Vascular and venous valve implant prostheses

• US 5,824,061 A
• Filed: 06/06/1995
• Issued: 10/20/1998
• Est. Priority Date: 05/31/1989
• Status: Expired due to Term

• Current Assignee: 3F Therapeutics Incorporated (Medtronic Plc)
• Original Assignee: Baxter International Inc.
• Inventors: Quijano, Rodolfo C., Nashef, Aws
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/467,496
• Time in Patent Office: 1,232 Days
• Field of Search: 623/2, 623/1, 606/153
• US Class Current: 623/1.13
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves

Abstract

Exovascular and endovascular stent devices and associated support/restrictor assemblies for use in conjunction with prosthetic vascular grafts, including venous valve grafts made from preserved bioprosthetic venous valves. Also disclosed are methods for preparing vascular grafts such as venous valve grafts using the devices and assemblies of the present invention.

Claims

1. A vascular implant system for facilitating the surgical implantation of a tubular vascular graft between opposing cut ends of a blood vessel from which a segment has been resected and removed, said system comprising:

a) an exovascular stent component configured to receive and hold said tubular vascular graft therein, said exovascular stent component comprising;

a tubular stent body having a first end, a second end, and a hollow bore extending longitudinally therethrough;

a first flange formed around the first end of said tubular body;

a second flange formed around the second end of said tubular body;

said stent component being sized relative to said tubular vascular graft such that said tubular graft is coaxially positionable in the hollow bore of said stent with the ends of said graft being in contact with said first and second flanges; and

b) first and second dilation restrictor components respectively positionable on the cut ends of said blood vessel for limiting the extent to which said blood vessel may dilate relative to the size of said tubular vascular graft, each of said dilation restrictor components comprising;

an elongate tubular body having a first end, a second end and a hollow bore extending longitudinally therethrough;

an outwardly extending flange formed about the second end of said tubular body;

the tubular body of such dilation restrictor component being sized and configured to pass, first end first, over the cut end of said blood vessel such that said cut end may be attached to the flange of said dilation restrictor component with the tubular body of said restrictor component remaining disposed around said blood vessel to prevent said blood vessel from dilating to a size larger than the hollow bore of said surrounding tubular body.

2. A vascular implant system according to claim 1, wherein the first and second flanges of the tubular stent body and the outwardly extending flanges of the first and second dilation restrictor components have suture apertures for suturing the exovascular stent component to the first and second dilation restrictor components.

3. A vascular implant system according to claim 1, wherein the hollow bore of each respective dilation restrictor component is tapered so as to have a smaller cross-sectional dimension at the second end thereof than at the first end thereof.

4. A vascular implant system according to claim 3, wherein the cross-sectional dimension of the first end of the hollow bore of said tubular body is 4-22 mm, and the cross-sectional dimension of the second end of the hollow bore of said tubular body is 5-24 mm.

5. An endovascular venous valve prosthesis, comprising:

an endovascular stent assembly including a stent having a generally cylindrical body with a hollow bore extending longitudinally therethrough and inflow and outflow ends, and first and second support struts formed on opposite sides of the outflow end of said cylindrical body and extending generally longitudinally therefrom; and

a preserved segment of vein having an outer wall and a venous valve positioned therein, said valve having two leaflets extending generally longitudinally within said segment of vein with lateral edges adjacent the outer wall;

wherein said segment of vein is coaxially disposed within the hollow bore of said stent and attached thereto such that the leaflets of the venous valve extend transversely between the opposed support struts of said stent with said lateral edges positioned adjacent said struts, the stent and segment of vein adapted to be implanted as a unit in a patient.

6. An endovascular venous valve prosthesis according to claim 5, wherein the stent comprises a plurality of suture apertures for facilitating suturing of the vein segment to the stent.

7. An endovascular venous valve prosthesis according to claim 5, wherein the stent comprises at least one annular groove formed around said cylindrical body such that a surrounding ligature may be received and nested within said groove.

8. A vascular implant system for facilitating the surgical implantation of a tubular vascular graft between opposing cut ends of a blood vessel from which a segment has been resected and removed, said system comprising:

a) a stent component having a tubular stent body having a first end, a second end, and a conduit extending longitudinally therethrough, and being configured to receive and hold said tubular vascular graft coaxially therein, said stent component further comprising;

a first flange formed proximal to the first end of said tubular body; and

a second flange formed proximal to the second end of said tubular body;

b) first and second interconnection members for attaching the stent component to the cut ends of the blood vessel, each interconnection member configured to receive a respective cut end of said blood vessel and having a flange which attaches to the respective cut end, the flange of the first interconnection member configured to be coupled to the first flange of the tubular body, the flange of the second interconnection member configured to be coupled to the second flange of the tubular body.

9. A vascular implant system according to claim 8, wherein the first and second flanges of the tubular stent body have a plurality of suture apertures formed respectively therein for suturing the tubular stent body to the first and second interconnection members.

10. A vascular implant system according to claim 8, wherein each interconnection member has a tapered conduit extending therethrough.

