DEVICES AND METHODS FOR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS

• US 20090287145A1
• Filed: 05/14/2009
• Published: 11/19/2009
• Est. Priority Date: 05/15/2008
• Status: Abandoned Application

• Current Assignee: Altura Medical, Inc. (Lombard Medical, Inc.)
• Original Assignee: Altura Interventional Inc. (Lombard Medical, Inc.)
• Inventors: Cragg, Andrew H., Wallace, George, Tu, Hosheng, Sosnowski, Stephen, Socci, Robert J. JR., Quijano, Rodolfo C.
• Application Number:
  US12/466,044
• Publication Number:
  US 20090287145A1
• Time in Patent Office: Days
• US Class Current: 604/96.10
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 modular
• CPC Class Codes: A61F 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/077 having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61M 2025/0096 : being laterally outward extensions or tools, e.g. hooks or fibres

Abstract

Methods and devices with two individual tubes for treating abdominal aortic aneurysm that bypass the aneurysm and are placed from the upper aorta to the iliac arteries. A separate upper cuff may also be provided, to secure the tubes above the aneurysm.

Claims

1. An endograft system for treatment of an abdominal aortic aneurysm (AAA), comprising a cuff and at least two endograft units, each endograft unit having a lumen, a proximal end and a distal end, wherein said endograft units are made of flexible water-tight tubes having the proximal ends placed and secured at the cuff and the distal ends to be placed and fixed in each of iliac arteries.

2. The endograft system according to claim 1, wherein said endograft units are made of compressible water-tight foam tubes.

3. The endograft system according to claim 1, said system comprising four endograft units, each endograft unit having a lumen, a proximal end and a distal end, all four proximal ends are placed and secured at the cuff whereas a first distal end extends and is to be fixed in right iliac artery, a second distal end extends and is to be fixed in left iliac artery, a third distal end extends and is to be fixed in right renal artery and a fourth distal end extends and is to be fixed in left renal artery.

4. The endograft system according to claim 1, wherein the cuff has prongs that hold the endograft units in place.

5. The endograft system according to claim 1, wherein the cuff comprises a foam cuff.

6. The endograft system according to claim 5, wherein the foam is made of hardenable foam material.

7. The endograft system according to claim 6, wherein the foam material is selected from the group consisting of polyvinyl alcohol foam, poly(ethylene-co-vinyl alcohol), cellulose acetate, poly(2-hydroxyethyl methacrylate), acrylates, and combinations thereof.

8. The endograft system according to claim 6, wherein the foam material is treated with UV light or heat.

9. The endograft system according to claim 1, wherein the first proximal end of a first endograft unit is located at a substantial distance proximal to the second proximal end of a second endograft unit.

10. The endograft system according to claim 1, wherein the endograft unit comprises an inner layer of a water-tight flexible tube, a middle layer of semi-rigid mesh-like material, and an outer layer of water-tight flexible overlap, wherein the endograft unit is characterized with at least two water-tight layers.

11. The endograft system according to claim 10, wherein the inner layer is made of stretchable PTFE tube and the outer layer is made of stretchable PTFE overlap.

12. The endograft system according to claim 1, wherein the endograft unit is compressible and expandable.

13. The endograft system according to claim 1, wherein said endograft units are made of microfiber woven material.

14. A method for treatment of AAA using an endograft system according to claim 1, the method comprising steps of:

(a) placing a renal stent inside a renal artery, wherein a first end of the renal stent is inside the renal artery and wherein a second end of said renal stent is positioned at about the renal artery ostium;

(b) placing a first endograft unit in the AAA area, wherein said endograft unit intimately and compressively contacts the renal artery ostium;

(c) providing a wire from inside the lumen of said endograft unit at about the ostium site and piercing through said endograft unit so to create a hole facing the renal artery configured for blood communication from aorta to the renal artery.

15. The method according to claim 14, further comprising a step of balloon expansion at about the hole to enlarge the hole and urge the second end of the renal stent to protrude into said endograft unit.

16. The method according to claim 14, further comprising steps of:

(a) placing a second renal stent inside a second renal artery, wherein a first end of the second renal stent is inside the second renal artery and wherein a second end of said second renal stent is positioned at about the second renal artery ostium;

(b) placing a second endograft unit in the AAA area, wherein said second endograft unit intimately and compressively contacts the second renal artery ostium;

(c) providing a wire from inside the lumen of said second endograft unit at about said second ostium site and piercing through said second endograft unit so to create a hole facing the second renal artery configured for blood communication from aorta to the second renal artery.

