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US3988782A Expired / Lapsed US ⏱️ 0.0 years remaining

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

Assignee: DARDIK SHEIL R PLAINTIFF
•
Filing: 1975-04-01
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Granted: 1976-11-02
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Expires: 1995-04-01
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Abstract

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.

Inventors

  • 👤 Irving I. Dardik
  • 👤 Herbert Dardik

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 19:24
CPC Classifications
A; A61; A61L; A61L27/00; A61L27/36; A61L27/3604; A61L27/3625; A61F; A61F2/00; A61F2/02; A61F2/04; A61F2/06; A61L27/3683; A61L33/00; A61L33/0076; A61L33/0082; Y; Y10; Y10S; Y10S623/00; Y10S623/915; Y10S623/916

Claims Analysis

Total Claims: 57
Claim 1
Independent Claim 37 words
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.
Claim 2
Dependent Claim 37 words
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.
Claim 3
Dependent Claim 16 words
The segment as defined in claim 1 wherein said segment is a portion of a vein.
Claim 4
Dependent Claim 16 words
The segment as defined in claim 1 wherein said segment is a portion of an artery.
Claim 5
Dependent Claim 12 words
The segment as defined in claim 1 wherein said segment is sterile.
Claim 6
Dependent Claim 25 words
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.
Claim 7
Dependent Claim 14 words
The segment as defined in claim 1 wherein said segment is tubular in form.
Claim 8
Dependent Claim 18 words
The segment as defined in claim 6 wherein said tubular segment is free of the valves of Hoboken.
Claim 9
Dependent Claim 17 words
The segment as defined in claim 1 wherein the thickness dimension of said segment is essentially uniform.
Claim 10
Dependent Claim 17 words
The segment as defined in claim 1, wherein said mammalian umbilical cord is a human umbilical cord.
Claim 11
Dependent Claim 45 words
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.
Claim 12
Dependent Claim 45 words
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.
Claim 13
Dependent Claim 23 words
The process as defined in claim 10 further comprising the step of passing a cleansing liquid through said vessel to remove blood therefrom.
Claim 14
Dependent Claim 28 words
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.
Claim 15
Dependent Claim 21 words
The process as defined in claim 10 wherein the separation of said vessel from said umbilical cord is carried out mechanically.
Claim 16
Dependent Claim 21 words
The process as defined in claim 10 wherein a mandrel is inserted into said vessel as a means of shaping same.
Claim 17
Dependent Claim 61 words
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.
Claim 18
Dependent Claim 24 words
The process as defined in claim 10, wherein said shaping is carried out by hardening said vessel while mounted on a mandrel inserted therein.
Claim 19
Dependent Claim 66 words
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.
Claim 20
Dependent Claim 55 words
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.
Claim 21
Dependent Claim 62 words
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.
Claim 22
Dependent Claim 24 words
The process as defined in claim 10, wherein said hardening is effected by bringing said vessel in contact with a solution of an aldehyde.
Claim 23
Dependent Claim 23 words
The process as defined in claim 20, wherein said aldehyde is selected from the group consisting of glutaraldehyde, dialdehyde starch, glyoxal and formaldehyde.
Claim 24
Dependent Claim 42 words
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.
Claim 25
Dependent Claim 33 words
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.
Claim 26
Dependent Claim 33 words
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.
Claim 27
Dependent Claim 40 words
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.
Claim 28
Dependent Claim 30 words
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.
Claim 29
Dependent Claim 17 words
The process as defined in claim 25 wherein said reagent is an alkali salt of L-glutamic acid.
Claim 30
Dependent Claim 29 words
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.
Claim 31
Dependent Claim 51 words
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.
Claim 32
Dependent Claim 55 words
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.
Claim 33
Dependent Claim 16 words
The process as defined in claim 30, wherein said aldehyde solution is a dilute glutaraldehyde solution.
Claim 34
Dependent Claim 16 words
The process as defined in claim 10, wherein said umbilical cord is that of a human.
Claim 35
Dependent Claim 80 words
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.
Claim 36
Dependent Claim 32 words
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.
Claim 37
Dependent Claim 30 words
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.
Claim 38
Dependent Claim 42 words
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.
Claim 39
Dependent Claim 32 words
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.
Claim 40
Dependent Claim 32 words
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.
Claim 41
Dependent Claim 27 words
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.
Claim 42
Dependent Claim 25 words
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.
Claim 43
Dependent Claim 19 words
The process as defined in claim 10, wherein said shaped vessel is used for surgical repair of an esophagus.
Claim 44
Dependent Claim 20 words
The process as defined in claim 10, wherein said shaped vessel is used as a patch over a surface trauma.
Claim 45
Dependent Claim 13 words
The process as defined in claim 42 wherein said trauma is a burn.
Claim 46
Dependent Claim 13 words
The process as defined in claim 42, wherein said trauma is a wound.
Claim 47
Dependent Claim 12 words
The process as defined in claim 42, wherein said trauma is infected.
Claim 48
Dependent Claim 19 words
The process as defined in claim 10, wherein said shaped vessel is used as filler material in plastic surgery.
Claim 49
Dependent Claim 13 words
The process as defined in claim 10, wherein said vessel is a vein.
Claim 50
Dependent Claim 13 words
The process as defined in claim 10, wherein said vessel is an artery.
Claim 51
Dependent Claim 13 words
The process as defined in claim 10, wherein said mammal is a human.
Claim 52
Dependent Claim 23 words
The process as defined in claim 10, wherein said shaped vessel is used as a covering for artificial, implanted organs and parts thereof.
Claim 53
Dependent Claim 14 words
The process as defined in claim 50, wherein said organ is a heart valve.
Claim 54
Dependent Claim 13 words
The process as defined in claim 50, wherein said organ is a pacemaker.
Claim 55
Dependent Claim 21 words
The process as defined in claim 10, wherein said hardening process is carried out at elevated temperature to accelerate said process.
Claim 56
Dependent Claim 33 words
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.
Claim 57
Dependent Claim 39 words
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.

References Cited (Backward Citations)

US2127903A Cited
US3562820A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1979-11-02 1980-05-03 1980-11-02 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1983-11-02 1984-05-03 1984-11-02 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1987-11-02 1988-05-03 1988-11-02 $7700.00 Window Closed / Lapsed

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