11. A method of generating a venous valve prosthesis that is adapted to restore venous valvular function within a valve-deficient vein of a patient, the method comprising the steps of:

extracting a vein segment from a biological source other than the patient, the vein segment comprising a valve reservoir having an intact venous valve formed therein, the venous valve having at least one leaflet;

processing the vein segment to preserve the venous valve in a condition in which the venous valve is competent under venous conditions; and

assembling the prosthesis, the step of assembling comprising positioning a support structure over an exterior surface of at least a portion of the valve reservoir.

12. The method according to claim 11, wherein the step of processing comprises exposing the vein segment to a chemical fixing agent.

13. The method according to claim 11, wherein the support structure has a conduit extending therethrough, and the step of positioning comprises advancing the vein segment coaxially within the conduit.

14. The method according to claim 13, further comprising attaching the vein segment to the support structure with the valve reservoir positioned within the conduit.

15. The method according to claim 11, further comprising the step of implanting the venous valve prosthesis within a human in place of a valve-deficient vein segment.

16. The method according to claim 14, wherein the support structure includes first and second outwardly-extending flanges at opposite respective ends of the conduit, and the step of attaching comprises spreading the first and second ends of the vein segment outward and attaching the first and second ends, respectively, to the first and second flanges.

17. The method according to claim 11, wherein the step of extracting a vein segment comprises extracting the vein segment from a cadaverous human.

18. The method according to claim 11, wherein the step of extracting a vein segment comprises extracting the vein segment from an animal source.

19. The method according to claim 11, wherein the support structure comprises a tubular member having a first end and a second end, and wherein the step of assembling the prosthesis comprises suturing a first end of the vein segment to the first end of the tubular member and suturing a second end of the vein segment to the second end of the tubular member.

20. A method of generating a venous valve prosthesis, the method comprising the steps of:

extracting a vein segment from an animal, the vein segment comprising a valve reservoir having an intact venous valve formed therein, the venous valve having at least one leaflet;

processing the vein segment to preserve the venous valve in an operable condition;

positioning a support structure over an exterior surface of at least a portion of the valve reservoir, the support structure having a conduit extending therethrough, and including first and second outwardly-extending flanges at opposite respective ends of the conduit; and

attaching the vein segment to the support structure with the valve reservoir positioned within the conduit, the step of attaching comprising splaying the first and second ends of the vein segment and suturing the first and second ends, respectively, to the first and second flanges.

21. The method according to claim 20, wherein the step of processing comprises exposing the vein segment to a chemical fixing agent.

22. The method according to claim 20, further comprising the step of implanting the venous valve prosthesis within a human in place of a valve-deficient vein segment.

23. The method according to claim 22, wherein the step of implanting comprises attaching a first cut of an existing vein of the human to the first flange, and attaching a second cut end of the existing vein to the second flange.

24. A venous valve prosthesis that is adapted to restore venous valvular function within a valve-deficient vein, the prosthesis comprising:

a harvested vein segment, the vein segment comprising a valve reservoir having a least one intact venous valve formed therein, the venous valve having at least one leaflet, the vein segment being conditioned to preserve the competency of the venous valve; and

a support member positioned over an exterior surface of at least the valve reservoir, the support member providing support for the valve reservoir following implantation of the prosthesis.

25. The venous valve prosthesis according to claim 24, wherein the harvested vein segment is chemically fixed.

26. The venous valve prosthesis according to claim 24, wherein the support member is configured to prevent the overexpansion of the valve reservoir without inhibiting a normal dilation of the valve reservoir.

27. The venous valve prosthesis according to claim 24, wherein the support member comprises a tubular member having a conduit, and the harvested vein segment is disposed coaxially within the conduit.

28. The venous valve prosthesis according to claim 27, wherein the tubular member has a plurality of openings which extend through a tubular wall thereof, the openings configured to allow fluid to pass into and out of the conduit following implantation of the prosthesis.

29. The venous valve prosthesis according to claim 27, wherein the support member further comprises first and second outwardly-extending flanges at first and second ends of the tubular member, respectively, and wherein first and second ends of the harvested vein segment are attached to the first and second flanges, respectively.

30. The venous valve prosthesis according to claim 27, wherein a first end of the vein segment is attached to a first end of the tubular member, and a second end of the vein segment is attached to a second end of the tubular member.

31. A venous valve prosthesis for implantation within a human, the prosthesis comprising:

a harvested vein segment, the vein segment comprising a valve reservoir having a least one intact venous valve formed therein, the venous valve having at least one leaflet, the vein segment being conditioned to preserve the venous valve in an operable condition; and

a support member comprising a tubular member having a conduit, and having first and second outwardly-extending flanges at first and second ends of the tubular member, respectively;

wherein the harvested vein segment is disposed coaxially within the conduit with the support member is positioned over an exterior surface of at least the valve reservoir, and wherein first and second ends of the harvested vein segment are attached to the first and second flanges, respectively.

32. The venous valve prosthesis according to claim 31, wherein first and second ends of the harvested vein segment are sutured to the first and second flanges, respectively.

33. The venous valve prosthesis according to claim 31, wherein the harvested vein segment is chemically fixed.

34. The venous valve prosthesis according to claim 31, wherein the tubular member has a plurality of openings which extend through a tubular wall thereof, the openings configured to allow fluid to pass into and out of the conduit following implantation of the prosthesis.