CN1079912A - The fetal membrane pipe that is used for neural and blood vessel transplantation - Google Patents
The fetal membrane pipe that is used for neural and blood vessel transplantation Download PDFInfo
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- CN1079912A CN1079912A CN92114817A CN92114817A CN1079912A CN 1079912 A CN1079912 A CN 1079912A CN 92114817 A CN92114817 A CN 92114817A CN 92114817 A CN92114817 A CN 92114817A CN 1079912 A CN1079912 A CN 1079912A
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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
- A61L27/3604—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
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- 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
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- 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
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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
- A61L27/227—Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24
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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
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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
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/005—Ingredients of undetermined constitution or reaction products thereof
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/044—Collagen
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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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/043—Proteins; Polypeptides; Degradation products thereof
- A61L31/047—Other specific proteins or polypeptides not covered by A61L31/044 - A61L31/046
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00365—Proteins; Polypeptides; Degradation products thereof
-
- 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
- A61L2430/32—Materials or treatment for tissue regeneration for nerve reconstruction
Abstract
The invention discloses a kind of be used for neural and the cylinder of blood vessel transplantation, its manufacture method and application.The crosslinked I of disinfectant, II that the tube wall of this cylinder is obtained from Placenta Hominis by one deck at least and III class collagen or its constitute.This nerve graft can promote axonal regeneration.This nerve and blood vessel graft are non-immune, can be made into the pipe of all lengths and diameter, and are easy to handle, and in use keep closing or opening.
Description
The present invention relates to fetal membrane pipe neural and that blood vessel transplantation is used.
Fetal membrane, amniotic membrane and chorion are based on following reason as preferred material.Though the animal fetal membrane also can adopt, preferably use the human body fetal membrane.(1) as one aspect of the present invention, we have illustrated that by experiment human body amniotic membrane and chorion pipe have hypoimmunity on one's body rat, and this is when adopting some mark and elisa technique to measure various antigens (mainly being I, II and III class collagen, fibronectin and laminine) in the film and confirmed; (2) incalculability that obtains of Placenta Hominis limits, and cheap; Amniotic membrane and chorion are widely used in medical treatment and the surgery indication always over (3) 90 years; (4) they can be used in the neovascularity reconstruction; (5) they also can implanted subcutis in, in seven weeks, do not have acute rejection.Fetal membrane has complicated biochemical structure and uncommon physical property.Their available processing methods that describes below from physically be transformed into semihard, resilient, have the pipe of different length, diameter and thickness.Amniotic membrane and chorial biochemical component are mainly I, II and III class collagen, laminine, fibronectin and other glycoprotein.Have been found that laminine by with belong to receptor and integrate plain member's aixs cylinder glycoprotein reaction and can impel aixs cylinder to uphold.The immunocytochemical study that we carried out makes us can improve our amniotic membrane and chorion processing method, and laminine is kept the main component as the film pipe, this will narrate below.
Though preferably use human body amniotic membrane and chorion, another aspect of the present invention also comprises amniotic membrane and the chorion from other animal (for example cattle).
Think that clinically neural autotransplantation is the method that is used for re-constructing neural gaps.Neural autoplastic shortcoming shows in many aspects: promptly need to carry out additional surgical operation, may have numb or hypersensitive problem in the wound of donor, and be subjected to the restriction of transplant size through regular meeting.Though neural heteroplastic transplantation can overcome autoplastic many shortcomings, rejection is a subject matter, although can use immunoregulatory agent, has still limited its clinical practice.
Present problem and direction from now on aspect nerve research concentrate on the ideal nerve trachea of the clinical usefulness of development.Researcheres have adopted multiple different material, comprise silicone rubber, politef, poe, polyglactin(material that can absorb surgical sutures), a leather hose, intramuscular basal layer and blood vessel graft be as neurocele.Above-mentioned every kind of material all has shortcoming, and the ideal neural material that reproduces all can not be provided.Ideal nerve trachea, but should be obtain easily, inexpensive, easy manufacturing, have different size, non-immunogenic, porous, not easy to break biodeterioration, and have and can provide reproducing the biochemical component of aixs cylinder favorable environment.As described below, we have developed a kind of nerve trachea that adopts the human body amniotic membrane, and it has the numerous characteristics that ideal neurocele has.
