FILL TUBE MANIFOLD AND DELIVERY METHODS FOR ENDOVASCULAR GRAFT

• US 20110218609A1
• Filed: 02/09/2011
• Published: 09/08/2011
• Est. Priority Date: 02/10/2010
• Status: Abandoned Application

• Current Assignee: Endologix
• Original Assignee: Trivascular Incorporated
• Inventors: Marston, Mary Jane, Stephens, Patrick, Purter, Mark E,, Watson, James R., Chobotov, Michael V., Whirley, Robert G.
• Application Number:
  US13/024,255
• Publication Number:
  US 20110218609A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61B 6/4441 the rigid structure being a C-arm or U-arm
• CPC Class Codes: A61B 6/487 involving fluoroscopy
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2/9661 the proximal portion of the stent or stent-graft is released first
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

Some embodiments relate in part to endovascular prostheses and methods of deploying same. Embodiments may be directed more specifically to inflatable stent grafts and methods of positioning and deploying such devices within the body of a patient. Some embodiments include inflation devices and methods that allow an inflatable portion of an inflatable stent graft to be inflated from a desired location within the inflatable portion.

Claims

1. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature;

partially deploying the endovascular graft so as to allow at least a portion of a proximal self-expanding member of the endovascular graft to radially expand;

aligning an imaging system relative to the patient'"'"'s body such that an imaging axis of the imaging system is substantially orthogonal to a longitudinal axis of a tubular main body portion of the endovascular stent graft;

positioning the partially deployed endovascular graft in an axial direction to a desired position within the patient'"'"'s vasculature; and

fully deploying the proximal self-expanding member of the endovascular graft so as to engage an interior luminal surface within the patient'"'"'s vasculature.

2. The method of claim 1 wherein the imaging system is aligned relative to the patient'"'"'s body by aligning a plane defined by a plurality of radiopaque markers substantially along the imaging axis of the imaging system, wherein the radiopaque markers are disposed about a circumference of a tubular portion of the stent graft and lie in a plane which is substantially orthogonal to a longitudinal axis of the tubular main body portion of the endovascular stent graft.

3. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature;

partially deploying the endovascular graft so as to allow at least a portion of a proximal self-expanding member of the endovascular graft to radially expand;

aligning an imaging system relative to the patient'"'"'s body such that an imaging axis of the imaging system is substantially orthogonal to a longitudinal axis of a tubular main body portion of the endovascular stent graft;

positioning the partially deployed endovascular graft in an axial direction to a desired position within the patient'"'"'s vasculature;

fully deploying the proximal self-expanding member of the endovascular graft so as to engage an interior luminal surface within the patient'"'"'s vasculature; and

inflating an inflatable portion of the endovascular stent graft with a fill material.

4. The method of claim 3 wherein the imaging system is aligned relative to the patient'"'"'s body by aligning a plane defined by a plurality of radiopaque markers substantially along the imaging axis of the imaging system, wherein the radiopaque markers are disposed about a circumference of a tubular portion of the stent graft and lie in a plane which is substantially orthogonal to a longitudinal axis of the tubular main body portion of the endovascular stent graft.

5. The method of claim 4 wherein the plurality of radiopaque markers are disposed about a circumference of the proximal self-expanding member of the stent graft.

6. The method of claim 4 wherein the plurality of radiopaque markers are disposed about a circumference of connector members of the proximal self-expanding member of the stent graft.

7. The method of claim 3 further comprising deploying a distal self-expanding member of the endovascular stent graft so as to engage an interior luminal surface within the patient'"'"'s vasculature.

8. The method of claim 3 wherein the stent graft comprises a bifurcated AAA stent graft including an ipsilateral leg and a contralateral leg and further comprising deploying an ipsilateral stent graft extension into the ipsilateral leg of the bifurcated stent graft and deploying a contralateral stent graft extension into the contralateral leg of the bifurcated stent graft.

9. An endovascular stent graft, comprising:

a tubular flexible main body portion;

a proximal self-expanding stent member; and

a plurality of radiopaque markers circumferentially disposed about a tubular portion of the endovascular stent graft and lying in a plane that is substantially orthogonal to a longitudinal axis of the tubular main body portion.

10. The stent graft of claim 9 wherein the plurality of radiopaque markers are disposed about a circumference of the proximal self-expanding member of the stent graft.

