CN109124826A - ophthalmic lens - Google Patents

ophthalmic lens Download PDF

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Publication number
CN109124826A
CN109124826A CN201710507219.4A CN201710507219A CN109124826A CN 109124826 A CN109124826 A CN 109124826A CN 201710507219 A CN201710507219 A CN 201710507219A CN 109124826 A CN109124826 A CN 109124826A
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China
Prior art keywords
ophthalmic lens
lens
light
extention
photosensitizer
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CN201710507219.4A
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Inventor
解江冰
王曌
田芸
隋信策
魏永吉
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EYEBRIGHT (BEIJING) MEDICAL TECHNOLOGY Co Ltd
Eyebright Medical Technology Beijing Co Ltd
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EYEBRIGHT (BEIJING) MEDICAL TECHNOLOGY Co Ltd
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Priority to CN201710507219.4A priority Critical patent/CN109124826A/en
Publication of CN109124826A publication Critical patent/CN109124826A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/14Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16Intraocular lenses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/16Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/062Photodynamic therapy, i.e. excitation of an agent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/41Anti-inflammatory agents, e.g. NSAIDs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/442Colorants, dyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0612Eyes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N2005/0635Radiation therapy using light characterised by the body area to be irradiated
    • A61N2005/0643Applicators, probes irradiating specific body areas in close proximity
    • A61N2005/0645Applicators worn by the patient

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pathology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The present invention relates to ophthalmic lens such as intraocular lens comprising: a) ophthalmic lens main part, wherein the main part includes optics area and optionally one or more light absorptions area, wherein light absorption area includes light absorber;B) optionally, one or more extentions comprising active agent are located in ophthalmic lens main part and are connected with ophthalmic lens main part, and extention width is 0.05 to 3.5mm, preferably 0.1 to 1.5mm, more preferable 0.2 to 0.8mm;Extention is with a thickness of 0.01 to 2mm, preferably 0.01 to 1mm, more preferable 0.01 to 0.7mm, wherein the interior edge of extention is greater than 2mm away from the centre distance of ophthalmic lens, wherein the ophthalmic lens include at least one of light absorption area and extention.

Description

Ophthalmic lens
Technical field
The present invention relates to medical devices, especially ophthalmic lens such as intraocular lens, more specifically, including, for example, drug or work The property extention of reagent and/or the ophthalmic lens in light absorption area.
Background technique
A variety of causes such as aging, heredity, local dystrophia, immune and metabolic disorder, wound, poisoning, radiation etc. can Cause crystalline lens metabolic disorder, cause crystallins to be denaturalized and muddiness occurs, referred to as cataract, with population in the world old-age group Change, cataract incidence and illness population are all being continuously increased.By operation, replacement intraocular lens are to treat at present Cataract most efficient method.However, patient still suffers from significant problem: posterior capsular opacification (PCO) after cataract operation. Post gelating time is mainly due to the remaining lens epithelial cells of postcataract (Lens Epithelium Cells, LECs) Along the proliferation of rear cyst wall, migration, fiber metaplasia and formed, be the most common complication that affects vision after cataract operation. Its disease incidence is in 30 ~ 50%(5 in adult), wherein there is 20%~30% patient to blind once again because of inverse position method, there is 43% Patient perform the operation again because of inverse position method, the disease incidence of After cataract in children is 100%.When the remaining lens epithelial of postcataract When along preceding cyst wall cell growth occurs for cell, capsule is muddy before generating, referred to as " ACO ".
Furthermore postoperative after intraocular lens IOL implantation to also occur that inflammatory reaction, such as infectious endophthalmitis, uveitis Deng.Therefore for cataract patient implantable artificial crystalline lens after, carry out the treatment of medicine.Using steroids and non-hormone anti-inflammatory agent Eye droppings treatment, prevention of postoperative uveitis and fibroplasia are carried out, acute iridocyclitis, upper sclerotitis, anaphylaxis are prevented Keratitis and macular edema etc..Cooperate ofloxacin eye drops simultaneously, inhibits bacterial conjunctivitis, keratitis, dacryocystitis, postoperative The infection such as infection.Inflammation is treated by the way of eye droppings there are intraocular chemical concentration is periodically higher, fluctuates larger, cannot be stablized Sustained anti-microbial is anti-inflammatory, due to needing the operation and cooperation of patient, the inconvenience of life is increased to patient, increases burden of patients.It is existing There is technology to treat established PCO by laser Posterior capsulotomy, laser Posterior capsulotomy may some adverse conditions of product, due to Capsule destroys natural barrier after incision, causes postoperative complication, including intraocular implants' bulk damage, postoperative intraocular pressure raising, macular edema, Detachment of retina and Dislocated IOL etc., therefore, for PCO, people strive to find prevent its formed approach and Method.
The method of prevention at present and/or treatment PCO are generally started in terms of several: the design of intraocular lens, operation behaviour Make the improvement of mode, artificial lens carries the methods of medicine, laser Posterior capsulotomy.
In the design aspect of intraocular lens, sharp, square edges are used in intraocular lens optic, as the U.S. is special Benefit 6162249 and 6468306, has proved to be a kind of method that post gelating time can be effectively reduced, because this design can hinder Gear Lens Epithelial Cells move between the rear surface of intraocular lens and rear capsule (referring to the article of Buehl et al., Journal Of Cataract and Refractive Surgery, volume 34,1976-1985.In in recent years, there are many work to use for the industry In forming the IOL with sharp rear edge, to generate sharp discontinuous bending part in rear cyst wall, as the U.S. Nishi is special Benefit 5171320, Woffinden United States Patent (USP) 5693093, CN1310625C, CN1684643, CN102711666A, CN201888856U。
Similar design further includes patent CN1856281, and it discloses a kind of intraocular lens, is set in optic periphery Have a sharp bevel edge, the sharp bevel edge the segmental arc that limits of engaging portion between button loop and optical section at link position prolong It stretches;Patent CN2626458Y, a kind of intraocular lens of careless mistake are it is characterized in that the of common intraocular lens' non-optic portion Two faces edge increase by a raised step, to block the migration of epithelial cell to grow, after reaching prevention implantation of artificial lens The problem of post gelating time;CN2717403Y devises a kind of Sigma intraocular lens, by the side of intraocular lens' optical lens Edge design is processed as the wedge shape being inwardly recessed, and a kind of sharp bevel edge, after being similar to Greek alphabet Σ prevention from the side While capsule muddiness, dazzle is prevented.
This field research reduces the risk of post gelating time also by crystalline lens material design is changed.Referring to " the third of Mandle Olefin(e) acid intraocular lens' ratio PMMA, siloxanes IOL cause less post gelating time " ophthalmology news, the phase of volume 14 15, page 23 (1996).And " relationship between artificial lens biomaterial and posterior capsule opacification " (Relationship of Ursell et al. Between Intraocular Lens Biomaterials and Posterior Capsule Opacification. J. Cataract. Refract. Surg., 24:352-360,1998) and patent CN1188178C by change crystalline lens material Material mode reduces posterior capsular opacification risk, including front surface layer and different from the rear surface layer of front surface layer.
Carry in prescription formula in intraocular lens, a kind of mode carry it is medicinal prevent post-operation inflammatory and microorganism infection, be each Class antibiotic, steroidal anti-inflammatory medicine and non-steroidal anti-inflammatory drugs, as patent CN2531755Y " slow-releasing agent carried artificial lens " are open A kind of slow-releasing agent carried artificial lens punch on artificial lens button loop, filled with sustained release agent drug for preventing in hole Intraocular inflammation after implantation of artificial lens;It is slow that CN104434811A discloses a kind of drug that can be embedded on intraocular lens' button loop Microballoon is released, postcataract microorganism infection, antagonism inflammatory reaction, prevention are effectively prevented and inhibits After Cataract.It is another Kind is to eliminate LEC by carrying lens epithelial cells target agent or inhibit the mitosis of epithelial cell, including anti-generation It thanks class drug and mitotic inhibitor, the drug immunotoxin of inhibition inflammatory reaction and cytotoxin, inhibit cell and cell The drug of epimatrix adherency induces cell apoptosis drug.As the United States Patent (USP) 5620013 of Bretton " is destroyed on remaining crystalline lens The method of chrotoplast ", United States Patent (USP) 4918165 propose to prevent posterior capsular opacification using methotrexate (MTX);United States Patent (USP) US5576345A Posterior capsular opacification is prevented using taxol, further includes the patented technology of following discloses.
Chitosan-polyacrylic acid is prepared fluorouracil nano particle preparations by patent CN100553692C, mixing Coating increases intraocular lens' biocompatibility on PMMA intraocular lens surface, prevents the generation of PCO and ACO; Anti-cell proliferation agents are coated on artificial lens by CN101053680B using polymeric coating material, can slow release drug To pouch and ambitus cell, inhibit the growth of Lens Epithelial Cells, prevents and treats the formation of inverse position method;Patent CN101269240B, Disclose a kind of intraocular lens of the surface with anti-transforming grouth factor beta 2 antibody membrane;CN200973766 delays annular pharmaceutical It releases carrier to be fixed on the outside of intraocular lens ambitus, slow release inhibits lens epithelial cell proliferation medicine after implantation Object prevents the generation of inverse position method;Patent CN103099706 discloses a kind of intraocular lens prevented and/or treat inverse position method, It can selectively be destroyed crystalline in lens capsule in the fixed trypsase in lenticular surface when being implanted in lens capsule Body epithelial cell prevents the generation of post gelating time.
Although suitable on these theoretical methods, it is secondary that the toxicity of drug itself will lead to serious complication, intraocular poison Significant reaction, poor specificity or curative effect be not high, and there are drug excessive velocities, discharge unstable situation, cannot be guaranteed simultaneously All people's work Lens Epithelial Cells in pouch are killed, there are certain difficulties for these Technical investment clinical applications, any remaining LEC final hyperplasia and may be moved on intraocular lens after pharmacy effect disappearance, eventually lead to PCO.
In terms of Surgical technique, oculist understands that remaining crystal body cell causes post gelating time, therefore is performing the operation In always strive to improve modus operandi reduces the residual of epithelial cell as far as possible, and its carefully remove it is all remnants crystalline lenses Epithelial cell also develops the instrument of removal, such as: it is white that patent CN103099705A discloses a kind of prevention and treatment late coming The device of cataract or glaucoma (PCO) can be optionally removed lens epithelial cells in operation, to prevent the generation of post gelating time. However although having done many effort, generally also has a considerable amount of epithelial cells and stay on the inner surface of lens capsule, this is Because epithelial cell is difficult to recognize and is often difficult to touch due to the limitation of their positions on the inner surface of lens capsule And.
