Apparatus and methods for deployment of vascular prostheses

• US 7,892,274 B2
• Filed: 11/16/2006
• Issued: 02/22/2011
• Est. Priority Date: 12/03/2001
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Andreas, Bernard, Chew, Sunmi, Will, Allan
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/560,739
• Publication Number:
  US 20070129733A1
• Time in Patent Office: 1,559 Days
• Field of Search: 606/108, 606191-198, 623 111- 112, 623/1.16
• 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. A method of treating a lesion in a body lumen between a distal treatment boundary and a proximal treatment boundary, the method comprising:

positioning a catheter in the body lumen, the catheter having a catheter body with a longitudinal axis which carries a prosthesis positionable over an expandable member and a sheath positionable over the prosthesis, wherein the prosthesis comprises a plurality of separable prosthetic segments, and wherein the sheath comprises an inwardly extending valve member disposed on an inside surface of a distal portion of the sheath and a distal extremity reinforced so as to resist radial expansion when the expandable member is expanded;

moving the catheter though the body lumen until a distal end of the prosthesis is disposed at or distal to the distal treatment boundary;

maintaining the position of the catheter body in the body lumen while retracting the sheath relative to the catheter body and fluoroscopically viewing a radiopaque sheath marker on the sheath until the radiopaque sheath marker is disposed within a predetermined distance of the proximal treatment boundary, wherein a deployable portion of the prosthesis, the deployable portion comprising a first plurality of the prosthetic segments, is exposed outside the sheath in an unexpanded condition and a retained portion of the prosthesis remains covered by the sheath and wherein a proximal end of the deployable portion is disposed at or proximal to the proximal treatment boundary;

axially separating the unexpanded deployable portion from the retained portion of the prosthesis to create a space between the deployable portion and the retained portion along the longitudinal axis of the catheter body by engaging the retained portion of the prosthesis with the valve member and moving the retained portion away from the unexpanded deployable portion; and

radially expanding the entire deployable portion of the prosthesis as a single portion while the retained portion remains covered by the sheath, wherein the expanded deployable portion extends from the proximal treatment boundary to the distal treatment boundary.

2. The method of claim 1, wherein the step of moving the catheter comprises fluoroscopically viewing a radiopaque distal marker on the catheter body, the catheter being moved until the radiopaque distal marker is disposed within a predetermined distance from the distal treatment boundary.

3. The method of claim 1, wherein the radiopaque sheath marker is at a distal end of the sheath, and the sheath is retracted until the radiopaque sheath marker is proximal to the proximal treatment boundary.

4. The method of claim 3, wherein the radiopaque sheath marker comprises a marker band affixed to the sheath.

5. The method of claim 1, wherein the prosthetic segments are axially movable over the expandable member.

6. The method of claim 5, further comprising axially moving a prosthetic segment of the retained portion distally on the expandable member after expanding the first plurality.

7. The method of claim 5, wherein the prosthetic segments are positionable at a predetermined position on the expandable member relative to the radiopaque distal marker.

8. The method of claim 1, further comprising constraining a proximal portion of the expandable member with the reinforced distal extremity of the sheath as the deployable portion is radially expanded with a distal portion of the expandable member.

9. The method of claim 1, wherein separating comprises axially separating a proximal prosthetic segment in the deployable portion from a second prosthetic segment in the retained portion.

10. The method of claim 9, wherein moving the retained portion away comprises engaging the second prosthetic segment with the valve member on the sheath, and further retracting the sheath relative to the catheter body.

11. The method of claim 10, wherein the sheath is further retracted while fluoroscopically viewing a radiopaque sheath marker thereon relative to the proximal prosthetic segment until a desired separation distance is disposed therebetween.

12. The method of claim 9, wherein the deployable portion is expanded by an expandable member positioned within the prosthetic segments, the proximal prosthetic segment being axially separated so as to allow the expandable member to fully expand the prosthetic segments in the deployable portion without expanding any portion of the second prosthetic segment.