17. The method according to claim 14, wherein the wire is provided via a guide catheter from outside of a patient.

18. A method for treatment of AAA using an endograft system according to claim 1, the method comprising steps of:

(a) placing a renal stent inside a renal artery, wherein a first end of the renal stent is inside the renal artery and wherein a second end of the renal stent protrudes beyond a renal artery ostium;

(b) placing the endograft unit in about the AAA area, wherein the endograft unit intimately contacts the renal artery ostium;

(c) applying RF energy to the second end of the renal stent so to create a hole on the endograft unit and to cause the renal stent to protrude into the lumen of the endograft unit configured for blood communication from aorta to the renal artery.

50. A stent graft system comprising a first and a second stent grafts of claim 4, wherein the proximal section of either stent graft is shaped to have a semi-circular like side and a mating side, wherein the first mating side of the first stent graft mates and matches intimately the second mating side of the second stent graft when the proximal sections of the two grafts are mated against each other to form a cylindrical-like tubular configuration.

51. The stent graft system according to claim 50, wherein the first distal section of the first stent graft is flexible for inserting into a right iliac artery and the second distal section of the second stent graft is flexible for inserting into a left iliac artery.

52. The stent graft system according to claim 50, wherein the first mating side of the first stent graft is configured to have positive charged magnet and the opposite second mating side of the second stent graft is configured to have negative charged magnet so to ensure control seal and intimate contact upon been mated.

53. The stent graft system according to claim 50, wherein the proximal sections of the two stent grafts in the cylindrical-like tubular configuration are radially expandable to intimately fit and secure to the blood vessel.

62. A method of temporarily placing a hemostatic cuff at an incision of a blood vessel when inserting an endograft into a patient, the method comprising:

(a) loading the hemostatic cuff on the expandable sheath of claim 1 at the first configuration;

(b) inserting the compressed sheath through the incision into the blood vessel;

(c) advancing the endograft into the blood vessel via a sheath lumen to expand the sheath to the second configuration;

(d) holding the hemostatic cuff at proximity of the incision; and

(e) removing the expanded sheath after the endograft and the cuff are properly positioned in place.

19. A method for treatment of circumscribed dilatation of a large blood vessel, comprising positioning a modular multi-luminal endograft system for reducing a diameter of said large blood vessel by generating multiple lumina for down-stream flow continuity.

20. An endograft for treatment of an abdominal aortic aneurysm (AAA) comprising a neck attachment section, a graft body, and a leg section, the neck attachment section having a multiple-anchoring mechanism that comprises at least a first anchoring element for placement at proximal to a renal artery and a second anchoring element axially spaced apart from the first anchoring element, wherein the second anchoring element is configured for placement at distal to said renal artery.

21. The endograft according to claim 20, wherein the multiple-anchoring mechanism comprises a third anchoring element configured for placement at about a region between two renal arteries.

22. An endograft for treatment of AAA comprising a neck attachment section, a first foam tube having a proximal end and a length to extend from the neck attachment section to a first iliac artery for fixation inside the first iliac artery, and a second form tube having a proximal end and a length to extend from the neck attachment section to a second iliac artery for fixation inside the second iliac artery, wherein both foam tubes are secured to the neck attachment section.

23. The endograft according to claim 22, wherein the first proximal end of a first foam tube is located at a substantial distance proximal to the second proximal end of a second foam tube.

24. The endograft according to claim 22, wherein the neck attachment element comprises a hanger, and wherein the proximal end of the first foam tube is configured with a hook to securely couple the hook to the hanger.

25. The endograft according to claim 22, wherein the proximal end of the first foam tube is magnetically coupled to the neck attachment element.

26. The endograft according to claim 22, wherein a distal end of the first foam tube is flared to anchor and seal the distal end to surrounding tissue of the first iliac artery.

27. The endograft according to claim 22, wherein a distal end of the first foam tube is balloon expanded to anchor and seal the distal end to surrounding tissue of the first iliac artery.

28. The endograft according to claim 22, wherein a distal end of the first foam tube is made of shape memory material to anchor and seal the distal end to surrounding tissue of the first iliac artery.

29. The endograft according to claim 22, wherein a proximal section of said foam tubes is made of inflatable elements, and wherein said proximal section is distendable to anchor and secure the proximal section against wall of a blood vessel.

30. The endograft according to claim 22, wherein at least one of the foam tubes further comprises an inflatable tube body.

