CN103357068A - Novel biological endocranium patch - Google Patents
Novel biological endocranium patch Download PDFInfo
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- CN103357068A CN103357068A CN 201210102907 CN201210102907A CN103357068A CN 103357068 A CN103357068 A CN 103357068A CN 201210102907 CN201210102907 CN 201210102907 CN 201210102907 A CN201210102907 A CN 201210102907A CN 103357068 A CN103357068 A CN 103357068A
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- collagen
- dura mater
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- cerebral dura
- endocranium
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- 102000012422 Collagen Type I Human genes 0.000 claims abstract description 14
- 108010022452 Collagen Type I Proteins 0.000 claims abstract description 14
- 238000000034 method Methods 0.000 claims abstract description 14
- 230000002490 cerebral effect Effects 0.000 claims description 24
- 210000001951 dura mater Anatomy 0.000 claims description 24
- 230000001954 sterilising effect Effects 0.000 claims description 12
- 238000004659 sterilization and disinfection Methods 0.000 claims description 10
- 238000004108 freeze drying Methods 0.000 claims description 6
- 241000283690 Bos taurus Species 0.000 claims description 4
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- 230000008569 process Effects 0.000 claims description 4
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- 210000001519 tissue Anatomy 0.000 abstract description 15
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- 102000008186 Collagen Human genes 0.000 description 11
- 108010035532 Collagen Proteins 0.000 description 11
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 10
- 229920001436 collagen Polymers 0.000 description 7
- 238000002360 preparation method Methods 0.000 description 6
- 229960000583 acetic acid Drugs 0.000 description 5
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Landscapes
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a novel biological endocranium patch, which is prepared from type I collagen, has a unique fiber structure, can absorb cerebrospinal fluid without increasing the volume, has a nutrition protection effect on nervous tissues, has good biocompatibility, induces the growth of fibroblasts, has the effect of guiding tissue regeneration, is simple and feasible in endocranium repairing method, has a satisfactory effect, does not increase the infection rate after operation, and is an effective endocranium repairing material.
Description
Technical field
The present invention relates to a kind of new bio cerebral dura mater sticking patch, particularly lyophilized collagen cerebral dura mater sticking patch and application thereof.
Background technology
Cerebral dura mater is the together important barrier of protection cerebral tissue, for safeguarding that neural structure and functional activity are significant.Wound or craniocerebral operations can cause dura defect, as not repairing, easily cause non-healing wounds, and the complication such as hypohydrops, cerebrospinal leak, intracranial infection occur; The oozing of blood of scalp or flesh layer can permeate into subarachnoid space Stimulation of The Brain tissue, causes heating, headache, aseptic inflammation or meningeal irritation sign; The direct adhesion healing of cerebral tissue and scalp has increased the epilepsy chance of occurrence.The operative repair cerebral dura mater, sealing cerebral dura mater cavity of resorption can obviously reduce or prevents the complication such as cerebrospinal leak, intracranial infection, epilepsy, and this has reached common understanding in neurosurgery circle, but the cerebral dura mater repair materials is a lot of, and curative effect differs.Along with medical science and tissue engineering technique development, various biomaterials, synthetic material occur in succession.
The material of desirable duramater reparation should possess following condition: 1. have stable any biological inert, do not cause the active chronic inflammation reaction.2. have safety, avirulence without carcinogenic, teratogenesis, can not be propagated potential known or unknown infection to the artificial meninges requirement of biological film type.3. histocompatibility is good, without rejection.4. compactness is good, without permeability, prevents cerebrospinal leak, the protection cerebral tissue.5. have toughness, can bear stitching.6. can impel meninges regeneration, the adhesion of meninges brain does not occur.7. easy to use, operation is simple, easily gives sterilization.8. draw materials extensively, cheap.
