Device and method for modifying the shape of a body organ

• US 20040010305A1
• Filed: 05/02/2003
• Published: 01/15/2004
• Est. Priority Date: 12/05/2001
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kowalsky, Leonard, Mathis, Mark L., Alferness, Clifton A., Beeson, Cruz, Adams, John M., Reuter, David G.
• Granted Patent: US 7,179,282 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

An intravascular support device includes a support or reshaper wire, a proximal anchor and a distal anchor. The support wire engages a vessel wall to change the shape of tissue adjacent the vessel in which the intravascular support is placed. The anchors and support wire are designed such that the vessel in which the support is placed remains open and can be accessed by other devices if necessary. The device provides a minimal metal surface area to blood flowing within the vessel to limit the creation of thrombosis. The anchors can be locked in place to secure the support within the vessel.

Claims

1. A device for modifying the shape of tissue adjacent to a lumen, the device comprising:

an anchor adapted to securely contact a lumen wall when the device is deployed in a lumen,

a reshaper extending from the anchor and adapted to contact the lumen wall when the device is deployed in the lumen to modify the shape of tissue adjacent to the lumen wall;

the anchor being expandable within the lumen from a first configuration to a second configuration such that the anchor'"'"'s diameter perpendicular to the central axis of the lumen in the second configuration is at least 50% greater than the anchor'"'"'s diameter perpendicular to the central axis of the lumen in the first configuration.

2. The device of claim 1 further comprising a lock adapted to resist the return of the anchor from the second configuration to the first configuration.

3. The device of claim 1 wherein the anchor is further adapted to expand from the first configuration to the second configuration after being deployed from a catheter.

4. The device of claim 1 wherein the anchor is further adapted to be recaptured by a catheter after being deployed from a catheter.

5. The device of claim 4 wherein the anchor is adapted to change shape to fit within a catheter in response to a recapture force applied to the anchor.

6. The device of claim 5 wherein the recapture force is less than 20 lbs.

7. The device of claim 1 wherein the anchor is further adapted to expand to a third configuration as the lumen distends.

8. The device of claim 1 wherein the anchor is a first anchor, the device further comprising a second anchor, the reshaper extending from the first anchor to the second anchor.

9. A method of modifying the shape of tissue adjacent to a lumen, the method comprising:

providing a device in a catheter, the device comprising an anchor and a reshaper extending from the anchor;

inserting a distal end of the catheter into a lumen; and

deploying the device from the distal end of the catheter into the lumen, the deploying step comprising;

expanding the anchor to contact a lumen wall, the anchor expanding from a first configuration to a second configuration such that the anchor'"'"'s diameter perpendicular to the central axis of the lumen in the second configuration is at least 50% greater than the anchor'"'"'s diameter perpendicular to the central axis of the lumen in the first configuration; and

placing the reshaper in contact with the lumen wall to modify the shape of tissue adjacent to the lumen wall.

10. The method of claim 9 wherein the placing step comprises:

applying a proximally-directed force to the anchor and the reshaper.

11. The method of claim 9 further comprising locking the anchor.

12. The method of claim 9 wherein the anchor is a first anchor and the device further comprises a second anchor, the method further comprising:

expanding the second anchor from a first configuration to a second configuration such that the anchor'"'"'s diameter perpendicular to the central axis of the lumen in the second configuration is at least 100% greater than the anchor'"'"'s diameter perpendicular to the central axis of the lumen in the first configuration.

13. The method of claim 12 further comprising locking the second anchor.

14. The method of claim 12 further comprising:

recaptured the device into a catheter.

15. The method of claim 9 further comprising:

recapturing the anchor into a catheter.

16. A device for modifying the shape of tissue adjacent to a lumen, the device comprising:

an anchor adapted to securely contact a lumen wall when the device is deployed in a lumen; and

a reshaper extending from the anchor and adapted to contact the lumen wall when the device is deployed in the lumen to modify the shape of tissue adjacent to the lumen wall,

the anchor being deployable to a deployed configuration within the lumen such that the anchor'"'"'s open cross-sectional area measured perpendicular to a central axis of the lumen is at least 50% of the lumen cross-sectional area.

17. The device of claim 16 further comprising a lock adapted to maintain the anchor in the deployed configuration.

18. The device of claim 16 wherein the anchor is adapted to expand to the deployed configuration after being deployed from a catheter.

19. The device of claim 18 wherein the anchor is further adapted to be recaptured by a catheter after being deployed from the catheter.

20. The device of claim 18 wherein the anchor is adapted to change shape to fit within a catheter in response to a recapture force applied to the anchor.

21. The device of claim 20 wherein the recapture force is less than 20 lbs.

22. The device of claim 16 wherein the anchor is further adapted to expand as the lumen distends.

23. The device of claim 16 wherein the anchor is a first anchor, the device further comprising a second anchor, the reshaper extending from the first anchor to the second anchor.

