阅读说明：本技术 经皮瓣膜植入物的锚定件和锁定件 (Anchors and locks for percutaneous valve implants ) 是由 埃里·拜尔 埃拉德·雅克比 丹·萨尔兹曼 于 2020-01-13 设计创作，主要内容包括：一种装置包括线状物(58)和联接到该线状物的组织锚定件(60)。锚定件包括近侧部分(60p)、远侧部分(60d)和将近侧部分结合到远侧部分的多个条带(84),近侧部分成形为限定一个或更多个附件(82)。该锚定件被配置为借助于径向地展开的附件将线状物锚定在受试者的组织(42)处,并且当将径向约束力从锚定件移除时,条带径向地展开以在组织的远侧处形成相应的环。还描述了其他实施例。(A device includes a wire (58) and a tissue anchor (60) coupled to the wire. The anchor includes a proximal portion (60p) shaped to define one or more appendages (82), a distal portion (60d), and a plurality of straps (84) joining the proximal portion to the distal portion. The anchor is configured to anchor the wire at a tissue (42) of the subject by means of the radially-expanding appendage, and when the radially-constraining force is removed from the anchor, the strips radially expand to form respective loops at a distal side of the tissue. Other embodiments are also described.)

1. An apparatus, comprising:

a wire; and

a tissue anchor coupled to the wire and comprising:

a proximal portion shaped to define one or more appendages;

a distal portion; and

a plurality of straps joining the proximal portion to the distal portion,

the anchor is configured to anchor the wire at a tissue of a subject by means of the radially-expanding appendage, and when a radially-constraining force is removed from the anchor, the strips radially expand to form respective loops at a distal side of the tissue.

2. The apparatus of claim 1, wherein the strip is configured to be deployed such that the loops are arranged in a circular formation.

3. The device of claim 1, wherein the appendage includes a corresponding tine.

4. The device of claim 1, wherein the wire at least partially passes through the anchor.

5. The device of claim 4, wherein the anchor is coupled to the wire by tying a knot in the wire distal to the anchor.

6. The device of claim 4, wherein the anchor is coupled to the wire by virtue of the wire being attached to an inner wall of the distal portion of the anchor.

7. The device of claim 1, wherein the strips comprise 2-8 strips.

8. The device of any one of claims 1-7, wherein, for each of the strips, a circumferential angle between a proximal end of the strip and a distal end of the strip is at least 5 degrees.

9. The device of claim 8, wherein the circumferential angle is between 10 and 30 degrees.

10. The device according to any one of claims 1-7, wherein the proximal portion of the anchor is shaped to define the appendage by virtue of a corresponding recess being defined below the appendage as a result of shaping.

11. The device of claim 10, wherein the appendage does not extend radially beyond any other portion of the anchor prior to removal of the restraining force.

12. The device of any one of claims 1-7, wherein an angle between each of the appendages and a longitudinal axis of the proximal portion of the anchor is between 5 degrees and 60 degrees as the appendages are deployed.

13. A method for anchoring a wire at a tissue of a subject, the method comprising:

delivering a tissue anchor radially constrained within a tube and coupled to the wire to the tissue;

passing the tube through the tissue; and

after passing the tube through the tissue, urging the anchor from the tube such that one or more appendages at a proximal portion of the anchor radially expand and a plurality of straps for joining the proximal portion of the anchor to a distal portion of the anchor radially expand to form respective loops at a distal side of the tissue.

14. The method of claim 13, wherein urging the anchor from the tube comprises urging the anchor from the tube such that the appendage deploys proximally of the tissue.

15. The method of claim 13, wherein pushing the anchor from the tube comprises pushing the anchor from the tube such that the appendage deploys within the tissue.

16. The method of any of claims 13-15, wherein the wire is passed at least partially through the anchor.

17. The method of claim 16, wherein the anchor is coupled to the wire by knotting the wire distal to the anchor.

18. A device configured to lock an in vivo implant onto a wire passing through the implant, the device comprising:

a locking body configured to be advanced over the wire to the implant and including at least one rotatable element, the locking body configured to clamp the wire proximally of the implant upon rotation of the rotatable element; and

a rotational retaining element configured to inhibit reversal of rotation of the rotatable element by engagement with the locking body.

19. The device of claim 18, wherein the locking body comprises a serrated surface, and wherein the locking body is configured to grip the wire with the serrated surface.

20. The device of claim 19, wherein the rotatable element comprises the serrated surface.

21. The device of claim 18, wherein the locking body further comprises a block, and wherein the locking body is configured to clamp the wire between the rotatable element and the block.

22. The apparatus of claim 21, wherein the first and second electrodes are disposed in a common plane,

wherein the block is shaped to define a recess,

wherein the rotatable element is shaped to define a protrusion configured to fit into the recess upon rotation of the rotatable element, and

wherein the locking body is configured to clamp the wire between the protrusion and the recess.

23. The device of claim 18, wherein the at least one rotatable element comprises a pair of opposing rotatable elements, and wherein the locking body is configured to clamp the wire between the pair of opposing rotatable elements.

24. The device of any one of claims 18-23, wherein the rotation retaining element comprises a ring configured to cause rotation of the rotatable element by fitting over the locking body and to inhibit reversal of the rotation.

25. The device of claim 24, wherein the locking body is shaped to define one or more notches, and wherein the collar is shaped to define respective tabs configured to fit into the notches.

26. The device of claim 24, wherein the ring is configured to cause rotation of the rotatable element by fitting over the rotatable element.

27. The apparatus of claim 26, further comprising:

a hollow outer longitudinal element configured to push the annulus onto the rotatable element; and

a hollow inner longitudinal element configured to advance the locking body over the wire as the wire passes through the inner longitudinal element and the inner longitudinal element passes through the outer longitudinal element before the ring is pushed over the rotatable element.

28. The apparatus as set forth in claim 27, wherein,

wherein the inner longitudinal element is shaped to define an aperture, and

wherein the ring is shaped to define a tab configured to fit into the aperture as the locking body is advanced over the wire.

29. The device of claim 27, wherein the inner longitudinal element comprises a sharp distal edge configured to cut the wire after the ring is pushed onto the rotatable element.

30. The device of claim 24, wherein the locking body further comprises a shaft disposed alongside the rotatable element, and wherein the ring is configured to cause the rotatable element to rotate by fitting over the shaft such that the ring pushes against the rotatable element.

31. The apparatus of claim 30, wherein the first and second electrodes are,

wherein the shaft is shaped to define a slanted groove,

wherein the locking body further comprises:

a first pin coupled to the rotatable element and passing through the groove;

a block; and

a second pin passing through the rotatable element and through the block, the rotatable element configured to rotate relative to the second pin, and

wherein, as movement of the first pin is constrained by the groove, the ring is configured to pull the block toward the shaft by rotating the rotatable element such that the locking body clamps the wire between the block and the shaft.

32. The device of claim 31, wherein the shaft is shaped to define a bore, and wherein the ring is shaped to define a tab configured to fit into the bore.

33. The apparatus of claim 31, further comprising:

a hollow inner longitudinal element configured to push the collar onto the shaft; and

a hollow outer longitudinal element configured to advance the locking body over the wire as the wire passes through the inner longitudinal element and the inner longitudinal element passes through the outer longitudinal element.

34. The device of claim 33, wherein the outer longitudinal element is configured to retain the locking body while advancing the locking body over the wire.

35. The apparatus as set forth in claim 33, wherein,

wherein the outer longitudinal element comprises:

an outer tube; and

an appendage shaped to define an aperture, the appendage coupled to and extending from a distal end of the outer tube,

wherein the block is shaped to define a protrusion, and

wherein the outer longitudinal element is configured to retain the locking body by means of the protrusion through the hole.

36. The device of claim 35, wherein the appendage is tubular.

37. The device of claim 35, wherein the collar is configured to release the locking body from the outer longitudinal element by pulling the block towards the shaft such that the protrusion is pulled out of the bore.

38. The apparatus as set forth in claim 33, wherein,

wherein the inner longitudinal element comprises:

an inner tube; and

a ring bias attachment shaped to define a side opening, the ring bias attachment coupled to and extending beyond the distal end of the inner tube, and

wherein the inner longitudinal element is configured to push the ring onto the shaft when the ring pushing accessory contacts the ring and the wire passes through the inner tube via the side opening.

39. The device of claim 38, wherein the ring pushing accessory comprises a sharp edge configured to cut the wire after pushing the ring onto the shaft.

40. The device of any one of claims 18-23, wherein the rotational retaining element comprises a spring.

41. The device of claim 40, wherein the spring comprises a coil coiled around the rotatable element and configured to cause rotation of the rotatable element by urging the rotatable element and inhibit reversal of the rotation.

42. The device of claim 41, wherein the at least one rotatable element comprises a pair of opposing rotatable elements, and wherein the pair of rotatable elements are configured to clamp the wire between respective proximal ends of the pair of rotatable elements.

43. The apparatus of claim 42, further comprising:

a hollow inner longitudinal element comprising a distal end configured to be inserted between respective proximal ends of the pair of rotatable elements when the locking body is advanced to the implant and when the wire passes through the inner longitudinal element; and

a hollow outer longitudinal element configured to apply a reaction force to the locking body when the inner longitudinal element passes through the outer longitudinal element and the distal end of the inner longitudinal element is withdrawn from between the respective proximal ends of the pair of rotatable elements such that the pair of rotatable elements rotate toward each other by means of the coil pushing the pair of rotatable elements together.

44. The device of claim 43, wherein the outer longitudinal element comprises a sharp distal edge configured to cut the wire following rotation of the pair of rotatable elements.

45. The device of claim 43, wherein the respective proximal ends of the rotatable elements are shaped to define respective notches, and wherein the distal end of the inner longitudinal element is configured to fit into the notches.

46. The device of claim 40, wherein the rotatable element is shaped to define an aperture, and wherein the spring comprises a wire configured to spring into the aperture as the rotatable element rotates, thereby inhibiting reversal of the rotation.

47. The apparatus of claim 46, further comprising:

a hollow inner longitudinal element configured to rotate the rotatable element by withdrawing from the locking body when the wire is passed through the inner longitudinal element; and

a hollow outer longitudinal element configured to apply a counter force to the locking body when the inner longitudinal element passes through the outer longitudinal element and when the inner longitudinal element is withdrawn from the locking body.

48. The apparatus in accordance with claim 47 wherein the first and second electrodes are,

wherein the distal end of the inner longitudinal element is shaped to define a distal end aperture, an

Wherein the rotatable element is shaped to define a protrusion configured to fit within the distal end bore as the locking body is advanced to the implant.

49. The apparatus according to claim 47, wherein the inner longitudinal element is shaped to define a side opening, and wherein the inner longitudinal element is configured to advance the locking body to the implant as the wire passes therethrough via the side opening.

