CN110025402A - Artificial cornea containing biomaterial - Google Patents
Artificial cornea containing biomaterial Download PDFInfo
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- CN110025402A CN110025402A CN201910422471.4A CN201910422471A CN110025402A CN 110025402 A CN110025402 A CN 110025402A CN 201910422471 A CN201910422471 A CN 201910422471A CN 110025402 A CN110025402 A CN 110025402A
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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
- A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
- A61F2/142—Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
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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
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea
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- Transplantation (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
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- Oral & Maxillofacial Surgery (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Ophthalmology & Optometry (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a kind of artificial corneas containing biomaterial comprising opticator and biomaterial component, above-mentioned biomaterial component are made of biomaterial, and above-mentioned biomaterial includes autologous material and/or non-autologous material.Novel artificial cornea of the invention has good biocompatibility, optical property and mechanical strength performance, suitable for the various complicated and blind treatments of reporting on completion of a task of severe corneal, can use autologous patient cornea can also do carrier using donor's cornea, and large-scale promotion is facilitated to use.
Description
Technical field
The present invention relates to pharmaceutical technology fields, and in particular to a kind of novel artificial cornea containing biomaterial.
Background technique
According to World Health Organization (WHO) 2009, the whole world about corneal blindness patient 8,000,000.There are about 300 in China
Ten thousand corneal blindness patients.Penetrating keratoplasty is the means of mainly recovering lost eyesight of current corneal blindness, and low 5 years success rates of danger lesion are reachable
70%.But for the high risk cases with volume cornea rebirth blood vessel etc., success rate is 50% hereinafter, especially for severe acid
The serious scar of cornea caused by the chemical burns such as alkali, vascularization, the eyelid that can not restore caused by infection or immunity disease or
Conjunctival sac dysfunction, such as completeness closed atretoblepharia, Steven-Johnson syndrome (SJS), eye cicatricial class day
Blister sore (ocular cicatricialpemphigoid, OCP), and repeatedly corneal transplantation failure is newborn with serious plant bed
Corneal blindness caused by vascularization etc., corneal graft can not succeed, clinically referred to as terminal phase corneal blindness, can not pass through cornea
Transplanting, which is realized, recovers lost eyesight, and terminal phase corneal blindness is not only Major health problems and social concern, brings greatly to personal, family
Pain, social economical burden are heavy.Application of keratoprosthesis for corneal opacity unsuitable for keratoplasty is its uniquely recover lost eyesight means and method.
Artificial cornea (Keratoprosthesis, Kpro) is to play its optics and biology function for substituting pathological corneas
The artificial apparatus of energy is the means of finally recovering lost eyesight that can not use the opacity of the cornea patient that operation on cornea is recovered lost eyesight.To reach ideal light
Learn effect, artificial cornea mostly uses through at present, i.e., artificial cornea opticator penetrates through cornea holostrome, by bracket by optics
Part is fixed on Central corneal, one of most important clinical indices of artificial cornea be exactly in bit rate, in the past various artificial corneas by
It being infected in histolysis, foreign body reaction etc. can cause artificial cornea to be discharged, and because of artificial cornea opticator and peripheral bracket and group
It knits and has certain gap between structure.Clinically, between artificial cornea and surrounding tissue there are potential lacuna, can not biological combination,
It is dangerous to increase artificial cornea discharge, also increases microorganism into intraocular chance, may cause artificial cornea severe postoperative
Complication-infectious endophthalmitis, seriously threaten visual function.
