CA2217581A1 - Bioremodelable prosthesis and methods of preparing and uses thereof - Google Patents

Bioremodelable prosthesis and methods of preparing and uses thereof

Info

Publication number
CA2217581A1
CA2217581A1 CA002217581A CA2217581A CA2217581A1 CA 2217581 A1 CA2217581 A1 CA 2217581A1 CA 002217581 A CA002217581 A CA 002217581A CA 2217581 A CA2217581 A CA 2217581A CA 2217581 A1 CA2217581 A1 CA 2217581A1
Authority
CA
Canada
Prior art keywords
prosthesis
collagen
patient
layers
implanted
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002217581A
Other languages
French (fr)
Other versions
CA2217581C (en
Inventor
Robert M. Carr, Jr.
Paul L. Termin
Kimberlie D. Condon
Janet Hardin Young
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Organogenesis Inc
Original Assignee
Organogenesis Inc.
Robert M. Carr, Jr.
Paul L. Termin
Kimberlie D. Condon
Janet Hardin Young
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=23655691&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2217581(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Organogenesis Inc., Robert M. Carr, Jr., Paul L. Termin, Kimberlie D. Condon, Janet Hardin Young filed Critical Organogenesis Inc.
Publication of CA2217581A1 publication Critical patent/CA2217581A1/en
Application granted granted Critical
Publication of CA2217581C publication Critical patent/CA2217581C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix 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
    • A61L27/3691—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix 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 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
    • A61L27/24—Collagen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix 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
    • A61L27/3687—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix 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 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth

Abstract

This invention is directed to prosthesis, which, when implanted into a mammalian patient, serves as a functioning replacement for a body part, or tissue structure, and will undergo controlled biodegradation occurring concomitantly with bioremodeling by the patient's living cells. The prosthesis is treated so that it is rendered non-antigenic so as not to elicit a significant humoral immune response. The prosthesis of this invention, in its various embodiments, thus has dual properties. First, it functions as a substitute body part, and second, it functions as bioremodeling template for the ingrowth of host cells.

Claims (7)

1. A prosthesis comprising two or more superimposed, bonded layers of collagen material which, when implanted into a mammalian patient, undergoes controlled biodegradation occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells.
2. The prosthesis of claim 1 wherein the shape of said prosthesis is flat, tubular, or complex.
3. The prosthesis of claim 1 wherein said collagen material is from a mammalian source and is intestinal material, fascia lata, dura mater, and pericardium.
4. The prosthesis of claim 3 wherein said collagen material is the tunica submucosa of the small intestine.
5. The prosthesis of claim 1 wherein said collagen layers are bonded together byheat welding for a time and under conditions sufficient to effect the bonding of the collagen layers.
6. The prosthesis of claim 1 wherein said prosthesis is crosslinked with a crosslinking agent.
7. The prosthesis of claim 6 wherein said prosthesis is crosslinked with the crosslinking agent 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride.8. The prosthesis of claim 6 wherein sulfo-N-hydroxysuccinimide is added to the crosslinking agent.
9. The prosthesis of claim 6 wherein acetone is added to the crosslinking agent.10. The prosthesis of claim 1 wherein the prosthesis is sterilized with peracetic acid.
11. The prosthesis of claim 10 wherein said prosthesis is non-antigenic.
12. The prosthesis of claim 1 wherein one or more surfaces of said prosthesis iscoated with a collagenous material which acts as a smooth flow surface.
13. The prosthesis of claim 1 wherein said prosthesis further contains pores.

14. The prosthesis of claim 1 wherein said prosthesis is further composed of chopped collagen fibers.
15. The prosthesis of claim 1 wherein said prosthesis is further composed of collagen threads.
16. The prosthesis of claim 15 wherein said collagen threads are arranged to form a felt, a bundle, a weave or a braid.
17. The prosthesis of any of claims 14-16 wherein said collagen fibers or threads are partially or completely crosslinked.
18. The prosthesis of claim 1 wherein said prosthesis additionally contains an anticoagulant; one or more antibiotics, or one or more growth factors.
19. The method of preparing a prosthesis having two or more superimposed, bonded layers of collagen material comprising:
(a) bonding two or more collagen layers together using heat welding by heating said collagen layers for a time and under conditions sufficient to effect the bonding of the collagen layers and to form a prosthesis;
(b) cooling said heated prosthesis; and, (c) crosslinking said prosthesis, wherein said thus formed prosthesis when implanted into a mammalian patient, undergoes controlled biodegradation occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells.
20. The method of claim 19 wherein said collagen layers are formed from two or more layers of collagen material from a mammalian source and is intestinal material, fascia lata, dura mater, and pericardium.
21. The method of claim 20 wherein said collagen material is the tunica submucosa of the small intestine.
22. The method of claim 19 wherein said heat welding is from about 50°C to about 75°C, more preferably from about 60° to 65°C and most preferably at about 62°C.

