System for improving cardiac function

• US 8,657,873 B2
• Filed: 05/07/2007
• Issued: 02/25/2014
• 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): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US11/801,075
• Publication Number:
  US 20070213815A1
• Time in Patent Office: 2,486 Days
• Field of Search: 623 21- 33, 623/3.1, 606/200
• US Class Current: 623/3.1
• 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 device for partitioning a patient'"'"'s ventricle into a primary productive portion and a secondary non-productive portion, the device comprising:

an expandable frame formed of a plurality of ribs having distal ends secured to a central hub and free outwardly flared proximal ends, wherein in an expanded, deployed configuration the expandable frame is configured to seal off a portion of the patient'"'"'s ventricle from fluid flow and partition the patient'"'"'s ventricle to form the primary productive portion;

a plurality of passive tissue penetrating anchors each disposed at the free ends of the ribs to secure the periphery of the partitioning device to the heart chamber.

2. The device of claim 1 wherein the expandable frame has a contracted configuration for delivery to a patient'"'"'s heart chamber to be partitioned.

3. The device of claim 1 wherein the expandable frame is formed at least in part of a membrane.

4. The device of claim 3 wherein the membrane is formed at least in part of a polymeric fabric.

5. The device of claim 1 wherein the free proximal ends of the ribs are outwardly curved.

6. The device of claim 1 wherein the passive tissue penetrating anchors on the free proximal ends of the ribs are configured to penetrate the tissue lining the heart chamber at an angle of not more than 30°

away from a line perpendicular to the center line axis of the partitioning device.

7. The device of claim 1 wherein the pressure receiving surface has radial dimensions from a center line axis of about 10 to about 100 mm.

8. The device of claim 1 wherein the frame has at least 3 ribs.

9. The device of claim 1 wherein the frame is formed at least partially of NiTi, alloy.

10. The device of claim 3 wherein the membrane is formed at least in part of expanded fluoropolymer.

11. The device of claim 3 wherein the expanded fluoropolymer is polytetrafluoroethylene.

15. The device of claim 1 wherein the frame has a size and shape adapted to span a portion of the ventricle.

16. The device of claim 3 further comprising a seal adapted to seal off the primary productive portion of the ventricle from the non-productive portion of the ventricle.

17. The device of claim 16 wherein the seal comprises an element extending radially outward from the membrane.

18. The device of claim 17 wherein the seal comprises a plurality of fibers.

12. A partitioning apparatus for partitioning a patient'"'"'s ventricle to improve cardiac ejection fraction, the apparatus comprising:

a central hub;

an expandable frame having a plurality of ribs with free proximal ends and distal ends secured to the central hub;

a membrane secured to the expandable frame ribs and configured to block fluid flow;

passive tissue penetrating anchors on a plurality of the free proximal ends that are configured to penetrate tissue lining the heart chamber; and

a seal adapted to seal off a volume from fluid flow below an outer edge of the frame from another volume above the outer edge of the frame.

13. The partitioning apparatus of claim 12 wherein the membrane is secured to the proximal side of the ribs.

14. The partitioning apparatus of claim 12 wherein the membrane is secured to the distal side of the ribs.

19. The partitioning apparatus of claim 12 wherein the seal comprises an element extending radially outward from the membrane.

20. The partitioning apparatus of claim 19 wherein the seal comprises a plurality of fibers.

21. The partitioning apparatus of claim 20 wherein the fibers are configured to interface with the trabeculae.