CN110338941A - A kind of compound artificial eye holder and preparation method thereof - Google Patents
A kind of compound artificial eye holder and preparation method thereof Download PDFInfo
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- CN110338941A CN110338941A CN201910583206.4A CN201910583206A CN110338941A CN 110338941 A CN110338941 A CN 110338941A CN 201910583206 A CN201910583206 A CN 201910583206A CN 110338941 A CN110338941 A CN 110338941A
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- base material
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- artificial eye
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- 238000000034 method Methods 0.000 claims abstract description 16
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- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims description 6
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- 239000003431 cross linking reagent Substances 0.000 claims description 6
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- 238000005406 washing Methods 0.000 claims description 6
- IBFYXTRXDNAPMM-BVTMAQQCSA-N Geniposide Chemical compound O([C@@H]1OC=C([C@@H]2[C@H]1C(=CC2)CO)C(=O)OC)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O IBFYXTRXDNAPMM-BVTMAQQCSA-N 0.000 claims description 4
- IBFYXTRXDNAPMM-FZEIBHLUSA-N Geniposide Natural products COC(=O)C1=CO[C@@H](O[C@H]2O[C@@H](CO)[C@H](O)[C@@H](O)[C@@H]2O)[C@H]2[C@@H]1CC=C2CO IBFYXTRXDNAPMM-FZEIBHLUSA-N 0.000 claims description 4
- VGLLGNISLBPZNL-RBUKDIBWSA-N arborescoside Natural products O=C(OC)C=1[C@@H]2C([C@H](O[C@H]3[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O3)OC=1)=C(CO)CC2 VGLLGNISLBPZNL-RBUKDIBWSA-N 0.000 claims description 4
- 241001494479 Pecora Species 0.000 claims description 3
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 230000005484 gravity Effects 0.000 abstract description 6
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- 230000006378 damage Effects 0.000 abstract description 5
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- 238000002513 implantation Methods 0.000 abstract description 4
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- 238000010586 diagram Methods 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
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- 229910052588 hydroxylapatite Inorganic materials 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical group [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 2
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 2
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- AZKVWQKMDGGDSV-BCMRRPTOSA-N Genipin Chemical compound COC(=O)C1=CO[C@@H](O)[C@@H]2C(CO)=CC[C@H]12 AZKVWQKMDGGDSV-BCMRRPTOSA-N 0.000 description 1
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- 229920001436 collagen Polymers 0.000 description 1
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- 235000013305 food Nutrition 0.000 description 1
- AZKVWQKMDGGDSV-UHFFFAOYSA-N genipin Natural products COC(=O)C1=COC(O)C2C(CO)=CCC12 AZKVWQKMDGGDSV-UHFFFAOYSA-N 0.000 description 1
- 210000000554 iris Anatomy 0.000 description 1
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- 231100000956 nontoxicity Toxicity 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/141—Artificial eyes
Landscapes
- Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Ophthalmology & Optometry (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a kind of compound artificial eye holder and preparation method thereof, compound artificial eye holder includes sphere and peplos, and sphere uses silica gel or hydrogel, diameter 16mm~24mm；Peplos uses the biomembrane of crosslinked processing, is wrapped in the periphery of sphere, with a thickness of 0.2~0.8mm, breaking strength reaches 1~5kg/mm2, preparation method includes the selection of outsourcing film base material, the pretreatment of outsourcing film base material, outsourcing film base material curing process, sphere production, combined processing, packaging sterilizing.Compound artificial eye holder of the invention, surface is smooth, is easily placed in flesh cone, damage when reducing implantation to ball week tissue；It is light-weight, it is easy to fix in flesh is bored, reduce because of sinking or deviation caused by gravity；The peplos of crosslinking Treatment is not easy to be degraded, and intensity and toughness are big, can suture and be coupled with rectus not-go-end, it is convenient to operate, and can increase the mobility of artificial eye holder；Histocompatbility is good, and conjunctiva wound is easy healing, reduces the generation of the complication such as rejection exposure and infection.
Description
Technical field
The present invention relates to Implantable Medical Device technical fields, and in particular to a kind of compound artificial eye holder.
