SIDEPORT ENGAGEMENT AND SEALING MECHANISM FOR ENDOLUMINAL STENT-GRAFTS

• US 20120179236A1
• Filed: 07/14/2010
• Published: 07/12/2012
• Est. Priority Date: 07/14/2009
• Status: Abandoned Application

• Current Assignee: Endospan Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon, Benary, Rafael
• Application Number:
  US13/384,075
• Publication Number:
  US 20120179236A1
• Time in Patent Office: Days
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• 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 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

An endovascular prosthesis (10) includes first and second endovascular stent-grafts (20, 22), which include respective first and second stent bodies (32, 108), and respective first and second fluid flow guides (102, 109). The first stent-graft (20) is shaped to define an interface portion (103) having a distal interface end (34) that meets a proximal end (36) of the first stent body (32) at a peripheral juncture (104). The second stent-graft (22) defines an interface aperture (110), within which part of the interface portion (103) is positionable. The interface portion (103) comprises engagement support members (105) disposed around a periphery thereof, which are configured to transition from an initial state to (b) a sealing state, thereby sealingly coupling the first stent-graft (20) to the second stent-graft (22) when the part of the interface portion (103) is positioned within the interface aperture (110). Other embodiments are also described.

Claims

1. Apparatus comprising an endovascular prosthesis, which comprises:

first and second endovascular stent-grafts, which are configured to transition from respective radially-compressed states to respective radially-expanded states, in which respective radially-expanded states an average diameter of the first stent-graft is greater than an average diameter of the second stent-graft, and which first and second stent-grafts are suitable for implantation at an aorto-iliac bifurcation of a human subject and comprise;

first and second structural members, respectively, which comprise first structural stent elements and second structural stent elements, respectively, at least respective portions of which define first and second stent bodies, which are generally tubular when the first and second stent-grafts assume the respective radially-expanded states; and

first and second fluid flow guides, respectively, which are coupled to the first and second stent bodies, respectively, so as to cover at least respective portions of the first and second stent bodies,

wherein the first structural member has proximal and distal ends, and is shaped so as to define an interface portion having a distal interface end that meets a proximal end of the first stent body at a peripheral juncture,

wherein, when the second stent-graft assumes its radially-expanded state, the second stent-graft is shaped so as to define an interface aperture at a location other than at ends of the second stent-graft,

wherein the interface portion and the interface aperture are configured such that part of the interface portion is positionable within the interface aperture, and

wherein the interface portion comprises a plurality of engagement support members disposed around a periphery of the interface portion, which engagement support members are configured to transition from an initial state to a sealing state, thereby sealingly coupling the first stent-graft to the second stent-graft when the part of the interface portion is positioned within the interface aperture.

5. The apparatus according to claim 1, wherein a portion of at least some of the engagement support members is distally convex.

6. The apparatus according to claim 7, wherein the engagement support members and the second stent-graft are configured such that the engagement support members internally press against a surface of the bulge of the second stent-graft surrounding the interface aperture, when the part of the interface portion is positioned within the interface aperture, the first and second stent-grafts assume their respective radially-expanded states, and the engagement support members assume the sealing state.

7. The apparatus according to claim 1, wherein the second fluid flow guide is shaped so as to define a radially-outward bulge at least partially surrounding the interface aperture, when the second stent-graft assumes its radially-expanded state.

22. The apparatus according to claim 1, wherein the engagement support members are configured to extend proximally when in the initial state, and to extend distally toward a distal end of the first stent body when in the sealing state.

23. The apparatus according to claim 1, wherein a perpendicular cross-sectional area of a portion of the first stent body defined by the first structural stent elements and covered by the first fluid flow guide increases from the peripheral juncture in a direction toward a distal end of the first stent body, such that the portion of the first stent body serves as a sealing countersurface, which contacts an external surface of the second stent-graft surrounding the interface aperture when the part of the interface portion is positioned within the interface aperture, the first and second stent-grafts assume their respective radially-expanded states, and the engagement support members assume the sealing state.

24. The apparatus according to claim 23, wherein the engagement support members and the second stent-graft are configured such that the engagement support members and the sealing countersurface sandwich a surface of the second stent-graft surrounding the interface aperture, when the part of the interface portion is positioned within the interface aperture, the first and second stent-grafts assume their respective radially-expanded states, and the engagement support members assume the sealing state.

28. The apparatus according to claim 1, wherein the first stent-graft comprises a non-covered portion that extends proximally beyond the interface portion, which non-covered portion comprises a portion of the first structural member.

31. The apparatus according to claim 1, wherein the first fluid flow guide at least partially covers the engagement support members, and wherein, when the first stent-graft assumes its radially-expanded state, the engagement support members are shaped so as to define respective radially-inward portions and radially-outward portions, and wherein the first fluid flow guide covers the radially-inward portions but not the radially outward portions.

