Devices and methods for controlling expandable prostheses during deployment

• US 20050288766A1
• Filed: 06/28/2004
• Published: 12/29/2005
• Est. Priority Date: 06/28/2004
• Status: Abandoned Application

• Current Assignee: XTENT, Inc.
• Original Assignee: XTENT, Inc.
• Inventors: Plain, Henry, Andreas, Bernard, Snow, David W.
• Application Number:
  US10/879,949
• Publication Number:
  US 20050288766A1
• Time in Patent Office: Days
• US Class Current: 623/1.12
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2/97 the outer sleeve being splittable
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2002/9665 with additional retaining means

Abstract

Prosthesis delivery devices and methods are provided that enable precise control of prosthesis position during deployment. The prosthesis delivery devices may carry multiple prostheses and include deployment mechanisms for delivery of a selectable number of prostheses. Control mechanisms are provided in the prosthesis delivery devices that control either or both of the axial and rotational positions of the prostheses during deployment. This enables the deployment of multiple prostheses at a target site with precision and predictability, eliminating excessive spacing or overlap between prostheses. In particular embodiments, the prostheses of the invention are deployed in stenotic lesions in coronary or peripheral arteries or in other vascular locations.

Claims

1. A prosthesis delivery catheter comprising:

an outer shaft having a first lumen;

a plurality of self-expanding tubular prostheses carried within the first lumen, the prostheses being adapted to radially expand upon deployment from the first lumen;

a deployment mechanism for deploying a selected number of the prostheses from the first lumen; and

a control member interactive with the prostheses to control expansion of the prostheses when the prostheses are deployed from the first lumen.

2. The prosthesis delivery catheter of claim 1 wherein the control member comprises a plurality of axially-extending wires, the prostheses being coupled to the wires and axially slidable thereon, the wires being radially deflectable to allow controlled expansion of the prostheses.

3. The prosthesis delivery catheter of claim 2 wherein the wires have free distal ends configured to move radially outward as the prostheses expand.

4. The prosthesis delivery catheter of claim 3 wherein the distal ends are retractable into the outer shaft following deployment of the selected number of prostheses.

5. The prosthesis delivery catheter of claim 2 wherein the prostheses have sidewalls with a plurality of openings, the wires being threaded through the openings.

6. The prosthesis delivery catheter of claim 2 wherein the wires form a loop extending around the outside of the prostheses and through the inside of the prostheses.

7. The prosthesis delivery catheter of claim 6 wherein the wires can be withdrawn from around the prostheses following deployment thereof.

8. The prosthesis delivery catheter of claim 7 wherein at least one end of each wire is releasable to allow the wire to be withdrawn following prosthesis deployment.

9. The prosthesis delivery catheter of claim 8 further comprising an inner shaft disposed in the first lumen, the prostheses being slidably disposed around the inner shaft, wherein a distal end of each wire is releasably coupled to the inner shaft.

10. The prosthesis delivery catheter of claim 9 further comprising a nosecone attached to the inner shaft distally of the prostheses, the distal end of each wire being releasably coupled to the nosecone.

11. The prosthesis delivery catheter of claim 9 wherein the inner shaft has an inner lumen and at least one port in communication with the inner lumen, the wires being slidably disposed through the inner lumen and the port.

12. The prosthesis delivery catheter of claim 1 wherein the control member comprises a sleeve disposed around the prostheses, the sleeve being expandable to allow controlled expansion of the prostheses.

13. The prosthesis delivery catheter of claim 12 wherein the sleeve is elastomeric.

14. The prosthesis delivery catheter of claim 12 wherein the sleeve is slidable relative to the outer shaft.

15. The prosthesis delivery catheter of claim 12 wherein the sleeve has at least one longitudinal slit therein, the sleeve expanding by splitting at the longitudinal slit.

16. The prosthesis delivery catheter of claim 15 wherein the sleeve comprises a plurality of longitudinal sections separated by longitudinal slits, the longitudinal sections being deflectable outwardly to allow controlled expansion of the prostheses.

17. The prosthesis delivery catheter of claim 16 further comprising a retainer releasably coupled to the longitudinal sections to selectively prevent radial deflection thereof.

18. The prosthesis delivery catheter of claim 17 further comprising an inner shaft slidably disposed through the first lumen and having a distal end, the retainer being coupled to the distal end.

19. The prosthesis delivery catheter of claim 15 wherein the sleeve expands by forming a cone shape that flares in the distal direction.

20. The prosthesis delivery catheter of claim 19 wherein the sleeve has a pair of opposing edges bordering the longitudinal slit, the cone shape being formed by moving the edges at an angle relative to each other.