Background technique
Clinically since various eye part diseases need row eyeball excise, to cause syndrome after eyeball excise, including eye
Correct Hollow of The Eye Socket, ptosis, lower eyelid ectropion etc. cause the defect of patient facial region's appearance, seriously affect appearance.In order to improve patient this
The defect of kind facial appearance, maintains eye shape and beauty, then needs to be implanted into artificial eye holder in musculus orbitalis cone, fill eyeball to fill up
The space such as eyeball is lacked after excision, and eyeball is prevented to lack such as caused structure in orbit disorder.Operation implantation artificial eye holder, before be cladded with knot
Film, after conjunctiva wound healing, the wearable Artificial eye for simulating sclera, cornea, iris and pupil, Artificial eye is cambered surface sheet knot
Structure voluntarily can be worn or remove, the almost true eye of appearance after wearing, and face is whole to be maintained.
Artificial eye holder is a kind of clinical Implantable Medical Device, and mostly spherical, size has different diameters such as eyeball, with
Individuation adapts to the patient of different demands, though not being related to patients' visual recovery, can improve facial defects.
Artificial eye holder material is clinically used at present, there is hydroxyapatite, high-density porous polyethylene (Medpor), calcium phosphate
Bioceramic, but there are some defects in application:
(1) rough surface easily sticks with tissue, causes to be implanted into difficulty in operation, is not easy to be put into flesh cone, once there is exposure
It has been easy bacterium attachment, has caused to infect；
(2) density is big, postoperative because gravity is big, is easy sinking or deviation；
(3) hardness is high, and surface cannot be sutured with rectus to be coupled, the decline of ocular prosthesis mobility；
(4) histocompatbility is poor, there is different degrees of rejection, is easy to cause the risks such as artificial eye holder exposure and infection.
In view of this, being badly in need of improving existing artificial eye holder structure, to facilitate implantation, surgical effect is improved.
Summary of the invention
Exist the technical problem to be solved by the present invention is to existing artificial eye holder structure and be not easy to be implanted into, surgical effect difference is asked
Topic.
In order to solve the above-mentioned technical problem, the technical scheme adopted by the invention is that providing a kind of compound artificial eye holder, packet
It includes:
Sphere, using silica gel or hydrogel, the diameter 16mm~24mm；
Peplos is wrapped in the periphery of the sphere, suture site is labeled on the peplos, using crosslinked processing
Biomembrane, with a thickness of 0.2~0.8mm, breaking strength reaches 1~5kg/mm2。
In another preferred embodiment, suture site is labeled on the peplos.
In another preferred embodiment, the biomembrane uses animal pericardium, endocranium.
In another preferred embodiment, the biomembrane is taken from pig, ox or sheep.
The present invention also provides a kind of preparation methods of the compound artificial eye holder of above structure, comprising the following steps:
The selection of outsourcing film base material: the biomembrane tissue through slaughtered animals of quarantining is selected；
The pretreatment of outsourcing film base material: de- cell cleaning, cleaning by degreasing remove excess tissue；
Outsourcing film base material curing process: it immerses in the closed vessel of crosslinking treatment fluid, substrate weight: solution weight 1:
3~5, concussion is rocked, and the degree of cross linking is made to reach 60%~95%, obtains peplos；
Sphere production: silica gel or hydrogel are used, diameter is fabricated to spherical shape according to demand；
Combined processing: sphere is wrapped up using peplos, sutures tying；
Packaging sterilizing: sealed package is packaged, and is chemically or physically sterilized to get finished product is arrived.
In another preferred embodiment, by after the pretreatment of outsourcing film base material, combined processing is first carried out, then by outsourcing
Film base material and sphere carry out curing process together.
In another preferred embodiment, in outsourcing film base material curing process, crosslinking Treatment liquid is Geniposide or penta 2
Aldehyde.
In another preferred embodiment, in the pretreatment of outsourcing film base material, specifically includes the following steps:
De- cell cleaning: with distilled water immersion, it is disintegrated haemocyte, physiological saline soaking and washing；
Cleaning by degreasing: degreasing in absolute alcohol, physiological saline soaking and washing are immersed；
Remove excess tissue: removal became uneven is even, and the tissue of tensile capacity difference obtains rough lumber.