Since Quengsy (1789) propose the manually concept of cornea, the research and application of artificial cornea are achieved
Remarkable progress.Have in the world using more artificial cornea at present: Boston artificial cornea I type, II type (Dohlman C,
Harissi-Dagher M.Digital J Ophalmol.2007;13:3.), United States Patent (USP) US5354332A disclose with
PMMA is the artificial cornea skirt hanger of material, and novel B oston KPro replaces PMMA hub disk (Cruzat with titanium alloy hub disk
A.et al.Cornea.2013;32 (12): 1531-1536.), there are also bone flute profile artificial cornea (Osteo-
Odonotokeratoprosthesis, OOKP) (Tan, X.W., et al.Invest Ophthalmol Vis Sci,
2011.52 (1): p.21-9.) and Russia's MICOF artificial cornea (Huang, Y.et al.Ophthalmology, 2011.118
(1):p.41-6.)。
Although these materials can form bracket, there are still more problems in practical applications.Case is applied most in the whole world at present
More is Boston I type, which is made of PMMA material, and indication is multiple corneal transplantation failure case, right
In terminal phase corneal blindness patient because its tear and ocular condition are poor, the severe complications such as corneal solution easily occur.Boston people
Work cornea needs corneal graft to do carrier.II type of Boston artificial cornea, OOKP and MICOF artificial cornea are suitable for the terminal phase
Corneal blindness, best in bit rate with OOKP artificial cornea, longest is kept more than 20 years, and those skilled in the art generally believe dentale
Vascularity abundant for artificial cornea be indispensable in bit rate.But its human teeth used and bone tissue
Bending strength is low, and in use it is not easy to operate, preparation is difficult, operation is complicated, donor site damage is larger, need individual processing and cannot
The factors such as batch production limit the clinical expansion of such artificial cornea.And hydrogel artificial cornea then lacks enough pressure resistances
Degree, and height is required to ocular and tear condition, be not suitable for such patient.Therefore the artificial cornea for disadvantages mentioned above can be overcome
There are still needs.
Summary of the invention
In conclusion still having good biocompatibility concurrently there is an urgent need to one kind in the prior art and there is good biological
Mechanical property, the artificial cornea abundant with bending strength and compression strength, source.
It is a primary object of the present invention to overcome drawbacks described above present in existing artificial cornea, provide a kind of containing life
The artificial cornea and method for implantation of object material reduce artificial cornea and were using to enhance the bio-integration of artificial cornea
Discharge and reduction infection rate in journey.
The present inventor to achieve the goals above, autologous material, non-of the discovery selected from for example, self cartilage after study
Self cartilage, bovine pericardium, tissue engineering material, any one or a few non-in de- cell material and polymeric biomaterial
The biomaterial of autologous material, has certain bioactivity and biomechanics characteristic, using these biomaterials as artificial
Component in operation on cornea can reinforce the infringements such as the dissolution of artificial cornea surrounding tissue resisted organize, infection, enhance artificial cornea
Bio-integration, reduce artificial cornea use process in infection rate.
The present invention causes using autologous material and/or non-autologous material as the reinforcement material of artificial cornea, reduction optical frames column
Foreign body reaction, avoid the expansion of long-term optical frames column and surrounding tissue gap in vivo, the adjustable design of fixed disk can
It is completely embedded mirror column with surrounding tissue, reduces the microorganisms such as bacterium and enter infection rate in intraocular secondary eye, to reach
Better bio-compatible performance, mechanical strength and surgical effect.
To achieve the above object, the present invention can take following technical proposals:
One aspect of the present invention provides a kind of artificial cornea containing biomaterial comprising opticator and biological material
Expect that component, above-mentioned biomaterial component are made of biomaterial, above-mentioned biomaterial includes autologous material and/or non-self material
Material.
By using above scheme, the biocompatibility of artificial cornea can be improved, can eliminate opticator and periphery
Existing gap between bracket and institutional framework, the infection rate in use process so as to reduce artificial cornea, enhancing
The bio-integration of artificial cornea.
In a specific embodiment, above-mentioned opticator penetrates above-mentioned patient's cornea when being implanted into patient's cornea,
Above-mentioned biomaterial component substitutes patient's cornea or the front surface positioned at above-mentioned patient's cornea when being implanted into patient's cornea, wherein
The fixed form of artificial cornea is fixed before wearing formula after including and is fixed after before wearing formula.
In a specific embodiment, above-mentioned opticator includes optical frames column and connect with above-mentioned optical frames column
The material of other parts, the material and optical frames column of above-mentioned other parts is identical or different, and above-mentioned opticator is implanted into patient's body
It can play the role of optical effect after interior, above-mentioned other parts play fixed above-mentioned optical frames column, preferably above-mentioned other parts
Including supporting table and/or fixed disk, worn after when fixing before formula, above-mentioned other parts further include upper ring, fixed after preceding wearing formula
When, above-mentioned other parts further include lock.
In one preferred embodiment, opticator is fixed using adjustable fixed disk design.Adjustable fixed ring
It is to refer to be adjusted according to the thickness of patient's cornea and tissue to fix the ring of front and back disk, this avoid different patient angles
The case where film, difference caused the gap of artificial cornea.
