CN102793593B - Heterogeneous scleral piece used for posterior scleral reinforcement and preparation method thereof - Google Patents
Heterogeneous scleral piece used for posterior scleral reinforcement and preparation method thereof Download PDFInfo
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Abstract
The invention provides a heterogeneous scleral piece used for posterior scleral reinforcement and a preparation method thereof. According to the heterogeneous scleral piece, the base materials are wide in sources, the hardness and the elasticity are proper, the adaptability is good, the heterogeneous scleral piece is easy to implant and can be attached, sewn and fixed with a receptor scleral easily; after being implanted into a human body, the heterogeneous scleral piece is non-toxic, high in mechanical strength, good in histocompatibility, strong in anti-degradation capability, can not be calcified easily, and does not have rejection reaction, and scars can not be left; and due to the special shape design of the scleral piece, venae vorticosae can be prevented from being pressed and damaged, the sclearl piece can not be twisted and turned easily in the implanting and penetrating process, and can be left in the body for a long time, the complication caused by the frequency operations can be avoided, and the effect of treating the progressive myopia and the high myopia for a long time is achieved.
Description
Technical field
The present invention relates to tissue engineering and materialogy field, specifically, relate to the xenogenesis sclera sheet and preparation method thereof for Posterior scleral reinforcement.
Background technology
Scleral reinforcement operation is treatment progressive myopia, and high myopia is method safely and effectively.In clinical practice in the past, scleral reinforcement is performed the operation the material used, and mostly takes from allogeneic corpse source cerebral dura mater with it or sclera, is namely directly used in operation clinical after the simple process of ophthalmologist.But be subject to the restriction of doctor's level of skill and medical condition, homemade posterior scleral tablet quality standard differs, and there is certain operation risk, in addition, if some major disease is suffered from corpse source before death, is then not suitable as donor.Because the restriction of drawing materials makes scleral reinforcement operation slower development, cannot large-scale promotion application.
Summary of the invention
The present invention is intended to overcome the defect existed in prior art, and provide a kind of base material wide material sources, consistency and elasticity is suitable for, and is easy to implant and without the xenogenesis sclera sheet being applicable to Posterior scleral reinforcement of rejection.
Another object of the present invention is to provide the above-mentioned preparation method being applicable to the xenogenesis sclera sheet of Posterior scleral reinforcement.
In order to realize the object of the invention, a kind of xenogenesis sclera sheet for Posterior scleral reinforcement of the present invention, described xenogenesis sclera sheet comprises three kinds of specifications: the first specification sclera sheet is rectangle, and length is 18 ~ 22mm, and wide be 8 ~ 12mm(preferably length × wide is 20mm × 10mm); The second specification sclera sheet is rectangle, and length is 75 ~ 80mm, and wide is the preferred 10mm of 8 ~ 12mm(); The third specification sclera sheet is left-right asymmetry " recessed " font, and each limit has certain radian, and the length of being somebody's turn to do " recessed " font sclera sheet is 24 ~ 26mm, and wide is 19 ~ 20mm; The thickness of above three kinds of specification sclera sheets is 0.6-1mm; The base material of sclera sheet derives from pericardium or the sclera of animal.Described animal is the domestic animals such as cattle, pig or rabbit.The preferably healthy domestic animal of about 2 years.
The present invention also provides the preparation method of the above-mentioned xenogenesis sclera sheet for Posterior scleral reinforcement, comprises the following steps:
1) base material is selected: pericardium or the sclera of choosing animal;
2) base material pretreatment: removing pericardium or episcleral excess tissue (as fatty tissue), be then soaked in base material in detergent and remove impurity, make rough lumber;
3) cut out shaping: as required, cut out rough lumber or cut into the posterior scleral plate shape of required specification;
4) de-cell process: respectively with the rough lumber that trypsin solution and TritonX-100 process are shaped, fully to digest and cell lysis, make smart material;
5) disinfection: chemistry or physical sterilization are carried out to smart material;
6) adjust pH: with the smart material after the PBS buffer solution for cleaning sterilizing of pH value 7.2-7.4, get product.
