SYSTEM AND METHOD FOR DEPLOYING AN ENDOLUMINAL PROSTHESIS AT A SURGICAL SITE

• US 20100234932A1
• Filed: 03/12/2010
• Published: 09/16/2010
• Est. Priority Date: 03/13/2009
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Manguno, Joseph A. JR., Canning, John C., Christian, Fletcher, Arbefeuille, Samuel
• Granted Patent: US 9,101,506 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A system for implanting a prosthesis includes a control lumen and a nose cone affixed at a distal end of the control lumen. At least one supporting wire is affixed at one end, is substantially parallel to a major axis of the control lumen and is free at an opposite end, wherein the free end of at least one of the supporting wires is arcuate. Alternatively, a system for implanting a prosthesis includes at least one suture extending from a nose cone affixed to a distal end of a control lumen. The suture extends from the nose cone to a proximal end to a stent graft extending about the control lumen and from the stent graft to a fixed location on the control lumen. The suture is releasable from the stent graft by remote activation, whereby the suture separates from the nose cone to thereby deploy the stent graft.

Claims

1. A system for implanting a prosthesis, comprising:

a) a control lumen;

b) a nose cone fixed at a distal end of the control lumen; and

c) at least one supporting wire fixed at one end and substantially parallel to a major axis of the control lumen and free at an opposite end, wherein the free end of at least one of the supporting wires is arcuate.

2. The system of claim 1, further including at least one stop, having a diameter greater than that of the supporting wire, proximate to the free end of the supporting wire.

3. The system of claim 1, further including an outer control tube slideable along the control lumen, wherein the supporting wire is fixed at one end to the outer control tube.

4. The system of claim 3, wherein the supporting wire is fixed at one end to the outer control tube proximal to the nose cone and the free end is distal to the fixed end and is proximate to the nose cone.

5. The system of claim 4, further including an apex clasp at an end of the outer control tube and slideable along the control lumen with movement of the outer control tube.

6. The system of claim 5, further including a stent graft extending about the outer control tube and the supporting wires, the stent graft including a proximal end at the clasp and a distal end that is proximal to the clasp.

7. The system of claim 6, wherein the stent graft includes at least one clasp stent defining at least one exposed portion that is releasably secured to the clasp.

8. The system of claim 7, wherein the stent graft includes for each supporting wire, a loop within the stent graft that releasably secures the free end of each respective supporting wire.

9. The system of claim 8, wherein the stent graft includes a crown stent at the proximate end of the stent graft.

10. The system of claim 9, wherein the crown stent is secured to an interior portion of a graft portion of the graft stent.

11. The system of claim 10, wherein the crown stent is between the clasp stent and the proximal end of the graft stent.

12. The system of claim 1, further including a pusher support tube distal or proximal to the fixed end of the supporting wires and slideable along the control lumen.

13. The system of claim 12, further including an outer control tube slideable along the control lumen, wherein the supporting wire is fixed at one end to the outer control tube.

14. The system of claim 13, further including an apex clasp at an end of the outer control tube and slideable along the control lumen with movement of the outer control tube.

15. The system of claim 6, wherein the stent graft is a bifurcated stent graft.

16. The system of claim 6, wherein the stent graft further includes at least one radiopaque marker.

17. The system of claim 15, wherein the bifurcated stent graft further includes at least one radiopaque marker.

18. The system of claim 1, wherein the supporting wire is formed of at least one member selected from the group consisting of a metal, an alloy and a polymer.

19. The system of claim 18, wherein the metal includes stainless steel.

20. The system of claim 18, wherein the alloy includes a shape memory alloy.

21. The system of claim 20, wherein the shape memory alloy includes a nickel titanium alloy.

22. The system of claim 1, wherein the system includes at least two supporting wires.

23. The system of claim 22, wherein the system includes two supporting wires.

24. The system of claim 23, wherein the free ends of the supporting wires each include a bulbous tip.

25. The system of claim 24, wherein each of the supporting wires is cantilevered.

26. The system of claim 25, further including a sheath lumen that is slideable along the outer catheter proximal to the supporting wires.