33. The apparatus according to claim 1,

wherein the engagement support members are proximal engagement support members, wherein the first stent-graft further comprises a plurality of distal engagement support members, which are disposed more distally on the first stent-graft than are the proximal engagement support members, and

wherein the distal and proximal engagement support members are configured to sandwich a surface of the second stent-graft surrounding the interface aperture, when the part of the interface portion is positioned within the interface aperture, the first and second stent-grafts assume their respective radially-expanded states, and the proximal engagement support members assume the sealing state.

39. The apparatus according to claim 1, wherein the first fluid flow guide and the second fluid flow guide together define a continuous fluid flow path that begins at a distal end of the first fluid flow guide, passes through the interface aperture, bifurcates proximally to the interface aperture, and passes through both ends of the second fluid flow guide.

75. The apparatus according to claim 1, wherein the engagement support members comprise a portion of first structural stent elements.

76. The apparatus according to claim 7, wherein the second fluid flow guide is shaped such that a peak of the bulge is farther than the interface aperture from a longitudinal axis of the second stent graft, when the second stent-graft assumes its radially-expanded state.

77. The apparatus according to claim 76, wherein the engagement support members are configured to extend proximally when in the initial state, and to extend distally toward a distal end of the first stent body when in the sealing state.

78. The apparatus according to claim 23, wherein, when the second stent-graft assumes its radially-expanded state, the second fluid flow guide is shaped so as to define a radially-outward bulge at least partially surrounding the interface aperture, an external surface of which bulge contacts the sealing countersurface when the first stent-graft is sealingly coupled to the second stent-graft.

2-4. -4. (canceled)

8-21. -21. (canceled)

25-27. -27. (canceled)

29-30. -30. (canceled)

32. (canceled)

34-38. -38. (canceled)

40. (canceled)

41. Apparatus comprising an endovascular stent-graft, which is configured to transition from a radially-compressed state to a radially-expanded state, and which comprises:

a structural member, which comprises structural stent elements, at least a portion of which defines a stent body, which is generally tubular when the stent-graft assumes the radially-expanded state; and

a fluid flow guide, which is coupled to the stent body, so as to cover at least a portion of the stent body,

wherein the structural member has proximal and distal ends, and is shaped so as to define an interface portion having a distal interface end that meets a proximal end of the stent body at a peripheral juncture,

wherein the interface portion comprises a plurality of engagement support members disposed around a periphery of the interface portion, which engagement support members are configured to transition from an initial state to a sealing state.

43. The apparatus according to claim 41, wherein the fluid flow guide at least partially covers the engagement support members, and wherein, when the stent-graft assumes the radially-expanded state, the engagement support members are shaped so as to define respective radially-inward portions and radially-outward portions, and wherein the fluid flow guide covers the radially-inward portions but not the radially outward portions.

45. The apparatus according to claim 41, wherein the engagement support members are configured to extend proximally when in the initial state, and to extend distally toward a distal end of the first stent body when in the sealing state.

51. The apparatus according to claim 41, wherein a perpendicular cross-sectional area of a portion of the stent body defined by the structural stent elements and covered by the fluid flow guide increases from the peripheral juncture in a direction toward a distal end of the stent body, such that the portion of the stent body serves as a sealing countersurface, when the stent-graft assumes the radially-expanded state.

52. The apparatus according to claim 41, wherein the engagement support members are proximal engagement support members, and wherein the stent-graft further comprises a plurality of distal engagement support members, which are disposed more distally on the stent-graft than are the proximal engagement support members.

42. (canceled)

44. (canceled)

46-50. -50. (canceled)

53. A method comprising:

providing first and second endovascular stent-grafts, which are configured to transition from respective radially-compressed states to respective radially-expanded states, in which respective radially-expanded states an average diameter of the first stent-graft is greater than an average diameter of the second stent-graft, and which first and second stent-grafts include (a) first and second structural members, respectively, which comprise first structural stent elements and second structural stent elements, respectively, at least respective portions of which define first and second stent bodies, respectively, which are generally tubular when the first and second stent-grafts assume the respective radially-expanded states, and (b) first and second fluid flow guides, respectively, which are coupled to the first and second stent bodies, respectively, so as to cover at least respective portions of the first and second stent bodies, wherein the first structural member has proximal and distal ends;

transvascularly introducing the second stent-graft, while in its radially-compressed state, into one or two first blood vessels of a human subject, such that the second stent-graft spans a bifurcation between (a) the one or two first blood vessels and (b) a second blood vessel;

transitioning the second stent-graft to its radially-expanded state, such that an interface aperture defined by the second fluid flow guide is positioned at the bifurcation;

transvascularly introducing the first stent-graft, while in its radially-compressed state, into the second blood vessel via the interface aperture;

positioning, within the interface aperture, an interface portion defined by the first structural member of the first stent-graft, which interface portion has a distal interface end that meets a proximal end of the first stent body at a peripheral juncture; and

transitioning the first stent-graft to its radially-expanded state, such that a plurality of engagement support members thereof, which are disposed around a periphery of the interface portion, transition from an initial state to a sealing state, thereby sealingly coupling the first stent-graft to the second stent-graft.

