Annuloplasty ring with intra-ring anchoring

• US 9,119,719 B2
• Filed: 01/24/2013
• Issued: 09/01/2015
• 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:
  US13/749,153
• Publication Number:
  US 20130190866A1
• Time in Patent Office: 950 Days
• Field of Search: 623/2.11, 623 236- 241
• US Class Current: 1/1
• 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

A method includes positioning an anchor deployment manipulator at least partially within a lumen of a sleeve of an annuloplasty ring, the sleeve having a lateral wall shaped to define the lumen, and the lumen extending longitudinally along a length of the sleeve. A portion of the sleeve that contains a distal end of the deployment manipulator is placed into an atrium in a vicinity of an annulus of an atrioventricular valve. An anchor is deployed from the distal end of the deployment manipulator through the lateral wall of the sleeve into cardiac tissue, 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 lateral wall of the sleeve at a point at which the anchor penetrates the lateral wall.

Claims

1. 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 lateral wall shaped to define the lumen, and the lumen extending longitudinally along a length 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 a plurality of anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into cardiac tissue of the subject by;

using the distal end of the deployment manipulator to bring a portion of the sleeve into contact with the cardiac tissue,

thereafter, deploying one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue while the deployment manipulator is positioned at a site along the annulus,

thereafter, using the distal end of the deployment manipulator to bring, into contact with the cardiac tissue, another portion of the sleeve that was not in contact with the cardiac tissue during deployment of the one of the anchors, by positioning the deployment manipulator at another site along the annulus, and

thereafter, deploying another one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue while the deployment manipulator is positioned at the other site along the annulus.

2. The method according to claim 1, wherein deploying the one of the anchors comprises deploying the one of the anchors 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 lateral wall of the sleeve at a point at which the one of the anchors penetrates the lateral wall.

3. The method according to claim 2, wherein deploying the one of the anchors comprises deploying the one of the anchors while the angle is between 75 and 90 degrees.

4. The method according to claim 2,

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

wherein the one of the anchors is a currently-being-deployed anchor,

wherein the plurality of anchors also includes a most-recently-deployed anchor most recently deployed before the currently-being-deployed anchor through a second point on the lateral wall, and

wherein deploying the currently-being-deployed anchor comprises deploying the currently-being-deployed 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.

5. The method according to claim 4, wherein deploying the currently-being-deployed anchor comprises deploying the currently-being-deployed anchor while a portion of the sleeve proximal to the distal end of the deployment manipulator is positioned such that a central longitudinal axis of the portion of the sleeve forms the second angle with the line defined by the first point and the second point.

6. The method according to claim 2, wherein the angle is a first angle, and wherein deploying the one of the anchors comprises deploying the one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue while the distal end is positioned such that the central longitudinal axis through the distal end of the manipulator forms a second angle of between 45 and 90 degrees with a plane tangential to a surface of the cardiac tissue at a location at which the one of the anchors penetrates the cardiac tissue.

7. The method according to claim 6, wherein deploying the one of the anchors comprises deploying the one of the anchors while the second angle is between 75 and 90 degrees.

8. The method according to claim 2, wherein deploying the one of the anchors comprises deploying the one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue, while a portion of the sleeve proximal to the distal end of the deployment manipulator is positioned such that a central longitudinal axis of the portion of the sleeve forms the angle with the lateral wall of the sleeve at the point at which the one of the anchors penetrates the lateral wall.

9. The method according to claim 2, wherein deploying the one of the anchors comprises deploying the one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue, while the sleeve is folded at the angle near the point at which the anchor penetrates the lateral wall.

10. The method according to claim 1, further comprising tightening the annuloplasty ring after deploying the plurality of anchors.

11. The method according to claim 1, wherein positioning the anchor deployment manipulator at least partially within the lumen of the sleeve comprises positioning an outer tube of the anchor deployment manipulator snugly within the lumen of the sleeve.

12. The method according to claim 1, wherein deploying the one of the anchors comprises deploying the one of the anchors from the distal end of the deployment manipulator through a point on the lateral wall of the sleeve into the cardiac tissue, while the distal end of the deployment manipulator presses the point of the lateral wall of the sleeve against the cardiac tissue.

13. The method according to claim 1, wherein deploying the one of the anchors comprises deploying the one of the anchors while the distal end of the deployment is positioned such that a central longitudinal axis of the deployment manipulator through the distal end of the manipulator forms an angle of between 45 and 90 degrees with a plane tangential to a surface of the cardiac tissue at a location at which the one of the anchors penetrates the cardiac tissue.

