CN102793593A - 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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- CN102793593A CN102793593A CN2012103226439A CN201210322643A CN102793593A CN 102793593 A CN102793593 A CN 102793593A CN 2012103226439 A CN2012103226439 A CN 2012103226439A CN 201210322643 A CN201210322643 A CN 201210322643A CN 102793593 A CN102793593 A CN 102793593A
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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 xenogenesis sclera sheet that is used for back sclera Reinforcement and preparation method thereof.
Background technology
It is the treatment progressive myopia that back sclera is reinforced operation, the high myopia safe and effective procedure.In clinical practice in the past, back sclera is reinforced the employed material of operation, takes from allogeneic corpse source cerebral dura mater or sclera on one's body mostly, and is clinical through promptly directly being used to perform the operation after ophthalmologist's the simple process.Yet, receiving the restriction of doctor's level of skill and medical condition, homemade back sclera tablet quality standard differs, and has certain operation risk, in addition, if some major disease is suffered from the corpse source before death, is not suitable as donor.Because the restriction of drawing materials makes the back sclera reinforce the operation slower development, can't large-scale promotion application.
Summary of the invention
The present invention is intended to overcome the defective that exists in the prior art, and a kind of base material wide material sources are provided, and consistency and elasticity is suitable, is easy to implant and do not have the xenogenesis sclera sheet that is applicable to back sclera Reinforcement of rejection.
Another object of the present invention provides the above-mentioned xenogenesis of back sclera Reinforcement that is applicable to and consolidates diaphragm-operated method for preparing.
In order to realize the object of the invention; A kind of xenogenesis sclera sheet that is used for back sclera Reinforcement of the present invention; Said xenogenesis sclera sheet comprises three kinds of specifications: first kind of specification sclera sheet is rectangle, and length is 18 ~ 22mm, and wide is that 8 ~ 12mm is (preferred long * as widely to be 20mm * 10mm); Second kind of specification sclera sheet is rectangle, and length is 75 ~ 80mm, and wide is 8 ~ 12mm (preferred 10mm); The third specification sclera sheet is asymmetric " recessed " font that falls in the left and right sides, and each limit has certain radian, and it is 24 ~ 26mm that " recessed " font that should fall consolidates diaphragm-operated length, and wide is 19 ~ 20mm; More than three kinds of specifications consolidate diaphragm-operated thickness and be 0.6-1mm; Consolidate pericardium or sclera that diaphragm-operated base material derives from animal.Said animal is domestic animals such as cattle, pig or rabbit.Preferred about 2 years healthy domestic animal.
The present invention also provides the above-mentioned xenogenesis that is used for back sclera Reinforcement to consolidate diaphragm-operated method for preparing, may further comprise the steps:
1) base material is selected: pericardium or the sclera of choosing animal;
2) base material pretreatment: remove pericardium or episcleral unnecessary tissue (like fatty tissue), base material is soaked in removes impurity in the detergent then, process rough lumber;
3) cut out shaping: as required, rough lumber is cut out or cut into the back sclera plate shape of required specification;
4) taking off cell handles: handle the rough lumber that is shaped with trypsin solution and TritonX-100 respectively, with abundant digestion and cell lysis, process smart material;
5) disinfection: smart material is carried out chemistry or physical sterilization;
6) adjust pH: the smart material with after the PBS buffer solution for cleaning sterilization of pH value 7.2-7.4 gets product.
In the preceding method, animal described in the step 1) is domestic animals such as cattle, pig or rabbit.
In the preceding method, step 2) detergent is a chlorhexidine described in, and soak time is 30-40min.Main purpose is to utilize the destruction of detergent cell membrane fat and lipoprotein, destroys the permeability barrier on the antibacterial endochylema film, causes part endochylema seepage, and the sterilizing effect is played in endochylema cohesion degeneration.
In the preceding method, trypsin solution that uses in the step 4) and the concentration of TritonX-100 are respectively 0.25% and 2%.Be specially: the rough lumber that is shaped is soaked in 12h in the trypsin solution, is transferred to oscillation treatment 36h among the TritonX-100 then.Through the tryptic digestion of inhibitor, make the albuminous degeneration on the cell membrane, through the hydrolysis of trypsin pair cell nuclear, removed the cell component in the tissue effectively.Adopt neutral detergent TrtionX-100 cell lysis in constant temperature oscillator, treated rough lumber keeps natural structure, and protein structure keeps steady statue, makes through cracked cell devitalization.
In the preceding method, the sterilization method of step 5) is preferably with glutaraldehyde and handles smart material 1h.Glutaraldehyde can react with protein, thereby kills various microorganisms.
In the preceding method, cobalt-60 irradiation sterilization is adopted in the step 5) sterilization.
In the preceding method, also comprise sclera sheet finished product is stored in 75% the alcoholic solution.
Sclera sheet operation instruction is following behind the xenogenesis of three kinds of specifications:
1, first kind of back sclera sheet that specification is four packings mainly is applicable to the low myopia adolescent patient of near-sighted degree at 200 ~ 500 degree.
