WO2007012282A1 - Vaisseau sanguin artificiel biologique et son procede de preparation - Google Patents
Vaisseau sanguin artificiel biologique et son procede de preparation Download PDFInfo
- Publication number
- WO2007012282A1 WO2007012282A1 PCT/CN2006/001880 CN2006001880W WO2007012282A1 WO 2007012282 A1 WO2007012282 A1 WO 2007012282A1 CN 2006001880 W CN2006001880 W CN 2006001880W WO 2007012282 A1 WO2007012282 A1 WO 2007012282A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- blood vessel
- substrate
- vessel according
- epoxide
- surface layer
- Prior art date
Links
Classifications
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- 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
- A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
-
- 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
- A61L27/3625—Vascular tissue, e.g. heart valves
-
- 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
-
- 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
- A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
- A61L33/06—Use of macromolecular materials
- A61L33/12—Polypeptides, proteins or derivatives thereof, e.g. degradation products thereof
- A61L33/128—Other specific proteins or polypeptides not covered by A61L33/122 - A61L33/126
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/062—Apparatus for the production of blood vessels made from natural tissue or with layers of living cells
-
- 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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices
Definitions
- the present invention relates to an artificial blood vessel which is a device for replacing a damaged blood vessel or for vascular bypass, and belongs to a medical device implanted in a human body.
- BACKGROUND OF THE INVENTION Vascular disease has become one of the most important diseases that threaten human health and life.
- the main treatment for vascular disease is to replace the diseased blood vessels with artificial blood vessels or bridge the sides of the lesion.
- the artificial blood vessels used in clinical application are mainly polyester braided tubes and expanded polytetrafluoroethylene tubes, which are all made of synthetic materials. Although they can form pseudointimal membranes and maintain their long-term smoothness, they are always present as permanent foreign bodies in the body.
- glutaraldehyde immobilization treatment is to crosslink the protein molecules in animal tissues by acetal reaction, so that the treated implant will release toxic glutaraldehyde when it is slowly degraded in vivo, thereby inhibiting vascular endothelial cells.
- decellularization is an effective means of removing antigens.
- antigens are not derived from cells, but are active sites derived from certain specific positions of proteins and polysaccharides. Groups, or special isoforms, these specific groups or conformations are collectively referred to as antigenic determinants.
- Another object of the present invention is to provide a method for producing the above-described bioartificial blood vessel.
- the technical solution of the present invention is: a bioartificial blood vessel comprising a substrate formed by a fixed agent cross-linked and de-antigen-treated animal blood vessel, and an anticoagulant group bonded to the inner surface of the substrate.
- the surface layer of the sub-composition Animal vascular tissue is mainly composed of collagen, glycosaminoglycan, etc., and is easily degraded or decomposed by microorganisms.
- aldehydes (formaldehyde, glutaraldehyde, etc.) are cross-linked and fixed to improve their stability; however, aldehydes are cross-linked with proteins by acetal reaction, and the cross-linked products are degraded to release toxic aldehydes. , so that products fixed with aldehyde have long-term residual toxicity.
- a non-aldehyde fixing agent such as an epoxide or a diacid diamine or a diisocyanate or a carbodiimide is used instead of an aldehyde as a fixing agent, there is no such disadvantage, and an epoxide is exemplified by an epoxide.
- the degradation products are polyols that can be metabolized by the body, no residual toxicity of aldehydes, and stability of animal blood vessels after treatment. It is also higher than the original aldehydes; according to modern immunology theory, the antigenicity of animal tissues is mainly caused by reactive groups and specific isoforms at certain specific positions in the protein. These reactive groups are mainly -OH, - NH 2 , -SH, etc., and the special isomers are often caused by some special hydrogen bonds in the helical chain of the protein molecule.
- one or more active reagents that react easily with these groups such as An acid anhydride, acid chloride, amide, epoxide, etc.
- a strong hydrogen bond reagent such as a terpenoid
- the hydrogen bond that causes the specific isomer is changed, and its conformation is changed to further eliminate its antigenicity.
- the anticoagulant component in the anticoagulant layer may be a substance having a negative charge on the surface layer, or a heparin having high anticoagulant property, but the surface negative charge is too strong to be disadvantageous to a negatively charged blood vessel.
- the implantation and reproduction of endothelial cells is better with heparin.
- vascular growth factors such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-derived growth factor (PDGF-bb), vascular permeability factor (VPF), etc. Broad-spectrum adhesion and enrichment, thereby promoting the formation of new blood vessels.
- vascular growth factors such as vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-derived growth factor (PDGF-bb), vascular permeability factor (VPF), etc.