14. The method according to claim 13, wherein deploying the one of the anchors comprises deploying the one of the anchors while the angle is between 75 and 90degrees.

15. The method according to claim 13, wherein positioning the anchor deployment manipulator at least partially within the lumen of the sleeve comprises positioning an outer tube of the anchor deployment manipulator snugly within the lumen of the sleeve.

16. The method according to claim 13, wherein deploying the one of the anchors comprises deploying the one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue, while a portion of the sleeve proximal to the distal end of the deployment manipulator is positioned such that a central longitudinal axis of the portion of the sleeve forms the angle with the lateral wall of the sleeve at a point at which the one of the anchors penetrates the lateral wall.

17. The method according to claim 13, wherein deploying the one of the anchors comprises deploying the one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue, while the sleeve is folded at the angle near a point at which the one of the anchors penetrates the lateral wall.

18. The method according to claim 13, wherein deploying the one of the anchors comprises deploying the one of the anchors from the distal end of the deployment manipulator through a point on the lateral wall of the sleeve into the cardiac tissue, while the distal end of the deployment manipulator presses the point of the lateral wall of the sleeve against the cardiac tissue.

19. The method according to claim 13, further comprising tightening the annuloplasty ring after deploying the plurality of anchors.

20. The method according to claim 13, wherein deploying the plurality of anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue of the subject comprises using the deployment manipulator to shape the sleeve around at least a portion of the annulus.

21. The method according to claim 13, wherein deploying the plurality of anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue of the subject comprises:

deploying the one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue while the deployment manipulator is positioned at the site along the annulus;

thereafter, using the deployment manipulator to draw the sleeve from the site toward the other site along the annulus; and

thereafter, deploying the other one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue, while the deployment manipulator is positioned at the other site.

22. The method according to claim 21, wherein using the deployment manipulator to draw the sleeve from the site toward the other site comprises applying tension to the sleeve between the site and the other site.

23. The method according to claim 13,

wherein placing the at least a portion of the sleeve into the atrium comprises advancing a sheath into the atrium, and advancing the sleeve through the sheath and into the atrium, and

wherein deploying the plurality of anchors comprises deploying at least two of the anchors while the sleeve is positioned partially within the sheath.

24. The method according to claim 23, wherein deploying the at least two of the anchors comprises:

deploying the one of the anchors into the cardiac tissue while the sleeve partially extends out of the sheath;

thereafter, further extending the sleeve out of the sheath; and

thereafter, deploying the other one of the anchors into the cardiac tissue.

25. The method according to claim 23, wherein deploying the at least two of the anchors comprises deploying the at least two of the anchors while the sleeve is positioned partially within the sheath and while the sheath is in the atrium.

26. The method according to claim 1, wherein deploying the plurality of anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue of the subject comprises using the deployment manipulator to shape the sleeve around at least a portion of the annulus.

27. The method according to claim 1, wherein deploying the plurality of anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue of the subject comprises:

deploying the one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue while the deployment manipulator is positioned at the site along the annulus;

thereafter, using the deployment manipulator to draw the sleeve from the site toward the other site along the annulus; and

thereafter, deploying the other one of the anchors from the distal end of the deployment manipulator through the lateral wall of the sleeve into the cardiac tissue, while the deployment manipulator is positioned at the other site.

28. The method according to claim 27, wherein using the deployment manipulator to draw the sleeve from the site toward the other site comprises applying tension to the sleeve between the site and the other site.

29. The method according to claim 1,

wherein placing the at least a portion of the sleeve into the atrium comprises advancing a sheath into the atrium, and advancing the sleeve through the sheath and into the atrium, and

wherein deploying the plurality of anchors comprises deploying at least two of the anchors while the sleeve is positioned partially within the sheath.

30. The method according to claim 29, wherein deploying the at least two of the anchors comprises:

deploying the one of the anchors into the cardiac tissue while the sleeve partially extends out of the sheath;

thereafter, further extending the sleeve out of the sheath; and

thereafter, deploying the other one of the anchors into the cardiac tissue.

31. The method according to claim 29, wherein deploying the at least two of the anchors comprises deploying the at least two of the anchors while the sleeve is positioned partially within the sheath and while the sheath is in the atrium.