In a specific embodiment, above-mentioned autologous material is self cartilage, and preferably Auricular cartilage is above-mentioned non-
Autologous material is non-self cartilage, tissue engineering material, de- cell material, compound stem cell into cartilage and polymeric biomaterial
In any one or a few.
In a specific embodiment, above-mentioned non-self cartilage is non-Auricular cartilage, above-mentioned tissue engineering material
For tissue engineered bone or cartilage, above-mentioned de- cell material is Acellular bone tissue or cartilaginous tissue, and above-mentioned compound stem cell is at soft
Compound stem cell used in bone is various Derived Stem Cells, preferably mescenchymal stem cell, embryonic stem cell or induced multi-potent
Stem cell.
In a specific embodiment, above-mentioned optical frames column is by being selected from poly hydroxy ethyl acrylate, poly- methyl-prop
At least one of e pioic acid methyl ester, Silica hydrogel, glass material is made, preferably by the other polymethyl methacrylate of medical grade
(PMMA) material is made.
In a specific embodiment, it is original all to substitute patient when being implanted into patient's cornea for above-mentioned optical frames column
Or partial plate layer and/or Full-thickness corneal.
In a specific embodiment, above-mentioned other parts are and above-mentioned optical frames column one or what is be connected play
Optical frames column is fixed on to the structure of the effect of eye.
In a specific embodiment, above-mentioned artificial cornea is combined type artificial cornea.Preferred embodiment is above-mentioned multiple
Box-like artificial cornea include screwed optical frames column, the supporting table being connected as one with optical frames column, can be with optical frames column
On the fixed disk that is spirally connected of screw thread and upper ring and/or lock ring.
Another aspect of the present invention provides the purposes that biomaterial is used to prepare in the implantation material for the treatment of corneal blindness.
The effect of invention
The advantage of the invention is that using biomaterial as artificial cornea component, inflammatory reaction is slight, reduces optical section
Foreign body reaction caused by point, makes opticator and surrounding tissue achieve the purpose that biointegration, so that it is steady for a long time to increase people's cornea
It is qualitative and in bit rate, the gap of opticator and surrounding tissue is reduced, the microorganisms such as bacterium is reduced and enters intraocular chance.And
Above-mentioned biomaterial has certain bioactivity and biomechanics characteristic, can be tightly combined with opticator, artificial cornea
Possessed inherent characteristic is still kept, and achievees the effect that treatment, nursing best.
Novel artificial cornea disclosed by the invention have good biocompatibility optical property and mechanical strength performance and
Large-scale promotion is facilitated to use.
Detailed description of the invention
Fig. 1 (a)~(f) is first embodiment of the invention containing fixing artificial cornea before wearing formula after biomaterial
Structural schematic diagram, wherein Fig. 1 (a) is the side view of the optical frames column with supporting table, and Fig. 1 (b) is the optical frames column with supporting table
Top view, Fig. 1 (c) be artificial cornea fixed disk perspective view, Fig. 1 (d) be artificial cornea upper ring perspective view, Fig. 1
It (e) is the completed assembled figure of the opticator of artificial cornea, Fig. 1 (f) is the implementation result figure of artificial cornea in vivo.
Fig. 2 (a)~(g) is second embodiment of the present invention containing fixing in artificial cornea after wearing formula before biomaterial
Structural schematic diagram, wherein Fig. 2 (a) is the side view of optical frames column, and Fig. 2 (b) is the perspective view of preceding fixed disk, and Fig. 2 (c) is
The perspective view of fixed disk afterwards, Fig. 2 (d) are the perspective view of lock ring, and Fig. 2 (e) is the completed assembled figure of the opticator of artificial cornea,
Fig. 2 (f) is the artificial cornea completed assembled cross-sectional view of the line A-A of Fig. 2 (e), and Fig. 2 (g) is implementation result figure in artificial cornea body.
Fig. 3 (a)~(b) is the photo of state after indicating the implementation of other artificial corneas, and Fig. 3 (a) is without biomaterial
Russia produces the photo of 3 months brackets exposure after artificial cornea bracket (1 type artificial cornea of Boston) implantation, and Fig. 3 (b) is to make
Artificial cornea bracket (1 type artificial cornea of Boston) long-term photo in place is produced with the Russia of Ear cartilage reinforcing and repairing.
Fig. 4 is of the invention each containing the opticator worn in the actual product for fixing artificial cornea before formula after biomaterial
The photo of a component.