In recent years, photodynamic therapy or photo-thermal therapy also attract attention in the research of field of ophthalmology.Patent WO2013/ 027222 reports the chlorophyll photosensitizer for treating disease of eye;Patent CN103083133 reports a kind of based on Jenner The retinopathy photothermal laser treatment system of rice stick;Patent WO97/33619 reports a kind of photodynamic therapy by eye and changes The method of kind eyesight;Patent WO98/25648 reports a kind of light sensitivity for being used to prepare eye disease optical dynamic therapy medicine Close object;WO98/25610 reports a kind of for treating the green Porphyrin-Based Sensitizer drug of After Cataract;It is treating in white United States Patent (USP) 5733276 discloses prophylactic laser retinopexy method in terms of barrier inverse position method.According to the method, go irradiation artificial with laser Crystalline peplos, to destroy remaining lens epithelial cells;Patent CN100455276C coats two on intraocular lens surface TiOx nano film inhibits lens epithelium by the inhibition and oxidation of titanium dioxide optical catalyst cell proliferation Cell.
But traditional photodynamic therapy and photo-thermal therapy is all limited by photosensitizer and can not treat intraocular implants Body post gelating time is widely used.Photosensitizer used in traditional photodynamic therapy and photo-thermal therapy, including light power type are photosensitive Agent and photo-thermal type photosensitizer, finally require that liquid preparation is made, and enter lesion after entering blood by modes such as intravenous injections Tissue or direct injection enter pathological tissues, and after treatment end, photosensitizer needs that body is discharged by the modes such as degrading or being metabolized Outside.The problems such as safety and metabolism of traditional photodynamic therapy and photo-thermal therapy due to needing to consider photosensitizer, significantly Limit the range and type of photosensitizer selection.Although the toxic side effect very little of photodynamic therapy, used photosensitizer Human body is eventually entered into, there is certain toxicity.And photosensitizer can not generally be used alone, and need and other drugs or compound Collective effect is entered in human body in the form of solution, outstanding mixed liquid or lotion, and the compound of these and photosensitizer interaction also will With certain toxicity, increase Operative risk.In addition, since photosensitizer needs are internal from being injected intravenously, and require injection speed Quickly, also quickly, the organ-tissues such as sick human heart and blood vessel need to bear photosensitizer over the course for the treatment of fast removing speed degree It is uncomfortable brought by speed injection;And only when photosensitizer passes through pathological tissues, laser irradiation can be opened and carried out effectively Treatment, therefore to delivery time and hold time and all propose higher requirement, bring difficulty for therapeutic process.
The prior art prevents the migration of epithelial cell by the design of intraocular lens, and then reaches prevention inverse position method Purpose, effect are limited.It removes lens epithelial as far as possible in operative process, the generation of inverse position method can also be reduced Rate, but actually it is difficult fully erased epithelium with physical method, these operations need the additional time, may will increase ocular tissue Damage, causes the destruction of blood-aqueous barrier to increase, and damage have stimulated the proliferation of residual epithelium cell again;Though the IOL of sharp edges So it is proved to be able to inhibit PCO, but there are still LEC along rear capsule and a possibility that in IOL surface migration, such case is especially held Easily occur under the contact and the non-uniform situation of power between intraocular lens periphery and pouch, as intraocular lens exist after performing the operation Moving in rotation in pouch;Drug and chemical method are removing or are destroying residual lens epithelial cells proliferation and migration is that have very much Effect, but drug and chemical method the problem of there is drugs to other tissue toxic side effects, in the same of damaged epithelium When, can also toxic damages be generated to its intraocular hetero-organization, this is still the failure to solve the problems, such as very well, in addition, there are also active drugs The concentration duration is short, needs the problem of being administered continuously;Traditional photodynamic therapy and photo-thermal therapy is all by the limit of photosensitizer It makes and can not be widely used in treatment intraocular lens' post gelating time.Laser Posterior capsulotomy is still treatment After Cataract at present Main means, but also bring a series of complication, including IOL damage, postoperative intraocular pressure increase, macular cystoid edema, view Film is detached from and IOL dislocation.
Therefore, the prior art can not prevent the generation of inverse position method well, and clinically there are no a kind of effective at present Method prevents and treats inverse position method.
In addition, intraocular lens are generally made of transparent material in ophthalmic applications, it is divided into optics area and Support. Optics area is located at intraocular lens centre, for changing the refractive status of human eye, realizes the purpose of optical imagery.Support portion Divide and be called support button loop, can be template, L-type, c-type etc., for intraocular lens' supporting and fixing in human eye.Optics area and Support can be made of same material, can also be made of not same material.The intraocular implants made of soft material Body can fold, be implanted into intraocular intraocular implants after this folding or curling under rolled state by a lesser notch Body being capable of Automatic-expanding after entering human eye.
In field of ophthalmology, the optics area of ophthalmic lens (such as intraocular lens) generally comprises former and later two curved tables Face since its material refractive index is different from intraocular aqueous humor refractive index, and generates the effect of dioptric, refraction.Ophthalmic lens are (as manually Crystalline lens) optics area generally comprise optical lens, be located at ophthalmic lens (such as intraocular lens) center, be ophthalmic lens (such as intraocular lens) realize the core part of dioptric function, and part ophthalmic lens (such as intraocular lens) are with outside optics area The structure being connected with support section.After ophthalmic lens (such as intraocular lens) are implanted into eye, optics area is placed in the middle, ophthalmic lens (such as people Work crystalline lens) with eye own optical structure collectively constitute an optical system.Ophthalmic lens (such as intraocular lens) optics area packet Containing optical imaging moieties, does not allow generally to be blocked, interfere.
All there are some non-predetermined light and finally throw on imaging surface in any optical system, these light due to many reasons Line is referred to as stray light, it is the interference light beam for influencing optical system normal imaging.Most of stray light is not imaged in image planes, And a bright background is generated in image planes, decline picture contrast, influences image quality;There are also the mesh of some high brightness Mark can form ghost image (also referred to as secondary picture) in image planes.The presence of interference light can be such that patient experiences after implantable artificial crystalline lens To bad optical phenomenas such as ghost, dazzle, abnormal specks.
For ophthalmic lens (such as intraocular lens) in this optical system of eye, interference light and ghost image main source have two Kind: one is the additional image generated near optical system focal plane due to lens surface multiple reflections, this ghost image mainly leads to The reasonable optical surface profile of lens front and rear surfaces is crossed to be designed to deal with or alleviate.Another kind is that light is incident to rims of the lens, by side The reflection of edge section or refraction form harmful light, and this harmful light is affected to visual effect, and patient is postoperative often anti-in clinic Phenomena such as " now side have tear sense " of feedback, " having bright ring/bright border ", " edge glare ", is caused by the interference light of the type.Especially It is the refractive index that the Refractive Index of Material of ophthalmic lens (such as intraocular lens) is generally higher than surrounding aqueous humor, light by refractive index compared with High optically denser medium is incident on the lower optically thinner medium of refractive index, and light is oblique incidence, and incidence angle is generally very big, is easy to Total reflection phenomenon is generated, light is all reflected to human eye after being incident to intraocular lens edge, by severe jamming visual quality. The artificial crystalline lens material higher for refractive index, this phenomenon are more serious.It is known in those skilled in the art to be, total reflection Refer to when light is incident on optically thinner medium by optically denser medium, and incidence angle is greater than Brewster's angle, light will all be reflected Phenomenon.
The mode for solving intraocular implants' marginal interference light at present is mainly alleviated by edge shape design and surface treatment, Reflection as attempted reduction marginal interference light in United States Patent (USP) US6884262 using the edge shape of special gradient, the U.S. are special The mirror-reflection at edge is become by diffusing reflection using frosted edge in sharp US8012203, reduces interference light and ghost image.These sides Method has relaxation effect for rim ray reflection, but can not accomplish to eliminate comprehensively.The method bevel angle list that US6884262 is used One, it is only capable of playing the role of elimination to part interference light;The local frosted processing of US8012203 is upper extremely difficult in technique realization, And diffusing reflection still will form certain interference light, only the brightness of light be interfered to be reduced and alleviate.
Inventor's discovery, the medical device (such as lens) by providing a kind of specific structure can solve above-mentioned each Kind problem, such as reduce bad optical phenomena, reduce the problems such as marginal interference light and local treatment (such as preventing inverse position method), and It can be used for device relevant to optical medical devices, as ophthalmic lens (for example, intraocular lens), frame eyeglasses, cornea connect It touches mirror built in mirror (contact lenses), cornea, have the various ophthalmic lens such as crystal Pseudophakia (implanted contact lenses).
Summary of the invention
The present invention provides the ophthalmic lens (particularly, intraocular lens) with the extention comprising active agent.Tool Body, the extention can be carried in conjunction with the design of sharp right side ophthalmic lens, ophthalmic lens medicine, photodynamic therapy etc. it is a kind of or A variety for the treatment of means solve ophthalmic lens epithelial cell and are not easy to thoroughly remove and various optics (such as marginal interference light) in one The problem of.In addition, other unexpected with bringing in the edge additional optical uptake zone of ophthalmic lens (such as intraocular lens) Effect such as improves biocompatibility and safety, has the effects that certain light treatment, anti-inverse position method, drug therapy.
The present invention relates to ophthalmic lens such as intraocular lens comprising:
A) ophthalmic lens main part, wherein the main part includes optics area and optionally one or more light absorptions area, Wherein light absorption area includes light absorber;
B) optionally, it is one or more include active agent extentions, be located in ophthalmic lens main part and with Ophthalmic lens main part is connected, extention width be 0.05 to 3.5mm, preferably 0.1 to 1.5mm, more preferable 0.2 to 0.8mm;Extention is with a thickness of 0.01 to 2mm, preferably 0.01 to 1mm, more preferable 0.01 to 0.7mm, wherein extention Centre distance of the interior edge away from ophthalmic lens be greater than 2mm,
Wherein, the ophthalmic lens include at least one of light absorption area and extention.
Another specific embodiment according to the present invention, ophthalmic lens main part and extention by physics mode or Chemical mode combines.
Another specific embodiment according to the present invention, physics mode, which is selected from, to be inlayed, bonds, spraying, printing, being deposited.
Another specific embodiment according to the present invention, chemical mode are selected from substep copolymerization molding, grafting and modifying.
Another specific embodiment, the extention are located at the rear table of ophthalmic lens main part according to the present invention Face.
Another specific embodiment according to the present invention, ophthalmic lens main part have one or more grooves, add Part is embedded into intraocular lens' main part groove.
Another specific embodiment according to the present invention, the extention include active agent.In the present invention, active Reagent can be any type and can be used in the active agent of ophthalmic lens of the present invention, can be according to the final use of product It is selected.