50. The device of claim 49 wherein the inner longitudinal element comprises a sharp edge at least partially surrounding the side opening and configured to cut the wire when the inner longitudinal element is withdrawn.

51. A method for locking an in vivo implant to a wire passing through the implant, the method comprising:

advancing a locking body comprising at least one rotatable element over the wire to the implant; and

after advancing the locking body to the implant, rotating the rotatable element such that the locking body clamps the wire proximally of the implant.

52. The method of claim 51, wherein rotating the rotatable element comprises rotating the rotatable element by fitting a ring on the locking body.

53. The method of claim 52, wherein mating the collar on the locking body comprises mating the collar on the rotatable element.

54. The method of claim 53, in which the first and second regions are different,

wherein fitting the ring on the rotatable element comprises fitting the ring on the rotatable element by pushing the ring onto the rotatable element using a hollow outer longitudinal element, and

wherein advancing the locking body to the implant comprises advancing the locking body to the implant using the inner longitudinal element as the wire is passed through the hollow inner longitudinal element and the inner longitudinal element is passed through the outer longitudinal element.

55. The method of claim 54, further comprising, after pushing the ring onto the rotatable element, cutting the wire with the sharp distal edge of the inner longitudinal element.

56. The method of claim 52, wherein engaging the ring on the locking body comprises engaging the ring on a shaft disposed alongside the rotatable element such that the ring pushes against the rotatable element.

57. In accordance with the method set forth in claim 56,

wherein the shaft is shaped to define a slanted groove,

wherein the locking body further comprises:

a first pin coupled to the rotatable element and passing through the groove,

a block; and

a second pin passing through the rotatable element and through the block, the rotatable element configured to rotate relative to the second pin, and

wherein rotating the rotatable element comprises rotating the rotatable element such that the block is drawn toward the shaft by movement of the first pin constrained by the groove such that the locking body clamps the wire between the block and the shaft.

58. In accordance with the method set forth in claim 57,

wherein fitting the collar on the shaft comprises pushing the collar onto the shaft using a hollow inner longitudinal element, and

wherein advancing the locking body over the wire comprises advancing the locking body over the wire using the outer longitudinal element as the wire is passed through the inner longitudinal element and the inner longitudinal element is passed through the hollow outer longitudinal element.

59. The method of claim 58, further comprising retaining the locking body with the outer longitudinal element while advancing the locking body over the wire.

60. The method according to claim 59, wherein said step of treating the sample,

wherein the outer longitudinal element comprises:

an outer tube, and

an appendage shaped to define an aperture, the appendage coupled to and extending from a distal end of the outer tube,

wherein the block is shaped to define a protrusion, and

wherein retaining the locking body comprises retaining the locking body by means of the protrusion passing through the aperture.

61. The method according to claim 60, wherein rotating the rotatable element comprises rotating the rotatable element such that the locking body is released from the outer longitudinal element by means of the protrusion being pulled out of the hole.

62. The method of any one of claims 58-61,

wherein the inner longitudinal element comprises:

an inner tube, and

a ring bias attachment shaped to define a side opening, the ring bias attachment coupled to and extending beyond the distal end of the inner tube, and

wherein pushing the ring onto the shaft comprises pushing the ring onto the shaft when the ring pushing appendage contacts the ring and the wire passes through the inner tube via the side opening.

63. The method of claim 62 further comprising cutting the wire with a sharp edge of the ring pushing appendage after pushing the ring onto the shaft.

64. The method of claim 51, wherein rotating the rotatable element comprises rotating the rotatable element by causing a coil wound around the rotatable element to push against the rotatable element.

65. The method according to claim 64, wherein the at least one rotatable element comprises a pair of opposing rotatable elements, and wherein the method comprises rotating the pair of rotatable elements such that the pair of rotatable elements grip the wire between their respective proximal ends.

66. The method in accordance with claim 65, wherein,

wherein advancing the locking body to the implant comprises advancing the locking body to the implant while the wire is inserted through the hollow inner longitudinal element and the distal end of the inner longitudinal element is inserted between the respective proximal ends of the pair of rotatable elements, and

wherein rotating the rotatable element comprises rotating the rotatable element by: withdrawing the distal end of the inner longitudinal element from between the respective proximal ends of the pair of rotatable elements while applying a counter force to the locking body using a hollow outer longitudinal element through which the inner longitudinal element passes such that the pair of rotatable elements rotate towards each other by means of the coil pushing the pair of rotatable elements together.

67. The method of claim 66, further comprising cutting the wire using the sharp distal edge of the outer longitudinal element after rotating the pair of rotatable elements.

68. The method of claim 51, wherein the rotatable element is shaped to define an aperture, and wherein the method comprises inhibiting reversal of the rotation by rotating the rotatable element such that a wire springs into the aperture.

69. The method of claim 68, wherein rotating the rotatable element comprises rotating the rotatable element by: withdrawing the inner longitudinal element from the locking body while applying a counter force to the locking body using the outer longitudinal element as the thread passes through the hollow inner longitudinal element and the inner longitudinal element passes through the hollow outer longitudinal element.

70. The method of claim 69, wherein the inner longitudinal member is shaped to define a side opening, and wherein advancing the locking body to the implant comprises advancing the locking body to the implant as the wire passes through the inner longitudinal member via the side opening.

71. The method of claim 70, further comprising cutting the wire as the inner longitudinal element is withdrawn using a sharp edge of the inner longitudinal element at least partially surrounding the side opening.

Technical Field

Embodiments of the present invention generally relate to the field of medical devices, and more particularly, to devices and methods for percutaneous valve (percutaneous valve) repair and replacement.

Background

In some subjects, the implants may be used to repair or replace an intracardiac valve.

Us patent 10,278,820 to Bar et al, the disclosure of which is incorporated herein by reference, describes a device comprising an assembly of tubes, each shaped to define a lumen. The device further comprises a plurality of tissue anchors, an expandable loop structure, and a plurality of control wires, each tissue anchor disposed within a respective one of the lumens; the deployable ring structure includes a plurality of teeth coupled to the tube assembly; a plurality of control wires are coupled to the loop structure and configured to position the tube by manipulating the loop structure to deploy the tissue anchors from the lumen.

Bar et al, U.S. patent application 10,463,486, describes a device comprising a plurality of flexible tube guides, an assembly of looped tubes, a plurality of wires, and an expandable loop structure, each tube slidably disposed within a respective one of the tube guides; each wire includes a distal end carried by a respective one of the tubes; an expandable loop structure is coupled to the tube guide, the expandable loop structure configured to expand the assembly of tubes from a collapsed configuration on tissue of the subject by moving the tube guide radially outward. The device also includes a plurality of control wires coupled to the tube guide configured to position the tube after deployment of the assembly for deployment of the wire from the tube and into tissue by bending the tube guide.

Summary of The Invention

According to some embodiments of the present invention, a device is provided that includes a wire and a tissue anchor coupled to the wire. The tissue anchor includes a proximal portion, a distal portion, and a plurality of straps joining the proximal portion to the distal portion, the proximal portion being shaped to define one or more appendages. The anchor is configured to anchor the wire at tissue of the subject by means of the radially-expanding attachment, and when the radially-constraining force is removed from the anchor, the strips radially expand to form respective loops at a distal side of the tissue.

In some embodiments, the strap is configured to be deployed such that the loop is arranged in a circular fashion.

In some embodiments, the attachment includes a corresponding tine.

In some embodiments, the wire is at least partially threaded through the anchor.

In some embodiments, the anchor is coupled to the wire by tying a knot in the wire distal to the anchor.

In some embodiments, the anchor is coupled to the wire by means of a wire attached to a distal portion of the anchor.

In some embodiments, the strips comprise 2-8 strips.

In some embodiments, for each of the strips, a circumferential angle between the proximal end of the strip and the distal end of the strip is at least 5 degrees.

In some embodiments, the circumferential angle is between 10 degrees and 30 degrees.

In some embodiments, the proximal portion of the anchor is shaped to define the appendage by virtue of being shaped to define a corresponding recess below the appendage.

In some embodiments, the radial extension of the appendage does not exceed any other portion of the anchor prior to removal of the restraining force.

In some embodiments, the angle between each appendage and the longitudinal axis of the proximal portion of the anchor is between 5 degrees and 60 degrees as the appendages are deployed.

There is also provided, according to some embodiments of the invention, a method for anchoring a wire to tissue of a subject. The method includes delivering a tissue anchor to tissue, the tissue anchor being radially constrained within a tube and coupled to a wire. The method further includes passing a tube through the tissue, and after passing the tube through the tissue, pushing the anchor from the tube such that the one or more appendages at the proximal portion of the anchor are radially deployed and a plurality of straps radially deployed to form respective loops at a distal side of the tissue, the plurality of straps joining the proximal portion of the anchor to the distal portion of the anchor.

In some embodiments, pushing the anchor from the tube includes pushing the anchor from the tube such that the appendage deploys proximal to the tissue.

In some embodiments, pushing the anchor from the tube includes pushing the anchor from the tube such that the appendage deploys within the tissue.

In some embodiments, the wire is threaded through the anchor.

In some embodiments, the anchor is coupled to the wire by tying a knot in the wire distal to the anchor.

There is also provided, in accordance with some embodiments of the present invention, a device configured to lock an intracorporeal implant to a wire passed through the implant. The device includes a locking body configured to be advanced over the wire to the implant and including at least one rotatable element, the locking body configured to grip the wire proximally of the implant upon rotation of the rotatable element. The device also includes a rotational retaining element configured to inhibit reversal of rotation of the rotatable element by engagement with the locking body.

In some embodiments, the locking body includes a serrated surface, and the locking body is configured to grip a wire with the serrated surface.

In some embodiments, the rotatable element comprises a serrated surface.

In some embodiments, the locking body further comprises a block, and the locking body is configured to clamp the wire between the rotatable element and the block.

In some embodiments of the present invention, the,

the block is shaped to define a recess,

the rotatable element is shaped to define a protrusion configured to fit into the recess upon rotation of the rotatable element, and

the locking body is configured to clamp the wire between the protrusion and the recess.

In some embodiments, the at least one rotatable element includes a pair of opposing rotatable elements, and the locking body is configured to clamp the wire between the pair of opposing rotatable elements.

In some embodiments, the rotational retaining element comprises a ring configured to cause rotation of the rotatable element by fitting over the locking body and to inhibit reversal of that rotation.

In some embodiments, the locking body is shaped to define one or more notches and the collar is shaped to define corresponding tabs configured to fit into the notches.

In some embodiments, the ring is configured to cause rotation of the rotatable element by fitting over the rotatable element.

In some embodiments, the apparatus further comprises:

a hollow outer longitudinal element configured to push the annulus onto the rotatable element; and

a hollow inner longitudinal member configured to advance the locking body over the wire as the wire passes through the inner longitudinal member and the inner longitudinal member passes through the outer longitudinal member before the loop is pushed over the rotatable member.

