Tubular prosthesis for vascular reconstructive surgery and process for preparing same

• US 5,131,908 A
• Filed: 11/23/1990
• Issued: 07/21/1992
• Est. Priority Date: 09/01/1987
• Status: Expired due to Fees

• Current Assignee: Sheila Dardik
• Original Assignee: Sheila Dardik
• Inventors: Dardik, Irving I., Dardik, Herbert
• Primary Examiner(s): Shay, Randy C.
• Assistant Examiner(s): Gualtieri, Gina
• Application Number:
  US07/622,338
• Time in Patent Office: 606 Days
• Field of Search: 600/36, 606/158, 606/191, 606/194, 8/94.1 R, 8/94.11, 8/94.19 R
• US Class Current: 600/36
• 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: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: Y10S 623/916 Blood vessel

Abstract

Arteries and veins of umbilical cords are treated by processes described, fitted with a biodegradable mesh support and used as tubular prosthesis for vascular reconstructive surgery.

Claims

1. A process for producing a tubular prosthesis for vascular reconstructive surgery from a selected blood vessel of the human umbilical cord, wherein said umbilical cord comprises blood vessels and umbilical cord tissue, said blood vessels comprising a vein and two arteries, the process comprising the steps of:

a. cleansing the umbilical cord;

b. separating the two arteries and vein from the umbilical cord tissue and from one another;

c. removing umbilical cord tissue from the outer surface of said selected blood vessel;

d. establishing and maintaining a minimum bore dimension of said selected blood vessel by inserting within the bore of said selected blood vessel a mandrel having an outer diameter essentially equal to said minimum bore dimension of said selected blood vessel and a length substantially equal to the length of said selected blood vessel, said selected blood vessel being open at least at one end; and

e. treating said selected blood vessel by applying tanning agent under cyclic pressure to the outer surface of said selected blood vessel such that said selected blood vessel contracts down to said outer diameter of said mandrel.

2. The process according to claim 1, comprising the further step of treating said selected blood vessel with an antithrombogenic agent after said tanning step.

3. The process according to claim 1, comprising the further step of applying a sleeve-like biodegradable mesh support externally and generally coaxially along the length of the tanned selected blood vessel.

4. A process according to claim 1, wherein the tanning agent used in step (e) is gluteraldehyde at a concentration in the range of about 0.15% to 1.0%.

5. A process according to claim 1, wherein treating said selected blood vessel comprises flowing the tanning agent under said cyclic pressure while it is in contact with said selected blood vessel.

6. A process according to claim 1, wherein the cyclic pressure is in the range of about 0 to 200 mm Hg.

7. A process according to claim 1, wherein treating said vein comprises applying said cyclic pressure at a rate of 20 to 30 times/minute.

8. A process according to claim 1, step (e), wherein said selected blood vessel is treated with a tanning agent under cyclic pressure for a time period in the range of 24 to 36 hours.

9. A process according to claim 3, wherein the biodegradable mesh support is polylactic acid or polygalactic acid polymer.

10. A process according to claim 1, wherein the mandrel inserted in step (d) is a solid rod measuring 5 mm in diameter.

11. A tubular prosthesis made according to the process of claim 1 suitable for repairing, replacing or augmenting a vein or artery of a human, primate or mammal body, said prosthesis comprising a selected blood vessel of a human, primate or mammal umbilical cord that has been separated from the outer umbilical cord tissue, shaped on a mandrel and tanned with a tanning agent applied under cyclic pressure.

12. The tubular prosthesis of claim 11 wherein a biodegradable mesh support is fitted coaxially about and along the length of said tanned selected blood vessel.

13. A process for producing a tubular prosthesis for vascular reconstructive surgery from a selected blood vessel of the human umbilical cord, wherein said umbilical cord comprises blood vessels and umbilical cord tissue, said blood vessels comprising a vein and two arteries, the process comprising the steps of:

a. cleansing the umbilical cord;

b. separating the two arteries and vein from the umbilical cord tissue and from one another;

c. removing umbilical cord tissue from the outer surface of said selected blood vessel;

d. establishing and maintaining a minimum bore dimension of said selected blood vessel by inserting within the bore of said selected blood vessel a mandrel having an outer diameter essentially equal to said minimum bore dimension of said selected blood vessel;

e. positioning and maintaining tanning fluid around the selected blood vessel to be tanned; and

f. treating said selected blood vessel by applying tanning agent under cyclic pressure to the outer surface of said selected blood vessel such that said selected blood vessel contracts down to said outer diameter of said mandrel.