23. The method of claim 19 wherein said cooling is accomplished by quenching 24. The method of claim 19 wherein said heat welding is accomplished for a time from about 7 minutes to about 24 hours, preferably about 1 hour.
25. The method of claim 19 wherein said prosthesis is crosslinked with the crosslinking agent 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride.26. The method of claim 19 wherein said prosthesis is sterilized with peracetic acid.
27. The method of claim 26 wherein said prosthesis is non-antigenic.
28. A method of repairing or replacing a damaged tissue comprising implanting a prosthesis in a patient comprising two or more superimposed, bonded layers of collagen material which, when implanted into a mammalian patient, undergoes controlled biodegradation occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells.
29. A sterile, non-pyrogenic, and non-antigenic prosthesis formed from mammalianderived collagenous tissue for engraftment to a recipient patient, whereby said engrafted prosthesis does not elicit a humoral immune response to components in said collagenous tissue and wherein said prosthesis concomitantly undergoes bioremodeling occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells.
30. The prosthesis if claim 29 wherein said humoral immune response to components derived from said collagenous tissue demonstrates no significant increase in antibody titer for antibodies to ICL proteins from baseline titer levels when blood serum obtained from a recipient of a prosthesis is tested for antibodies to proteins in extracts of the collagenous tissue..
31. The prosthesis of claim 30 wherein said antibody titer levels is 1:40 or less for a patient or host previously non-sensitized to ICL proteins.
32. A method of preparing a non-antigenic prosthesis prepared from collagen material derived from a mammalian source, comprising:

(a) disinfecting the collagen material with an agent that retains the bioremodelable properties of said material; and, (b) crosslinking said disinfected collagen material with a crosslinking agent;
wherein said thus formed prosthesis when implanted into a mammalian patient, undergoes controlled bioremodeling occurring with adequate living cell replacement such that the original implanted prosthesis is remodeled by the patient's living cells without eliciting a significant humoral immune response.
33. The method of claim 32 wherein said mammalian source is selected from the group consisting of intestinal material, fascia lata, dura mater, and pericardium.
34. The method of claim 33 wherein said collagen material is the tunica submucosa of the small intestine.
35. The method of claim 32 wherein said collagen material is formed from two or more layers of superimposed, bonded layers of collagen material.
36. The method of claim 32 wherein said peracetic acid is at a concentration between about 0.01 and 0.3% v/v in water.
CA2217581A 1995-04-07 1996-03-12 Bioremodelable prosthesis and methods of preparing and uses thereof Expired - Fee Related CA2217581C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/417,868 US5733337A (en) 1995-04-07 1995-04-07 Tissue repair fabric
US08/417,868 1995-04-07
PCT/US1996/003336 WO1996031157A1 (en) 1995-04-07 1996-03-12 Peracetic acid crosslinked non-antigenic icl grafts

Publications (2)

Publication Number Publication Date
CA2217581A1 true CA2217581A1 (en) 1996-10-10
CA2217581C CA2217581C (en) 2012-05-08

Family

ID=23655691

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2217581A Expired - Fee Related CA2217581C (en) 1995-04-07 1996-03-12 Bioremodelable prosthesis and methods of preparing and uses thereof

Country Status (9)

Country Link
US (1) US5733337A (en)
EP (2) EP1623681B1 (en)
JP (3) JP3756187B2 (en)
AT (1) ATE308926T1 (en)
AU (1) AU711900B2 (en)
CA (1) CA2217581C (en)
DE (1) DE69635414T2 (en)
ES (2) ES2252753T3 (en)
WO (1) WO1996031157A1 (en)

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