Flanged occlusion devices and methods

• US 20060247680A1
• Filed: 06/27/2006
• Published: 11/02/2006
• Est. Priority Date: 04/08/2004
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories)
• Inventors: Russo, Pat, Thill, Gary A., Amplatz, Kurt, Gu, Xiaoping, Santer, Jana
• Granted Patent: US 9,743,932 B2
• Time in Patent Office: Days
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• 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 2017/00632 Occluding a cavity, i.e. closing a blind opening

Abstract

Implantable occlusion devices that include one or more flanges extending from a tubular body are disclosed. The flange or flanges may assist in retention of the device within a vessel, cavity, appendage, etc. At least one flange on the occlusion device may include a concave surface proximate one end of a body. Because of the shape of the flange, e.g., its concavity, the occlusion device may resist dislocation due to e.g., the forces generated within the left atrial appendage during atrial filbrillation.

Claims

1. A medical device for deployment in a body, wherein the device comprises:

a tubular body comprising a first end and a second end, wherein the body defines a longitudinal axis extending between the first end and the second end; and

wherein the body comprises a body width measured transverse to the longitudinal axis when the device is in a relaxed configuration; and

a flange attached to the body proximate the second end of the body, the flange comprising a concave outer surface facing the first end of the body and a flange width transverse to the longitudinal axis when the device is in a relaxed configuration;

wherein, when the device is in the relaxed configuration, the body width proximate the flange is half or more of the flange width.

5. A medical device according to claim 1, wherein the flange defines a convex surface facing away from the first end of the body when the device is in the relaxed configuration.

6. A medical device according to claim 5, wherein the concave outer surface and the convex surface of the flange meet proximate the flange lip.

7. A medical device according to claim 1, wherein the device comprises a collapsed configuration in which the distance between the first end and the second end is increased such that the body width and the flange width are reduced, enabling passage of the device through a lumen of a catheter, and wherein the device reverts to the relaxed configuration after removal from the lumen.

8. A medical device according to claim 1, wherein the device comprises a plurality of strands treated to conform in shape to the relaxed configuration of the device, wherein each strand of the plurality of strands comprises a proximal end and a distal end, wherein at least one of the proximal ends and the distal ends of the plurality of strands are secured at a common endpoint.

9. A medical device according to claim 8, wherein the plurality of strands are arranged into a fabric.

10. A medical device according to claim 9, wherein the flange comprises two layers of the fabric.

11. A medical device according to claim 8, further comprising a clamp attached to the device at the common endpoint.

12. A medical device according to claim 11, wherein the clamp comprises a thread adapted to rotationally receive a delivery device that comprises complementary threads.

13. A medical device according to claim 8, wherein the common end point is located proximate the first end of the device.

14. A method of treating a physiological condition, the method comprising deploying a medical device according to any one of claims 1-13 and 18-25 within a left atrial appendage of a heart.

15. A method according to claim 14, wherein the first end of the body of the medical device faces an interior of the left atrial appendage and wherein the second end is proximate an opening into the left atrial appendage.

16. A method according to claim 14, wherein, if the flange comprises a concave surface facing the first end of the body of the medical device, the concave surface faces an interior of the left atrial appendage.

17. A method according to claim 14, wherein, if the flange comprises a flange lip, the flange lip is biased against an interior surface of the left atrial appendage.

23. A medical device according to claim 5, wherein the device comprises a collapsed configuration in which the distance between the first end and the second end is increased such that the body width and the flange width are reduced, enabling passage of the device through a lumen of a catheter, and wherein the device reverts to the relaxed configuration after removal from the lumen.

24. A medical device according to claim 6, wherein the device comprises a collapsed configuration in which the distance between the first end and the second end is increased such that the body width and the flange width are reduced, enabling passage of the device through a lumen of a catheter, and wherein the device reverts to the relaxed configuration after removal from the lumen.

28. A medical device according to claim 5, wherein the device comprises a plurality of strands treated to conform in shape to the relaxed configuration of the device, wherein each strand of the plurality of strands comprises a proximal end and a distal end, wherein at least one of the proximal ends and the distal ends of the plurality of strands are secured at a common endpoint.

