Medical device for modification of left atrial appendage and related systems and methods

• US 8,845,711 B2
• Filed: 10/17/2008
• Issued: 09/30/2014
• Est. Priority Date: 10/19/2007
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Linder, Richard J., Davis, Clark C., Whisenant, Brian K., Edmiston, Daryl R., Fox, DeWayne C.
• Primary Examiner(s): ANDERSON, GREGORY A
• Application Number:
  US12/253,831
• Publication Number:
  US 20090112249A1
• Time in Patent Office: 2,174 Days
• Field of Search: 606/200, 623/1.11, 623/2.11
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/1214 Coils or wires
• 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 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/1205 Introduction devices

Abstract

Several embodiments are set forth of devices, systems and methods for modifying an atrial appendage such as a left atrial appendage (LAA). In one embodiment, a device includes a body that is collapsible and self-expanding. The body includes a textured surface with protruding portions and recessed portions. The body may be formed of a reticulated foam material and may exhibit a substantially spherical geometry or a truncated spherical geometry. The body may be substantially hollow. In one embodiment, portions of the textured surface may be metalized or have a coating placed thereon to enhance frictional engagement of the body with the atrial appendage wall. In another embodiment, a mesh bag is disposed within an LAA and one or more self-expanding bodies are disposed within the mesh bag. The mesh bag is then secured to retain the self-expanding bodies within the bag and the LAA.

Claims

1. A medical device for modifying a left atrial appendage (LAA), comprising:

a polymer foam body formed of a self-expanding porous material, the body exhibiting a textured surface including a plurality of protruding portions and a plurality of recesses, each protruding portion being separated from an adjacent protruding portion by a recess of the plurality of recesses, each of the recesses having a predetermined depth defined relative to the adjacent protruding portions, each protruding portion having a square shaped end to define a first side, a second side, a third side, and a fourth side such that the first side is opposite the second side and the third side is opposite the fourth side, at least one protruding portion being separated from an adjacent protruding portion on each of the first side, the second side, the third side, and the fourth side of the at least one protruding portion;

wherein the plurality of protruding portions of the polymer foam body are configured to engage an inner wall of the LAA and anchor the polymer foam body in the LAA.

2. The medical device of claim 1, wherein the body, when in an expanded state, exhibits a substantially spherical geometry.

3. The medical device of claim 2, further comprising a substantially hollow cavity defined within an interior of the body.

4. The medical device of claim 1, wherein the body is formed of a material comprising at least one of a polyurethane, polyester, and polyvinyl acetate.

5. The medical device of claim 1, wherein the body, when in an expanded state, substantially exhibits a geometry of a truncated sphere.

6. The medical device of claim 5, wherein an opening is defined within a surface at the truncated end of the sphere and wherein the opening exposes an internal cavity of the body.

7. The medical device of claim 1, further comprising a coating of metal or graphite on at least some of the protruding portions.

8. The medical device of claim 7, wherein, when in a collapsed state, the protruding portions that are intended to engage a surface of delivery mechanism are substantially devoid of any metal or graphite coating.

9. The medical device of claim 1, further comprising a mesh bag disposed about the body.

10. The medical device of claim 1, further comprising a plurality of ties circumscribing the body, wherein each tie is disposed in a recess of the plurality of recesses.

11. The medical device of claim 1, further comprising at least one radio opaque marker associated with the body.

12. A medical device for modifying a left atrial appendage (LAA), comprising:

a mesh bag defining an opening moveable from an open position to a closed position, the mesh bag configured to be positioned within the LAA; and

a plurality of self-expanding foam bodies configured to be disposed within the mesh bag upon the mesh bag being positioned within the LAA, each of the foam bodies being separate and discrete from each other in a disconnected manner, wherein, upon the foam bodies being disposed within the mesh bag, the opening of the mesh bag is configured to be moved and secured to the closed position.

13. The medical device of claim 12, wherein the mesh bag is formed of a material comprising at least one of nylon, polyester or silicone.