14. A process for producing a tubular prosthesis for vascular reconstructive surgery from a selected blood vessel of the human umbilical cord, wherein said umbilical cord comprises blood vessels and umbilical cord tissue, said blood vessels comprising a vein and two arteries, the process comprising the steps of:

a. cleansing the umbilical cord;

b. separating the two arteries and vein from the umbilical cord tissue and from one another;

c. removing umbilical cord tissue from the outer surface of said selected blood vessel;

d. establishing and maintaining a predetermined inner diameter of said selected blood vessel along its entire circumferential inner surface; and

e. maintaining said predetermined inner diameter while applying tanning agent under cyclic pressure to the outer surface of said selected blood vessel such that said selected blood vessel contracts down to said outer diameter of said mandrel.

15. A process according to claim 14 wherein a mandrel having an outer diameter essentially equal to said predetermined inner diameter of said blood vessel is inserted within the bore of said selected blood vessel in step (d) to establish and maintain a predetermined inner diameter of said vessel.

16. A process for tanning the outer surface of a selected blood vessel of an umbilical cord under cyclic pressure, said tanned vessel having utility as a prosthesis for vascular reconstructive surgery, comprising the steps of:

a. establishing and maintaining a predetermined inner dimension of said selected blood vessel along its entire circumference; and

b. treating said selected blood vessel by applying tanning agent under cyclic pressure to the outer surface of said selected blood vessel.

17. A process for producing a tubular prosthesis for vascular reconstructive surgery from a selected blood vessel of the human umbilical cord, wherein said umbilical cord comprises blood vessels and umbilical cord tissue, said blood vessels comprising a vein and two arteries, the process comprising the steps of:

a. cleansing the umbilical cord;

b. separating the two arteries and vein from the umbilical cord tissue and from one another;

c. removing umbilical cord tissue from the outer surface of said selected blood vessel;

d. establishing and maintaining a minimum bore dimension of said selected blood vessel by inserting within the bore of said selected blood vessel a mandrel having an outer diameter essentially equal to said minimum bore dimension of said selected blood vessel and a length substantially equal to the length of said selected blood vessel, said selected blood vessel being open at both ends; and

e. treating said selected blood vessel by applying tanning agent under cyclic pressure to the outer surface of said selected blood vessel such that said selected blood vessel contracts down to said outer diameter of said mandrel.

18. A process for producing a tubular prosthesis for vascular reconstructive surgery form a selected blood vessel of the human umbilical cord, wherein said umbilical cord comprises blood vessels and umbilical cord tissue, said blood vessels comprising a vein and two arteries, the process comprising the steps of:

a. cleansing the umbilical cord;

b. separating the two arteries and vein from the umbilical cord tissue and from one another;

c. removing umbilical cord tissue from the outer surface of said selected blood vessel;

d. establishing and maintaining a minimum bore dimension of said selected blood vessel by inserting within the bore of said selected blood vessel a mandrel having an outer diameter essentially equal to said minimum bore dimension of said selected blood vessel and a length substantially equal to the length of said selected blood vessel, said selected blood vessel being open at least at one end; and

e. treating said selected blood vessel by applying tanning agent under cyclic pressure to the outer surface of said selected blood vessel such that said selected blood vessel contracts down to said outer diameter of said mandrel, wherein said cyclic pressure to which said selected blood vessel is subjected is greater than the physiologic range when said selected blood vessel is implanted.

19. A process according to claim 18 wherein said cyclic pressure is in the range of 120 nm to 200 mm Hg.

20. A process for producing a tubular prosthesis for vascular reconstructive surgery from a selected blood vessel of the human umbilical cord, wherein said umbilical cord comprises blood vessels and umbilical cord tissue, said blood vessels comprising a vein and two arteries, the process comprising the steps of:

a. cleansing the umbilical cord;

b. separating the two arteries and vein from the umbilical cord tissue and from one another;

c. removing umbilical cord tissue from the outer surface of said selected blood vessel;

d. establishing and maintaining a minimum bore dimension of said selected blood vessel by inserting within the bore of said selected blood vessel a mandrel having an outer diameter essentially equal to said minimum bore dimension of said selected blood vessel and a length substantially equal to the length of said selected blood vessel, said selected blood vessel being open at both ends; and

e. treating said selected blood vessel by applying tanning agent under cyclic pressure to the outer surface of said selected blood vessel such that said selected blood vessel contracts down to said outer diameter of said mandrel, wherein said cyclic pressure to which said selected blood vessel is subjected is greater than the physiologic range when said selected blood vessel is implanted.