Annuloplasty ring with intra-ring anchoring

• US 8,715,342 B2
• Filed: 05/07/2009
• Issued: 05/06/2014
• Est. Priority Date: 05/07/2009
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Zipory, Yuval, Cabiri, Oz, Gross, Yossi
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US12/437,103
• Publication Number:
  US 20100286767A1
• Time in Patent Office: 1,825 Days
• Field of Search: 623/2.11, 623 236- 241
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Apparatus is provided that includes an annuloplasty system for use on a subject. The system includes an annuloplasty ring, which includes a sleeve having a lumen, and at least one anchor, shaped so as to define a coupling head and a tissue coupling element, which tissue coupling element is shaped so as to define a longitudinal axis, and is configured to penetrate cardiac tissue of the subject in a direction parallel to the longitudinal axis. The system further includes an anchor deployment manipulator, configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the tissue coupling element from a distal end of the deployment manipulator through a wall of the sleeve into the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to a central longitudinal axis through the distal end of the deployment manipulator.

Claims

1. Apparatus comprising an annuloplasty system for use on a subject, which comprises:

an annuloplasty ring, which comprises a sleeve having a wall defining a lumen that extends longitudinally along a length of the sleeve;

a contracting mechanism, coupled to the sleeve;

a contracting member that extends along at least a portion of the sleeve and is coupled at respective locations along the contracting member to (a) the contracting mechanism and (b) a portion of the sleeve, wherein the contracting mechanism is configured to contract the annuloplasty ring by pulling on the portion of the sleeve;

at least one anchor, shaped so as to define a tissue coupling element, which tissue coupling element is shaped so as to define a longitudinal axis, and is configured to penetrate cardiac tissue of the subject in a direction parallel to the longitudinal axis; and

an anchor deployment manipulator, configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the tissue coupling element from a distal end of the deployment manipulator by rotating the tissue coupling element in order to penetrate the tissue coupling element through the wall of the sleeve into the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to a central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator.

2. The apparatus according to claim 1, wherein the annuloplasty ring has first and second longitudinally-opposed ends, and wherein the lumen extends longitudinally between the first and second ends.

3. The apparatus according to claim 2, wherein the annuloplasty ring comprises a partial annuloplasty ring.

4. The apparatus according to claim 2, wherein one of the first and the second ends of the annuloplasty ring is closed.

5. The apparatus according to claim 2, wherein a proximal end of the sleeve has a natural tendency to close when not held open by the anchor deployment manipulator.

6. The apparatus according to claim 1, wherein the coupling element is shaped so as to define a shape selected from the group consisting of:

a helix, a spiral, and a screw shaft.

7. The apparatus according to claim 1, wherein the contracting mechanism comprises a spool, wherein the contracting member has a portion wound around the spool, and wherein the spool is arranged such that rotation of the spool contracts the annuloplasty ring by winding the contracting member around the spool.

8. The apparatus according to claim 1, wherein the deployment manipulator comprises steering functionality.

9. The apparatus according to claim 1,

wherein the apparatus further comprises a steerable tube, which is configured to provide steering functionality,

wherein the deployment manipulator further comprises (a) an outer tube and (b) an anchor driver, which is at least partially positioned within the outer tube and comprises an elongated, flexible shaft, and

wherein the outer tube is at least partially positioned within the steerable tube, such that a portion of the sleeve is radially between the outer tube and the steerable tube.

10. The apparatus according to claim 9, wherein the apparatus further comprises a sheath, through which the steerable tube, the sleeve, and the deployment manipulator are advanceable.

11. The apparatus according to claim 1, wherein the deployment manipulator is configured to deploy the at least one anchor from the distal end of the deployment manipulator through the wall of the sleeve into the cardiac tissue, while the distal end of the deployment manipulator is positioned such that the central longitudinal axis through the distal end of the deployment manipulator forms an angle of between 45 and 90 degrees with the wall of the sleeve at a point at which the anchor penetrates the wall.

12. The apparatus according to claim 11,

wherein the point on the wall is a first point on the wall, and the angle is a first angle,

wherein the at least one anchor is a first anchor of a plurality of anchors that also includes a second anchor most recently deployed before the first anchor through a second point on the wall, and

wherein the deployment manipulator is configured to deploy the first anchor while the distal end of the deployment manipulator is positioned such that the central longitudinal axis forms a second angle of between 45 and 90 degrees with a line defined by the first point and the second point.

