Non-antigenic, non-thrombogenic infection-resistant grafts from umbilical cord vessels and process for preparing and using same

• US 3,988,782 A
• Filed: 04/01/1975
• Issued: 11/02/1976
• Est. Priority Date: 07/06/1973
• Status: Expired due to Term

• Current Assignee: Sheil R., Plaintiff Dardik
• Original Assignee: Herbert Dardik, Irving I. Dardik
• Inventors: Dardik, Irving I., Dardik, Herbert
• Primary Examiner(s): Frinks, Ronald L.
• Application Number:
  US05/563,998
• Time in Patent Office: 581 Days
• Field of Search: 3/1, 3/1.4, 3/13, 128/1 R, 128/334 R, 128/334 C, 128/335, 128/335.5
• US Class Current: 623/23.72
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 33/0082 by reacting with an organic compound other than heparin
• CPC Class Codes: Y10S 623/916 Blood vessel

Abstract

Arteries and veins of umbilical cords are hardened and shaped by processes described. Prostheses in the form of tubes, patches and conduits are prepared from the shaped vessels. The prostheses are used as reinforcements and replacements for vessels, ducts, intestines and urinary bladders. The processes result in products which have vanishingly low antigenicity and thrombogenicity, are resistant to infection and which may be stored indefinitely for use when needed by a surgeon.

Claims

1. A flexible, hardened segment of a mammalian umbilical cord vessel in a shape other than that in which it occurs in nature, for use as a prosthesis in mammals, said segment having vanishingly low antigenicity and thrombogenicity.

2. The segment as defined in claim 1 wherein said segment is a portion of a vein.

3. The segment as defined in claim 1 wherein said segment is a portion of an artery.

4. The segment as defined in claim 1 wherein said segment is sterile.

5. The segment as defined in claim 1 wherein said segment has a shape such that it can be manipulated into essentially planar form without wrinkling.

6. The segment as defined in claim 1 wherein said segment is tubular in form.

7. The segment as defined in claim 6 wherein said tubular segment is free of the valves of Hoboken.

8. The segment as defined in claim 1 wherein the thickness dimension of said segment is essentially uniform.

9. The segment as defined in claim 1, wherein said mammalian umbilical cord is a human umbilical cord.

10. A process for preparing a prosthesis for use in surgery comprising the steps of

a. separating and removing at least one of the principal blood vessels from a mammalian umbilical cord;

b. hardening said blood vessel by means of a reagent;

c. shaping said vessel.

11. The process as defined in claim 10 further comprising the step of passing a cleansing liquid through said vessel to remove blood therefrom.

12. The process as defined in claim 11, wherein said cleansing liquid is selected from the group consisting of hydrogen peroxide, Ringer'"'"'s lactate solution, sterile saline solution and water.

13. The process as defined in claim 10 wherein the separation of said vessel from said umbilical cord is carried out mechanically.

14. The process as defined in claim 10 wherein a mandrel is inserted into said vessel as a means of shaping same.

15. The process as defined in claim 10 wherein said vessel is shaped subsequent to removal of same from said umbilical cord and said shaping step comprises the substeps of inserting said vessel in an essentially tubular mold, distending said vessel against the wall of said tubular mold, and hardening said vessel so that it retains the shape of said tubular mold.

16. The process as defined in claim 10, wherein said shaping is carried out by hardening said vessel while mounted on a mandrel inserted therein.

17. The process as defined in claim 16 wherein said mandrel has an axis and is of circular cross-section throughout, and further comprising the steps of mounting said mandrel in a rotatable chuck, the axis of said chuck coinciding with the axis of said mandrel, rotating said chuck and said mandrel, and applying a cutting tool against the exterior of said vessel to shape the exterior thereof.

18. The process as defined in claim 10 wherein said vessel is shaped by hardening same while on a mandrel, and further comprising the steps of mounting said mandrel in a chuck for rotation, and cutting away the remainder of said umbilical cord by means of a cutting tool while rotating said vessel on said mandrel.

19. The process as defined in claim 10 wherein said vessel is mounted on a mandrel prior to hardening, and further comprising the steps of freezing said umbilical cord including said vessel on said mandrel, mounting said mandrel in a rotatable chuck and removing the remainder of said umbilical cord from said vessel by means of a cutting tool while rotating said mandrel.

20. The process as defined in claim 10, wherein said hardening is effected by bringing said vessel in contact with a solution of an aldehyde.

21. The process as defined in claim 20, wherein said aldehyde is selected from the group consisting of glutaraldehyde, dialdehyde starch, glyoxal and formaldehyde.