Specific embodiment
Artificial cornea containing biomaterial of the invention comprising opticator and biomaterial component, above-mentioned biology material
Material component is made of biomaterial, and above-mentioned biomaterial includes autologous material and/or non-autologous material.
It is mostly in the past polymethyl methacrylate (PMMA), titanium alloy etc materials for biological response of synthetic materials used for keratoprosthesis.These
Material is respectively present insufficient poor biocompatibility, resistance to compression and bending strength, operation complexity and limitation large-scale promotion application
The defects of.And the present inventor in a creative way for the first time using autologous material and/or non-autologous material manufacturing artificial cornea bracket and
Reinforcement material, cartilage never be used to or report make for the bracket of artificial cornea in the past.First demonstration that and effectively
Using autologous material and/or non-autologous material manufacturing artificial corneal stent and reinforcement material.
There is good biocompatibility to close biomechanics characteristic for autologous material and/or non-autologous material, meet artificial angle
Biological nature needed for film and physicochemical property, and material source is sufficient, affordable.
In a specific embodiment, above-mentioned self cartilage is preferably Auricular cartilage, and above-mentioned non-autologous material is
Non- self cartilage, tissue engineering material, de- cell material, compound stem cell are at any one in cartilage and polymeric biomaterial
Kind is several, wherein above-mentioned non-self cartilage is non-Auricular cartilage, and above-mentioned tissue engineering material is tissue engineered bone or soft
Bone, above-mentioned de- cell material are Acellular bone tissue or cartilaginous tissue, and above-mentioned compound stem cell is at composite dry used in cartilage
Cell is various Derived Stem Cells, preferably mescenchymal stem cell, embryonic stem cell or is induced multi-potent stem cell.It is above-mentioned non-self
The particularly preferably de- cellular cartilage of material and compound stem cell at cartilage,
Wherein, the tissue that tissue engineering material, de- cell material can be used may come from mankind or animal, such as skin
Skin, pleuroperitoneum, esophageal mucosa membrane, mucous membrane of small intestine, pericardium, blood vessel, nerve, heart valve, bone, cartilage, tendon, amnion, placenta
Deng obtaining de- cell tissue, after the process such as inactivation of virus, degreasing, de- cell for a kind of cell-free three-dimensional netted knot
Structure tissue retains extracellular matrix components.Those of ordinary skill in the art, which understand, prepares cell free method.Than even more preferably
The tissue of ox, pig or people.
Tissue engineered bone or cartilage refer to the bone or cartilage synthesized by organizational project, Acellular bone tissue or cartilage group
It knits and refers to by the bone tissue or cartilage group of non-immunogenicity or low immunogenicity after method chemically or physically removes cell
It knits, polymeric biomaterial includes cellulose, chitin, hyaluronic acid, collagen, gelatin and sodium alginate, polyurethane, silicon
Rubber, polyester fiber, polyvinylpyrrolidone, polyether-ether-ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, poly- second
Alkene etc..Stem cell (in vitro or in body) is the cartilage formed using stem cell composite biological material at cartilage, and wherein stem cell is
Various Derived Stem Cells, preferably mescenchymal stem cell, embryonic stem cell induce multi-potent stem cell.
In a specific embodiment, above-mentioned opticator penetrates above-mentioned patient's cornea when being implanted into patient's cornea,
Above-mentioned biomaterial component can substitute patient's cornea or the front surface positioned at above-mentioned patient's cornea when being implanted into patient's cornea.
The two kinds of fixed forms fixed after formula are fixed and before worn to the fixed form of artificial cornea before wearing formula after may include.Afterwards
Fixed before formula as shown in Figure 1, main fixation member (such as: upper ring) is worn in anterior corneal surface, it is preceding wear it is fixed after formula as shown in Fig. 2,
Main fixation member (such as: lock) is inside cornea or later.
In a specific embodiment, above-mentioned opticator include optical frames column and connect with optical frames column other
The material of part, above-mentioned other parts is identical as the material of optical frames column, and above-mentioned opticator can rise after being implanted into the patient
To optical effect, above-mentioned other parts play the role of fixed optical frames column.
In one preferred embodiment, above-mentioned other parts include supporting table and/or fixed disk, are consolidated before formula is worn after
Periodically, above-mentioned other parts further include upper ring, and when fixing after preceding wearing formula, above-mentioned other parts further include lock.