In preceding method, animal described in step 1) is the domestic animals such as cattle, pig or rabbit.
In preceding method, step 2) described in detergent be chlorhexidine, soak time is 30-40min.Main purpose is the destruction utilizing detergent cell membrane fat and lipoprotein, destroys the permeability barrier on bacterial cytoplasm film, causes part endochylema seepage, and endochylema cohesion degeneration, plays sterilizing effect.
In preceding method, the trypsin solution used in step 4) and the concentration of TritonX-100 are respectively 0.25% and 2%.Be specially: the rough lumber of shaping is soaked in 12h in trypsin solution, be then transferred to oscillation treatment 36h in TritonX-100.Through the tryptic digestion of inhibitor, make the albuminous degeneration on cell membrane, by trypsin to nuclear hydrolysis, effectively removes the cell component in tissue.Adopt neutral detergent TrtionX-100 cell lysis in constant temperature oscillator, treated rough lumber keeps natural structure, and protein structure keeps steady statue, makes the cell loss vigor through cracking.
In preceding method, the sterilization method of step 5) is preferably with glutaraldehyde process essence material 1h.Glutaraldehyde can react with protein, thus kills various microorganism.
In preceding method, step 5) sterilizing adopts cobalt-60 irradiation sterilization.
In preceding method, also comprise and sclera sheet finished product is stored in the alcoholic solution of 75%.
The xenogenesis posterior scleral sheet operation instruction of three kinds of specifications is as follows:
1, the first specification is the posterior scleral sheets of four packagings, is mainly applicable to near-sighted degree at the low myopia adolescent patient of 200 ~ 500 degree.
2, the second specification is the posterior scleral sheet of a slice packaging, is mainly applicable to the high myopia of 500 ~ 900 degree.
3, the third is the posterior scleral sheet of left-right asymmetry " recessed " font, mainly for high myopia complication patient.
Adopt detergent associating enzyme to take off cell technology and thoroughly can slough the impurity such as all cells, antigen, lipid, soluble protein in tissue, retain and there is integral outer appearance histology and Ultrastructural insoluble matrix composition, mainly comprise collagen, elastin laminin, proteoglycan, glycosaminoglycan and non-collagen sugar albumen etc., eliminate and cause immunoreactive cell component, make base material only play the carrier of support effect.
The present invention uses the pericardium of xenogenesis domestic animal or sclera to substitute people of the same race source sclera material, solve for a long time that Posterior scleral reinforcement material resources is rare, material safety difference and be subject to the problem such as restriction of Medical Ethics, only need to clean the pericardium or sclera base material that derive from domestic animal, degrease, decontamination, the de-processed such as cell, sterilization operation.Adopt the allosome posterior scleral sheet that the inventive method is made, consistency and elasticity is suitable for, and compliance is good, is easy to implant, and easy and recipient sclera attaches and sew up fixing; After implant into body, toxicity is low, and mechanical strength is high, without rejection, histocompatibility is good, can not scar, and anti-degradation capability is strong, not easily calcification, sclera sheet is special shape design, can avoid vorticose veins pressurized and damage, implants and walks in process, be not easy to cause distortion to overturn, can extended stationary periods in body, avoid the complication because frequent operation technique causes, reach the effect of long-term treatment progressive myopia and high myopia.By carrying out mechanical test to four kinds of posterior scleral materials (bovine pericardium sticking patch, Cor Sus domestica bag sticking patch, rabbit sclera sheet and people's sclera sheet), result shows that bovine pericardium is for the best material of scleral reinforcement operation.
Accompanying drawing explanation
Fig. 1 is preparation technology's flow chart of the sclera sheet for Posterior scleral reinforcement of the embodiment of the present invention 1.
Fig. 2 is the posterior scleral sheet of the first specification of preparation in the embodiment of the present invention 1.
Fig. 3 is the posterior scleral sheet of the second specification of preparation in the embodiment of the present invention 1.
Fig. 4 is the posterior scleral sheet of the third specification of preparation in the embodiment of the present invention 1.
Detailed description of the invention
Following examples for illustration of the present invention, but are not used for limiting the scope of the invention.If do not specialize, the conventional means that technological means used in embodiment is well known to those skilled in the art, is raw materials usedly commercial goods.