24. A method of modifying the shape of tissue adjacent to a lumen, the method comprising:

providing a device in a catheter, the device comprising an anchor and a reshaper extending from the anchor;

inserting a distal end of the catheter into a lumen; and

deploying the device from the distal end of the catheter into the lumen, the deploying step comprising;

expanding the anchor to contact a wall of the lumen, the anchor expanding from a first configuration to a second configuration such that the anchor'"'"'s open cross-sectional area measured perpendicular to a central axis of the lumen is at least 50% of the lumen cross-sectional area; and

placing the reshaper in contact with the lumen wall to modify the shape of tissue adjacent to the lumen wall.

25. The method of claim 24 wherein the placing step comprises:

applying a proximally-directed force to the anchor and the reshaper.

26. The method of claim 24 further comprising locking the anchor.

27. The method of claim 24 further comprising recapturing the device into a catheter.

28. A device for modifying the shape of tissue adjacent to a lumen, the device comprising:

first and second anchors, each adapted to securely contact a lumen wall when the device is deployed in a lumen; and

a reshaper extending proximally from the first anchor to the second anchor and adapted to contact the lumen wall when the device is deployed in the lumen to modify the shape of tissue adjacent to the lumen wall,

the first and second anchors and the reshaper providing metal coverage within the lumen of less than 30%.

29. The device of claim 28 wherein the reshaper is adapted to contact the lumen wall when the device is deployed in the lumen.

30. The device of claim 28 wherein the device is adapted to modify the shape of tissue adjacent to the lumen when a proximally-directed force is applied to the first anchor through the reshaper.

31. The device of claim 28 wherein the first and second anchors are adapted to expand from a first configuration to a second configuration after being deployed from a catheter.

32. The device of claim 31 further comprising a lock adapted to resist the return of the anchor from the second configuration to the first configuration.

33. The device of claim 28 wherein the anchor is further adapted to be recaptured by a catheter after being deployed from a catheter.

34. The device of claim 33 wherein the anchor is adapted to change shape to fit within a catheter in response to a recapture force applied to the anchor.

35. The device of claim 34 wherein the recapture force is less than 20 lbs.

36. A method of modifying the shape of tissue adjacent to a lumen, the method comprising:

providing a device in a catheter, the device comprising first and second anchors and a reshaper extending from the first anchor to the second anchor;

inserting a distal end of the catheter into a lumen; and

deploying the device from the distal end of the catheter into the lumen, the deploying step comprising;

expanding the first anchor to contact a wall of the lumen;

placing the reshaper in contact with the lumen wall to modify the shape of tissue adjacent to the lumen wall;

expanding the second anchor;

the first and second anchors and the reshaper providing metal coverage within the lumen of less than 30%.

37. The method of claim 36 wherein the placing step comprises:

applying a proximally-directed force to the first anchor and the reshaper.

38. The method of claim 36 further comprising locking the first and second anchors.

39. The method of claim 36 further comprising recapturing the device into a catheter.

40. A device for modifying the shape of tissue adjacent to a lumen, the device comprising:

first and second anchors each adapted to expand to securely contact a lumen wall when the device is deployed in a lumen, the lumen having a lumen volume;

a reshaper extending between the first and second anchors and adapted to contact the lumen wall when the device is deployed in the lumen to modify the shape of tissue adjacent to the lumen wall;

the device occupying between about 1.5% and about 5.5% of the lumen volume.

41. The device of claim 40 further comprising first and second anchor locks.

42. The device of claim 40 wherein the first and second anchors are further adapted to be recaptured by a catheter after being deployed by a catheter.

43. The device of claim 42 wherein the anchor is adapted to change shape to fit within a catheter in response to a recapture force applied to the anchor.

44. The device of claim 43 wherein the recapture force is less than 20 lbs.

45. A device for modifying the shape of tissue adjacent to a lumen, the device comprising:

an anchor adapted to securely contact a lumen wall when the device is deployed in a lumen, the lumen having a lumen volume;

a reshaper extending from the anchor and adapted to contact the lumen wall when the device is deployed in the lumen to modify the shape of tissue adjacent to the lumen wall;

the device occupying between about 1.5% and about 5.5% of the lumen volume.

46. The device of claim 45 wherein the anchor is further adapted to expand within the lumen from a first configuration to a second configuration.

47. A method of modifying the shape of tissue adjacent to a lumen, the method comprising:

delivering a device into a lumen volume within the lumen, the device comprising an anchor and a reshaper extending from the anchor, the device occupying between about 1.5% and about 5.5% of the lumen volume;

placing the anchor in secure contact with a lumen wall; and

placing the reshaper in contact with the lumen wall to apply force to the lumen wall to modify the shape of tissue adjacent to the lumen wall.

48. The method of claim 47 wherein the step of placing the anchor comprises expanding the anchor.

49. The method of claim 47 wherein the anchor is a first anchor and the device further comprises a second anchor, the method further comprising placing the second anchor in secure contact with a lumen wall.

50. The method of claim 49 wherein the step of placing the second anchor comprises expanding the second anchor.

51. The device of claim 47 wherein the lumen is a coronary sinus, the step of placing an anchor comprising placing an anchor in secure contact with a wall of the coronary sinus, the step of placing a reshaper comprising placing a reshaper in contact with the coronary sinus wall to apply force to the posterior of a mitral valve annulus through the coronary sinus wall.