Wherein, threaded in upper ring, upper ring is located at the most surface of artificial cornea, can prevent surrounding tissue from growing into, artificial angle
The surface of film forms artificial cornea cephacoria.Upper ring can be made of inorganic material identical with mirror column material, preferably PMMA.
Lock is the structure of fixed entire artificial cornea, buckle structure enter it is fixed after the card slot of mirror column, before preventing
The structure of fixed disk is slipped from mirror column afterwards.Lock can be made of metals such as titaniums.
Above-mentioned optical frames column can be by being selected from poly hydroxy ethyl acrylate, polymethyl methacrylate, Silica hydrogel, glass
At least one of material be made, be preferably made of the other polymethyl methacrylate of medical grade (PMMA) material.
In a specific embodiment, the above-mentioned other parts connecting with optical frames column are supporting table and/or fixation
Disk, preferably above-mentioned fixed disk can be made of PMMA or titanium alloy material, i.e., fixed disk can be PMMA or titanium dish.
In a specific embodiment, it is original all to substitute patient when being implanted into patient's cornea for above-mentioned optical frames column
Or partial plate layer and/or Full-thickness corneal.Although cornea is very thin, this body structure of cornea can be divided into corneal epithelium again from outside to inside
Layer, bowman's lamina, hypothallus, descemet's membrane, corneal endothelial layer, wherein lamellar keratoplasty is the portion of tissue with cornea
For the operation that operation object carries out, only excision has the cornea shallow layer tissue of lesion, and the more intact acceptor's cornea of deep layer is still protected
It gives over to as transplant bed, then takes onesize and thickness corneal material shallow-layer corneal film, be sewn on the surface of a wound of patient's cornea.
In a specific embodiment, can use autologous patient cornea can also do carrier using donor's cornea,
Donor's cornea and expense can be saved using autologous patient cornea, it is serious or when thickness is insufficient in patient's corneal lesion, it can
To do carrier using donor's cornea, including glycerol saves or other de- cell xenogenesis intrastromal corneals.
In a specific embodiment, above-mentioned other parts are and optical frames column one or what is be connected play fixation
Structure of the optical frames column in the effect of eye.
In a specific embodiment, with craft or area of computer aided 3D cutting mode, by autologous material and/or non-
Autologous material presses certain corneal curvature design form excision forming, can be round, ellipse or all kinds of irregular forms, can be
Various thickness, the hole containing different-diameter can be the type of being integrated that is bonded into optics cylindrical mirror, or at similar cornea/artificial angle
It is used in front of membrane support as reinforcement material.Autologous material and/or non-autologous material are in vivo and in vitro at cartilage process in the present invention
The middle amendment for having carried out suitable eye microenvironment feature and avoid degradation caused by cartilaginous tissue volume reduce and dissolution,
Solve the problems, such as the long-term rear Forward in place of artificial cornea bracket and discharge.
In a specific embodiment, above-mentioned artificial cornea is combined type artificial cornea, and combined type artificial cornea is
Refer to the artificial cornea comprising above-mentioned biomaterial and organic material.
In a specific embodiment, above-mentioned combined type artificial cornea includes screwed optical frames column and light
Learn the mirror column supporting table being connected as one, the fixed disk that can be spirally connected with the screw thread on optical frames column and upper ring and/or lock ring knot
Structure.Wherein, upper ring is that have band internal thread annular component, primarily to do preceding fixation, and lock ring is primarily to carry out
After fix, be a kind of embodiment of above-mentioned lock.
Hereinafter, referring to attached drawing, detailed description of embodiments of the present invention.
Fig. 1 (a)~(f) is first embodiment of the invention containing fixing artificial cornea before wearing formula after biomaterial
Structural schematic diagram, Fig. 1 (a) are the side view of the optical frames column with supporting table, and Fig. 1 (b) is bowing for the optical frames column with supporting table
View, Fig. 1 (c) are the perspective view of the fixed disk of artificial cornea, and Fig. 1 (d) is the perspective view of the upper ring of artificial cornea, and Fig. 1 (e) is
The completed assembled figure of artificial cornea opticator, Fig. 1 (f) are the implementation result figure of artificial cornea in vivo.
In the first embodiment, as shown in Fig. 1 (a) and Fig. 1 (b), the optical frames column in opticator can be to plant
When entering patient's cornea positioned at the inside or interlayer of above-mentioned patient's cornea part the biggish optical frames column of outer diameter, such as can be
The screwed cylindrical-shaped structure of multistage cylindrical-shaped structure or outer surface, the supporting table for being used to support artificial cornea can be with optics
Mirror column is connected as one, and optical frames column can be by being selected from poly hydroxy ethyl acrylate (PHEMA), polymethyl methacrylate
(PMMA), Silica hydrogel, any materials in glass are constituted, and are preferably made of the other polymethyl methacrylate materials of medical grade.