In another preferred embodiment, outsourcing film base material curing process, specifically includes the following steps:
Pretreated outsourcing film base material is immersed in crosslinking Treatment liquid with flat, crosslinking Treatment liquid is containing crosslinking agent
Alcoholic solution, alcohol concentration is 40%~75%, and the concentration of crosslinking agent is 0.1%~2%, PH5.0~7.0, maintains temperature
It 15 DEG C~35 DEG C, shakes 3~35 days；
Remove thickness, elasticity and the non-uniform material of hardness.
Compared with prior art, advantage of the present invention are as follows:
1. surface is smooth, in operative process, adhesion can be reduced and be organized, is easily placed in flesh cone, is reduced and plant
The fashionable damage to ball week tissue；
2. ball material use silica gel or hydrogel, density low-quality it is soft, weight is small, thus reduce it is postoperative because gravity sink
Or deviation；
3. the peplos Jing Guo crosslinking Treatment, intensity and toughness are big, can suture and be coupled with rectus not-go-end, and it is convenient to operate,
And the mobility of artificial eye holder can be increased；
4. histocompatbility is good, conjunctiva wound is easy healing, and no antigen is not easy to be degraded and absorbed, no after being implanted into human body
Rejection is generated, the generation of the complication such as rejection exposure and infection is reduced, for Artificial eye comfortable wearing and increases ocular prosthesis
Flexibility lays a good foundation.
Detailed description of the invention
Fig. 1 is the perspective view of artificial eye holder in the present invention；
Fig. 2 is that peplos is wrapped in the structural schematic diagram on sphere in the present invention；
Fig. 3 is the structural schematic diagram of another angle of artificial eye holder in the present invention.
Specific embodiment
The present invention provides a kind of compound artificial eye holders and preparation method thereof, and surface is smooth, can reduce and organize adhesion,
It is easily placed in flesh cone, damage when reducing implantation to ball week tissue；Sphere is light-weight, is easy to fix in flesh is bored, thus
It reduces postoperative because of sinking or deviation caused by gravity；By the peplos of crosslinking Treatment, intensity and toughness are big, can stop with rectus
End suture is coupled, and it is convenient to operate, and can increase the mobility of artificial eye holder；Histocompatbility is good, and conjunctiva wound is easy healing, is not easy
It is degraded and absorbed, reduces the generation of the complication such as rejection exposure and infection.With reference to the accompanying drawings of the specification and specific embodiment party
Formula is described in detail the present invention.
As depicted in figs. 1 and 2, a kind of compound artificial eye holder provided by the invention, including sphere 10 and peplos 20.Sphere
10 use silica gel or hydrogel, and the diameter of sphere 10 is 16mm~24mm.Hydroxyapatite in the prior art, porous poly- second
Alkene, the quality hardness of calcium phosphate biological ceramic are high, and silica gel, the density of hydrogel are low, and quality is softer, can effectively reduce weight,
It can be avoided because of the big sinking of gravity or deviation, also can according to need and select other light materials, select corresponding specification.
Peplos 20 is wrapped in the periphery of sphere 10, is broken using the biomembrane of crosslinked processing with a thickness of 0.2~0.8mm
Resistance to spalling reaches 1~5kg/mm2.The biomaterial toughness of crosslinked processing is high, mechanical strength increases, anticollagenase degradation energy
Power enhancing, stable in physicochemical property remove antigen, and histocompatbility is good.It is wrapped in using peplos 20 on the periphery of sphere 10, film
Tissue surface is smooth, is easy to immerse in flesh cone, can reduce the damage to periocular tissues.Peplos can be sutured with rectus to be joined
Knot avoids dislocation from being coupled, the mobility after capable of increasing Orbital implant.Peplos membrane tissue compatibility is good, avoids repelling anti-
It should and infect, can be good at wrapping up sphere 10, be not easy to expose after Orbital implant.
Wherein, as shown in figure 3, being labeled on peplos 20 for suturing the suture site 30 being coupled with rectus, seam is utilized
Coincidence point 30 is convenient to be connected and fixed with eye rectus, can significantly improve the convenience of operation, improves procedure efficiency, and accelerates to be cured
It closes, guarantees the mobility of artificial eye holder.