Many researcheres collagen on probation recently is as neurocele.This collagen in substance must for foreign gene or the allosome reproduction, hinder neural immunoreation of reproducing thereby can produce.Immunoassay to amniotic membrane of the present invention, chorion neurocele demonstrates very little immunoreation, thereby has avoided hindering neural factor of reproducing.Although amniotic membrane, chorion pipe demonstrate biodeterioration and whole structural rearrangement, the while can be observed under ultramicroscope and is limited to the tube wall slight inflammatory cell infiltration of locality on every side, and it does not also have to produce the pathological changes that is similar to long-term nerve compression.And the latter is the subject matter that runs into when adopting the silicone rubber pipe to do neural reproducing.
Confirm that to adopting amniotic membrane, chorion pipe to make the neural function and the morphological analysis that are carried out of reproducing it is better than neural autotransplantation and silicone tubing.
In addition, when removing, need the blood vessel that blood vessel near end and body end far away are linked up when the generation thrombosis and with the blood vessel cut-out and with vessel segment.In by-pass operation, can avoid from lower limb, peeling off for this purpose vein; Equally, when patient does not have enough veins to substitute the tremulous pulse of the generation thrombosis that is removed and in the by-pass operation of carrying out subsequently, be like this yet.And, breakage of transplanted veins wall and obliteration thereof and to make donor place morbidity be subject matter, thus limited its application.The vein blood vessel that is used for blood vessel transplantation is generally taken from patient's lower limb or arm.Donor pathological changes and can not give the opening of material as the vein transplantation thing that coronary artery bypass and peripheral vessels insert bypass graft is well-known.Several blood vessel grafies have been tried out, the cattle vein transplantation thing, terylene repair implant, polytetrafluoroethylene and the umbilical artery graft that comprise preservation commonly used.The high incidence of thrombosis and the infection of graft also are problems.As ideal blood vessel graft, should be no thrombosis gene, tractable, have different-diameter and length, extending and resilient.
Amniotic membrane of the present invention, chorion collagen tube are non-immunogene, and are easy to make the pipe of all lengths and diameter.Amniotic membrane of the present invention and chorion pipe are very suitable for as nerve graft and are used for coronary artery bypass or the vascular bypass of vascular bypass operation.
The invention provides the blood vessel or the conduit that are used to transplant with in nerve and vascular space bridging.The physical property of membranaceous I, II and the III class collagen that obtains from the amniotic membrane of Placenta Hominis and chorion is through modification and make pipe, thereby can keep its opening and elasticity, so that blood flows through through its tube chamber, and its tube wall can tolerate internal pressure, wherein the tyre surface of film or shiny surface are inside, then can promote axon growth under the neural transplantation situation.
According to an aspect of the present invention, for this graft is provided, preferably obtain amniotic membrane and chorion in people's the Placenta Hominis from fresh human placenta, amniotic membrane and fine hair rete are separated and are separated from each other from Placenta Hominis, cell monolayer material in the topped basic unit on the tyre surface of film is removed, for example can be by being immersed in trypsin or the pepsin, amniotic membrane and chorion are washed in phosphate buffer or distilled water repeatedly to clean, reuse gamma ray or chemical cross-linking agent such as glutaraldehyde make amniotic membrane or chorion crosslinked, tissue is carried out disinfection, viral infection resisting is provided, strengthens its intensity and make this material be molded as catheter-like again from lamellar.Then amniotic membrane and the layering of fine hair diaphragm are twined, so that slick tyre surface is towards the inner surface of light tubulation.Twine length and diameter that the number of plies depends on pipe.With the pipe drying, put into bottle again, seal and tag, shine once more with further sterilization as the gamma ray of available 2,500,000 rads of needs, and make conduit collagen further crosslinked.If desired, for example fibrin is glued together for glue that can each layer usefulness is suitable, to avoid disengagement, especially for the bigger conduit of blood vessel transplantation.
Under-20 ℃, pipe or conduit are stored for future use subsequently.
For neural transplantation, use neural augmentor therein at implantation amniotic membrane and chorion Guan Shike, for example basal layer granule, fibronectin, collagen extract, neurolin or other auxin.
