Endovascular graft having bifurcation and apparatus and method for deploying the same

• US 5,489,295 A
• Filed: 05/21/1993
• Issued: 02/06/1996
• Est. Priority Date: 04/11/1991
• Status: Expired due to Term

• Current Assignee: Lifeport Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Piplani, Alec A., Quiachon, Dinah B., Sterman, Wesley D.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/066,414
• Time in Patent Office: 991 Days
• Field of Search: 623/1, 623/2, 623/11, 623/12, 606/151-158, 606/191-200, 600/36
• US Class Current: 623/1.35
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• 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 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

Graft having a bifurcation for repairing an aneurysm in the vicinity of an aortic bifurcation in a patient comprising a main tubular body and first and second tubular legs joined to said main body in a bifurcation. The main body and the legs are formed of a flexible surgically implantable material. The main body and each of the first and second legs having an opening therein in communication with the other openings. Expandable spring attachments are secured to the main body adjacent the opening in the main body. An additional expandable spring attachment is secured to one of said legs adjacent the opening in said one leg.

Claims

1. A graft device having a bifurcation for repairing an aortic aneurysm close to or involving the aortic bifurcation having an arterial wall and comprising the aorta and the first and second iliac arteries extending therefrom and in fluid communication therewith in a patient, the graft device comprising:

a main tubular body;

first and second tubular legs joined to said main tubular body in a bifurcation, said main tubular body and said first and second tubular legs being formed of a flexible surgically implantable material, said main tubular body and said first and second tubular legs having respectively first, second and third openings therein in communication with each other;

first expandable attachment means for anchoring said main body, said first attachment means being secured to said main tubular body adjacent the first opening; and

second expandable attachment means for anchoring said first tubular leg said second attachment means being secured to said first tubular leg adjacent the second opening,

wherein said graft device is capable of intraluminal implantation by a catheter into the aortic bifurcation through said first iliac artery such that said main body can be anchored by said first attachment means in said aorta, said first tubular leg can be anchored by said second attachment means in said first iliac artery, and said second tubular leg can be deployed in said second iliac artery.

2. A graft device as in claim 1 wherein said expandable anchor means and said additional expandable anchor means are in the form of spring attachment means, each having hook-like elements disposed outwardly therefrom adapted to come into engagement with the arterial wall of the patient.

6. A graft device as in claim 1, wherein the main body includes a plurality of radiopaque markers spaced longitudinally along the body of said graft whereby twisting of the main body may be detected by viewing said radiopaque markers by fluoroscopy.

7. A graft device as in claim 1, wherein a plurality of longitudinally spaced apart radiopaque markers are carried by each of the first and second tubular legs whereby twisting of the legs may be detected by viewing said radiopaque markers by fluoroscopy.

3. An endovascular kit for repairing an aortic aneurysm close to or involving the aortic bifurcation, said kit comprising:

a graft having a main tubular body and having first and second tubular legs joined to the main body in a bifurcation;

wherein the main body and the first and second legs are formed of a flexible surgically implantable material;

wherein the main body and the first and second legs have respectively first, second and third openings therein in communication with each other;

an expandable anchor means secured to the main body adjacent the first opening and additional expandable anchor means secured to the first leg adjacent the second opening; and

a pull line removably connected to the second leg.

4. The endovascular kit as in claim 3 wherein said pull line includes a single line which is looped through the material forming the second leg and a knot formed in said pull line apart from the second leg.

5. The endovascular kit as in claim 4 further comprising:

a flexible tubular member extending over said pull line into a region in close proximity to the second leg;

means carried by said flexible tubular member for engaging said knot to prevent said flexible tubular member from accidentally being removed from said pull line; and

said flexible tubular member having an aperture therein.

8. An endovascular graft suitable for permanent implantation in the vasculature of a patient for repairing an aortic aneurysm proximate the aortic bifurcation, the endovascular graft comprising:

a) support means for reinforcing the aortic bifurcation proximate the aneurysm to prevent rupture, said support means having a main tubular member and first and second tubular leg members in fluid communication with the vasculature;

b) a plurality of anchoring means for attaching the main tubular member and at least one of the first and second tubular leg member to the vasculature and for forming a substantially fluid-tight seal with the vasculature; and

c) marker means for positioning said support means in the aortic bifurcation relative to the aneurysm so that said anchoring means may be affixed to healthy vasculature tissue on either side of said aneurysm, wherein the endovascular graft is intraluminally deployed into the vasculature using a catheter.

