Endocardial splint and method therefor

• US 7,288,104 B2
• Filed: 06/25/2004
• Issued: 10/30/2007
• Est. Priority Date: 06/25/2004
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Heil, Ronald W. Jr.
• Primary Examiner(s): Lacyk; John P.
• Application Number:
  US10/877,905
• Publication Number:
  US 20050288613A1
• Time in Patent Office: 1,222 Days
• Field of Search: 128897-899, 600/16, 600/37, 602/5, 602/16, 604/11, 604/13, 604/15, 604174-175, 606/151, 606/153, 606/213, 606/215, 606/220, 607/119, 607/129, 623/2.1, 623/2.11, 623/11.11, 623/66.1
• US Class Current: 606/213
• 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 17/0401 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A splint assembly includes an elongate body. An active fixation fastener is coupled substantially adjacent to a distal end of the elongate body. The splint assembly includes at least one flange coupled to the elongate body proximal the active fixation fastener. In one option, a stop of the at least one flange projects outside of an outer perimeter of the elongate body. In another option, the active fixation fastener is spaced from the at least one flange where the active fixation fastener and the at least one flange pull at least one heart chamber toward a substantially unexpanded shape when in an implanted condition within the heart an artery or a vein. In yet another option, the elongate body includes a predetermined curvature along at least a portion of the elongate body between the active fixation fastener and the at least one flange.

Claims

1. A splint apparatus comprising:

an elongate body;

at least one flange coupled around at least a portion of the elongate body, wherein the at least one flange includes at least one stop extending outside an outer perimeter of the elongate body; and

an active fixation fastener associated with a distal end of the elongate body, wherein the active fixation fastener is spaced from the at least one flange where the active fixation fastener and the at least one flange pull at least one heart chamber toward a substantially unexpanded shape when in an implanted condition within a heart, an artery or a vein, wherein the elongate body and active fixation fastener fail to penetrate a heart outer wall.

2. The splint apparatus of claim 1, wherein at least a portion of the active fixation fastener has a textured surface.

3. The splint apparatus of claim 1, wherein at least another portion of the elongate body between a position proximal to the at least one flange and the active fixation fastener has a textured surface.

4. The splint apparatus of claim 1, wherein the elongate body has a predetermined curvature along at least a portion of the elongate body between the active fixation fastener and the at least one flange.

5. The splint apparatus of claim 1, wherein the at least one flange is spaced from the active fixation fastener so when in the implanted condition the at least one flange is substantially adjacent to a septal wall disposed between a right ventricle and a left ventricle when the active fixation fastener is implanted in an inner surface of a left ventricle wall.

6. The splint apparatus of claim 5, further comprising a second flange coupled to the elongate body and proximal to the at least one flange, wherein the second flange is spaced from the active fixation fastener so the second flange is substantially adjacent to the vein.

7. The splint apparatus of claim 1, wherein the at least one flange is slidably coupled to the outer perimeter of the elongate body.

8. The splint apparatus of claim 7, wherein the at least one flange is deformable and an inner surface of the at least one flange grasps the outer perimeter of the elongate body in a deformed condition.

9. The splint apparatus of claim 1, wherein the active fixation fastener includes a helix projection.

31. The splint apparatus of claim 1, wherein flange and the active fixation fastener are contained within the heart or extend through the artery or vein.

10. A splint apparatus comprising:

an elongate body;

a flange coupled around at least a portion of the elongate body, wherein the flange includes at least one stop extending outside an outer perimeter of the elongate body;

an active fixation fastener associated with a distal end of the elongate body, wherein at least a portion of the elongate body between the active fixation fastener and the flange includes a predetermined curvature, the predetermined curvature adapted to pull at least one heart chamber toward a substantially unexpanded shape when in an implanted condition within a heart, an artery or a vein.

11. The splint apparatus of claim 10, further comprising a conductor included within the elongate body, wherein the active fixation fastener is coupled with the conductor.

12. The splint apparatus of claim 10, wherein the elongate body includes a lumen extending therethrough, the lumen is dimensioned and configured to receive a stylet.

13. The splint apparatus of claim 10, wherein the flange is spaced from the active fixation fastener so the flange is implantable in an aorta and the active fixation fastener is implantable in a left ventricle.

14. The splint apparatus of claim 10, wherein the elongate body includes a shape memory material to apply the predetermined curvature.

15. A method comprising:

inserting an elongate body through a vein or artery;

advancing a distal end of the elongate body into a heart chamber;

coupling the distal end of the elongate body to an inner surface of a heart;

coupling at least one flange to the heart or vasculature so at least a portion of the elongate body traverses the heart chamber, wherein the at least one flange is coupled to the elongate body proximal the distal end; and

tensioning at least the portion of the elongate body that traverses the heart chamber, the tensioned portion of the elongate body and the distal end of the elongate body contained within at least one of the heart or the vasculature.

16. The method of claim 15, wherein coupling the distal end of the elongate body to the inner surface of the heart includes coupling an active fixation fastener to the inner surface of the heart.

17. The method of claim 15, wherein coupling the at least one flange to the heart, artery or vein includes disposing the at least one flange within a puncture in the heart, artery or vein.

18. The method of claim 15, wherein coupling the at least one flange to the heart, artery or vein includes engaging the at least one flange against a septal wall of the heart, where the at least one flange seals around a puncture of the septal wall.

19. The method of claim 18, wherein engaging the at least one flange against the septal wall includes using at least one of low or high pressure to draw or press the flange against the septal wall.

20. The method of claim 15, wherein tensioning at least the portion of the elongate body that traverses the heart chamber includes moving the at least one flange along the elongate body and immobilizing the at least one flange on the elongate body.

21. The method of claim 20, wherein the at least one flange is deformable and immobilizing the at least one flange includes suturing tissue around the at least one flange to deform the at least one flange and grasp the elongate body.

22. The method of claim 15, wherein tensioning at least the portion of the elongate body that traverses the heart chamber includes tensioning with a predetermined curvature of the elongate body.

23. The method of claim 15, further comprising providing electrical stimulation to the heart through the elongate body.

24. A method comprising:

anchoring a distal end of an elongate body within a first heart surface;

coupling at least one flange to a second surface, wherein the at least one flange is disposed along the elongate body; and

tensioning at least a portion of the elongate body that extends between the at least one flange and the distal end, the distal end of the elongate body contained within a heart, and the flange contained within the heart or extending through vasculature surrounding the heart.

25. The method of claim 24, wherein coupling the at least one flange to a second surface includes disposing the at least one flange within a puncture in a heart, artery or vein.

26. The method of claim 24, wherein coupling the at least one flange to a second surface includes engaging the at least one flange against a septal wall of the heart, where the at least one flange seals around a puncture of the septal wall.

27. The method of claim 24, wherein tensioning at least the portion of the elongate body that extends between the at least one flange and the distal end includes moving the at least one flange along the elongate body.

28. The method of claim 24, wherein tensioning at least the portion of the elongate body that extends between the at least one flange and the distal end includes tensioning with a predetermined curvature of the elongate body.

29. The method of claim 24, frothier comprising constraining movement of at least one of the first surface or the second surface away from the other of the first surface or the second surface.

30. The method of claim 24, further comprising pulling at least one of the first surface or the second surface toward the other of the first surface or the second surface.