Self-aligning stent graft delivery system, kit, and method

• US 20050049667A1
• Filed: 07/02/2004
• Published: 03/03/2005
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Berra, Humberto A., Ouellette, Gerry
• Granted Patent: US 7,763,063 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2/9517 handle assemblies therefor
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• 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 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A delivery system and kit for endovascularly delivering a prosthesis along a guidewire to an curved implantation site includes a control handle having a handle body with a prosthesis movement control assembly movably disposed thereto. A proximal end of a catheter is connected to the control handle. A prosthesis delivery assembly is movably disposed in the catheter. The delivery assembly has a guidewire lumen slidably receiving therein the guidewire and having a curved distal end orienting the delivery assembly when passing through a curved vessel portion. A method for automatic endovascular alignment of the prosthesis includes loading it in the distal delivery assembly, positioning the guidewire into the curved implantation site, and threading the guidewire lumen over the guidewire with the delivery assembly and into the implantation site to at least approximately align the curved distal portion to a curve of the curved implantation site and, thereby, orient the prosthesis.

Claims

22-1. The method according to claim 1, which further comprises connecting the guidewire lumen to the prosthesis delivery system at a proximal-most area of the guidewire lumen to minimize a restoring force when the guidewire lumen is rotated along its longitudinal axis.

34. A method for automatic endovascular alignment of a prosthesis in a curved implantation site of a vessel, which comprises:

advancing a guidewire lumen having a curved distal portion along a guidewire and into the curved implantation site to at least approximately align the curved distal portion to a curve of the curved implantation site.

35. A delivery system for endovascularly delivering a prosthesis along a guidewire to an implantation site having a curved shape, the delivery system comprising:

a proximal control handle having;

a handle body; and

a prosthesis movement control assembly movably disposed at said handle body;

a hollow catheter having a proximal end connected to said control handle and a distal end, said catheter defining an interior cavity therein; and

a hollow prosthesis delivery assembly movably disposed in said interior cavity, said prosthesis delivery assembly having at least one hollow guidewire lumen for slidably receiving therein the guidewire, said guidewire lumen having a curved distal end for orienting said prosthesis delivery assembly when passing through a curved portion of a vessel.

36. The system according to claim 35, wherein said curved distal end of said guidewire lumen has a curved shaped substantially corresponding to the curved shape of the implantation site.

37. The system according to claim 35, wherein said catheter is rotatably mounted on said control handle.

38. The system according to claim 35, wherein:

the implantation site having the curved shape is a curved portion of an aorta; and

said curved distal end has a curved shape substantially corresponding to a curve of the aorta of the patient in which the prosthesis is to be implanted.

39. The system according to claim 35, wherein said guidewire lumen is of metal.

40. The system according to claim 39, wherein said metal is stainless steel.

41. The system according to claim 37, wherein said catheter is rotatably connected to said control handle and said control assembly is connected to said delivery assembly to permit rotation of said handle body and, thereby, said delivery assembly in the implantation site while said catheter remains substantially rotationally stable.

42. The system according to claim 35, wherein said guidewire lumen is rotatably mounted to said prosthesis delivery assembly.

43. The system according to claim 35, wherein said prosthesis delivery assembly has a rotating coupling rotatably mounting said guidewire lumen to said prosthesis delivery assembly.

44. A delivery system for endovascularly delivering a prosthesis along a guidewire to an implantation site having a curved shape, the delivery system comprising:

a proximal control handle having;

a handle body; and

a prosthesis movement control assembly movably disposed at said handle body;

a hollow catheter having a proximal end connected to said control handle and a distal end, said catheter defining an interior cavity therein;

a hollow prosthesis delivery assembly movably disposed in said interior cavity;

said delivery assembly having at least one hollow guidewire lumen for slidably receiving therein the guidewire;

said guidewire lumen having a pre-curved distal end with a curved shape for orienting said prosthesis delivery assembly when passing through a curved portion of a vessel; and

said pre-curved distal end having;

when disposed entirely in said catheter, a shape substantially corresponding to a shape of a surrounding portion of said catheter;

when disposed partly in said catheter and partly out of said catheter, a shape substantially corresponding to;

a first shape of a surrounding portion of said catheter for a first portion of said pre-curved distal end disposed in said catheter; and

a second curved shape for a second portion of said pre-curved distal end disposed outside said catheter; and

when said pre-curved distal end is disposed entirely out of said catheter, one of;

said curved shape; and

a shape substantially corresponding to the curved shape of the implantation site.

