System for improving cardiac function

• US 8,747,454 B2
• Filed: 05/07/2007
• Issued: 06/10/2014
• Est. Priority Date: 08/09/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Khairkhahan, Alexander, Sharkey, Hugh R., Nikolic, Serjan D.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US11/800,998
• Publication Number:
  US 20070213578A1
• Time in Patent Office: 2,591 Days
• Field of Search: 600/16, 600/37, 600/375, 604/508, 606/200, 606/213, 606/232, 623/23.67, 623/3.16, 623/1.11
• US Class Current: 623/1.23
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/12095 Threaded connection

Abstract

A system for improving cardiac function is provided. A foldable and expandable frame having at least one anchoring formation is attached to an elongate manipulator and placed in a catheter tube while folded. The tube is inserted into a left ventricle of a heart where the frame is ejected from the tube and expands in the left ventricle. Movements of the elongate manipulator cause the anchor to penetrate the heart muscle and the elongate manipulator to release the frame. The installed frame minimizes the effects of an akinetic portion of the heart forming an aneurysmic bulge.

Claims

1. A method of altering blood flow through the left ventricle, comprising the steps of:

advancing an element which is movable between a collapsed and an expanded condition into the left ventricle in the collapsed condition with a delivery device that holds the element in the collapsed condition;

expanding the element in the left ventricle; and

securing the element to the wall of the left ventricle to form a circumferential attachment to the wall of the left ventricle, wherein the element separates the left ventricle into a blood flow side and a non-blood flow side,

the element forming a hemostatic seal at the circumferential attachment so that pressure in the blood flow side is not communicated to the non-blood flow side thereby reducing pressure on the ventricular wall of the non-blood flow side.

2. The method of claim 1, wherein:

the securing step is carried out with the circumferential attachment being below at least one papillary muscle.

3. The method of claim 1, wherein:

the advancing step is carried out with the element being delivered through a peripheral vessel, through the aortic valve and into the left ventricle.

4. The method of claim 1, wherein:

the advancing step is carried out with the element being delivered through a wall of the left ventricle.

5. The method of claim 1, wherein:

the securing step is carried out with the circumferential attachment separating the left ventricle into a blood flow side and a non-blood flow side, the blood flow side being a side in which blood circulates through the heart.

6. The method of claim 1, wherein:

the expanding step is carried out with the element having an outer surface which is at least partly separated from the inner wall of the left ventricle to form the non blood flow side.

7. The method of claim 1, wherein:

the securing step is carried out without cutting a wall of the left ventricle.

8. The method of claim 1, further comprising the step of:

introducing a tool into the chest;

engaging the heart with the tool; and

securing the element in the left ventricle using the tool.

9. The method of claim 1, wherein:

the securing step is carried out with the tool extending through a portion of the left ventricle which is part of an isolated portion of the left ventricle, the isolated portion not forming part of a blood flow path through the left ventricle.

10. The method of claim 1, wherein:

the providing step is carried out with the element having a plurality of support members extending toward the apex.

11. The method of claim 1, further comprising the step of:

collapsing the element after the expanding step; and

removing the element from the wall of the left ventricle after the collapsing step.

12. A method of altering blood flow through the left ventricle, comprising the steps of:

advancing an element which is movable from a collapsed position to an expanded position into a left ventricle using a delivery device, the element being in the collapsed position while in the delivery device;

expanding the element within the left ventricle;

securing the element to an inner wall of the left ventricle at a position below at least one papillary muscle that the element separates the left ventricle into a blood flow side and an isolated side, wherein the blood flow side forms part of a blood flow path through the heart and the isolated side does not.

13. The method of claim 12, wherein:

the securing step is carried out with the circumferential attachment being below the at least one papillary muscle.

14. The method of claim 12, wherein:

the advancing step is carried out with the element being delivered through a peripheral vessel, through the aortic valve and into the left ventricle.

15. The method of claim 12, wherein:

the advancing step is carried out with the element being delivered through a wall of the left ventricle.

16. The method of claim 12, wherein:

the securing step is carried out with the circumferential attachment separating the left ventricle into a blood flow side and a non-blood flow side, the blood flow side being a side in which blood circulates through the heart.

17. The method of claim 12, wherein:

the expanding step is carried out with the element having an outer surface which is at least partly separated from the inner wall of the left ventricle to form an isolated portion of the left ventricle.

18. The method of claim 12, wherein:

the securing step is carried out without cutting a wall of the left ventricle.

19. The method of claim 12, further comprising the step of:

introducing a tool into the chest; and

engaging the heart with the tool;

wherein the securing step is carried out with the element being secured in the left ventricle using the tool.

20. The method of claim 19, wherein:

the securing step is carried out with the tool extending through a portion of the left ventricle which is part of an isolated portion of the left ventricle, the isolated portion not forming part of a blood flow path through the left ventricle.

21. The method of claim 19, wherein:

the securing step is carried out by driving an anchor through the wall of the left ventricle and into engagement with the element.

22. The method of claim 12, further comprising the step of:

collapsing the element after the expanding step;

repositioning the element after the collapsing step; and

reexpanding the element after the repositioning step.

23. A method of altering blood flow through the left ventricle, comprising the steps of:

collapsing an element in a delivery device, wherein the element is movable between collapsed and expanded conditions;

advancing the element into the left ventricle in the collapsed condition with the delivery device;

expanding the element in the left ventricle; and

securing the element to the wall of the left ventricle to separate the left ventricle into a blood flow side and a non-blood flow side.

24. The method of claim 23, further comprising the step of:

maintaining a reduced volume in the non-blood flow side.

25. The method of claim 23, wherein:

the reducing step is carried out with the element forming a seal which prevents blood from passing from the blood flow side to the non-blood flow side.

26. The method of claim 23, wherein:

the reducing step is carried out with the element forming a hemostatic seal with the wall of the left ventricle.

27. The method of claim 23, wherein:

the securing step is carried out with the element forming a hemostatic seal at the circumferential attachment so that pressure in the blood flow side is not communicated to the non-blood flow side thereby reducing pressure on the ventricular wall of the non-blood flow side.

28. The method of claim 23, wherein:

the securing step is carried out with the circumferential attachment being below at least one papillary muscle.

29. The method of claim 23, wherein:

the advancing step is carried out with the element being delivered through a wall of the left ventricle.

30. The method of claim 23, wherein:

the reducing step is carried out until at least part of the left ventricle wall moves into contact with the element.

31. The method of claim 23, further comprising the step of:

introducing a tool into the chest;

engaging the heart with the tool; and

securing the element in the left ventricle using the tool.

32. The method of claim 23, wherein:

the securing step is carried out with the tool extending through a portion of the left ventricle which is part of an isolated portion of the left ventricle, the isolated portion not forming part of a blood flow path through the left ventricle.

33. The method of claim 23, wherein:

the securing step is carried out by driving an anchor through the wall of the left ventricle and into engagement with the element.

34. The method of claim 23, further comprising the step of:

collapsing the element after the expanding step;

repositioning the element after the collapsing step; and

reexpanding the element after the repositioning step.

35. A method of altering blood flow through the left ventricle, comprising the steps of:

collapsing an element in a delivery device, wherein the element is movable between collapsed and expanded conditions, the element comprising a frame having a plurality of segments extending from a central axis and a membrane attached to the segments;

advancing the element into the left ventricle in the collapsed condition with the delivery device;

expanding the element in the left ventricle; and

securing the element to the wall of the left ventricle.