In some embodiments of the present invention, the,

the inner longitudinal member is shaped to define an aperture, and

the ring is shaped to define a tab configured to fit into the hole as the locking body is advanced over the wire.

In some embodiments, the inner longitudinal element includes a sharp distal edge configured to cut the wire after pushing the ring onto the rotatable element.

In some embodiments, the locking body further comprises a shaft disposed alongside the rotatable element, and the ring is configured to cause the rotatable element to rotate by fitting on the shaft such that the ring pushes against the rotatable element.

In some embodiments of the present invention, the,

the shaft is shaped to define a slanted channel,

the locking body further includes:

a first pin coupled to the rotatable element and passing through the groove;

a block; and

a second pin passing through the rotatable element and through the block, the rotatable element configured to rotate relative to the second pin, an

Since movement of the first pin is constrained by the groove, the ring is configured to cause the block to be drawn toward the shaft by rotating the rotatable element such that the locking body clamps the wire between the block and the shaft.

In some embodiments, the shaft is shaped to define a bore and the collar is shaped to define a tab configured to fit into the bore.

In some embodiments, the apparatus further comprises:

a hollow inner longitudinal element configured to push the collar onto the shaft; and

a hollow outer longitudinal member configured to advance the locking body over the wire as the wire passes through the inner longitudinal member and the inner longitudinal member passes through the outer longitudinal member.

In some embodiments, the outer longitudinal element is configured to retain the locking body while advancing the locking body over the wire.

In some embodiments of the present invention, the,

the outer longitudinal element comprises:

an outer tube; and

an appendage shaped to define an aperture, the appendage coupled to and extending from the distal end of the outer tube,

the block is shaped to define a protrusion, and

the outer longitudinal element is configured to hold the locking body by means of a protrusion through the hole.

In some embodiments, the accessory is tubular.

In some embodiments, the collar is configured to release the locking body from the outer longitudinal element by pulling the block towards the shaft such that the protrusion is pulled out of the hole.

In some embodiments of the present invention, the,

the inner longitudinal element comprises:

an inner tube; and

a ring pushing appendage shaped to define a side opening, the ring pushing appendage coupled to and extending beyond the distal end of the inner tube, and

the inner longitudinal element is configured to push the ring onto the shaft when the ring pushing appendage contacts the ring and the wire passes through the inner tube via the side opening.

In some embodiments, the ring pushing accessory includes a sharp edge configured to cut the wire-like object after pushing the ring onto the shaft.

In some embodiments, the rotational retaining element comprises a spring.

In some embodiments, the spring comprises a coil (coil) wound around the rotatable element, and the coil is configured to cause rotation of the rotatable element by pushing against the rotatable element and to inhibit reversal of the rotation.

In some embodiments, the at least one rotatable element comprises a pair of opposing rotatable elements, and the pair of rotatable elements is configured to grip the wire between their respective proximal ends.

In some embodiments, the apparatus further comprises:

a hollow inner longitudinal element comprising a distal end configured to be inserted between the respective proximal ends of the pair of rotatable elements when the locking body is advanced to the implant and when the wire is passed through the inner longitudinal element; and

a hollow outer longitudinal element configured to apply a reaction force to the locking body when the inner longitudinal element passes through the outer longitudinal element and the distal end of the inner longitudinal element is withdrawn from between the respective proximal ends of the pair of rotatable elements such that the pair of rotatable elements are rotated towards each other by means of the coil pushing the pair of rotatable elements together.

In some embodiments, the outer longitudinal element includes a sharp distal edge configured to cut the wire-like object upon rotation of the pair of rotatable elements.

In some embodiments, the respective proximal ends of the rotatable elements are shaped to define respective notches, and the distal ends of the inner longitudinal elements are configured to fit into the notches.

In some embodiments, the rotatable element is shaped to define a bore, and the spring comprises a wire (wire) configured to spring into the bore with rotation of the rotatable element, thereby inhibiting reversal of the rotation.

In some embodiments, the apparatus further comprises:

a hollow inner longitudinal element configured to rotate the rotatable element by withdrawing from the locking body when the wire is passed through the inner longitudinal element; and

a hollow outer longitudinal element configured to apply a counter force to the locking body when the inner longitudinal element passes through the outer longitudinal element and when the inner longitudinal element is withdrawn from the locking body.

In some embodiments of the present invention, the,

the distal end of the inner longitudinal element is shaped to define a distal end aperture, an

The rotatable element is shaped to define a protrusion configured to fit within the distal end bore as the locking body is advanced into the implant.

In some embodiments, the inner longitudinal member is shaped to define a side opening, and the inner longitudinal member is configured to advance the locking body to the implant as the wire passes through the inner longitudinal member via the side opening.

In some embodiments, the inner longitudinal element includes a sharp edge at least partially surrounding the side opening, and the sharp edge is configured to cut the wire-like object upon withdrawal of the inner longitudinal element.

There is also provided, in accordance with some embodiments of the present invention, a method for locking an in vivo implant to a wire passing through the implant. The method includes advancing a locking body including at least one rotatable element over the wire to the implant. The method further includes, after advancing the locking body to the implant, rotating the rotatable element such that the locking body clamps the wire proximally of the implant.

The present invention will be more fully understood from the following detailed description of embodiments of the invention taken together with the accompanying drawings, in which:

brief Description of Drawings

Fig. 1 is a schematic view of a wire deployment device deployed within the left atrium of a subject's heart, according to some embodiments of the invention;

FIG. 2 is a schematic view of a wire deployment device in its deployed state according to some embodiments of the invention;

FIG. 3 is a schematic illustration of a longitudinal cross-section through a tube and a tube guide according to some embodiments of the invention;

FIG. 4 is a schematic view of an alternative wire deployment device according to some embodiments of the invention;

FIG. 5 is a schematic view of a wire deployment element according to some embodiments of the invention;

6A-6D collectively illustrate deployment of a wire into tissue by a wire deployment element, according to some embodiments of the invention;

FIG. 7 is a schematic view of an alternative wire deployment element according to some embodiments of the invention;

8A-8D collectively illustrate deployment of a wire into tissue by a wire deployment element, according to some embodiments of the invention;

fig. 9 is a schematic illustration of delivery of an implant to the mitral annulus according to some embodiments of the present invention;

FIG. 10 is a schematic view of a tissue anchor held within a tube according to some embodiments of the invention;

FIG. 11 is a schematic view of a tissue anchor in a constrained state according to some embodiments of the invention;

FIG. 12 is a schematic view of a tissue anchor in a deployed state according to some embodiments of the present invention;

fig. 13 is a schematic view of a tissue anchor anchoring a wire at a tissue of a subject, according to some embodiments of the present invention;

FIG. 14 is a schematic view of a lock according to some embodiments of the invention;

15A-15B are schematic illustrations of longitudinal cross sections through the lock of FIG. 14 according to various embodiments of the invention;

FIG. 16A is a schematic view of a locking instrument for locking a lock to an implant according to some embodiments of the present invention;

FIG. 16B is a schematic illustration of a longitudinal cross-section through a portion of the locking instrument of FIG. 16A, according to some embodiments of the present invention;

FIG. 17 is a schematic view of a locking body being advanced over a wire according to some embodiments of the invention;

FIG. 18 is a schematic view of a collar being pushed onto a locking body according to some embodiments of the invention;

FIG. 19 is a schematic view of a lock according to some embodiments of the invention;

fig. 20A is a schematic view of a locking instrument for locking a lock to an implant according to some embodiments of the present invention;

FIG. 20B is a schematic illustration of a longitudinal cross-section through a portion of the locking instrument of FIG. 20A, according to some embodiments of the present invention;

FIG. 21 is a schematic view of a locking body being advanced over a wire according to some embodiments of the invention;

FIG. 22 is a schematic view of a collar being pushed onto a locking body according to some embodiments of the invention;

FIG. 23 is a schematic view of a lock according to some embodiments of the invention;

FIG. 24 is a schematic view of a locking instrument for locking a lock to an implant according to some embodiments of the present invention;

FIG. 25 is a schematic view of a locking element being advanced over a wire according to some embodiments of the invention;

FIG. 26 is a schematic view of the locking member according to some embodiments of the invention;

FIG. 27 is a schematic view of a lock according to some embodiments of the invention;

FIG. 28A is a schematic view of a locking instrument for locking a lock to an implant according to some embodiments of the present invention;

FIG. 28B illustrates a longitudinal cross-section through a portion of the locking instrument of FIG. 28A, according to some embodiments of the present invention;

fig. 29 is a schematic view of a locking element being advanced over a wire according to some embodiments of the invention; and

FIG. 30 is a schematic illustration of locking of a locking member according to some embodiments of the invention.

Detailed Description

SUMMARY

Embodiments of the present invention provide devices and methods for percutaneously implanting annuloplasty valves and other implants.

In embodiments of the invention, one or more wires are deployed at an implantation site within a subject, such as the subject's mitral valve annulus. Subsequently, an implant (such as an annuloplasty valve) is advanced (or "delivered") over the wire to the implantation site. Next, the corresponding locking element is advanced over the wire to the implant and locked proximal to the implant. Upon locking the locking element, the locking element grips the wire, thereby locking the implant in place. After locking the implant, the wire is severed proximal of the lock.

In some embodiments, during deployment of the wire, respective tissue anchors coupled to the wire are deployed at the tissue at the implantation site such that the anchors anchor the wire to the tissue. One particular type of anchor described herein includes a tube made of a shape memory material and one or more appendages at a proximal portion of the tube, and the tube includes a plurality of straps that join the proximal portion of the tube to a distal portion of the tube. Upon deployment of the anchors, the strips radially expand at the distal side of the tissue to form respective loops, and the appendages radially expand within or proximal to the tissue. Advantageously, the loop inhibits proximal migration of the anchor (and thus the wire) from the tissue while also distributing the stress applied to the tissue, while the appendage inhibits distal migration of the anchor (and thus the wire) from the tissue.

In other embodiments, the wire is looped through the tissue such that a tissue anchor may not be required.

Embodiments of the present invention also include various types of locking elements. Each lock includes at least one rotatable element and is configured to grip the wire as the rotatable element rotates. For example, the rotatable element may press the wire against another portion of the lock as the rotatable element rotates. Each lock further includes a rotational retaining element configured to retain the rotatable element in the position to which it is rotated, and thus maintain the grip on the wire. For example, the lock may comprise a ring that inhibits rearward rotation of the rotatable element by fitting over the rotatable element or another part of the lock.

Wire deployment and implant delivery

Referring first to fig. 1, fig. 1 is a schematic view of a wire deployment device 20 deployed within the left atrium 22 of a subject's heart 24, according to some embodiments of the invention.