Another specific embodiment, ophthalmic lens main part have at least two sharp edges according to the present invention.
Another specific embodiment according to the present invention, ophthalmic lens are intraocular lens, in main part, support loop At an angle with ophthalmic lens optical flat;Supporting the proximal end of the rear surface of loop has square edge staircase structural model;Branch The far-end for supportting the rear surface of loop has square edge staircase structural model, wherein the proximal end of support loop rear surface staircase structural model Thickness is greater than far-end thickness.
Another specific embodiment according to the present invention, ophthalmic lens are intraocular lens, support loop rear surface far-end The step drop height of square edge staircase structural model be 0.1-5 millimeter, preferably 0.1-1 millimeters, more preferable 0.2-0.5 is in the least Rice, wherein the proximal end thickness of support loop rear surface staircase structural model is greater than far-end thickness.
Another specific embodiment according to the present invention, ophthalmic lens are intraocular lens, in support loop rear surface proximal end The step drop of the square edge staircase structural model at place is 0.1-5 millimeters, preferably 0.3-3 millimeters, 0.5-2 millimeters more preferable, The proximal end thickness of middle support loop rear surface staircase structural model is greater than far-end thickness.
Another specific embodiment according to the present invention, the rear surface of the optical section of the ophthalmic lens main part are convex Shape spherical surface and its radius of curvature is in the range of 6.6 millimeters -80.0 millimeters.
Another specific embodiment according to the present invention, the song of the rear surface of the optical section of the ophthalmic lens main part Rate radius is the 17.8%-60.0% of the radius of curvature of the front surface of the optical section.
Another specific embodiment, the ophthalmic lens are prepared by materials described below according to the present invention, the material Including being copolymerized the copolymer prepared by the polymerisable monomer comprising esters of acrylic acid, wherein gathering comprising esters of acrylic acid Closing monomer includes hydrophilic acrylate's class monomer and hydrophobic acrylic acid's esters monomer, wherein hydrophilic acrylate's class list The molar ratio of body and hydrophobic acrylic acid's esters monomer is 20:80-80:20, preferably 30:70-70:30, more preferable 40:60-60: 40, the material has the following properties:
A, moisture content is 5-15wt%, preferably 6-13wt%, more preferable 7-12wt% at 35 DEG C;
B, index of refraction (hygrometric state) is 1.49-1.54, preferably 1.49-1.53, more preferable 1.50-1.52 at 35 DEG C.
Another specific embodiment, hydrophilic acrylate's class monomer are selected from hydrophilic radical according to the present invention Acrylic ester monomer meets following formula:
Wherein, R1It is H or C1-6Alkyl, preferably H or CH3
R2It is linear chain or branched chain, saturation or unsaturation C1-20Alkyl or C6-20Aryl alkyl, or straight chain or C6-20Heteroaryl alkane Base;
X can be O, S or NR4, wherein R4It is H, linear chain or branched chain, saturation or unsaturation C1-20Alkyl or C6-20Aryl alkyl, Or C6-20Heteroaryl alkyl, or C3-20Heterocyclylalkyl group;
R3It is CnH2n+1Om, wherein m or n is equal to 0 or selected from the integer for being greater than 1, and m≤n or C3-20Heterocyclylalkyl group or C3-20Naphthenic base.
Another specific embodiment, hydrophobic acrylic acid's esters monomer are selected from hydrophobic group according to the present invention Acrylic ester monomer meets following formula:
Wherein, R1It is H or C1-6Alkyl, preferably H or CH3
R5It is linear chain or branched chain, saturation or unsaturation C1-20Alkyl or C6-20Aryl alkyl, or C6-20Heteroaryl alkyl, or C6-20Heterocyclylalkyl group or C3-20Naphthenic base;
Y can be H or Z-R6, wherein Z may exist or be not present, it can be selected from hetero atom such as O or S,
R6It is C6-20Aryl alkyl, or C6-20Heteroaryl alkyl.
Another specific embodiment, hydrophilic acrylate's class monomer are selected from according to the present invention: methacrylic acid hydroxyl Ethyl ester, Hydroxyethyl Acrylate, hydroxy propyl methacrylate, hydroxypropyl acrylate, vinyl pyrrolidone, methacrylic acid second Oxygroup ethoxy ethyl ester, ethoxyethoxy ethyl acrylate, ethoxyethyl methacrylates, ethoxyethyl acrylate, Methoxyethyl methacrylate, acrylic acid methoxy ethyl ester, dimethacrylate (1,3 butylene glycol) ester, dimethacrylate second two Alcohol ester, polyethylene glycol methacrylate-styrene polymer, polyethylene glycol 200 dimethylacrylate (such as AGEFLEX PEG200DMA), Polyethylene glycol acrylate, methoxypolyethylene glycol methacrylate, methoxypolyethylene glycol acrylate, Glycidyl methacrylate Glyceride, glycidyl acrylate, acrylic acid, methacrylic acid, 2- (trifluoromethyl) acrylic acid, phenylacrylic acid, propylene Amide, Methacrylamide, N hydroxymethyl acrylamide, N- methylol methacrylamide or above-mentioned substance derivative, or The mixture of above-mentioned substance, preferably hydroxyethyl methacrylate.
Another specific embodiment according to the present invention, hydrophobic acrylic acid's esters monomer be selected from methyl methacrylate, Ethyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, hexyl methacrylate, acrylic acid oneself The tertiary fourth of ester, isopropyl methacrylate, isopropyl acrylate, Isobutyl methacrylate, isobutyl acrylate, methacrylic acid Ester, tert-butyl acrylate, isooctyl methacrylate, Isooctyl acrylate monomer, isodecyl acrylate, isodecyl methacrylate, Lauryl methacrylate, lauryl acrylate, octadecyl methacrylate, octadecyl acrylate, metering system Acid -9- anthracene methyl esters, olefin(e) acid -9- anthracene methyl esters, cyclohexyl methacrylate, cyclohexyl acrylate, acrylate, Dimethylaminoethyl methacrylate, N, N- dimethylmethacryl amide, N, N- dimethacrylamide, acrylic acid N, N- diethylamino ethyl ester, methacrylic acid N, N- diethylamino ethyl ester, N tert butyl acrylamide, N- tertbutyl methyl Acrylamide, n-isopropyl acrylamide, N- isopropyl acrylamide, methacrylic acid tetrahydro furfuryl ester, acrylic acid four Tetrahydrofurfuryl ester, trifluoroethyl methacrylate, acrylic acid trifluoro ethyl ester, Hexafluorobutyl mathacrylate, hexafluorobutyl acrylate, 2- perfluoro decyl ethyl acrylate, 2- perfluoro decyl ethyl methacrylate, 2- (perfluoro capryl) ethylmethyl acrylate, 2- (perfluoro capryl) ethyl propylene acid esters, methacrylic acid solketal ester, acrylic acid solketal ester, acrylic acid tetrahydro furan It mutters ester, tetrahydrofurfuryl methacrylate, phenyl methacrylate, phenyl acrylate, methacrylic acid phenyl chlorocarbonate, acrylic acid Phenyl chlorocarbonate, phenoxyethyl methacrylate, phenoxyethyl acrylate, benzyl methacrylate, benzyl acrylate, Acetoacetoxyethyl methacrylate, acetoacetyl ethyl acrylate, Diacetone Acrylamide, diacetone methacryl Amine, allyl methacrylate, the derivative of phenoxyethyl acrylate or above-mentioned substance or above-mentioned substance mixture, it is excellent Select ethyl acrylate, phenoxyethyl acrylate.
Another specific embodiment according to the present invention, the glass transition of the material of the present invention for preparing ophthalmic lens Temperature (dry state is tested by DSC and obtained) is 10-35 DEG C, preferably 15-30 DEG C, more preferable 20-25 DEG C.
Another specific embodiment according to the present invention, the elongation at break of the material of the present invention for preparing ophthalmic lens (hygrometric state) > 180%, breaking strength (hygrometric state) > 2.5 MPa.
Another specific embodiment according to the present invention, in the ophthalmic lens for reducing bad optical phenomena, the optics Area is for being imaged, and light absorption area is for shielding the bad optical phenomena such as ghost caused by marginal interference light, dazzle, speck. Therefore, the ophthalmic lens have light absorption area, and it includes light absorbers, such as shielding caused by marginal interference light The light absorber of the bad optical phenomena such as ghost, dazzle, speck.
Another specific embodiment according to the present invention, the light absorption area comprising light absorber be located at optics area edge with/ Or the equatorial region of optical section.
Another specific embodiment according to the present invention, the ophthalmic lens are a kind of intraocular lens, the artificial crystalline substance Shape body includes that main part and support are fastened with a rope, string, etc., and the main part includes optics area and light absorption area, and the optics area is located at artificial Crystalline lens centre, the light absorption area is located at optics area edge, closely coupled with optics area, and light is contained in the light absorption area Absorbent component.
Another specific embodiment according to the present invention, in light absorption area along away from optics district center apart from >=1. 0mm, it is excellent Choosing >=2.1mm, more preferably >=2.25mm.
Another specific embodiment according to the present invention, light absorption area is annular in shape, and width is 0.05 ~ 3.5mm, preferably 0.1 ~ 1.5mm, more preferable 0.2 ~ 0.8mm.
Another specific embodiment according to the present invention, light absorption area is annular in shape, with a thickness of 0.01 ~ 2mm, preferably 0.01 ~ 1mm, more preferable 0.01 ~ 0.7mm.
Another specific embodiment according to the present invention, light absorber included in light absorption area is to 300 ~ 1100nm wave Light in long range has absorption, the preferably visible light of 400 ~ 700nm.
Another specific embodiment according to the present invention, light absorber included in light absorption area are including but not limited to each Kind of organic dyestuff, such as the light absorber includes but is not limited to various organic dyestuff, such as phyllins (such as it is purplish red Element 18), azo system, anthraquinone system, fragrant methaneseries, indigoids system, porphyrin system, phthalocyanine system, nitro and nitrous base system, methine and polymethine System, heterocycle based compound and its derivative;Various organic or inorganic pigments, such as carbon black, graphite, graphene, metallic particles, gold Belong to oxide, metal salt compound, metal alkaloid compound, metal sulfide etc..Preferred light absorber includes being applied to The various dyestuffs or pigment of the contact lenses of coloring, for example, by United States Patent (USP) US4668240, US4857072, US5272010, Compound disclosed in US8915590 and Chinese patent CN200580017745.8 etc., and include quilt in medical instrument Any colorant of FDA license and approval, such as D&C indigo plant 6, D&C are green 6, D&C purple 2, carbazole violet, certain copper complex, certain chromium Complex compound, various ferriferous oxides, phthalocyanine green, phthalocyanine blue etc.;Preferable pigment include the phthalocyanine of blue it is blue (pigment blue 15, C.I. 74160), cobalt blue (pigment blue 15, C.I. 77343), green phthalocyanine green (pigment Green 7, C.I. 74260) and three Aoxidize two chromium, the various ferriferous oxides of yellow, red, brown and black, the carbazole violet of purple, the Monolith black of black C-K(Ciba) etc..Preferred light absorber includes carbon black, phyllins (such as purpurine 18).