Therefore, the gillies' graft that the object of the present invention is to provide a kind of perineural near body that will cut off and body root far away to join or the nearly body and the body end far away of blood vessel joined, it can avoid the shortcoming in the above-mentioned prior art, and has above-mentioned advantage.
The graft that another object of the present invention provides a kind of perineural near body that will cut off and body root far away joins or the nearly body and the body end far away of blood vessel joined, it comprises the tube wall through disinfectant I, II and III class collagen layer formation that obtains from Placenta Hominis, Cytoplasm on this Placenta Hominis is removed basically, its tyre surface is inside, and its collagen is crosslinked by radiation or chemical method; This cylinder has the abundant number of plies to keep its patent or opening; The length of cylinder is greater than the distance between nearly body and body root far away or end, its diameter equal at least to link to each other with body root far away or end diameter of tissue.
Another object of the present invention provides a kind of like this graft, and amniotic membrane wherein and/or chorial each layer are bonded to together, opens to prevent each pull-up.
Another object of the present invention provides a kind of like this cylindrical shape graft, and its tube wall can make interstitial fluid flow through wherein, think that graft provides early nutrition, and under the situation of neural transplantation, the growth that can be Schwann cell provides nutrition.
Another object of the present invention provides a kind of cylindrical shape graft, and it is used for the neural drug research that reproduces in neurological field as the study model of material inclusion body.
Another object of the present invention provides a kind of nerve graft, and it comprises amniotic membrane and/or the chorion pipe that contains the relative growth element.
Another object of the present invention provides a kind of nerve graft, and it comprises contains particulate amniotic membrane of basal layer and/or chorion pipe.
Another object of the present invention provides a kind of like this nerve graft, and it can be made into length, does not twist together, and can keep its shape, and its passage can keep patent and opening.
Other purpose of the present invention as can be seen, characteristic and advantage from this description.
Introduce most preferred embodiment of the present invention below.
A. amniotic membrane obtains and prepares
This obtains amniotic membrane from fresh Placenta Hominis on the one hand according to the present invention.Placenta Hominis is from the childbirth in the hospital, and takes in 24 hours minute puerperiums.Can only use process acquired immune deficiency syndrome (AIDS) and hepatitis virus to detect and do not belong to the Placenta Hominis of mother's output of abusing high-risk crowds such as intravenous injection (IV) medicine.Should be careful, avoid skin and blood and tissue to contact, with the degree that minimizes of the pollution with these material work area.
Available finger is peeled off rete layer from Placenta Hominis.From the amniotic membrane that is obtained, choose the maximum uniform membrane film of thickness.The most handy phosphate buffered solution or distilled water thoroughly clean the diaphragm of selecting, to remove blood stains and fragment.Further flushing is extremely pure white and translucent with diaphragm again.
Can remove the cell monolayer on the basal layer on its tyre surface in the trypsin by this film is immersed in.At room temperature this film was immersed in distilled water and tryptic 1: 1 solution two hours.Used trypsin is preferably taken from procine pancreas, and concentration is 25%, does not have calcium and magnesium.After trypsin treatment, the most handy phosphate buffered solution or distilled water wash repeatedly to amniotic membrane, up to the pure white film that obtains not have pink colour trypsin vestige.
The membrane film that has washed places distilled water bottle, and with the gamma-ray irradiation of 500,000 rads.The irradiation amniotic membrane can make collagen cross-linking, and tissue is carried out disinfection, and the animal protection that provides antiviral to propagate is molded as conduit or tubulose with this material by lamellar subsequently again.Then bottle is stored in-80 ℃ the refrigerator-freezer.If desired, for example available glutaraldehyde makes amniotic membrane carry out chemical crosslinking.
The making of B conduit
Amniotic membrane is taken out from refrigerator-freezer, at room temperature thawed three to four hours.Under operating microscope, membrane film is checked, to check the tyre surface or the shiny surface of its defective and definite film.By using chaser, the membrane film of carefully width enough being made required catheter length and diameter collects.The orientation of membrane film should make the inner surface of its slick tyre surface towards the pipe that obtains at last.
Though available any suitable mode is twined membrane film, preferably use to have the press polished rustless steel stent of suitable diameter with membrane film coiled layer.
