Prosthetic vascular graft with a pleated structure

• US 5,653,745 A
• Filed: 04/27/1995
• Issued: 08/05/1997
• Est. Priority Date: 02/28/1991
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wolf, Michael, Trescony, Paul V., Lindell, Elaine, Molacek, Richard
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/429,991
• Time in Patent Office: 831 Days
• Field of Search: 623/1, 623/11, 623/12, 606/194, 606/195, 606/198, 606/151-158
• US Class Current: 623/1.29
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61M 25/0043 characterised by structural features

Abstract

A vascular graft having a pleated circumference accommodates blood pressure changes with minimal change in internal surface area. A highly compliant graft may be made from a wide variety of polymers including non-elastomeric materials.

Claims

1. A vascular graft comprising:

(a) a tubular wall structure;

(b) longitudinally extending pleats on the tubular wall structure;

the pleats comprised of a biocompatible polymer capable of responding flexurally to changes in blood pressure by providing the tubular wall structure with a first cross sectional area when maintained at a low normal physiological blood pressure, and a second, greater cross sectional area when maintained at a high normal physiological blood pressure, while maintaining a constant interior wall perimeter for the tubular wall structure.

2. A vascular graft according to claim 1 wherein the second, greater cross sectional area is at least 25% greater than the first cross sectional area.

3. A vascular graft according to claim 1 wherein the wall structure has at least 8 pleats.

4. A vascular graft according to claim 1 wherein the tubular wall structure is made from a biocompatible polymer selected from the goup consisting of silicone polymers, polytetrafluoroethylene, polyesters, polystyrene, polyurethanes, styrene-olefin copolymers, styrene block copolymers, polyethylene, and polypropylene.

5. A vascular graft according to claim 1 wherein the polymer flexural modulus is lower than its tensile modulus.

6. A vascular graft comprising:

(a) a tubular wall structure wherein the wall thickness is at most 0.007 inch;

(b) longitudinally extending pleats on the tubular wall structure;

the pleats comprised of a biocompatible polymer capable of responding flexually to changes in blood pressure by providing the tubular wall structure with a first cross sectional area when maintained at a low normal physiological blood pressure, and a second, greater cross sectional area when maintained at a high normal physiological blood pressme, while maintaining a constant interior wall perimeter for the tubular wall structure.

7. A vascular graft comprising:

(a) a tubular wall structure;

(b) longitudinally extending pleats on the tubular wall structure, the pleats twisted about the longitudinal axis of the tubular wall structure;

the pleats comprised of a biocompatible polymer capable of responding flexurally to changes in blood pressure by providing the tubular wall structure with a first cross sectional area when maintained at a low normal physiological blood pressure, and a second, greater cross sectional area when maintained at a high normal physiological blood pressure, while maintaining a constant interior wall perimeter for the tubular wall structure.

8. A vascular graft comprising:

(a) a tubular wall structure;

(b) longitudinally extending pleats on the tubular wall structure, a portion of the pleats corrugated in the longitudinal direction of the tubular wall structure;

the pleats comprised of a biocompatible polymer capable of responding flexurally to changes in blood pressure by providing the tubular wall structure with a first cross sectional area when maintained at a low normal physiological blood pressure, and a second, greater cross sectional area when maintained at a high normal physiological blood pressure, while maintaining a constant interior wall perimeter for the tubular wall structure.

9. A vascular graft comprising:

(a) a tubular wall structure;

(b) longitudinally extending pleats on the tubular wall structure;

the pleats comprised of a longitudinally extending solid extrusion of a biocompatible polymer, the pleats capable of responding flexurally to changes in blood pressure by providing the tubular wall structure with a first cross sectional area when maintained at a low normal physiological blood pressure, and a second, greater cross sectional area when maintained at a high normal physiological blood pressure, while maintaining a constant interior wall perimeter for the tubular wall structure.

10. A vascular graft according to claim 9 wherein the wall structure has at least 8 pleats.

11. A vascular graft according to claim 9 wherein the pleats are made from a biocompatible polymer selected from the group consisting of silicone polymers, polytetrafluoroethylene, polyesters, polystyrene, polyurethanes, styrene-olefin copolymers, styrene block copolymers, polyethylene, and polypropylene.

12. A vascular graft according to claim 9 wherein the wall thickness is at most 0.007 inch.

13. A vascular graft according to claim 9 wherein the pleats are twisted about the longitudinal axis of the tubular wall structure.

14. A vascular graft according to claim 9 wherein a portion of the pleats are corrugated in the longitudinal direction of the tubular wall structure.

15. A vascular graft comprising:

(a) a tubular wall structure;

(b) longitudinally extending pleats on the tubular wall structure;

the pleats comprised of a biocompatible polymer, the pleats having a flexural response such that the pleats are capable of opening and closing in response to changes in blood pressure by providing the tubular wall structure with a first cross sectional area when maintained at a low normal physiological blood pressure, and a second, greater cross sectional area while maintained at a high normal physiological blood pressure such that the pleats are not fully opened when maintained at the high normal physiological blood pressure, the pleats maintaining a constant interior wall perimeter for the tubular wall structure as the pleats open and close.

16. A vascular graft according to claim 15 wherein the second, greater cross sectional area is at least 25% greater than the first cross sectional area.

17. A vascular graft according to claim 15 wherein the wall structure has at least 8 pleats.

18. A vascular graft according to claim 15 wherein the pleats are made from a biocompatible polymer selected from the group consisting of silicone polymers, polytetrafluoromethylene, polyesters, polystyrene, polyurethanes, styrene-olefin copolymers, styrene block copolymers, polyethylene, and polypropylene.

19. A vascular graft according to claim 15 wherein the wall thickness is at most 0.007 inch.

20. A vascular graft according to claim 15 wherein the pleats are twisted about the longitudinal axis of the tubular wall structure.

21. A vascular graft according to claim 15 wherein a portion of the pleats are corrugated in the longitudinal direction of the tubular wall structure.

22. A vascular graft according to claim 15 wherein the polymer flexural modulus is lower than its tensile modulus.