13. The apparatus according to claim 1, further comprising a pusher element which is positioned within the sleeve, and which is configured to, upon being pushed distally, move the distal end of the deployment manipulator proximally within the sleeve by engaging an interior surface of the sleeve.

14. The apparatus according to claim 1, wherein the at least one anchor comprises at least first and second anchors, the first and the second anchors being shaped so as to define respective tissue coupling elements, which tissue coupling elements are shaped so as to define respective longitudinal axes, and are configured to penetrate cardiac tissue of the subject in directions parallel to the respective longitudinal axes, and wherein the deployment manipulator is configured to:

deploy, from within the lumen, the tissue coupling element of the first anchor from the distal end of the deployment manipulator through a first portion of the wall of the sleeve defining the lumen, by penetrating the tissue coupling element of the first anchor through the first portion of the wall of the sleeve, into a first portion of the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to the central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator, and

subsequently to deploying the tissue coupling element of the first anchor, deploy, from within the lumen, the tissue coupling element of the second anchor from the distal end of the deployment manipulator through a second portion of the wall of the sleeve defining the lumen, by penetrating the tissue coupling element of the second anchor through the second portion of the wall of the sleeve, into a second portion of the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to the central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator.

15. The apparatus according to claim 1, wherein the deployment manipulator is configured to be removably positioned within the lumen of the sleeve longitudinally along the length of the sleeve, and, while so positioned, to deploy the tissue coupling element from the distal end of the deployment manipulator.

16. The apparatus according to claim 1, wherein the at least one anchor is shaped so as to define a coupling head and the tissue coupling element.

17. The apparatus according to claim 1, wherein the anchor deployment manipulator comprises an outer tube that is sized to fit snugly within the lumen of the sleeve.

27. The apparatus according to claim 10,

wherein the apparatus further comprises a steerable tube, which is configured to provide steering functionality,

wherein the deployment manipulator further comprises (a) an outer tube and (b) an anchor driver, which is at least partially positioned within the outer tube and comprises an elongated, flexible shaft, and

wherein the outer tube is at least partially positioned within the steerable tube, such that a portion of the sleeve is radially between the outer tube and the steerable tube.

28. The apparatus according to claim 27, wherein the apparatus further comprises a sheath, through which the steerable tube, the sleeve, and the deployment manipulator are advanceable.

18. A method comprising:

positioning an anchor deployment manipulator at least partially within a lumen of a sleeve of an annuloplasty ring, the sleeve having a wall shaped to define the lumen, and the lumen extending longitudinally along a length of the sleeve, wherein the annuloplasty ring includes a contracting mechanism, coupled to the sleeve, and a contracting member that extends along at least a portion of the sleeve and is coupled at a respective locations along the contracting member to (a) the contracting mechanism and (b) a portion of the sleeve;

placing, into an atrium of a subject in a vicinity of an annulus of an atrioventricular valve, at least a portion of the sleeve that contains a distal end of the deployment manipulator; and

deploying at least one anchor from the distal end of the deployment manipulator, by rotating a tissue coupling element of the anchor in order to penetrate the tissue coupling element through the wall of the sleeve such that the tissue coupling element of the anchor enters cardiac tissue of the subject in a direction parallel to a central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator,

wherein the tissue coupling element is shaped so as to define a longitudinal axis, and wherein deploying the at least one anchor comprises deploying the at least one anchor from the distal end of the deployment manipulator through the wall of the sleeve, by penetrating the tissue coupling element through the wall of the sleeve, such that the tissue coupling element of the anchor enters cardiac tissue of the subject in a direction parallel to the longitudinal axis of the tissue coupling element, and

further comprising contracting the annuloplasty ring by actuating the contracting mechanism to pull on the portion of the sleeve.

19. The method according to claim 18, wherein deploying comprises deploying the at least one anchor from the distal end of the deployment manipulator through the wall of the sleeve into the cardiac tissue, while the distal end of the deployment manipulator is positioned such that the central longitudinal axis through the distal end of the deployment manipulator forms an angle of between 45 and 90 degrees with the wall of the sleeve at a point at which the anchor penetrates the wall.