Another specific embodiment according to the present invention, the optics area material and light absorption area material of ophthalmic lens are at 35 DEG C Refractive index (hygrometric state) is 1.43 ~ 1.56, it is preferred that 1.47 ~ 1.53, it is furthermore preferred that 1.50 ~ 1.52.
Another specific embodiment according to the present invention, Refractive Index of Material >=optics area Refractive Index of Material of uptake zone.
Another specific embodiment according to the present invention, the light absorber is added by modes such as coating, surface graftings Enter the material surface to the light absorption area.
Another specific embodiment according to the present invention, the light absorber are by sides such as chemical synthesis, physics blending Formula is added to the material internal in the light absorption area.
The material in another specific embodiment according to the present invention, optics area and light absorption area be it is integrated, pass through chemistry Mode combine.
The material in another specific embodiment according to the present invention, the optics area and light absorption area be it is non-integral, lead to Cross physics mode combination.
Another specific embodiment according to the present invention, the optics area edge have one or more grooves, light absorption Area is embedded in groove as extra section.
Another specific embodiment according to the present invention, the groove, which can be, to be penetrated, it is preferred that is risen to extention To better fixed function, optionally, groove is also possible to nonpenetrating.
Another specific embodiment according to the present invention, the opening of the groove are located at the rear surface of lens (towards eyeground Position be after, before the position towards regarded object is).
Another specific embodiment according to the present invention, the groove have passed through frosted processing, or coarse table is made Face.
Another specific embodiment according to the present invention, the main view diagram shape of the uptake zone can be in circular ring shapes, polygon Shape or the shape that light absorption closed loop can be arbitrarily formed around optics area.
Another specific embodiment according to the present invention, the main view diagram shape in the optics area can be in circular ring shapes, polygon Shape or the shape that light absorption closed loop can be arbitrarily formed around optics area.
Another specific embodiment according to the present invention, the optics area, light absorption area and support button loop use different materials It is made, three regions pass through by combining by way of physically or chemically.
Another specific embodiment according to the present invention, optics area and support button loop be it is integrated, uptake zone is as additional portion Point, by way of physically or chemically in conjunction with optics area.
Another specific embodiment according to the present invention, light absorption area and support button loop be it is integrated, be added to light absorption Agent, optics area is as extra section, by way of physically or chemically in conjunction with light absorption area.
Another specific embodiment according to the present invention, diopter of the intraocular lens in aqueous humor be -25.0D ~+ 36.0D, it is preferred that -10.0D ~+36.0D, it is furthermore preferred that+6.0D ~+30.0D.
Another specific embodiment, main part edge have the thickness of 0.08 ~ 0.6mm according to the present invention, it is preferred that Thickness with 0.1 ~ 0.5mm, it is furthermore preferred that 0.15 ~ 0.3mm.
Another specific embodiment according to the present invention, light absorption area and optics area joining place shape and intraocular implants' dignity Shape is agreed with, and distal end of the extention from optics area is slightly higher for intraocular lens' main body, forms square edge step structure, step Drop is 0.001 ~ 1.0mm, preferred 0.005 ~ 0.4mm, it is furthermore preferred that 0.01 ~ 0.3mm.
Another specific embodiment according to the present invention, light absorption area is located at main part edge.
Another specific embodiment according to the present invention, light absorption area is other than containing light absorber, it is also possible to including extremely Few a kind of other ingredients, such as drug, light absorber, fluorescer and/or photosensitizer.
Another specific embodiment according to the present invention, extention further includes at least one drug, light absorber, fluorescence Agent and/or photosensitizer.
Another specific embodiment according to the present invention, drug, light included in light absorption area and/or extention The combination of absorbent, fluorescer and/or photosensitizer and light absorption area and/or extention material (for example, copolymer) is selected From:
Drug, light absorber, fluorescer and/or photosensitizer are joined in light absorption area and/or extention material forming process With polymerize;
Drug, light absorber, fluorescer and/or photosensitizer are in the light absorption area and/or extention material forming process In be added in copolymer material by physical dispersion;
Drug, light absorber, fluorescer and/or photosensitizer are fixed on the light absorption in a manner of surface grafting, surface modification Area and/or extention material surface;And/or
Drug, light absorber, fluorescer and/or photosensitizer are fixed on the light absorption area and/or attached with surface coating method Add some materials surface.
Specifically, when light absorption area and/or extention material are copolymers,
Drug, light absorber, fluorescer and/or photosensitizer participate in polymerization in the copolymer forming process;
Drug, light absorber, fluorescer and/or photosensitizer are added in the copolymer forming process by physical dispersion In copolymer material;
Drug, light absorber, fluorescer and/or photosensitizer are fixed on the copolymer in a manner of surface grafting, surface modification Surface;And/or
Drug, light absorber, fluorescer and/or photosensitizer are fixed on the copolymer surface with surface coating method.
The invention further relates to the ophthalmic lens prevent epithelial cell migration, epithelial cell proliferation, prevent after capsule it is mixed Turbid generation prevents inverse position method and reduces the aborning application of bad optical phenomena.
The invention further relates to the medical devices comprising the ophthalmic lens.
The invention further relates to application of the ophthalmic lens in the medical device for treating eye disease, particularly, The medical device is used to prevent migration, the epithelial cell proliferation, the generation for preventing post gelating time of epithelial cell, prevents inverse position method And reduce the generation of bad optical phenomena.
Detailed description of the invention
The main part of ophthalmic lens (such as intraocular lens) of the present invention can be any type of eye known in the art The main part of section's lens (such as intraocular lens) comprising optical component and at least one support loop form, wherein optical section Part and support loop are to be made from a different material then multistep molding or an entirety made of same material.Optical component is divided into Front surface and rear surface.Front surface and/or rear surface can be according to the case where user and/or requiring to set comprising any optics It is standby, for example, being selected from aspherical equipment, multifocal point device, double-curved surface equipment, non-dispersive equipment, zoom point device, light filter plant Or the conventional suitable various equipment in this field.
A kind of specific embodiment, ophthalmic lens can be intraocular lens according to the present invention, manually brilliant if any crystal eye Shape body, aphakia intraocular lens are also possible to other suitable ophthalmic lens.
A kind of specific embodiment according to the present invention, the rear surface of ophthalmic lens (such as intraocular lens) main part is in Area and peripheral region composition are entreated, wherein peripheral region may be at least 0.2 millimeter thicker than the edge of central area, so as to after supporting loop A square edge staircase structural model is arranged in surface at optical component.The step drop of square edge staircase structural model is 0.1-5 millimeters, preferably 0.3-3 millimeters, most preferably 0.5-2 millimeters.This square edge staircase structural model is conducive to stop crystal The proliferation apoptosis of epithelial cell to optical component rear surface, to reduce the probability of post gelating time.
A kind of specific embodiment according to the present invention, the support loop and eye of ophthalmic lens (such as intraocular lens) main part Section's lens (such as intraocular lens) optical flat (optical flat is vertical with optic axis) is angled, general any suitable Angle be ok, preferably 1-20 degree, most preferably 5-10 degree.Support loop with above-mentioned angle, can guarantee ophthalmic lens (such as people Work crystalline lens) when by (eye) capsule squeezing action power, optical component is protruded to eye rear or movement.Support loop proximal end (that is, Support loop close to one end of optical component), open slot is set, to as a power transmission fulcrum.When support loop is by periphery capsule When extruding, can axially it be rotated using open slot as fulcrum, without stress is passed to optical component, to ensure that optical component exists Intraocular stability.It supports at the distal end (that is, the support one end of loop far from optical component) of the rear surface of loop, from proximal end right angle At at least 1.5 millimeters of marginal texture, it is in addition provided with square edge staircase structural model.The step of square edge staircase structural model is fallen Difference is 0.1-5 millimeters, preferably 0.1-1 millimeters, most preferably 0.2-0.5 millimeters.Square edge staircase structural model can further stop The proliferation apoptosis of Lens Epithelial Cells rearward surface, and a supporting point can be manufactured between support loop and rear capsule, it improves Stability of the ophthalmic lens (such as intraocular lens) in (eye) capsule.In addition, when ophthalmic lens device is when folding, this step Formula structure can cause certain space between its optical component and support loop, to reduce the adhesion strength between them, favorably It is opened automatically after ophthalmic lens implantation in support loop.
A kind of specific embodiment according to the present invention, ophthalmic lens (such as intraocular lens) include main part and support portion Divide (such as support button loop), the main part includes optics area and light absorption area, and wherein optics area is located at the centre of main body, is The imaging moiety of ophthalmic lens (such as intraocular lens).
A kind of specific embodiment according to the present invention, light absorption area of the invention is one of main functional areas.
A kind of specific embodiment according to the present invention, the present invention prepare the material in light absorption area and the material of preparation main part Material may be the same or different, any suitable material selected from the material of main part comprising polymerisable monomer or preferred good biocompatibility Material.Wherein, polymerisable monomer be selected from hydrophilic polymerisable monomer or hydrophobic polymerizable monomer, can be monomer homopolymer or The copolymer of various of monomer.It can be selected from high-molecular biologic degradation material simultaneously.
It is preferred that being prepared by the material containing light absorber.The light absorption area is located at optics area edge, with optics area It is in close contact, the photo-absorption region contains light absorber ingredient, spectrum of the photo-absorption region to visible light, human eye sensitivity With absorption, the photo-absorption region can reduce the reflection of intraocular lens' rim ray.
A kind of specific embodiment according to the present invention, the light absorption area can be integrally formed with optics area part (block of material) is also possible to seperated molding (two pieces or muti-piece material).It is molding if it is fission, combination between the two (such as the modes such as engaging, insertion) that can be physics are also possible to (such as the modes such as bonding, molding) of chemistry.For example, working as It when needing to bond, can be attached by adhesive, adhesive is selected from but not limited to a-cyanoacrylate class medical adhesive Agent, such as α-cyanoacrylaten-butyl, α-n-octylcyanoacrylate, isobutyl alpha-cyanoacrylate and its two kinds of components or three The mixture of kind component;It can be used selected from medical organic silicon adhesive.As Nusil company MED-1131, MED-1137, MED-1511, MED-1540, MED-1555, MED-2000, MED1-4213 and with phase same-action medical organic silicon bonding Agent.