To deliver the wire deployment device 20 to the left atrium 22, the sheath 26 is first inserted percutaneously into the heart 24, for example, via the femoral and inferior vena cava, or via the jugular and superior vena cava. Subsequently, the sheath 26 is passed through the atrial septum and into the left atrium using techniques known in the art. The sheath 26 is typically advanced over the guidewire under fluoroscopic guidance and/or under guidance of any other suitable imaging modality, such as ultrasound (e.g., transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE)), Magnetic Resonance Imaging (MRI), or Computed Tomography (CT).

After delivery of the sheath to the left atrium, device 20 is advanced distally from sheath 26. In some embodiments, the catheter 28 is first advanced from the sheath, and then the device 20 is pushed through the catheter 28, emerging from the distal end of the catheter.

In some embodiments, as shown in fig. 1, the sheath 26 is curved within the left atrium such that the distal opening of the sheath 26 faces the mitral valve. The conduit 28 is similarly curved. The device 20 is then pushed from the distal opening of the catheter 28 towards the mitral valve. Alternatively, for embodiments in which the sheath 26 curves within the left atrium, the catheter 28 may not be needed, and the device 20 may be held by the sheath 26 and pushed against the device 20 from the sheath 26.

In other embodiments, the sheath 26 does not bend within the left atrium; instead, the catheter 28 bends after being advanced from the sheath so that the opening of the catheter faces the mitral valve. Device 20 is then advanced from the catheter.

Initially, the device 20 is in a folded or "rolled" state. In some embodiments, a retaining tip 30, which initially covers the distal end of the device 20, maintains the device in this folded state. After the device 20 is advanced distally from the sheath 26, the retention tip 30 is pushed away from the distal end of the device by using a push wire that passes from the retention tip through the length of the sheath 26 to the exterior of the subject. The device 20 may then be deployed (or "opened") within the atrium. In addition to removing the retention tip 30, the slider 32 may be used to open the device, as further described below with reference to fig. 2. Instead of using the slider 32, the covering sheath can be withdrawn from the device.

The device 20 comprises an annular assembly (or "assemblage") of tubes 34, and a plurality of flexible tube guides 35. Each tube 34 is slidably disposed within a respective tube guide 35 such that the tube guides guide the movement of the tube. Typically, each tube guide is cylindrical in shape.

The device 20 further includes an expandable loop structure 36, the loop structure 36 being coupled to the tube guide. In some embodiments, the loop structure 36 is made of a suitable shape memory material (e.g., nitinol). The push-off of the retention tip 30 and/or the appropriate movement of the slider 32 allows the ring-shaped structure 36 to expand such that the ring-shaped structure 36 expands radially outward toward its predetermined "memory" shape. In other embodiments, the ring structure 36 is made of a non-shape-memory material (e.g., stainless steel, polymeric tubing, and/or any other suitable metal, polymer, or combination thereof). In such embodiments, the push-off of the retention tip 30 and/or the appropriate movement of the slider 32 allows the loop 36 to spring back from its crimped state. In any event, when the loop is deployed, the loop deploys the assembly of tubes on the tissue 42 of the subject by moving the tube guide 35 radially outward.

A plurality of wires (not shown) pass from the tube 34 to the exterior of the subject. As the annular structure (and hence the assembly of annular tubes) is deployed within the subject, the tubes are positioned and/or oriented on the tissue 42 for subsequent deployment of the wires from the tubes into the tissue 42. For example, the tube may be positioned over the mitral annulus (i.e., within the left atrium, at the top surface of the ring) for subsequent deployment of the wire into the ring.

In general, the device 20 may include any suitable number of tubes, such as 4-20 tubes. The tube 34 may be made of any suitable metal or plastic material. Typically, the tube passes through the entire length of the sheath 26, such that the proximal end of the tube 34 is outside of the subject throughout delivery, deployment and subsequent use of the device 20. Typically, the device 20 is rotatable about a central longitudinal axis 44 of the device.

Typically, the device 20 includes a plurality of longitudinal wires 38, the longitudinal wires 38 typically being coupled to the ring-shaped structure at a proximal end (or "top") thereof. As described further below with reference to fig. 2, longitudinal wire 38 may help adjust the radius of device 20, thereby helping position tube 34 for deployment of the wire from the tube, and/or help crimp the device after deployment of the wire. In some embodiments, the longitudinal wires 38 may further be used to manipulate the loop structures 36, thereby facilitating the positioning of the tubes. For example, by applying a pushing force to the annular structure, the longitudinal wires 38 may move the annular structure 36 (and thus also the tubes) in an axial direction (i.e., in a direction parallel to the central longitudinal axis 44) such that each tube is in contact with the valve annulus.

Typically, the device 20 also includes a plurality of control wires 40, the control wires 40 being coupled to respective distal portions of the tube guide 35. Control wire 40 is configured to bend the tube guide to position and/or orient the tube for subsequent deployment of the wire. For example, to move the wire deployment position radially inward (i.e., toward axis 44), as described with reference to fig. 12A-12D of us patent 10,463,486, Bar et al, the associated tube may be bent radially inward; conversely, to move the wire deployment position radially outward, the associated tube may be bent radially outward.

After any necessary positioning and/or orientation of any particular tube 34, the tube is pushed through a tube guide that contains the tube such that the tube pierces the tissue 42. The wire is then deployed from the tube, i.e., the wire passes through the tube or from the outer surface of the tube and through the tissue, as further described below with reference to fig. 3. (the wire may pass through the outer surface of the tube by retracting the tube, and/or by pushing an anchor coupled to the wire from the outer surface of the tube.)

Although fig. 1 specifically illustrates deployment of device 20 within the left atrium, it should be noted that device 20 may similarly be deployed at other suitable locations within the body of a subject. For example, the device 20 may be deployed within the right atrium of a subject to facilitate delivery of a wire to the tricuspid annulus.

Referring now to fig. 2, fig. 2 is a schematic view of a wire deployment device 20 in an expanded state according to some embodiments of the present invention.

Referring first to the inset portion of fig. 2, there is shown tube 34 partially through tube guide 35, and a wire 58 passing from the distal end of the tube guide.

As described above with reference to fig. 1, the tube guide 35 is flexible. For example, the tube guide 35 may be shaped to define a plurality of circumferential grooves 54. For example, each groove 54 may extend at least 50%, such as at least 65%, of the circumference of the tube guide 35 such that the tube guide 35 is divided by the groove into a plurality of semi-communicating sections 56. In such an embodiment, the tube guide 35 is flexible due to the groove 54, as the sections 56 can rotate relative to each other. Alternatively, the tube guide 35 may be flexible due to the material from which the tube guide is made and/or any suitable manufacturing process. Typically, the tube guide 35 may be made of any suitable plastic or metal material, such as nitinol.

As described above with reference to fig. 1, the tube guide 35 guides the passage of the tube, thereby facilitating deployment of the wire 58 from the tube. In some embodiments, the distal end of the wire 58 is carried within the tube 34 prior to deployment of the wire 58, as further described below with reference to fig. 3. In such embodiments, the wire 58 may pass through the distal end of the tube guide 35 and then extend along the outside of the tube guide 35 and the tube 34 to the exterior of the subject. Alternatively, instead of passing through the distal end of the tube guide, the wire 58 may pass through a hole in the tube wall and/or a hole in the tube guide wall. Alternatively, the wire 58 may extend inside the tube 34 to the exterior of the subject.

In other embodiments, the distal end of the wire 58 is carried on the outer surface of the tube 34 prior to deployment of the wire 58. However, for ease of description, the remainder of this specification generally assumes that the distal end of the wire is carried within a tube 34 as shown in fig. 2.

Typically, each tube guide is coupled to at least one control wire 40. In some embodiments, as shown in fig. 2, each control wire 40 includes an annular distal end 46, the annular distal end 46 coupled to a respective one of the tube guides. Typically, the annular distal end 46 is radially oriented such that an outer arm 48 of the annular distal end closer to the tube and tube guide is disposed at a first radius and an inner arm 50 of the annular distal end further from the tube and tube guide is disposed at a second radius that is less than the first radius. (in this context, "radius" refers to the distance from axis 44.)

(it may be noted that outer arm 48 and inner arm 50 may also be said to belong to the entire control wire, not just to annular distal end 46. thus, for example, outer arm 48 and inner arm 50 may be said to extend from annular distal end 46 to the exterior of the subject.)

In some embodiments, control line 40 is coupled directly to the tube guide. In other embodiments, the control line is indirectly coupled to the tube guide, e.g., the control line is coupled to the loop structure 36, which in turn is coupled to the tube guide. It is noted that in the context of this application, including the claims, the term "coupled" may include within its scope either a direct coupling or an indirect coupling.

Typically, for embodiments in which the control wire is looped, each tube guide is bent by moving one proximal end of the attached control wire relative to the other proximal end of the control wire. For example, while proximal end 48p of outer arm 48 is held in place or allowed to slide freely, proximal end 50p of inner arm 50 may be pulled or pushed; optionally, the proximal end 48p may be pulled or pushed while the proximal end 50p is held in place or allowed to slide freely. The bending of the tube guide facilitates positioning of the tube as described with reference to fig. 12A-12D of us patent 10,463,486 to Bar et al.

In other embodiments, the control line is not looped, but is longitudinal, similar to longitudinal line 38. Typically, in such embodiments, each tube is coupled to two control lines, wherein one of the two control lines is disposed at a larger radius than the other control line. (in such embodiments, the outer control line is similar to outer arm 48, and thus may be referred to as an "outer control arm," and the inner control line is similar to inner arm 50, and thus may be referred to as an "inner control arm"). Alternatively, the outer control wire may be coupled at a more proximal location than the inner control wire. For example, two control wires may be coupled to two different sections 56 belonging to the tube, respectively, at a distance of 0.5-10mm from each other.

In other embodiments, a single longitudinal control wire is coupled to each of the tube guides. In such embodiments, each tube guide may be bent by moving the attached control line relative to the tube passing through the tube guide.

As described above with reference to fig. 1, the slider 32 may be used to both expand (i.e., open) and crimp (i.e., close) the assembly of the tube 34 and the loop structure 36. Typically, the slider 32 slides along a "track" formed by the control line 40; for example, the slider 32 can slide along the inner and outer arms 50, 48 of the control wire. When the slide is in (or near) its distal-most position on the track, the assembly of tubes and the loop structure are held in the crimped position. Thus, to crimp the device, the slider 32 may be slid distally along the control wire such that the slider exerts a crimping force on the assembly of tubes and the loop structure. After distal sliding of the slider, the catheter 28 and/or sheath 26 may be slid distally along the longitudinal wire 38, thereby further crimping the device. Finally, the catheter 28 and/or sheath 26 may be passed over the device. Conversely, to deploy the device, the slider 32 may be slid proximally along the control wire, for example, to allow the loop structure, and thus the assembly of tubes, to be deployed.

