Prosthetic vascular graft

• US 6,436,135 B1
• Filed: 10/24/1974
• Issued: 08/20/2002
• Est. Priority Date: 10/24/1974
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: David Goldfarb
• Inventors: Goldfarb, David
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US05/517,415
• Time in Patent Office: 10,162 Days
• Field of Search: 3/1, 3/14, 128/92.C, 128/334.R, 128/334.C, 128/DIG.14, 260/2.5 R, 260/2.5 M, 264/288, 264/289, 623/1.1, 623/1.39, 623/1.4, 623/1.49, 623/23.64, 623/23.71, 623/23.76
• US Class Current: 623/1.39
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/443 with carbon fillers
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 33/025 Carbon; Graphite
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A prosthetic vascular graft with walls less than O.8B millimeters in thickness and formed of highly expanded polytetrafluoroethylene with a microscopic superstructure of nodes and interconnecting fibrils, which nodes are substantially uniformly separated by an average distance greater than a typical red cell. The superstructure of the graft controls transmural cellular ingrowth and assures the establishment and maintenance of a thin,viable neointima.

Claims

1. A prosthetic vascular structure of expanded polytetrafluorethylene having:

(i) a macroscopically tubular configuration with proximal and distal ends, and

(ii) a microscopic superstructure of irregularly spaced nodes of various sizes and shapes interconnected by fibrils;

said vascular structure further comprising;

a. an average wall thickness in the range between 0.2 and 0.8 millimeters;

b. a substantially uniform distribution of nodes throughout said tubular configuration;

c. an average density in the range between 0.2 and 0.5 grams per milliliter; and

d. an average distance between said nodes small enough to prevent transmural blood flow and thrombosis but no less than the maximum dimension of an average red cell;

whereby said structure may provide for the smooth flow of blood between at least two points in a living organism while controlling cellular ingrowth through the wall of the tubular configuration to promote and nourish a thin, viable neointima over the inner surface thereof and to firmly attach said prosthetic vascular structure to adjacent tissue of said living organism.

2. The prosthetic vascular structure of claim 1 wherein said nodes are generally ellipsoidal in shape and have an average dimension along their minor axes less than three times the maximum dimension of an average red cell.

3. The prosthetic vascular structure of claim 2 wherein the major axes of said nodes are in a generally radial orientation with respect to the tubular configuration.

4. The prosthetic vascular structure of claim 1 wherein the tubular configuration thereof has an average inside diameter of less than 8 millimeters.

5. The prosthetic vascular structure of claim 4 wherein the tubular configuration thereof has an average inside diameter of between 2 and 6 millimeters.

6. The prosthetic vascular structure of claim 1 wherein the tubular configuration thereof has an average inside diameter of less than 40 millimeters.

7. The prosthetic vascular structure of claim 1 further having a tensile strength in the range between 2500 and 6500 psi.

8. The prosthetic vascular structure of claim 1 wherein the tubular configuration thereof tapers from a first inside diameter at the proximal end to a second inside diameter at the distal end.

9. The prosthetic vascular structure of claim 8 wherein said first inside diameter is in the range between 5 and 8 millimeters and the second inside diameter is in the range of between 2 and 6 millimeters.

10. A prosthetic vascular structure as set forth in claim 1 wherein said average distance between said nodes is no greater than about 80 microns.

11. The prosthetic vascular structure of claim 2 wherein the minor axes of the nodes are substantially transverse to generally radial direction of the tubular configuration.

12. A prosthetic vascular structure of expanded polytetrafluorethylene having:

(i) a macroscopically tubular configuration with proximal and distal ends, and

(ii) a microscopic superstructure of irregularly spaced nodes of various sizes and shapes interconnected by fibrils;

said vascular structure including;

a. an average inside diameter in the range between 2 and 6 millimeters;

b. an average wall thickness in the range between 0.2 and 0.8 millimeters;

c. a substantially uniform distribution of generally ellipsoidal nodes having major axes disposed in a generally radial orientation with respect to the tubular configuration and an average minor axis dimension less than 18 microns;

d. an average density in the range between 0.2 and 0.8 grams per milliliter; and

e. a tensile strength in the range of between 2500 and 6500 pounds per square inch;

whereby said structure may provide for the smooth flow of blood between at least two points in a living organism while controlling cellular ingrowth through the wall of the tubular configuration to promote and nourish a thin, viable neointima over the inner surface thereof and to firmly attach said prosthetic vascular structure to adjacent tissue of said living organism.