The light absorber of a kind of specific embodiment according to the present invention, the light absorption area can on the surface of the material, can also In material internal;It can be by modes such as copolymerization, blending, coating, injections in conjunction with material.
A kind of specific embodiment according to the present invention is inhaled in ophthalmic lens (such as intraocular lens) optics area edge coating light Receive agent.The advantages of this embodiment, is that, since material is coated in intraocular implants' body side surface, optics area range is by maximum journey The protection of degree.
Another embodiment according to the present invention attached light in ophthalmic lens (such as intraocular lens) optics area edge and inhale Area is received, light absorption area has coating or structure comprising light absorber.For example, by chemical polymerization, physical blending, surface treatment Mode add light absorber in light absorption area matrix, wherein light absorption area basis material can be with ophthalmic lens (as artificial Crystalline lens) optics area material is identical, it can also be different.Preferably, the area ophthalmic lens (such as intraocular lens) Guang Xi basis material It is prepared using the material based on silica gel.The light absorption area is incorporated in one with optics area by way of chemically or physically It rises.Preferably, in order to keep the service performance of ophthalmic lens (such as intraocular lens), the light absorption area and ophthalmic lens are (such as Intraocular lens) the substantially same physical characteristic of optics area material holding, such as flexible folding intraocular lens, light absorption area Material also should be flexible folding.
Extention of the present invention can be by any preparation ophthalmic lens of the present invention known in the art that are suitable for (such as artificial crystalline substance Shape body) material prepare;Particularly, there is appropriate aqueous rate and suitable refractive power by suitable manufacture micro-incision artificial lens The ophthalmology medical material of rate prepares.Wherein, it is described preparation extention material and prepare Medical Devices, such as ophthalmic lens The material of (such as intraocular lens) main body may be the same or different.
Another specific embodiment according to the present invention, extention is another main functional area, according to the present invention The function of reaching, does not limit the shape of extention, and extention can be cyclic annular, rectangular, trapezoidal, interruption or continual attached Add any shapes such as part, triangle, sector, the shape of any extention for being likely to be breached function of the present invention is all in the present invention Protection scope within.
Extention of the invention is preferably obtained by the material preparation containing drug, light absorber, photosensitizer and/or fluorescer , or drug, light absorber and/or photosensitizer can be carried and/or filter dye, photosensitizer are fixed in extention material Portion or surface, while extention edge can be with ophthalmic lens optical section optical surface sharp right side in 90 °, and appendix Divide the front surface and/or rear surface that can be located at ophthalmic lens (such as intraocular lens) optical section, it is possible to reduce or eliminate artificial The harmful reflected light of crystalline lens or other ophthalmic lens edges, reduce intraocular lens or other ophthalmic lens using rear dazzle, The bad visual effect occurrence probability such as ghost improves patient visual's experience, and it is mixed to prevent and treat preceding capsule muddiness, rear capsule The illnesss such as turbid and postoperative endophthalmitis disease.Wherein, the light absorber of extention can be with the light absorber phase in light absorption area It is same or different.
Another specific embodiment according to the present invention, extention of the present invention include therapeutic agent, wherein described Drug includes all kinds of antibiotic, steroidal anti-inflammatory medicine and non-steroidal anti-inflammatory drugs, prevents post-operation inflammatory and microorganism infection.It can also be with It carries antimetabolitas and mitotic inhibitor, the drug immunotoxin of inhibition inflammatory reaction and cytotoxin, inhibit thin The drug of born of the same parents and extracellular matrix adhesion induces cell apoptosis drug to eliminate LEC or inhibit the mitosis of epithelial cell, in advance Anti- and treatment post gelating time.As Ofloxacin, ascorbic acid, aspirin, colchicin, lidocaine, nepafenac, ketone are coughed up Acid, Bromfenac, lepirudin 023 ludon, methotrexate, 5 FU 5 fluorouracil, taxol, adriamycin, daunorubicin, saponaretin, and Other known or unknown drugs or composition with identity function.
Another specific embodiment according to the present invention, extention of the present invention include light absorber, and wherein light is inhaled Agent is received to be selected according to the final use of medical device (particularly ophthalmic lens (such as intraocular lens)).Particularly, light is inhaled Receiving agent includes but is not limited to various organic dyestuff, for example, azo system, anthraquinone system, fragrant methaneseries, indigoids system, porphyrin system, phthalocyanine system, Nitro and nitrous base system, methine and polymethine system, heterocycle based compound and its derivative;Various organic or inorganic pigments, such as Carbon black, graphite, graphene, metallic particles, metal oxide, metal salt compound, metal alkaloid compound, metal sulfide Deng.Preferred light absorber includes the various dyestuffs or pigment applied to the contact lenses of coloring, such as by United States Patent (USP) Disclosed in US4668240, US4857072, US5272010, US8915590 and Chinese patent CN200580017745.8 etc. Compound, and include any colorant permitted and ratified by FDA in medical instrument, such as D&C indigo plant 6, D&C are green 6, D& C purple 2, carbazole violet, certain copper complex, certain chromium complex, various ferriferous oxides, phthalocyanine green, phthalocyanine blue etc.;Preferable pigment Phthalocyanine indigo plant (pigment blue 15, C.I. 74160), cobalt blue (pigment blue 15, C.I. 77343) including blue, green phthalein flower Dark green (pigment Green 7, C.I. 74260) and chrome green, the various ferriferous oxides of yellow, red, brown and black, purple Carbazole violet, the Monolith black C-K(Ciba of black) etc..According to another preferred embodiment, light absorber is also It may include carbon black, phyllins (such as purpurine 18).
Another specific embodiment according to the present invention, extention of the present invention include photosensitizer, wherein photosensitizer It is any light-sensitive coloring agent for being activated wave-length coverage and being 300~1100 nanometers, it is preferable that activation wavelength range is selected from 500~1000 Nanometer;Particularly, activation wavelength range is selected from 600~900 nanometers;In particular, activation wavelength range is selected from 700~900 nanometers Or activation wavelength range is selected from 800~1100 nanometers.Photosensitizer be selected from selected from porphyrin, porphines, chlorophyll, purpurine, fluorescein, Phthalocyanine, metal phthalocyanine, indocyanine green, tricarbocyanine, nanogold, metal nanoparticle, metal oxide nanoparticles, metal vulcanization The derivative products of object nanoparticle, metal carbides nanoparticle, carbon nanotube, graphene etc. and above compound, or on Or mixtures thereof the catabolite of compound or the salt form of above compound are stated,.
Another specific embodiment according to the present invention, extention of the present invention can be used for appendix containing any The filter dye divided, filter dye is selected from the compound for having filtration sexual function to particular range of wavelengths, as extention includes Blue-light absorbers, wherein blue-light absorbers, which are selected from, has selectivity filter to wave-length coverage for the blue light within the scope of 400~500 nm Cross the compound of function.Weld class compound in preferred molecular structure formula containing azo group.Can further preferably it gather Close group Yellow dye compound, polymerizable groups be selected from vinyl, allyl, cyclobutenyl, acetenyl, acryloxy, Methacryloxy, acrylamido, methacryl amido, vinyl ether, etc..
Since extention of the present invention includes to fix in drug, light absorber, photosensitizer and/or fluorescer or extention There are drug, light absorber, photosensitizer and/or fluorescer, the medical device (particularly ophthalmic lens (such as intraocular lens)) Optical problem (such as light interferes) and implantation latter aspect, which can be reduced, can play the role of prevention, on the other hand when the tissue Or position without i.e. acceptable laser therapy of being performed the operation again, and solves the optical problem once falling ill;It is more special , material provided by the invention does not have the effect of repeat function, after the completion of a laser therapy, due to photosensitizer not by It eliminates and still exists in diseased region, it is photosensitive without multiple injection when again or repeatedly late coming lesion occurs for the position Agent can again or repeatedly receive laser therapy, have the repeatability for the treatment of.Specifically, the present invention provides a kind of for preventing And/or the ophthalmic lens (such as intraocular lens) for the treatment of After Cataract, containing photosensitizer, the ophthalmic lens are (as manually Crystalline lens) in cataract operation be implanted into patient it is intraocular after, under conditions of selected laser eye external exposure, photosensitizer is activated, Have cytotoxic active oxygen by generating, or generate high warm, lens epithelial cells in lens capsule can be killed, reached To the effect for preventing or treating After Cataract.Specifically, ophthalmic lens extention of the invention contains photosensitizer, has Photothermy.Extention with photothermy, which passes through, physically or chemically combines lens body part, wherein Physics mode is selected from and casts, inlays, bonding, spraying, printing, being deposited;Chemical mode is selected from substep copolymerization molding, grafting and modifying. The ophthalmic lens are under the laser irradiation of selected wavelength (such as 300-1100 nanometers), capsule Lens Epithelial Cells after can killing, The effect of reaching prevention and/or treatment After Cataract.Particularly, it is led since Lens Epithelial Cells prolong the generation of optics area periphery Inverse position method is caused, while photosensitizer region also is located at crystal optics area periphery, therefore, when the ophthalmic lens carry out photo-thermal therapy, The normal cell of other regional organizations, Small side effects can not be damaged while killing residual Lens Epithelial Cells.Particularly Ground does not touch crystal optics imaging region since photosensitizer region is located at optics area periphery, so crystal has and normal ophthalmology The consistent visible light transmittance of lens, no optical energy loss do not influence patient in the visual experience of any scene state, free from glare feelings Condition.
Medical device (particularly ophthalmic lens (such as intraocular lens)) main part and/or extention of the present invention can be with By any material known in the art for being suitable for preparing Medical Devices (especially ophthalmic medical equipment, such as ophthalmic lens) of the present invention It prepares.It is particularly preferred that the eye with appropriate aqueous rate and suitable index of refraction by being suitble to manufacture micro-incision ophthalmic lens Section's medical material prepares, and is copolymerized and is prepared by acrylic ester monomer, and wherein acrylic ester monomer includes hydrophily third Olefin(e) acid esters monomer and hydrophobic acrylic acid's esters monomer, wherein the molar ratio of hydrophilic monomer and hydrophobic monomer is 20: 80-80:20, preferably 30:70-70:30, more preferable 40:60-60:40, the specific following properties of the material:
A, moisture content is 5-15wt%, preferably 6-13wt%, more preferable 7-12wt% or even 8-11wt%, especially 9- at 35 DEG C 11wt%;
B, index of refraction (hygrometric state) is 1.49-1.54, preferably 1.49-1.53, more preferable 1.50-1.52 at 35 DEG C.