Typically, the radius of each inner arm through the slide is smaller than the radius of the respective outer arm through the slide. For example, the slider 32 can include a first cylinder 67a (through which the respective outer arm of the control wire passes) and a second cylinder 67b (through which the respective inner arm of the control wire passes), the second cylinder 67b being disposed distal to the first cylinder 67a and being disposed narrower than the first cylinder 67a (i.e., the second cylinder 67b has a radius that is less than the radius of the first cylinder 67 a). This configuration facilitates crimping of the device because the slider 32 can slide to a more distal position than would otherwise be possible.

Typically, the ring structure 36 comprises a triangular wave-shaped annulus having alternating top and bottom vertices, each bottom vertex being coupled to a respective one of the tube guides. In such embodiments, the longitudinal line 38 is typically coupled to the top apex of the loop structure. As described above, the longitudinal wires 38 facilitate adjusting the radius of the device 20, as the radius may be adjusted by sliding the catheter 28 (and/or sheath 26) along the longitudinal wires. Such adjustment may assist in positioning the tube 34 to deploy the wire from the tube, and/or to crimp the device after deployment of the wire.

Referring now to fig. 3, fig. 3 is a schematic illustration of a longitudinal cross-section through a tube 34 and a tube guide 35 according to some embodiments of the invention.

Typically, a plurality of deployable tissue anchors 60 are respectively disposed within the tubes 34. Further, a plurality of anchor pusher elements 62 are each disposed within the tube proximal of the anchor 60.

In some embodiments, as shown in fig. 3, the distal end of each wire 58 is tethered to a respective anchor 60. In such embodiments, as shown in fig. 3, the wire 58 may pass through the distal end of the tube and the distal end of the tube guide and extend with the tube 34 to the exterior of the subject; alternatively, the wire may pass through the tube. In other embodiments, the wire is coupled to the anchor by passing the wire through the anchor and tying a knot distal to the anchor (such that the diameter of the knot is greater than the diameter of the anchor). In such embodiments, typically, as shown in fig. 10 (described below), the wire is passed through the tube, such as by passing through an anchor pushing element 62.

To deploy a particular wire, the tube carrying the wire is passed through the tissue so that the wire also passes through the tissue. (the tube 34 may extend outside of the subject, in which case the tube may be pushed directly; alternatively, the tube may be pushed using a separate tube pushing element disposed proximal to the tube and extending outside of the subject.) subsequently, the anchor 60 is pushed from the tube using the anchor pushing element 62. Once out of the tube, the anchor 60 is deployed at the distal side of the tissue, as shown, for example, in fig. 9 and 13. The tube and anchor pushing element are then retracted into the tube guide 35.

After deployment of the anchor 60, tension may be continuously applied to the wire 58 to hold the anchor 60 in place until the implant is locked in place, for example, as described below with reference to fig. 14-30. Alternatively or additionally, the anchor may include one or more attachments that assist in holding the anchor in place by engaging with tissue, for example, as described below with reference to fig. 13.

In some embodiments, as shown in fig. 3, each tube 34 includes a pointed distal end 64. In such embodiments, tube 34 may alternatively be referred to as a "needle," and tube guide 35 as a "needle guide," in some embodiments, tube 34 is coupled distally to a needle that includes a distal end 64. In the context of the present application, including the claims, such a needle may be considered as an extension of the tube.

As described above with reference to fig. 1, the tube 34 may be located within the left atrium at the top surface of the mitral annulus. In some embodiments, to deploy the anchor 60, the tube 34 is passed through the annulus and into the left ventricle such that the anchor 60 is deployed within the left ventricle and under the valve leaflets. In other embodiments, the tube emerges from the tissue above the valve leaflets within the left atrium. In some embodiments, the pointed distal end 64 is bent radially inward such that the tube exits the valve annulus through a radially-inward-facing face of the valve annulus. In such embodiments, the anchors may be deployed along the radially inward face of the valve annulus, as shown in fig. 9. (Note that in the context of the present application, including the claims, the term "distal", when used to refer to tissue at the site of implantation, may include the radially inward face of the valve annulus.)

In some embodiments, the tubes pierce the tissue only after all of the tubes have been properly positioned and/or oriented. In other embodiments, at least one tube may pierce the tissue before all tubes have been properly positioned and/or oriented, such that subsequent positioning of the other tubes does not cause the first tube to move from its intended piercing position. For example, (i) positioning and/or orienting the tubes, (ii) passing the tubes through the mitral annulus, (iii) passing the tissue anchors from the tubes, and (iv) retrieving the tubes and anchor pushing elements, the above sequence can be performed for each tube (one tube at a time). Optionally, for example, after each tube is positioned and/or oriented, the tube may pierce the tissue of the ring, but the tissue anchor may not pass through the tube until at least some other tubes have also pierced the tissue.

It should be noted that each tube, along with the respective tube guide and/or any of the other components described above that facilitate wire deployment, may be referred to as a "wire deployment element" such that device 20 may be referred to as a ring assembly of wire deployment elements.

Referring now to fig. 4, fig. 4 is a schematic view of an alternative wire deployment device 20a according to some embodiments of the invention.

Typically, the device 20a is similar to the device 20, for example, with respect to the manner in which the assembly of the tube 34 can be deployed over tissue with the deployment loop 36 prior to deployment of the wire, and the manner in which the tube is positioned and/or oriented is similar to the device 20. However, device 20a differs from device 20 in the configuration of tube 34 and the manner in which the wire is deployed.

In particular, in device 20a, each tube 34 includes an arcuate distal portion 66 disposed proximate to tube guide 35. For example, the distal portion 66 may be shaped to define a distally facing crescent including a first tube end 68a and a second tube end 68 b. Typically, the arcuate distal portion 66 is less flexible than the more proximal portion of the tube 34; for example, the arcuate distal portion 66 may be rigid. (in some embodiments, a portion of tube 34 immediately proximal to the arcuate distal portion may also be rigid.)

As further described below with reference to fig. 5 and 7, at least one arcuate needle is disposed within the arcuate distal portion 66. Each arcuate needle is coupled to a distal end of a respective wire 58 (not shown in fig. 4), as in device 20, wires 58 may extend with tube 34 or within tube 34 to the exterior of the subject. As described further below, the arcuate needle is configured to pass the wire in an arcuate manner from the arcuate distal portion 66 through tissue to loop the wire through the tissue of the valve annulus. With the wire looped through the tissue, it may not be necessary to deploy any anchors.

Typically, the first and second tube ends 68a, 68b are pointed. (thus, as in device 20, tube 34 may be referred to as a "needle" and tube guide 35 may be referred to as a "needle guide.) in such embodiments, to facilitate deployment of the thread, first tube end 68a and second tube end 68b may pierce the tissue of the annulus before the arcuate needle passes from arcuate distal portion 66 and through the tissue.

Each tube, as well as the arcuate needle contained therein and/or any other components described below that facilitate wire deployment, may be referred to as a "wire deployment element," such that device 20a may be referred to as a ring assembly of wire deployment elements. In this regard, referring now to fig. 5, fig. 5 is a schematic view of a wire deployment element 65 according to some embodiments of the invention. (FIG. 5 does not show the portion of tube 34 proximal to distal portion 66, or tube guide 35.)

In the particular embodiment shown in fig. 5, a single arcuate needle 70 having a pointed distal end 70d is disposed within the arcuate distal portion 66. The thread 58 is coupled to the proximal end 70p of the needle 70. The wire deployment element 65 includes one or more (e.g., exactly two) distal shafts 72, the distal shafts 72 being coupled to the tube in contact with the needle 70. As further described below with reference to fig. 6A-6D, shaft 72 is configured to rotate needle 70 through tissue 42. Typically, shaft 72 is rotated by rotating one or more proximal shafts 74. For example, one or more bands 76 may collectively mechanically couple the shafts 72 to each other and to the proximal shaft 74 such that the distal shaft 72 rotates in response to rotation of the proximal shaft. (Note that any shaft that does not contact needle 70 is referred to herein as a "proximal shaft," even if the shaft is relatively close to distal portion 66 of the tube.)

Reference is now made to fig. 6A-6D, which collectively illustrate deployment of a wire 58 into tissue 42 by a wire deployment element 65, in accordance with some embodiments of the present invention.

Fig. 6A shows the arcuate distal portion 66 of tube 34 piercing through tissue 42. After piercing tissue, as shown in fig. 6B, the distal shaft 72 is rotated (by rotation of the proximal shaft 74) such that the needle 70 passes through the tissue 42 in an arcuate manner from the arcuate distal portion 66. (the motion of the needle may also be described as "rotating") as the needle passes through tissue, the thread 58 coupled to the proximal end of the needle also passes through the tissue. Typically, the needle is rotated so that the entire needle (i) passes through one of the tube ends and into the tissue, (ii) passes through the tissue, and (iii) passes through the other tube end. For example, the needle may undergo a full rotation of 360 degrees.

Fig. 6C shows the configuration of wire deployment element 65 after needle 70 has been rotated. In this configuration, the wire 58 passes through the tissue in an arcuate manner from one tube end, through the other tube end, and then from the aperture in the arcuate distal portion 66 to the exterior of the subject. (for clarity, the path of the line 58 is emphasized in FIG. 6℃)

After the needle is rotated, tube 34 is withdrawn through the tube guide, causing arcuate distal portion 66 to withdraw from the tissue, as shown in fig. 6D. After withdrawal of the wire deployment element, the wire 58 is looped through the tissue 42 such that after withdrawal of the device 20a from the subject's body, two different sections of the wire (first section 63a and second section 63b) pass from the tissue to the exterior of the subject.

Referring now to fig. 7, fig. 7 is a schematic view of an alternative wire deployment element 51 according to some embodiments of the invention. (similar to FIG. 5, FIG. 7 does not show the entirety of tube 34 or tube guide 35.)

Wire deployment element 51 may be used with wire deployment device 20a (fig. 4) as an alternative or in addition to wire deployment element 65. Wire deployment element 51 is similar at least in some respects to wire deployment element 65. For example, in the wire deployment element 51, the tube 34 includes an arcuate distal portion 66 that includes tube ends 68a and 68 b. Additionally, wire deployment element 51 differs from wire deployment element 65 in at least some respects. For example, instead of a single arcuate needle, the thread deployment element 51 comprises a pair of arcuate needles including a first arcuate needle 70a and a second arcuate needle 70 b. Typically, first arcuate needle 70a includes a first pointed distal end 59a and a first needle body 61a that are reversibly coupled to one another. Similarly, second arcuate needle 70b includes a second pointed distal end 59b and a second needle body 61b that are reversibly coupled to each other. The first wire 58a is coupled to the first pointed distal end 59a, while the second wire 58b is coupled to the second pointed distal end 59 b.