29. A medical device according to claim 6, wherein the device comprises a plurality of strands treated to conform in shape to the relaxed configuration of the device, wherein each strand of the plurality of strands comprises a proximal end and a distal end, wherein at least one of the proximal ends and the distal ends of the plurality of strands are secured at a common endpoint.

30. A medical device according to claim 7, wherein the device comprises a plurality of strands treated to conform in shape to the relaxed configuration of the device, wherein each strand of the plurality of strands comprises a proximal end and a distal end, wherein at least one of the proximal ends and the distal ends of the plurality of strands are secured at a common endpoint.

31. A medical device according to claim 9, wherein the common end point is located proximate the first end of the device.

32. A medical device according to claim 10, wherein the common end point is located proximate the first end of the device.

33. A medical device according to claim 11, wherein the common end point is located proximate the first end of the device.

34. A medical device according to claim 12, wherein the common end point is located proximate the first end of the device.

2. A medical device for deployment in a body, when the device comprises:

a tubular body comprising a first end and a second end, wherein the body defines a longitudinal axis extending between the first end and the second end; and

wherein the body comprises a body width measured transverse to the longitudinal axis when the device is in a relaxed configuration; and

a plurality of flanges attached to the body proximate the second end of the body, wherein each flange of the plurality of flanges comprises a concave outer surface facing the first end of the body and a flange width transverse to the longitudinal axis when the device is in the relaxed configuration, and wherein the body width proximate each flange of the plurality of flanges is less than the flange width.

18. A medical device according to claim 2, wherein the flange comprises a flange lip located distal from the longitudinal axis, and wherein the flange lip is located between the first end and the second end of the body when the device is in the expanded configuration.

20. A medical device according to claim 2, wherein the device comprises a collapsed configuration in which the distance between the first end and the second end is increased such that the body width and the flange width are reduced, enabling passage of the device through a lumen of a catheter, and wherein the device reverts to the relaxed configuration after removal from the lumen.

25. A medical device according to claim 2, wherein the device comprises a plurality of strands treated to conform in shape to the relaxed configuration of the device, wherein each strand of the plurality of strands comprises a proximal end and a distal end, wherein at least one of the proximal ends and the distal ends of the plurality of strands are secured at a common endpoint.

3. A medical device for deployment in a body, wherein the device comprises:

a tubular body comprising a first end and a second end, wherein the body defines a longitudinal axis extending between the first end and the second end; and

wherein the body comprises a body width measured transverse to the longitudinal axis when the device is in a relaxed configuration; and

only one flange attached to the body proximate the second end of the body, the only one flange comprising a concave outer surface facing the first end of the body and a flange width transverse to the longitudinal axis when the device is in the relaxed configuration, and wherein the body width proximate the only one flange is less than the flange width.

19. A medical device according to claim 3, wherein the flange comprises a flange lip located distal from the longitudinal axis, and wherein the flange lip is located between the first end and the second end of the body when the device is in the expanded configuration.

21. A medical device according to claim 3, wherein the device comprises a collapsed configuration in which the distance between the first end and the second end is increased such that the body width and the flange width are reduced, enabling passage of the device through a lumen of a catheter, and wherein the device reverts to the relaxed configuration after removal from the lumen.

26. A medical device according to claim 3, wherein the device comprises a plurality of strands treated to conform in shape to the relaxed configuration of the device, wherein each strand of the plurality of strands comprises a proximal end and a distal end, wherein at least one of the proximal ends and the distal ends of the plurality of strands are secured at a common endpoint.

4. A medical device according to claim 4, wherein the flange comprises a flange lip located distal from the longitudinal axis, and wherein the flange lip is located between the first end and the second end of the body when the device is in the expanded configuration.

22. A medical device according to claim 4, wherein the device comprises a collapsed configuration in which the distance between the first end and the second end is increased such that the body width and the flange width are reduced, enabling passage of the device through a lumen of a catheter, and wherein the device reverts to the relaxed configuration after removal from the lumen.

27. A medical device according to claim 4, wherein the device comprises a plurality of strands treated to conform in shape to the relaxed configuration of the device, wherein each strand of the plurality of strands comprises a proximal end and a distal end, wherein at least one of the proximal ends and the distal ends of the plurality of strands are secured at a common endpoint.