Heretofore described hydrophilic acrylate's class monomer is selected from the acrylic ester monomer with hydrophilic radical, Meet following formula:
R1It is H or C1-6Alkyl, preferably H or CH3
R2It is linear chain or branched chain, saturation or unsaturation C1-20Alkyl or C6-20Aryl alkyl, or straight chain or C6-20Heteroaryl alkane Base;
X can be O, S or NR4, wherein R4It is H, linear chain or branched chain, saturation or unsaturation C1-20Alkyl or C6-20Aryl alkyl, Or C6-20Heteroaryl alkyl, or C3-20Heterocyclylalkyl group;
R3It is CnH2n+1Om, wherein m or n is equal to 0 or selected from the integer for being greater than 1, and m≤n or C3-20Heterocyclylalkyl group or C3-20Naphthenic base.
Hydrophilic acrylate is the esters of acrylic acid with hydrophilic radical in the present invention, such as selected from metering system Sour hydroxy methacrylate, Hydroxyethyl Acrylate, hydroxy propyl methacrylate, hydroxypropyl acrylate, vinyl pyrrolidone, methyl-prop Olefin(e) acid ethoxy ethoxyethyl acrylate, ethoxyethoxy ethyl acrylate, ethoxyethyl methacrylates, ethioxy Ethyl ester, methoxyethyl methacrylate, acrylic acid methoxy ethyl ester, dimethacrylate (1,3 butylene glycol) ester, dimethyl allene Sour glycol ester, polyethylene glycol methacrylate-styrene polymer, polyethylene glycol 200 dimethylacrylate (such as AGEFLEX PEG200DMA), polyethylene glycol acrylate, methoxypolyethylene glycol methacrylate, methoxypolyethylene glycol acrylate, first Base glycidyl acrylate, glycidyl acrylate, acrylic acid, methacrylic acid, 2- (trifluoromethyl) acrylic acid, phenyl Acrylic acid, acrylamide, Methacrylamide, N hydroxymethyl acrylamide, N- methylol methacrylamide or above-mentioned substance Derivative or above-mentioned substance mixture.It is preferred that hydroxyethyl methacrylate.
Hydrophobic acrylic acid's esters monomer is selected from the acrylic ester monomer with hydrophobic group in the present invention, under meeting Formula:
R1It is H or C1-6Alkyl, preferably H or CH3
R5It is linear chain or branched chain, saturation or unsaturation C1-20Alkyl or C6-20Aryl alkyl, or C6-20Heteroaryl alkyl, or C6-20Heterocyclylalkyl group or C3-20Naphthenic base;
Y can be H or Z-R6, wherein Z may exist or be not present, it can be selected from hetero atom such as O or S,
R6It is C6-20Aryl alkyl, or C6-20Heteroaryl alkyl.
Heretofore described hydrophobic acrylic acid's ester is the esters of acrylic acid with hydrophobic group, such as selected from first Base methyl acrylate, ethyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, methacrylic acid oneself Ester, Hexyl 2-propenoate, isopropyl methacrylate, isopropyl acrylate, Isobutyl methacrylate, isobutyl acrylate, first Base tert-butyl acrylate, tert-butyl acrylate, isooctyl methacrylate, Isooctyl acrylate monomer, isodecyl acrylate, methyl-prop Olefin(e) acid isodecyl ester, lauryl methacrylate, lauryl acrylate, octadecyl methacrylate, octadecyl base Ester, methacrylic acid -9- anthracene methyl esters, olefin(e) acid -9- anthracene methyl esters, cyclohexyl methacrylate, cyclohexyl acrylate, acrylic acid diformazan Base amino ethyl ester, dimethylaminoethyl methacrylate, N, N- dimethylmethacryl amide, N, N- dimethyl allene acyl Amine, acrylic acid N, N- diethylamino ethyl ester, methacrylic acid N, N- diethylamino ethyl ester, N tert butyl acrylamide, N- t-butylmethacrylamide, n-isopropyl acrylamide, N- isopropyl acrylamide, methacrylic acid tetrahydrofurfuryl Ester, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, acrylic acid trifluoro ethyl ester, Hexafluorobutyl mathacrylate, propylene Sour hexafluoro butyl ester, 2- perfluoro decyl ethyl acrylate, 2- perfluoro decyl ethyl methacrylate, 2- (perfluoro capryl) ethyl-methyl Acrylate, 2- (perfluoro capryl) ethyl propylene acid esters, methacrylic acid solketal ester, acrylic acid solketal ester, Acrylic acid tetrahydrofuran ester, tetrahydrofurfuryl methacrylate, phenyl methacrylate, phenyl acrylate, methacrylic acid benzene Base ethyl ester, phenylethyl acrylate, phenoxyethyl methacrylate, phenoxyethyl acrylate, benzyl methacrylate, It is benzyl acrylate, acetoacetoxyethyl methacrylate, acetoacetyl ethyl acrylate, Diacetone Acrylamide, double Acetone Methacrylamide, allyl methacrylate, phenoxyethyl acrylate or above-mentioned substance derivative or above-mentioned The mixture of substance.It is preferred that ethyl acrylate and/or phenoxyethyl acrylate.
The present invention is used to prepare the material of ophthalmic lens (such as intraocular lens), in the case of necessary, should also contain one Kind or several additives, such as crosslinking agent, ultraviolet absorber, blue-light absorbers.
Material of the present invention for ophthalmic lens (such as intraocular lens) can contain crosslinking agent, wherein crosslinking agent is selected from tool There are two or more than two degree of functionality polymerisable monomer, comprising: ethylene glycol dimethacrylate, diacrylate ethylene glycol Ester, tetramethylene dimethacrylate, butanediol diacrylate, dimethacrylate hexylene glycol ester, diacrylate hexylene glycol Ester, diethyleneglycol dimethacrylate, diethyleneglycol diacrylate, diethylene glycol dimethacrylate, diacrylate Triglycol ester, dimethacrylate poly glycol ester, diacrylate poly glycol ester, trimethylolpropane tris acrylic acid Ester, trimethylol-propane trimethacrylate, triethylol propane triacrylate, triethylol propane trimethacrylate acid Ester, bisphenol-A glycerine double methyl methacrylate, bisphenol-A glycerine double methacrylate, Diacrylate, pentanediol two Methacrylate, methacrylic anhydride, acrylic anhydride, N, N '-methylene-bisacrylamide, N, N '-di-2-ethylhexylphosphine oxide methyl-prop The mixture of acrylamide, the derivative of divinylbenzene or above-mentioned substance or above-mentioned substance.It is preferred that dimethacrylate second two Alcohol ester.
The material that the present invention is used to prepare ophthalmic lens (such as intraocular lens) can contain ultraviolet absorber, wherein ultraviolet Absorbent is selected from the compound to wave-length coverage in 380 nm ultraviolet light below with efficient absorption function.Preferred security High benzophenone compound and/or benzotriazole compound.The further preferably benzophenone of polymerizable groups Object and/or benzotriazole compound compound are closed, polymerizable groups are selected from vinyl, allyl, cyclobutenyl, acetenyl, third Alkene acyloxy, methacryloxy, acrylamido, methacryl amido, vinyl ether, etc..
The material that the present invention is used to prepare ophthalmic lens (such as intraocular lens) can contain blue-light absorbers, wherein blue light Absorbent is selected from the compound to wave-length coverage for the blue light within the scope of 400~500 nm with selective filtering function.It is preferred that Weld class compound in molecular structural formula containing azo group.The further preferably weld chemical combination of polymerizable groups Object, polymerizable groups are selected from vinyl, allyl, cyclobutenyl, acetenyl, acryloxy, methacryloxy, acryloyl Amido, methacryl amido, vinyl ether, etc..
Another specific embodiment, the present invention are used to prepare the material of ophthalmic lens (such as intraocular lens) according to the present invention Material is by hydrophobic acrylic acid's ester monomer and hydrophilic acrylate monomer, optional additives such as crosslinking agent, ultraviolet absorber, indigo plant Light absorber etc., is obtained by polymerization methods.Wherein, polymerization methods are selected from bulk polymerization, preferably are selected from by basic body polymerization side Formula.Radical polymerization initiator may be selected the common radical polymerization initiator in this field, such as selected from azo-initiator, And/or peroxide initiator, preferred peroxidating double lauroyl, bis- (4- tert-butylcyclohexyl) peroxy dicarbonates, peroxidating The double tetradecane base esters of two (cetyl) two carbonic esters, dicetyl peroxydicarbonate, azodiisobutyronitrile, azobisisovaleronitrile, azo Two different heptonitriles, cumyl peroxide, benzoyl peroxide, 2,5- dimethyl -2,5- two (t-butylperoxy) hexane, tertiary fourth Base peroxidating carbonic acid -2- ethylhexyl, peroxidating tertiary pentyl -2 ethyl hexanoic acid ester, peroxidating (2- ethylhexyl) carbonic acid uncle penta Bis- (2 ethyl hexanoic acid peroxidating) hexanes of ester, 2,5- dimethyl -2,5-, 2,5- dimethyl -2,5- di-t-butyl peroxy -3- oneself Alkynes, peroxidating (2 ethyl hexanoic acid) tert-butyl ester, 1,1- cyclohexane di-tert-butyl peroxide, new last of the ten Heavenly stems peroxide tert-butyl acrylate, peroxidating The neopentanoic acid tert-butyl ester, the 2- ethylbutane peroxycarboxylic acid tert-butyl ester, 1,1- di-tert-butyl peroxide -3,3,5- trimethyl-cyclohexane, Three peroxide nonane of 3,6,9- triethyl group -3,6,9- trimethyl -1,4,7-, bis- (3,5,5- trimethyl acetyl) peroxide, peroxide Change 2 ethyl hexanoic acid 1,1,3,3- tetramethyl butyl ester, tert-butyl hydroperoxide -3,5,5 Trimethylhexanoic acid ester, tert-butyl hydroperoxide Hydrogen, two tertiary butane of peroxidating, peroxidized t-butyl perbenzoate, tert-butylperoxyiso-propyl formic acid esters, (the 2- ethyl hexyl of peroxidating two Base) two carbonic esters, peroxide acetic acid butyl ester, cumyl hydroperoxide, di-isopropylbenzene hydroperoxide, tert-butyl peroxide be different The mixture of propyl benzene, tertiary amyl hydrogen peroxide or above-mentioned substance.It is preferred that azodiisobutyronitrile.