Embodiment 1 is for the preparation of the xenogenesis sclera sheet of Posterior scleral reinforcement
1 material and source
Getting the bovine pericardium of butchering is base material, cattle for quarantine anosis, draw materials and transportation to note sterile working.
2 for the preparation technology (see Fig. 1) of the sclera sheet of Posterior scleral reinforcement
2.1 base material pretreatment: remove the impurity on pericardium and redundance (as fatty tissue), with distilled water immersion, disintegrate hemocyte; Then base material is soaked in 40min in detergent chlorhexidine, removes impurity, make rough lumber.
2.2 cut out shaping: the part removing thickness, elasticity, hardness and irregular colour on rough lumber after 2.1 process, choose the position of thickness 0.6-1mm, cut out rough lumber or cut into the shape of different size.
2.3 de-cell process: the rough lumber of shaping is soaked in 12h peptic cell in the trypsin solution of 0.25%, is then transferred to neutral detergent TrtionX-100 cell lysis 36h in constant temperature (37 DEG C) agitator of 2%, makes smart material.
2.4 disinfections: above-mentioned obtained smart material is soaked in 1h in glutaraldehyde.
2.5 adjust pHs: after sterilizing terminates, take out the PBS buffer solution for cleaning of smart material pH value 7.2-7.4, obtain the sclera sheet finished product for Posterior scleral reinforcement.
Sclera sheet finished product is stored in the alcoholic solution of 75% for subsequent use by 2.6.
When carrying out scleral reinforcement operation, suitably can prune sclera sheet finished product according to the actual demand of patient.
The xenogenesis posterior scleral sheet of three kinds of specifications and operation instruction thereof:
1, the first specification: length × wide=20mm × 10mm(is see Fig. 2), be the posterior scleral sheets of four packagings, be mainly applicable to near-sighted degree at the low myopia adolescent patient of 200 ~ 500 degree.
2, the second specification: length × wide=75 ~ 80mm × 10mm(is see Fig. 3), be the posterior scleral sheet of a slice packaging, be mainly applicable to the high myopia of 500 ~ 900 degree.
3, the third is the posterior scleral sheet (see Fig. 4) of left-right asymmetry " recessed " font, mainly for high myopia complication patient.
The research of the biomechanics characteristic of embodiment 2 xenogenesis Posterior scleral reinforcement posterior scleral sheet
1 material and preparation
Respectively with bovine pericardium sticking patch, Cor Sus domestica bag sticking patch and rabbit sclera sheet for base material, with the preparation technology of embodiment 1, make corresponding posterior scleral sheet.
In biomechanics Research the present embodiment of the posterior scleral sheet of 2 different materials, measure the thickness of posterior scleral with micro-calibrator, draw the sectional area of posterior scleral sheet.With tensilon, different pulling force is imposed to posterior scleral sheet to be measured, the mechanical property of posterior scleral sheet can be measured.
In observing the zooperal mechanics of bovine pericardium, Cor Sus domestica bag, rabbit sclera, select rabbit as experimental subject.Implement scleral reinforcement operation to experimental rabbit left eye, right eye is not performed an operation, and observes through 180 days, puts to death animal, takes out experimental rabbit eyeball and dynamically observes under light microscopic, transmission electron microscope.Result display bovine pericardium patching material is finally substituted by self connective tissue; Bovine pericardium sticking patch forms the tissue morphology of planting sheet fiber and self connective tissue and being interweaved gradually; Fibre composition and host's fibrous connective tissue of material are interweaved, and its fiber becomes support, plants around sheet and is also wrapped in fibrous tissue, not easily move and are separated.Under light microscopic, in finding foreign-body giant cell and transmission electron microscope observing Cytoplasm, rough endoplasmic reticulum and ribosome increase, show in above three kinds of materials, the uniaxial tension of bovine pericardium, creep, ultimate tensible strength are all better than other materials, can stimulation of host metabolic activity in cells strengthen simultaneously, hamartoplasia is enlivened, but its composition is not absorbed, firmly relation can be formed with sclera.Bovine pericardial material is the optimal material of stability and safety as Posterior scleral reinforcement treatment.