27. The system of claim 26, further including an inner sheath extending distally from the sheath lumen.

28. The system of claim 27, wherein the inner sheath includes at least one through-hole at a proximal end of the inner sheath.

29. The system of claim 27, wherein the inner sheath includes at least one radiopaque marker.

30. The system of claim 29, wherein at least one radiopaque marker is located on the inner sheath facing away from a concavity of a curve defined by the control lumen and the radiopaque marker of the inner sheath overlaps at least one radiopaque mark of the stent graft when the stem graft is partially deployed.

31. The system of claim 30, wherein the inner sheath defines a flared opening at a distal end of the inner sheath.

32. The system of claim 31, wherein the flared opening is asymmetric.

33. The system of claim 32, wherein the control lumen is arcuate.

34. The system of claim 33, wherein the supporting wires are clustered within a curve defined by the control lumen.

35. The system of claim 34, wherein the supporting wires are connected at a concavity of the outer control tube.

36. The system of claim 33, wherein a major portion of the flared opening of the inner sheath is within the curve defined by the control lumen.

37. The system of claim 36, wherein the flared opening faces a concavity of the curve defined by the control lumen.

38. The system of claim 1, wherein the supporting wire is fixed to the outer control tube proximate to the nose cone, and wherein the free end of the supporting wire is proximal to the fixed end.

39. The system of claim 38, further including an inner sheath that is fixed to the nose cone and extends proximally from the nose cone about the supporting wire.

40. The system of claim 39, further including a stent graft extending about the control lumen and supporting wire and within the inner sheath.

41. The system of claim 40, wherein the stent graft includes a loop within the stent graft that releasably secures the free end of each respective supporting wire.

42. The system of claim 41, wherein the free end of at least one supporting wire is arcuate.

43. The system of claim 42, further including at least one stop, having a diameter greater than that of the supporting wire, proximate to the free end of the supporting wire.

44. The system of claim 42, wherein the loop releasably secures the free end of each respective supporting wire between the free end and the stop, whereby movement of the loop along the supporting wire is restricted.

45. The system of claim 1, further including an inner sheath, and wherein the nose cone defines a proximal cavity into which a distal portion of the inner sheath fits, whereby relative motion of the nose cone and inner sheath releases the distal end of the inner sheath from the cavity.

46. The system of claim 45, wherein the nose cone is retractable within the inner sheath after release of the inner sheath.

47. The system of claim 46, further including a stent graft within the inner sheath, inner sheath and the nose cone are retractable relative to the stent graft.

48. The system of claim 46, whereby the stent graft is deployed by joint retraction of the inner sheath and the nose cone.

49. The system of claim 47, wherein the stent graft includes a loop inside the stent graft that releasably secures a respective supporting wire, whereby movement of the loop along the supporting wire is restricted.

50. A system for implanting a prosthesis, comprising;

a) a control lumen;

b) a nose cone fixed at a distal end of the control lumen;

c) a stent graft extending about the control lumen; and

d) at least one suture extending from the nose cone to a proximal end of the stent graft, and from the stent graft to a fixed location on the control lumen, said suture being releasable from the stent graft by remote activation.

51. A system for implanting a prosthesis, comprising:

a) a control lumen;

b) a nose cone fixed at a distal end of the control lumen; and

c) an inner sheath extending about the control lumen that defines a distal opening at a distal end of the inner sheath, wherein the nose cone is retractable within the inner sheath.

52. The system of claim 51, further including an introducer sheath about the inner sheath, wherein the introducer sheath is retractable relative to the inner sheath to thereby release the distal end of the inner sheath, and whereby the nose cone can thereafter be retracted within the inner sheath.

53. The system of claim 52, further including a stent graft extending with the inner sheath and about the external lumen.

54. The system of claim 53, wherein the inner sheath is retractable relative to the nose cone.

55. The system of claim 54, wherein the inner sheath includes at least one through-hole at a proximal end of the inner sheath.

56. The system of claim 51, wherein the nose cone defines a cavity with which the distal end of the inner sheath can fit, and which will release the distal end upon retraction of the inner sheath relative to the nose cone.

