Adjustable height focal tissue deflector

• US 7,635,387 B2
• Filed: 06/03/2004
• Issued: 12/22/2009
• Est. Priority Date: 11/01/2001
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Beeson, Cruz, Reuter, David, Mathis, Mark, Nieminen, Greg
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US10/861,782
• Publication Number:
  US 20050021121A1
• Time in Patent Office: 2,028 Days
• Field of Search: 623/1.12, 623/1.15, 623/1.3, 623/2.36, 623/2.11, 623/2.37
• US Class Current: 623/2.37
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes

Abstract

A tissue shaping device adapted to reshape target tissue adjacent to a lumen. In some embodiments, the device includes an expandable and contractable anchor, with the anchor having an adjustable height anchoring portion adapted to engage a wall of the lumen in at least first and second anchor heights, the anchoring portion being further adapted to be changed from the first anchor height to the second anchor height by a substantially proximally or a substantially distally directed actuation force. The invention is also a tissue shaping system including a tissue shaping device and a tool for adjusting the height of an anchor of the device. The invention also includes methods of using such tissue shaping devices and systems.

Claims

1. A tissue shaping device adapted to reshape target tissue adjacent to a lumen, the device comprising an expandable and contractable anchor, the anchor comprising an adjustable height anchoring portion adapted to engage a wall of the lumen in at least first and second anchor heights, the anchoring portion being further adapted to be changed from the first anchor height to the second anchor height by a substantially proximally or a substantially distally directed actuation force,

wherein the adjustable height anchoring portion comprises a bent wire portion which is adapted to change its shape in response to the actuation force

wherein the anchor further comprises a plurality of locks each adapted to lock the anchoring portion in an anchoring height.

2. The tissue shaping device of claim 1 wherein the bent wire portion comprises a locking portion adapted to cooperate with each lock to maintain the bent wire portion'"'"'s shape.

3. A tissue shaping device adapted to reshape target tissue adjacent to a lumen, the device comprising

an expandable and contractable anchor, the anchor comprising an adjustable height anchoring portion adapted to engage a wall of the lumen in at least first and second anchor heights, the anchoring portion being further adapted to be changed from the first anchor height to the second anchor height by a substantially proximally or a substantially distally directed actuation force,

wherein the adjustable height anchoring portion comprises a bent wire portion, and

wherein the bent wire portion is formed in a figure 8 configuration.

4. A tissue shaping device adapted to reshape target tissue adjacent to a lumen, the device comprising an expandable and contractable anchor, the anchor comprising an adjustable height anchoring portion adapted to engage a wall of the lumen in at least first and second anchor heights, the anchoring portion being further adapted to be changed from the first anchor height to the second anchor height by a substantially proximally or a substantially distally directed actuation force,

the device further comprising an anchor height adjustment tool interface.

5. A tissue shaping device adapted to reshape target tissue adjacent to a lumen, the device comprising an expandable and contractable anchor, the anchor comprising an adjustable height anchoring portion adapted to engage a wall of the lumen in at least first and second anchor heights, the anchoring portion being further adapted to be changed from the first anchor height to the second anchor height by a substantially proximally or a substantially distally directed actuation force,

the device further comprising an anchor height adjustment mechanism adapted to register the adjustable height anchoring portion in a plurality of predetermined anchor heights.

6. The tissue shaping device of claim 5 wherein the anchor height adjustment mechanism comprises locks locking the adjustable height anchoring portion in each of the predetermined anchor heights.

7. The tissue shaping device of claim 5 wherein the anchor further comprises a base portion, the anchor height adjustment mechanism comprising a plurality of points of connection between the adjustable height anchoring portion and the base portion.

8. The tissue shaping device of claim 7 wherein the adjustable height anchoring portion comprises a bent wire portion.

9. The tissue shaping device of claim 8 wherein the base portion comprises a tube, the anchor height adjustment mechanism comprising slots formed in the tube and shaped to receive at least a portion of the anchor'"'"'s bent wire portion.

10. The tissue shaping device of claim 8 wherein the anchor height adjustment mechanism comprises shape changeable locks adapted to cooperate with a locking portion of the bent wire portion.