54. The method according to claim 53, wherein transitioning the first stent-graft comprises transitioning the first stent-graft to its radially-expanded state, such that the plurality of engagement support members transition from (a) the initial state, in which the engagement support members extend proximally, to (b) the sealing state, in which the engagement support members extend distally toward a distal end of the first stent body.

57. The method according to claim 53, wherein the one or two first blood vessels are right and left iliac arteries, wherein the second blood vessel is a descending aorta, and wherein transvascularly introducing the second stent-graft comprises transvascularly introducing the second stent-graft into the right and left iliac arteries, such that the second stent-graft spans the aorto-iliac bifurcation.

59. The method according to claim 61, wherein transitioning the first stent-graft comprises transitioning the first stent-graft to its radially-expanded state such that the engagement support members internally press against a surface of the bulge of the second stent-graft surrounding the interface aperture.

61. The method according to claim 53, wherein providing the second fluid flow guide comprises providing the second fluid flow guide shaped so as to define a radially-outward bulge at least partially surrounding the interface aperture, when the second stent-graft assumes its radially-expanded state.

63. The method according to claim 53, wherein providing the first stent-graft comprises providing the first stent-graft in which a perpendicular cross-sectional area of a portion of the first stent body defined by the first structural stent elements and covered by the first fluid flow guide increases from the peripheral juncture in a direction toward a distal end of the first stent body, such that the portion of the first stent body serves as a sealing countersurface, and wherein positioning the interface portion and transitioning the first stent-graft to its radially-expanded state comprises causing an external surface of the second stent-graft surrounding the interface aperture to contact the sealing countersurface.

64. The method according to claim 63, wherein causing comprises causing the engagement support members and the sealing countersurface to sandwich a surface of the second stent-graft surrounding the interface aperture.

65. The method according to claim 53, wherein the first stent-graft includes a non-covered portion that extends proximally beyond the interface portion, which non-covered portion comprises a portion of the first structural member, and transvascularly introducing the second stent-graft comprises positioning the non-covered portion in exactly one of the one or two first blood vessels.

66. The method according to claim 53, wherein providing the first stent-graft comprises providing the first stent-graft in which the first fluid flow guide at least partially covers the engagement support members, and, when the first stent-graft assumes its radially-expanded state, the engagement support members are shaped so as to define respective radially-inward portions and radially-outward portions, and the first fluid flow guide covers the radially-inward portions but not the radially outward portions.

67. The method according to claim 53,

wherein providing the first and second stent-grafts comprises providing the first and second stent-grafts in which the first fluid flow guide and the second fluid flow guide together define a continuous fluid flow path that begins at a distal end of the first fluid flow guide, passes through the interface aperture, bifurcates proximally to the interface aperture, and passes through both ends of the second fluid flow guide, and

wherein introducing the second and the first stent-grafts comprises introducing (a) the second stent-graft into the one or two first blood vessels and (b) the first stent-graft into the second blood vessel, such that blood flows into the distal end of the first fluid guide, passes through the interface aperture, and passes out of both the ends of the second fluid flow guide.

69. The method according to claim 53, wherein providing the first stent-graft comprises providing the first stent-graft in which a portion of at least some of the engagement support members is distally convex.

70. The method according to claim 53, wherein the engagement support members are configured to extend proximally when in the initial state, and wherein transitioning the first stent-graft to its radially-expanded state comprises transitioning the first stent-graft to its radially-expanded state, such that the engagement support members transition from the initial state to the sealing state in which sealing state the engagement support members extend distally toward a distal end of the first stent body.

71. The method according to claim 53, wherein providing the first stent-graft comprises providing the first stent-graft in which the engagement support members include a portion of first structural stent elements.

72. The method according to claim 61, wherein providing the second fluid flow guide comprises providing the second fluid guide shaped such that a peak of the bulge is farther than the interface aperture from a longitudinal axis of the second stent graft, when the second stent-graft assumes its radially-expanded state.

73. The method according to claim 72, wherein the engagement support members are configured to extend proximally when in the initial state, and wherein transitioning the first stent-graft to its radially-expanded state comprises transitioning the first stent-graft to its radially-expanded state, such that the engagement support members transition from the initial state to the sealing state in which sealing state the engagement support members extend distally toward a distal end of the first stent body.

74. The method according to claim 63, wherein providing the second fluid flow guide comprises providing the second fluid flow guide shaped so as to define a radially-outward bulge at least partially surrounding the interface aperture, when the second stent-graft assumes its radially-expanded state, and wherein transitioning the first stent-graft to its radially-expanded state comprises causing an external surface of the bulge to contact the sealing countersurface.

55-56. -56. (canceled)

58. (canceled)

60. (canceled)

62. (canceled)

68. (canceled)