp plane 747 along the anchor shaft axis 749, respectively, the intermediate portions 735A, 735B, and 835 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 portion) and at least one of the two cusp teeth 743A, 743B, and 843 (direct contact, or via a coating or the optional fabric described above).

[0326] For some of these applications, the tissue anchors 720A, 720B, and 820 are configured such that when the proximal ends 728, 828 of the straight anchor shaft portions 726A, 726B, and 826 are pulled away from the cusp plane 747 along the anchor shaft axis 749, respectively, the intermediate portions 735A, 735B, and 835 are in mechanical contact with the tissue attachment portions 731A, 731B, and 831, respectively, at the junctions 751A, 751B, and 851 where the intermediate portion bifurcates into two cusp teeth.

[0327] Still referring to Figures 9A to 9B and Figure 10 . Generally, 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 any of the features of the anchor head 33 described above with reference to Figure 1A . Alternatively, the tissue anchor does not include an anchor head, such as that described above with reference to Figure 1D regarding the tissue anchor 70. A tissue anchor system can be provided that includes one of the tissue anchors 720A, 720B, and 820 and a tether, and optionally, a second tissue anchor, such as that described above with reference to Figure 1A and Figure 1D described.

[0328] For some applications, the tissue anchors 720A, 720B, and 820 are generally as described above with reference to Figure 8Deployed as described for the tissue anchor 20, with necessary modifications. The tissue anchor is delivered into the heart chamber within the delivery tool, where the tissue engagement portion is in an undilated generally elongated configuration. The tissue engagement portion is delivered from a first side of the heart tissue wall through the heart tissue wall to a second distal side of the heart tissue wall in the undilated generally elongated configuration. The tissue anchor is released from the delivery tool such that the straight anchor shaft portion of the wire is at least partially disposed within the heart tissue wall and the tissue engagement portion is disposed external to the second distal side of the heart tissue wall (optionally within the pericardial cavity 180, as Figure 8 shown), and the tines of the tissue anchor pass through a portion between the two tines.

[0329] Typically, after the tissue anchor is released from the delivery tool, tension is applied to the tissue anchor by pulling the proximal end of the straight anchor shaft portion away from the tine plane generally defined by the two tines along the anchor shaft axis of the straight anchor shaft portion.

[0330] For some applications, the tissue anchor is released from the delivery tool such that the intermediate portion is not in mechanical contact (direct contact, or via a coating or the optional fabric described above) with itself or with either of the two tines. The proximal end of the straight anchor shaft portion is pulled away from the tine plane such that the intermediate portion is 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. For example, pulling the proximal end of the straight anchor shaft portion away from the tine plane can cause the intermediate portion to be in mechanical contact with the tissue engagement portion at the junction where the tissue engagement portion bifurcates into the two tines.

[0331] Typically, pulling the proximal end of the straight anchor shaft portion away from the tine plane along the anchor shaft axis can tightly pull the tines against the second distal side of the heart tissue wall (typically via the epicardium 182).

[0332] For some applications, the heart tissue wall is a myocardial tissue wall, and the tissue engagement portion is delivered through the myocardial tissue wall in the undilated generally elongated configuration into the pericardial cavity between the epicardium and the pericardial wall layer, generally along and against the pericardial wall layer without penetrating the pericardial wall layer.

