Apparatus and methods for delivery of multiple distributed stents

• US 20040093061A1
• Filed: 04/10/2003
• Published: 05/13/2004
• Est. Priority Date: 12/03/2001
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Andreas, Bernard, Acosta, Pablo, Snow, David W., Landreville, Steve
• Granted Patent: US 7,137,993 B2
• Time in Patent Office: Days
• 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 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2002/91541 Adjacent bands are arranged out of phase
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• 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 2250/006 : modular
• CPC Class Codes: A61F 2250/0071 : breakable or frangible
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0075 : Valve means
• CPC Class Codes: A61M 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: H01Q 3/2676 : Optically controlled phased array

Abstract

Delivery catheters and systems are adapted for delivering multiple discreet prostheses in body lumens. An exemplary delivery catheter comprises a sheath, a pusher for moving the prostheses relative to the sheath, and a valve member for selectively retaining the prostheses in the sheath. For balloon expandable stents, an elongated shaft and an expandable member are slidably disposed in the sheath, and the prostheses are positionable on the expandable member for deployment in the body lumen. The valve member allows a selected number of prostheses to be deployed from the sheath while retaining other prostheses within the sheath.

Claims

1. A catheter for delivering a plurality of prostheses to a treatment site comprising:

a sheath having a proximal end, a distal end, an opening at the distal end, and a passage in communication with the opening, the plurality of prostheses being movably disposed in the passage; and

a valve member near the distal end of the sheath adapted for selectively retaining at least one prosthesis within the passage.

2. The catheter of claim 1, wherein the valve member prevents the prosthesis from advancing through the passage under a first force and allows the prosthesis to pass through the passage under a second force higher than the first force.

3. The catheter of claim 1, wherein the valve member comprises a pair of lobes extending radially into the passage and adapted to engage the prosthesis therein.

4. The catheter of claim 1, wherein the valve member comprises an annular structure having an inner diameter smaller than the inner diameter of the sheath so as to engage the prosthesis therein.

5. The catheter of claim 1, wherein the valve member comprises a plurality of valve structures axially spaced apart along the passage.

6. The catheter of claim 1, wherein the valve member comprises a first stage and a second stage, the second stage being closer to the distal end of the sheath than the second stage.

7. The catheter of claim 6, wherein the first stage comprises a tubular structure and the second stage comprises a pair of lobes.

8. The catheter of claim 7, wherein the tubular structure is tapered.

9. The catheter of claim 6, wherein the first stage comprises at least one rib and the second stage comprises a pair of lobes.

10. The catheter of claim 1, wherein the valve member comprises a plurality of projections projecting into the passage to engage the prosthesis therein.

11. The catheter of claim 10, wherein the projections comprise a plurality of bristles.

12. The catheter of claim 10, wherein the projections comprise flexible shafts.

13. The catheter of claim 10, wherein the projections are configured to rotationally align the prostheses within the passage.

14. The catheter of claim 1, wherein the valve member comprises a plurality of movable flaps coupled to the sheath.

15. The catheter of claim 1, wherein the valve member comprises a diaphragm valve coupled to the sheath, the diaphragm valve having an opening and a flexible member adjacent thereto, the flexible member being configured to deflect when engaged by the prosthesis.

16. The catheter of claim 1, wherein the valve member comprises a leaf spring coupled to the sheath and biased inwardly into the passage to engage the prostheses.

17. The catheter of claim 1, wherein the valve member is movable from a contracted shape to an expanded shape, the valve member engaging the prostheses in the expanded shape.

18. The catheter of claim 17, wherein the valve member comprises an inflatable member, the catheter further comprising an inflation lumen in communication with the inflatable member for delivering an inflation fluid thereto.

19. The catheter of claim 1, wherein the valve member is movable from a retracted position to an extended position, the valve member engaging the prosthesis in the extended position.

20. The catheter of claim 1, wherein the valve member comprises a pawl coupled to the sheath, the catheter further comprising a wire coupled to the pawl for moving the pawl from the extended position to the retracted position.

21. The catheter of claim 19, wherein the valve member comprises a hydraulic piston, the catheter further comprising a fluid lumen for delivering a fluid to move the piston.

22. The catheter of claim 19, wherein the valve member comprises a wire, the wire being composed at least partially of a heat-activated shape-memory alloy, the wire changing between the retracted position and the extended position in response to a temperature change in the wire, the catheter further comprising a conductor for delivering a current to the wire.

