Apparatus and methods for deployment of vascular prostheses

• US 7,309,350 B2
• Filed: 08/08/2003
• Issued: 12/18/2007
• Est. Priority Date: 12/03/2001
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Landreville, Steve, Andreas, Bernard, Chew, Sunmi, Acosta, Pablo
• Primary Examiner(s): Ho, (Jackie) Tan-Uyen T.
• Application Number:
  US10/637,713
• Publication Number:
  US 20040098081A1
• Time in Patent Office: 1,593 Days
• Field of Search: 623/1.11, 606/108, 606/194, 604/103.04, 604/103.05, 604/103.09
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91525 within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/9155 Adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• 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 2210/0033 electrically, e.g. heated by resistor
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61F 2250/0071 breakable or frangible
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/10182 : Injector syringes
• CPC Class Codes: A61M 25/10187 : Indicators for the level of inflation or deflation
• CPC Class Codes: H01Q 3/2676 : Optically controlled phased array

Abstract

Apparatus for delivering stents to body lumens include one or more tubular prostheses carried at the distal end of a catheter shaft, a sheath slidably disposed over the prostheses, and a guidewire tube extending from within the sheath to the exterior of the sheath through an exit port in a sidewall thereof. A guidewire extends slidably through the guidewire tube. The sheath can be moved relative to the catheter shaft and the guidewire tube to expose the prostheses for deployment. Methods of delivering stents are also provided.

Claims

1. Apparatus for delivering a prosthesis into a target vessel comprising:

a flexible catheter shaft having proximal and distal ends and a first lumen therein;

a tubular prosthesis releasably carried near the distal end of the catheter shaft, the tubular prosthesis being expandable to a shape suitable for engaging the target vessel;

a sheath disposed over the catheter shaft and the tubular prosthesis and being retractable relative thereto to a retracted position in which the tubular prosthesis is exposed for deployment, the sheath having proximal and distal ends, and an exit port between the proximal and distal ends; and

a guidewire tube extending through the exit port and having a distal extremity extending through the tubular prosthesis and being fixedly attached to the catheter shaft within the sheath and a proximal extremity disposed outside of the sheath, the guidewire tube being adapted for slidably receiving a guidewire therethrough and wherein the guidewire tube slides through the exit port as the sheath is retracted relative to the catheter shaft.

2. The apparatus of claim 1 wherein the exit port is fluidly sealed around the guidewire tube.

3. The apparatus of claim 1 wherein the guidewire tube is fixed relative to the catheter shaft.

4. The apparatus of claim 1 wherein the sheath has a proximal portion proximal to the exit port and a distal portion distal to the exit port, the proximal portion having a smaller outer diameter than the distal portion.

5. The apparatus of claim 1 wherein the exit port is oriented so as to face generally in a proximal direction.

6. The apparatus of claim 1 wherein the proximal extremity of the guidewire tube is about 3-15 cm in length.

7. The apparatus of claim 1 wherein the guidewire tube has a proximal end disposed a distance of less than about ½

the length of the catheter shaft from the distal end thereof.

8. The apparatus of claim 1 wherein the tubular prosthesis is self-expanding.

9. The apparatus of claim 8 wherein the sheath constrains expansion of the tubular prosthesis and is retractable to allow the tubular prosthesis to expand.

10. The apparatus of claim 1 further comprising an expandable member mounted to the catheter shaft near the distal end thereof, the tubular prosthesis being positionable over the expandable member for expansion therewith.

11. The apparatus of claim 10 wherein the expandable member comprises a balloon having an interior, the inner lumen in the catheter shaft being in communication with the interior for delivery of inflation fluid thereto.

12. The apparatus of claim 11 wherein the guidewire tube extends through the interior of the balloon.

13. The apparatus of claim 10 wherein the sheath is axially positionable relative to the expandable member and configured to restrain expansion of a selected portion of the expandable member.

14. The apparatus of claim 13 wherein the sheath is reinforced to prevent expansion thereof by the expandable member.

15. The apparatus of claim 1 wherein the tubular prosthesis comprises a plurality of prosthesis segments.

16. The apparatus of claim 15 wherein the sheath is axially movable relative to the prosthesis segments and configured to restrain expansion of a selectable number of prosthesis segments.

17. The apparatus of claim 1 further comprising a pusher slidably disposed over the catheter shaft within the sheath, the pusher having a distal end in engagement with the tubular prosthesis for moving the tubular prosthesis relative to the catheter shaft or the sheath.