2, second kind of specification is the back sclera sheet that a slice is packed, and mainly is applicable to the high myopia patient of 500 ~ 900 degree.
3, the third is the asymmetric back sclera sheet of " recessed " font in the left and right sides, is primarily aimed at high myopia complication patient.
Adopt detergent associating enzyme to take off cell technology and can thoroughly slough impurity such as all cells in the tissue, antigen, lipid, soluble protein; Keep and have integral outer appearance form and histology and Ultrastructural insoluble matrix composition; Mainly comprise collagen, elastin laminin, proteoglycan, glycosaminoglycan and non-collagen sugar albumen etc.; Removed and caused immunoreactive cell component, made base material only play the carrier of support effect.
The present invention uses pericardium of xenogenesis domestic animal or sclera to substitute people of the same race source sclera material; Sclera Reinforcement material resources is rare after having solved for a long time; Material safety property difference and receive the problems such as restriction of Medical Ethics only needs clean, degrease, decontamination, take off processed operations such as cell, antibacterial pericardium or the sclera base material that derives from domestic animal.Adopt sclera sheet behind the allosome that the inventive method processes, consistency and elasticity is suitable, and compliance is good, is easy to implant, and pastes pair and sutured with the receptor sclera easily; Toxicity is low behind the implant into body, and mechanical strength is high, no rejection, and histocompatibility is good; Can not stay cicatrix, anti-degradation capability is strong, is difficult for calcification, and the sclera sheet is the special shape design; Can avoid vorticose veins pressurized and damage, implant and walk in the process, be not easy to cause the distortion upset; Can stay in for a long time in the body, avoid the complication that causes because of frequent operation technique, reach the effect of long-term treatment progressive myopia and high myopia.Through sclera material (bovine pericardium sticking patch, Cor Sus domestica bag sticking patch, rabbit sclera sheet and people's sclera sheet) after four kinds is carried out mechanical test, the result shows that bovine pericardium is to be used for the back sclera to reinforce the best material of operation.
Description of drawings
Fig. 1 is the diaphragm-operated preparation technology's flow chart of Gong that is used for back sclera Reinforcement of the embodiment of the invention 1.
Fig. 2 is the back sclera sheet of first kind of specification of preparation in the embodiment of the invention 1.
Fig. 3 is the back sclera sheet of second kind of specification of preparation in the embodiment of the invention 1.
Fig. 4 is the back sclera sheet of the third specification of preparation in the embodiment of the invention 1.
The specific embodiment
Following examples are used to explain the present invention, but are not used for limiting scope of the present invention.If do not specialize the conventional means that used technological means is well known to those skilled in the art among the embodiment, the raw materials used commercial goods that is.
The xenogenesis that embodiment 1 is used for back sclera Reinforcement consolidates diaphragm-operated preparation
1 material and source
Getting the bovine pericardium of butchering is base material, cattle for the quarantine anosis, draw materials with transportation to note the sterile working.
2 are used for the diaphragm-operated preparation technology of Gong (referring to Fig. 1) of back sclera Reinforcement
2.1 base material pretreatment: remove impurity and redundance (like fatty tissue) on the pericardium, with distilled water immersion, the disintegrate hemocyte; Then base material is soaked in 40min in the detergent chlorhexidine, removes impurity, process rough lumber.
2.2 cut out shaping: remove the part of thickness, elasticity, hardness and irregular colour on rough lumber after 2.1 processing, choose the position of thickness 0.6-1mm, the shape of rough lumber being cut out or cutting into different size.
2.3 taking off cell handles: the rough lumber that is shaped is soaked in 12h peptic cell in 0.25% the trypsin solution, is transferred to neutral detergent TrtionX-100 cell lysis 36h in constant temperature (37 ℃) agitator of 2% then, process smart material.
2.4 disinfection: the above-mentioned smart material that makes is soaked in 1h in the glutaraldehyde.
2.5 adjust pH: sterilization is taken out the PBS buffer solution for cleaning of smart material with pH value 7.2-7.4 after finishing, and promptly gets the sclera sheet finished product that is used for back sclera Reinforcement.
2.6 sclera sheet finished product is stored in 75% the alcoholic solution subsequent use.
When carrying out back sclera reinforcing operation, can suitably prune sclera sheet finished product according to patient's actual demand.
Sclera sheet and operation instruction thereof behind the xenogenesis of three kinds of specifications:
1, first kind of specification: length * wide=20mm * 10mm (referring to Fig. 2) is the back sclera sheet of four packings, mainly is applicable to the low myopia adolescent patient of near-sighted degree at 200 ~ 500 degree.
2, second kind of specification: length * wide=75 ~ 80mm * 10mm (referring to Fig. 3) is the back sclera sheet of a slice packing, mainly is applicable to the high myopia patient of 500 ~ 900 degree.
3, the third is the asymmetric back sclera sheet (referring to Fig. 4) of " recessed " font in the left and right sides, is primarily aimed at high myopia complication patient.
Consolidate diaphragm-operated Biomechanical properties behind embodiment 2 xenogenesis behind the sclera Reinforcement
1 material and preparation
Be base material with bovine pericardium sticking patch, Cor Sus domestica bag sticking patch and rabbit sclera sheet respectively,, process corresponding back sclera sheet with the preparation technology of embodiment 1.