20. The method according to claim 19,

wherein the point on the wall is a first point on the wall, and the angle is a first angle,

wherein the at least one anchor is a first anchor of a plurality of anchors that also includes a second anchor most recently deployed before the first anchor through a second point on the wall, and

wherein deploying the first anchor comprises deploying the first anchor while the distal end of the deployment manipulator is positioned such that the central longitudinal axis forms a second angle of between 45 and 90 degrees with a line defined by the first point and the second point.

21. The method according to claim 18, wherein the annuloplasty ring has first and second ends, wherein the lumen extends longitudinally between the first and second ends, wherein positioning the deployment manipulator comprises positioning the deployment manipulator within the lumen of the partial annuloplasty ring, and wherein the method further comprises advancing the deployment manipulator within the lumen between the first and second ends.

22. The method according to claim 18, wherein the deployment manipulator comprises steering functionality, and wherein placing the sleeve comprises steering the deployment manipulator using the steering functionality.

23. The method according to claim 18, wherein deploying the anchor comprises deploying the anchor from the atrium into an upper region of a ventricular wall near the atrium.

24. The method according to claim 18, further comprising:

positioning a pusher element at least partially within the lumen of the sleeve of the annuloplasty ring; and

moving the distal end of the deployment manipulator proximally within the sleeve by pushing the pusher element distally such that the pusher element engages an interior surface of the sleeve.

25. The method according to claim 18, wherein the contracting mechanism includes a spool, and wherein contracting the annuloplasty ring comprises contracting the annuloplasty ring by winding the contracting member around the spool.

26. The method according to claim 18, wherein:

deploying the at least one anchor comprises deploying a first anchor through a first portion of the wall of the sleeve by penetrating a tissue coupling element of the first anchor through the first portion of the wall of the sleeve from within the lumen, such that the tissue coupling element of the first anchor enters a first portion of cardiac tissue, and

the method further comprises, subsequently to deploying the first anchor through the first portion of the wall of the sleeve, deploying a second anchor from the distal end of the deployment manipulator through a second portion of the wall of the sleeve, by penetrating a tissue coupling element of the second anchor through the second portion of the wall of the sleeve from within the lumen, such that the tissue coupling element of the second anchor enters a second portion of cardiac tissue of the subject in the direction parallel to the central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator.

29. The method according to claim 18,

wherein placing the at least a portion of the sleeve in the vicinity of the annulus comprises steering the deployment manipulator using a steerable tube, which is configured to provide steering functionality,

wherein deploying the at least one anchor comprises deploying the at least one anchor using an anchor driver of the deployment manipulator, which anchor driver includes an elongated, flexible shaft which is at least partially positioned within an outer tube of the deployment manipulator, and

wherein the outer tube is at least partially positioned within the steerable tube, such that a portion of the sleeve is radially between the outer tube and the steerable tube.

30. The method according to claim 29, wherein placing the at least a portion of the sleeve comprises advancing the steerable tube, the sleeve, and the deployment manipulator through a sheath into the atrium.

31. Apparatus comprising an annuloplasty system for use on a subject, which comprises:

an annuloplasty ring, which comprises a sleeve having a wall defining a lumen that extends longitudinally along a length of the sleeve;

a contracting mechanism, coupled to the sleeve;

a contracting member that extends along at least a portion of the sleeve and is coupled at respective locations along the contracting member to (a) the contracting mechanism and (b) a portion of the sleeve, wherein the contracting mechanism is configured to contract the annuloplasty ring by pulling on the portion of the sleeve;

at least one anchor; and

an anchor deployment manipulator configured to be removably positioned within the lumen of the sleeve, and, while so positioned, to deploy the at least one anchor from a distal end of the deployment manipulator by rotating a tissue coupling element of the anchor in order to penetrate the tissue coupling element through the wall of the sleeve into cardiac tissue of the subject, while the distal end of the deployment manipulator is positioned such that a central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator forms an angle of between 45 and 90 degrees with the wall of the sleeve at a point at which the anchor penetrates the wall.

32. The apparatus according to claim 31, wherein the annuloplasty ring has first and second longitudinally-opposed ends, and wherein the lumen extends longitudinally between the first and second ends.

33. The apparatus according to claim 32, wherein the annuloplasty ring comprises a partial annuloplasty ring.

34. The apparatus according to claim 32, wherein one of the first and the second ends of the annuloplasty ring is closed.

35. The apparatus according to claim 32, wherein a proximal end of the sleeve has a natural tendency to close when not held open by the anchor deployment manipulator.