11. The stent graft of claim 9 wherein the plurality of radiopaque markers are disposed about on connector members of the proximal self-expanding member of the stent graft.

12. The stent graft of claim 9 wherein the flexible graft body portion comprises at least one flexible layer of material.

13. The stent graft of claim 12 wherein the flexible layer of material comprises PTFE.

14. The stent graft of claim 9 wherein the proximal stent member comprises a substantially tubular self-expanding stent including a plurality of struts connected in a zig-zag configuration.

15. The stent graft of claim 14 wherein the proximal stent member comprises a superelastic alloy.

16. An inflatable endovascular stent graft, comprising:

a tubular flexible main body portion;

a proximal self-expanding stent member;

a proximal inflatable cuff; and

a plurality of radiopaque markers circumferentially disposed about a tubular portion of the endovascular stent graft and lying in a plane that is substantially orthogonal to a longitudinal axis of the tubular main body portion.

17. The stent graft of claim 16 wherein the plurality of radiopaque markers are disposed about a circumference of the proximal self-expanding member of the stent graft.

18. The stent graft of claim 16 wherein the plurality of radiopaque markers are disposed on connector members of the proximal self-expanding member of the stent graft.

19. The stent graft of claim 16 further comprising a distal self-expanding member of the endovascular stent graft disposed at a distal end of the tubular main body portion and configured to engage an interior luminal surface within the patient'"'"'s vasculature.

20. The stent graft of claim 16 wherein the stent graft comprises a bifurcated stent graft and includes an ipsilateral leg including an inner lumen in fluid communication with an inner lumen of the tubular main body portion and a contralateral leg having an inner lumen in fluid communication with the inner lumen of the main body portion.

21. The stent graft of claim 16 wherein the flexible graft body portion comprises at least one flexible layer of material.

22. The stent graft of claim 21 wherein the flexible layer of material comprises PTFE.

23. The stent graft of claim 16 wherein the proximal stent member comprises a substantially tubular self-expanding stent including a plurality of struts connected in a zig-zag configuration.

24. The stent graft of claim 23 wherein the proximal stent member comprises a superelastic alloy.

25. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature;

rotating the delivery catheter about a longitudinal axis of the delivery catheter until a longitudinal inflatable channel of an inflatable portion of the endovascular stent graft that extends longitudinally along a main body portion of the stent graft is disposed along a greater curve of a vascular lumen of the patient'"'"'s vasculature within which the delivery system is disposed; and

deploying the stent graft at the deployment site with the longitudinal inflatable channel disposed along the greater curve of the vascular lumen and inflating an inflatable portion including the longitudinal inflatable channel of the endovascular stent graft.

26. The method of claim 25 further comprising retracting an outer sheath of the delivery catheter after rotating the delivery catheter about a longitudinal axis of the delivery catheter until a longitudinal inflatable channel of the endovascular stent graft that extends longitudinally along a main body portion of the stent graft is disposed along a greater curve of a vascular lumen of the patient'"'"'s vasculature.

27. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature;

rotating the delivery catheter about a longitudinal axis of the delivery catheter until a longitudinal inflatable channel of the endovascular stent graft that extends longitudinally along a main body portion of the stent graft is disposed along a greater curve of a vascular lumen of the patient'"'"'s vasculature within which the delivery system is disposed;

partially deploying the endovascular stent graft so as to allow at least a portion of a proximal self-expanding member of the endovascular graft to radially expand;

positioning the partially deployed endovascular graft in an axial direction to a desired position within the patient'"'"'s vasculature;

fully deploying the self-expanding member of the endovascular graft so as to allow the proximal self-expanding member of the endovascular graft to expand and engage an inner luminal surface of the patient'"'"'s vasculature; and

inflating an inflatable portion of the endovascular stent graft including the longitudinal inflatable channel with a fill material.

28. The method of claim 27 further comprising aligning an imaging system relative to the patient'"'"'s body after partial deployment of the proximal self-expanding member such that an imaging axis of the imaging system is substantially orthogonal to a longitudinal axis of the tubular main body portion of the endovascular stent graft.

29. The method of claim 28 wherein the imaging system is aligned relative to the patient'"'"'s body by aligning a plane defined by a plurality of radiopaque markers substantially along the imaging axis of the imaging system, wherein the radiopaque marker are disposed on the self-expanding member of the stent graft and lie in a plane which is substantially orthogonal to a longitudinal axis of the tubular main body portion of the endovascular stent graft.

