Closed band for percutaneous annuloplasty

• US 8,926,697 B2
• Filed: 06/23/2011
• Issued: 01/06/2015
• Est. Priority Date: 06/23/2011
• Status: Active Grant

• Current Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Original Assignee: Valtech Cardio Ltd (Edwards Lifesciences Corporation)
• Inventors: Gross, Amir, Sheps, Tal, Hammer, Tal, Reich, Tal
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): Coburn, Leslie
• Application Number:
  US13/167,492
• Publication Number:
  US 20120330411A1
• Time in Patent Office: 1,293 Days
• Field of Search: 623 236- 237
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 Delivery devices therefor

Abstract

An implantable structure includes a flexible sleeve, having first and second sleeve ends, and a contracting assembly, which is configured to longitudinally contract the sleeve, and includes a contracting mechanism, which is disposed longitudinally at a first site of the sleeve, and a longitudinal contracting member, having (a) a first member end, (b) a second member end, which is coupled to the sleeve longitudinally at a second site longitudinally between the first site and the second sleeve end, exclusive, and (c) a first member end portion, which is coupled to the contracting mechanism. The sleeve is arranged in a closed loop, such that first and second portions of the sleeve together define a longitudinally overlapping portion of the sleeve. The implantable structure is configured such that the contracting assembly longitudinally applies a longitudinal contracting force only between the first and the second sites, and not along the overlapping portion.

Claims

1. A method of valve repair comprising:

providing an implantable structure, which includes (a) a flexible sleeve, which defines a lumen and has first and second sleeve ends, and (b) a contracting assembly, which is configured to longitudinally contract the flexible sleeve, and which includes (i) a contracting mechanism, which comprises a housing, and (ii) one or more longitudinal contracting members coupled to the contracting mechanism;

placing the implantable structure in a closed loop completely around an annulus of an atrioventricular valve of a subject, such that none of the one or more longitudinal contracting members is positioned along an anterior portion of the annulus between fibrous trigones of the valve;

fastening the implantable structure to the annulus;

tightening at least a portion of a posterior portion of the annulus, while preserving a length of the anterior portion of the annulus, by tightening the implantable structure by actuating the contracting assembly to cause the one or more longitudinal contracting members to apply a longitudinal contracting force to a longitudinal portion of the flexible sleeve not positioned along the anterior portion of the annulus; and

leaving the entire implantable structure in a body of the subject after completing the valve repair.

2. The method according to claim 1,

wherein the one or more longitudinal contracting members are positioned at least partially within the lumen of the flexible sleeve,

wherein the flexible sleeve has first and second portions that longitudinally extend from the first and the second sleeve ends, respectively,

wherein placing the implantable structure in the closed loop comprises arranging the flexible sleeve in the closed loop such that the first and second portions of the flexible sleeve overlap each other so as to together define a longitudinally overlapping portion of the flexible sleeve positioned at least partially along the anterior portion of the annulus, and

wherein none of the one or more longitudinal contracting members is positioned along the longitudinally overlapping portion of the flexible sleeve.

3. The method according to claim 2,

wherein fastening the implantable structure to the annulus comprises fastening the flexible sleeve to the annulus using a plurality of tissue anchors, at least one of which penetrates both the first and second portions of the sleeve at the longitudinally overlapping portion,

wherein the plurality of tissue anchors includes a plurality of first tissue anchors of a first configuration, and a plurality of second tissue anchors of a second configuration different from the first configuration, and

wherein fastening the implantable structure to the annulus comprises:

coupling the first tissue anchors to the flexible sleeve at intervals along a first longitudinally-contiguous portion of the closed loop positioned along a portion of the annulus other than the anterior portion of the annulus, and

coupling the second tissue anchors to the sleeve at intervals along a second longitudinally-contiguous portion of the closed loop positioned along the anterior portion of the annulus.

4. The method according to claim 2, wherein providing the implantable structure comprises providing the implantable structure in which none of the one or more contracting members extends along the first portion of the flexible sleeve, or along the second portion of the flexible sleeve.

5. The method according to claim 2, wherein fastening the implantable structure to the annulus comprises fastening the flexible sleeve to the annulus using a plurality of tissue anchors, at least one of which penetrates both the first and second portions of the sleeve at the longitudinally overlapping portion.