22. The process as defined in claim 20, wherein said vessel is hardened by bringing same in contact with a solution of glutaraldehyde at a concentration of from 0.15% to 0.6% by weight for a period of about 15 to about 45 minutes.

23. The process as defined in claim 20 wherein said vessel is hardened by bringing same in contact with a solution of dialdehyde starch at a concentration between about 0.5 and 2.0% by weight.

24. The process as defined in claim 10, further comprising the step of slitting said hardened vessel axially so that said vessel may be manipulated into essentially flat shape, and, optionally, cut into segments.

25. The process as defined in claim 20, further comprising the steps of washing the aldehyde-treated vessel with water, normal saline or dilute sodium bicarbonate to remove aldehyde, and then with a suitable reagent for the purpose of eliminating residual aldehyde.

26. the process as defined in claim 25 wherein said reagent is selected from the group consisting of amino acids, alkali salts of aminoacids, amines, hydroxylamines, peracids, peroxides and alkali hydrochlorite.

27. The process as defined in claim 25 wherein said reagent is an alkali salt of L-glutamic acid.

28. The process as defined in claim 10 further comprising the step of soaking said vessel in ethanol prior to hardening same, the purpose being to produce a stiffer product.

29. The process as defined in claim 10, further comprising the step of soaking said umbilical cord in a solution of hyaluronidase prior to shaping said vessel, the purpose being removal of a portion of the Wharton'"'"'s jelly from said cord, and thereby to facilitate separation of said vessel from said cord.

30. The process as defined in claim 10, further comprising the step of storing said shaped vessel in a member selected from the group consisting of a dilute solution of aldehyde and a 40-50% aqueous alcohol solution containing 1% by weight of propylene oxide, in perparation for use of said shaped vessel in a surgical procedure.

31. The process as defined in claim 30, wherein said aldehyde solution is a dilute glutaraldehyde solution.

32. The process as defined in claim 10, wherein said umbilical cord is that of a human.

33. The process as defined in claim 10, wherein said shaped vessel has a form such that it is manually deformable into an essentially flat strip, and further comprising the step of binding a suitably-sized strip of said vessel about an eye as part of a surgical procedure for holding a detached retina against the inner wall of the eyeball, the strip being fastened about the eyeball so as to compress it sufficiently to generate a selected internal pressure above atmospheric.

34. The process as defined in claim 10, wherein a suitably shaped segment of said vessel is surgically attached to the interior of the pericardium of the heart to form a lining thereof.

35. The process as defined in claim 10, wherein said shaped vessel is cut to form a segment suitably shaped for use as a patch over an opening in a bowel.

36. The process as defined in claim 16, wherein said vessel is cut to form a patch for use as a reinforcement over a gap in a bowel, vessel or other organ which has been sewn together and said patch is so used.

37. The process as defined in claim 10, wherein said shaped vessel is cut into a strip and said strip is sewn over an anastamosis as a reinforcement and to prevent leakage therethrough.

38. The process as defined in claim 10, wherein said shaped vessel is used as a replacement for at least a part of an artery, a vein, a bile duct or a ureter.

39. The process as defined in claim 10, wherein said shaped vessel is used to form an artificial conduit between the bladder and the exterior of a patient.

40. The process as defined in claim 10 wherein said vessel is used as a patch to bridge or reinforce a defect in a urinary bladder.

41. The process as defined in claim 10, wherein said shaped vessel is used for surgical repair of an esophagus.

42. The process as defined in claim 10, wherein said shaped vessel is used as a patch over a surface trauma.

43. The process as defined in claim 42 wherein said trauma is a burn.

44. The process as defined in claim 42, wherein said trauma is a wound.

45. The process as defined in claim 42, wherein said trauma is infected.

46. The process as defined in claim 10, wherein said shaped vessel is used as filler material in plastic surgery.

47. The process as defined in claim 10, wherein said vessel is a vein.

48. The process as defined in claim 10, wherein said vessel is an artery.

49. The process as defined in claim 10, wherein said mammal is a human.

50. The process as defined in claim 10, wherein said shaped vessel is used as a covering for artificial, implanted organs and parts thereof.

51. The process as defined in claim 50, wherein said organ is a heart valve.

52. The process as defined in claim 50, wherein said organ is a pacemaker.

53. The process as defined in claim 10, wherein said hardening process is carried out at elevated temperature to accelerate said process.

54. The process as defined in claim 10, further comprising the step of treating said vessel with a solution for essentially eliminating any residual carbonyl groups, said step being carried out at elevated temperature.

55. The process as defined in claim 10, wherein said vessel is treated with said reagent for up to 6 days and further comprising treating said vessel with a reactant for essentially eliminating all of said reagent from said vessel.