IMPLANTATION OF FLEXIBLE IMPLANT

• US 20150182336A1
• Filed: 12/26/2013
• Published: 07/02/2015
• Est. Priority Date: 12/26/2013
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: ZIPORY, Yuval, HAMMER, Tal
• Granted Patent: US 9,610,162 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/309 using white LEDs
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• 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 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A method is provided, including introducing into a heart atrium, an annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall. A first tissue anchor is deployed through the surface of the end wall of the sleeve and into a first portion of annulus tissue. A second tissue anchor is deployed through a portion of the tubular side wall and into a second portion of annulus tissue, such that the first tissue anchor and the second tissue anchor are both deployed consecutively, to extend in a substantially same direction and into a common, substantially planar surface of a valve annulus, the common, substantially planar surface including the first and second portions of the annulus tissue. Other applications are also described.

Claims

1. A method of deploying an annuloplasty structure, the method comprising:

introducing into a heart atrium, the annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall;

deploying a first tissue anchor through the surface of the end wall of the sleeve and into a first portion of annulus tissue; and

deploying a second tissue anchor through a portion of the tubular side wall and into a second portion of annulus tissue, such that the first tissue anchor and the second tissue anchor are both deployed consecutively, to extend in a substantially same direction and into a common, substantially planar surface of a valve annulus, the common, substantially planar surface including the first and second portions of the annulus tissue.

4. The method according to claim 1, wherein deploying the second tissue anchor through the tubular wall comprises deploying the second tissue anchor substantially parallel with respect to the first tissue anchor.

5. The method according to claim 1, wherein deploying the second tissue anchor through the tubular wall comprises deploying the second tissue anchor between 0 and 45 degrees with respect to the first tissue anchor.

6. The method according to claim 1, wherein deploying the second tissue anchor through the tubular wall, comprises deploying the second tissue anchor between 0 and 20 degrees with respect to the first tissue anchor.

8. The method according to claim 1, wherein deploying the first anchor comprises deploying the first anchor from a distal end of a deployment manipulator through the surface of the end wall of the sleeve into the cardiac tissue, while the distal end of the deployment manipulator is positioned such that a central longitudinal axis through the distal end of the deployment manipulator forms an angle of between 20 and 90 degrees with the distal end wall of the sleeve at a point at which the first anchor penetrates the end wall.

10. The method according to claim 1, wherein deploying the second anchor comprises deploying the second anchor from a distal end of a deployment manipulator through the surface of the portion of the tubular wall of the sleeve into the cardiac tissue, while the distal end of the deployment manipulator is positioned such that a central longitudinal axis through the distal end of the deployment manipulator forms an angle of between 20 and 90 degrees with the portion of the tubular wall of the sleeve at a point at which the second anchor penetrates the portion of the tubular wall.

12. The method according to claim 1, wherein deploying the first anchor comprises deploying the first anchor through a channel disposed within a lumen of the sleeve, the channel having a distal end defining an opening through with the first anchor passes, and wherein deploying the first anchor comprises sandwiching the surface of the end wall of the sleeve between the distal end of the channel and the first portion of annulus tissue.

13. The method according to claim 12, wherein sandwiching comprises positioning the distal end of the channel in a manner in which the distal end of the channel is aligned substantially parallel to the planar surface.

14. The method according to claim 1, wherein deploying the second anchor comprises deploying the second anchor through a channel disposed within a lumen of the sleeve, the channel having a distal end defining an opening through with the second anchor passes, and wherein deploying the second anchor comprises sandwiching the portion of the tubular side wall of the sleeve between the distal end of the channel and the second portion of annulus tissue.

15. The method according to claim 14, wherein sandwiching comprises positioning the distal end of the channel in a manner in which the distal end of the channel is aligned substantially parallel to the planar surface.

18. The method according to claim 1, further comprising forming a distal portion of the sleeve between the first and second tissue anchors into a shape.

19. The method according to claim 18, wherein forming the distal portion of the sleeve into the shape comprises forming the distal portion of the sleeve into the shape prior to the deploying of the second anchor by flexing the distal portion of the sleeve.

20. The method according to claim 18, wherein forming the distal portion of the sleeve into the shape comprises forming the distal portion of the sleeve into the shape responsively to the deploying of the second anchor.

21. The method according to claim 18, wherein the annuloplasty structure includes a stiffener configured to bias the annuloplasty structure into the shape.