Fig. 1 (c) is the perspective view of the fixed disk of artificial cornea, can be PMMA or titanium dish, and fixed disk can be for porose company
Continuous cyclic structure, wherein hole number is unlimited, can also not have hole, diameter is unlimited, distribution is unlimited.It can be three equally distributed rings
Shape closes button loop structure, also closes button loop structure for two equally distributed ring-types.It is implanted into inter-lamination of cornea for performing the operation, it can be according to cornea item
Part is fastened with a rope, string, etc. using two or more buttons loop design, and suitable with cornea radian, center is compared for platform-like with previous artificial cornea can maximum limit
Degree reduces the area of inter-lamination of cornea separation, retains the intensity of cornea tissue, increases the stability of artificial cornea, facilitate artificial cornea
The repairing and reset of preceding layer tissue, convenient for suturing the operation such as fixed with suture.
Fig. 1 (d) is the perspective view of the upper ring of artificial cornea, upper ring worn after being fix before formula artificial cornea for it is fixed manually
The component of cornea, upper ring can within it is threaded, and be spirally connected with optical frames column, be located at cornea most surface, surrounding tissue can be prevented long
Enter, artificial cornea surface forms artificial cornea cephacoria.
Fig. 1 (e) is the completed assembled figure of artificial optics of cornea part, it can be seen that it is internally gone from outer corneal surface,
Successively there is upper ring, fixed disk and supporting table on optical frames column.
Fig. 1 (f) is the implementation result figure of artificial cornea in vivo.As shown in Fig. 1 (f), opticator is at implantation patient angle
Patient's cornea is penetrated when film, biomaterial component is when being implanted into patient's cornea positioned at the outer surface of patient's cornea.Specifically, branch
Support platform is located on rear side of cornea, and fixed disk is located on front side of cornea, and rear side herein is referred to as inside, i.e., internal side, front side
It is properly termed as outside, i.e., external side.And biomaterial component is located at and is more leaned on front side of cornea than fixed disk, before upper ring is located at cornea most
Side, and it is located at the outer surface of conjunctiva or skin.
The plan view shape of biomaterial component is round, ellipse or all kinds of irregular forms, can be various thickness, can
Hole containing different-diameter can be the type of being integrated that is bonded into optics cylindrical mirror, or make in front of similar cornea/artificial cornea bracket
For reinforcement material use.Biomaterial component is made of above-mentioned biomaterial, and above-mentioned biomaterial includes autologous material and/or non-
Autologous material.Above-mentioned autologous material is self cartilage, and above-mentioned self cartilage can be Auricular cartilage, and above-mentioned non-autologous material is
Non- self cartilage, tissue engineering material, de- cell material, compound stem cell are at any one in cartilage and polymeric biomaterial
Kind is several, wherein above-mentioned non-self cartilage is non-Auricular cartilage, and above-mentioned tissue engineering material is tissue engineered bone or soft
Bone, above-mentioned de- cell material are Acellular bone tissue or cartilaginous tissue, and above-mentioned compound stem cell is at composite dry used in cartilage
Cell is various Derived Stem Cells, for mescenchymal stem cell, embryonic stem cell or can be induced multi-potent stem cell.Wherein, in figure
Tensor capsule refer to subconjunctival tissue.
Fig. 2 (a)~(g) is second embodiment of the present invention containing fixing in artificial cornea after wearing formula before biomaterial
Structural schematic diagram, wherein Fig. 2 (a) be optical frames column side view, Fig. 2 (b) be preceding fixed disk perspective view, after Fig. 2 (c) is
The perspective view of fixed disk, Fig. 2 (d) are the perspective view of lock ring, and Fig. 2 (e) is the completed assembled figure of the opticator of artificial cornea, figure
2 (f) be the artificial cornea completed assembled cross-sectional view of the line A-A of Fig. 2 (e), and Fig. 2 (g) is implementation result figure in artificial cornea body.