13. The method of claim 12, wherein upon expansion the expandable member has a tapered region which tapers from an expanded diameter outside the sheath to a constrained diameter inside the sheath, the proximal prosthesis being axially separated such that no prosthetic segments are disposed over the tapered region.

14. The method of claim 1, further comprising without removing the catheter from the body lumen:

returning the sheath to a distal position on the catheter body;

repositioning the catheter to a second treatment site in the body lumen;

retracting the sheath to expose a third portion of the prosthesis outside the sheath; and

radially expanding the third portion of the prosthesis in the body lumen.

15. A method of treating a lesion in a body lumen between a distal treatment boundary and a proximal treatment boundary, the method comprising:

positioning a catheter in the body lumen, the catheter having a catheter body with a longitudinal axis, an expandable member coupled to the catheter body, a plurality of separable tubular prostheses positionable over the expandable member, and a sheath positionable over the prostheses, wherein the sheath comprises an inwardly extending valve member disposed on an inside surface of a distal portion of the sheath and a distal extremity reinforced so as to resist radial expansion when the expandable member is expanded;

moving the catheter in the body lumen until a distal prosthesis is positioned at or distal to the distal treatment boundary;

maintaining the position of the catheter body in the body lumen while retracting the sheath relative to the catheter body until a first plurality of the prostheses are exposed outside the sheath in an unexpanded configuration, wherein at least a second prosthesis remains covered by the sheath and wherein a proximal prosthesis in the first plurality is positioned at or proximal to the proximal treatment boundary;

axially separating the unexpanded first plurality of the prostheses from the second prosthesis covered by the sheath to create a space between the first plurality of prostheses and the second prosthesis along the longitudinal axis of the catheter body by engaging the second prosthesis with the valve member and moving the second prosthesis away from the unexpanded first plurality of prostheses; and

expanding the expandable member to radially expand all of the first plurality of prostheses at the same time so that the first plurality of prostheses extend from the distal treatment boundary to the proximal treatment boundary after expansion.

16. The method of claim 15, wherein the step of moving the catheter through the body lumen comprises fluoroscopically viewing a radiopaque distal marker on the catheter body, the catheter being moved until the radiopaque distal marker is disposed within a predetermined spacing from the distal treatment boundary.

17. The method of claim 16, wherein the plurality of prostheses are positionable at a predetermined position on the expandable member relative to the radiopaque distal marker.

18. The method of claim 15, wherein the sheath is retracted while fluoroscopically viewing a radiopaque sheath marker thereon until the radiopaque sheath marker is disposed within a second predetermined distance from the proximal treatment boundary.

19. The method of claim 18, wherein the radiopaque sheath marker is disposed at the distal end of the sheath.

20. The method of claim 15, wherein the plurality of prostheses are axially movable over the expandable member.

21. The method of claim 20, further comprising axially moving the second prosthesis distally on the expandable member after expanding the first plurality.

22. The method of claim 15, further comprising constraining a proximal portion of the expandable member with the reinforced distal extremity of the sheath as the first plurality is radially expanded with a distal portion of the expandable member.

23. The method of claim 15, wherein the first plurality of prostheses comprises a plurality of prosthetic segments unconnected to each other prior to expansion.

24. The method of claim 15, wherein axially separating comprises engaging the second prosthesis with the valve member on the sheath, and further retracting the sheath relative to the catheter body.

25. The method of claim 24, wherein the sheath is further retracted while fluoroscopically viewing the radiopaque sheath marker relative to the proximal prosthesis until a desired separation distance is disposed therebetween.

26. The method of claim 15, wherein the first plurality of prostheses are axially separated from the second prosthesis to allow the expandable member to fully expand all of the first plurality of prostheses without expanding any portion of the second prosthesis.

27. The method of claim 15, wherein upon expansion the expandable member has a tapered region which tapers from an expanded diameter outside the sheath to a constrained diameter inside the sheath, the first plurality of prostheses being axially separated from the sheath such that none of the prostheses are disposed over the tapered region.