For keeping the amniotic membrane barrel shape, avoid twisting together and keeping patent or open required membrane film to twine the number of plies, depend on the length and the diameter of pipe or cylinder.For example the conduit of 1.6～1.8 inch diameters needs 10 layers of membrane film approximately, and diameter is 2.5 inches 15 layers of Guan Yuexu.This conduit can have any length.Be entangled in the pipe on the stent, and then in 40～60 ℃ baking oven dry about 30 minutes.Drying can make pipe be easy to take off from stent.If desired, for preventing to throw off, can use suitable adhesive or glue (for example Fibrin Glue) that the amniotic membrane lamella is sticked together.Then pipe is placed in the bottle, sealing tags, with the gamma-ray irradiation of 2,000,000 rads with further sterilization and make collagen cross-linking.Subsequently, conduit stores for future use under-20 ℃.
Example 1
In this example, the basement membrane globality of human body amniotic membrane and thin layer composition are all measured by immunocytochemistry after reaching before it makes conduit.Human body amniotic membrane conduit of the present invention has hypoimmunity, and it is when the various antigens of measuring with some mark or ELISA method in the amniotic membrane (mainly being I class collagen, fibronectin and laminine) and confirmed.Amniotic membrane is widely used in various medical treatment and surgery indication over nearly 90 years, and shows and can be used for the neovascularity reconstruction.It also can implanted subcutis in, in reaching 7 time-of-weeks, do not have acute renal allograft rejection disease.
Fetal membrane has complicated biochemical structure and uncommon physical property.They are transformed into semihard, resilient, as to have different length, diameter and thickness conduit with above-mentioned processing method from physical angle among the present invention.The biochemical component of amniotic membrane is mainly I, III class collagen, laminine, fibronectin (fibronectin) and other glycogen protein matter.Have been found that laminine by integrating the plain member's of family aixs cylinder glycogen protein qualitative response, can impel aixs cylinder to uphold with belonging to receptor.The present invention is the main component that laminine is left these components to the processing method of amniotic membrane.Use gamma ray that several benefits is arranged among the present invention.Under the radiation of 200,000 rad doses, all antibacterials, fungus and virus (comprising HIV (human immunodeficiency virus) (Human Immunodeficiency Virus)) all can be destroyed.Preferably adopt the dosage of 2,500,000 rads, to guarantee the thorough disinfection of finished-product material.This dosage can also strengthen the crosslinked of collagen membrane, thereby its intensity is increased, to guarantee that this amniotic membrane conduit is made the semihard shape keeps elasticity simultaneously, so that keep patent after implantation.But it also is desirable as previously mentioned, adopting known method (for example being immersed in the glutaraldehyde) to carry out chemical crosslinking.
Confirm that by immunity test the amniotic membrane nerve trachea has very little inapparent immunoreation.So just avoided some influences to reproduce neural unfavorable factor.Although amniotic membrane has shown the sign and the whole structural rearrangement of biodeterioration, and observes the local inflammation cellular infiltration that is limited to the catheter wall peripheral region under ultramicroscope, it does not produce the pathological changes of long-term nerve compression.And the subject matter that the latter runs into when to be the silicone rubber pipe of recent clinical use do neural reproducing.
To the long-term observation of amniotic membrane conduit, can see with Schwann cell changing that show biodeterioration and reorganization phenomenon, this is a characteristic of amniotic membrane conduit through the infiltration of vessel layers and the primary structure that collagen is reassembled as feature.
As previously mentioned, amniotic duct of the present invention can be used as the carrier of the material [as basal layer, fibronectin (fibronectin), collagen extract, neurolin and other auxin] of many promotion nerve growths.As United States Patent (USP) 5,002,071 is described, and collagen extract can be the collagen that extracts from the human body fetal membrane.For example when implanting, basal layer can be applied in the amniotic duct with lyophilizing precipitate, form polarized or that be stored in any preservation liquid.
Example 2
In this example, the nerve that carries out with conduit of the present invention on experimental animals reproduces, and will be on morphology aspect and the function compares with the neurocele of autotransplantation and other type.
11 cats are divided into five groups of tibial nerve to 4 centimetres of gaps reproduces and estimates.
First group (3 animals): amniotic duct;
Second group (3 animals): amniotic duct, with the basal layer that extracts in the muscle as neurolin;
The 3rd group (3 animals): neural autotransplantation;
The 4th group (1 animal): control with sham-operation;
The 5th group (1 animal): do not repair.