[0333] The scope of the present invention includes the embodiments described in the following applications, which are assigned to the assignee of the present application and incorporated herein by reference. For some applications, the techniques and devices described in one or more of the following applications are combined with the techniques and devices 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 on January 9, 2013; U.S. Provisional Application 61 / 783,224 filed on March 14, 2013; U.S. Provisional Application 61 / 897,491 filed on October 30, 2013; U.S. Provisional Application 61 / 897,509 filed on 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 on June 19, 2014; PCT Publication WO 2015 / 063580; U.S. Patent Application Publication 2015 / 0119936; U.S. Provisional Application 62 / 086,269 filed on December 2, 2014; U.S. Provisional Application 62 / 131,636 filed on March 11, 2015; U.S. Provisional Application 62 / 167,660 filed on 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 2016 / 0262741; U.S. Provisional Application 62 / 376,685 filed on August 18, 2016; U.S. Provisional Application 62 / 456,206 filed on February 8, 2017; U.S. Provisional Application 62 / 456,202 filed on February 8, 2017; U.S. Provisional Application 62 / 465,410 filed on March 1, 2017; U.S. Provisional Application 62 / 465,400 filed on March 1, 2017; U.S. Provisional Application 62 / 516,894 filed on June 8, 2017; U.S. Provisional Application 62 / 530,372 filed on June 10, 2017; PCT Publication WO 2018 / 035378; U.S. Provisional Application 62 / 570,226 filed on October 10, 2017; U.S. Provisional Application 62 / 579,281 filed on October 31, 2017;U.S. Provisional Application 62 / 596,658 filed on December 8, 2017; PCT Publication WO 2018 / 148364; U.S. Patent Application Publication 2018 / 0221148; U.S. Provisional Application 62 / 628,457 filed on February 9, 2018; PCT Publication WO2018 / 160456; U.S. Patent Application Publication 2018 / 0249993; International Application PCT / US18 / 036609 filed on June 8, 2018; U.S. Patent Application Publication 2018 / 0353297; PCT Publication WO 2019 / 013994; International Application PCT / US2018 / 045523 filed on August 7, 2018; PCT Publication WO 2019 / 074815; PCT Publication WO 2019 / 089262; and PCT Publication WO 2019 / 157116.

[0334] Patents and patent application publications incorporated by reference in this patent application are to be considered an integral part of this application, except to the extent that any terms are defined in these incorporated patents and patent application publications in a manner that conflicts with the definitions made explicitly or implicitly in this specification, in which case only the definitions in this specification shall be considered.

[0335] Those skilled in the art will understand that the invention is not limited to what has been specifically shown and described above. Rather, the scope of the invention includes combinations and sub - combinations of the various features described above, as well as variations and modifications thereof that are not in the prior art and that will occur to those skilled in the art upon reading the above description.

Claims

1. An organizational anchor (720A, 720B, 820), comprising: a straight anchor shaft portion (726A, 726B, 826); and an organizational connection portion (731A, 731B, 831), wherein the organizational anchor (720A, 720B, 820) is configured such that when the organizational connection portion (731A, 731B, 831) is in an unconstrained state where the organizational connection portion (731A, 731B, 831) is not subject to any external force: the organizational connection portion (731A, 731B, 831) is shaped to define (i) an elongated intermediate portion (735A, 735B, 835) extending from the distal end (730A, 730B, 830) of the straight anchor shaft portion (726A, 726B, 826), and (ii) a forked distal portion (737A, 737B, 837) extending from the distal end (741A, 741B, 841) of the intermediate portion (735A, 735B, 835) and defining two pointed teeth (743A, 743B, 843), characterized in that the organizational anchor (720A, 720B, 820) is further configured such that when the organizational connection portion (731A, 731B, 831) is in an unconstrained state where the organizational connection portion (731A, 731B, 831) is not subject to any external force: a tooth passing portion (745A, 745B, 845B) of the organizational anchor (720A, 720B, 820) passes between the two pointed teeth (743A, 743B, 843), and the tooth passing portion (745A, 745B, 845B) is defined by at least one of the group consisting of: the straight anchor shaft portion (726A, 726B, 826) and the intermediate portion (735A, 735B, 835).

2. The organizational anchor (720A, 820) according to claim 1, wherein the tooth passing portion (745A, 845B) is defined by the straight anchor shaft portion (726A, 826).

3. The organizational anchor (720B) according to claim 1, wherein the tooth passing portion (745B) is defined by the intermediate portion (735B).

4. The organizational anchor (720A, 720B, 820) according to claim 1, wherein the organizational anchor (720A, 720B, 820) is configured such that when the organizational connection portion (731A, 731B, 831) is in an unconstrained state, only one tooth passing portion (745A, 745B, 845B) of the organizational anchor (720A, 720B, 820) passes between the two pointed teeth (743A, 743B, 843).