The material that the present invention is used to prepare ophthalmic lens (such as intraocular lens) has moderate moisture content, is ophthalmic lens (such as intraocular lens) are suitable for lubricity and flexibility necessary to minimal access surgery provides, and (special to medical device simultaneously Other ground ophthalmic lens (such as intraocular lens)) index of refraction and mechanical performance do not cause serious negative sense to influence.Therefore, of the invention Material (such as the material for preparing medical device (particularly ophthalmic lens (such as intraocular lens))), the state in simulation human eye Under (35 DEG C of physiological saline) saturated aqueous rate be selected from 5~15 weight %, preferably 6~13 weight %, more preferable 7~12 weight %, very To 8-11wt%, especially 9-11wt%.
The material that the present invention is used to prepare ophthalmic lens (such as intraocular lens) has moderate index of refraction, is processed into same Diopter medical device (particularly ophthalmic lens (such as intraocular lens)), can accomplish than relatively thin, to cut more suitable for micro- Mouth implant surgery;And the excessively high caused effect of dispersion of index of refraction is overcome simultaneously, to avoid medical device (particularly ophthalmology Lens (such as intraocular lens)) implantation after generate dazzle.Therefore, material of the present invention (such as prepares medical device (particularly ophthalmology Lens (such as intraocular lens)) material), (35 DEG C of physiological saline) index of refraction is selected from 1.49 under state in simulation human eye ~1.54, preferably 1.49~1.53, more preferable 1.50~1.52.
The material that the present invention is used to prepare ophthalmic lens (such as intraocular lens) has special mechanical performance, in dry state room Stiff materials are rendered as in temperature or the following environment of room temperature, being processed to medical device, (particularly ophthalmic lens are (such as artificial crystalline substance Shape body));And it is rendered as flexible material in hygrometric state (after fully hydrated) room temperature or simulation human eye (35 DEG C) environment, it can be rolled over It folds to enter in human eye pouch by catwalk, then can automatically, slowly restore to medical device (particularly eye Section's lens (such as intraocular lens)) original state, and stable working condition can be kept in pouch.Therefore, material of the present invention (such as the material for preparing medical device (particularly ophthalmic lens (such as intraocular lens))), the choosing of dry state glass transition temperature From 10~35 DEG C, preferably 15~30 DEG C, more preferable 20~25 DEG C;Material of the present invention (such as prepare medical device (particularly Ophthalmic lens (such as intraocular lens)) material), there is moderate mechanics mechanical strength, hygrometric state (fully hydrated after) room temperature Elongation at break is at least 180% in environment, and breaking strength is at least 2.5 MPa, can meet wanting for minimal access surgery implantation It asks, in turn avoids medical device (particularly ophthalmic lens (such as intraocular lens)) and folding button loop, fracture occur in implantation process It happens, guarantees safety in art.
Inventor's discovery can be used to prepare ophthalmology by the selection and proportion of monomer, the finally obtained present invention The material of lens (such as intraocular lens) can have such as above-mentioned comprehensive performance, such as have the following properties simultaneously:
A, moisture content is 5-15wt%, preferably 6-13wt%, more preferable 7-12wt% at 35 DEG C;
B, index of refraction (hygrometric state) is 1.49-1.54, preferably 1.49-1.53, more preferable 1.50-1.52 at 35 DEG C.Material of the present invention (such as the material for preparing medical device (particularly ophthalmic lens (such as intraocular lens))), hydrophilic monomer and hydrophobic monomer Molar ratio be 20:80~80:20, preferably 25:75-75:25, preferably 30:70~70:30, preferably 35:65-65:35 is excellent Select 40:60-60:40, more preferable 45:55~55:45, or even about 50:50.
The material that the present invention is used to prepare ophthalmic lens (such as intraocular lens) (is used in particular for preparing the material of extention Material) it can further include at least one drug, fluorescer and/or at least one photosensitizer.
Another specific embodiment according to the present invention, the present invention is used to prepare medical device, and (particularly ophthalmic lens are (such as Intraocular lens)) material when including fluorescer, fluorescer is fixed on inside final material or surface.The stable knot of fluorescer It closes in final material, can use fluorescence possessed by material of the present invention at this time, such as medicine detection can be carried out, specifically Ground makes material fluoresce under crack lamp source or Pentero microscope, oculist can clearly, clearly judge material The suitability of material and cornea thoroughly gets rid of exogenous cornea fluorescent dye since material cornea does not make corneal dyeing, So that carrying out medicine detection without adding any additional reagent (including fluorescer) using material of the present invention.
Another specific embodiment, the present invention are used to prepare the material of ophthalmic lens (such as intraocular lens) according to the present invention When material is comprising photosensitizer, photosensitizer is fixed on inside final material or surface, and the material is implanted into diseased region by operation, When needing to treat diseased region, the laser of selected wavelength is irradiated to it;After treatment end, it is only necessary to remove sharp Light.Since photosensitizer is bound in material internal or surface, freely other groups of human body cannot be entered via blood or other body fluid In knitting, therefore the toxicity of photosensitizer itself can be ignored, and the range of choice of photosensitizer is also no longer influenced by limitation.Particularly, Material provided by the invention can be implanted in advance in the tissue that may be fallen ill or position with other operated eyes, a side Face can play the role of prevention, on the other hand can connect once falling ill without operation is carried out again when the tissue or position It is excited light treatment;More specifically, material provided by the invention has the effect of repeat function, when a laser therapy is completed Afterwards, it due to photosensitizer and is not eliminated and still exists in diseased region, when late coming lesion occurs again or repeatedly for the position When, it can again or repeatedly receive laser therapy without multiple injection photosensitizer, there is the repeatability for the treatment of.
The present invention is used to prepare in the material of ophthalmic lens (such as intraocular lens), is made when being copolymerized by acrylic ester monomer The standby copolymer obtained further comprises at least one drug, fluorescer and/or at least one photosensitizer as copolymer material When, the combination of drug, light absorber, fluorescer and/or photosensitizer and copolymer material is selected from:
Drug, light absorber, fluorescer and/or photosensitizer participate in polymerization in copolymer material forming process;
Drug, light absorber, fluorescer and/or photosensitizer are added in copolymer material forming process by physical dispersion In copolymer material;
Drug, light absorber, fluorescer and/or photosensitizer are fixed on copolymer material in a manner of surface grafting, surface modification Surface;And/or
Drug, light absorber, fluorescer and/or photosensitizer are fixed on copolymer material surface with surface coating method.
When the combination of (1) drug, light absorber, fluorescer and/or photosensitizer and copolymer material is drug, light suction When receipts agent, fluorescer and/or photosensitizer participate in polymerization in copolymer material forming process, drug, light absorber, fluorescer And/or photosensitizer includes the material of polymerisable monomer.
When the combination of (2) drug, light absorber, fluorescer and/or photosensitizer and copolymer material is drug, light suction Agent, fluorescer and/or photosensitizer is received to be added in copolymer material in copolymer material forming process by physical dispersion When, drug, light absorber, fluorescer and/or photosensitizer can be any suitable drug, light absorber, fluorescer and/or light Quick dose, optionally include polymerisable monomer.
When the combination of (3) drug, light absorber, fluorescer and/or photosensitizer and copolymer material is drug, light suction When receipts agent, fluorescer and/or photosensitizer are fixed on molded copolymer material surface in a manner of surface grafting, surface modification, Copolymer material is molded material, but includes polymerizable groups on copolymer material surface.
Polymerizable groups herein can be, such as: vinyl, allyl, butylene, acryloxy, methacryl Oxygroup, acrylamido, methacryl amido, vinyl ether, alkynyl, hydroxyl, sulfydryl, amino, imino group, carboxyl, acid anhydrides, Aldehyde radical, isocyanate group, siloxy group, epoxy group, ring nitrogen base, etc..
When the combination of (4) drug, light absorber, fluorescer and/or photosensitizer and copolymer material is drug, light suction When receipts agent, fluorescer and/or photosensitizer are fixed on molded copolymer material surface with surface coating method, copolymer material It is molded material.
Another embodiment according to the present invention coats light absorption in ophthalmic lens (such as intraocular lens) optics area edge Agent.The advantages of this embodiment, is that, since material is coated in intraocular implants' body side surface, optics area range is by utmostly Protection.
In another embodiment of the present invention, fluorescer of the present invention is selected from: fluoresceins (sodium), cyanine fluorochrome, Fluorescein isothiocynate, the rhodamine substance with fluorescent characteristic, the lanthanide chelate with fluorescent characteristic, phycoerythrin (P-phycoerythrin, PE) generates for example more dinoflagellate phyllochlorins (PerCP) of substance of fluorescence, propidium iodide after enzyme effect And other modifys with launch wavelength based on the above fluorescer or the derivatives of modification or will be changed above at 300-850 nanometers Or mixtures thereof the fluorescer that object sensible load is formed into nano material is closed,.
In another embodiment of the present invention, light absorber and ophthalmic lens (such as intraocular lens) combination can be with It is to be copolymerized, be blended, inlaying, bonding, spraying, printing, being deposited.
In another embodiment of the invention, that containing edge light absorbing material or structure is non-intraocular lens Other ophthalmic lens, mirror etc. as built in frame eyeglasses, contact lens (contact lenses), cornea.
In another embodiment of the invention, the main view diagram shape in light absorption area can be circular ring shape, polygon or The shape of light absorption closed loop can be arbitrarily formed around optics area.
In another embodiment of the invention, light absorption area is other than containing light absorber, it is also possible to containing photosensitive Other ingredients such as agent, slow releasing pharmaceutical.
In another embodiment of the invention, the optics area edge of intraocular lens uses the material with light absorber Material is made, and optics area is made with button loop of different materials, and three regions pass through by combining by way of physically or chemically synthesizing.
According to a preferred embodiment of the present invention, the Refractive Index of Material in intraocular lens' light absorption area is greater than or waits Refractive Index of Material in optics area, in this case, light are incident to intraocular implants' bulk optics area and have a common boundary with uptake zone and will not make At total reflection phenomenon, and reduce the incidence angle that light is incident to aqueous humor from uptake zone, avoids secondary total reflection.
In another embodiment of the invention, ophthalmic lens (such as intraocular lens) main part has groove, should Ophthalmic lens (such as intraocular lens) have the feature that
Refractive index (is tested) in 35 DEG C of water: 1.43-1.56, and preferred 1.47 ~ 1.53, more preferable 1.50 ~ 1.52
Focal power: -25.0D ~+36.0D, it is preferred that -10.0D ~+36.0D, it is furthermore preferred that+6.0D ~+30.0D
Optical area diameter: >=2.0mm, preferably >=4.2mm, more preferably >=4.5mm
Center thickness: 0.1mm ~ 1.5mm, it is preferred that 0.2mm ~ 1.0mm, it is furthermore preferred that 0.5 ~ 0.9mm
Body rim thickness: 0.08 ~ 0.6mm, preferably 0.1-0.5mm, it is furthermore preferred that 0.15 ~ 0.3mm
Depth of groove: 0.01 to 2mm, preferably 0.01 to 1mm, more preferable 0.01 to 0.7mm
Recess width: 0.05 to 3.5mm, preferably 0.1 to 1.5mm, more preferable 0.2 to 0.8mm
Groove inner edge is apart from lens centre: >=1.0 mm, preferably >=2.1mm, more preferably >=2.25mm.