These animal survivals were killed after six months, then nerve segment were carried out morphology and Histological research.
Adopt Demerol and phenobarbital intramuscular injection and halogenation ethane and NO
2Mixture sucks and cat is anaesthetized.Expose tibial nerve, the nerve segment reparation situation of 4 centimeter length is as follows:
At first group (amniotic membrane), amniotic duct is sewn on the nearly body and body root far away in 4 centimetres in gap.Two sutures are positioned at 180 ° both sides, and pass the whole thickness of the epineurial pipe that only comprises nerve root.
At second group (amniotic membrane-basal layer), with last identical, 4 centimetres nerve segments are cut, by the amniotic duct of filling basal layer this gap is put up a bridge.
The 3rd group (neural moving from body grown), 4 centimetres nerve segment is cut open, and reuse epineurium technology is adhered to again.
The 4th group (sham-operation), tibial nerve is cut open but not change.
The 5th group (repair), 4 centimetres tibial nerve is cut open, and does not see to repair and the nerve broken end is sewn on the lower muscle.
Animals survived six months is not all observed function at each experimental group and is improved except that one group of sham-operation.
After six months cat is killed, and carry out morphology and Histological research.The result shows that the amniotic membrane basal layer is extremely favourable material to neuranagenesis, and adds the basal layer of muscle in the collagen membrane pipe, can promote neuranagenesis.
In the histogram of axon diameter, amniotic membrane basal layer group has shown the distribution similar to sham operated rats, even bigger aixs cylinder, and (9%) aixs cylinder of significant proportion is in 1.5～2.25 microns scope.From the body value of moving, its histogram can be compared with sham operated rats for nerve, but a large amount of (37%) aixs cylinders is between 0.5～0.75 micron.In the amniotic duct group, axon diameter is between 0.1～1 micron, and most (58%) aixs cylinder is in 0.25～0.5 micrometer range.The histogram of axon diameter shows that basal layer helps to obtain bigger aixs cylinder, and the most approaching with normal condition.
The conclusion of this example is: human body amniotic membrane conduit is the good substitute that is used for neural transplantation, and the basal layer of muscle is good neurotrophy material in being added to the collagen membrane pipe time; The amniotic membrane conduit that is filled with basal layer is better than neural moving from body and grows; Human body collagen membrane pipe is good conduit for neuranagenesis, and can hold any neurotrophy material.
Example 3
In this example, replace the human body amniotic membrane with the human body chorion.Chorion and amniotic membrane are separated, handle by same method in the above-mentioned A section again,, have and example 1 and 2 similar character, and be applicable to nerve growth and as blood vessel by the conduit that the same quadrat method of narrating in the B section is made.As chorion and amniotic membrane are separated, then can save above-mentioned employing trypsin or pepsic step.
Example 4
In this example, use I, II and the III class collagen and the combination thereof that from the amniotic membrane of cattle and chorion, obtain to replace the human body film, and as above-mentioned conduit or the pipe made, it can obtain identical with the human body film to be used for nerve growth and as the satisfactory result of blood vessel.
Method of the present invention comprises that the nearly body of the nerve that will cut off with pipe and the nearly body and the body end far away of body root far away or blood vessel couple together, this pipe comprise one deck at least do not contain cell or go up leather material, by the disinfectant cross linking membrane that I, II and III class collagen or its mixture, laminine, fibronectin and other glycogen protein are formed, its tyre surface is inwardly.This film carries out disinfection with irradiation or chemical method and is crosslinked, and has enough numbers of plies to keep its patent.This length of tube equals the distance between nearly body and body root far away or nearly body and body end far away at least, and its diameter equals, preferably is a bit larger tham the conjunctive tissue of nearly body and body root far away or nearly body and body end far away at least.For neural transplantation, Guan Zhongke contains neurolin, for example basal layer, fibronectin or collagen extract or its combination, as mentioned above.This pipe is sewn or is fixed on the conjunctive tissue adjacent with nerve root or blood vessel end with other method.
But this graft long term storage is to provide stand-by at any time graft materials source.This graft can be made into random length and diameter, and each layer of graft can be sticked together, and each pull-up is opened when preventing to use.