The artificial cornea of second embodiment of the present invention fixes artificial cornea, optical frames column such as Fig. 2 after wearing formula before being
It (a) is the screwed cylindrical-shaped structure in outer surface without supporting table shown in.Before wear and fix artificial cornea after formula and can have
There are preceding fixed disk and rear fixed disk, wherein Fig. 2 (b) is the perspective view of preceding fixed disk, and Fig. 2 (c) is the perspective view of rear fixed disk,
The Nomenclature Composition and Structure of Complexes of preceding fixed disk and rear fixed disk can be identical as the fixed disk of first embodiment of the invention.Fixed disk afterwards
Size and thickness with preceding fixed disk can not be identical, such as the diameter of fixed disk can be less than the diameter of preceding fixed disk afterwards, after
The thickness of fixed disk can be greater than the thickness of preceding fixed disk.
Fig. 2 (d) is the perspective view of lock ring.Lock ring structure enters fixed after the card slot of mirror column, prevents rear fixed disk
Structure is slipped from mirror column.Lock can be made of metals such as titaniums.
Fig. 2 (e) is the completed assembled figure of the opticator of artificial cornea, and Fig. 2 (f) is the cross-sectional view of the line A-A of Fig. 2 (e),
By Fig. 2 (f) it can be seen that internally being gone from outer corneal surface, i.e., direction from top to bottom, successively has on optical frames column in figure
There are upper ring, preceding fixed disk, rear fixed disk and lock ring.
Artificial cornea can be using rear fixed disk and the integrated design of lock when assembling, such as such as does in rear fixed disk
One c-type design, the design of lock is placed in rear fixed disk.
Fig. 2 (g) is implementation result figure in artificial cornea body, and opticator penetrates patient's cornea when being implanted into patient's cornea,
Biomaterial component is when being implanted into patient's cornea positioned at the outer surface of above-mentioned patient's cornea.Opticator include optical frames column and with
The other parts of optical frames column connection, the other parts can be above explained various fixed structures, in implantation patient's cornea
When inside and outside above-mentioned patient's cornea/donor's cornea and/or self/allosome biomaterial, thereby, it is possible to make optical frames
Column is firmly secured to, and when preventing patient's intraocular pressure from increasing, artificial cornea falls off, and reduces the gap of opticator and surrounding tissue, into
One step reduces the microorganisms such as bacterium and enters intraocular chance.The material of above-mentioned other parts it is identical as the material of optical frames column or by
Other biological describing property material is made, and above-mentioned opticator can play optical effect and/or fixed light after being implanted into the patient
Learn the effect of mirror column.Above-mentioned optical frames column can substitute the original all or part of plate layer of patient when being implanted into patient's cornea
And/or Full-thickness corneal.Above-mentioned other parts are and optical frames column one or what is be connected play fixed optical frames column in eye
The structure of effect.
Fig. 3 (a)~(b) is the photo of state after indicating the implementation of other artificial corneas, and Fig. 3 (a) is without biomaterial
Russia produces the photo of 3 months brackets exposure after artificial cornea bracket (1 type artificial cornea of Boston) implantation, and Fig. 3 (b) is to make
Artificial cornea bracket (1 type artificial cornea of Boston) surface well-grown is produced with the Russia of Ear cartilage reinforcing and repairing, is existed for a long time
The photo of position, wherein Russia produces artificial cornea itself and is free of biomaterial.As shown in Fig. 3 (a), the people without biomaterial
There is the problem of exposure (corneal solution) in work corneal stent.And by using Ear cartilage to the Russia after exposure (corneal solution)
It produces artificial cornea bracket and carries out reinforcing and repairing, as shown in Fig. 3 (b), property in place obtains a degree of improvement.However Fig. 3 (b)
For Ear cartilage reinforce 1 type artificial cornea of Boston and artificial cornea structure of the invention it is entirely different, it is by being implanted into
The Titanium button loop shape structure composition of inter-lamination of cornea, operation needs to be divided into the completion of two phases, and has the knot of artificial cornea of the invention
One phase of operation of structure, particularly the artificial cornea of opticator structure can be completed, and overcome 1 type artificial cornea of Boston
Disadvantage, and property in place is excellent.
Fig. 4 is of the invention each containing the opticator worn in the actual product for fixing artificial cornea before formula after biomaterial
The photo of a component.In figure from left to right shown in component be respectively be connected with supporting table and the threaded optical frames column of tool, on
Ring structure and the fixed disk that can be spirally connected with the screw thread on optical frames column, wherein supporting table is connected as one with optical frames column.