8A-8D, first and second arcuate needles 70a, 70b deploy first and second wires 58A, 58b through tissue 42 in an arcuate manner toward each other from first and second tube ends 68A, 68b, respectively. When the two arcuate needles collide with each other within the tissue, the first pointed distal end 59a and the second pointed distal end 59b are coupled to each other such that the first thread 58a is coupled to the second thread 58 b. Thus, the two wires effectively become a single wire that passes annularly through the tissue, similar to the loop of wire 58 shown in fig. 6D.

Typically, the respective proximal ends of the arcuate needles are coupled to a hinge 55, and the hinge 55 may be controlled by a hinge lever 53. Typically, as shown in fig. 7, the hinge 55 is v-shaped, with the respective proximal ends of the arcuate needles coupled to the respective ends of the hinge, and the distal end of the hinge lever 53 disposed inside the hinge. A spring (or "clamp") 57 applies a closing force to the hinge so that when the distal end of the hinge lever 53 is in a relatively proximal position (as shown in fig. 7), the hinge is nearly closed and the arcuate needle is inside the arcuate distal portion 66. Conversely, when the hinge lever 53 is pushed to a more distal position against the hinge, the hinge opens, causing the arcuate needle to pass from the arcuate distal portion 66 and through the tissue of the subject.

The first pointed distal end 59a and the second pointed distal end 59b may be configured to couple to each other in any suitable manner. For example, as shown in fig. 7, the first pointed distal end 59a can be shaped to define a male connecting tip and the second pointed distal end 59b can be shaped to define a female connecting tip configured to matingly receive the first pointed distal end 59 a. When sufficient force is applied to the hinge 55 by the hinge lever 53, the first pointed distal end 59a is forced into the second pointed distal end 59 b.

Reference is now made to fig. 8A-8D, which collectively illustrate deployment of wires 58A and 58b into tissue 42 by wire deployment element 51, in accordance with some embodiments of the present invention.

First, as shown in FIG. 8A, the first tube end 68A and the second tube end 68b pierce the tissue 42. Next, as indicated by the downward arrow in FIG. 8B, the hinge lever pushes against the hinge causing the hinge to open and the arcuate needle to pass through the tissue. When the hinge is fully open, the first pointed distal end 59a is coupled to the second pointed distal end 59 b. Subsequently, as indicated by the upward arrow in fig. 8C, the hinge lever is withdrawn (i.e., moved proximally), so that the hinge 55 is closed by the spring 57. When the hinge is closed, the force exerted by the hinge on the first and second needle bodies 61a, 61b exceeds the connection force between the needle bodies and the respective distal ends of the needles. Thus, the needle body of the needle is separated from the respective distal end portion. Finally, as shown in fig. 8D, the retrieval wire deployment element 51 is withdrawn.

Reference is now made to fig. 9, which is a schematic illustration of delivery of an implant 71 to the mitral annulus 75, according to some embodiments of the present invention.

After deployment of the wire 58, the wire deployment device is crimped, inserted into the catheter 28 and/or sheath 26 (fig. 1), and then withdrawn from the subject. Subsequently, implant 71 may be delivered over the wire to the mitral valve annulus 75. As shown in fig. 9, implant 71 may comprise an annuloplasty ring. Alternatively, for example, the implant may include a replacement valve.

First, the implant 71 is loaded onto the wire by passing the proximal end of the wire through a corresponding hole in the implant. (Note that the implant can be loaded onto the wire even before the wire is deployed.) As described above for device 20a (FIG. 4), a single wire looped through tissue can be used as two separate wires, as each segment (or "arm") of the loop can pass through a different respective hole in the implant.

Next, a plurality of hollow push rods 73 including respective distal heads 79 may be loaded to the wire proximally of the implant. The push rod 73 can then push the implant along the wire through the sheath 26 to the valve annulus. Note that pushrod 73 is typically flexible such that the pushrod can follow any number of turns in the subject. Similarly, various other rods, tubes, and other instruments for advancing various elements (e.g., locks) along a wire are typically flexible, as described herein.

In some embodiments, one or more retrieval wires 69 encircle implant 71. If the physician determines that the implant is improperly positioned (i.e., the wire is improperly placed), decides to replace implant 71 with another implant (e.g., due to the incorrect size or shape of implant 71), or decides not to implant any at all, retrieval wire 69 may be used to retrieve implant 71. Subsequently, even without implantation, invasive surgery may not be required on the subject; instead, assuming that the anchor 60 is fixed, it is sufficient to simply cut the wire 58.

Note that each wire may comprise a polymer, a metal (e.g., nitinol), and/or any other suitable material. For embodiments in which the wire is metal, the wire may also be referred to as a "wire".

Anchoring member

Referring now to fig. 10, fig. 10 is a schematic view of a tissue anchor 60 retained within a tube 34 according to some embodiments of the present invention. With additional reference to fig. 11 and 12, fig. 11 is a schematic view of the anchor 60 in a constrained state according to some embodiments of the present invention, and fig. 12 is a schematic view of the anchor 60 in a deployed state according to some embodiments of the present invention. (FIG. 12 shows both an isometric view of the anchor and a view from the distal end of the anchor.)

In some embodiments, the anchor 60 includes a proximal portion 60p, a distal portion 60d, and a plurality (e.g., between two and eight) of strips 84 joining the proximal portion 60p to the distal portion 60 d. Typically, the proximal portion 60p is shaped to define one or more (e.g., two) appendages (or "arms") 82, the appendages 82 being joined at their proximal ends to the remainder of the proximal portion 60 p. The attachment 82 may include, for example, corresponding tines 83 or a ring.

Typically, the anchor is at least partially hollow, and the wire is at least partially threaded through the anchor. To couple the anchor to the wire (i.e., inhibit the wire from sliding from the anchor), the wire may be knotted distal to the anchor. Alternatively, the wire (e.g., the distal end of the wire) may be attached to the inner wall of the distal portion of the anchor, for example, by applying an adhesive or by welding. (to facilitate such attachment, the distal portion 60d may be shaped to define the side opening 77.) alternatively, the wire may be knotted distally of the proximal portion of the anchor, or attached to the inner wall of the proximal portion of the anchor. (typically, the polymer wire is tied off and the metal wire is attached to the inner wall of the anchor.)

In some embodiments, anchor pushing element 62 comprises a hollow shaft, and wire 58 extends through the shaft. In other embodiments, the anchor pusher member comprises a solid shaft, and the wire extends through the tube with the shaft.

When held within the tube 34, the anchor 60 is in a constrained state, as shown in fig. 10-11, by virtue of the radial constraint force applied to the anchor by the tube. Typically, the diameter D0 of the anchor is between 0.3mm and 2mm when the anchor is constrained. Alternatively or additionally, the length L0 of the anchor may be between 5mm and 50 mm.

Typically, the proximal portion of the anchor is shaped to define the appendage 82 by virtue of the corresponding recess 88 being defined below the appendage as a result of the shaping; in other words, typically, the appendage 82 is cut from a proximal portion of the anchor. Advantageously, therefore, the radial extension of the appendage, when constrained, may not exceed any other portion of the anchor.

When the tube 34 reaches the location where the wire 58 is to be deployed, the tube is passed through the tissue and the anchor 60 is then urged from the tube using the anchor urging element 62. When the radially constraining force applied by the tube is removed, the anchoring elements radially deploy, adopting the deployed state shown in fig. 12. In particular, the strips 84 are radially expanded to form respective loops, typically arranged in a circular fashion. Furthermore, the appendages 82 are radially spread out. Typically, the angle θ between the longitudinal axis 90 of the proximal portion of each appendage and the anchor is between 5 degrees and 60 degrees as appendages 82 are deployed.

Typically, the strap is not parallel to the longitudinal axis 90 even when the anchor is constrained. Instead, there is a circumferential angular displacement between the proximal end of each strip (which is connected to the proximal portion 60p) and the distal end of the strip (which is connected to the distal portion 60 d). For example, as shown in the particular strip 84a identified in fig. 12, the circumferential angle a between the proximal and distal ends of the strip may be at least 5 degrees, such as 5-200 degrees, such as 10-30 degrees. Advantageously, due to this angular displacement, the plane 85 defined by each strip after its deployment is at least partially perpendicular to the longitudinal axis 90 and therefore at least partially parallel to the surface 92 of the tissue (fig. 13). Thus, the tape can distribute the stress applied to the tissue over a larger area.

Typically, the anchor 60 is made of a shape memory material (e.g., nitinol). The strip 84 is formed by cutting a slit 86 (e.g., a helical slit) in the middle portion of the tube, while the appendage 82 is formed by cutting a groove 88 in the proximal portion of the tube. (the slits 86 and recesses 88 may be laser cut, or may be formed using any other suitable technique.) after the slits 86 and recesses 88 are cut, the anchor is heat set to its deployed shape.

Referring now to fig. 13, fig. 13 is a schematic view of anchor 60 anchoring wire 58 at tissue 42, according to some embodiments of the present invention.

To anchor the wire 58, the tube 34 (FIG. 10) is passed through the tissue 42. The anchor 60 is then partially urged from the tube so that the strip 84 radially expands at the distal side (or "distal side") of the tissue 42, i.e., at the side of the tissue opposite the proximal side (or "proximal side") where the implant 71 is to be implanted. Due to the deployment of the strip (which in its deployed state may alternatively be referred to as a "loop"), proximal migration of the anchor and wire from the tissue is inhibited.

Next, the wire is pulled so that the strip 84 is pulled toward the distal surface 92 of the tissue. When the cable is pulled, the tube is withdrawn from the proximal portion of the anchor, causing the appendage 82 to also deploy. Depending on the distance between the appendage and the strip relative to the thickness of the tissue, the appendage can be deployed within the tissue (as shown in fig. 13) or at the proximal side of the tissue, e.g., such that the distal end of the appendage contacts the proximal surface 94 of the tissue. In either case, the anchor and wire are inhibited from migrating distally from the tissue as the deployed appendages engage the tissue.

Typically, the diameter D1 of the tape (which may also be referred to as the maximum diameter of the anchor) is between 4mm and 30mm after the tape is deployed. Alternatively or additionally, the length L1 of the anchor (which is less than the length L0 (fig. 11) due to the radial deployment of the strip) may be between 4mm and 30 mm.

After all the anchors are deployed, the tube is withdrawn from the subject. The implant 71 is then delivered over the wire as described above with reference to fig. 9. Next, after withdrawal of the pusher rod 73 (fig. 9), a corresponding locking element 80 (shown schematically in fig. 13 without structural details) is advanced over the wire to the implant. As described in detail below with reference to the subsequent figures, which show various embodiments of locking element 80, the locking element clamps the wire proximal to the implant, thereby locking the implant to the wire.

Locking piece

Each of the various locking members described below includes a locking body configured to be advanced over one of the wires to the implant, the locking body including at least one rotatable element. The locking body is configured to grip the wire proximally of the implant upon rotation of the rotatable element. Each lock further comprises a rotational retaining element configured to inhibit reversal of rotation of the rotatable element by engagement with the lock body, i.e. configured to retain the rotatable element in the position to which it is rotated and thereby maintain clamping of the wire.

