Device and method for modifying the shape of a body organ

• US 20060142854A1
• Filed: 05/02/2003
• Published: 06/29/2006
• 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 7,857,846 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 with radially outwardly directed force when the device is deployed in a lumen; and

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

2. 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.

3. The device of claim 1 wherein the anchor is further adapted to be expandable within the lumen from a first configuration to a second configuration, the anchor contacting the lumen wall in the second configuration.

4. The device of claim 3 wherein the anchor is further adapted to fit within a catheter in the first configuration.

5. The device of claim 4 wherein the anchor is adapted to be deformed from an expanded configuration into the first configuration and to at least partially recover to the second configuration when deployed from a catheter.

6. The device of claim 3 wherein the anchor comprises shape memory material.

7. The device of claim 6 wherein the reshaper comprises shape memory material.

8. The device of claim 7 wherein the percentage of shape memory material by volume in the device is in the range of about 30% to about 100%.

9. The device of claim 8 wherein the percentage of shape memory material by volume in the device is in the range of about 40% to about 60%.

10. The device of claim 1 wherein the reshaper has a modulus of elasticity between about 5×

10⁶ psi and about 20×

10⁶ psi.

11. The device of claim 1 wherein the lumen is a coronary sinus, the anchor being adapted to securely contact a wall of the coronary sinus with radially outwardly directed force when the device is deployed in the coronary sinus, the reshaper being adapted to contact the coronary sinus wall and to apply force to the posterior of a mitral valve annulus through the coronary sinus wall.

12. The device of claim 11 wherein the force applied by the reshaper to the mitral valve annulus changes during a heartbeat.

13. The device of claim 1 wherein the lumen is a coronary sinus, device being further adapted to automatically rotate within the coronary sinus from a delivered position to a deployed position in which the reshaper contacts a portion of the coronary sinus wall adjacent to the mitral valve annulus.

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

delivering a device into the lumen, the device comprising an anchor and a reshaper extending from the anchor;

placing the anchor in secure contact with a lumen wall with radially outwardly directed force; 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.

15. The method of claim 14 wherein the step of placing the anchor comprises expanding the anchor from a first configuration to a second configuration, the anchor contacting the lumen wall in the second configuration.

16. The method of claim 15 wherein the anchor is a first anchor, the method further comprising expanding a second anchor, the reshaper extending from the first anchor to the second anchor.

17. The method of claim 15 further comprising the steps of:

deforming the anchor from an expanded configuration into the first configuration;

placing the anchor in a catheter;

placing a distal end of the catheter in the lumen;

deploying the anchor from the distal end of the catheter; and

at least partially recovering the anchor to the second configuration.

18. The method of claim 14 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 with radially outwardly directed force when the device is deployed in 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.

19. The method of claim 18 wherein the force applied by the reshaper to the mitral valve annulus changes during a heartbeat.

20. 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 and apply force to the lumen wall when the device is deployed in the lumen to modify the shape of tissue adjacent to the lumen wall, the reshaper having a modulus of elasticity between about 5×

10⁶ psi and about 20×

10⁶ psi.

21. The device of claim 20 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.

22. The device of claim 20 wherein the anchor is further adapted to be expandable within the lumen from a first configuration to a second configuration, the anchor contacting the lumen wall in the second configuration.

23. The device of claim 22 wherein the anchor is further adapted to fit within a catheter in the first configuration.

24. The device of claim 22 wherein the anchor is adapted to be deformed from an expanded configuration into the first configuration and to at least partially recover to the second configuration when deployed from a catheter.

25. The device of claim 22 wherein the anchor comprises shape memory material.

26. The device of claim 25 wherein the reshaper comprises shape memory material.

27. The device of claim 26 wherein the percentage of shape memory material by volume in the device is in the range of about 30% to about 100%.

28. The device of claim 27 wherein the percentage of shape memory material by volume in the device is in the range of about 40% to about 60%.

29. The device of claim 20 wherein the lumen is a coronary sinus, the anchor being adapted to securely contact a wall of the coronary sinus with radially outwardly directed force when the device is deployed in the coronary sinus, the reshaper being adapted to contact the coronary sinus wall and to apply force to the posterior of a mitral valve annulus through the coronary sinus wall.

30. The device of claim 29 wherein the force applied by the reshaper to the mitral valve annulus changes during a heartbeat.

31. 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 anchor comprising shape memory material; and

a reshaper extending from the anchor and adapted to contact and apply force to the lumen wall when the device is deployed in the lumen to modify the shape of tissue adjacent to the lumen wall, the reshaper comprising shape memory material;

the percentage of shape memory material by volume in the device being in the range of about 30% to about 100%.

32. The device of claim 31 wherein the percentage of shape memory material by volume in the device is in the range of about 40% to about 60%.

33. The device of claim 31 wherein the anchor is a first anchor, the device further comprising a second anchor, the second anchor comprising shape memory material, the reshaper extending from the first anchor to the second anchor.

34. The device of claim 31 wherein the anchor is further adapted to be expandable within the lumen from a first configuration to a second configuration, the anchor contacting the lumen wall in the second configuration.

35. The device of claim 34 wherein the anchor is further adapted to fit within a catheter in the first configuration.

36. The device of claim 34 wherein the anchor is adapted to be deformed from an expanded configuration into the first configuration and to at least partially recover to the second configuration when deployed from a catheter.

37. The device of claim 31 wherein the lumen is a coronary sinus, the anchor being adapted to securely contact a wall of the coronary sinus with radially outwardly directed force when the device is deployed in the coronary sinus, the reshaper being adapted to contact the coronary sinus wall and to apply force to the posterior of a mitral valve annulus through the coronary sinus wall.

38. The device of claim 37 wherein the force applied by the reshaper to the mitral valve annulus changes during a heartbeat.

39. An intravascular support comprising:

a support wire having a proximal end and a distal end;

a proximal anchor that circumferentially engages a vessel wall in which the support is placed; and

a distal anchor that circumferentially engages a vessel wall in which the support is placed;

wherein the support wire extends between the proximal and distal anchors so that the support wire is urged against the vessel wall to compress tissue that is adjacent the vessel.

40. The intravascular support of claim 39, wherein the proximal and distal anchors are formed of wire loops that engage the vessel wall.

41. The intravascular support of claim 40, wherein the wire loops have a figure eight configuration.

42. The intravascular support of claim 39, wherein the support wire includes locks that secure the position of the proximal and distal anchors in an extended position.

43. The intravascular support of claim 39, wherein the support wire includes crimp tubes that orient the proximal and distal anchors.

44. The intravascular support of claim 39, wherein the proximal and distal anchors are oriented at different angles with respect to each other.

45. An intravascular support, comprising:

a distal anchor that expands within a vessel to circumferentially engage a vessel wall and defining a lumen therethrough;

a proximal anchor that expands within a vessel to circumferentially engage the vessel wall and defining a lumen therethrough; and

a support wire secured to the proximal and distal anchors such that the support wire is offset from the lumens defined by the proximal and distal anchors and is urged against the vessel wall by the proximal and distal anchors.

46. The intravascular support of claim 45, wherein the distal anchor has a collapsed configuration and an expanded configuration and the support wire has a distal end and a distal lock whereby the distal anchor is constrained between the distal end and the distal lock in the expanded configuration.

47. The intravascular support of claim 45, wherein the proximal and distal anchors are secured to the support wire with crimp tubes through which the support wire passes.

48. The intravascular support of claim 47, wherein the proximal and distal anchors are made of wires that are bent in a figure eight configuration with distal ends within the crimp tubes and proximal ends that form a movable eyelet that is slidable over the support wire to expand the proximal and distal anchors.