6. The method according to claim 5, wherein the at least one of the plurality of tissue anchors includes a coupling head and a tissue coupling element, and wherein fastening the flexible sleeve to the annulus comprises fastening the flexible sleeve to the annulus such that the tissue coupling element penetrates both the first and second portions of the flexible sleeve at the longitudinally overlapping portion, and the coupling head is positioned within one of the first and second portions of the flexible sleeve at the longitudinally overlapping portion.

7. The method according to claim 1, wherein placing the implantable structure comprises placing the implantable structure such that the one or more longitudinal contracting members are positioned along a non-anterior portion of the annulus, which non-anterior portion does not reach either of the fibrous trigones.

8. The method according to claim 1, wherein placing the implantable structure in the closed loop comprises introducing the flexible sleeve into an atrium while the first and the second sleeve ends are not coupled to each other.

9. A method of valve repair comprising:

providing an implantable structure, which includes (a) a flexible sleeve, which defines a lumen and has first and second sleeve ends, and (b) a contracting assembly, which is configured to longitudinally contract the flexible sleeve, and which includes (i) a contracting mechanism, which is disposed longitudinally at a first site of the flexible sleeve, and (ii) a longitudinal contracting member which is positioned at least partially within the lumen, and has (x) a first member end, (y) a second member end, which is fixed to the flexible sleeve longitudinally at a second site, which is longitudinally between the first site and the second sleeve end, exclusive, and (z) a first member end portion, which (1) extends from the first member end toward the second member end along only a longitudinal portion of the longitudinal contracting member, and (2) is coupled to the contracting mechanism;

placing the implantable structure at least partially around an annulus of an atrioventricular valve of a subject;

using a plurality of tissue anchors, fastening the implantable structure to the annulus, including coupling one or more of the plurality of tissue anchors to the flexible sleeve and tissue of the annulus at respective third sites longitudinally between the second site and the second sleeve end, exclusive;

actuating the contracting assembly to contract a longitudinal portion of the flexible sleeve; and

leaving the entire implantable structure in a body of the subject after completing the valve repair.

10. The method according to claim 9, wherein a first portion of the flexible sleeve longitudinally extends from the first sleeve end toward the first site, wherein a second portion of the flexible sleeve longitudinally extends from the second sleeve end toward the second site, and wherein placing the implantable structure comprises arranging the flexible sleeve in a closed loop, such that the first and second portions of the flexible sleeve overlap each other so as to together define a longitudinally overlapping portion of the flexible sleeve.

11. The method according to claim 10, wherein placing the implantable structure comprises placing the implantable structure such that the longitudinally overlapping portion is positioned along an anterior portion of the annulus between fibrous trigones of the valve.

12. The method according to claim 10, wherein fastening comprises coupling at least one of the plurality of tissue anchors to the tissue such that the anchor penetrates both the first and second portions of the sleeve at the longitudinally overlapping portion.

13. The method according to claim 10, wherein providing the implantable structure comprises providing the implantable structure in which the longitudinally overlapping portion has a length of between 5 and 60 mm.

14. The method according to claim 10, wherein providing the implantable structure comprises providing the implantable structure in which the longitudinal contracting member does not extend along the first portion of the flexible sleeve, and does not extend along the second portion of the flexible sleeve.

15. The method according to claim 9, wherein coupling the one or more of the plurality of tissue anchors comprises coupling at least two of the tissue anchors to the flexible sleeve and the tissue at respective third sites longitudinally between the second member end and the second sleeve end, exclusive.

16. The method according to claim 9, wherein providing the implantable structure comprises providing the implantable structure in which the second site is at least 5 mm from the second sleeve end, measured when the flexible sleeve is in a straight, relaxed, non-contracted state.

17. The method according to claim 9, wherein providing the implantable structure comprises providing the implantable structure in which the second site is at a longitudinal distance from the second sleeve end, which distance is no greater than 30% of a total length of the flexible sleeve, the distance and length measured when the flexible sleeve is in the straight, relaxed, non-contracted state.

18. The method according to claim 9, wherein coupling the one or more of the plurality of tissue anchors comprises coupling at least three of the plurality of tissue anchors to the flexible sleeve alongside the longitudinal contracting member, longitudinally between the first and second sites, exclusive.

