CA2334364A1 - Bioengineered flat sheet graft prostheses - Google Patents
Bioengineered flat sheet graft prostheses Download PDFInfo
- Publication number
- CA2334364A1 CA2334364A1 CA002334364A CA2334364A CA2334364A1 CA 2334364 A1 CA2334364 A1 CA 2334364A1 CA 002334364 A CA002334364 A CA 002334364A CA 2334364 A CA2334364 A CA 2334364A CA 2334364 A1 CA2334364 A1 CA 2334364A1
- Authority
- CA
- Canada
- Prior art keywords
- prosthesis
- layers
- patient
- implanted
- superimposed
- 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
Links
Classifications
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- 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
- A61L27/3695—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 function or physical properties of the final product, where no specific conditions are defined to achieve this
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- 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
- A61L27/3629—Intestinal tissue, e.g. small intestinal submucosa
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- 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
- A61L27/3641—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 site of application in the body
-
- 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
- A61L27/36—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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C53/00—Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
- B29C53/36—Bending and joining, e.g. for making hollow articles
- B29C53/38—Bending and joining, e.g. for making hollow articles by bending sheets or strips at right angles to the longitudinal axis of the article being formed and joining the edges
- B29C53/40—Bending and joining, e.g. for making hollow articles by bending sheets or strips at right angles to the longitudinal axis of the article being formed and joining the edges for articles of definite length, i.e. discrete articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C53/00—Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
- B29C53/56—Winding and joining, e.g. winding spirally
- B29C53/562—Winding and joining, e.g. winding spirally spirally
Abstract
The invention is directed to bioengineered graft prostheses made from two or more superimposed, chemically bonded layers of processed tissue material prepared from cleaned tissue material derived from animal sources. The bioengineered graft prostheses of the invention are prepared using methods that preserve cell compatibility, strength, and bioremodelability of the processed tissue matrix. The bioengineered graft prostheses are used for implantation, repair, or for use in a mammalian host.
Claims (8)
1. A prosthesis comprising two or more superimposed, chemically bonded layers of processed tissue 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. A prosthesis comprising two or more superimposed, chemically bonded layers of processed tunics submucosa of small intestine 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.
3. The prosthesis of claim 2 wherein said prosthesis is chemically bonded with the crosslinking agent 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide hydrochloride.
4. The method of preparing a prosthesis having two or more superimposed, bonded layers of processed tissue matrix, comprising:
(a) layering two or more sheets of hydrated processed tissue layers;
(b) dehydrating said tissue layers to adhere the layers together;
(c) crosslinking said tissue layers with a crosslinking agent to bond the layers together; and, (d) rinsing said layers to remove the crosslinking agent;
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.
(a) layering two or more sheets of hydrated processed tissue layers;
(b) dehydrating said tissue layers to adhere the layers together;
(c) crosslinking said tissue layers with a crosslinking agent to bond the layers together; and, (d) rinsing said layers to remove the crosslinking agent;
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.
5. The method of claim 4 wherein said processed tissue matrix is derived from the tunica submucosa of the small intestine.
6. The method of claim 5 wherein the tunics submucosa is essentially acellular telopeptide collagen.
7. 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.
8. The method of claim 7 wherein the prosthesis is a hernia repair patch, a pericardial patch, a bladder sling, a uterus sling, intra-cardiac patch.
replacement heart valve or a vascular patch.
replacement heart valve or a vascular patch.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US8819898P | 1998-06-05 | 1998-06-05 | |
US60/088,198 | 1998-06-05 | ||
US12054799P | 1999-02-17 | 1999-02-17 | |
US60/120,547 | 1999-02-17 | ||
PCT/US1999/012400 WO1999063051A2 (en) | 1998-06-05 | 1999-06-04 | Bioengineered flat sheet graft prostheses |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2334364A1 true CA2334364A1 (en) | 1999-12-09 |
CA2334364C CA2334364C (en) | 2011-01-04 |
Family
ID=26778405
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2334364A Expired - Lifetime CA2334364C (en) | 1998-06-05 | 1999-06-04 | Bioengineered flat sheet graft prostheses |
Country Status (10)
Country | Link |
---|---|
US (1) | US7121999B2 (en) |
EP (1) | EP1082071B1 (en) |
JP (1) | JP4606583B2 (en) |
AT (1) | ATE424164T1 (en) |
AU (1) | AU754838B2 (en) |
CA (1) | CA2334364C (en) |
DE (1) | DE69940504D1 (en) |
ES (1) | ES2323661T3 (en) |
MX (1) | MXPA00012062A (en) |
WO (1) | WO1999063051A2 (en) |
Families Citing this family (69)
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AU2001291092B2 (en) * | 2000-09-18 | 2007-08-23 | Organogenesis Inc. | Bioengineered flat sheet graft prosthesis and its use |
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CA2464661C (en) | 2001-10-26 | 2011-11-29 | Cook Biotech Incorporated | Medical graft device with meshed structure |
US20050283256A1 (en) * | 2004-02-09 | 2005-12-22 | Codman & Shurtleff, Inc. | Collagen device and method of preparing the same |
AU2005215211B2 (en) | 2004-02-13 | 2011-11-03 | Smith & Nephew Orthopaedics Ag | Wound healing profile |
FR2870450B1 (en) * | 2004-05-18 | 2007-04-20 | David Jean Marie Nocca | ADJUSTABLE PROSTHETIC STRIP |
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US8568761B2 (en) * | 2005-07-15 | 2013-10-29 | Cormatrix Cardiovascular, Inc. | Compositions for regenerating defective or absent myocardium |
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1999
- 1999-06-04 CA CA2334364A patent/CA2334364C/en not_active Expired - Lifetime
- 1999-06-04 ES ES99927195T patent/ES2323661T3/en not_active Expired - Lifetime
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- 1999-06-04 EP EP99927195A patent/EP1082071B1/en not_active Expired - Lifetime
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- 1999-06-04 DE DE69940504T patent/DE69940504D1/de not_active Expired - Lifetime
- 1999-06-04 AU AU44163/99A patent/AU754838B2/en not_active Ceased
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2003
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JP4606583B2 (en) | 2011-01-05 |
DE69940504D1 (en) | 2009-04-16 |
CA2334364C (en) | 2011-01-04 |
AU754838B2 (en) | 2002-11-28 |
JP2003527137A (en) | 2003-09-16 |
MXPA00012062A (en) | 2003-04-22 |
ATE424164T1 (en) | 2009-03-15 |
EP1082071A2 (en) | 2001-03-14 |
AU4416399A (en) | 1999-12-20 |
WO1999063051A3 (en) | 2000-01-27 |
WO1999063051A2 (en) | 1999-12-09 |
US7121999B2 (en) | 2006-10-17 |
US20030130747A1 (en) | 2003-07-10 |
EP1082071B1 (en) | 2009-03-04 |
EP1082071A4 (en) | 2005-01-19 |
ES2323661T3 (en) | 2009-07-22 |
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