Method of implanting an adjustable occlusion device

• US 8,663,273 B2
• Filed: 10/17/2011
• Issued: 03/04/2014
• 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:
  US13/274,380
• Publication Number:
  US 20120035643A1
• Time in Patent Office: 869 Days
• Field of Search: 606/108, 606/151, 606/194, 606/195, 606/200, 606/213
• US Class Current: 606/213
• 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 occlusion device comprising:

an occluding member having a compressed configuration and a radially expanded configuration, the occluding member being biased to the radially expanded configuration;

a bulking element having a compressed configuration and a radially expanded configuration, the bulking element being biased to the radially expanded configuration;

a first hub having an outer surface;

a second hub having an outer surface; and

a central waist having an outer surface,

the occluding member being disposed between the first hub and the central waist,

the bulking element being disposed between the central waist and the second hub,

the occlusion device configured such that when the occluding member and the bulking element are in their radially expanded configurations, the occluding member extends radially out past the outer surface of the first hub and the outer surface of the central waist and the bulking element extends radially out past the outer surface of the central waist and the outer surface of the second hub,

wherein the occluding member comprises a barrier disposed on a frame, wherein the frame comprises nitinol wires;

wherein in their radially expanded configurations, the occluding member extends radially farther from a central longitudinal axis of the occlusion device than the bulking element;

wherein when unconstrained by a delivery device in the radially expanded configuration, a first convex portion of the occluding member extends proximally from a plane to the first hub, and a second convex portion of the occluding member extends distally from the plane to the central waist, the plane being disposed normal to the central longitudinal axis through a radialmost extent of the occluding member.

2. The implantable occlusion device of claim 1 wherein the barrier comprises a first layer of porous polymer material and a second layer of porous polymer material.

3. The implantable occlusion device of claim 2 wherein the barrier comprises a third porous layer disposed between the first layer and the second layer.

4. The implantable occlusion device of claim 1 wherein the first hub has a length and an outer diameter and wherein the length is equal to or greater than the outer diameter.

5. The implantable occlusion device of claim 1 wherein the second hub has a length and an outer diameter and wherein the length is equal to or greater than the outer diameter.

6. The implantable occlusion device of claim 1 wherein the waist has an outer diameter and spaces the occluding member from the bulking element a distance at least equal to the outer diameter of the waist.

7. The implantable occlusion device of claim 1 wherein when the occluding member is in the radially expanded configuration, the occluding member has a diameter and a length and wherein the diameter is greater than the length.

8. The implantable occlusion device of claim 1 wherein when the bulking element is in the radially expanded configuration, the bulking element has a diameter and a length and wherein the diameter is greater than the length.

9. The implantable occlusion device of claim 1 wherein the nitinol wires comprise wires having a circular cross section.

10. The implantable occlusion device of claim 1 wherein the barrier is joined to the frame by sutures.

11. The implantable occlusion device of claim 1 wherein the barrier has an open surface area in the range of about 10% to about 90%.

12. The implantable occlusion device of claim 1 wherein the barrier has an open surface area in the range of about 30% to about 60%.

13. The implantable occlusion device of claim 1 wherein the occluding member and the waist are formed from adjoining sections of a precursor tubular member.

14. The implantable occlusion device of claim 1 wherein the occluding member, the waist and the bulking element are formed from adjoining sections of a precursor tubular member.

15. The implantable occlusion device of claim 1 wherein the occluding member comprises an expandable mesh.

16. The implantable occlusion device of claim 1 wherein when the occluding member is in the radially expanded configuration, a portion of the occluding member adjoining the first hub tapers to the first hub.

17. The implantable occlusion device of claim 1 wherein when the bulking element is in the radially expanded configuration, a portion of the bulking element adjoining the second hub tapers to the second hub.

18. The implantable occlusion device of claim 1 wherein the occluding member has a first end and a second end opposite the first end, the first end joined to the first hub and the second end joined to the central waist.

19. The implantable occlusion device of claim 1 wherein the bulking element has a first end and a second end opposite the first end, the first end joined to the central waist and the second end joined to the second hub.