Self-Suturing Anchors

• US 20120226294A1
• Filed: 03/01/2011
• Published: 09/06/2012
• Est. Priority Date: 03/01/2011
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Tuval, Yosi
• Granted Patent: US 8,454,656 B2
• Time in Patent Office: Days
• US Class Current: 606/148
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/0682 for applying U-shaped staples or clamps, e.g. without a forming anvil
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses

Abstract

Apparatus and methods are provided, including a plurality of anchoring elements, each of the anchoring elements being an elongate element that is curved to define an opening. A housing holds each of the anchoring elements. A mandrel is reversibly disposable through the openings defined by the anchoring elements. The anchoring elements are configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements. Other embodiments are also described.

Claims

1. Apparatus, comprising:

a plurality of anchoring elements, each of the anchoring elements being an elongate element that is curved to define an opening;

a housing configured to hold each of the anchoring elements; and

a mandrel that is reversibly disposable through the openings defined by the anchoring elements,

the anchoring elements being configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements.

2. The apparatus according to claim 1, wherein ends of the anchoring elements are sharp.

3. The apparatus according to claim 1, wherein each of the anchoring elements is configured to automatically become anchored to tissue of a subject, by entering the tissue via an entry route, in response to removal of the mandrel from the opening defined by the anchoring element.

4. The apparatus according to claim 3, wherein each of the anchoring elements is configured to automatically exit the tissue via an exit route that is a reverse of the entry route, in response to reinsertion of the mandrel through the opening.

5. The apparatus according to claim 1, wherein the anchoring elements are configured to couple the housing to the tissue by becoming anchored to the tissue.

6. The apparatus according to claim 5, wherein the housing comprises flexible portions thereof, the flexible portions being disposed between adjacent anchoring elements of the anchoring elements.

7. The apparatus according to claim 1, wherein the anchoring elements comprise a P1-anchor, a P2-anchor, and a P3-anchor configured to become coupled to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve.

8. The apparatus according to claim 7, further comprising a tether configured to pass through the anchors.

9. The apparatus according to claim 8, wherein the tether is fixedly coupled to the P2-anchor and is slidably coupled to the P1-anchor and the P3-anchor.

10. The apparatus according to claim 8, further comprising a cardiac-site anchor configured to anchor ends of the tether to a cardiac site of a heart of a subject.

11. Apparatus, comprising:

a plurality of anchoring elements;

a mandrel that is reversibly disposable through the anchoring elements,

each of the anchoring elements being configured to;

automatically become anchored to tissue of a subject, by entering the tissue via an entry route, in response to removal of the mandrel from the anchoring element; and

subsequently, automatically exit the tissue via an exit route that is a reverse of the entry route, in response to reinsertion of the mandrel through the anchoring element.

12. The apparatus according to claim 11, wherein ends of the anchoring elements are sharp.

13. The apparatus according to claim 11, wherein each of the anchoring elements comprises an elongate element that is curved to define an opening, wherein the mandrel is reversibly disposable through the openings, and wherein ends of respective anchoring elements are configured to automatically become anchored to the respective locations of the tissue by moving outwardly, in response to removal of the mandrel from the openings.

14. The apparatus according to claim 13, wherein the anchoring elements are configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements.

15. The apparatus according to claim 11, wherein the anchoring elements are disposed in a housing, and wherein the anchoring elements are configured to couple the housing to the tissue by becoming anchored to the tissue.

16. The apparatus according to claim 15, wherein the housing comprises flexible portions thereof, the flexible portions being disposed between adjacent anchoring elements of the anchoring elements.

17. The apparatus according to claim 11, wherein the anchoring elements comprise a P1-anchor, a P2-anchor, and a P3-anchor configured to become coupled to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve.

18. The apparatus according to claim 17, further comprising a tether configured to pass through the anchors.

19. The apparatus according to claim 18, wherein the tether is fixedly coupled to the P2-anchor and is slidably coupled to the P1-anchor and the P3-anchor.

20. The apparatus according to claim 18, further comprising a cardiac-site anchor configured to anchor ends of the tether to a cardiac site of a heart of a subject.