Therefore, with the nerve that cuts off or the nearly body of blood vessel and the graft that the gap between body end far away couples together is cylindrical shape, its tube wall comprises the disinfectant cross linking membrane that extracts in I, II and the III class collagen and the compositions thereof of one deck from Placenta Hominis at least, and this graft is very satisfactory.
Therefore, the present invention has realized goal of the invention well, and has advantage and performance and the further feature of pointing out above.
Though provided most preferred embodiment of the present invention for the purpose of introducing, in the scope of the invention defined by the claims, can make some changes and improvements.
Claims (10)
1, a kind of at the nerve that cuts off nearly body and body root far away between and the graft of gap bridging usefulness between the nearly body of blood vessel and the body end far away, comprising:
A cylinder, its length equal to cut off the nearly body of nerve or blood vessel and the distance between body end far away at least, and its diameter equals to cut off the nearly body of nerve or blood vessel and the diameter of body end far away at least;
The tube wall of this cylinder is made of one deck disinfectant cross linking membrane at least, and this film comprises and is selected from the one group of collagen that is made of I class, II class, III class and composition thereof;
Above-mentioned collagen obtains from amniotic membrane, chorion or its compositions group of Placenta Hominis.
2, graft as claimed in claim 1 is characterized in that: described tube wall comprises coherent two-layer laminar film at least, and each pull-up is opened when preventing to use.
3, graft as claimed in claim 1 is characterized in that, this graft can make interstitial fluid flow through the tube wall of its cylinder.
4, as claim 1,2 or 3 graft, it is characterized in that: this graft is a nerve graft, and comprises a kind of neurolin at least.
5, as claim 1,2 or 3 graft, it is characterized in that: this graft is a nerve graft, and comprises basal layer, fibronectin, collagen membrane extract or its combination.
6, a kind of recovery is cut off the method for function of nervous system, comprises with claim 1,2 or 3 described grafts will cutting off neural nearly body and body end far away couples together.
7, a kind of recovery is cut off the method for function of nervous system, comprising: the nearly body and the body end far away that will cut off nerve with claim 1,2 or 3 described grafts couple together; This nerve graft comprises a kind of neurolin at least.
8, a kind of recovery is cut off the method for function of nervous system, comprises with claim 1,2 or 3 grafts described and that comprise basal layer will cut off neural nearly body and body end far away couples together.
9, a kind of method of replacing blood vessel comprises with claim 1,2 or 3 described grafts the nearly body and the body end far away of blood vessel are coupled together.
10, as claim 1,2,3,4 or 5 graft, wherein amniotic membrane or chorion are taken from Placenta Hominis.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US79951791A | 1991-11-26 | 1991-11-26 | |
| US07/799,517 | 1991-11-26 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1079912A true CN1079912A (en) | 1993-12-29 |
Family
ID=25176121
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN92114817A Pending CN1079912A (en) | 1991-11-26 | 1992-11-26 | The fetal membrane pipe that is used for neural and blood vessel transplantation |
Country Status (13)
| Country | Link |
|---|---|
| EP (1) | EP0614345A4 (en) |
| JP (1) | JPH07501465A (en) |
| CN (1) | CN1079912A (en) |
| AU (1) | AU663150B2 (en) |
| CA (1) | CA2124190A1 (en) |
| FI (1) | FI942425A (en) |