45. The delivery system according to claim 44, wherein a curve of said pre-curved distal end substantially corresponds to the curved shape of the implantation site.

46. The delivery system according to claim 44, wherein:

said catheter is substantially linear; and

when disposed entirely in said catheter, said pre-curved distal end has a substantially linear shape substantially corresponding to said surrounding portion of said catheter.

47. The system according to claim 44, wherein said catheter is rotatably mounted on said control handle.

48. The system according to claim 44, wherein:

the implantation site having the curved shape is a curved portion of an aorta; and

said curved distal end has a curved shape substantially corresponding to a curve of the aorta of the patient in which the prosthesis is to be implanted.

49. The system according to claim 44, wherein said guidewire lumen is of metal.

50. The system according to claim 49, wherein said metal is stainless steel.

51. The system according to claim 47, wherein said catheter is rotatably connected to said control handle and said control assembly is connected to said delivery assembly to permit rotation of said handle body and, thereby, said delivery assembly in the implantation site while said catheter remains substantially rotationally stable.

52. The system according to claim 44, wherein said prosthesis delivery assembly has a rotating coupling rotatably mounting said guidewire lumen to said prosthesis delivery assembly.

53. In combination with a delivery system for endovascularly delivering a prosthesis loaded in a prosthesis delivery assembly along a guidewire to an implantation site having a curved shape, a self-aligning prosthesis control assembly comprising:

a hollow guidewire lumen for slidably receiving therein the guidewire;

said guidewire lumen having a pre-curved distal end with a curved shape for orienting the prosthesis delivery assembly when passing through a curved portion of a vessel; and

said pre-curved distal end having;

when disposed entirely in the delivery system, a shape substantially corresponding to a shape of a surrounding portion of the delivery system;

when disposed partly in the delivery system and partly out of the delivery system, a shape substantially corresponding to;

a first shape of a surrounding portion of the delivery system for a first portion of said pre-curved distal end disposed in the delivery system; and

a second curved shape for a second portion of said pre-curved distal end outside the delivery system; and

when said pre-curved distal end is disposed entirely out of the delivery system, one of;

said curved shape; and

a shape substantially corresponding to the curved shape of the implantation site.

54. The delivery system according to claim 53, wherein a curve of said pre-curved distal end substantially corresponds to the curved shape of the implantation site.

55. The delivery system according to claim 53, wherein, when disposed entirely in the delivery system, said surrounding portion of the delivery system is linear and said pre-curved distal end has a substantially linear shape substantially corresponding to said linear surrounding portion.

56. The delivery system according to claim 53, wherein:

a portion of the delivery system surrounding said pre-curved distal end is substantially linear; and

said pre-curved distal end has a substantially linear shape substantially corresponding to said surrounding portion of the delivery system when disposed entirely in the delivery system.

57. The system according to claim 53, wherein:

the implantation site having the curved shape is a curved portion of an aorta; and

said pre-curved distal end has a curved shape substantially corresponding to the curved portion of the aorta of the patient in which the prosthesis is to be implanted

58. The system according to claim 53, wherein said guidewire lumen is of metal.

59. The system according to claim 58, wherein said metal is stainless steel.

60. The system according to claim 53, further comprising a rotating coupling rotatably mounting said guidewire lumen to said prosthesis delivery assembly.