- VEGF vascular endothelial growth factor
- FGF fibroblast growth factor
- PDGF-bb platelet-derived growth factor
- VPF vascular permeability factor
- One of these specific polypeptides is composed of 16 lysines (K16>, glycine (G), arginine (R), aspartic acid (D), serine (S), proline (P) and cysteine.
- the substrate is in the shape of a straight tubular body or a U-shaped tubular body or a C-shaped tubular body or Y-shaped tubular body, so as to be suitable for different implantation occasions.
- the preparation method of bio-artificial blood vessel is based on natural animal blood vessels, including the following steps
- Pretreatment Pruning and removing excess tissue after initial sterilization using a broad-spectrum high-efficiency and low-toxic sterilizing agent
- Fixation cross-linking the protein molecules in the substrate with a fixative
- the anticoagulant component is coupled to the inner surface of the substrate using a coupling agent to form an anticoagulant surface layer.
- a polypeptide having broad-spectrum adhesion ability to growth factors is also coupled by a coupling agent in the surface layer.
- the preparation method for the preparation of the bioartificial blood vessel may be an epoxide, or may be a diacid diamine, a diisocyanate or a carbodiimide, and an epoxide is preferred.
- the active reagent described in the method for producing a bioartificial blood vessel may be a small molecule organic acid anhydride, an acid chloride, an amide, a monoepoxide or the like, and the strong hydrogen bonding reagent is an anthraquinone compound.
- the anticoagulant component described in the method for preparing a bioartificial blood vessel may be such that the surface layer is negative
- the substance to be charged may also be heparin having high coagulability
- the coupling agent to be used may be an epoxide or an internal dianhydride or a diacid chloride or the like.
- the coupling agent used for the coupling of the polypeptide component in the preparation method of the bioartificial blood vessel may be a difunctional diamine or a dianhydride or a bisepoxide or other bifunctional group capable of undergoing condensation reaction with -NH 2 , -OH, -COOH or the like. Reagents.
- the invention has the advantages that: the treated animal has high blood vessel stability, complete antigen removal, does not cause rejection reaction, has good blood compatibility, is not easy to cause coagulation, and can ensure long-term patency after implantation into the human body, due to its basic composition Similar to the human body, the final product of degradation is 20 kinds of amino acids and sugars that make up all biological proteins. It can be absorbed and utilized by human tissues, has good histocompatibility, and is a good carrier for angiogenesis, which can induce vascular tissue to grow into it. After coupling a specific polypeptide, it can also enrich the growth factor, promote the growth of endothelial cells and the formation of new blood vessels, and finally be autologous into neovascular tissue.
- FIG. 1 is a schematic structural view of a first embodiment of the present invention
- FIG. 2 is a vertical sectional view of a first embodiment of the present invention
- FIG. 3 is a schematic structural view of a second embodiment of the present invention
- 3 is a schematic structural view of a fourth embodiment of the present invention
- DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiment 1 As shown in FIGS.
- a bioartificial blood vessel which is formed of a substrate 1 formed by epoxide cross-linking and de-antigen-treated animal blood vessels, and bonded to a base
- the surface layer 2 containing the anticoagulant component on the inner surface of the material 1 is composed.
- the substrate 1 is a straight tubular body, the anticoagulant component in the surface layer 2 is heparin; the surface layer 2 further contains 16 lysine (K16), glycine (G), arginine A polypeptide obtained by polycondensation of (R), aspartic acid (D), serine (S), proline (P), and cysteine (C).
- the preparation method of the biological artificial blood vessel is based on natural animal blood vessels, and includes the following steps:
- pretreatment using a broad-spectrum sterilizer such as chlorpheniramine, chlorhexidine, etc. for initial sterilization and trimming to remove excess tissue
- degreasing using organic solvents such as chloroform, ethyl acetate, absolute alcohol or Their blend extracts the fat in the substrate 1;
- An active reagent such as a small molecule organic acid anhydrides, acid chlorides, amides, and other monoepoxide blocking specific active groups of proteins in the substrate or -OH -NH 2 or -SH, and strong hydrogen bonds with reagents
- the hydrazine compound 3 ⁇ 41 replaces a special hydrogen bond in the helical chain of the substrate protein molecule;
- Anticoagulant modification The anticoagulant component is coupled to the inner surface of the substrate 1 using a coupling agent to form the surface layer 2.
- Embodiment 3 As shown in Fig. 4, the substrate 1 is a C-tubular body, and the immobilized protein molecule uses a diacyl diamine. Other technical features are the same as those in the embodiment 1, which will not be described herein.
