Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft

• US 5,102,417 A
• Filed: 03/28/1988
• Issued: 04/07/1992
• Est. Priority Date: 11/07/1985
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Expandable Grafts Partnership
• Inventors: Palmaz, Julio C.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Bockelman, Mark
• Application Number:
  US07/174,246
• Time in Patent Office: 1,471 Days
• Field of Search: 128/343, 128/344, 604/93, 604/49, 604/282, 604/343, 604/97, 604/8, 604/283, 623/1, 623/12, 623/11, 606/191-195, 606/108
• US Class Current: 606/195
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A plurality of expandable and deformable intraluminal vascular grafts are expanded within a blood vessel by an angioplasty balloon associated with a catheter to dilate and expand the lumen of a blood vessel. The grafts may be thin-walled tubular members having a plurality of slots disposed substantially parallel to the longitudinal axis of the tubular members, and adjacent grafts are flexibly connected by at least one connector member.

Claims

1. A method for implanting a plurality of prostheses within a body passageway comprising the steps of:

disposing at least one connector member between adjacent prostheses to flexibly connect adjacent prostheses to each other;

disposing the plurality of connected prostheses upon a catheter;

inserting the prostheses and catheter within the body passageway by catheterization of said body passageway; and

providing controllable expansion of at least one of the prostheses at a desired location within the body passageway by expanding a portion of the catheter associated with the prostheses to force at least one of the prostheses radially outwardly into contact with the body passageway, by deforming a portion of the at least one prosthesis with a force in excess of the elastic limit of the portion of the at least one prosthesis, to implant the prostheses within the body passageway.

2. The method of claim 1, further including the steps of:

collapsing the portion of the catheter associated with the prostheses, and removing the catheter from the body passageway.

3. The method of claim 1, including the steps of:

utilizing a catheter having an expandable, inflatable portion associated therewith; and

the expansion and deformation of the prostheses and the portion of the catheter is accomplished by inflating the expandable, inflatable portion of the catheter.

4. The method of claim 1, wherein at least one prosthesis is provided with a biologically compatible coating on the outer surface of the prosthesis.

5. The method of claim 1, including the step of disposing the at least one connector member in a non-parallel relationship with respect to the longitudinal axis of adjacent prostheses.

6. The method of claim 1, including the step of:

utilizing a wire mesh tube as each prosthesis, the wire mesh tubes having a first predetermined collapsed diameter which permits the tubes to be disposed upon the catheter and inserted into the body passageway.

7. The method of claim 6, including the step of disposing the at least one connector member coplanar with each wire mesh tube and non-parallel to the longitudinal axis of the wire mesh tubes.

8. The method of claim 6, wherein tantalum is utilized for the wire mesh tube.

9. The method of claim 1, wherein a thin-walled, tubular member is utilized as each prosthesis, each tubular member having a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of the tubular member.

10. The method of claim 9, wherein tantalum is utilized for the tubular member.

11. The method of claim 9, wherein the slots are uniformly and circumferentially spaced from adjacent slots and the slots are uniformly spaced from adjacent slots along the longitudinal axis of each tubular member, whereby at least one elongate member is formed between adjacent slots.

12. The method of claim 11, wherein the thin-walled tubular member and the elongate members disposed between adjacent slots have a uniform wall thickness.

13. The method of claim 9, wherein each thin-walled tubular member is expanded and deformed to a second diameter within the body passageway;

the second, expanded diameter being variable and determined by the internal diameter of the body passageway, whereby each expanded thin-walled tubular member will not migrate from the desired location within the body passageway and the expansion of each thin-walled tubular member does not cause a rupture of the body passageway.

14. The method of claim 13, wherein each thin-walled tubular member is uniformly, outwardly expanded and deformed along its length.

15. The method of claim 9, including the step of disposing the at least one connector member coplanar with each tubular member and non-parallel to the longitudinal axis of the tubular members.

16. The method of claim 9, including the step of forming the at least one connector member as a thin-walled spiral member, coplanar with adjacent tubular members.

17. A method for expanding the lumen of a body passageway comprising the steps of:

connecting a plurality of intraluminal grafts by at least one flexible connector member disposed between adjacent grafts;

inserting the plurality of connected intraluminal grafts, disposed upon a catheter, into the body passageway until the grafts are disposed adjacent a desired location within the body passageway; and

expanding a portion of the catheter to provide controllable expansion of the intraluminal grafts radially, outwardly into contact with the body passageway, by deforming a portion of the intraluminal grafts with a force in excess of the elastic limit of the portion of the intraluminal grafts, until the lumen of the body passageway at the desired location in the body passageway has been expanded, whereby the intraluminal grafts prevent the body passageway from collapsing and decreasing the size of the expanded lumen, and the intraluminal rafts remain in the passageway.