30. An endovascular stent graft, comprising:

a flexible graft body portion including a proximal end, a distal end, and an inflatable portion including at least one longitudinal inflation channel;

a self-expanding stent member secured to the proximal end of the graft body portion; and

one or more radiopaque markers configured to distinguish circumferential rotational position of the at least one longitudinal inflation channel prior to being filled with fill material.

31. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature with a proximal end of the stent graft disposed towards a flow of blood within the patient'"'"'s vasculature;

axially positioning the stent graft in the constrained state relative to the deployment site;

deploying a proximal self-expanding member of the endovascular graft to expand and engage an interior luminal surface the patient'"'"'s vasculature;

positioning a distal end of the stent graft in an axial direction until a tubular main body portion of the stent graft achieves a desired configuration; and

deploying a distal self-expanding member so as to allow the distal self-expanding member to expand and engage an interior luminal surface of the patient'"'"'s vasculature.

32. The method of claim 31 further comprising aligning an imaging system relative to the patient'"'"'s body such that an imaging axis of the imaging system is substantially orthogonal to a longitudinal axis of a tubular main body portion of the endovascular stent graft prior to axially positioning the stent graft.

33. The method of claim 31 further comprising inflating an inflatable portion of the endovascular stent graft with a fill material after the proximal self-expanding member has been deployed.

34. The method of claim 31 wherein deploying the proximal self-expanding member comprises:

partially deploying the endovascular graft allowing at least a portion of a proximal self-expanding member of the endovascular graft to radially expand;

positioning the partially deployed endovascular graft in an axial direction to a desired position within the patient'"'"'s vasculature; and

fully deploying the proximal self-expanding member of the endovascular graft so as to allow the proximal self-expanding member to expand and engage an interior luminal surface the patient'"'"'s vasculature.

35. The method of claim 32 wherein the imaging system is aligned relative to the patient'"'"'s body by aligning a plane defined by a plurality of radiopaque markers substantially along the imaging axis of the imaging system, wherein the radiopaque markers are disposed on the self-expanding member of the stent graft and lie in a plane which is substantially orthogonal to a longitudinal axis of the tubular main body portion of the endovascular stent graft.

36. The method of claim 31 wherein the deployment site of the patient'"'"'s vasculature comprises a curved configuration and wherein the distal end of the stent graft is positioned in an axial orientation until the tubular main body portion of the stent graft achieves a desired radius of curvature and radial position within the patient'"'"'s vasculature.

37. The method of claim 36 wherein the desired radial position within the patient'"'"'s vasculature comprises a radial position disposed along a greater curve of the patient'"'"'s vasculature.

38. The method of claim 36 wherein the desired radial position within the patient'"'"'s vasculature comprises a radial position disposed along a least curve of the patient'"'"'s vasculature.

39. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature with a proximal end of the stent graft disposed towards a flow of blood within the patient'"'"'s vasculature;

partially deploying the endovascular graft so as to allow at least a portion of a proximal self-expanding member of the endovascular graft to radially expand;

aligning an imaging system relative to the patient'"'"'s body such that an imaging axis of the imaging system is substantially orthogonal to a longitudinal axis of a tubular main body portion of the endovascular stent graft;

positioning the partially deployed endovascular graft in an axial direction to a desired position within the patient'"'"'s vasculature;

fully deploying the proximal self-expanding member of the endovascular graft so as to allow the proximal self-expanding member to expand and engage an interior luminal surface the patient'"'"'s vasculature;

inflating an inflatable portion of the endovascular stent graft with a fill material;

positioning a distal end of the stent graft in an axial orientation until a tubular main body portion of the stent graft achieves a desired configuration; and

deploying a distal self-expanding member so as to allow the distal self-expanding member to expand and engage an interior luminal surface of the patient'"'"'s vasculature.

40. The method of claim 39 wherein the imaging system is aligned relative to the patient'"'"'s body by aligning a plane defined by a plurality of radiopaque markers substantially along the imaging axis of the imaging system, wherein the radiopaque markers are disposed on the self-expanding member of the stent graft and lie in a plane which is substantially orthogonal to a longitudinal axis of the tubular main body portion of the endovascular stent graft.