21. A method, comprising:

inserting a plurality of anchoring elements into tissue of a subject by removing a mandrel from the anchoring elements, each of the anchoring elements being configured to enter the tissue via an entry route; and

subsequently, causing each of the anchoring elements to automatically exit the tissue via an exit route in response to reinsertion of the mandrel through the anchoring elements, the exit route of each anchoring element being a reverse of the entry route of the anchoring element.

22. The method according to claim 21, wherein the anchoring elements include anchoring elements that are elongate elements that are curved to define openings, and wherein inserting the plurality of anchoring elements into the tissue comprises causing ends of the anchoring elements to automatically become anchored to respective locations of the tissue by moving outwardly, by removing the mandrel from the openings.

23. The method according to claim 21, wherein the tissue includes prosthetic tissue, and wherein inserting the anchors into the tissue comprises inserting the anchors into the prosthetic tissue.

24. The method according to claim 21, wherein the tissue includes natural tissue, and wherein inserting the anchors into the tissue comprises inserting the anchors into the natural tissue.

25. The method according to claim 24, wherein the tissue includes tissue at a site selected from the group consisting of a site of a gastrointestinal tract of the subject and a cardiac site of the subject, and wherein inserting the anchors into the tissue comprises inserting the anchors into the tissue at the selected site.

26. The method according to claim 21, wherein inserting the plurality of anchoring elements into the tissue comprises anchoring a P1-anchor, a P2-anchor, and a P3-anchor, to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve.

27. The method according to claim 26, further comprising pulling a tether that passes through the anchors, and anchoring the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet.

28. The method according to claim 27, wherein anchoring the anchor to the anchoring location comprises anchoring the anchor to an inner surface of the heart at a vicinity of an apex of the heart.

29. The method according to claim 27, wherein anchoring the anchor to the anchoring location comprises anchoring the anchor to an outer surface of the heart at a vicinity of an apex of the heart.

30. The method according to claim 27, wherein anchoring the P1-anchor, the P2-anchor, and the P3-anchor comprises inserting the anchors into a left atrium of the subject, and anchoring the anchors to a left atrial side of the posterior leaflet of the mitral valve.

31. The method according to claim 27, wherein anchoring the P1-anchor, the P2-anchor, and the P3-anchor comprises inserting the anchors into a left ventricle of the subject and inserting the anchors into a left ventricular side of the posterior leaflet of the mitral valve, such that the anchors penetrate tissue of the posterior leaflet.

32. The method according to claim 27, wherein anchoring the tether to the anchoring location comprises decreasing a ratio of an anteroposterior diameter of a mitral annulus of the subject to a lateral diameter of the mitral annulus.

33. The method according to claim 27, wherein anchoring the tether to the anchoring location comprises restoring a saddle-shape of a mitral annulus of the subject.

34. The method according to claim 27, wherein anchoring the tether to the anchoring location comprises decreasing a circumference of a mitral annulus of the subject.

35. The method according to claim 27, wherein anchoring the tether to the anchoring location comprises reshaping a left ventricle of the subject.

36. The method according to claim 27, wherein anchoring the P1-anchor, the P2-anchor, and the P3-anchor comprises anchoring the anchors to the tissue, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1 and P3 anchors.

37. Apparatus for use with tissue of a subject, comprising:

a plurality of anchoring elements configured to become anchored to respective locations of the tissue, each of the anchoring elements being an elongate element that is curved to define an opening;

a housing configured to hold each of the anchoring elements, during anchoring of the anchoring elements to the tissue; and

a mandrel that is disposed through the openings defined by the anchoring elements,

ends of the anchoring elements being configured to automatically become anchored to the respective locations of the tissue by moving outwardly, in response to removal of the mandrel from the openings.

38. The apparatus according to claim 37, wherein ends of the anchoring elements are sharp.

39. The apparatus according to claim 37, wherein the anchoring elements are configured such that, in response to removal of the mandrel from the openings, ends of the anchoring elements automatically move outwardly, and diameters of the openings decrease, due to elastic loading of the anchoring elements.

40. The apparatus according to claim 37, wherein each of the anchoring elements is configured to automatically become anchored to tissue of a subject, by entering the tissue via an entry route, in response to removal of the mandrel from the opening defined by the anchoring element.

41. The apparatus according to claim 40, wherein each of the anchoring elements is configured to automatically exit the tissue via an exit route that is a reverse of the entry route, in response to reinsertion of the mandrel through the opening.