57. The system of claim 51, further including at least one supporting wire fixed at one end and substantially parallel to a major axis of the control lumen and free at an opposite end, wherein the free end of at least one of the supporting wires is arcuate and wherein the stent graft includes a loop inside the stent graft that releasably secures at least one supporting wire, whereby movement of the loop along the supporting wire is restricted.

58. A method for implanting a prosthesis, comprising the steps of:

a) delivering a stent graft through an artery to an aneurysm site of a patient, the stent graft being radially constrained by an inner sheath and supported at least in part by a control lumen, the stent graft further being longitudinally constrained by at least one supporting wire extending from a nose cone, from the control lumen or from an outer control tube extending about and slideable along the control lumen, wherein the free end of at least one of the supporting wires is arcuate and extends through a loop within a proximal end of the stent graft;

b) partially retracting the inner sheath from the stent graft, whereby the supporting wire at least partially restricts longitudinal movement of the proximal end of the stent graft until the proximal end of the stent graft is secure within the artery to thereby prevent rotation of a portion of the proximal end of the stent graft at an inferior portion of the artery;

c) retracting the inner sheath; and

d) retracting the supporting wire, thereby removing the supporting wire from the loop and deploying the stent graft within the artery at the aneurysm site in the patient.

59. The method of claim 58, wherein the control lumen and the supporting wire are retracted jointly.

60. The method of claim 59, wherein the inner sheath and supporting wire are jointly retracted.

61. The method of claim 58, wherein the supporting wire has at least one stop, the stop limiting movement of the loop along the supporting wire.

62. The method of claim 58, wherein the stent graft and the inner sheath each include a radiopaque marker longitudinally aligned along a path of relative movement of the inner sheath and stent graft during deployment of the stent graft, and spaced apart from each other, whereby the partial retraction of the inner sheath will cause overlap of the radiopaque markers.

63. The method of claim 62, wherein the radiopaque markers are on superior portions of the inner sheath and the stent graft.

64. The method of claim 63, wherein the radiopaque marker in the inner sheath is asymmetric, wherein a shape of the marker changes as the marker is aligned with a major longitudinal axis of the inner sheath.

65. The method of claim 64, wherein the radiopaque marker of the stent graft is elongate and substantially aligned with the major longitudinal axis of the inner sheath.

66. The method of claim 58, wherein the inner sheath is releasably secured at a distal end within a cavity defined by a proximal end of the nose cone, and further including the steps of:

a) partially retracting the inner sheath to release said distal end of the inner sheath from the nose cone and thereby cause partial deployment of the stent graft;

b) at least partially retracting the nose cone to within the stent graft;

c) advancing the stent graft to a final position within the artery; and

d) jointly retracting the inner sheath, the nose cone and the supporting wires to fully deploy the stent graft within the artery at the aneurysm site in the patient.

67. The method of claim 66, wherein the inner sheath defines at least one through hole at a proximal end of the inner sheath.

68. The method of claim 58, wherein at least the stent graft is further constrained at at least one end by a clasp, and further including the step of releasing the clasp prior to retraction of the supporting wire from the loop in the graft stent.

69. The method of claim 58, wherein the stent graft further includes at least one radiopaque marker.

70. The method of claim 69, wherein the radiopaque marker is located on the stent graft facing away from a concavity of a curve defined by the control lumen.

71. The method of claim 70, wherein the inner sheath further includes at least one radiopaque marker.

72. The method of claim 71, wherein the radiopaque marker of the inner sheath is located on the inner sheath facing away from the concavity of the curve defined by the control lumen and the radiopaque marker of the inner sheath overlaps at least one radiopaque marker of the stent graft when the stent graft is partially deployed.

73. The method of claim 58, wherein the stent graft is further constrained by a pusher support tube distal or proximal to the fixed end of the supporting wire.