22. The method according to claim 18, wherein forming the distal portion of the sleeve into the shape comprises forming the distal portion of the sleeve into a shape in which:

a first part of the lateral surface of the tubular side wall is positioned close to the tissue of the annulus,

a second part of the lateral surface of the tubular side wall is disposed opposite the first part of the lateral surface of the tubular side wall and away from the tissue of the annulus, and

the second part of the lateral surface of the tubular side wall has a degree of tension that is larger than a degree of tension of the first part of the lateral surface of the tubular side.

23. The method according to claim 22, wherein the first part of the lateral surface of the tubular side wall is ruffled and is disposed adjacent the tissue of the annulus.

24. The method according to claim 22, wherein forming the distal portion of the sleeve into the shape comprises forming the distal portion of the sleeve into a shape having a concavity.

25. The method according to claim 24, wherein forming the distal portion of the sleeve into the shape having the concavity comprises creating a gap between the distal portion of the sleeve and the annulus tissue, the gap having a longest distance between 0.2 and 7.5 mm.

28. The method according to claim 1, wherein deploying the first tissue anchor and deploying the second tissue anchor comprises deploying the first and second tissue anchors from within a lumen of a channel disposed within a lumen of the sleeve while at least a proximal portion of the sleeve is surrounded by a catheter.

2-3. -3. (canceled)

7. (canceled)

9. (canceled)

11. (canceled)

16-17. -17. (canceled)

26-27. -27. (canceled)

29. (canceled)

30. A method of repairing a cardiac valve, the method comprising:

introducing into a heart atrium, a flexible annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall;

anchoring the distal end wall of the sleeve to a valve annulus on an atrial surface of the valve by deploying a first tissue anchor;

while the distal end wall is anchored, positioning alongside the valve annulus a portion of the tubular side wall that is proximal to the distal end wall in a manner in which the portion of the tubular side wall assumes a shape in which;

a first part of the lateral surface of the tubular side wall is positioned close to the tissue of the annulus,

a second part of the lateral surface of the tubular side wall is disposed opposite the first part of the lateral surface of the tubular side wall and away from the tissue of the annulus, and

the second part of the lateral surface of the tubular side wall has a degree of tension that is larger than a degree of tension of the first part of the lateral surface of the tubular side;

anchoring the portion of the tubular side wall to the annulus by deploying a second tissue anchor consecutively to the first tissue anchor; and

continuing to position the annuloplasty structure about a circumference of the atrial surface of the annulus while periodically anchoring additional locations of the tubular side wall of the sleeve to the atrial surface of the annulus.

34. The method according to claim 30, wherein the first part of the lateral surface of the tubular side wall is ruffled and is disposed adjacent the tissue of the annulus.

35. The method according to claim 30, wherein positioning comprises forming the distal portion of the sleeve into a shape having a concavity.

36. The method according to claim 35, wherein forming the distal portion of the sleeve into the shape having the concavity comprises creating a gap between the distal portion of the sleeve and the annulus tissue, the gap having a longest distance between 0.2 and 7.5 mm.

38. The method according to claim 30, wherein deploying the first tissue anchor and deploying the second tissue anchor comprises deploying the first and second tissue anchors consecutively, to extend in a substantially same direction and into a common, substantially planar surface of a valve annulus, the common, substantially planar surface including the first and second portions of the annulus tissue.

39. The method according to claim 38, wherein deploying the second tissue anchor comprises deploying the second tissue anchor substantially parallel with respect to the first tissue anchor.

31-33. -33. (canceled)

37. (canceled)

40-46. -46. (canceled)

47. Apparatus for repairing a cardiac valve, the apparatus comprising:

a flexible annuloplasty structure having a sleeve with an elongated tubular side wall and at least one distal end wall having a surface substantially transverse to a lateral surface of the tubular side wall;

a first tissue anchor passing through the distal end wall of the sleeve; and

a second tissue anchor passing through the tubular side wall, the first and second tissue anchors being disposed consecutively and to extend in a substantially same direction.

51. The apparatus according to claim 47, wherein the second tissue anchor is disposed between 0 and 20 degrees with respect to the first tissue anchor.

53. The apparatus according to claim 47, wherein the first and second tissue anchors are disposed in a manner in which a portion of the tubular side wall that is between the first and second tissue anchors assumes a shape in which:

the portion has a first part of the lateral surface of the tubular side wall and a second part of the lateral surface of the tubular side wall opposite the first part, and

the second part of the lateral surface of the tubular side wall has a degree of tension that is larger than a degree of tension of the first part of the lateral surface of the tubular side wall.

48-50. -50. (canceled)

52. (canceled)

54-74. -74. (canceled)