Devices and methods for excluding the left atrial appendage

• US 9,943,315 B2
• Filed: 03/10/2014
• Issued: 04/17/2018
• 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.
• Primary Examiner(s): Ou, Jing
• Application Number:
  US14/203,187
• Publication Number:
  US 20140277074A1
• Time in Patent Office: 1,499 Days
• 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 guidewire lumen extending through the foam body;

a layer having an inner portion extending from within the guidewire lumen and an outer portion everting out around the proximal end of the foam body to form a seamless proximal face for facing the left atrium and continuing over an outer side of the side wall and at least partially over the distal end of the foam body, with a first end of the inner portion of the layer disposed distally of the distal end of the foam body and concentrically within a second end of the outer portion of the layer, with the first end and the second end connected together with an attachment structure;

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

wherein the outer portion of the layer has at least one opening to permit contact of left atrial appendage tissue with the foam body to permit tissue ingrowth into the foam body.

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

3. A left atrial appendage occlusion device as in claim 1, comprising at least one tissue ingrowth surface on the side wall of the foam body.

4. A left atrial appendage occlusion device as in claim 3, wherein the tissue ingrowth surface comprises an exposed surface of the foam body which is not covered by the layer.

5. A left atrial appendage occlusion device as in claim 4, wherein the tissue ingrowth surface comprises at least about 20% of the surface area of the side wall of the foam body.

6. A left atrial appendage occlusion device as in claim 1, wherein the layer comprises a tubular sleeve and the first end and second end are connected to each other to enclose the foam body.

7. A left atrial appendage occlusion device as in claim 6, comprising a plurality of openings in the layer to permit tissue ingrowth into the foam body.

8. A left atrial appendage occlusion device as in claim 1, wherein the first end and second end are connected to each other by a crimp.

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

10. A left atrial appendage occlusion device as in claim 9, wherein the radiopaque marker comprises a radiopaque thread.

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

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

13. A left atrial appendage occlusion device as in claim 12, wherein the anchor comprises a tissue penetrating element.

14. A left atrial appendage occlusion device as in claim 13, wherein the tissue penetrating element comprises a helical wire.

15. 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 left atrial appendage occlusion device compressed within the distal end of the delivery catheter;

an axially movable deployment control extending through the lumen, for deploying the left atrial appendage occlusion device from the distal end of the delivery catheter; and

wherein the left atrial appendage occlusion device comprises;

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 guidewire lumen extending through the foam body;

a layer having an inner portion extending from within the guidewire lumen and an outer portion everting out around the proximal end of the foam body to form a seamless proximal face for facing the left atrium and continuing over an outer side of the side wall and at least partially over the distal end of the foam body, with a first end of the inner portion of the layer disposed distally of the distal end of the foam body and concentrically within a second end of the outer portion of the layer, with the first end and the second end connected together with an attachment structure;

wherein the foam body can be compressed within the delivery catheter which has an inside diameter of no more than about 20F, and

wherein the foam body can self-expand to a diameter of at least about 25 mm when released from the delivery catheter; and

wherein the outer portion of the layer has at least one opening to permit contact of left atrial appendage tissue with the foam body to permit tissue ingrowth into the foam body.

16. A left atrial appendage closure system as in claim 15, further comprising a guidewire, wherein the guidewire has an inflatable balloon thereon.

17. A left atrial appendage closure system as in claim 15, additionally wherein the layer comprises a skin covering at least a portion of the foam body.