31. The endograft according to claim 22, wherein at least one of the foam tubes comprises a double-walled, baffled tube body filled with form-filling material that functions as a flexible graft with sufficient hoop strength to obviate use of a radial positioning structure.

32. The endograft according to claim 31, wherein a portion of the baffled layer of at least one end of the foam tube is everted to create a cuff.

33. The endograft according to claim 22, wherein an aneurysm sac of the AAA is filled with foam material that is subsequently hardened in situ.

34. The endograft according to claim 33, wherein the foam material is introduced via a one-way valve mounted on the first form tube into the aneurysm sac.

35. The endograft according to claim 33, wherein the foam material is selected from the group consisting of polyvinyl alcohol foam, poly(ethylene-co-vinyl alcohol), cellulose acetate, poly(2-hydroxyethyl methacrylate), acrylates, and combinations thereof.

36. The endograft according to claim 33, wherein the foam material is treated with UV light or heat in situ.

37. A flexible stent graft for inserting into a blood vessel, comprising a distal section, a proximal section and a graft body with a lumen that connects the distal and proximal sections, said graft having a first layer of flexible rigid or semi-rigid material, and a second layer of water-tight flexible overlap, wherein the graft is collapsible and is characterized with a low profile during the inserting operation.

38. The stent graft according to claim 37, wherein the first layer comprises a spiral wire that is compressible within a sheath during the inserting operation.

39. The stent graft according to claim 37, wherein the second layer invaginates onto the first layer after the first layer is positioned in place.

40. The stent graft according to claim 37, further comprising a third layer of water-tight flexible tube, wherein the graft is characterized with at least two water-tight layers.

41. The stent graft according to claim 37, wherein the third layer is made of stretchable PTFE tube and the second layer is made of stretchable PTFE overlap.

42. The stent graft according to claim 37, wherein the proximal section is shaped in a D-shaped configuration.

43. The stent graft according to claim 37, wherein a sleeve at an end of the stent graft is formed by inverting an extra length of the third layer over the first and second layers.

44. The graft according to claim 43, wherein the inverted sheath is secured to the first layer by fastening means for securing the inverted sheath with the first layer, said fastening means comprising suturing, stapling, gluing, or bonding.

45. The stent graft according to claim 37, wherein the third layer is made of flexible fabrics or polymer tube and the second layer is made of flexible fabrics or polymer overlap.

46. The stent graft according to claim 45, wherein the second layer or the third layer is made of substantially water-tight microfibers woven material.

47. The stent graft according to claim 37, wherein barbs are incorporated and spaced apart appropriately at about the proximal section of the stent graft configured for anchoring said graft at wall of a blood vessel.

48. The stent graft according to claim 47, wherein the barbs are made of shape memory material or temperature-sensitive material.

49. The stent graft according to claim 37, wherein anchors are provided at about the proximal section of said graft configured for anchoring said graft at wall of a blood vessel as a secondary operation.

54. A method of repairing an abdominal aortic aneurysm (AAA), the method comprising steps of:

(a) percutaneously introducing and advancing a guidewire into a first femoral artery, into a first iliac artery and then into a lumen of an aorta beyond area of the aneurysm;

(b) assembling a neck attachment element in a collapsed state to be placed at about a distal end segment of a first deployment catheter, wherein the first deployment catheter having a guidewire lumen formed therein adapted to be fitted over the guidewire;

(c) delivering the neck attachment element to a site of the aorta close to a renal artery ostium to provide an attachment seat of predetermined size approximating a diameter of the aorta lumen beyond and proximal to the area of the aneurysm;

(d) deploying by means of self-expanding or balloon-expanding the neck attachment element to anchor securely the neck attachment element in place;

(e) withdrawing the first deployment catheter;

(f) assembling a first elongated tubular graft prosthesis in a collapsed state to be placed at about a distal end segment of a second deployment catheter, said first graft prosthesis having a proximal end, a distal end, and a continuous side wall extending between the proximal end to the distal end;

(g) delivering the first graft prosthesis with the proximal end being positioned at about the neck attachment element and the distal end being positioned at about the first iliac artery;

(h) deploying by means of anchoring the proximal end of the first graft prosthesis onto the neck attachment element while deploying the distal end in the first iliac artery;

(i) percutaneously withdrawing the second deployment catheter.