Wherein, fixed disk is with porose continuous annular structure, wherein can be set in fixed disk in biomaterial.
Embodiment
The present invention evaluates the implementation result of artificial cornea of the invention, exposure using the exposure of artificial cornea bracket
Namely rejection rate.The experience that II type artificial cornea of MICOF and Boston is used according to applicant implants existing without life
The artificial cornea patient of object material members being made of PMMA after surgery 5 years exposure (rejection rate) be 60%.And applicant
The implant surgery of totally 156 artificial corneas containing Auricular cartilage is carried out, exposure is only 6, under exposure after as a result 5 years
It is reduced to 3.8%.
More than, optimal embodiment of the invention is illustrated, but the present invention is not limited thereto, is not departing from this
Various modifications may be made in the range of the purport of invention.
Industrial availability
Using the artificial cornea of the invention containing biomaterial, the bio-integration of artificial cornea can be enhanced, reduce people
Infection rate in the use process of work cornea, and artificial cornea of the invention has good biocompatibility and mechanics
Strength character, therefore large-scale promotion is facilitated to use.
Claims (10)
1. a kind of artificial cornea containing biomaterial, it is characterised in that:
The artificial cornea includes opticator and biomaterial component, and the biomaterial component is made of biomaterial, institute
Stating biomaterial includes autologous material and/or non-autologous material.
2. artificial cornea according to claim 1, it is characterised in that:
The opticator penetrates patient's cornea when being implanted into patient's cornea, and the biomaterial component is when being implanted into patient's cornea
Substitute patient's cornea or the front surface positioned at patient's cornea, worn after artificial cornea it is fixed before formula or before wear it is fixed after formula
Fixed form be fixed.
3. artificial cornea according to claim 1 or 2, it is characterised in that:
The opticator includes optical frames column and the other parts that connect with the optical frames column, the material of the other parts
Identical or different with the material of the optical frames column, the opticator can play optical effect, institute after being implanted into the patient
It states other parts and plays the role of the fixed optical frames column,
It is preferred that the other parts include supporting table and/or fixed disk, worn after when fixing before formula, the other parts further include
Upper ring, when fixing after preceding wearing formula, the other parts further include lock.
4. artificial cornea biomaterial described in any one of claim 1 to 3, it is characterised in that:
The autologous material is self cartilage, preferably Auricular cartilage, and the non-autologous material is non-self cartilage, group weaver
Journey material, de- cell material, stem cell are at any one or a few in cartilage and polymeric biomaterial.
5. artificial cornea according to claim 4, it is characterised in that:
The non-self cartilage is non-Auricular cartilage, and the tissue engineering material is tissue engineered bone or cartilage, described de- thin
Born of the same parents' material is cell free bone tissue or cartilaginous tissue, and the stem cell is that various sources are dry thin at stem cell used in cartilage
Born of the same parents, preferably mescenchymal stem cell, embryonic stem cell induce multi-potent stem cell.
6. the artificial cornea according to any one of claim 3~5, it is characterised in that:
The optical frames column by poly hydroxy ethyl acrylate, polymethyl methacrylate, Silica hydrogel and glass extremely
A kind of few material is made, and is preferably made of the other polymethyl methacrylate of medical grade (PMMA) material.
7. the artificial cornea according to any one of claim 3~6, it is characterised in that:
The optical frames column substitutes patient original all or part of plate layer and/or Full-thickness corneal when being implanted into patient's cornea.
8. the artificial cornea according to any one of claim 3~7, it is characterised in that:
The other parts are that the optical frames column is fixed on eye with optical frames column one or playing of being connected
The structure of effect.
9. artificial cornea described according to claim 1~any one of 8, it is characterised in that:
The artificial cornea is combined type artificial cornea, it is preferable that the combined type artificial cornea includes screwed optics
Mirror column, the supporting table being connected as one with optical frames column, the fixed disk that can be spirally connected with the screw thread on optical frames column and upper ring
And/or lock ring.
10. biomaterial is used to prepare the purposes in the implantation material for the treatment of corneal blindness.
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Effective date of registration: 20221101 Address after: 100039 No. 69, Yongding Road, Beijing, Haidian District Patentee after: Third Medical Center, General Hospital of the Chinese PLA Address before: 100853 Department of Ophthalmology, 301 Hospital, 28 Fuxing Road, Haidian District, Beijing Patentee before: Wang Liqiang Patentee before: Huang Yifei |