28. The method of claim 15, further comprising without removing the catheter from the body lumen:

returning the sheath to a distal position on the catheter body;

repositioning the catheter to a second treatment site in the body lumen;

retracting the sheath to expose a third plurality of prostheses outside the sheath; and

expanding the expandable member to radially expand the third plurality of prostheses in the body lumen.

29. A method of deploying a prosthesis in a vascular lesion having proximal and distal boundaries, comprising:

positioning a catheter across the vascular lesion such that a distal end of the catheter is distal to the distal boundary, the catheter carrying the prosthesis positionable over an expandable member, wherein the prosthesis comprises a plurality of separable prosthetic segments covered by a sheath, and wherein the sheath comprises an inwardly extending valve member disposed on an inside surface of a distal portion of the sheath and a distal extremity reinforced so as to resist radial expansion when the expandable member is expanded;

maintaining the position of the catheter in the body lumen while retracting the sheath under fluoroscopic visualization until a distal end of the sheath is visualized as being proximal to the proximal boundary, wherein a deployable portion of the prosthesis is exposed outside the sheath in an unexpanded condition while a retained portion of the prosthesis remains covered by the sheath, wherein the deployable portion comprises a first plurality of prosthetic segments and the retained portion comprises one or more prosthetic segments;

axially separating the unexpanded first plurality of the prostheses from the retained portion to create a space between the first plurality and the retained portion along the longitudinal axis of the catheter body, wherein separating comprises engaging the retained portion with the valve member and moving the retained portion away from the unexpanded first plurality; and

radially expanding the entire deployable portion as a single portion with the expandable member while the retained portion of the prosthesis remains covered by the sheath, wherein the expanded deployable portion extends between the proximal and distal boundaries.

30. The method of claim 29, wherein the step of positioning the catheter comprises fluoroscopically viewing a radiopaque distal marker on the catheter body, the catheter being moved until the radiopaque distal marker is disposed within a predetermined distance from the distal boundary.

31. The method of claim 29, wherein the sheath has a radiopaque sheath marker on the distal end thereof, and the sheath is retracted until the radiopaque sheath marker is proximal to the proximal boundary.

32. The method of claim 29, wherein the prostheses are axially movable over the expandable member.

33. The method of claim 32, further comprising axially moving the retained portion distally on the expandable member after expanding the first plurality.

34. The method of claim 32, wherein the plurality of prosthetic segments are positionable at a predetermined position on the expandable member relative to the radiopaque distal marker.

35. The method of claim 29, further comprising constraining a proximal portion of the expandable member with the reinforced distal extremity sheath as the deployable portion is radially expanded with a distal portion of the expandable member.

36. The method of claim 29, wherein axially separating comprises engaging the retained portion with the valve member on the sheath, and further retracting the sheath relative to the catheter body.

37. The method of claim 36, wherein the sheath is further retracted while fluoroscopically viewing a radiopaque sheath marker thereon relative to the proximal prosthetic segment until a desired separation distance is disposed therebetween.

38. The method of claim 29, wherein the deployable portion is expanded by an expandable member positioned within the prosthetic segments, the first plurality being axially separated so as to allow the expandable member to fully expand each of the prosthetic segments in the deployable portion without expanding any portion of the retained portion.

39. The method of claim 38, wherein upon expansion the expandable member has a tapered region which tapers from an expanded diameter outside the sheath to a constrained diameter inside the sheath, the deployable portion being axially separated such that no prosthetic segments are disposed over the tapered region.

40. The method of claim 29, further comprising without removing the catheter from the body lumen:

returning the sheath to a distal position on the catheter body;

repositioning the catheter to a second treatment site in the body lumen;

retracting the sheath to expose a third portion of the prosthesis outside the sheath; and

radially expanding the third portion of the prosthesis in the body lumen.