61. An endovascular prosthesis delivery kit for endovascularly delivering a prosthesis along a guidewire to an implantation site having a curved shape, the delivery kit comprising:

a proximal control handle having;

a handle body; and

a prosthesis movement control assembly movably disposed at said handle body;

a hollow catheter having a proximal end connected to said control handle and a distal end, said catheter defining an interior cavity therein;

a hollow prosthesis delivery assembly movably disposed in said interior cavity, said prosthesis delivery assembly having at least one hollow guidewire lumen for slidably receiving therein the guidewire, said guidewire lumen having a curved distal end for orienting said prosthesis delivery assembly when passing through a curved portion of a vessel; and

a curving device forming a curved shape of said curved distal portion.

62. The kit according to claim 61, wherein a shape of said curving device at least approximately corresponds to the curved shape of the vessel in which the prosthesis is to be implanted.

63. The kit according to claim 61, wherein a shape of said curving device substantially corresponds to the curved shape of the vessel in which the prosthesis is to be implanted.

64. The kit according to claim 61, wherein said curving device is a set of curving devices having differently curved shapes and at least one of said curving devices forming said curved shape of said curved distal portion to at least approximately correspond said curved shape to the curved shape of the vessel in which the prosthesis is to be implanted.

65. The kit according to claim 61, wherein said curving device is a set of curving devices having differently curved shapes and at least one of said curving devices forming said curved shape of said curved distal portion to substantially correspond said curved shape to the curved shape of the vessel in which the prosthesis is to be implanted.

66. The system according to claim 61, wherein said catheter is rotatably mounted on said control handle.

67. The system according to claim 61, wherein:

the implantation site having the curved shape is a curved portion of an aorta; and

said curved distal end has a curved shape at least approximately corresponding to a curve of the aorta of the patient in which the prosthesis is to be implanted.

68. The system according to claim 61, wherein:

the implantation site having the curved shape is a curved portion of an aorta; and

said curved distal end has a curved shape substantially corresponding to a curve of the aorta of the patient in which the prosthesis is to be implanted.

69. The system according to claim 61, wherein said guidewire lumen is of metal.

70. The system according to claim 69, wherein said metal is stainless steel.

71. The system according to claim 66, wherein said catheter is rotatably connected to said control handle and said control assembly is connected to said delivery assembly to permit rotation of said handle body and, thereby, said delivery assembly in the implantation site while said catheter remains substantially rotationally stable.

72. The system according to claim 61, wherein said guidewire lumen is rotatably mounted to said prosthesis delivery assembly.

73. The system according to claim 61, wherein said prosthesis delivery assembly has a rotating coupling rotatably mounting said guidewire lumen to said prosthesis delivery assembly.

74. The kit according to claim 61, wherein said pre-curved distal end has:

when disposed entirely in said catheter, a shape substantially corresponding to a shape of a surrounding portion of said catheter;

when disposed partly in said catheter and partly out of said catheter, a shape substantially corresponding to;

a first shape of a surrounding portion of said catheter for a first portion of said pre-curved distal end disposed in said catheter; and

a second curved shape for a second portion of said pre-curved distal end disposed outside said catheter; and

when said pre-curved distal end is disposed entirely out of said catheter, one of;

said curved shape; and

a shape substantially corresponding to the curved shape of the implantation site.

75. A self-aligning delivery system for endovascularly delivering at least one of a prosthesis and a prosthesis delivery assembly loaded with a prosthesis along a guidewire to a vessel implantation site having a curved shape, the delivery system comprising:

a hollow guidewire lumen for slidably receiving therein the guidewire, said guidewire lumen having a pre-curved distal end orienting at least one of the prosthesis and the prosthesis delivery assembly when said pre-curved distal end passes through a curved portion of a vessel.

76. A method for automatic endovascular alignment of a prosthesis, loaded in a delivery assembly, in a curved implantation site of a vessel having positioned therein a guidewire extending at least into the implantation site, which comprises:

providing a prosthesis delivery system with a longitudinally movable guidewire lumen having a curved distal portion;

threading the guidewire lumen over the guidewire along with the loaded distal delivery assembly to advance the guidewire lumen and the loaded distal delivery assembly towards the implantation site; and

advancing the curved distal portion and the loaded distal delivery assembly into the curved implantation site to at least approximately align the curved distal portion to a curve of the curved implantation site and, thereby, orient the prosthesis.