Ventricular volume reduction

• US 9,039,597 B2
• Filed: 06/13/2014
• Issued: 05/26/2015
• Est. Priority Date: 10/26/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Cardiokinetix Incorporated
• Inventors: Kermode, James R., Alexander, Miles D., Boutillette, Michael P., Davila, Matthew T., Tan, Irene Bing Bie
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US14/304,834
• Publication Number:
  US 20140296624A1
• Time in Patent Office: 347 Days
• Field of Search: 600 16- 18, 600/37
• US Class Current: 600/37
• 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 2017/0053 Loading magazines or sutures into applying tools
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61M 2205/32 with radio-opaque indicia
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 25/0067 characterised by the distal end, e.g. tips A61M25/0054, A61M25/04 take precedence; balloon catheters A61M25/10
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 60/17 inside a ventricle, e.g. intraventricular balloon pumps
• CPC Class Codes: A61M 60/274 the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
• CPC Class Codes: A61M 60/289 Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
• CPC Class Codes: A61M 60/295 Balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/468 the force acting on the actuation means being hydraulic or pneumatic
• CPC Class Codes: A61M 60/47 the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel
• CPC Class Codes: A61M 60/497 for balloon pumps for circulatory assistance
• CPC Class Codes: A61M 60/833 Occluders for preventing backflow
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/865 Devices for guiding or inserting pumps or pumping devices into the patient's body
• CPC Class Codes: A61M 60/867 using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter

Abstract

Devices and systems including implants (which may be removable) and methods of using them for reducing ventricular volume. The implants described herein are cardiac implants that may be inserted into a patient'"'"'s heart, particularly the left ventricle. The implant may support the heart wall, or may be secured to the heart wall. The implants are typically ventricular partitioning device for partitioning the ventricle into productive and non-productive regions in order to reduce the ventricular volume.

Claims

1. A ventricular partitioning implant for insertion into a patient'"'"'s ventricle, the implant comprising:

a partitioning membrane configured to span the ventricle to partition the ventricle;

a support frame comprising a central hub and a plurality of support struts extending proximally from the central hub, the plurality of support struts supporting the partitioning membrane;

a plurality of anchoring struts extending proximally from the central hub of the support frame and configured to anchor the partitioning member across the ventricle, wherein the plurality of anchoring struts are separate from the plurality of support struts; and

a foot extending distally from the central hub;

wherein the implant is configured to be inserted in a collapsed configuration and expanded into a deployed configuration within the ventricle.

2. The implant of claim 1, wherein the plurality of anchoring struts are not directly connected to the partitioning membrane.

3. The implant of claim 1, wherein the plurality of anchoring struts are located between an end of the central hub and the partitioning membrane.

4. The implant of claim 1, wherein the plurality of anchoring struts have free ends with anchoring members.

5. The implant of claim 4, wherein the anchoring members are barbs.

6. The implant of claim 4, wherein the anchoring members are hooks.

7. The implant of claim 1, wherein the plurality of support struts have free ends with anchoring members.

8. The implant of claim 1, wherein the central hub comprises an atraumatic foot.

9. The implant of claim 1, wherein the plurality of support struts extend from a first tube and the plurality of anchoring struts are cut from a second tube.

10. The implant of claim 9, wherein the first tube is an inner tube and the second tube is an outer tube.

11. The implant of claim 1, wherein the support struts are thinner than the anchoring struts.

12. An implant for partitioning a heart chamber, the implant comprising:

an inner tube cut to form a plurality of support struts;

an outer tube cut to form a plurality of anchoring struts, wherein the inner tube and outer tube are arranged concentrically and are each coupled to a hub; and

a partitioning membrane supported by the plurality of support struts.

13. The implant of claim 12, wherein the support struts are thinner than the anchoring struts.

14. The implant of claim 12, wherein the hub is formed of uncut portions of the inner tube and the outer tube.

15. A method of partitioning a ventricle, the method comprising:

delivering an implant to the ventricle in a collapsed configuration, the implant comprising a partitioning membrane configured to span the ventricle to partition the ventricle, a support frame comprising a central hub and a plurality of support struts extending proximally from the central hub, the plurality of support struts supporting the partitioning membrane, and a plurality of anchoring struts extending proximally from the central hub and configured to anchor the partitioning member across the ventricle, wherein the plurality of anchoring struts are separate from the plurality of support struts;

expanding the implant in the ventricle to an expanded configuration;

partitioning the ventricle with the partitioning membrane into a functional portion and a nonfunctional portion; and

anchoring the anchoring struts into the ventricle wall.

16. The method of claim 15, wherein the plurality of anchoring struts are not directly connected to the partitioning membrane.

17. The method of claim 15, further comprising anchoring one or more of the support struts into the ventricle wall.

18. The method of claim 15, wherein the plurality of anchoring struts are located between an end of the central hub and the partitioning membrane.

19. The method of claim 15, wherein the support struts are thinner than the anchoring struts.

20. The method of claim 15, wherein the plurality of anchoring struts have free ends with anchoring members.