For further details, reference is first made to fig. 14, fig. 14 being a schematic illustration of a locking element 80a according to some embodiments of the present invention. Reference is further made to fig. 15A-15B, which are schematic longitudinal cross-sectional views through locking element 80a, in accordance with various respective embodiments of the present invention.

Lock 80a includes a lock body 96, lock body 96 including a pin 100, alternatively referred to as a "wire" or a "rod," and a rotatable element 102, rotatable element 102 being rotatably coupled to pin 100 by a pin passing through rotatable element 102. (rotatable element 102, and each of the other rotatable elements described herein, may have any suitable shape.) typically, the locking body further comprises two support blocks 106, one on each side of element 102, support blocks 106 supporting the pin; in other words, typically a pin passes through element 102 from one support block 106 to the other. The rotatable element 102 is configured to lock the implant to the wire 58 by rotating toward another portion of the locking body 96 such that the rotatable element presses the wire against the other portion of the locking body.

For example, the locking body may include a non-rotating block 104, and the rotatable element may press the wire against the block 104 as the rotatable element is rotated toward the block. (the block 104, as well as each of the other blocks described herein, may have any suitable shape.) alternatively, instead of the block 104, the locking body may comprise another opposing rotatable element, and the pair of opposing rotatable elements may be configured to rotate toward each other, thereby clamping the wire therebetween.

The locking member 80a further includes a ring 98 configured to cause rotation of the rotatable element by engaging the rotatable element and inhibit reversal of the rotation. (as shown in fig. 14, the ring may be fitted over the rotatable element by fitting over the entire locking body.) in some embodiments, the block 104 is shaped to define one or more notches 108, and the ring 98 is shaped to define corresponding tabs 110 configured to fit into the notches 108. Advantageously, the engagement of the tab 110 into the notch inhibits the ring from sliding off the locking body.

In some embodiments, as shown in fig. 15A, the rotatable element and/or the block 104 includes a serrated surface 116, and the locking body is configured to grip a wire with the serrated surface 116. Alternatively or additionally, as shown in fig. 15B, the block 104 may be shaped to define a recess 114, the rotatable element 102 may be shaped to define a complementary protrusion 112, the protrusion 112 is configured to fit into the recess 114 upon rotation of the rotatable element, and the locking body may be configured to clamp the wire between the protrusion 112 and the recess 114. Advantageously, the curvature of the serrated surface and/or the portion of the wire pressed into the recess by the protrusions increases the friction generated by any sliding of the wire through the locking body, thereby inhibiting any such sliding.

Reference is now made to fig. 16A, which is a schematic illustration of a locking instrument 118a for locking the lock 80a to the implant, according to some embodiments of the present invention. With further reference to fig. 16B, fig. 16B is a schematic illustration of a longitudinal cross-section through a portion of the instrument 118a, according to some embodiments of the present invention.

The instrument 118a includes an outer longitudinal member 120, the outer longitudinal member 120 being configured to lock the lock 80a by pushing the ring 98 onto the rotatable element 102. Typically, the outer longitudinal element 120 comprises a distal tube 120d or any other suitably shaped structure, the distal tube 120d having an inner and/or outer diameter that is the same as the inner and/or outer diameter of the ring such that the distal surface of the tube 120d may contact the proximal surface of the ring. Typically, the outer longitudinal element also includes a narrower, more proximal tube 120p, the tube 120p being joined to a distal tube 120 d.

Typically, the instrument 118a also includes an inner longitudinal member 122, the inner longitudinal member 122 being configured to advance the locking body 96 over the wire as the wire passes through the inner longitudinal member 122 and the inner longitudinal member passes through the outer longitudinal member.

For further details, reference is now additionally made to fig. 17 and 18, fig. 17 being a schematic illustration of a locking body being advanced over a wire according to some embodiments of the invention, and fig. 18 being a schematic illustration of a ring being advanced onto the locking body according to some embodiments of the invention.

Typically, the loop and locking body are advanced together over the wire. For example, the ring may be partially loaded onto the locking body 96 such that the ring covers a proximal portion of the locking body at which the pin 100 is disposed without the distal portion of the rotatable element pushing against the wire. Subsequently, the outer longitudinal element and the inner longitudinal element can be advanced over the wire that passes between the rotatable element 102 and the block 104, such that both the ring and the locking body are advanced from outside the subject to the implant. (the outer longitudinal member may be urged into the locking body by urging the collar by virtue of the collar being partially loaded onto the locking body, and/or the inner longitudinal member may be urged into the collar by urging the locking body.) subsequently, in response to the lock contacting the implant, the outer longitudinal member may be used to urge the collar further onto the locking body while the implant provides a counter force to the locking body, thereby urging the rotatable member to rotate.

In some embodiments, the inner longitudinal element 122 is shaped to define an aperture 124 (or notch), and one of the tabs 110 is configured to fit into the aperture 124 as the locking body is advanced over the wire. Advantageously, the aperture 124 facilitates advancement of the collar and locking body together by inhibiting the collar from sliding off the locking body.

For example, the ring may be loaded onto the locking body such that the proximal tab 110p of the ring fits into the aperture 124 and the distal tab 110d of the ring fits into one of the notches 108, e.g., the proximal-most notch 108. Subsequently, a pushing force exerted by the outer longitudinal element on the ring may force the proximal tab 110p out of the aperture 124, and then push the ring onto the locking body until the proximal tab 110p snaps into one of the notches 108, e.g., the proximal-most notch 108.

Typically, in such embodiments, the inner longitudinal element comprises a distal tube 122d or any other suitably shaped structure, the distal tube 122d having the same outer diameter as the inner diameter of the ring 98 and being shaped to define a bore 124 such that the tabs 110p may fit into the bore. Typically, the inner longitudinal member also includes a narrower proximal tube 122p, the proximal tube 122p being joined to a distal tube 122 d.

Typically, the inner longitudinal member 122 includes a sharp distal edge 126, the edge 126 configured to cut the wire 58 after the ring is pushed onto the rotatable element 102. For example, after locking the lock, the instrument 118a may be withdrawn slightly from the lock. Subsequently, the inner longitudinal member can be pushed out of the outer longitudinal member such that the edge 126 cuts the wire-form. Subsequently, the instrument 118a and the proximal portion of the wire 58 can be removed from the subject.

Referring now to fig. 19, fig. 19 is a schematic view of another lock 80b according to some embodiments of the present invention.

Locking element 80b is similar in several respects to locking element 80a (fig. 14). For example, the locking member 80b also includes a locking body 96, the locking body 96 including at least one rotatable element. As a specific example, locking member 80b may include a block 103, a first rotatable element 102a disposed at one side of block 103, and a second rotatable element 102b disposed at an opposite side of block, a pin 100 passing through the block and the two rotatable elements. Further, similar to the locking element 80a, the locking element 80b comprises a ring 98, the ring 98 being configured to rotate the rotatable element(s) by fitting on the locking body.

However, the locking member 80b is also different from the locking member 80 a. For example, in the lock 80b, the lock body includes a shaft 130 disposed alongside at least one rotatable element (e.g., between the first and second rotatable elements 102a, 102b, opposite the block 103), and the ring 98 is configured to cause the rotatable element to rotate by fitting over the shaft 130 such that the ring pushes against the rotatable element(s). Furthermore, the locking body comprises a further pin 128. Further details regarding these features, as well as other features of the locking member 80b, will be described below with reference to subsequent figures.

Reference is now made to fig. 20A, which is a schematic illustration of a locking instrument 118b for locking the lock 80b to the implant, according to some embodiments of the present invention. Referring also to fig. 20B, fig. 20B is a schematic illustration of a longitudinal cross-section through a portion of the instrument 118B, according to some embodiments of the invention. (for clarity, rotatable element 102a is drawn transparently in FIG. 20B.)

The instrument 118b includes a hollow inner longitudinal member 132, the hollow inner longitudinal member 132 being configured to push the collar onto the shaft 130. For example, the inner longitudinal element 132 may include an inner tube 138 and a ring bias appendage 140, the ring bias appendage 140 shaped to define a side opening 142, the ring bias appendage 140 coupled to and extending beyond a distal end of the inner tube 138. In such an embodiment, the inner longitudinal element may push the ring onto the shaft while the ring pushing appendage 140 contacts the ring and the wire passes through the inner tube via the side opening 142. (in some embodiments, the loop pushing accessory comprises a loop having a plurality of distally projecting legs 144 with side openings 142 disposed between the legs 144.) alternatively, the inner tube 138 itself may be shaped to define the side openings 142 so that the inner tube can push the loop onto the shaft while the inner tube contacts the loop and the wire passes through the side openings.

The instrument 118b further includes a hollow outer longitudinal member 134, the hollow outer longitudinal member 134 being configured to advance the locking body over the wire 58 as the wire is passed through the inner longitudinal member (as described above) and the inner longitudinal member is passed through the outer longitudinal member 134. For example, the outer longitudinal element 134 may comprise an outer tube 136 contacting the locking body, such that the outer tube 136 directly pushes against the locking body. Optionally, in addition to the outer tube 136, the outer longitudinal element may include an appendage 146 (e.g., comprising another tube wider than the outer tube 136), the appendage 146 coupled to and extending from a distal end of the outer tube such that the outer longitudinal element pushes against the locking body by the appendage 146 contacting the locking body.

Typically, the outer longitudinal element 134 is configured to retain the locking body while advancing the locking body over the wire. For example, the appendage 146 (or the outer tube itself) may be shaped to define an aperture 148, the block 103 may be shaped to define a protrusion 150, and the outer longitudinal element may retain the locking body by the protrusion 150 passing through the aperture 148.

Referring now to fig. 21 and 22, fig. 21 is a schematic view of a locking body being advanced over a wire according to some embodiments of the present invention, and fig. 22 is a schematic view of a ring being advanced over the locking body according to some embodiments of the present invention. (FIGS. 21-22 show a longitudinal cross-section through instrument 118b and locking body 96, with rotatable element 102a not shown.)

Shaft 130 is shaped to define an angled channel 152, which angled channel 152 is angled away from block 103 at least along a proximal portion 156 thereof. The pins 128 coupled to the rotatable elements 102a and 102b pass through the grooves 152. As described above with reference to fig. 19, a pin 100 defining the axis of rotation of the rotatable element passes through the block 103 and both rotatable elements. Typically, the shaft 130 is shaped to define a bore 154 (or notch), and the tab 110 is configured to fit into the bore 154. In some embodiments, shaft 130 and/or block 103 includes serrated surface 116; alternatively or additionally, the shaft and the block may be shaped to define complementary protrusions and recesses.