The dura defect repair materials is according to source and performance, and the dural repairment material that at present research is used has 4 classes: autologous tissue's patching material, allogeneic material, heterogeneity biological material and synthetic material.Yet synthetic material can cause serious rejection, and because the reaction of local organization, can cause the stimulation to cerebral tissue, form cicatrix or encapsulation reaction, meningitis symptom or the severe complication such as hemorrhage, and present Chinese synthetic cerebral dura mater repair materials dependence on import mostly, expensive causing is difficult in clinical middle popularization; Although autologous tissue's patching material good biocompatibility, immunoreation is low, easily increases the time of operation and treatment, is now replaced by foreign material gradually; The heterogeneity biological material has good biocompatibility, domestic bovine pericardium, Cor Caprae seu ovis bag, cattle peritoneum, pig peritoneum, the mesentery etc. of often using clinically, but because it adopts the modes such as glutaraldehyde or epoxide crosslinked usually, easy trigger cell toxicity, its safety issue is still a problem.The present invention overcomes the defective of above-mentioned material, and the employing type i collagen is raw material, by the irradiation technique sterilization, makes it not only have advantages of the heterogeneity biological material, and has improved greatly the safety of its clinical use.
Summary of the invention
The object of the present invention is to provide a kind of new bio cerebral dura mater sticking patch, the hard brain sticking patch of this biology refers to type i collagen azelon cerebral dura mater.
A further object of the invention provide a kind of novel be biological cerebral dura mater sticking patch, this collagen fabric is a kind of cancellated monofilm, this film helps fibroblastic growth, has guaranteed that simultaneously the speed of its fibroblastic growth is consistent with the speed of degraded in the film body.
The present invention also provide a kind of novel be the preparation method of biological cerebral dura mater sticking patch, this film is to have a cancellated film by what freeze drying process formed.
The present invention also provides a kind of new bio cerebral dura mater sticking patch sterilizing methods.
Wherein, described type i collagen azelon derives from the mammal heel string.
Further, derive from the mammal heel strings such as pig, cattle, horse one or more.
Wherein, described preparation method is with in type i collagen fibrolysis and the glacial acetic acid, adopts the freeze drying process molding.
Be specially:
1) type i collagen albumen is dissolved in the glacial acetic acid aqueous solution that PH is 2.5-5.0 by the consumption that the 600ml glacial acetic acid aqueous solution contains dried collagen protein 3-5g.
2) with described step 1) preparation solution stirring 1-2 hour, obtain serosity;
3) will carry out lyophilization behind the serosity evacuation that stir.
Wherein, described new bio cerebral dura mater sticking patch sterilizing methods is to realize by the irradiation sterilization mode.
Further, the dosage of its irradiation sterilization is 25～50kGy for the irradiation dose of fully sterilization, preferred 30-40kGy.
Collagen sponge of the present invention can absorb the cerebrospinal fluid volume and not increase because its distinctive mesh sponge shape structure has it; to the nutritious protective effect of nervous tissue; mesh sponge shape structure does not produce mechanical injuries to nervous tissue; collagen sponge separates nervous tissue with surrounding tissue; epidural scarring tissue and neural adhesion have been reduced; it is movable that its collagen characteristic also has the fibroblast of promotion, accelerates the function of dura mater regeneration.Collagen sponge surface coated biological fibrin glue, form one deck bioprotein film, form complex with collagen sponge, in hemostasis, make the isolation of nervous tissue and extraneous complete closed, prevent that cerebrospinal fluid from leaking outside, and stop oozing of blood to enter the dura mater chamber, reduce intradural hematoma formation and machine formation cicatrix, and alleviate the adhesion between nervous tissue.Collagen sponge and biological fibrin glue all have good biocompatibility and degradable, do not cause that the host rejects and inflammatory reaction, and after new dura mater formed, composite can be absorbed gradually, bring harmful effect in case long-term complete interior foreign body retains to body and mind.This kind dura mater method for repairing and mending is simple, and good results does not increase infection rate after abortion operation, a kind of effective cerebral dura mater sticking patch of can yet be regarded as.
The specific embodiment
Embodiment 1
1.I the dural preparation of collagen type fiber
1.1 raw material thaws:
Collagen protein takes out from refrigerating chamber, calculates when batch use amount according to water content meter, places the sterilization plate, the room temperature rear use of thawing.
1.2 preparation computational methods:
0.05M the 600ml glacial acetic acid solution contains dried collagen protein 3-5g
1.3I the preparation of collagen type solution, the collagen protein after will thawing takes by weighing 9.1-15.2g collagen according to water content and puts into agitator tank, adds the 0.05M glacial acetic acid of 600-800ml, stirs 1-2 hour.