5. The organizational anchor (720A, 720B, 820) according to claim 1, wherein The tissue anchors (720A, 720B, 820) are configured such that when the tissue engaging portions (731A, 731B, 831) are in an unconstrained state, the two tines (743A, 743B, 843) generally define a tine plane (747) that forms an angle between 60 degrees and 90 degrees with the anchor axis (749) of the straight anchor shaft portion (726A, 726B, 826).

6. The tissue anchor (720A, 720B, 820) according to claim 1, wherein, the tissue anchor (720A, 720B, 820) is configured such that when the tissue engaging portions (731A, 731B, 831) are in an unconstrained state, the intermediate portion (735A, 735B, 835) is at least partially curved.

7. The tissue anchor (720A, 720B, 820) according to claim 1, further comprising a fabric that at least partially covers the tissue engaging portions (731A, 731B, 831).

8. The tissue anchor (720A, 720B) according to any one of claims 1 to 7, wherein, the tissue anchor (720A, 720B) includes a single wire (722) shaped to define the straight anchor shaft portion (726A, 726B) and the tissue engaging portions (731A, 731B).

9. The tissue anchor (720A, 720B) according to claim 8, wherein, a proximal end (728) of the straight anchor shaft portion (726A, 726B) coincides with a proximal end (724) of the wire (722).

10. The tissue anchor (820) according to any one of claims 1 to 7, wherein, the tissue anchor (820) includes two wires (822A, 822B) shaped to together define the straight anchor shaft portion (826) and the tissue engaging portion (831), and wherein the tissue anchor (820) is configured such that when the tissue engaging portion (831) is in an unconstrained state, the two wires (822A, 822B): extend side by side along at least a portion of the straight anchor shaft portion (826) and along at least a portion of the intermediate portion (835), and separate from each other along the forked distal portion (837) such that the two wires (822A, 822B) respectively define two tines (843).

11. The tissue anchor (820) according to claim 10, wherein, the two wires (822A, 822B) are at least partially fixed to each other along at least a portion of the straight anchor shaft portion (826) and at least a portion of the intermediate portion (835).

12. The tissue anchor (820) according to claim 10, wherein, a proximal end (828) of the straight anchor shaft portion (826) coincides with a proximal end (824A, 824B) of at least one of the two wires (822A, 822B).

13. The tissue anchor (720A, 720B, 820) according to any one of claims 1 to 7, wherein, the tissue anchor (720A, 720B, 820) is configured such that: when the tissue coupling portion (731A, 731B, 831) is in an unconstrained state, the intermediate portion (735A, 735B, 835) does not mechanically contact itself or either of the two tines (743A, 743B, 843), and when the proximal end (728, 828) of the straight anchor shaft portion (726A, 726B, 826) is pulled away from the tine plane (747) generally defined by the two tines (743A, 743B, 843) along the anchor shaft axis (749) of the straight anchor shaft portion (726A, 726B, 826), the intermediate portion (735A, 735B, 835) mechanically contacts at least one element selected from the group consisting of: the intermediate portion (735A, 735B, 835) and at least one of the two tines (743A, 743B, 843).

14. The tissue anchor (720A, 720B, 820) according to claim 13, wherein, the tissue anchor (720A, 720B, 820) is configured such that when the proximal end (728, 828) of the straight anchor shaft portion (726A, 726B, 826) is pulled away from the tine plane (747) along the anchor shaft axis (749), the intermediate portion (735A, 735B, 835) mechanically contacts the tissue coupling portion (731A, 731B, 831) at the junction (751A, 751B, 851) where the tissue coupling portion (731A, 731B, 831) bifurcates into the two tines (743A, 743B, 843).

15. The tissue anchor (720A, 720B, 820) according to any one of claims 1 to 7, further comprising an anchor head that is coupled to and supports the straight anchor shaft portion (726A, 726B, 826).

16. A system comprising the tissue anchor (720A, 720B, 820) according to any one of claims 1 to 7, the system further comprising a tether fixed to the tissue anchor (720A, 720B, 820).

17. The system according to claim 16, wherein, the tissue anchor (720A, 720B, 820) is a first tissue anchor, and wherein the system further comprises a second tissue anchor that is separate and different from the first tissue anchor, and the second tissue anchor is coupled to the first tissue anchor by the tether.

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