Typically, the locking body and the ring 98 are advanced together over the wire 58. First, the ring 98 is partially loaded onto the shaft 130 such that the tabs 110 are proximal to the apertures 154. Subsequently, inner longitudinal member 132 and outer longitudinal member 134 push the locking member on wire 58, and wire 58 passes between block 103 and shaft 130 until the locking member contacts implant 71. (with the ring partially loaded on the shaft, the outer longitudinal element can advance the ring by pushing against the locking body, and/or the inner longitudinal element can advance the locking body by pushing against the ring.) when the lock is advanced to the implant, the rotatable elements are in their rest (non-rotated) position such that the pin 128 is disposed at or near the proximal end of the channel 152.

In response to the locking element contacting the implant, inner longitudinal member 132 serves to push collar 98 further onto the shaft while the implant provides a reactive force to push against. When this pushing is performed, the ring pushes against the rotatable element, causing the rotatable element to rotate. Since the movement of the pins 128 is constrained by the grooves 152 (and since the distance between the two pins is fixed), by rotating the rotatable element, the ring causes the block 103 to be pulled towards the shaft, so that the locking body clamps the wire between the block and the shaft. Furthermore, by pulling the block piece, the rotatable element may pull the protrusion 150 from the hole 148, such that the locking body is released from the outer longitudinal element.

When the tab 110 snaps into the aperture 154, the ring is locked onto the shaft, thereby maintaining the rotated position of the rotatable element and thus the grip of the wire. To further facilitate locking of the lock, the distal portion 158 of the groove may be angled toward the block such that proximal movement of the pin 128 through the groove is inhibited.

After locking the locking piece of the lock, the outer longitudinal member and the inner longitudinal member are withdrawn. Typically, the inner tube 138 or ring pushing accessory 140 includes a sharp edge 160, the edge 160 configured to cut the wire-like object after pushing the ring onto the shaft. Thus, the wire can be cut by pushing on the inner tube while pulling on the wire.

It should be noted that the above description of fig. 21-22 also applies to embodiments in which the locking body comprises a single rotatable element (represented by rotatable element 102b in fig. 21-22) instead of two rotatable elements.

Referring now to fig. 23, fig. 23 is a schematic view of another locking element 80c according to some embodiments of the present invention.

Similar to locking elements 80a and 80b, locking element 80c includes a locking body 96, and locking body 96 includes at least one rotatable element. Further, as in locks 80a and 80b, the locking body is configured to grip wire 58 at the proximal side of the implant as the rotatable element is rotated.

For example, the locking body may include a pair of opposing rotatable elements configured to grip a wire between respective proximal ends of the rotatable elements as the rotatable elements rotate. The pair of rotatable elements may include a first rotatable element 102a configured to rotate relative to the first pin 100a, and a second rotatable element 102b configured to rotate relative to the second pin 100 b. One or both rotatable elements may include a serrated surface 116 such that the rotatable element is configured to grip a wire with the serrated surface; alternatively or additionally, the pair of rotatable elements may be shaped to define complementary protrusions and recesses.

However, locking member 80c differs from locking members 80a and 80b at least in that in locking member 80c, the rotational retaining element comprises a spring 162, and spring 162 comprises a coil 164 coiled around the rotatable element. The coil 164 is configured to cause the rotatable elements to rotate by pushing the rotatable elements together and to inhibit any reversal of rotation. In some embodiments, to inhibit the coil from sliding off the rotatable element, at least one rotatable element is shaped to define a ridged surface 166, and the coil 164 passes between the ridges of the ridged surface. Further details regarding the locking of the locking member 80c will be described below with reference to subsequent figures.

Reference is now made to fig. 24, which is a schematic illustration of a locking instrument 118c for locking the lock 80c to the implant, according to some embodiments of the present invention. (A portion of the instrument 118c is shown in cross-section for clarity.) with further reference to FIGS. 25 and 26, FIG. 25 is a schematic illustration of a locking element being advanced over a wire according to some embodiments of the present invention, and FIG. 26 is a schematic illustration of locking of the locking element according to some embodiments of the present invention.

The instrument 118c includes a hollow outer longitudinal member 168 and a hollow inner longitudinal member 174, the hollow outer longitudinal member 168 may include a narrower proximal outer tube 170 joined to a wider distal outer tube 172. The inner longitudinal element 174 includes a distal end 180, the distal end 180 configured to be inserted between the respective proximal ends of the rotatable elements as the locking body is advanced to the implant. Due to this insertion, the wire can pass between the rotatable elements (and through the inner longitudinal element) without being gripped by the locking body. In some embodiments, to facilitate such insertion, the respective proximal ends of the rotatable elements are shaped to define respective notches 182, and the distal ends 180 are configured to fit into the notches 182.

In some embodiments, inner longitudinal member 174 includes an inner tube 176 and an appendage 178, such as a tubular appendage, the appendage 178 coupled to and extending from a distal end of tube 176, the appendage 178 including a distal end 180. Alternatively, the inner tube 176 itself may include the distal end 180.

To advance the locking body to the implant, the inner longitudinal member and/or the outer longitudinal member can be used to push against the locking body while the wire 58 passes through the inner longitudinal member and the inner longitudinal member passes through the outer longitudinal member. During advancement of the locking body, the coil is extended outwardly by the rotatable element by insertion of the distal end 180.

As shown in fig. 26, as the locking body is advanced, the distal end of the inner longitudinal member is withdrawn from between the pair of rotatable elements in response to the locking body contacting the implant while the outer longitudinal member applies a reaction force to the locking body. Withdrawal of the inner longitudinal member causes the coil to spring back inwardly from its extended state, thereby urging the pair of rotatable elements toward one another, causing the pair of rotatable elements to rotate toward one another and thereby clamping the wire therebetween.

After locking of the locking member, the instrument 118c is withdrawn. In some embodiments, the outer longitudinal element includes a sharpened distal edge 184, the distal edge 184 configured to cut the wire-like object upon rotation of the rotatable element.

In some embodiments, the locking body comprises a single rotatable element and opposing (non-rotatable) pieces. In such embodiments, the coil is wound around the rotatable element and the block such that the coil causes the wire to be clamped between the rotatable element and the block. The rotatable element and/or the block may comprise a serrated surface; alternatively or additionally, these elements may be shaped to define complementary protrusions and recesses.

Referring now to fig. 27, fig. 27 is a schematic view of another lock 80d according to some embodiments of the present invention.

Similar to the lock 80c, the lock 80d includes a spring 162, the spring 162 being configured to maintain the rotated position of the rotatable element 102. However, in the lock 80d, the rotatable element is shaped to define a bore 186, and the spring 162 includes a wire 188, the wire 188 being configured to spring into the bore 186 as the rotatable element rotates, thereby inhibiting any reversal of that rotation.

For example, in the locking member 80d, the locking body 96 may include a first panel 190a, a second panel 190b, and a block 192 disposed between the first panel 190a and the second panel 190 b. As shown in fig. 31-32, described below, the wire 188 may extend along the second panel 190b, through the rotatable element 102, through the first panel 190a, and finally through a recess 194 (or hole) in the first panel 190a such that the end of the wire reaches the rotatable element. When the rotatable element is rotated relative to the wire 188 (i.e., relative to the axis of rotation defined by the wire), the rotatable element presses the wire against the block 192 and the wire 188 springs into the bore 186.

For further details, reference is now made to fig. 28A and 28B, fig. 28A being a schematic illustration of a locking instrument 118d for locking a lock to an implant according to some embodiments of the present invention, and fig. 28B showing a longitudinal cross-section through a portion of the instrument 118d according to some embodiments of the present invention. (in fig. 28B, the first panel 190a is not shown such that the rotatable element 102 is exposed.) referring also to fig. 29 and 30, fig. 29 is a schematic illustration of a lock being advanced over the wire 58 according to some embodiments of the invention, and fig. 30 is a schematic illustration of a lock to a lock according to some embodiments of the invention. (the right portion of each of FIGS. 29-30 shows the locking body viewed from the side of the left portion of the figures, with block 192 hidden to expose rotatable element 102.)

The instrument 118d includes an outer longitudinal member 196, and the outer longitudinal member 196 includes, for example, an outer tube. The instrument 118d further includes an inner longitudinal member 198, the inner longitudinal member 198 comprising, for example, an inner tube. To advance the locking body to the implant, the outer longitudinal member 196 and/or the inner longitudinal member 198 can be used to push the locking body while the wire 58 passes through the inner longitudinal member and the inner longitudinal member passes through the outer longitudinal member.

Typically, the distal end of the inner longitudinal element is shaped to define a hole 202 (or recess), and the rotatable element 102 is shaped to define a protrusion 204, the protrusion 204 being configured to fit within the hole 202. As shown in fig. 29, when the locking body is advanced to the implant, the protrusion 204 is within the aperture 202 and the wire 58 extends between the rotatable element and the block 192 without being pinched by the locking body. Furthermore, during advancement of the locking body, the wire 188 is deformed from its rest state as the end 208 of the wire 188 is pushed away from the locking body by the rotatable element 102.

As shown in FIG. 30, in response to the locking body contacting the implant, the inner longitudinal member 198 is withdrawn from the locking body while the outer longitudinal member 196 applies a reactive force to the locking body. Withdrawal of the inner longitudinal member dislodges the protrusion 204 from the aperture 202 and rotates the rotatable member such that the surface 206 of the rotatable member presses the wire against the block 192. (surface 206 may be serrated, and/or surface 206 and block 192 may be shaped to define complementary protrusions and recesses.) rotation of the rotatable element also aligns the aperture 186 with the end 208 of the wire, causing the wire to spring into the aperture, locking the rotatable element in the position to which it is rotated.

Typically, inner longitudinal member 198 is shaped to define a side opening 200, and the inner longitudinal member is configured to advance the locking body to the implant as the wire is passed through the inner longitudinal member via the side opening. Typically, the outer longitudinal element is also shaped to define a side opening 210 such that a wire passes through the locking body, through the side opening 210, through the side opening 200, and through the inner longitudinal element. In some embodiments, the inner longitudinal element comprises a sharp edge 212 at least partially surrounding the side opening 200, and the sharp edge 212 is configured to cut a wire-like object upon withdrawal of the inner longitudinal element.

In some embodiments, where multiple locking elements are required for the implant, the locking elements are delivered to the implant and locked sequentially, e.g., each locking element is delivered and locked using the same locking instrument. In other embodiments, different respective locking instruments are used, simultaneously delivering and locking the locking members. For example, a plurality of locking elements 80a may be delivered and locked using different respective locking instruments 118 a. In such embodiments, a locking instrument may also be used to deliver the implant in place of pusher rod 73 (FIG. 9). That is, the implant can be loaded onto the wire, the lock can be loaded onto the wire proximal of the implant, and then the locking instrument can advance the implant and lock together to the implantation site.

It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not in the prior art.