| IL (1) | IL103893A (en) |
| NO (1) | NO941917D0 (en) |
| NZ (1) | NZ245286A (en) |
| RU (1) | RU94028108A (en) |
| TW (1) | TW310273B (en) |
| WO (1) | WO1993010722A2 (en) |
| ZA (1) | ZA929119B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1101704C (en) * | 1998-05-28 | 2003-02-19 | 南京市鼓楼医院 | Blood vessel graft preparing technology using human umbilical artery |
| CN100368534C (en) * | 2003-05-01 | 2008-02-13 | 四川大学华西医院 | Bioderived amnion, composite bioderived amnion and its preparation method |
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| GB9400163D0 (en) * | 1994-01-06 | 1994-03-02 | Geistlich Soehne Ag | Membrane |
| US5834029A (en) * | 1994-07-20 | 1998-11-10 | Cytotherapeutics, Inc. | Nerve guidance channel containing bioartificial three-dimensional hydrogel extracellular matrix derivatized with cell adhesive peptide fragment |
| GB9503492D0 (en) | 1995-02-22 | 1995-04-12 | Ed Geistlich S Hne A G F R Che | Chemical product |
| CA2173508A1 (en) * | 1995-03-31 | 1996-10-01 | Tooru Yui | Medical device and method for producing the same |
| US5733337A (en) * | 1995-04-07 | 1998-03-31 | Organogenesis, Inc. | Tissue repair fabric |
| JPH09122227A (en) * | 1995-10-31 | 1997-05-13 | Bio Eng Lab:Kk | Medical material and manufacture thereof |
| JPH09122225A (en) * | 1995-10-31 | 1997-05-13 | Bio Eng Lab:Kk | Raw membrane material for medical material and manufacture thereof |
| JP3476631B2 (en) * | 1995-12-21 | 2003-12-10 | 株式会社アムニオテック | Medical material composed of human-derived natural collagen membrane |
| TW528600B (en) * | 1996-11-20 | 2003-04-21 | Yasuhiko Shimizu | Artificial neural canal |
| US8858981B2 (en) | 1997-10-10 | 2014-10-14 | Ed. Geistlich Soehne Fuer Chemistrie Industrie | Bone healing material comprising matrix carrying bone-forming cells |
| US9034315B2 (en) | 1997-10-10 | 2015-05-19 | Ed. Geistlich Soehne Ag Fuer Chemische Industrie | Cell-charged multi-layer collagen membrane |
| US20050186283A1 (en) | 1997-10-10 | 2005-08-25 | Ed. Geistlich Soehne Ag Fuer Chemistrie Industrie | Collagen carrier of therapeutic genetic material, and method |
| WO1999063908A1 (en) * | 1998-06-10 | 1999-12-16 | Tapic International Co., Ltd. | Artificial neural tube |
| US6773723B1 (en) * | 2000-08-30 | 2004-08-10 | Depuy Acromed, Inc. | Collagen/polysaccharide bilayer matrix |
| US6713085B2 (en) | 2001-04-27 | 2004-03-30 | Ed. Geistlich Soehne Ag Fuer Chemische Industrie | Method and membrane for mucosa regeneration |
| DE10141652B4 (en) * | 2001-08-24 | 2011-04-07 | Lts Lohmann Therapie-Systeme Ag | Transdermal therapeutic system based on polyacrylate pressure-sensitive adhesives without functional groups and its use |
| WO2003020327A2 (en) * | 2001-09-06 | 2003-03-13 | Bone Sa | A cross-linked collagenous biomaterial |
| CA2412012C (en) | 2001-11-20 | 2011-08-02 | Ed. Geistlich Soehne Ag Fuer Chemische Industrie | Resorbable extracellular matrix containing collagen i and collagen ii for reconstruction of cartilage |
| CN1986001B (en) * | 2005-12-20 | 2011-09-14 | 广东冠昊生物科技股份有限公司 | Biological wound-protecting film |
| US8372437B2 (en) | 2006-08-17 | 2013-02-12 | Mimedx Group, Inc. | Placental tissue grafts |
| CA2736663C (en) | 2007-09-07 | 2018-01-02 | Surgical Biologics, Llc. | Placental tissue grafts and improved methods of preparing and using the same |
| CA2723801A1 (en) * | 2008-05-09 | 2009-11-12 | The General Hospital Corporation | Tissue engineered constructs |
| KR20140114277A (en) | 2011-02-14 | 2014-09-26 | 미메딕스 그룹 인크. | Laminated tissue grafts composed of wharton's jelly and methods of making and using the same |
| WO2012112417A2 (en) | 2011-02-14 | 2012-08-23 | Mimedx Group Inc. | Tissue grafts modified with a cross-linking agent and method of making and using the same |
| US9585983B1 (en) | 2011-10-12 | 2017-03-07 | BioDlogics, LLC | Wound covering and method of preparation |