18. The method of claim 17, including the step of disposing the at least one connector member in a non-parallel relationship with respect to the longitudinal axis of the intraluminal grafts.

19. The method of claim 17, including the step of:

utilizing a wire mesh tube as the intraluminal graft, the wire mesh tube having a first predetermined, collapsed diameter which permits the tube to be inserted within the body passageway at the desired location.

20. The method of claim 19, including the step of disposing the at least one connector member coplanar with each wire mesh tube and non-parallel to the longitudinal axis of the wire mesh tubes.

21. The method of claim 19, wherein tantalum is utilized for the wire mesh tube.

22. The method of claim 17, wherein a thin-walled tubular member is utilized as each intraluminal graft, each tubular member having a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of the tubular members.

23. The method of claim 22, including the step of disposing the at least one connector member coplanar with each tubular member and non-parallel to the longitudinal axis of the tubular members.

24. The method of claim 22, including the step of forming the at least one connector member as a thin-walled spiral member, coplanar with adjacent tubular members.

25. An expandable intraluminal vascular graft, comprising:

a plurality of thin-walled tubular members, each having first and second ends and a wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of each tubular member;

at least one connector member being disposed between adjacent tubular members to flexibly connect adjacent tubular members;

each tubular member having a first diameter which permits intraluminal delivery of the tubular members into a body passageway having a lumen; and

the tubular members having a second, expanded and deformed diameter, upon the application from the interior of the tubular members of a radially, outwardly extending force, which second diameter is variable and dependent upon the amount of force applied to the tubular members, whereby the tubular members may be expanded and deformed to expand the lumen of the body passageway.

26. The expandable intraluminal graft of claim 25, wherein at least one connector member is disposed in a non-parallel relationship with respect to the longitudinal axis of the tubular members.

27. The expandable intraluminal graft of claim 25, wherein the at least one connector member is disposed coplanar with each tubular member and non-parallel to the longitudinal axis of the tubular members.

28. The expandable intraluminal graft of claim 25, wherein the at least one connector member is a thin-walled, spiral member, coplanar with adjacent tubular members.

29. An expandable prosthesis for a body passageway, comprising:

a plurality of thin-walled tubular members, each having first and second ends and a wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of each tubular member;

at least one connector member being disposed between adjacent tubular members to flexibly connect adjacent tubular members;

each tubular member having a first diameter which permits intraluminal delivery of the tubular members into a body passageway having a lumen; and

the tubular members having a second, expanded and deformed diameter, upon the application from the interior of the tubular members, of a radially, outwardly extending force, which second diameter is variable and dependent upon the amount of force applied to the tubular member, whereby the tubular member may be expanded and deformed to expand the lumen of the body passageway.

30. The expandable prosthesis of claim 29, wherein at least one connector member is disposed in a non-parallel relationship with respect to the longitudinal axis of the tubular members.

31. The expandable prosthesis of claim 29, wherein the at least one connector member is disposed coplanar with each tubular member and non-parallel to the longitudinal axis of the tubular members.

32. The expandable prosthesis of claim 29, wherein the at least one connector member is a thin-walled, spiral member, coplanar with adjacent tubular members.

33. An apparatus for intraluminally reinforcing a body passageway, comprising:

a plurality of expandable and deformable, thin-walled tubular prostheses, each prosthesis having first and second ends, and a wall surface disposed between the first and second ends, the wall surface having a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axes of the prostheses, at least one connector member being disposed between adjacent tubular members to flexibly connect adjacent tubular members; and

a catheter, having an expandable, inflatable portion associated therewith and including means for mounting and retaining the expandable, thin-walled tubular prostheses on the expandable, inflatable portion,

whereby upon inflation of the expandable, inflatable portion of the catheter, the prostheses are expanded and deformed radially outwardly into contact with the body passageway.

34. The apparatus of claim 33, wherein the mounting and retaining means comprises retainer ring members disposed on the catheter adjacent the expandable, inflatable portion and adjacent the ends of the expandable, tubular prostheses.

35. An apparatus for expanding the lumen of a body passageway comprising:

a plurality of expandable and deformable thin-walled intraluminal vascular grafts, each graft having first and second ends, and a wall surface disposed between the first and second ends, the wall surface having a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axes of the grafts, at least one connector member being disposed between adjacent tubular members to flexibly connect adjacent tubular members; and

a catheter, having an expandable, inflatable portion associated therewith and including means for mounting and retaining the expandable, deformable intraluminal vascular grafts on the expandable, inflatable portion,

whereby upon inflation of the expandable, inflatable portion of the catheter, the intraluminal vascular grafts are expanded and deformed radially outwardly into contact with the body passageway.

36. The apparatus of claim 35, wherein the mounting and retaining means comprises retainer ring members disposed on the catheter adjacent the expandable, inflatable portion and adjacent the ends of the expandable intraluminal vascular grafts.