19. The method according to claim 9, wherein actuating the contracting assembly comprises actuating the contracting assembly to apply a longitudinal contracting force only between the first and the second sites along the longitudinal contracting member.

20. The method according to claim 9, wherein providing the implantable structure comprises providing the implantable structure in which the contracting mechanism comprises a housing, which is disposed longitudinally at the first site.

21. The method according to claim 9, wherein actuating the contracting assembly to contract the longitudinal portion of the flexible sleeve comprises actuating the contracting assembly to cause the longitudinal contracting member to apply a longitudinal contracting force to the longitudinal portion of the flexible sleeve.

22. A method of valve repair comprising:

providing an implantable structure, which includes (a) a flexible sleeve, which defines a lumen and has first and second sleeve ends, and (b) a contracting assembly, which includes (i) a contracting mechanism, which is disposed longitudinally at a first site of the flexible sleeve, and (ii) a longitudinal contracting member which is positioned at least partially within the lumen, and has (x) a first member end, (y) a second member end, which is fixed to the flexible sleeve longitudinally at a second site, which is longitudinally between the first site and the second sleeve end, exclusive, and (z) a first member end portion, which (1) extends from the first member end toward the second member end along only a longitudinal portion of the longitudinal contracting member, and (2) is coupled to the contracting mechanism, wherein the contracting mechanism is configured to apply a longitudinal contracting force only between the first and the second sites; and

placing the implantable structure at least partially around an annulus of an atrioventricular valve of a subject;

using a plurality of tissue anchors, fastening the implantable structure to the annulus, including coupling one or more of the plurality of tissue anchors to the flexible sleeve and tissue of the annulus at respective third sites selected from the group of sites consisting of;

one or more sites longitudinally between the first site and the first sleeve end, exclusive, and one or more sites longitudinally between the second site and the second sleeve end, exclusive;

actuating the contracting assembly to contract a longitudinal portion of the flexible sleeve by applying the longitudinal contracting force only between the first and the second sites; and

leaving the entire implantable structure in a body of the subject after completing the valve repair.

23. The method according to claim 22, wherein at least one of the third sites is longitudinally between the first site and the first sleeve end, exclusive.

24. The method according to claim 23, wherein at least two of the third sites are longitudinally between the first site and the first sleeve end, exclusive.

25. The method according to claim 22, wherein at least one of the third sites is longitudinally between the second site and the second sleeve end, exclusive.

26. The method according to claim 25, wherein at least two of the third sites are longitudinally between the second site and the second sleeve end, exclusive.

27. The method according to claim 22, wherein at least one of the third sites is longitudinally between the first site and the first sleeve end, exclusive, and wherein at least one of the third sites is longitudinally between the second site and the second sleeve end, exclusive.

28. The method according to claim 22, wherein providing the implantable structure comprises providing the implantable structure in which the first site is a first longitudinal distance from the first sleeve end, the second site is at a second longitudinal distance from the second sleeve end, which first and second longitudinal distances are measured when the flexible sleeve is in a straight, relaxed, non-contracted state, and at least one of the first and second longitudinal distances, taken separately, is at least 5 mm.

29. The method according to claim 22, wherein a first portion of the flexible sleeve longitudinally extends from the first sleeve end toward the first site, wherein a second portion of the flexible sleeve longitudinally extends from the second sleeve end toward the second site, and wherein placing the implantable structure comprises arranging the flexible sleeve in a closed loop, such that the first and second portions of the sleeve overlap each other so as to together define a longitudinally overlapping portion of the flexible sleeve.

30. The method according to claim 22,

wherein the longitudinal portion of the flexible sleeve is only between the first and the second sites, along at least a portion of the longitudinal contracting member, and

wherein actuating comprises actuating the contracting mechanism to contract the longitudinal portion of the flexible sleeve by applying the longitudinal contracting force only between the first and the second sites along the longitudinal contracting member.

31. The method according to claim 22, wherein providing the implantable structure comprises providing the implantable structure in which the contracting mechanism comprises a housing, which is disposed longitudinally at the first site.

32. The method according to claim 22, wherein actuating the contracting assembly to contract the longitudinal portion of the flexible sleeve comprises actuating the contracting assembly to cause the longitudinal contracting member to apply the longitudinal contracting force to the longitudinal portion of the flexible sleeve only between the first and the second sites.