Bioabsorbable left atrial appendage closure with endothelialization promoting surface

• US 10,667,896 B2
• Filed: 11/11/2016
• Issued: 06/02/2020
• Est. Priority Date: 11/13/2015
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Delaney, Jr., Joseph Thomas, Wulfman, David Robert, Gruba, Sarah Melissa
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/349,156
• Publication Number:
  US 20170135801A1
• Time in Patent Office: 1,299 Days
• Field of Search: 606200, 606213
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• 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 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

The disclosure pertains to percutaneously deliverable bioabsorbable closure devices for an ostium of a left atrial appendage which devices promote endothelialization across the ostium and then are bioabsorbed to leave little or no foreign residue, methods of manufacturing such bioabsorbable closure devices, and the use thereof.

Claims

1. A left atrial appendage closure device comprising:

a plurality of bioabsorbable struts having a proximal end and a distal end which are joined at their proximal portions to form an umbrella-like support structure which is concave when viewed from a distal end of the plurality of bioabsorbable struts,

wherein the umbrella-like support structure has a first compact delivery configuration and a second expanded deployed configuration in which the umbrella-like support structure has a proximal circumferential dimension sized and adapted to span and engage an ostium of a left atrial appendage and a longitudinal extent sized and adapted to be contained within the left atrial appendage;

a bioabsorbable porous cap coextensive with the joined proximal portions of the bioabsorbable struts and which extends distally therefrom along at least a portion of the umbrella-like support structure sized and adapted to be contained within the left atrial appendage,

wherein the pores of the bioabsorbable porous cap are sized and adapted to retain thrombi within the left atrial appendage when the left atrial appendage closure device is deployed within the left atrial appendage, and the bioabsorbable porous cap includes a tissue growth promoting component,

wherein the plurality of bioabsorbable struts and the bioabsorbable porous cap are integrally formed from a single polymer.

2. The left atrial appendage closure device of claim 1, wherein the bioabsorbable porous cap is selected from the group consisting of a textile, a nonwoven, a braid, a laser cut sheet, an etched sheet, and a 3D printed article.

3. The left atrial appendage closure device of claim 1, wherein the single polymer is selected from the group consisting of polyglycolic acid, polylactic acid, polycaprolactone, polyvalerolactone, poly(1,4-dioxane-2,3-dione), poly(1,3-dioxane-2-one), poly(p-dioxanone), poly(1,5-dioxepan-2-one), poly(P-R,S-malic acid), poly(α

-malic acid), polyhydroxyalkanoates, and mixtures or copolymers thereof.

4. The left atrial appendage closure device of claim 1, wherein the tissue growth promoting component is selected from the group consisting of fibronectin, vascular endothelial growth factor, and fibroblast growth factor.

5. The left atrial appendage closure device of claim 1, wherein tissue growth promoting component is a layer on the bioabsorbable porous cap.

6. The left atrial appendage closure device of claim 1, wherein tissue growth promoting component is dispersed within the bioabsorbable porous cap.

7. The left atrial appendage closure device of claim 1, wherein tissue growth promoting component is absorbed within a surface layer of the bioabsorbable porous cap.

8. The left atrial appendage closure device of claim 1, wherein thicknesses of the plurality of bioabsorbable struts and the bioabsorbable porous cap are selected to provide a controlled bioabsorption profile which minimizes release of particulate material.

9. The left atrial appendage closure device of claim 1, further comprising a hub attached to the plurality of bioabsorbable struts and adapted to be releaseably attached to a distal end of a delivery shaft.