Hydraulically actuated dilatation mechanism for vessel dilatation and vascular prosthesis delivery and methods of use

• US 5,989,263 A
• Filed: 03/11/1998
• Issued: 11/23/1999
• Est. Priority Date: 03/11/1998
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Arteria Medical Science, Inc.
• Inventors: Shmulewitz, Ascher
• Primary Examiner(s): Manahan, Todd E.
• Application Number:
  US09/038,798
• Time in Patent Office: 622 Days
• Field of Search: 606/108, 606/192, 606/194, 606/195, 606/198, 623/1
• US Class Current: 606/108
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Apparatus having a dilatation mechanism is provided wherein a plurality of radially expanding members are coupled to a plunger. The radially expanding members deflect outwardly in response to application of an hydraulic load to the plunger. The apparatus may be used in dilating vessels to treat obstructive vascular disease, or used in delivery systems to deploy vascular prostheses such as stents and grafts. Methods of using the apparatus are also provided.

Claims

1. A dilatation system comprising:

a catheter having a bore and a distal end;

a plunger disposed within the bore of the catheter; and

a dilatation mechanism comprising a plurality of radially expandable members, each one of the plurality of radially expandable members having a first end fixed relative to the distal end of the catheter and a second end coupled to the plunger,

wherein the radially expandable members move between a transit state having an undeflected position, and a deployed state, wherein the radially expandable members are deflected outwards, responsive to application of an hydraulic load to the plunger.

2. The dilatation system as defined in claim 1 wherein the dilatation mechanism further comprises:

a core member disposed within the bore of the catheter, the core member having a distal end;

an endcap affixed to the core member, wherein the distal ends of the plurality of radially expandable members are affixed to the endcap.

3. The dilatation system as defined in claim 2 wherein the dilatation mechanism further comprises:

a push block disposed for sliding translation on the core member distal of the plunger, the proximal end of each one of the plurality of radially expandable members affixed to the push block.

4. The dilatation system as defined in claim 3 wherein the push block is integrally formed with the plunger.

5. The dilatation system as defined in claim 2 wherein a proximal end of the core member has a groove in an exterior surface, and the dilatation system further comprises a locking element that retains the core member in a fixed position relative to the catheter.

6. The dilatation system as defined in claim 5 wherein the locking element is selectively removable to return the radially expandable members to the undeflected transit state.

7. The dilatation system as defined in claim 2 wherein the core member includes a portion defining a guide wire lumen.

8. The dilatation system as defined in claim 7 wherein the core member is configured for over-the-wire use with a guide wire.

9. The dilatation system as defined in claim 1 wherein the catheter further comprises an opening disposed adjacent to the plunger, the opening alleviating the hydraulic load when the radially expandable members attain the deployed state.

10. The dilatation system as defined in claim 1 wherein the plurality of radially expandable members are configured to treat obstructive vascular disease.

11. The dilatation system as defined in claim 1 wherein the plurality of radially expandable members are configured to deploy a vascular prosthesis or graft.

12. The dilatation system as defined in claim 1 wherein radially expandable members comprise an element having a cross-section selected from the group consisting of a rectangle, an oval, and ellipse and a circle.

13. The dilatation system as defined in claim 1 wherein the hydraulic load is imposed by a pressurizing medium introduced into the bore of the catheter.

14. A dilatation system comprising:

a catheter having a bore and proximal and distal ends;

a core member having a distal end and a proximal end, the core member disposed within the catheter;

an endcap disposed on the distal end of the core member;

a plunger disposed for sliding translation on the core member, the plunger having a proximal end;

a plurality of radially expandable members, each one of the plurality of radially expandable members having a distal end affixed to the endcap and a proximal end coupled to the plunger,

wherein the radially expandable members move between a transit state, wherein the radially expandable members are in an undeflected position, and a deployed state, wherein the radially expandable members are deflected outwards, responsive to application of an hydraulic load to the proximal end of the plunger.

15. The dilatation system as defined in claim 14 further comprising a push block disposed for sliding translation on the core member distal of the plunger, the proximal end of each one of the plurality of radially expandable members affixed to the push block.

16. The dilatation system as defined in claim 15 wherein the push block is integrally formed with the plunger.

17. The dilatation system as defined in claim 14 wherein the catheter further comprises an opening disposed adjacent to the plunger, the opening alleviating the hydraulic load when the radially expandable members attain the deployed state.

18. The dilatation system as defined in claim 14 wherein the proximal end of the core member has a groove in an exterior surface, and the dilatation system further comprises a locking element that retains the core member in a fixed position relative to the catheter.

19. The dilatation system as defined in claim 18 wherein the locking element is selectively removable to return the radially expandable members to the undeflected transit state.

20. The dilatation system as defined in claim 14 wherein the plurality of radially expandable members are configured to treat obstructive vascular disease.

21. The dilatation system as defined in claim 14 wherein the plurality of radially expandable members are configured to deploy a vascular prosthesis or graft.

22. The dilatation system as defined in claim 14 wherein the core member includes a portion defining a guide wire lumen.

23. The dilatation system as defined in claim 14 wherein radially expandable members comprise an element having a cross-section selected from the group consisting of a rectangle, an oval, and ellipse and a circle.

24. The dilatation system as defined in claim 14 wherein the hydraulic load is imposed by a pressurizing medium introduced into the bore of the catheter.

25. A method of dilating a vessel to treat obstructive vascular disease, the method comprising:

providing a dilatation system comprising a catheter, a plunger disposed within the catheter, and a dilatation mechanism comprising a plurality of radially expandable members coupled to the plunger, the radially expandable members movable between a transit state having an undeflected position, and a deployed state, wherein the radially expandable members are deflected outwards, responsive to application of an hydraulic load to the plunger;

inserting the dilatation system percutaneously and transluminally in a vessel to dispose the plurality of radially expandable members within a stenosis; and

introducing a pressurizing medium into the catheter to apply an hydraulic load to the plunger that urges the radially expandable members to deflect outwardly to the deployed state.

26. The method as described in claim 25 further comprising:

after maintaining the radially expandable members in the deployed state for a predetermined interval of time, returning the radially expandable members to the transit state; and

withdrawing the dilatation system from the vessel.

27. The method as defined in claim 25 wherein providing a dilatation system further comprises:

selecting a dilatation system including a dilatation mechanism having a length and a diameter, in the deployed state, suitable for treating a stenosis of predetermined size.

28. A method of deploying a vascular prosthesis, the method comprising:

providing a dilatation system comprising a catheter, a plunger disposed within the catheter, and a dilatation mechanism comprising a plurality of radially expandable members coupled to the plunger, the radially expandable members movable between a transit state having an undeflected position, and a deployed state, wherein the radially expandable members are deflected outwards, responsive to application of an hydraulic load to the plunger;

disposing a vascular prosthesis on the dilatation mechanism;

inserting the dilatation system and vascular prosthesis percutaneously and transluminally in a vessel to dispose the vascular prosthesis at a desired location within the vessel; and

introducing a pressurizing medium into the catheter to apply an hydraulic load to the plunger that urges the radially expandable members to deflect outwardly to the deployed state to expand the prosthesis into engagement with an interior surface of the vessel.

29. The method as described in claim 28 further comprising:

after maintaining the radially expandable members in the deployed state for a predetermined interval of time, returning the radially expandable members to the transit state; and

withdrawing the dilatation system from the vessel.

30. The method as defined in claim 28 wherein providing a dilatation system further comprises:

selecting a dilatation system including a dilatation mechanism having a length and a diameter, in the deployed state, suitable for expanding a vascular prosthesis of predetermined size.