Method for making a vascular graft

• US 4,909,979 A
• Filed: 12/06/1984
• Issued: 03/20/1990
• Est. Priority Date: 03/24/1983
• Status: Expired due to Fees

• Current Assignee: Medrad Incorporated (Bayer AG)
• Original Assignee: Possis Medical, Inc. (Bayer AG)
• Inventors: Nicoloff, Demetre M., Possis, Zinon C.
• Primary Examiner(s): Lorin, Hubert C.
• Application Number:
  US06/678,993
• Time in Patent Office: 1,930 Days
• Field of Search: 264/342 R, 264/571, 264/554, 264/230, 264/573, 264/232, 264/340, 128/334 R
• US Class Current: 264/571
• 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: B29C 53/083 bending longitudinally, i.e. modifying the curvature of the tube axis
• CPC Class Codes: B29C 53/82 Cores or mandrels
• CPC Class Codes: B29C 67/0014 for shaping tubes or blown tubular films
• CPC Class Codes: B29C 67/0025 and pressure difference
• CPC Class Codes: B29L 2023/22 Tubes or pipes, i.e. rigid bent tubes not for use as pipe couplings B29L2023/004

Abstract

A mandrel assembly supports an umbilical cord during the shaping and curing of the cord for use as a vascular graft. The mandrel assembly has a pair of mandrel members adapted to be releasably connected in end-to-end relation. Adjacent end sections of the mandrel members have reduced cross sectional shapes to provide the graft with a throat to restrict the flow of blood through the vascular graft. Each mandrel member has a low friction outer surface to facilitate the insertion and withdrawal of the mandrel member from the lumen of the umbilical cord. In one embodiment, the adjacent ends and neck portions of the mandrel members have small holes. A vacuum pump draws air from within the mandrel members to withdraw moisture from the tissue of the umbilical cord and hold the umbilical cord in conforming relationship with the joined mandrel members during the forming and curing of the umbilical cord.

Claims

1. A method of processing an umbilical cord having open opposite ends for use as a vascular graft having a section for restricting fluid flow through the graft with a mandrel assembly comprising first and second mandrel members having cooperating means to releasably connect the mandrel members together, and means for making the section for restricting fluid flow through said graft comprising:

inserting the first mandrel member into one end of the lumen of an uncured umbilical cord, inserting the second mandrel member into the other end of the lumen of the uncured umbilical cord, connecting the first and second mandrel members together with said cooperating means, forming said umbilical cord by shrinking said umbilical cord onto said connected first and second mandrel members and means for making the section for restricting fluid flow through said graft whereby the umbilical cord conforms to the shape of the connected mandrel members, curing the formed umbilical cord on the first and second mandrel members and said means for making the section for restricting fluid flow through said graft, and removing the first and second mandrel members from said one end and other end of the cured umbilical cord.

2. The method of claim 1 wherein:

said umbilical cord is formed by subjecting the uncured umbilical cord to alcohol to shrink the umbilical cord on the connected first and second mandrel members.

3. The method of claim 1 wherein:

the formed umbilical cord is cured with an aqueous solution of dialdehyde.

4. The method of claim 1 including:

removing the mesenchyme and umbilical arteries from the outside of the uncured umbilical cord that is located on the connected mandrel members before the forming thereof.

5. The method of claim 1 including:

flushing the uncured umbilical cord with a saline solution to remove loose tissue therefrom before insertion of the mandrel members into the lumen thereof.

6. The method of claim 1 including:

applying a suction force to the interior of the connected first and second mandrel members to draw the umbilical cord into conforming relation with the connected mandrel members.

7. The method of claim 6 wherein:

the suction force is continuously maintained on the umbilical cord during the forming and curing of the umbilical cord.

8. A method of processing an umbilical cord having open opposite ends for use as a vascular graft, said vascular graft having a section having a reduced cross sectional area for controlling the flow of liquid through the graft and the pressure of the liquid in the graft, with a mandrel assembly having first and second mandrel members adapted to be releasably connected to each other, said mandrel members having elongated hollow bodies when joined together forming a neck section having a cross sectional area smaller than the cross sectional area of a body, said bodies and neck section having a plurality of holes extended therethrough, comprising:

inserting the first mandrel member into one end of the lumen of an uncured umbilical cord, inserting the second mandrel member into the other end of the lumen of the uncured umbilical cord, joining the first and second mandrel members together to provide the neck section, applying a suction force to the interior of the first and second mandrel members to draw air from within the mandrel members and neck section and hold the umbilical cord in surface conforming relation with the mandrel members and neck section thereof, forming said umbilical cord by shrinking said cord onto the joined mandrel members and neck section thereof, curing the formed umbilical cord on the joined mandrel members and neck section thereof, and removing the first and second mandrel members from the one end and other end of the cured umbilical cord.

9. The method of claim 8 including:

removing the mesenchyme and umbilical arteries from the outside of the uncured umbilical cord that is located on the connected mandrel members before the forming thereof.

10. The method of claim 8 wherein:

said umbilical cord is formed by subjecting the uncured umbilical cord to alcohol to shrink the umbilical cord on the connected first and second mandrel members.

11. The method of claim 10 wherein:

the suction force is applied to the connected mandrel members and neck section during the forming of the umbilical cord.

12. The method of claim 8 wherein:

the formed umbilical cord is cured with an aqueous solution of dialdehyde.

13. The method of claim 12 wherein:

the suction force is applied to the connected mandrel members and neck section during the curing of the umbilical cord.

14. The method of claim 8 wherein:

the suction force is continuously applied to the connected mandrel members and neck section during the forming and curing of the umbilical cord.

15. A method of processing an umbilical cord having open opposite ends for use as a vascular graft with a mandrel assembly having first and second mandrel members adapted to be releasably connected to each other, comprising:

inserting the first mandrel member into one end of the lumen of an uncured umbilical cord, inserting the second mandrel into the other end of the lumen of the uncured umbilical cord, connecting adjacent portions of the first and second mandrel members together with the umbilical cord located thereon, forming said umbilical cord by shrinking said umbilical cord onto said connected first and second mandrel members, curing the formed umbilical cord on the first and second mandrel members, and removing the first and second mandrel members from one end and the other end of the cured umbilical cord.

16. The method of claim 15 wherein:

said umbilical cord is formed by subjecting the uncured umbilical cord to alcohol to shrink the umbilical cord on the connected first and second mandrel members.

17. The method of claim 15 wherein:

the formed umbilical cord is cured with an aqueous solution of dialdehyde.

18. The method of claim 15 including:

removing the mesenchyme and umbilical arteries from the outside of the uncured umbilical cord that is located on the connected mandrel members before the forming thereof.

19. The method of claim 15 including:

flushing the uncured umbilical cord with a saline solution to remove loose tissue therefrom before insertion of the first and second mandrel members into the lumen thereof.

20. The method of claim 15 including:

applying a suction force to the interior of the connected first and second mandrel members to draw the umbilical cord into conforming relation with the connected mandrel members.

21. The method of claim 20 wherein:

the suction force is continuously maintained on the umbilical cord during the forming and curing of the umbilical cord.