Custom length stent apparatus

• US 7,892,273 B2
• Filed: 09/01/2006
• Issued: 02/22/2011
• Est. Priority Date: 12/03/2001
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Carrison, Harold F., Acosta, Pablo, Snow, David W., George, Robert
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US11/469,773
• Publication Number:
  US 20070067012A1
• Time in Patent Office: 1,635 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 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 2002/91533 characterised by the phase between adjacent bands
• 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 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: H01Q 3/2676 Optically controlled phased array
• CPC Class Codes: H04B 10/2575 Radio-over-fibre, e.g. radio frequency signal modulated onto an optical carrier

Abstract

Apparatus and methods for delivering prosthetic segments to a body lumen, utilize a device having an elongated flexible member including proximal and distal ends, a plurality of prosthetic segments releasably arranged axially along the elongated flexible member near the distal end and an outer sheath slidably disposed over at least a portion of the prosthetic segments. The apparatus further includes a separator disposed on the outer sheath and adapted to engage the prosthetic segments. The separator is also adapted to be retracted proximally over the prosthetic segments and advanced distally to separate a proximal group of the prosthetic segments from a distal group of the prosthetic segments which are to be deployed in the body lumen.

Claims

1. A method for delivering prosthetic segments to a body lumen, the method comprising:

introducing a plurality of axially separable prosthetic segments positionable over an expandable member so as to be releasably arranged axially along the expandable member and an outer sheath slidably disposed over at least a portion of the prosthetic segments into a body lumen having a lesion with a lesion length at a first treatment site, wherein the sheath comprises an inwardly extending separator disposed on an inside surface of a distal portion of the sheath, the distal portion reinforced so as to resist radial expansion when the expandable member is expanded;

retracting the separator proximally relative to a group of unexpanded prosthetic segments selected for delivery, the group of prosthetic segments having a combined length that substantially matches the lesion length;

advancing the separator distally so that the separator engages a prosthetic segment in the selected group and axially separates the group of prosthetic segments from one or more remaining prosthetic segments creating a space between the segments selected for delivery and the remaining prosthetic segments;

exposing the selected group of unexpanded prosthetic segments so that the selected group of prosthetic segments are radially unconstrained from expansion by retracting the separator proximal of the proximal segment of the segments selected for delivery; and

deploying the selected group of prosthetic segments concurrently as a group at the first treatment site by expanding the expandable member.

2. A method as in claim 1, further comprising adding prosthetic segments to the selected group by advancing the separator distally a second time.

3. A method as in claim 1, wherein the plurality of prosthetic segments are introduced into a blood vessel.

4. A method as in claim 1, wherein deploying the selected group of prosthetic segments comprises plastically deforming the selected group of prosthetic segments.

5. A method as in claim 4, wherein the selected group of prosthetic segments are plastically deformed with a balloon.

6. A method as in claim 1, wherein the plurality of prosthetic segments carry a therapeutic agent adapted to being released therefrom.

7. A method as in claim 1, wherein the therapeutic agent comprises an anti-restenosis agent.

8. A method as in claim 1, wherein the plurality of prosthetic segments have a length in the range from about 2 mm to about 10 mm.

9. A method as in claim 1, wherein the plurality of prosthetic segments have a length about 3 mm to 6 mm.

10. A method as in claim 1, wherein the plurality of prosthetic segments have interleaved ends prior to deployment.

11. A method as in claim 1, wherein ends of the plurality of prosthetic segments are spaced apart prior to deployment to allow the separator to engage the prosthetic segments at their proximal ends.

12. A method as in claim 1, further comprising moving the selected group of prosthetic segments closer together when the separator is advanced distally.

13. A method as in claim 1, wherein the prosthetic segments are initially spaced proximally from a distal end of the elongated flexible member and the selected group is advanced toward the distal end by the separator.

14. A method as in claim 1, wherein the separator exerts substantially greater axial force against the prosthetic segments when the separator is advanced distally than when the separator is retracted proximally.

15. A method as in claim 1, wherein the separator comprises a plurality of resilient fingers projecting radially inward.

16. A method as in claim 15, wherein at least some of the fingers are inclined so that free ends of the fingers point distally allowing the fingers to pass over the prosthetic segments as the separator is retracted proximally but to engage a prosthetic segment when the separator is advanced distally.

17. A method as in claim 16, wherein at least some of the fingers are composed of metal.

18. A method as in claim 16, wherein at least some of the fingers are composed of a polymer.

19. A method as in claim 16, wherein at least some of the fingers comprise a radiused end substantially matching the curvature of the surface of the prosthetic segment thereby providing greater contact surface so as to facilitate engagement between the prosthetic segments and the separator as the separator is advanced distally while allowing the separator to pass over the prosthetic segments during proximal retraction of the separator.

20. A method as in claim 16, wherein the separator further comprises a hinge coupled to the resilient fingers, the resilient fingers deflecting radially outward over the prosthetic segments when the separator is retracted proximally.

21. A method as in claim 1, wherein the separator comprises an annular flange.

22. A method as in claim 1, wherein the annular flange is tapered.

23. A method as in claim 1, wherein the separator comprises a tapered conical nose.

24. A method as in claim 1, wherein the separator comprises a plurality of inclined ramps disposed on an inner surface of an outer sheath.

25. A method as in claim 1, wherein the inclined ramps are separated by about 90°

.

26. A method as in claim 1, wherein the separator comprises a compliant sharp edge.

27. A method as in claim 1, wherein the separator deflects outwardly during expansion of a balloon.

28. A method as in claim 1, wherein the separator is a wire-like coil.

29. A method as in claim 1, wherein advancing the separator distally comprises advancing an outer sheath distally.

30. A method as in claim 1, wherein advancing the separator distally comprises retracting the elongated flexible member proximally.