- Embodiment 4 As shown in Fig. 5, the substrate 1 of the bioartificial blood vessel is a Y-shaped tubular body, and other technical features are the same as those in the embodiment 1, which will not be described herein.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Botany (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Materials Engineering (AREA)
- Hematology (AREA)
- Surgery (AREA)
- Urology & Nephrology (AREA)
- Zoology (AREA)
- Pulmonology (AREA)
- Gastroenterology & Hepatology (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2008523108A JP5009291B2 (ja) | 2005-07-29 | 2006-07-27 | 生物型人工血管及びその調製方法 |
AU2006274362A AU2006274362B2 (en) | 2005-07-29 | 2006-07-27 | Biological artificial blood vessel and preparation method thereof |
EP06761594.8A EP1911417B1 (en) | 2005-07-29 | 2006-07-27 | Biological artificial blood vessel and preparation method thereof |
CA002617139A CA2617139A1 (en) | 2005-07-29 | 2006-07-27 | Biological artificial blood vessel and preparation method thereof |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN200510036175.9 | 2005-07-29 | ||
CNA2005100361759A CN1903143A (zh) | 2005-07-29 | 2005-07-29 | 生物型人工血管及其制备方法 |
Publications (1)
Publication Number | Publication Date |
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WO2007012282A1 true WO2007012282A1 (fr) | 2007-02-01 |
Family
ID=37672607
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CN2006/001880 WO2007012282A1 (fr) | 2005-07-29 | 2006-07-27 | Vaisseau sanguin artificiel biologique et son procede de preparation |
Country Status (8)
Country | Link |
---|---|
US (1) | US8292799B2 (zh) |
EP (1) | EP1911417B1 (zh) |
JP (1) | JP5009291B2 (zh) |
CN (1) | CN1903143A (zh) |
AU (1) | AU2006274362B2 (zh) |
CA (1) | CA2617139A1 (zh) |
RU (1) | RU2385689C2 (zh) |
WO (1) | WO2007012282A1 (zh) |
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CN101884810B (zh) * | 2010-07-02 | 2012-12-12 | 西南大学 | 以鱼肠为原料制备小口径人工血管的方法 |
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FR2968564B1 (fr) * | 2010-12-13 | 2013-06-21 | Perouse Medical | Dispositif medical destine a entrer en contact avec un tissu d'un patient et procede de fabrication associe. |
JP2015507974A (ja) * | 2012-02-14 | 2015-03-16 | ネオグラフト・テクノロジーズ,インコーポレーテッド | 耐キンク性グラフト装置並びに関連するシステムおよび方法 |
CN102784015B (zh) * | 2012-08-30 | 2015-06-03 | 广州迈普再生医学科技有限公司 | 一种加载有三七药物的人工血管及其制备方法与应用 |
WO2014175301A1 (ja) * | 2013-04-26 | 2014-10-30 | 東レ株式会社 | 人工血管 |
US20150037436A1 (en) | 2013-07-30 | 2015-02-05 | Musculoskeletal Transplant Foundation | Acellular soft tissue-derived matrices and methods for preparing same |
AU2014370031A1 (en) * | 2013-12-27 | 2016-07-21 | Neograft Technologies, Inc. | Artificial graft devices and related systems and methods |
RU2563251C1 (ru) * | 2014-07-18 | 2015-09-20 | Федеральное государственное бюджетное учреждение науки Иркутский институт химии им. А.Е. Фаворского Сибирского отделения Российской академии наук | Способ получения пентаглицидилового эфира глюкозы и композиция на его основе для химической сшивки коллагенсодержащих эндопротезов биологического происхождения |
CN106572901B (zh) * | 2014-08-12 | 2018-12-04 | 东丽株式会社 | 人工血管 |
US10912864B2 (en) | 2015-07-24 | 2021-02-09 | Musculoskeletal Transplant Foundation | Acellular soft tissue-derived matrices and methods for preparing same |
US11052175B2 (en) | 2015-08-19 | 2021-07-06 | Musculoskeletal Transplant Foundation | Cartilage-derived implants and methods of making and using same |
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CN113274165B (zh) * | 2021-05-06 | 2022-04-15 | 东华大学 | 一体化成型微纳米纤维/水凝胶双网络型人工血管及制法 |
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- 2006-07-27 EP EP06761594.8A patent/EP1911417B1/en active Active
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Also Published As
Publication number | Publication date |
---|---|
US8292799B2 (en) | 2012-10-23 |
EP1911417A1 (en) | 2008-04-16 |
JP2009502269A (ja) | 2009-01-29 |
AU2006274362B2 (en) | 2012-06-14 |
JP5009291B2 (ja) | 2012-08-22 |
AU2006274362A1 (en) | 2007-02-01 |
US20070027529A1 (en) | 2007-02-01 |
EP1911417B1 (en) | 2013-04-24 |
CN1903143A (zh) | 2007-01-31 |
CA2617139A1 (en) | 2007-02-01 |
RU2385689C2 (ru) | 2010-04-10 |
RU2008107017A (ru) | 2009-09-10 |
EP1911417A4 (en) | 2008-10-15 |
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