Ventricular volume reduction

• US 10,028,835 B2
• Filed: 05/19/2016
• Issued: 07/24/2018
• Est. Priority Date: 10/26/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• 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:
  US15/159,715
• Publication Number:
  US 20160262892A1
• Time in Patent Office: 796 Days
• Field of Search: 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 catheter for retrieving an implant having one or more anchoring members from a patient, the catheter comprising:

an elongate shaft having a tubular body;

a flexible region coupled to a distal end of the elongate shaft; and

a distal tip,

wherein the flexible region is deformable between a tubular configuration and a prolapsed configuration, and wherein, in the prolapsed configuration, the flexible region is collapsible around the one or more anchoring members of the implant for atraumatic removal of the implant.

2. The catheter of claim 1, wherein the flexible region comprises a braided mesh.

3. The catheter of claim 2, wherein the braided mesh is encapsulated in a polymer matrix.

4. The catheter of claim 1, wherein the distal tip comprises a radiopaque marker band.

5. The catheter of claim 1, further comprising a hook extending through the tubular body of the elongate shaft, wherein the hook is configured to engage and collapse the implant.

6. A system for performing a procedure in a patient'"'"'s ventricle, the system comprising:

an implant comprising;

a plurality of struts, and

a plurality of anchoring members, wherein each strut terminates in an anchoring member; and

a retrieval catheter comprising;

an elongate shaft having a tubular body,

a flexible region coupled to a distal end of the elongate shaft, and

a distal tip,

wherein the flexible region is deformable between a tubular configuration and a prolapsed configuration, and wherein, in the prolapsed configuration, the flexible region is collapsible around the plurality of anchoring members of the implant for atraumatic removal of the implant.

7. The system of claim 6, wherein the implant further comprises a string for collapsing the plurality of struts from an expanded, deployed configuration to a collapsed configuration.

8. The system of claim 6, wherein the implant further comprises a suture coupled to a central region of the implant to withdraw the collapsed implant from the patient'"'"'s ventricle.

9. The system of claim 8, wherein the central region of the implant is a central hub of the implant.

10. The system of claim 6, wherein the flexible region comprises a braided mesh.

11. The system of claim 10, wherein the braided mesh is encapsulated in a polymer matrix.

12. The system of claim 6, wherein the distal tip of the retrieval catheter further comprises a radiopaque marker band.

13. The system of claim 6, wherein the retrieval catheter further comprises a hook extending through the tubular body of the elongate shaft, wherein the hook is configured to engage and collapse the implant.

14. The system of claim 6, wherein the implant further comprises a removal feature.

15. The system of claim 14, wherein the retrieval catheter is configured to couple to the removal feature to retrieve the implant from a patient'"'"'s ventricle.

16. The system of claim 6, wherein the implant further comprises a membrane coupled to the plurality of struts.

17. The system of claim 6, wherein the flexible region is configured to collapse around the implant when the implant is drawn against the distal tip.