| WO2013095830A1 (en) | 2011-12-22 | 2013-06-27 | Mimedx Group Inc. | Cross-linked dehydrated placental tissue grafts and methods for making and using the same |
| US11338063B2 (en) * | 2012-08-15 | 2022-05-24 | Mimedx Group, Inc. | Placental tissue grafts modified with a cross-linking agent and methods of making and using the same |
| US9789138B1 (en) | 2013-03-06 | 2017-10-17 | BioDlogics, LLC | Neural repair construct and method of use |
| US11116871B2 (en) | 2015-09-17 | 2021-09-14 | Stimlabs Llc | Compositions derived from placenta and methods of producing the same |
| US11154641B2 (en) | 2017-12-22 | 2021-10-26 | Stimlabs Llc | Translucent, dehydrated placental tissue and methods of producing and using the same |
| CN113304321B (en) * | 2021-06-01 | 2022-08-26 | 山东隽秀生物科技股份有限公司 | Biological membrane material, preparation method thereof and application thereof in nerve repair |
| US11925532B2 (en) | 2021-12-10 | 2024-03-12 | Vivex Biologics Group, Inc. | Vented wound dressing barrier |
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| IL47062A (en) * | 1975-04-10 | 1979-07-25 | Yeda Res & Dev | Process for diminishing antigenicity of tissues to be usedas transplants by treatment with glutaraldehyde |
| US4894063A (en) * | 1983-05-24 | 1990-01-16 | Baxter International Inc. | Barrier layer for implantable tendons and ligaments |
| US5019087A (en) * | 1986-10-06 | 1991-05-28 | American Biomaterials Corporation | Nerve regeneration conduit |
| GB8803697D0 (en) * | 1988-02-17 | 1988-03-16 | Deltanine Research Ltd | Clinical developments using amniotic membrane cells |
| US5026381A (en) * | 1989-04-20 | 1991-06-25 | Colla-Tec, Incorporated | Multi-layered, semi-permeable conduit for nerve regeneration comprised of type 1 collagen, its method of manufacture and a method of nerve regeneration using said conduit |
-
1992
- 1992-11-25 AU AU32245/93A patent/AU663150B2/en not_active Ceased
- 1992-11-25 CA CA002124190A patent/CA2124190A1/en not_active Abandoned
- 1992-11-25 EP EP19930900646 patent/EP0614345A4/en not_active Ceased
- 1992-11-25 RU RU94028108/14A patent/RU94028108A/en unknown
- 1992-11-25 WO PCT/US1992/010165 patent/WO1993010722A2/en not_active Application Discontinuation
- 1992-11-25 JP JP5510233A patent/JPH07501465A/en active Pending
- 1992-11-25 ZA ZA929119A patent/ZA929119B/en unknown
- 1992-11-26 IL IL10389392A patent/IL103893A/en not_active IP Right Cessation
- 1992-11-26 NZ NZ245286A patent/NZ245286A/en unknown
- 1992-11-26 CN CN92114817A patent/CN1079912A/en active Pending
- 1992-12-15 TW TW081110056A patent/TW310273B/zh active
-
1994
- 1994-05-24 NO NO941917A patent/NO941917D0/en unknown
- 1994-05-25 FI FI942425A patent/FI942425A/en not_active Application Discontinuation
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1101704C (en) * | 1998-05-28 | 2003-02-19 | 南京市鼓楼医院 | Blood vessel graft preparing technology using human umbilical artery |
| CN100368534C (en) * | 2003-05-01 | 2008-02-13 | 四川大学华西医院 | Bioderived amnion, composite bioderived amnion and its preparation method |
Also Published As
| Publication number | Publication date |
|---|---|
| RU94028108A (en) | 1996-06-20 |
| EP0614345A4 (en) | 1994-12-07 |
| TW310273B (en) | 1997-07-11 |
| WO1993010722A3 (en) | 1993-06-24 |
| FI942425A0 (en) | 1994-05-25 |
| AU663150B2 (en) | 1995-09-28 |
| AU3224593A (en) | 1993-06-28 |
| NZ245286A (en) | 1995-06-27 |
| FI942425A (en) | 1994-05-25 |
| EP0614345A1 (en) | 1994-09-14 |
| CA2124190A1 (en) | 1993-06-10 |
| NO941917L (en) | 1994-05-24 |
| WO1993010722A2 (en) | 1993-06-10 |
| JPH07501465A (en) | 1995-02-16 |
| IL103893A (en) | 1997-02-18 |
| NO941917D0 (en) | 1994-05-24 |
| IL103893A0 (en) | 1993-04-04 |
| ZA929119B (en) | 1994-09-21 |
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