Method and apparatus for stabilizing vascular wall

• US 6,325,813 B1
• Filed: 08/18/1998
• Issued: 12/04/2001
• Est. Priority Date: 08/18/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Hektner, Thomas R.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/135,875
• Time in Patent Office: 1,204 Days
• Field of Search: 606/191, 606/198, 606/195, 606/194, 606/185, 606/171, 604/95, 604/281-2, 623/1
• US Class Current: 606/191
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A method and apparatus stabilize a vascular wall or vascular tissue during a surgical procedure. A stiffening member is inserted in a vessel to be accessed. The stiffening member is formed of a material having sufficient rigidity to significantly dampen movement of the vessel caused by normal heart action.

Claims

1. A method of treating a restriction in a lumen of a restricted vascular vessel of a mammal, the mammal having a heart contracting to pump blood, comprising:

transluminally deploying a first stabilizing device at a treatment site relative to the restricted vessel to dampen movement of the restricted vessel at the treatment site, caused by contraction of the heart to stabilize the restricted vessel at the treatment site;

transluminally deploying a second treatment device relative to the stabilized treatment site while the first device is deployed and treating the stabilized restricted vessel with the second treatment device; and

withdrawing the first stabilizing device and the second treatment device after treatment.

2. The method of claim 1 wherein the first device includes a first stiffening member and comprising:

transluminally advancing the first stiffening member through the lumen of the restricted vessel to the treatment site.

3. The method of claim 2 where the first stiffening member includes a first stiffening sleeve having a lumen therethrough and wherein transluminally advancing the stiffening member comprises:

transluminally advancing a guidewire to the treatment site; and

advancing the first stiffening sleeve over the guidewire to the treatment site.

4. The method of claim 3 further comprising:

advancing at least one additional stiffening sleeve over the guidewire to the treatment site.

5. The method of claim 4 wherein advancing the at least one additional stiffening sleeve comprises:

advancing the at least one additional sleeve to the treatment site such that the first stiffening sleeve and the at least one additional stiffening sleeve are in coaxial relation to one another at the treatment site.

6. The method of claim 4 wherein the first stiffening sleeve and the at least one additional stiffening sleeve include associated elongate push rods coupled thereto and wherein the first stiffening sleeve and the at least one additional stiffening sleeve are advanced by:

pushing the associated elongate push rods to advance the first stiffening sleeve and the at least one additional stiffening sleeve to the treatment site.

7. The method of claim 2 wherein the first stiffening member includes a preformed balloon, preformed to a stiffening shape and wherein transluminally advancing the first stiffening member includes:

transluminally advancing the balloon to the treatment site; and

inflating the balloon to the stiffening shape.

8. The method of claim 2 wherein the restricted vessel includes a vessel located closely proximate an endocardial wall of the heart, the heart including a chamber defined by an epicardial wall thereof, and further comprising:

transluminally advancing a second stiffening member into the chamber.

9. The method of claim 8 wherein the second stiffening member includes an expandable member and wherein transluminally advancing the second stiffening member includes:

advancing the expandable member into the chamber; and

expanding the expandable member such that it contacts the epicardial wall proximate the treatment site in the restricted vessel.

10. The method of claim 9 wherein expanding the expandable member comprises:

expanding and contracting the expandable member based on the contractions of the heart.

11. The method of claim 8 wherein the first and second stiffening members exert generally opposing forces on vascular tissue between the treatment site in the restricted vessel and a contact region of the epicardial wall at which the second stiffening member contacts the epicardial wall.

12. The method of claim 13 wherein the second stiffening member includes an expandable scaffolding and further comprising:

expanding the expandable scaffolding within the chamber such that the contact region is disposed proximate the treatment site.

13. The method of claim 2 wherein treating the stabilized restricted vessel includes providing a conduit between an access site in a source vessel and the restricted vessel and further comprising:

transluminally deploying a second stiffening member through the source vessel to dampen movement of the source vessel at the access site to a desired level.