23. The catheter of claim 19, wherein the sheath has a proximal portion having a first outer diameter and the valve member comprises an enlarged portion of the sheath distal to the proximal portion, the enlarged portion having a second outer diameter larger than the first outer diameter, the catheter further comprising a tubular member slidably disposed over the sheath and movable over the enlarged portion to urge the sheath into engagement with the prosthesis therein.

24. The catheter of claim 19, wherein the valve member has a first engagement element and a second engagement element each movable between retracted and extended positions, the first engagement element being axially spaced apart from the second engagement element by a distance of at least about the length of one of the prostheses.

25. The catheter of claim 24, wherein the first engagement element is in a retracted position when the second engagement element is in an extended position, and the first engagement element is in an extended position when the second engagement element is in a retracted position.

26. The catheter of claim 1 further comprising a shuttle member movable relative to the sheath, the shuttle member being configured to advance a selected number of prostheses a selected distance relative to the sheath.

27. The catheter of claim 26, wherein the shuttle member comprises a tubular member slidably mounted over the sheath, the tubular member having an engagement element extending inwardly to engage at least one prosthesis distally of the sheath.

28. The catheter of claim 26, wherein the shuttle member comprises a pusher element slidably disposed within the sheath, the pusher element being configured to engage at least one of the prostheses.

29. The catheter of claim 28, wherein the pusher element is configured to engage a proximal prosthesis disposed at a proximal end of the plurality of prostheses.

30. The catheter of claim 29, wherein the pusher element has an inner member slidably mounted to an outer member, the outer member being movable a preselected limited distance relative to the inner member.

31. The catheter of claim 26, wherein the shuttle member is movable a preselected limited distance relative to the sheath.

32. The catheter of claim 31, wherein the preselected limited distance is at least about the length of one of the prostheses.

33. The catheter of claim 28, wherein the pusher member comprises at least one engagement element extending inwardly into the passage to engage the prostheses.

34. The catheter of claim 33, wherein the pusher member comprises a plurality of engagement elements, the engagement elements being axially spaced apart a distance of at least about the length of one of the prostheses.

35. The catheter of claim 34, wherein the engagement elements are lobes extending inwardly into the passage to engage the prostheses.

36. The catheter of claim 33, wherein the pusher member is movable proximally relative to a selected number of prostheses in the sheath, and the pusher member is movable distally to advance the selected number of prostheses relative to the sheath.

37. The catheter of claim 36 further comprising engagement structure on the sheath for maintaining the position of the prostheses as the pusher member moves proximally.

38. The catheter of claim 37, wherein the engagement structure comprises a plurality of lobes in the sheath extending inwardly to engage the prostheses.

39. The catheter of claim 36, wherein the pusher member is configured to advance the selected number of prostheses distally of the valve member.

40. The catheter of claim 1 further comprising a balloon slidably positioned in the sheath, the prostheses being positionable on the balloon.

41. The catheter of claim 40 further comprising a pusher tube slidably mounted in the sheath, the pusher tube being adapted to exert a force on the prostheses to advance them distally relative to the sheath.

42. The catheter of claim 41, wherein the valve member is adapted to retain the prostheses within the sheath when the balloon is moved distally relative to the sheath unless force is exerted on the prostheses by the pusher tube.

52. The catheter of claim 51, wherein the projections comprise a plurality of bristles.

43. A catheter for delivering a plurality of prostheses to a treatment site comprising:

a sheath having a proximal end, a distal end, an opening at the distal end, and an interior passage in communication with the opening, the plurality of prostheses being movably disposed in the passage;

a shaft extending through the passage and being movable relative to the sheath, the shaft having an expandable member attached thereto, the prostheses being positionable over the expandable member;

a pusher tube movably disposed in the passage and having a distal end configured to apply a distal force to the prostheses; and

a valve member near the distal end of the sheath adapted for retaining the prostheses within the passage unless the distal force is applied to the prostheses by the pusher tube.

44. The catheter of claim 43, wherein the valve member comprises a pair of lobes extending radially into the passage and adapted to engage the prosthesis therein.

45. The catheter of claim 43, wherein the valve member comprises an annular structure having an inner diameter smaller than the inner diameter of the sheath so as to engage the prosthesis therein.

46. The catheter of claim 43, wherein the valve member comprises a plurality of valve structures axially spaced apart along the passage.

47. The catheter of claim 43, wherein the valve member comprises a first stage and a second stage, the second stage being closer to the distal end of the sheath than the second stage.