74. The method of claim 58, wherein the aneurysm site is an abdominal aorta.

75. The method of claim 58, wherein the aneurysm site is in an ascending aorta.

76. The method of claim 58, wherein the aneurysm site is a thoracic aorta.

77. A method for implanting a prosthesis, comprising the steps of:

a) delivering a stent graft through an artery to an aneurysm site in a patient, the stent graft being radially constrained by an inner sheath and supported at least in part by a control lumen, the stent graft further being constrained by at least one suture extending from a nose cone at a distal end of the control lumen to a proximal end of the stent graft extending to a fixed location on the control lumen, the suture being releasable from the nose cone and the stent graft by remote activation;

b) partially retracting the inner sheath from the stent graft, whereby the suture at least partially restricts longitudinal movement of the proximal end of the stent graft until the proximal end of the stent graft is secure within the artery, thereby preventing rotation of a portion of the proximal end of the stent graft at an inferior portion of the artery;

c) activating the suture, whereby the suture is released from the nose cone and releases the stent graft; and

d) retracting the inner sheath to thereby deploy the stent graft within the artery at the aneurysm site of the patient.

78. The method of claim 77, wherein the aneurysm site is an abdominal aorta.

79. The method of claim 77, wherein the aneurysm site is in an ascending aorta.

80. The method of claim 77, wherein the aneurysm site is a thoracic aorta.

81. The method of claim 77, wherein the aneurysm site is a descending aorta.

83. The system of claim 81, wherein the through-holes are defined by a mesh of the inner sheath.

82. A system for implanting a prosthesis, comprising:

a) a control lumen;

b) a nose cone fixed at a distal end of the control lumen;

c) a sheath lumen extending about the control lumen and slideable along the control lumen; and

d) an inner sheath extending distally from the sheath lumen and about the control lumen between the nose cone and the sheath lumen, the inner sheath defining at least one through-hole at a proximal end of the inner sheath proximate to the sheath lumen.

84. The system of claim 82, wherein the through-holes are elongate, having a major axis substantially parallel to a major axis of the inner sheath.

85. A system for implanting a prosthesis, comprising:

a) a control lumen;

b) a nose cone fixed at a distal end of the control lumen;

c) an outer control tube extending about the control lumen;

d) an apex clasp at a distal end of the outer control tube and slideable along the control lumen;

e) a sheath lumen extending about the outer control tube;

f) an inner sheath extending distally from the sheath lumen about the outer control tube, the inner sheath including a triangular piece at a distal end of the inner sheath; and

g) a stent graft between the outer control tube and the inner sheath, the stent graft including a proximal end proximate to the nose cone having a clasping stent at the proximal end, wherein the clasping stent has at least one exposed proximal apex releasably held by the apex clasp.

86. The system of claim 85, wherein the control lumen is arcuate, being a superior side, an inferior side, and wherein the triangular piece of the inner sheath is at the inferior side of the control lumen.

87. The system of claim 85, wherein the stent graft further includes a crown stent.

88. The system of claim 85, wherein the inner sheath includes at least one through-hole at a proximal end proximate to the sheath lumen.

89. A method for implanting a prosthesis, comprising the steps of:

a) delivering a stent graft through an artery to a point distal, relative to the patient, of an aneurysm site of a patient, the stent graft being radially constrained by an inner sheath, and affixed to an outer control tube, and wherein the inner sheath is constrained by an introducer sheath, the stent graft and the inner sheath each including at least one radiopaque marker on superior portions of the stent graft and the inner sheath, the radiopaque markers being separated along a major longitudinal axis of the inner sheath;

b) advancing the inner sheath, the stent graft and the outer control lumen beyond the introducer sheath until the stent graft spans the aneurysm site of the patient;

c) partially retracting the inner sheath from the stent graft, whereby the radiopaque marker of the stent graft overlaps to the radiopaque marker of the inner sheath;

d) positioning a proximal end of the stent graft within the artery; and

e) fully retracting the inner sheath to thereby fully deploy the stent graft within the artery.

90. The method of claim 89, wherein the radiopaque marker of the inner sheath is asymmetric.

91. The method of claim 90, wherein the asymmetric marker is D-shaped.

92. The method of claim 89, wherein the radiopaque marker of the stent graft is an elongate-shape.

93. The method of claim 89, wherein the inner sheath defines a flared opening at a distal end of the inner sheath.

94. The method of claim 93, wherein the flared opening is asymmetric.