13. A prosthetic vascular structure as defined in claim 12 wherein the distribution of nodes is such that the average internodal distance is no greater than about 80 microns.

14. A prosthetic vascular graft of expanded polytetrafluoroethylene having a microscopic structure of nodes interconnected by fibrils comprising:

a wall thickness within the range between 0.2 and 0.8 millimeters;

a substantially uniform distribution of nodes;

an average density in the range between 0.2 and 0.5 grams per milliliter; and

an average distance between nodes in the range of between about 6 to 80 microns.

15. A prosthetic vascular structure as defined in claim 14 which is in tubular form.

16. A prosthetic vascular structure as defined in claim 15 wherein the inner diameter of the graft is between 2 to 10 millimeters.

17. A prosthetic vascular structure of expanded polytetrafluoroethylene having:

(i) a macroscopically tubular configuration with proximal and distal ends, and

(ii) a microscopic superstructure of irregularly spaced nodes of various sizes and shapes interconnected by fibrils;

said vascular structure including;

a. an average inside diameter in the range between 2 and 6 millimeters;

b. an average wall thickness in the range between 0.2 and 0.8 millimeters;

c. a substantially uniform distribution of generally ellipsoidal nodes having minor axes disposed in a generally transverse orientation with respect to the radial direction of the tubular configuration and an average minor axis dimension less than 18 microns;

d. an average density in the range between 0.2 and 0.5 grams per milliliter; and

e. an average distance between said nodes small enough to prevent transmural blood flow and thrombosis but no less than the maximum dimension of an average red cell;

whereby said structure may provide for the smooth flow of blood between at least two points in a living organism while controlling cellular ingrowth through the wall of the tubular configuration to promote and nourish a thin, viable neointima over the inner surface thereof and to firmly attach said prosthetic vascular structure to adjacent tissue of said living organism.

18. A prosthetic structure as set forth in claim 17 wherein said average distance between said nodes is no greater than about 80 microns.

19. A prosthetic vascular structure as set forth in claim 17 wherein the average distance between said nodes is in the range of between 6 and 80 microns.

20. An artificial vascular prosthesis comprising expanded, porous, polytetrafluorocthylene having a microstructure consisting of nodes interconnected by fibrils which permits tissue ingrowth, wherein an average distance between nodes is not less than about 6 microns and is small enough to prevent transrmural blood flow.

21. The artificial vascular prosthesis as defined in claim 20 wherein said average—

distance between nodes is not greater than about 200 microns.

22. The artificial vascular prosthesis as defined in claim 20 wherein said average distance between nodes is not greater than about 150 microns.

23. The artificial vascular prosthesis as defined in claim 20 wherein said average distance between nodes does not extend beyond 150 to 200 microns.

24. The artificial vascular prosthesis as defined in claim 20 wherein said average distance between nodes is not greater than about 80 microns.

25. A prosthetic vascular graft of expanded polytetrafluoroethylene having a microscopic structure of nodes interconnected by fibrils, said graft comprising:

a wall thickness greater than about 0.2 millimeters and less than about 0.8 millimeters; and

an average distance between nodes in the range of between about 6 to 80 microns.

26. A prosthetic vascular graft of expanded polytetrafluoroethylene having a microscopic structure of nodes interconnected by fibrils, said graft comprising:

a wall thickness greater than about 0.2 millimeters and less than about 0.8 millimeters;

an average density in the range of between about 0.2 and 0.5 grams per milliliter; and

an average distance between nodes in the range of between about 6 to 80 microns.

27. An artificial vascular prosthesis comprising expanded, porous, polytetrafluoroetylene having a microstructure consisting of nodes interconnected by fibrils which permits tissue ingrowth, wherein an average distance between nodes is not less than about 6 microns and is not greater than about 80 microns.