System for improving cardiac function

• US 20070213815A1
• Filed: 05/07/2007
• Published: 09/13/2007
• Est. Priority Date: 08/09/1999
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Khairkhahan, Alexander, Nikolic, Serjan, Sharkey, Hugh
• Granted Patent: US 8,657,873 B2
• Time in Patent Office: Days
• US Class Current: 623/3.100
• 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
• 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 treating a patient with congestive heart failure by partitioning a chamber of the patient'"'"'s heart into a primary productive portion and a secondary non-productive portion, comprising:

(a) a partitioning component which has 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 defines in part the main productive portion of the patient'"'"'s heart chamber to be partitioned; and

(b) a plurality of tissue penetrating securing elements disposed at free ends of the ribs configured to penetrate tissue lining the heart chamber at an angle essentially perpendicular to the center line axis of the partitioning device to secure the periphery of the partitioning device to the heart chamber.

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

3. The device of claim 1 wherein the partitioning component 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 5 wherein the free proximal ends of the ribs have tips which 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.

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

(a) a central hub component;

(b) an expandable frame component having a plurality of ribs with free, outwardly flared proximal ends and distal ends secured to the central hub component;

(c) a membrane component secured to the expandable frame ribs; and

(d) tissue penetrating tips on a plurality of free, outwardly flared proximal ends which are configured to penetrate tissue lining the heart chamber to be partitioned at an angle essentially perpendicular to a center line axis of the partitioning device.

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

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

15. A partitioning apparatus for partitioning a ventricle of a patient'"'"'s heart comprising:

(a) a distal hub;

(b) an expandable frame having a plurality of segments extending radially and proximally from the hub, the frame having a size and shape adapted to span a portion of the ventricle to partition the ventricle into first and second volumes;

(c) a membrane secured to the segments; and

(d) a sharp anchor at the proximal end of each segment adapted to penetrate heart tissue.

16. The apparatus of claim 15 further comprising an anchor extending distally from the hub and adapted to penetrate heart tissue.

17. The apparatus of claim 15 wherein the frame and membrane form a cone-shaped body.

18. The apparatus of claim 15 further comprising a seal adapted to seal off the first volume from the second volume.

19. The apparatus of claim 18 wherein the seal comprises an element extending radially outward from the membrane.

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