Devices and methods for excluding the left atrial appendage

• US 10,617,425 B2
• Filed: 10/11/2016
• Issued: 04/14/2020
• Est. Priority Date: 03/10/2014
• Status: Active Grant

• Current Assignee: Conformal Medical, Inc.
• Original Assignee: Conformal Medical, Inc.
• Inventors: Kaplan, Aaron V., Melanson, David, Devellian, Carol, Levine, Andy H., Chamorro, Andres
• Primary Examiner(s): Holwerda, Kathleen S
• Assistant Examiner(s): Rwego, Kankindi
• Application Number:
  US15/290,692
• Publication Number:
  US 20170042549A1
• Time in Patent Office: 1,281 Days
• Field of Search: 606200, 606213
• 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 are described for occluding the left atrial appendage (LAA) to exclude the LAA from blood flow to prevent blood from clotting within the LAA and subsequently embolizing, particularly in patients with atrial fibrillation. A foam implant is delivered via transcatheter delivery into the LAA and anchored using an internal locking system of the implant. The locking system includes deployable anchors that can be deployed after deployment of the foam implant from the delivery catheter and expansion of the foam within the LAA. The implant location can thus be verified before deploying the anchors to secure the implant. The locking system can be reversible to allow retraction of the anchors and repositioning or retrieval of the implant.

Claims

1. A left atrial appendage occlusion device, comprising:

an open cell foam body having a proximal end and a distal end, the proximal end including an occlusion region comprising a blood contacting surface that is thromboresistant, the proximal end configured to face a left atrium and the distal end configured to face the left atrial appendage following implantation in the left atrial appendage, wherein the body can be compressed for delivery within a delivery catheter and can self-expand when removed from the delivery catheter; and

a central hub within the body and at least one deployable tissue anchor, the deployable anchor comprising a support segment connected to the hub and a tissue engaging segment extending along an axis and terminating in a tissue engaging tip, the deployable anchor configured to deploy from a constrained configuration to a deployed configuration where the tissue engaging tip of the deployable anchor penetrates the foam body and advances along the axis to position the tissue engaging tip outside the body to secure the body within the left atrial appendage,

wherein material within the foam body is removed to accommodate the hub and the support segment.

2. The left atrial appendage occlusion device of claim 1, further comprising at least one tissue ingrowth surface on a sidewall of the body.

3. The left atrial appendage occlusion device of claim 1, wherein the foam body is cylindrical.

4. The left atrial appendage occlusion device of claim 1, further comprising a locking system that includes a moveable restraint configured to hold the deployable anchor in the constrained configuration and to release the deployable anchor from the constrained configuration to allow the deployable anchor to deploy to the deployed configuration.

5. The left atrial appendage occlusion device of claim 1, further comprising a plurality of the deployable anchors rotatably coupled by a respective plurality of the support segments with the hub, wherein the plurality of anchors are configured to rotate to the deployed configuration.

6. The left atrial appendage occlusion device of claim 5, wherein the plurality of the support segments comprises a plurality of struts.

7. The left atrial appendage occlusion device of claim 1, further comprising a restraint that restrains the anchor in the constrained configuration, wherein the anchor is deployed from the constrained configuration to the deployed configuration by removing the restraint from the anchor.

8. The left atrial appendage occlusion device of claim 7, wherein the restraint is a sheath that restrains the anchor in the constrained configuration by covering the anchor, wherein the anchor is deployed from the constrained configuration to the deployed configuration by removing the sheath from covering the anchor.

9. The left atrial appendage occlusion device of claim 1, further comprising a skin.

10. The left atrial appendage occlusion device of claim 9, wherein the skin covers the proximal end of the body.

11. The left atrial appendage occlusion device of claim 9, wherein the skin comprises ePTFE.

12. The left atrial appendage occlusion device of claim 9, further comprising a plurality of openings in the skin to permit tissue ingrowth into the open cell foam body.

13. The left atrial appendage occlusion device of claim 12, wherein the plurality of openings of the skin are located in an anchoring region of the device located at least between the proximal and distal ends of the device.

14. 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; and

a left atrial appendage occlusion device configured to be compressed within the delivery catheter and to self-expand upon deployment from the delivery catheter, the device comprising;

a self-expandable open cell foam body having a proximal end and a distal end, the proximal end including an occlusion region comprising a blood contacting surface that is thromboresistant, and

a central hub within the body and a deployable anchor extending through a sidewall of the foam body and comprising a support segment connected to the hub and a tissue engaging segment terminating in a tissue engaging tip, the deployable anchor configured to deploy from a constrained configuration in which the tissue engaging tip is within an outer surface of the sidewall of the body to a deployed configuration where the tissue engaging tip has penetrated through and beyond the sidewall of the body to secure the body within the left atrial appendage, wherein material within the foam body is removed to accommodate the hub and the support segment.

15. The left atrial appendage closure system of claim 14, further comprising a sheath that restrains the anchor in the constrained configuration by covering the anchor, wherein the anchor is deployed from the constrained configuration to the deployed configuration by removing the sheath from covering the anchor.

16. The left atrial appendage closure system of claim 14, wherein the foam body further comprises a skin.

17. The left atrial appendage occlusion device of claim 16, wherein the skin comprises expanded polytetrafluoroethylene (ePTFE) and is carried on the proximal end of the body.

18. A left atrial appendage occlusion device, comprising:

an expandable foam body, wherein the body can be compressed for delivery within a delivery catheter and can self-expand when removed from the delivery catheter; and

a central hub within the body and a deployable anchor rotatably coupled with the hub, the deployable anchor configured to deploy from a constrained configuration within the body to a deployed configuration where a tissue engaging segment of the anchor penetrates through a sidewall of the body to position an anchor tip of the tissue engaging segment outside the body to secure the body within the left atrial appendage.

19. A left atrial appendage occlusion device, comprising:

an expandable foam body having a proximal face and a sidewall extending distally from the proximal face, wherein the body can be compressed for delivery within a delivery catheter and can self-expand when removed from the delivery catheter; and

a central hub within the body and a deployable anchor connected to the hub, the deployable anchor comprising a tissue engaging segment terminating in a tissue engaging tip, the anchor configured to deploy from a constrained configuration within the body to a deployed configuration where the tissue engaging segment penetrates through the sidewall of the body to position the tissue engaging tip of the deployable anchor outside the body to secure the body within the left atrial appendage.