41. The method of claim 39 wherein the deployment site of the patient'"'"'s vasculature comprises a curved configuration and wherein the distal end of the stent graft is positioned in an axial orientation until the tubular main body portion of the stent graft achieves a desired radius of curvature and radial position within the patient'"'"'s vasculature.

42. The method of claim 41 wherein the desired radial position within the patient'"'"'s vasculature comprises a radial position disposed along a greater curve of the patient'"'"'s vasculature.

43. The method of claim 41 wherein the desired radial position within the patient'"'"'s vasculature comprises a radial position disposed along a least curve of the patient'"'"'s vasculature.

44. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the inflatable endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature with a proximal end of the stent graft disposed towards a flow of blood within the patient'"'"'s vasculature;

deploying a proximal self-expanding member of the endovascular graft so as to allow the proximal self-expanding member to expand and engage an interior luminal surface the patient'"'"'s vasculature;

at least partially inflating an interior volume of an inflatable portion of the endovascular stent graft from a desired location within an interior volume of the inflatable portion with a fill material;

axially positioning a distal end of the stent graft such that a tubular main body portion of the stent graft achieves a desired deployed configuration; and

deploying a distal self-expanding member of the stent graft so as to allow the distal self-expanding member to expand and engage an interior luminal surface of the patient'"'"'s vasculature.

45. The method of claim 44 wherein at least partially inflating the inflatable portion of the endovascular stent graft from a desired portion of the inflatable portion comprises inflating through an inflation conduit, the inflatable conduit being disposed within the interior volume the inflatable portion and extending to a distal portion of the stent graft.

46. The method of claim 45 wherein the inflation conduit comprises a plurality of outlet ports along a wall of the conduit, the plurality of outlet ports being in fluid communication with an interior volume of the longitudinal inflatable channel and proximal cuff of the inflatable portion and configured in size and location so as to at least partially inflate the interior volume of the inflatable portion substantially evenly with respect to a longitudinal axis of the graft body portion.

47. The method of claim 46 wherein the outlet ports in the wall of the inflation conduit have a progressively larger area in a direction from a distal end of the inflation conduit to a proximal end of the inflation conduit and configured such that a pressure gradient of the fill material within the fill tube produces substantially even flow from each outlet port.

48. The method of claim 45 wherein the inflation conduit comprises a tubular member having a single outlet port disposed within an interior volume of the proximal cuff and configured to fill the inflatable portion from a proximal end of the inflatable portion.

49. The method of claim 44 further comprising maintaining a lumen opening within the inflation conduit prior to inflation with a bead disposed within the lumen of the inflation conduit.

50. An inflatable endovascular stent graft, comprising:

at least one self-expanding stent member;

a flexible graft body portion secured to the self-expanding member, the graft body portion including a proximal end, a distal end and an inflatable portion; and

an inflation conduit which extends into an interior volume of the inflatable portion and which includes at least one outlet port disposed at a desired position or desired positions within the inflatable portion and which is configured to emit fill material injected into the inflation conduit into an interior volume of the inflatable portion from the desired position or positions of the at least one outlet port.

51. The stent graft of claim 50 wherein the inflatable portion comprises a proximal inflatable cuff disposed at a proximal end of the graft body portion.

52. The stent graft of claim 51 wherein the inflatable portion comprises an inflatable channel extending distally from the proximal inflatable cuff.

53. The stent graft of claim 50 wherein the inflation conduit comprises a plurality of outlet ports along a wall of the inflation conduit, the plurality of outlet ports being in fluid communication with an interior volume of an inflation channel and proximal cuff of the graft body portion and configured in size and location so as to inflate the inflatable portion substantially evenly with respect to a longitudinal axis of the graft body portion.

54. The stent graft of claim 53 wherein the outlet ports in the wall of the inflation conduit have a progressively larger area in a direction from a distal end of the inflation conduit to a proximal end of the inflation conduit.

55. The stent graft of claim 50 wherein the inflation conduit comprises a tubular member having a single outlet port disposed within an inner volume of a proximal cuff of the graft body portion and is configured to fill the inflatable portion from a proximal end of the inflatable portion.

56. The stent graft of claim 50 wherein the flexible graft body portion comprises at least one flexible layer of material.

57. The stent graft of claim 56 wherein the flexible layer of material comprises PTFE.

58. The stent graft of claim 50 wherein the stent member comprises a substantially tubular self-expanding stent including a plurality of struts connected in a zig-zag configuration.