18. A method of delivering a prosthesis in a target vessel of a patient comprising:

inserting a guidewire through the patient'"'"'s vasculature to the target vessel;

slidably coupling a delivery catheter to the guidewire, the delivery catheter having proximal and distal ends, a tubular prosthesis carried near the distal end, a sheath with an exit port disposed between the proximal and distal ends, and a guidewire tube fixedly attached to the delivery catheter and extending through the exit port, a proximal extremity of the guidewire tube being outside the sheath and a distal extremity of the guidewire tube extending through the tubular prosthesis inside the sheath, the guidewire being slidable positioned through the guidewire tube;

advancing the delivery catheter over the guidewire to the target vessel;

retracting the sheath relative to the guidewire tube to expose a tubular prosthesis carried by the delivery catheter, the guidewire tube sliding through the exit port as the sheath is retracted; and

expanding the tubular prosthesis into engagement with the target vessel.

19. The method of claim 18 further comprising sealing the exit port around the guidewire tube to restrict fluid flow therethrough.

20. The method of claim 18 wherein the delivery catheter further includes a catheter shaft, the sheath being slidably disposed over the catheter shaft, and wherein retracting the sheath comprises moving the sheath relative to the catheter shaft.

21. The method of claim 20 wherein the delivery catheter further comprises an expandable member fixed to the catheter shaft, the tubular prosthesis being positionable over the expandable member, and wherein expanding the tubular prosthesis comprises expanding the expandable member.

22. The method of claim 21 further comprising covering a proximal portion of the expandable member by the sheath to constrain the proximal portion from expansion while a distal portion of the expandable member expands.

23. The method of claim 21 wherein the expandable member is inflatable, further comprising delivering inflation fluid to the expandable member through an inflation lumen in the catheter shaft.

24. The method of claim 21 wherein the expandable member has an interior, the guidewire tube extending through the interior.

25. The method of claim 21 wherein the tubular prosthesis comprises a plurality of prosthesis segments, further comprising positioning a first selected number of the prosthesis segments on the expandable member for expansion therewith.

26. The method of claim 25 further comprising positioning the sheath over a second selected number of the prosthesis segments to constrain expansion thereof.

27. The method of claim 25 wherein the delivery catheter further comprises a pusher slidably disposed within the sheath, and wherein positioning the first selected number of prosthesis segments comprises pushing the first selected number with the pusher.

28. The method of claim 18 wherein the tubular prosthesis self-expands when the sheath is retracted.

29. The method of claim 18 wherein the proximal extremity of the guidewire tube has a proximal end disposed a distance of less than about ½

the length of the sheath from a distal end thereof, the guidewire extending out of the proximal end.

30. The method of claim 18 wherein the exit port is oriented to face in a generally proximal direction such that guidewire tube slides axially through the exit port.

31. A balloon catheter for treating a target vessel comprising:

a flexible catheter shaft having proximal and distal ends and a first lumen therein;

an expandable member connected to the catheter shaft;

a sheath disposed over the catheter shaft and the expandable member and being retractable relative thereto to a retracted position in which at least a portion of the expandable member is exposed, the sheath having proximal and distal ends and an exit port between the proximal and distal ends; and

a guidewire tube extending through the exit port and having a distal extremity extending through the expandable member and being fixedly attached to the catheter shaft within the sheath and a proximal extremity disposed outside of the sheath, the guidewire tube being adapted for slidably receiving a guidewire therethrough and wherein the guidewire tube slides through the exit port as the sheath is retracted relative to the catheter shaft.

32. The apparatus of claim 31 wherein the exit port is fluidly sealed around the guidewire tube.

33. The apparatus of claim 31 wherein the guidewire tube is fixed relative to the catheter shaft.

34. The apparatus of claim 31 wherein the sheath has a proximal portion proximal to the exit port and a distal portion distal to the exit port, the proximal portion having a smaller outer diameter than the distal portion.

35. The apparatus of claim 31 wherein the exit port is oriented so as to face generally in a proximal direction.

36. The apparatus of claim 31 wherein the proximal extremity of the guidewire tube is about 3-15 cm in length.

37. The apparatus of claim 31 wherein the guidewire tube has a proximal end disposed a distance of less than about ½

the length of the catheter shaft from the distal end thereof.

38. The apparatus of claim 31 further comprising a tubular prosthesis disposed on the expandable member.

39. The apparatus of claim 38 wherein the tubular prosthesis comprises a plurality of unconnected stent segments.

40. The apparatus of claim 39 wherein the stent segments are slidable relative to the expandable member.

41. The apparatus of claim 39 wherein the sheath is positionable to expose a first selected portion of the stent segments while covering a second selected portion of the stent segments.

42. The apparatus of claim 31 wherein the expandable member comprises a balloon, the balloon being in fluid communication with the first lumen to receive inflation fluid therefrom.

43. The apparatus of claim 31 wherein the sheath is positionable to constrain a first selected portion of the expandable member from expansion while a second selected portion of the expandable member expands.