14. The medical device of claim 12, wherein the plurality of self-expanding bodies includes a plurality of spherical bodies.

15. The medical device of claim 12, wherein the plurality of foam bodies are formed of a material comprising at least one of a polymer foam, polyurethane, and polyvinyl acetate.

16. The medical device of claim 12, further comprising at least one radio opaque marker associated with the mesh bag or at least one of the plurality of self-expanding bodies.

17. A method of modifying a left atrial appendage (LAA), the method comprising:

providing a polymeric foam body formed of a self-expanding material, the body exhibiting a textured surface including a plurality of protruding portions and a plurality of recesses, each protruding portion being separated from an adjacent protruding portion by a recess of the plurality of recesses, each of the recesses having a predetermined depth defined relative to the adjacent protruding portions, and each protruding portion including a square shaped end to define a first side, a second side, a third side, and a fourth side such that the first side is opposite of the second side and the third side is opposite the fourth side, at least one protruding portion being separated from an adjacent protruding portion on each of the first side, the second side, the third side, and the fourth side of the at least one protruding portion;

compressing the polymeric foam body within a delivery vehicle;

positioning a portion of the delivery vehicle adjacent an opening of the LAA;

discharging the polymeric foam body from the delivery vehicle into the LAA;

expanding the polymeric foam body in the LAA; and

anchoring the polymeric foam body within the LAA with the plurality of protruding portions of the polymeric foam body engaging the side wall of the LAA and substantially occluding an opening of the LAA.

18. A method of modifying a left atrial appendage (LAA), the method comprising:

disposing a mesh bag within the LAA such that the mesh bag defines an opening moveable from an open position to a closed position;

disposing a plurality of self-expanding foam bodies through the opening and within an interior of the mesh bag, each of the foam bodies being separate and discrete from each other in a disconnected manner; and

securely closing the opening of the mesh bag to the closed position to retain the plurality of self-expanding foam bodies within the bag.

19. The method according to claim 18, wherein disposing a plurality of self-expanding foam bodies within an interior of the mesh bag further includes disposing a plurality of self-expanding spherical foam bodies within the interior of the mesh bag.

20. An implantable medical device for modifying a left atrial appendage (LAA), comprising:

a first frame member having a first flat configuration and configured to anchor within the LAA;

a second frame member having a second flat configuration, wherein the first and second frame members are configured to be substantially perpendicular relative to each other;

a spring member extending between a first end and a second end, the first end directly connected to the first frame member and the second end directly connected to the second frame member; and

a tissue in-growth member attached to the second frame member and configured to cover an opening of the LAA.

21. The implantable medical device of claim 20, wherein the first frame member comprises tines extending therefrom, the tines configured to be biased into tissue of the LAA with a spring element associated with the first frame member.

22. A medical device for modifying a left atrial appendage (LAA), comprising:

a frame member having a substantially flat configuration, the frame member including distal anchor members for anchoring the frame member within the LAA, the frame member including a unitary, seamless central portion having a plurality of struts defining a multi-cellular structure extending between and configured to self-expand and directly bias the distal anchor members against a wall in the LAA; and

a tissue in-growth member attached to the frame member and configured to cover an opening of the LAA, the tissue in-growth member extending in a substantially flat configuration, the tissue in-growth member oriented substantially perpendicular relative to the frame member.

23. A medical device for modifying a left atrial appendage (LAA), comprising:

a frame member including a unitary, seamless central portion including a plurality of struts defining a multi-cellular structure having a substantially flat configuration and an anchoring system, the plurality of struts extending between and configured to self-expand and directly bias the anchor system to anchor the frame member at least partially within the LAA, the anchoring system including;

a first distal anchor and a second distal anchor, the first distal anchor being co-planar with the second distal anchor; and

a third distal anchor and a fourth distal anchor, the third distal anchor being co-planar with the fourth distal anchor, the first distal anchor extending in a discrete plane relative the third distal anchor; and

a tissue in-growth member attached to the frame member and configured to prevent potential embolic material from escaping the LAA.