55. The method according to claim 54, further comprising steps of:

(a) assembling a second elongated tubular graft prosthesis in a collapsed state to be placed at about a distal end segment of a third deployment catheter, said second graft prosthesis having a proximal end, a distal end, and a continuous side wall extending between the proximal end to the distal end;

(g) delivering the second graft prosthesis with the proximal end being positioned at about the neck attachment element and the distal end being positioned at about the second iliac artery;

(h) deploying by means of anchoring the proximal end of the second graft prosthesis onto the neck attachment element while deploying the distal end in the second iliac artery;

(i) percutaneously withdrawing the third deployment catheter.

56. The method according to claim 55, wherein the first proximal end of the first graft prosthesis is located at a substantial distance proximal to the second proximal end of the second graft prosthesis.

57. The method according to claim 55, wherein a circumferential area beyond two luminal openings of the proximal ends of the two graft prostheses is sealed so to allow blood flowing through said luminal openings of the graft prostheses.

58. The method according to claim 54, wherein the distal end of the first graft prosthesis is sized and configured, after deployment, to seal the graft lumen and iliac arteries from the aneurysm.

59. The method according to claim 54, with, the proximal end of the first graft prosthesis comprises barbs configured for securing to the neck attachment element.

60. The method according to claim 54, wherein the first graft prosthesis is reinforced with a metal mesh or stenting element at either end or both ends.

61. A radially expandable sheath as a guiding sheath, comprising a continuous integral sheath body with a thin wall that is radially expandable under outward forces, wherein the radially expandable sheath is characterized with substantially little or no axial stretchability or contraction from a first configuration of a compressed state to a second configuration of an expanded state.

63. An endograft for treatment of an abdominal aortic aneurysm (AAA) comprising an impermeable section for excluding blood communication between a lumen of the endograft and a surrounding aneurysmal sac, and a porous section configured for placement across a renal artery ostium.

64. The endograft according to claim 63, wherein the endograft comprises a macro-porous sleeve that is longer than the impermeable section, the porous section being created by securing the macro-porous sleeve over at least a portion of the impermeable section.

65. A method for plugging an aneurysm in a patient, comprising introducing a PVA sponge substrate with a porosity at a first configuration of a dried compressed state into said aneurysm and allowing said sponge substrate to expand in situ to a second configuration to fill the aneurysm.

66. The method according to claim 65, wherein the sponge substrate is incorporated with a radiopaque marker for external visualization.

67. The method according to claim 65, wherein the aneurysm is an aneurysmal blood vessel, the sponge substrate comprising a conformable pair of spongy endo-plugs for treatment of the aneurysmal vessel, wherein the endo-plugs are compressed in a first configuration for delivery to the vessel and expand via re-hydration to a second configuration to plug the vessel.

68. The method according to claim 67, wherein each endo-plug has a through lumen.

69. The method according to claim 67, wherein each endo-plug has a matching flat surface facing each other.

70. The method according to claim 67, wherein each endo-plug has a matching ribbed surface to provide interlocked seal in the blood vessel after re-hydration.

71. The method according to claim 65, wherein the aneurysm is an aneurysmal blood vessel, the sponge substrate comprising a spongy endo-plug, wherein the endo-plug is compressed in a first configuration for delivery to the vessel and expands to a second configuration via an embedded shape memory Nitinol wire.

72. The method according to claim 65, wherein the sponge substrate comprises a spongy endo-plug with an anchoring means for securing the endo-plug in place without undue migration.

73. A method of treatment of an abdominal aortic aneurysm (AAA), comprising inserting soft, thrombogenic pipe-cleaner like soft filler material into a AAA sac with a delivery catheter.

74. The method according to claim 73, wherein the material is made of PVA (polyvinyl alcohol) or Dacron (polyester) thread that enhances thrombogenic properties.

75. A balloon endograft comprising:

a neck attachment member, a body and at least one distal end, wherein the endograft comprises double layers and a space between the layers, the space being configured to be filled with inflatable fluid or hardenable foam to inflate the balloon endograft.

76. The balloon endograft according to claim 75, wherein the endograft is characterized with no stiff component prior to inflating said balloon endograft.

77. The balloon endograft according to claim 75, wherein the body comprises two inflatable tubes, each inflatable tube having a proximal end secured to the neck attachment member, a distal end, and double layers with a space between the layers.

78. The balloon endograft according to claim 75, wherein the body is configured in a corrugated configuration.

79. The balloon endograft according to claim 75, wherein the neck attachment member comprises two inflatable neck attachment rings and at least two connecting units that connect the two rings, wherein said neck attachment rings are inflatable to anchor securely at wall of a blood vessel.