1.4 lyophilization: with the solution sabot under in 1.3, pour the type i collagen protein solution of different-thickness into according to clinical needs, carry out lyophilization according to following program:
| Step number | Control procedure | Flaggy control temperature | The control vacuum | Process time min |
| 1 | Pre-freeze | 3 | - | 5 |
| 2 | Freezing | -20 | - | 60 |
| 3 | Freezing | -40 | - | 160 |
| 4 | Find time | - | 0.2 | - |
| 5 | Dry | -20 | 0.2 | 20 |
| 6 | Dry | -20 | 0.2 | 300 |
| 7 | Dry | -15 | 0.2 | 10 |
| 8 | Dry | -15 | 0.2 | 360 |
| 9 | Dry | -10 | 0.2 | 300 |
| 10 | Dry | 0 | 0.2 | 20 |
| 11 | Dry | 0 | 0.2 | 30 |
| 12 | Dry | 20 | 0.2 | 60 |
| 13 | Dry | 20 | 0.2 | 60 |
| 14 | Dry | 20 | 0.2 | 30 |
1.5 irradiation sterilization:: it is 25kGy that lyophilizing type i collagen azelon membrane material is put into respectively dosage, 30kGy; 40kGy; In the 50kGy irradiation devices, take out room temperature preservation, for subsequent use behind the dynamic radioaction 72h.
Embodiment 2 void determinations
The method of employing embodiment 1 prepares the product of 4 kinds of different irradiation intensities, adopts Electronic Speculum to survey its structure mesopore size and is respectively 345um, 220um; 227um, 183um, wherein irradiation dose is that 30-40kGy group type i collagen azelon membrane aperture adapts to fibroblastic growth most.
The mensuration of embodiment 3 collagenase enzymolysis times
With the self-made punching device with the dural substitutes of 4 kinds of different exposure times make diameter 5mm disk each 10, be that 357U/mL collagenase liquid adds in the small test tube with sequin and enzymolysis buffer and enzyme activity unit again, 37 ℃ of constant temperature enzymolysis to sequins decompose the required time, are enzymolysis time (min).Recording its enzymolysis time is respectively: 25.3min, and 23.6min, 27.6min, 51.1min. is little in the enzymolysis time diversity of its type i collagen azelon film of 25-40KGy when irradiation dose, proves that its degree of cross linking impact on collagen is little.
Claims (7)
1. a new bio cerebral dura mater sticking patch it is characterized in that type i collagen azelon cerebral dura mater.
2. type i collagen azelon according to claim 1 is characterized in that deriving from the mammal heel string.
3. mammal heel string according to claim 2 it is characterized in that one or more in pig, cattle, the horse heel string.
4. type i collagen azelon cerebral dura mater according to claim 1 it is characterized in that a kind of film of fibrous reticular structure.
5. according to claim 1,4 described type i collagen azelon cerebral dura mateies it is characterized in that obtaining by freeze drying process.
6. a new bio cerebral dura mater sticking patch it is characterized in that obtaining sterile product by the irradiation technique sterilization.
7. irradiation sterilization technique according to claim 6, the dosage that it is characterized in that irradiation sterilization is 25～50kGy, preferred 30-40kGy.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210102907 CN103357068A (en) | 2012-04-10 | 2012-04-10 | Novel biological endocranium patch |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210102907 CN103357068A (en) | 2012-04-10 | 2012-04-10 | Novel biological endocranium patch |
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| Publication Number | Publication Date |
|---|---|
| CN103357068A true CN103357068A (en) | 2013-10-23 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201210102907 Pending CN103357068A (en) | 2012-04-10 | 2012-04-10 | Novel biological endocranium patch |
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| CN (1) | CN103357068A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104189955A (en) * | 2014-08-08 | 2014-12-10 | 苗九昌 | Degradable endocranium repair stent compounded by human amniotic membrane and bull dorsal aponeurosis and preparation method of repair stent |
-
2012
- 2012-04-10 CN CN 201210102907 patent/CN103357068A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104189955A (en) * | 2014-08-08 | 2014-12-10 | 苗九昌 | Degradable endocranium repair stent compounded by human amniotic membrane and bull dorsal aponeurosis and preparation method of repair stent |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20131023 |