Although above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this will be apparent to those skilled in the art.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, all belong to the scope of protection of present invention.
Claims (10)
1. for the xenogenesis sclera sheet of Posterior scleral reinforcement, it is characterized in that, described sclera sheet is left-right asymmetry " recessed " font, and each limit has certain radian, and the length of being somebody's turn to do " recessed " font sclera sheet is 24 ~ 26mm, and wide is 19 ~ 20mm; The thickness of described sclera sheet is 0.6-1mm; The base material of xenogenesis sclera sheet derives from pericardium or the sclera of animal.
2. xenogenesis sclera sheet according to claim 1, is characterized in that, described animal is cattle, pig or rabbit.
3. the preparation method of the xenogenesis sclera sheet for Posterior scleral reinforcement described in claim 1 or 2, is characterized in that,
Comprise the following steps:
1) base material is selected: pericardium or the sclera of choosing animal;
2) base material pretreatment: removing pericardium or episcleral excess tissue, be then soaked in base material in detergent and remove impurity, make rough lumber;
3) cut out shaping: as required, cut out rough lumber or cut into the posterior scleral plate shape of required specification;
4) de-cell process: respectively with the rough lumber that trypsin solution and TritonX-100 process are shaped, fully to digest and cell lysis, make smart material;
5) disinfection: chemistry or physical sterilization are carried out to smart material;
6) adjust pH: with the smart material after the PBS buffer solution for cleaning sterilizing of pH value 7.2-7.4, get product.
4. preparation method according to claim 3, is characterized in that, step 1) described in animal be cattle, pig or rabbit.
5. preparation method according to claim 3, is characterized in that, step 2) described in detergent be chlorhexidine, soak time is 30-40min.
6. preparation method according to claim 3, is characterized in that, step 4) in the trypsin solution that uses and the concentration of TritonX-100 be respectively 0.25% and 2%.
7. preparation method according to claim 6, is characterized in that, step 4) be specially: the rough lumber of shaping is soaked in 12h in trypsin solution, is then transferred to oscillation treatment 36h in TritonX-100.
8. preparation method according to claim 3, is characterized in that, step 5) be with glutaraldehyde process essence material 1h.
9. preparation method according to claim 3, is characterized in that, step 5) for adopting 60Coradiation sterilizing.
10. the preparation method according to any one of claim 3-9, is characterized in that, is stored in the alcoholic solution of 75% by sclera sheet finished product.
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| CN105769381B (en) * | 2015-05-26 | 2018-04-17 | 南通大学 | A kind of biological sticking patch for tissue damage reparation |
| CN107233143A (en) * | 2017-05-31 | 2017-10-10 | 广州新诚生物科技有限公司 | Remove cell corneal stroma lens and preparation method thereof |
| CN107233144A (en) * | 2017-05-31 | 2017-10-10 | 中山大学中山眼科中心 | Go application of the cell corneal stroma lens in treatment ophthalmology disease |
| CN107308496B (en) * | 2017-06-09 | 2020-08-04 | 广州悦清再生医学科技有限公司 | Biological tissue reinforcing scaffold material and preparation method thereof |
| CN109172866A (en) * | 2018-09-19 | 2019-01-11 | 杭州启明医疗器械有限公司 | A kind of drying biological cardiac valves and preparation method thereof for the flattening that can quickly absorb water |
| CN114306755B (en) * | 2022-02-11 | 2023-03-31 | 诺一迈尔（苏州）医学科技有限公司 | Biological patch for posterior scleral reinforcement and preparation method thereof |
| CN115837096A (en) * | 2022-08-19 | 2023-03-24 | 山东第一医科大学附属眼科研究所(山东省眼科研究所、山东第一医科大学附属青岛眼科医院) | Corneal repair material based on transparentized sclera and preparation method and application thereof |
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| 张世元.《高级医师案头丛书——眼科学》,张世元,第303-304页,中国协和医科大学出版社,20021231.《高级医师案头丛书——眼科学》.中国协和医科大学出版社,2002,第303-304页. * |
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