9. The endovascular graft of claim 8, wherein said marker means comprise a plurality of aligned, spaced apart radiopaque markers attached to said support means so that the graft can be properly located relative to the aneurysm and to allow correction of any twisting of said support means.

10. An endovascular graft for attachment in a patient'"'"'s vasculature for repairing an aortic aneurysm proximate to the aortic bifurcation, the endovascular graft comprising:

a) a main tubular body having a proximal end;

b) first and second tubular members each having distal ends and each joined to and in fluid communication with said main tubular body;

c) first means for anchoring said main tubular body at its proximal end to the vasculature;

d) second means for anchoring each of said first and second tubular members at their respective distal ends to the vasculature, said first means and second means configured to provide a substantially fluid-tight seal between the vasculature and the endovascular graft so that there is fluid communication between the vasculature and said main tubular body and said first and second tubular members, wherein the endovascular graft is intraluminally deployed into the vasculature using a catheter.

11. The endovascular graft of claim 10, wherein each of said anchoring means includes a self-expanding annular spring means having a plurality of hooks which forcibly engage the patient'"'"'s vasculature when said spring means self-expands.

12. The endovascular graft of claim 11, wherein said spring means has a low-profile collapsed diameter permitting free movement in the vasculature and, after it self-expands, an expanded diameter that is substantially the same as or larger than the inside diameter of the patient'"'"'s vasculature thereby creating a substantially fluid-tight seal.

13. The endovascular graft of claim 10, wherein said first and second tubular members are of substantially the same length.

14. An endovascular graft for permanent implantation in a patient'"'"'s vasculature for repairing the vasculature proximate to a bifurcation in the vasculature, the endovascular graft comprising:

a) a main tubular body having a proximal end and extending proximally into a bifurcation in a vasculature of a patient, the bifurcation forming a first artery and a second artery;

b) first and second tubular members each having distal ends and each joined to and in fluid communication with said main tubular body, said first tubular member configured to extend distally into the first artery and said second tubular member configured to extend distally into the second artery;

c) first means for anchoring said main tubular body at its proximal end to the vasculature;

d) second means for anchoring each of said first and second tubular members at their respective distal ends to the vasculature, said first means and second means configured to provide a substantially fluid-tight seal between the vasculature and the endovascular graft so that there is fluid communication between the vasculature and said main tubular body and said first and second tubular members, wherein the endovascular graft is intraluminally deployed into the vasculature using a catheter.

15. A graft for attachment in a patient'"'"'s vasculature having an inside diameter, the graft configured for repairing an aortic aneurysm proximate to the aortic bifurcation, the graft comprising:

a) a main tubular body having a proximal end and a distal end;

b) first and second tubular members each having proximal and distal ends, said first and second tubular members each being joined at its proximal end to and being in fluid communication with said distal end of said main tubular body;

c) first means for anchoring said main tubular body at its proximal end to an aorta; and

d) second means for anchoring said first tubular member at its distal end to a first iliac artery, wherein each of said first means and second means comprises a self-expanding spring means having a plurality of hooks for engaging the patient'"'"'s vasculature, said spring means having a first collapsed diameter and a second expanded diameter that is substantially the same as or larger than the inside diameter of the vasculature, wherein the graft is intraluminally deployed into the vasculature using a catheter.

16. The graft of claim 15, wherein said first and second tubular members are of substantially the same length, and said second member is folded over on itself.

17. The graft of claim 15, wherein said spring means comprises a cylinder, said cylinder being formed of a plurality of vees arranged around a central axis, each said vee having a first elongated leg and a second elongated leg, each leg having a first end and a second end, wherein the first end of the first leg is connected to the first end of the second leg at an angle to form an apex, the apex having hooks for engaging the patient'"'"'s vasculature.

18. The graft of claim 17, wherein each said apex has a helical spring which yieldably biases the legs away from each other to allow for self-expansion of said cylinder.