Wherein, peplos 20 uses animal pericardium, endocranium, and such as bovine pericardium, pig brain film, materials are convenient.Biomembrane
It is taken from pig, ox or sheep.
The present invention also provides a kind of preparation methods of compound artificial eye holder, comprising the following steps:
The selection of outsourcing film base material: the biomembrane tissue through slaughtered animals of quarantining is selected；
The pretreatment of outsourcing film base material: de- cell cleaning, cleaning by degreasing remove excess tissue；
Outsourcing film base material curing process: it immerses in the closed vessel of crosslinking treatment fluid, substrate weight: solution weight 1:
3~5, concussion is rocked, and the degree of cross linking is made to reach 60%~95%, obtains peplos 20；
Sphere 10 makes: selection silica gel or hydrogel, diameter is fabricated to spherical shape according to demand, obtains sphere 10；
Combined processing: sphere 10 is wrapped up using peplos 20, sutures tying；
Packaging sterilizing: sealed package is packaged, and is chemically or physically sterilized to get finished product is arrived.
Preferably, the step in above-mentioned steps can order change.After the pretreatment of outsourcing film base material, compound place is first carried out
Reason, then carries out curing process for outsourcing film base material and sphere 10 together.
Further, crosslinking Treatment liquid is Geniposide or glutaraldehyde.The bovine pericardium of glutaraldehyde cross-linking has been commonly used to face
Bed gradually individually or with materials such as polyester flakes is shared in the various congenital or acquired cardiovascular disease for the treatment of, outside uropoiesis
Section and field of orthopaedics also start to be widely applied, and can make various prostheses and ligament substitute.Biomembrane material processing is used
Crosslinking Treatment liquid be mainly glutaraldehyde, through bovine pericardium thickness about 0.25~0.34mm that glutaraldehyde cross-linking is fixed, placenta percreta
Mesothelial cell fall off substantially, Jin Sheng mesothelial cell lower layer is all lost at the fat cell of plexi in outer connective tissue layer.
Collagenous fibres and elastic fibers structural integrity in fibrous layer form firm cross-linked structure, mechanical strength between collagen molecules
It significantly improves, breaking strength can reach 2.45kg/mm2.After crosslinking Treatment, eliminate a large amount of soluble protein in biomembrane,
Antigenic group is covered and has been blocked in mucopolysaccharide and glycoprotein, the crosslinking of collagenous fibres, substantially reduces its antigenicity.
Geniposide is a kind of natural crosslinking Treatment liquid, can react with amino acid and generate blue pigment, because of its nontoxicity
And the dyestuff as food, toxicity are a ten thousandths of glutaraldehyde.Therefore, the biomaterial of genipin cross-linked is more suitable for clinic
Using.
Wherein, in the pretreatment of outsourcing film base material, specifically includes the following steps:
De- cell cleaning: with distilled water immersion, it is disintegrated haemocyte, physiological saline soaking and washing；
Cleaning by degreasing: degreasing in absolute alcohol, physiological saline soaking and washing are immersed；
Remove excess tissue: the tissue of the removal uniform tensile capacity difference of became uneven obtains rough lumber.
In a preferred embodiment, outsourcing film base material curing process, specifically includes the following steps:
Pretreated outsourcing film base material is immersed in crosslinking Treatment liquid with flat, crosslinking Treatment liquid is containing crosslinking agent
Alcoholic solution, alcohol concentration is 40%~75%, and the concentration of crosslinking agent is 0.1%~2%, PH5.0~7.0, maintains temperature
It 15 DEG C~35 DEG C, shakes 3~35 days；
Thickness, elasticity and the non-uniform material of hardness are removed, smart material is obtained.
Compared with prior art, advantage of the present invention are as follows:
1. surface is smooth, in operative process, adhesion can be reduced and be organized, is easily placed in flesh cone, is reduced and plant
The fashionable damage to ball week tissue；
2. ball material use silica gel or hydrogel, density low-quality it is soft, weight is small, thus reduce it is postoperative because gravity sink
Or deviation；
3. the peplos Jing Guo crosslinking Treatment, intensity and toughness are big, can suture and be coupled with rectus not-go-end, and it is convenient to operate,
And the mobility of artificial eye holder can be increased；
4. histocompatbility is good, conjunctiva wound is easy healing, and no antigen is not easy to be degraded and absorbed, no after being implanted into human body
Rejection is generated, the generation of the complication such as rejection exposure and infection is reduced, for Artificial eye comfortable wearing and increases ocular prosthesis
Flexibility lays a good foundation.