59. The stent graft of claim 58 wherein the stent member comprises a superelastic alloy.

60. The stent graft of claim 50 wherein the inflation conduit comprises a PTFE tube.

61. The stent graft of claim 50 further comprising a bead disposed within the lumen of the inflation conduit.

62. A method of deploying an inflatable endovascular stent graft, comprising:

advancing a delivery catheter that includes the endovascular stent graft in a radially constrained state to a deployment site within a patient'"'"'s vasculature with a proximal end of the stent graft disposed towards a flow of blood within the patient'"'"'s vasculature;

inflating a proximal portion of an inflatable portion of the endovascular stent graft with a fill material with the fill material flowing from a proximal portion of the inflatable portion to a distal portion of the inflatable portion.

63. The method of claim 62 further comprising inflating a proximal cuff of the stent graft and forming a seal with a luminal surface of the patient'"'"'s vasculature before the inflatable portion is completely filled.

64. The method of claim 62 further comprising deploying a proximal self-expanding member of the endovascular stent graft so as to allow the proximal self-expanding member to expand and engage an interior luminal surface the patient'"'"'s vasculature.

65. The method of claim 64 further comprising positioning a distal end of the stent graft in an axial position until a tubular main body portion of the stent graft achieves a desired configuration within the patient'"'"'s vasculature.

66. The method of claim 65 further comprising fully deploying a distal self-expanding member so as to allow the distal self-expanding member to expand and engage an interior luminal surface of the patient'"'"'s vasculature.

67. The method of claim 62 wherein inflating from a proximal portion of the inflatable portion comprises inflating through an inflation conduit, the inflatable conduit being disposed within the inflatable portion and extending to a proximal portion of the stent graft.

68. The method of claim 67 wherein the inflation conduit comprises an outlet port disposed in a proximal cuff of the stent graft and inflating a proximal portion of the inflatable portion comprises inflating the proximal cuff.

69. The method of claim 62 further comprising maintaining a lumen opening within the inflation conduit prior to inflation with a bead disposed within the lumen of the inflation conduit.

70. An inflatable endovascular stent graft, comprising:

at least one self-expanding stent member;

a flexible graft body portion secured to the self-expanding member, the graft body portion including at least one tubular portion, a proximal end a distal end and an inflatable portion; and

an inflation conduit disposed within the inflatable portion, the inflation conduit including a distal end with an inflation port in fluid communication with an exterior portion of the graft body portion and extending from the distal end into an interior volume of the inflatable portion.

71. The stent graft of claim 70 wherein the flexible graft body portion comprises at least one flexible layer of material.

72. The stent graft of claim 71 wherein the flexible layer of material comprises PTFE.

73. The stent graft of claim 70 wherein the stent member comprises a substantially tubular self-expanding stent including a plurality of struts connected in a zig-zag configuration.

74. The stent graft of claim 73 wherein the stent member comprises a superelastic alloy.

75. The stent graft of claim 70 wherein the inflation conduit comprises a PTFE tube.

76. The stent graft of claim 70 further comprising a bead disposed within the lumen of the inflation conduit.

77. An inflatable endovascular stent graft, comprising:

at least one self-expanding stent member;

a flexible graft body portion secured to the self-expanding member, the graft body portion including at least one tubular portion, a proximal end, a distal end and an inflatable portion comprising a proximal inflatable cuff disposed at the proximal end of the graft body portion and an inflatable channel extending distally from the proximal inflatable cuff; and

an inflation conduit disposed within the inflatable channel, the inflation conduit including a distal end with an inflation port in fluid communication with an exterior portion of the graft body portion and extending from the distal end through the inflatable channel and terminating with an outlet port disposed within or near an interior cavity of the proximal inflatable cuff.

78. The stent graft of claim 77 wherein the flexible graft body portion comprises at least one flexible layer of material.

79. The stent graft of claim 78 wherein the flexible layer of material comprises PTFE.

80. The stent graft of claim 77 wherein the stent member comprises a substantially tubular self-expanding stent including a plurality of struts connected in a zig-zag configuration.

81. The stent graft of claim 80 wherein the stent member comprises a superelastic alloy.

82. The stent graft of claim 77 wherein the inflation conduit comprises a PTFE tube.

83. The stent graft of claim 77 further comprising a bead disposed within the lumen of the inflation conduit.