14. The method of claim 13 wherein one of the restricted vessel and the source vessel is located closely proximate an outer heart wall of the heart having an inner wall defining a chamber, and further comprising:

transluminally deploying a third stiffening member within the heart chamber to exert a stiffening force on the inner wall to dampen movement of the wall of the heart to a desired level.

15. The method of claim 2 wherein the first stiffening member is coated with a material to reduce trauma to the vessel.

16. The method of claim 1 wherein treating the restricted vessel comprises:

coupling a conduit from an access site at a source vessel to the treatment site of the restricted vessel such that the restricted vessel, at the treatment site, is in fluid communication with the source vessel at the access site.

17. The method of claim 16 and further comprising:

transluminally stabilizing the source vessel

at the access site to dampen movement of

the source vessel, caused by contraction

of the heart, to a desired level.

18. A kit for stabilizing a treatment site in vascular tissue to be treated, comprising:

a plurality of independent incrementally sized stiffening sleeves, each stiffening sleeve including a proximal and distal end and each stiffening sleeve having an incrementally sized outer diameter and an incrementally sized lumen so that the plurality of stiffening sleeves can be concentrically aligned to form a plurality of radially extending stiffening layers and a plurality of push members coupled to the proximal end of each of the stiffening sleeves to transluminally track the stiffening sleeves to a remote intravascular treatment site while maintaining a portion of plurality of push members external to concentrically align selected stiffening sleeves to form a desired number of stiffening layers to dampen motion at the treatment site, caused by heart contractions, to a desired level.

19. The kit of claim 18 wherein the plurality of stiffening sleeves each comprise a stylet.

20. The kit of claim 18 wherein the plurality of stiffening sleeves are each formed of Nitinol.

21. The kit of claim 18 wherein the plurality of stiffening sleeves are coated with a material to reduce trauma to the vasculature.

22. A kit for dampening movement of a heart comprising:

a first transluminal device sized for insertion in an intravascular vessel and including a first stiffening member deployable at an intravascular treatment site to dampen movement of a restricted vessel at the treatment site; and

a second transluminally advanceable device including a second stiffening member formed of an expandable member deployable within a heart chamber to an expanded deployed dimension sized to fill a portion of the heart chamber and circumferentially contact an inner wall of the heart chamber to exert a stabilizing force on the inner wall of the heart chamber proximate the treatment site.

23. The kit of claim 22 wherein the first and second stiffening members are configured to exert generally opposing forces on intervening vascular tissue at the treatment site.

24. The kit of claim 22 wherein the second advanceable device includes:

an elongate member having a lumen therethrough, a distal end and a proximal end; and

the expandable member being coupled to the distal end of the elongate member.

25. The kit of claim 24 wherein the expandable member includes:

an expandable scaffolding sleeve.

26. The kit of claim 25 wherein the expandable member further comprises:

an inflatable member having an interior in fluid communication with the lumen in the elongate member, the inflatable member being sized such that inflation thereof drives the expandable scaffolding sleeve into an expanded position.

27. The kit of claim 22 wherein the first stiffening member comprises a balloon preformed to a stiffening shape and formed of a non-compliant material movable between a collapsed position and an inflated position and including a catheter having an inflation lumen therethrough in fluid communication with the balloon.

28. A method of stabilizing a desired portion of a heart wall of a heart, comprising:

transluminally advancing a stiffening member through vasculature into a chamber of the heart; and

deploying the stiffening member to exert a stiffening force on the desired portion of the heart wall, from within the chamber, to dampen movement of the desired portion of the heart wall to a desired level.

29. The method of claim 28 and further comprising:

transluminally advancing a second stiffening member into a vessel located closely proximate an outer wall of the heart.

30. The method of claim 29 and further comprising:

deploying the second stiffening member to exert a force on the heart wall generally opposing the stiffening force exerted by the stiffening member in the chamber of the heart.

31. The method of claim 29 wherein the second stiffening member is coated with a material to reduce trauma to the vessel.