The invention is not limited to above-mentioned preferred forms, and anyone should learn that is made under the inspiration of the present invention
Structure change, the technical schemes that are same or similar to the present invention are fallen within the scope of protection of the present invention.
Claims (9)
1. a kind of compound artificial eye holder characterized by comprising
Sphere, using silica gel or hydrogel, the diameter 16mm~24mm；
Peplos is wrapped in the periphery of the sphere, using the biomembrane of crosslinked processing, with a thickness of 0.2~0.8mm, fracture
Intensity reaches 1~5kg/mm2。
2. compound artificial eye holder according to claim 1, which is characterized in that be labeled with and be used for and rectus on the peplos
Suture the suture site being coupled.
3. compound artificial eye holder according to claim 1, which is characterized in that the biomembrane is using animal pericardium, hard
Meninx.
4. compound artificial eye holder according to claim 1, which is characterized in that the biomembrane is taken from pig, ox or sheep.
5. the preparation method of compound artificial eye holder according to claim 1, which comprises the following steps:
The selection of outsourcing film base material: the biomembrane tissue through slaughtered animals of quarantining is selected；
The pretreatment of outsourcing film base material: de- cell cleaning, cleaning by degreasing remove excess tissue；
Outsourcing film base material curing process: immerse in the closed vessel of crosslinking treatment fluid, substrate weight: solution weight be 1:3~
5, concussion is rocked, and the degree of cross linking is made to reach 60%~95%, obtains peplos；
Sphere production: silica gel or hydrogel are used, diameter is fabricated to spherical shape according to demand；
Combined processing: sphere is wrapped up using peplos, sutures tying；
Packaging sterilizing: sealed package is packaged, and is chemically or physically sterilized to get finished product is arrived.
6. preparation method according to claim 5, which is characterized in that after the pretreatment of outsourcing film base material, first carry out compound
Processing, then carries out curing process for outsourcing film base material and sphere together.
7. preparation method according to claim 5, which is characterized in that in outsourcing film base material curing process, crosslinking Treatment liquid
For Geniposide or glutaraldehyde.
8. preparation method according to claim 5, which is characterized in that in the pretreatment of outsourcing film base material, specifically include following
Step:
De- cell cleaning: with distilled water immersion, it is disintegrated haemocyte, physiological saline soaking and washing；
Cleaning by degreasing: degreasing in absolute alcohol, physiological saline soaking and washing are immersed；
Remove excess tissue: the tissue of the removal uniform tensile capacity difference of became uneven obtains rough lumber.
9. preparation method according to claim 5, which is characterized in that outsourcing film base material curing process specifically includes following
Step:
Pretreated outsourcing film base material is immersed in crosslinking Treatment liquid with flat, crosslinking Treatment liquid is the wine containing crosslinking agent
Smart solution, alcohol concentration are 40%~75%, and the concentration of crosslinking agent is 0.1%~2%, PH5.0~7.0, maintain 15 DEG C of temperature
It~35 DEG C, shakes 3~35 days；
Remove thickness, elasticity and the non-uniform material of hardness.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910583206.4A CN110338941B (en) | 2019-07-01 | 2019-07-01 | Composite type artificial eye table and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910583206.4A CN110338941B (en) | 2019-07-01 | 2019-07-01 | Composite type artificial eye table and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN110338941A true CN110338941A (en) | 2019-10-18 |
| CN110338941B CN110338941B (en) | 2024-07-26 |
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| CN201910583206.4A Active CN110338941B (en) | 2019-07-01 | 2019-07-01 | Composite type artificial eye table and preparation method thereof |
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| CN112891022A (en) * | 2021-02-04 | 2021-06-04 | 广东省第二人民医院（广东省卫生应急医院） | Artificial eye and manufacturing method thereof |
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| CN110338941B (en) | 2024-07-26 |
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