21. The prosthesis delivery catheter of claim 1 wherein the deployment mechanisms comprises a pushing element slidably disposed in the first lumen, the pushing element being in engagement with at least one of the prostheses to advance the prostheses distally relative to the outer shaft.

22. The prosthesis delivery catheter of claim 21 wherein the plurality of prostheses are releasably interconnected to each other.

23. The prosthesis delivery catheter of claim 22 wherein the control member comprises an interconnection structure on the pushing element, the interconnection structure being releasably coupled to at least one of the prostheses to resist distal movement of the prostheses relative to the outer shaft.

24. The prosthesis delivery catheter of claim 1 wherein the control member is configured to maintain rotational position of the prostheses relative to each other.

25. A prosthesis delivery catheter for delivering prostheses into a vessel lumen comprising:

an outer shaft having a first lumen;

a plurality of self-expanding tubular prostheses carried within the first lumen, the prostheses being adapted to radially expand upon deployment from the first lumen;

a deployment mechanism for deploying a selected number of the prostheses from the first lumen; and

a anchor member adapted to engage the vessel to limit movement of the outer shaft relative thereto when a prosthesis is being deployed.

26. The prosthesis delivery catheter of claim 25 wherein the anchor member comprises an expandable member mounted on an inner shaft, the inner shaft being slidably disposed in the first lumen.

27. The prosthesis delivery catheter of claim 26 wherein expandable member comprises a balloon.

28. The prosthesis delivery catheter of claim 26 wherein the expandable member is configured to expand within a deployed prosthesis in the vessel lumen.

29. The prosthesis delivery catheter of claim 28 wherein the expandable member is configured to remain expanded within the deployed prosthesis while a second prosthesis is deployed adjacent to the deployed prosthesis.

30. A prosthesis delivery catheter for delivering prostheses into a vessel lumen comprising:

an outer shaft having a first lumen;

a plurality of self-expanding tubular prostheses carried within the first lumen, the prostheses being adapted to radially expand upon deployment from the first lumen, each prosthesis comprising a distal portion and proximal portion, the distal portion being configured to expand into engagement with the vessel while the proximal portion is at least partially disposed in the first lumen; and

a deployment mechanism for deploying a selected number of the prostheses from the first lumen.

31. The prosthesis delivery catheter of claim 30 wherein the distal and proximal portions are interconnected by at least one spring member, the spring member having a retracted shape and an elongated shape and being biased into the retracted shape, wherein deployment of the distal portion into the vessel elongates the spring into the elongated shape.

32. The prosthesis delivery catheter of claim 31 wherein deployment of the proximal portion into the vessel allows the spring to return at least partially to the retracted shape to draw the proximal portion toward the distal portion.

33. The prosthesis delivery catheter of claim 30 wherein the distal portion is configured to engage the vessel prior to deployment of the proximal portion so that the prosthesis remains in a generally constant position relative to the catheter as the proximal portion is deployed.

34. A method of delivering one or more prostheses to a treatment site in a vessel comprising:

positioning a delivery catheter at the treatment site, the delivery catheter carrying a plurality of self-expanding prostheses;

selecting a desired number of the prostheses to deploy;

deploying the desired number of prostheses from the delivery catheter into the vessel, each prosthesis expanding into contact with the vessel upon deployment; and

controlling the axial displacement of each of the selected number of prostheses relative to the delivery catheter during the deployment thereof.

35. The method of claim 34 wherein the axial displacement is controlled by an expandable sleeve disposed around the desired number of prostheses.

36. The method of claim 35 further comprising retracting the sleeve from around the prostheses after the prostheses have been deployed.

37. The method of claim 34 wherein the axial displacement is controlled by a plurality of wires coupled with the desired number of prostheses.

38. The method of claim 37 further comprising retracting the wires from the prostheses after the prostheses have been deployed.

39. The method of claim 37 wherein the wires are threaded through openings in each of the prostheses.

40. The method of claim 34 further comprising controlling the rotational displacement of the selected number of prostheses relative to the delivery catheter during the deployment thereof.

41. The method of claim 34 wherein the axial displacement is controlled by expanding an expandable member in the vessel during deployment of at least a portion of the desired number of prostheses.

42. The method of claim 34 wherein the axial displacement is controlled by expanding a distal portion of a first of the prostheses into engagement with the vessel while a proximal portion of the first of the prostheses remains in the delivery catheter, then expanding the proximal portion of the first of the prostheses into engagement with the vessel.

43. The method of claim 34 wherein the prostheses are releasably interconnected while in the delivery catheter.

44. The method of claim 43 wherein the axial displacement is controlled by connecting at least one of the prostheses to a restraining member in the delivery catheter.

45. The method of claim 43 wherein the selected number of prostheses detach from the prostheses remaining in the delivery catheter upon deployment.