42. The apparatus according to claim 37, wherein the anchoring elements are configured to couple the housing to the tissue by becoming anchored to the tissue.

43. The apparatus according to claim 42, wherein the housing comprises flexible portions thereof, the flexible portions being disposed between adjacent anchoring elements of the anchoring elements.

44. The apparatus according to claim 37, wherein the anchoring elements comprise a P1-anchor, a P2-anchor, and a P3-anchor configured to become coupled to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve.

45. The apparatus according to claim 44, further comprising a tether configured to pass through the anchors.

46. The apparatus according to claim 45, wherein the tether is fixedly coupled to the P2-anchor and is slidably coupled to the P1-anchor and the P3-anchor.

47. The apparatus according to claim 45, further comprising a cardiac-site anchor configured to anchor ends of the tether to a cardiac site of a heart of a subject.

48. A method for use with tissue of a subject, comprising:

providing a plurality of anchoring elements, each of the anchoring elements being an elongate element that is curved to define an opening, and a mandrel that is disposed through the openings defined by the anchoring elements; and

causing ends of the anchoring elements to automatically become anchored to respective locations of the tissue by moving outwardly, by removing the mandrel from the openings.

49. The method according to claim 48, wherein causing the ends of the anchoring elements to automatically become anchored to respective locations of the tissue comprises causing each of the anchoring elements to enter tissue via an entry route, the method further comprising, subsequently, causing each of the anchoring elements to automatically exit the tissue via an exit route in response to reinsertion of the mandrel through the anchoring elements, the exit route of each anchoring element being a reverse of the entry route of the anchoring element.

50. The method according to claim 48, wherein the tissue includes prosthetic tissue, and wherein inserting the anchors into the tissue comprises inserting the anchors into the prosthetic tissue.

51. The method according to claim 48, wherein the tissue includes natural tissue, and wherein inserting the anchors into the tissue comprises inserting the anchors into the natural tissue.

52. The method according to claim 51, wherein the tissue includes tissue at a site selected from the group consisting of a site of a gastrointestinal tract of the subject and a cardiac site of the subject, and wherein inserting the anchors into the tissue comprises inserting the anchors into the tissue at the selected site.

53. The method according to claim 48, wherein inserting the plurality of anchoring elements into the tissue comprises anchoring a P1-anchor, a P2-anchor, and a P3-anchor, to tissue in a vicinity of, respectively, P1, P2 and P3 segments of a posterior leaflet of the mitral valve.

54. The method according to claim 53, further comprising pulling a tether that passes through the anchors, and anchoring the tether to an anchoring location that is at a cardiac site that is anterior and inferior to the posterior leaflet.

55. The method according to claim 54, wherein anchoring the anchor to the anchoring location comprises anchoring the anchor to an inner surface of the heart at a vicinity of an apex of the heart.

56. The method according to claim 54, wherein anchoring the anchor to the anchoring location comprises anchoring the anchor to an outer surface of the heart at a vicinity of an apex of the heart.

57. The method according to claim 54, wherein anchoring the P1-anchor, the P2-anchor, and the P3-anchor comprises inserting the anchors into a left atrium of the subject, and anchoring the anchors to a left atrial side of the posterior leaflet of the mitral valve.

58. The method according to claim 54, wherein anchoring the P1-anchor, the P2-anchor, and the P3-anchor comprises inserting the anchors into a left ventricle of the subject and inserting the anchors into a left ventricular side of the posterior leaflet of the mitral valve, such that the anchors penetrate tissue of the posterior leaflet.

59. The method according to claim 54, wherein anchoring the tether to the anchoring location comprises decreasing a ratio of an anteroposterior diameter of a mitral annulus of the subject to a lateral diameter of the mitral annulus.

60. The method according to claim 54, wherein anchoring the tether to the anchoring location comprises restoring a saddle-shape of a mitral annulus of the subject.

61. The method according to claim 54, wherein anchoring the tether to the anchoring location comprises decreasing a circumference of a mitral annulus of the subject.

62. The method according to claim 54, wherein anchoring the tether to the anchoring location comprises reshaping a left ventricle of the subject.

63. The method according to claim 54, wherein anchoring the P1-anchor, the P2-anchor, and the P3-anchor comprises anchoring the anchors to the tissue, a tether being fixedly coupled to the P2-anchor, and slidably coupled to the P1 and P3 anchors.