In the diaphragm-operated biomechanics Research present embodiment of the back Gong of 2 different materials, the thickness with micro-calibrator measurement back sclera draws the back and consolidates diaphragm-operated sectional area.Use omnipotent puller system, back to be measured sclera sheet is imposed different pulling force, can measure the back and consolidate diaphragm-operated mechanical property.
In the zooperal mechanics of bovine pericardium, Cor Sus domestica bag, rabbit sclera is observed, select rabbit as experimental subject.The experimental rabbit left eye is implemented the back sclera reinforce operation, right eye is not performed an operation, and through observation in 180 days, puts to death animal, takes out the experimental rabbit eyeball and under light microscopic, transmission electron microscope, dynamic observes.The result shows that the bovine pericardium patching material is finally substituted by self connective tissue; The bovine pericardium sticking patch forms gradually plants the tissue morphology that sheet fiber and self connective tissue are interweaved; The fibre composition of material and host's fibrous connective tissue are interweaved, and its fiber becomes support, plant sheet and also are wrapped in fibrous tissue on every side, are difficult for moving and separating.Interior rough endoplasmic reticulum of finding foreign-body giant cell and transmission electron microscope observing Cytoplasm and ribosome increase under the light microscopic; Show in above three kinds of materials; The uniaxial tension of bovine pericardium, creep, ultimate tensible strength all are better than other materials, can the stimulation of host metabolic activity in cells strengthen simultaneously, and hamartoplasia is active; But its composition is not absorbed, and can form firm relation with sclera.Bovine pericardial material is the optimal material of stability and safety as back sclera Reinforcement treatment.
Though, the present invention has been done detailed description in the preceding text with general explanation and specific embodiments, on basis of the present invention, can to some modifications of do or improvement, this will be apparent to those skilled in the art.Therefore, these modifications or the improvement on the basis of not departing from spirit of the present invention, made all belong to the scope that requirement of the present invention is protected.
Claims (10)
1. be used for the xenogenesis sclera sheet of back sclera Reinforcement, it is characterized in that said sclera sheet comprises three kinds of specifications: first kind of specification sclera sheet is rectangle, and length is 18 ~ 22mm, and wide is 8 ~ 12mm; Second kind of specification sclera sheet is rectangle, and length is 75 ~ 80mm, and wide is 8 ~ 12mm; The third specification sclera sheet is asymmetric " recessed " font that falls in the left and right sides, and each limit has certain radian, and it is 24 ~ 26mm that " recessed " font that should fall consolidates diaphragm-operated length, and wide is 19 ~ 20mm; More than three kinds of specifications consolidate diaphragm-operated thickness and be 0.6-1mm; Xenogenesis consolidates pericardium or the sclera that diaphragm-operated base material derives from animal.
2. xenogenesis sclera sheet according to claim 1 is characterized in that said animal is cattle, pig or rabbit.
3. the xenogenesis that is used for back sclera Reinforcement consolidates diaphragm-operated method for preparing, it is characterized in that,
May further comprise the steps:
1) base material is selected: pericardium or the sclera of choosing animal;
2) base material pretreatment: remove pericardium or episcleral unnecessary tissue, base material is soaked in removes impurity in the detergent then, process rough lumber;
3) cut out shaping: as required, rough lumber is cut out or cut into the back sclera plate shape of required specification;
4) taking off cell handles: handle the rough lumber that is shaped with trypsin solution and TritonX-100 respectively, with abundant digestion and cell lysis, process smart material;
5) disinfection: smart material is carried out chemistry or physical sterilization;
6) adjust pH: the smart material with after the PBS buffer solution for cleaning sterilization of pH value 7.2-7.4 gets product.
4. method for preparing according to claim 3 is characterized in that, animal described in the step 1) is cattle, pig or rabbit.
5. method for preparing according to claim 3 is characterized in that step 2) described in detergent be chlorhexidine, soak time is 30-40min.
6. method for preparing according to claim 3 is characterized in that, trypsin solution that uses in the step 4) and the concentration of TritonX-100 are respectively 0.25% and 2%.
7. method for preparing according to claim 6 is characterized in that step 4) is specially: the rough lumber that is shaped is soaked in 12h in the trypsin solution, is transferred to oscillation treatment 36h among the TritonX-100 then.
8. method for preparing according to claim 3 is characterized in that step 5) is for to handle smart material 1h with glutaraldehyde.
9. method for preparing according to claim 3 is characterized in that, step 5) is for adopting cobalt 60 irradiation sterilizations.
10. according to each described method for preparing of claim 3-9, it is characterized in that, sclera sheet finished product is stored in 75% the alcoholic solution.
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| 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 |
| CN107308496A (en) * | 2017-06-09 | 2017-11-03 | 广州悦清再生医学科技有限公司 | A kind of biological tissue reienforcement timbering material and preparation method thereof |
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| CN114306755A (en) * | 2022-02-11 | 2022-04-12 | 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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