11. A tissue shaping system comprising:

an anchor height adjustment tool; and

a tissue shaping device adapted to reshape target tissue adjacent to a lumen, the device comprising an expandable and contractable anchor, the anchor comprising;

an adjustable height anchoring portion adapted to engage a wall of the lumen in at least first and second anchor heights; and

a tool interface adapted to receive a proximally or distally directed actuation force from the anchor height adjustment tool to change the adjustable height anchoring portion from the first anchor height to the second anchor height.

12. The tissue shaping system of claim 11 wherein the adjustable height anchoring portion comprises a bent wire portion.

13. The tissue shaping system of claim 12 wherein the bent wire portion is adapted to change its shape in response to the actuation force.

14. The tissue shaping system of claim 13 wherein the anchor further comprises a plurality of locks each adapted to lock the anchoring portion in an anchoring height.

15. The tissue shaping system of claim 14 wherein the bent wire portion comprises a locking portion adapted to cooperate with each lock to maintain the bent wire portion'"'"'s shape.

16. The tissue shaping system of claim 11 wherein the anchor is a first anchor, the tissue shaping device further comprising a second anchor and a connector disposed between the first and second anchor.

17. The tissue shaping system of claim 11 wherein the tissue shaping device comprises an anchor height adjustment mechanism comprising the tool interface, the anchor height adjustment mechanism being adapted to register the adjustable height anchoring portion in a plurality of predetermined anchor heights.

18. The tissue shaping device of claim 17 wherein the anchor height adjustment mechanism comprises locks locking the adjustable height anchoring portion in each of the predetermined anchor heights.

19. The tissue shaping device of claim 17 wherein the anchor further comprises a base portion, the anchor height adjustment mechanism comprising a plurality of points of connection between the adjustable height anchoring portion and the base portion.

20. A method of shaping target tissue adjacent to a lumen, the method comprising:

delivering a tissue shaping device comprising an expandable and contractable anchor to a site in the lumen adjacent the target tissue, wherein the anchor has an anchor height;

locking the anchor in a first height;

applying a substantially distally or a substantially proximally directed actuation force on the anchor to change the anchor height from the first height to a second height; and

locking the anchor in the second height.

21. The method of claim 20 wherein the second lockable height is greater than the first lockable height, the applying step comprising applying a substantially distally directed force on the anchor.

22. The method of claim 20 wherein the first lockable height is greater than the second lockable height, the applying step comprising applying a substantially proximally directed force on the anchor.

24. The method of claim 20 further comprising unlocking the anchor from the first anchor height and locking the anchor in the second anchor height.

25. The method of claim 24 wherein the step of unlocking the anchor comprises changing a shape of an anchor lock.

26. The method of claim 24 wherein the step of locking comprises changing a shape of an anchor lock.

27. The method of claim 24 wherein the anchor comprises an anchoring portion adapted to engage a wall of the lumen, the step of unlocking comprising changing a shape of at least a portion of the anchor.

28. The method of claim 24 wherein the anchor comprises an anchoring portion adapted to engage a wall of the lumen, the step of locking comprising changing a shape of at least a portion of the anchor.

23. A method of shaping target tissue adjacent to a lumen, the method comprising:

delivering a tissue shaping device comprising an expandable and contractable anchor to a site in the lumen adjacent the target tissue, wherein the anchor has an anchor height;

locking the anchor in a first height;

applying a substantially distally or a substantially proximally directed actuation force on the anchor to change the anchor height from the first height to a second height; and

locking the anchor in the second height; and

wherein the anchor comprises a height adjustment tool interface, the applying step comprising engaging an anchor height adjustment tool with the height adjustment tool interface.

29. A tissue shaping device adapted to reshape target tissue adjacent to a lumen, the device comprising an expandable and contractable anchor, the anchor comprising an adjustable height anchoring portion adapted to engage a wall of the lumen in at least first and second lockable anchor heights, the anchoring portion being further adapted to be changed from the first lockable anchor height to the second lockable anchor height by a substantially proximally or a substantially distally directed actuation force, wherein the device further comprises at least a first lock element to lock the anchoring portion in the first lockable anchor height and a second lock element to lock the anchoring portion in the second lockable anchor height.