31. A method as in claim 1, wherein exposing the selected group of prosthetic segments comprises proximally retracting an outer sheath slidably disposed on the elongated flexible member.

32. A method as in claim 1, wherein retracting the separator comprises preventing proximal movement of the prosthetic segments with a backstop element disposed on the elongated flexible member.

33. A method as in claim 1, wherein the backstop element is a tube slidably disposed on the elongated flexible member.

34. A method as in claim 1, wherein the backstop element is an annular flange disposed on the elongated flexible member.

35. A method as in claim 1, wherein the backstop element is balloon.

36. A method as in claim 1, wherein the backstop element comprises a compliant spacer.

37. A method as in claim 1, wherein a stopping member is disposed on the distal end of the elongated flexible member, the stopping member preventing distal movement of the prosthetic segments when the separator is advanced distally.

38. A method for selectively delivering prosthetic segments to a treatment region in a body lumen, the method comprising:

advancing a delivery catheter through the body lumen to the treatment region, wherein a plurality of axially separable prosthetic segments positionable over an expandable member are disposed axially along the delivery catheter, and wherein an outer sheath is slidably disposed over at least a portion of the prosthetic segments;

retracting a separator over a first group of one or more unexpanded prosthetic segments, the separator disposed on an inside surface of a distal portion of the outer sheath and extending inwardly toward the portion of the prosthetic segments, the distal portion reinforced so as to resist radial expansion when the expandable member is expanded;

advancing the separator distally, the separator engaging the first group of prosthetic segments so as to axially separate the first group of unexpanded prosthetic segments from any remaining prosthetic segments to create a space between the first group and any remaining segments; and

inflating a balloon disposed on the delivery catheter so as to deploy the first group of prosthetic segments by expanding the segments concurrently as a group while any remaining prosthetic segments stay with the delivery catheter.

39. A method as in claim 38, further comprising adding prosthetic segments to the first group by advancing the separator distally a second time.

40. A method as in claim 38, wherein the plurality of prosthetic segments carry a therapeutic agent adapted to being released therefrom.

41. A method as in claim 38, wherein the therapeutic agent comprises an anti-restenosis agent.

42. A method as in claim 38, wherein the plurality of prosthetic segments have a length in the range from about 2 mm to about 10 mm.

43. A method as in claim 38, wherein the plurality of prosthetic segments have a length about 3 mm to 6 mm.

44. A method as in claim 38, wherein the plurality of prosthetic segments have interleaved ends prior to deployment.

45. A method as in claim 38, wherein ends of the plurality of prosthetic segments are spaced apart prior to deployment to allow the separator to engage the prosthetic segments at their proximal ends.

46. A method as in claim 38, further comprising moving the selected group of prosthetic segments closer together when the separator is advanced distally.

47. A method as in claim 38, wherein the prosthetic segments are initially spaced proximally from a distal end of the elongated flexible member and the selected group is advanced toward the distal end by the separator.

48. A method as in claim 38, wherein the separator exerts substantially greater axial against the prosthetic segments when the separator is advanced distally than when the separator is retracted proximally.

49. A method as in claim 38, wherein the separator comprises a plurality of resilient fingers projecting radially inward.

50. A method as in claim 49, wherein at least some of the fingers are inclined so that free ends of the fingers point distally allowing the fingers to pass over the prosthetic segments as the separator is retracted proximally but will engage a prosthetic segment when the separator is advanced distally.

51. A method as in claim 49, wherein at least some of the fingers are composed of metal.

52. A method as in claim 49, wherein at least some of the fingers are composed of a polymer.

53. A method as in claim 49, wherein at least some of the fingers comprise a radiused end substantially matching the curvature of the surface of the prosthetic segment thereby providing greater contact surface so as to facilitate engagement between the prosthetic segments and the separator as the separator is advanced distally while allowing the separator to pass over the prosthetic segments during proximal retraction of the separator.

54. A method as in claim 49, wherein the separator further comprises a hinge coupled to the resilient fingers, the resilient fingers deflecting radially outward over the prosthetic segments when the separator is retracted proximally.

55. A method as in claim 38, wherein the separator comprises an annular flange.

56. A method as in claim 55, wherein the annular flange is tapered.

57. A method as in claim 38, wherein the separator comprises a tapered conical nose.

58. A method as in claim 38, wherein the separator comprises a plurality of inclined ramps disposed on an inner surface of an outer sheath.

59. A method as in claim 58, wherein the inclined ramps are separated by about 90°

.

60. A method as in claim 38, wherein the separator comprises a compliant sharp edge.

61. A method as in claim 38, wherein the separator deflects outwardly during balloon inflation.

62. A method as in claim 38, wherein the separator is a wire-like coil.

63. A method as in claim 38, wherein retracting the separator comprises preventing proximal movement of the prosthetic segments with a backstop element disposed on the elongated flexible member.

64. A method as in claim 63, wherein the backstop element is a tube slidably disposed on the elongated flexible member.

65. A method as in claim 63, wherein the backstop element is an annular flange disposed on the elongated flexible member.

66. A method as in claim 63, wherein the backstop element is a balloon.

67. A method as in claim 63, wherein the backstop element comprises a compliant spacer.

68. A method as in claim 38, wherein a stopping member is disposed on the distal end of the elongate flexible member, the stopping member preventing distal movement of the prosthetic segments when the separator is advanced distally.