48. The catheter of claim 47, wherein the first stage comprises a tubular structure and the second stage comprises a pair of lobes.

49. The catheter of claim 48, wherein the tubular structure is tapered.

50. The catheter of claim 47, wherein the first stage comprises at least one rib and the second stage comprises a pair of lobes.

51. The catheter of claim 43, wherein the valve member comprises a plurality of projections projecting into the passage to engage the prosthesis therein.

53. The catheter of claim 51, wherein the projections comprise flexible shafts.

54. The catheter of claim 53, wherein the projections are configured to rotationally align the prostheses within the passage.

55. The catheter of claim 43, wherein the valve member comprises a plurality of movable flaps coupled to the sheath.

56. The catheter of claim 43, wherein the valve member comprises a diaphragm valve coupled to the sheath, the diaphragm valve having an opening and a flexible member adjacent thereto, the flexible member being configured to deflect when engaged by the prosthesis.

57. The catheter of claim 43, wherein the valve member comprises a leaf spring coupled to the sheath and biased inwardly into the passage to engage the prostheses.

58. The catheter of claim 43, wherein the valve member is adapted to retain the prostheses within the sheath during distal movement of the expandable member relative to the prostheses in the sheath.

59. A catheter for delivering a plurality of prostheses to a treatment site comprising:

a sheath having a proximal end, a distal end, an opening at the distal end, and an interior passage in communication with the opening, the plurality of prostheses being movably disposed in the passage; and

a valve member near the distal end of the sheath adapted for selectively retaining at least one prosthesis within the passage, the valve member being movable between a first configuration which inhibits movement of the prosthesis, and a second configuration which allows movement of the prosthesis.

60. The catheter of claim 59, wherein the valve member is movable from a contracted shape to an expanded shape, the valve member engaging the prostheses in the expanded shape.

61. The catheter of claim 60, wherein the valve member comprises an inflatable member, the catheter further comprising an inflation lumen in communication with the inflatable member for delivering an inflation fluid thereto.

62. The catheter of claim 59, wherein the valve member is movable from a retracted position to an extended position, the valve member engaging the prosthesis in the extended position.

63. The catheter of claim 59, wherein the valve member comprises a pawl coupled to the sheath, the catheter further comprising a wire coupled to the pawl for moving the pawl from the extended position to the retracted position.

64. The catheter of claim 62, wherein the valve member comprises a hydraulic piston, the catheter further comprising a fluid lumen for delivering a fluid to move the piston.

65. The catheter of claim 62, wherein the valve member comprises a wire, the wire being composed at least partially of a heat-activated shape-memory alloy, the wire changing between the retracted position and the extended position in response to a temperature change in the wire, the catheter further comprising a conductor for delivering a current to the wire.

66. The catheter of claim 62, wherein the sheath has a proximal portion having a first outer diameter and the valve member comprises an enlarged portion of the sheath distal to the proximal portion, the enlarged portion having a second outer diameter larger than the first outer diameter, the catheter further comprising a tubular member slidably disposed over the sheath and movable over the enlarged portion to urge the sheath into engagement with the prosthesis therein.

67. The catheter of claim 62, wherein the valve member has a first engagement element and a second engagement element each movable between retracted and extended positions, the first engagement element being axially spaced apart from the second engagement element by a distance of at least about the length of one of the prostheses.

68. The catheter of claim 67, wherein the first engagement element is in a retracted position when the second engagement element is in an extended position, and the first engagement element is in an extended position when the second engagement element is in a retracted position.

69. A catheter for delivering a plurality of prostheses to a treatment site comprising:

a sheath having a proximal end, a distal end, an opening at the distal end, and an interior passage in communication with the opening, the plurality of prostheses being movably disposed in the passage;

a catheter extending through the passage and being movable relative to the sheath, the prostheses being releasable coupled to the catheter; and

a valve member adapted for retaining at least a first prosthesis within the passage while allowing at least a second prosthesis to pass through the opening as the sheath moves proximally relative to the catheter.

73. The catheter of claim 69, wherein the valve member is movable from a first position which inhibits movement of prostheses through the opening, to a second position which allows movement of the prostheses through the opening.

70. The catheter of claim 70 further comprising an expandable member coupled to the catheter, the prostheses being positionable on the expandable member.

71. The catheter of claim 70 further comprising a pusher slidably disposed in the sheath and configured to apply a distally-directed force to the prostheses.

72. The catheter of claim 71, wherein the valve member allows the second prosthesis to pass through the opening in the sheath only under the distally directed force of the pusher.