36. The apparatus according to claim 31, wherein the deployment manipulator comprises steering functionality.

37. The apparatus according to claim 31,

wherein the point on the wall is a first point on the wall, and the angle is a first angle,

wherein the at least one anchor is a first anchor of a plurality of anchors that also includes a second anchor most recently deployed before the first anchor through a second point on the wall, and

wherein the anchor deployment manipulator is configured to deploy the first anchor while the distal end of the deployment manipulator is positioned such that the central longitudinal axis forms a second angle of between 45 and 90 degrees with a line defined by the first point and the second point.

38. The apparatus according to claim 31, wherein the anchor is shaped so as to define a tissue coupling element, which tissue coupling element is shaped so as to define a longitudinal axis, and is configured to penetrate cardiac tissue of the subject in a direction parallel to the longitudinal axis, and wherein the anchor deployment manipulator is configured to deploy the anchor from the distal end of the deployment manipulator such that the coupling element enters the cardiac tissue in a direction parallel to the central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator.

39. The apparatus according to claim 38, wherein the at least one anchor is shaped so as to define a coupling head and the tissue coupling element.

40. The apparatus according to claim 31, wherein the anchor is shaped so as to define a tissue coupling element, which is shaped so as to define a shape selected from the group consisting of:

a helix, a spiral, and a screw shaft.

41. The apparatus according to claim 31, wherein the at least one anchor comprises at least first and second anchors, the first and the second anchors being shaped so as to define respective tissue coupling elements, which tissue coupling elements are shaped so as to define respective longitudinal axes, and are configured to penetrate cardiac tissue of the subject in directions parallel to the respective longitudinal axes, and wherein the deployment manipulator is configured to:

deploy, from within the lumen, the tissue coupling element of the first anchor from the distal end of the deployment manipulator through a first portion of the wall of the sleeve defining the lumen, by penetrating the tissue coupling element of the first anchor through the first portion of the wall of the sleeve, into a first portion of the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to the central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator, and

subsequently to deploying the tissue coupling element of the first anchor, deploy, from within the lumen, the tissue coupling element of the second anchor from the distal end of the deployment manipulator through a second portion of the wall of the sleeve defining the lumen, by penetrating the tissue coupling element of the second anchor through the second portion of the wall of the sleeve, into a second portion of the cardiac tissue in the direction parallel to the longitudinal axis of the tissue coupling element and parallel to the central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator.

42. The apparatus according to claim 31, wherein the deployment manipulator is configured to be removably positioned within the lumen of the sleeve longitudinally along the length of the sleeve, and, while so positioned, to deploy the tissue coupling element from the distal end of the deployment manipulator.

43. The apparatus according to claim 31, wherein the contracting mechanism comprises a spool, wherein the contracting member has a portion wound around the spool, and wherein the spool is arranged such that rotation of the spool contracts the annuloplasty ring by winding the contracting member around the spool.

44. The apparatus according to claim 31, wherein the anchor deployment manipulator comprises an outer tube that is sized to fit snugly within the lumen of the sleeve.

45. A method comprising:

positioning an anchor deployment manipulator at least partially within a lumen of a sleeve of an annuloplasty ring, the sleeve having a wall shaped to define the lumen, and the lumen extending longitudinally along a length of the sleeve, wherein the annuloplasty ring includes a contracting mechanism, coupled to the sleeve, and a contracting member that extends along at least a portion of the sleeve and is coupled at a respective locations along the contracting member to (a) the contracting mechanism and (b) a portion of the sleeve;

placing, into an atrium of a subject in a vicinity of an annulus of an atrioventricular valve, at least a portion of the sleeve that contains a distal end of the deployment manipulator;

deploying at least one anchor from the distal end of the deployment manipulator, by rotating a tissue coupling element of the anchor in order to penetrate the tissue coupling element through the wall of the sleeve into cardiac tissue of the subject, while the distal end of the deployment manipulator is positioned such that a central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator forms an angle of between 45 and 90 degrees with the wall of the sleeve at a point at which the anchor penetrates the wall; and

contracting the annuloplasty ring by actuating the contracting mechanism to pull on the portion of the sleeve.

46. The method according to claim 45, wherein deploying comprises deploying the at least one anchor while the angle is between 75 and 90 degrees.

