Method of implanting an adjustable occlusion device

• US 9,943,299 B2
• Filed: 01/24/2014
• Issued: 04/17/2018
• Est. Priority Date: 11/08/1999
• Status: Expired due to Fees

• Current Assignee: Atritech Inc. (Boston Scientific Corporation)
• Original Assignee: Atritech Inc. (Boston Scientific Corporation)
• Inventors: Khairkhahan, Alexander K., Frazier, Andrew G. C., Klenk, Alan R., Kreidler, Marc S., Kume, Stewart M., Ogi, Darrell H., Roue, Chad C., van der Burg, Erik J., DeCicco, Dino, Lesh, Michael D.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US14/163,578
• Publication Number:
  US 20140148842A1
• Time in Patent Office: 1,544 Days
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61M 2025/1054 : having detachable or disposable balloons
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Disclosed is an adjustable occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device is removably carried by a deployment catheter. The device may be enlarged or reduced to facilitate optimal placement or removal. Methods are also disclosed.

Claims

1. An implantable left atrial appendage occlusion device comprising:

an occluding member, enlargeable from a reduced cross-section configuration to an enlarged cross-section configuration; and

a stabilizing member,

wherein the stabilizing member is enlargeable from a reduced cross-section state to an enlarged cross-section state,

wherein a cross-sectional area of the enlarged cross-section state of the stabilizing member is less than a cross-sectional area of the enlarged cross-section configuration of the occluding member,

wherein the stabilizing member comprises at least three radially outwardly moveable segments inclined radially outward in a proximal direction to terminate at atraumatic free ends, and

wherein the occluding member includes a membrane or mesh.

2. The implantable left atrial appendage occlusion device of claim 1, further comprising a hub between the occluding member and the stabilizing member.

3. The implantable left atrial appendage occlusion device of claim 2, wherein the occluding member comprises an expandable frame.

4. The implantable left atrial appendage occlusion device of claim 3, wherein the frame comprises at least two spokes.

5. The implantable left atrial appendage occlusion device of claim 4, wherein at least one spoke of the at least two spokes has a first end and a second end, and the first end is attached to the hub.

6. The implantable left atrial appendage occlusion device of claim 1, wherein the stabilizing member comprises at least two segments which are movable from an axial orientation when the stabilizing member is in the reduced cross-section state to an inclined orientation when the stabilizing member is in the enlarged cross-section state.

7. The implantable left atrial appendage occlusion device of claim 6, wherein each segment of the at least two segments of the stabilizing member comprises a proximal section, a distal section, and a bend in between the proximal section and the distal section when the stabilizing member is in the enlarged cross-section state.

8. The implantable left atrial appendage occlusion device of claim 6, wherein each element of the at least two segments of the stabilizing member comprises wire.

9. The implantable left atrial appendage occlusion device of claim 6, wherein the at least two segments of the stabilizing member are integrally formed.

10. The implantable left atrial appendage occlusion device of claim 1, further comprising at least one tissue attachment element on the occluding member or on the stabilizing member or on both.

11. The implantable left atrial appendage occlusion device of claim 10, wherein the at least one tissue attachment structure comprises a tissue piercing element.

12. An implantable left atrial appendage occlusion device comprising:

a body having a longitudinal axis;

an expandable occluding member at a first position on the longitudinal axis; and

a stabilizing member at a second position on the longitudinal axis,

wherein the stabilizing member comprises at least three radially outwardly moveable segments inclined radially outward in a proximal direction to terminate at atraumatic free ends,

wherein the expandable occluding member comprises a plurality of spokes which are hingedly attached to the body and movable between an axial orientation and a radially outwardly inclined orientation.

13. The implantable left atrial appendage occlusion device of claim 12, further comprising a membrane or mesh carried by the plurality of spokes.

14. The implantable left atrial appendage occlusion device of claim 12, wherein the at least three radially outwardly moveable segments comprise flexible metal.

15. The implantable left atrial appendage occlusion device of claim 12, further comprising a hinge on the body between the expandable occluding member and the stabilizing member.

16. The implantable left atrial appendage occlusion device of claim 15, wherein the hinge comprises a coil.

17. The implantable left atrial appendage occlusion device of claim 12, wherein at least one spoke of the plurality of spokes of the expandable occluding member is configured and adapted to engage tissue and to assist in retaining the implantable left atrial appendage occlusion device at a deployment site.