DEVICES AND METHODS FOR EXCLUDING THE LEFT ATRIAL APPENDAGE

• US 20140277074A1
• Filed: 03/10/2014
• Published: 09/18/2014
• Est. Priority Date: 03/13/2013
• Status: Active Grant

• Current Assignee: Conformal Medical, Inc.
• Original Assignee: Conformal Medical, Inc.
• Inventors: Kaplan, Aaron V., Melanson, David, Devellian, Carol, Levine, Andy H.
• Granted Patent: US 9,943,315 B2
• Time in Patent Office: Days
• US Class Current: 606/198
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22048 Balloons
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

Devices and methods for occluding the left atrial appendage (LAA) to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. A foam implant encapsulated with a tough thromboresistant membrane is placed via transvascular means into the LAA and anchored with adhesives and/or mechanical anchors. Tissue over- and in-growth are optimized to anchor the implant in place and provide a permanent occlusion.

Claims

1. A left atrial appendage occlusion device, comprising:

an expandable, open cell foam body having a proximal end for facing the left atrium following implantation in the left atrial appendage, a distal end for facing into the left atrial appendage following implantation, and a side wall;

a skin covering at least the proximal end of the body; and

a guidewire lumen extending through the body;

wherein the body can be compressed within a delivery catheter having an inside diameter of no more than about 20 F and can self-expand to a diameter of at least about 25 mm when released from the delivery catheter.

2. A left atrial appendage occlusion device as in claim 1, wherein the skin comprises ePTFE.

3. A left atrial appendage occlusion device as in claim 1, wherein the skin extends throughout the length of the guidewire lumen to the distal end.

4. A left atrial appendage occlusion device as in claim 3, wherein the skin additionally covers at least a portion of the distal end of the body.

5. A left atrial appendage occlusion device as in claim 1, comprising at least one tissue ingrowth surface on the sidewall of the body.

6. A left atrial appendage occlusion device as in claim 5, wherein the tissue ingrowth surface comprises an exposed surface of the foam which is not covered by the skin.

7. A left atrial appendage occlusion device as in claim 6, wherein the tissue ingrowth surface comprises at least about 20% of the surface area of the side wall of the body.

8. A left atrial appendage occlusion device as in claim 1, wherein the skin comprises a tubular sleeve that has a first end and a second end, and the sleeve extends through the guidewire lumen and everts back over the body so that the first end and second end are connected to each other to enclose the foam body.

9. A left atrial appendage occlusion device as in claim 8, wherein the first end and second end are connected to each other by a crimp.

10. A left atrial appendage occlusion device as in claim 1, further comprising at least one radiopaque marker.

11. A left atrial appendage occlusion device as in claim 10, wherein the radiopaque marker comprises a radiopaque thread.

12. A left atrial appendage occlusion device as in claim 8, comprising a plurality of openings in the skin to permit tissue ingrowth into the foam.

13. A left atrial appendage occlusion device as in claim 1, wherein the device comprises a substantially cylindrical configuration in an unconstrained expansion.

14. A left atrial appendage occlusion device as in claim 1, further comprising at least one anchor.

15. A left atrial appendage occlusion device as in claim 14, wherein the anchor comprises a tissue penetrating element.

16. A left atrial appendage occlusion device as in claim 15, wherein the tissue penetrating element comprises a helical wire.

17. A left atrial appendage closure system, comprising:

a delivery catheter comprising an elongate flexible tubular body, having a proximal end and a distal end and at least one lumen extending therethrough;

a self-expandable open cell foam body compressed within the distal end of the delivery catheter;

the body comprising a skin covering at least a portion of the body and a guidewire extending through the body; and

an axially movable deployment control extending through the lumen, for deploying the foam body from the distal end of the closure system.

18. A left atrial appendage closure system as in claim 17, additionally comprising a guidewire having an inflatable balloon thereon.

19. A left atrial appendage closure system as in claim 17, additionally comprising a skin covering at least a portion of the foam body.

20. A left atrial appendage closure system as in claim 19, additionally comprising at least one opening through the skin to permit tissue ingrowth into the foam body.

21. A left atrial appendage closure system as in claim 17, additionally comprising a second lumen extending through the tubular body.

22. A left atrial appendage closure system as in claim 21, wherein the second lumen is configured to deliver a flowable media to a surface of the foam body.

23. A left atrial appendage closure system as in claim 22, wherein the flowable media comprises an adhesive.

24. A method of excluding a left atrial appendage, comprising the steps of:

providing a delivery catheter having an elongate tubular body with a proximal end and a distal end;

advancing a guidewire into the left atrial appendage;

advancing the distal end over the guidewire and into the left atrial appendage;

deploying an implant from the distal end,

wherein the implant comprises a self-expanding body having an open cell foam and an outer layer, and the implant conforms to the surface of the left atrial appendage.

25. A method of excluding a left atrial appendage as in claim 24, further comprising the step of inflating a balloon on the wire prior to the deploying an implant step.

26. A method of excluding a left atrial appendage as in claim 24, further comprising the step of anchoring the implant to adjacent tissue.

27. A method of excluding a left atrial appendage as in claim 26, wherein the anchoring step comprises adhesively bonding the implant to adjacent tissue.

28. A method of excluding a left atrial appendage as in claim 26, wherein the anchoring step comprises mechanically engaging the adjacent tissue.