47. The method according to claim 45, wherein the deployment manipulator includes steering functionality, and wherein placing the sleeve comprises steering the deployment manipulator using the steering functionality.

48. The method according to claim 45, wherein the annuloplasty ring has first and second ends, wherein the lumen extends longitudinally between the first and second ends, wherein positioning the anchor deployment manipulator comprises positioning the anchor deployment manipulator at least partially within the lumen of the partial annuloplasty ring, and wherein the method further comprises advancing the deployment manipulator within the lumen between the first and second ends.

49. The method according to claim 45,

wherein the point on the wall is a first point on the wall, and the angle is a first angle,

wherein the at least one anchor is a first anchor of a plurality of anchors that also includes a second anchor most recently deployed before the first anchor through a second point on the wall, and

wherein deploying the first anchor comprises deploying the first anchor while the distal end of the deployment manipulator is positioned such that the central longitudinal axis forms a second angle of between 45 and 90 degrees with a line defined by the first point and the second point.

50. The method according to claim 45, wherein deploying the anchor comprises deploying the anchor from the distal end of the deployment manipulator such that a coupling element of the anchor enters the cardiac tissue in a direction parallel to the central longitudinal axis.

51. The method according to claim 45, wherein the anchor is shaped so as to define a tissue coupling element, which is shaped so as to define a shape selected from the group consisting of:

a helix, a spiral, and a screw shaft, and wherein deploying the anchor comprises screwing the tissue coupling element into the cardiac tissue.

52. The method according to claim 45, wherein the contracting mechanism includes a spool, and wherein contracting the annuloplasty ring comprises contracting the annuloplasty ring by winding the contracting member around the spool.

53. The method according to claim 45, wherein deploying the anchor comprises deploying the anchor from the atrium into an upper region of a ventricular wall near the atrium.

54. The method according to claim 45,

wherein the deployment manipulator includes an anchor driver positioned within a sheath,

wherein the at least one anchor comprises a plurality of anchors, and

wherein deploying the at least one anchor comprises:

loading a first one of the anchors onto the anchor driver;

deploying the first one of the anchors through a wall of the sleeve and into the cardiac tissue;

withdrawing the anchor driver from the sheath and a body of the subject, while leaving the sheath lumen of the sleeve;

subsequently loading a second one of the anchors onto the anchor driver while the anchor driver is outside the body;

subsequently reintroducing the anchor driver into the body and the sheath; and

subsequently deploying the second one of the anchors through the wall of the sleeve into the cardiac tissue.

55. The method according to claim 45, wherein placing the at least a portion of the sleeve comprises placing the at least a portion of the sleeve into a right atrium of the subject in a vicinity of a tricuspid valve.

56. The method according to claim 45, wherein placing the at least a portion of the sleeve comprises placing the at least a portion of the sleeve into a left atrium of the subject in a vicinity of the annulus of a mitral valve.

57. The method according to claim 45, wherein:

deploying the at least one anchor comprises deploying a first anchor through a first portion of the wall of the sleeve by penetrating a tissue coupling element of the first anchor through the first portion of the wall of the sleeve from within the lumen, such that the tissue coupling element of the first anchor enters a first portion of cardiac tissue, and

the method further comprises, subsequently to deploying the first anchor through the first portion of the wall of the sleeve, deploying a second anchor from the distal end of the deployment manipulator through a second portion of the wall of the sleeve, by penetrating a tissue coupling element of the second anchor through the second portion of the wall of the sleeve from within the lumen, such that the tissue coupling element of the second anchor enters a second portion of cardiac tissue of the subject in the direction parallel to the central longitudinal axis of the deployment manipulator through the distal end of the deployment manipulator.

58. The method according to claim 45,

wherein placing the at least a portion of the sleeve in the vicinity of the annulus comprises steering the deployment manipulator using a steerable tube, which is configured to provide steering functionality,

wherein deploying the at least one anchor comprises deploying the at least one anchor using an anchor driver of the deployment manipulator, which anchor driver includes an elongated, flexible shaft which is at least partially positioned within an outer tube of the deployment manipulator, and

wherein the outer tube is at least partially positioned within the steerable tube, such that a portion of the sleeve is radially between the outer tube and the steerable tube.

59. The method according to claim 58, wherein placing the at least a portion of the sleeve comprises advancing the steerable tube, the sleeve, and the deployment manipulator through a sheath into the atrium.