Above-mentioned groove can be one or more;It can be and penetrate, preferred groove is nonpenetrating;The opening of groove The front surface or rear surface of intraocular lens, preferably rear surface can be located at.Preferably, groove have passed through frosted processing, or Coarse surface is made.
In one embodiment of the present invention, photosensitizer of the present invention is selected from light power type photosensitizer or photo-thermal type photosensitizer. Photosensitizer of the present invention is any photosensitizer that the wave-length coverage for the laser light source being activated is 300~1100 nanometers.It is preferred that laser The wave-length coverage of light source is selected from 500~1000 nanometers;It is preferred that the wave-length coverage of laser light source is selected from 600~900 nanometers;It is preferred that The wave-length coverage of laser light source is selected from 700~900 nanometers or the wave-length coverage of laser light source is selected from 800~1100 nanometers.
In one embodiment of the present invention, the present invention contain the material of light power type photosensitizer selected wavelength (such as 300~1100 nanometers) laser irradiation under, the photosensitizer in material is excited, and generates and has cytotoxic active oxygen, can be with Diseased region cell is killed, achievees the effect that treatment.
In another embodiment of the present invention, the present invention contain the material of photo-thermal type photosensitizer selected wavelength (such as 300~1100 nanometers) laser irradiation under, the photosensitizer in material is excited, and luminous energy is converted into heat, makes ambient temperature It increases to kill pathological tissues cell.DNA, RNA and protein can be inhibited to close when diseased tissue area temperature reaches 43 DEG C At the safety margin of normal cell is 45 DEG C, therefore in the preferred scheme, the material containing photo-thermal type photosensitizer shines in laser Penetrating down can generate heat, and elevate the temperature 4~20 DEG C;In preferred scheme, the material containing photo-thermal type photosensitizer is in laser It can generate heat under irradiation, environment temperature is made to increase 6~12 DEG C;In preferred scheme, the material containing photo-thermal type photosensitizer It can generate heat under laser irradiation, environment temperature is made to increase 8~10 DEG C.Such as increase temperature and be greater than 38 DEG C, it is greater than 39 DEG C, preferably Greater than 40 DEG C, preferably greater than 41 DEG C, preferably greater than 42 DEG C, preferably greater than 43 DEG C, preferably greater than 44 DEG C, preferably greater than 45 DEG C are excellent Choosing is greater than 46 DEG C, preferably greater than 47 DEG C, preferably greater than 50 DEG C, and less than 55 DEG C, preferably greater than 56 DEG C, preferably greater than 57 DEG C are excellent Choosing is greater than 58 DEG C, preferably greater than 59 DEG C, preferably greater than 60 DEG C, preferably greater than 61 DEG C, preferably greater than 62 DEG C, preferably greater than 63 DEG C, Preferably greater than 64 DEG C, preferably greater than 65 DEG C, and preferably smaller than 66 DEG C, preferably smaller than 65 DEG C, preferably smaller than 64 DEG C, preferably smaller than 63 DEG C, preferably smaller than 62 DEG C, preferably smaller than 61 DEG C, preferably smaller than 60 DEG C, preferably smaller than 59 DEG C, preferably smaller than 58 DEG C, preferably smaller than 57 DEG C, preferably smaller than 56 DEG C, preferably smaller than 55 DEG C, preferably smaller than 54 DEG C, preferably smaller than 53 DEG C, preferably smaller than 52 DEG C are preferably small In 51 DEG C, preferably smaller than 50 DEG C, preferably smaller than 49 DEG C, preferably smaller than 48 DEG C, preferably smaller than 47 DEG C, preferably smaller than 46 DEG C.
In another embodiment of the present invention, be suitable for the invention photosensitizer be selected from porphyrin, metalloporphyrin, porphines, Chlorophyll, purpurine, fluorescein, phthalocyanine, metal phthalocyanine, indocyanine green, tricarbocyanine, nanogold particle, metal nanoparticle, gold Belong to oxide nano-particles, metallic sulfide nano-particle, metal carbides nanoparticle, carbon nanotube, graphene etc., and The salt form of the derivative products of above compound or the catabolite of above compound or above compound.Preferred scheme In, photosensitizer is selected from indoles simple cyanine (a methine cyanines), indoles carbon cyanines (cyanine dye), two carbon cyanines (Cyanine) of indoles, indoles Tricarbocyanine (seven methine cyanines), three carbon cyanine dyes, benzindole hemicyanine dye, Benzpyrole squaric acid cyanine dye, phthalocyanine, chlorophyll are derivative Object, pheophytin, Phephorbide a and its derivative, chlorin e 6 and its derivative, purpurine 18, chlorin p6 And its derivative, dihydroquinone e4 and its derivative, chlorin f and its derivative, protoporphyrin and its derivative, benzo leaf are green Porphyrin, metalloporphyrin, hematoporphyrin derivative (HpD), Porfimer Sodium, cancer light quinoline (PSD-007), nanogold, nanometer tungsten oxide, It Nanometer Copper sulfide, nano-iron oxide, nano nickel carbide, nanometer molybdenum oxide and other is repaired based on the above photosensitizer Decorations or modified water-soluble or fat-soluble derivative.
In another embodiment of the present invention, the wave-length coverage that photosensitizer can be the laser light source being activated is 400 The photosensitizer of~600nm, such as fluorescein;The wave-length coverage that photosensitizer can be the laser light source being activated is 600~750nm's Photosensitizer, such as purpurine 18;Photosensitizer can be the photosensitizer that the wave-length coverage for the laser light source being activated is 700~900nm, Such as indocyanine green ICG;Photosensitizer can be the photosensitizer that the wave-length coverage for the laser light source being activated is 800~1100nm, such as Nanogold.
In another embodiment of the present invention, it is suitable for the invention for reducing the light absorber of bad optical phenomena It can be selected from can be used for ophthalmic lens, particularly any light absorber for reducing bad optical phenomena of intraocular lens, such as: Organic dyestuff, such as azo system, anthraquinone system, fragrant methaneseries, indigoids system, porphyrin system, phthalocyanine system, nitro and nitrous base system, methine With polymethine system, heterocycle based compound and its derivative;Various organic or inorganic pigments, such as carbon black, graphite, graphene, gold Metal particles, metal oxide, metal salt compound, metal alkaloid compound, metal sulfide etc..Preferred light absorber packet Include applied to coloring contact lenses various dyestuffs or pigment, such as by United States Patent (USP) US4668240, US4857072, Compound disclosed in US5272010, US8915590 and Chinese patent CN200580017745.8 etc., and it is included in doctor Treat any colorant permitted and ratified by FDA in instrument, such as phyllins (such as purpurine 18), D&C indigo plant 6, D&C Green 6, D&C purple 2, carbazole violet, certain copper complex, certain chromium complex, various ferriferous oxides, phthalocyanine green, phthalocyanine blue etc.;Preferably Pigment include blue phthalocyanine indigo plant (pigment blue 15, C.I. 74160), cobalt blue (pigment blue 15, C.I. 77343), it is green Phthalocyanine green (pigment Green 7, C.I. 74260) and chrome green, the various iron oxidation of yellow, red, brown and black Object, the carbazole violet of purple, the Monolith black C-K(Ciba of black).
In another embodiment of the present invention, contain in drug, light absorber, fluorescer and/or photosensitizer molecule structure There is reactive group, such as: hydroxyl, sulfydryl, amino, imino group, carboxyl, acid anhydrides, aldehyde radical, isocyanate group, siloxy group, epoxy Base, ring nitrogen base, etc., it can be with the generation graft reaction of the group on copolymer material molecular side chain, photosensitizer molecule is with covalent bond Form is combined together with copolymer material strand, and photosensitizer is fixed on inside copolymer material or on its surface, equally It cannot be freely accessible in blood or other body fluid.
In one embodiment of the present invention, contain when in drug, light absorber, fluorescer and/or photosensitizer molecule structure There are polymerizable groups, such as: vinyl, allyl, butylene, acryloxy, methacryloxy, acrylamido, first Base acrylamido, vinyl ether, alkynyl, hydroxyl, sulfydryl, amino, imino group, carboxyl, acid anhydrides, aldehyde radical, isocyanate group, silicon Oxyalkyl, epoxy group, ring nitrogen base, etc. can be copolymerized together with the polymerisable monomer of copolymer material, drug, light Absorbent, fluorescer and/or photosensitizer molecule are present in copolymer material strand in the form of covalent bond, drug, light absorption Agent, fluorescer and/or photosensitizer are fixed in copolymer material, therefore drug, light absorber, fluorescer and/or photosensitizer The toxicity of itself can be ignored completely.
In another embodiment of the present invention, when drug, light absorber, fluorescer and/or photosensitizer are to be blended or mix The modes such as miscellaneous are dispersed in copolymer material, drug, light absorber, fluorescer and/or photosensitizer molecule and copolymer material point Subchain is combined together with hydrogen bond or van der Waals interaction, and drug, light absorber, fluorescer and/or photosensitizer molecule are bound In copolymer material, it cannot be freely accessible in blood or other body fluid.
In another embodiment of the present invention, when drug, light absorber, fluorescer and/or photosensitizer with surface grafting, When surface modification mode is fixed on copolymer material surface, copolymer material is selected from polymerizable copolymer material, preferably on surface The upper polymerizable groups comprising good biocompatibility, such as: vinyl, allyl, butylene, acryloxy, methacryl Oxygroup, acrylamido, methacryl amido, vinyl ether, alkynyl, hydroxyl, sulfydryl, amino, imino group, carboxyl, acid anhydrides, Aldehyde radical, isocyanate group, siloxy group, epoxy group, ring nitrogen base, etc. wherein drug, light absorber, fluorescer and/or photosensitizer Graft reaction, copolymer material and drug, light absorber, fluorescer and/or photosensitizer molecule can occur with copolymer material It is combined together in the form of covalent bond, drug, light absorber, fluorescer and/or photosensitizer are fixed on inside copolymer material Or on its surface, cannot equally it be freely accessible in blood or other body fluid.
In another preferred scheme, drug, light absorber, fluorescer and/or photosensitizer to dissolve, it is suspended, emulsification Etc. modes be dispersed in other auxiliary agents (such as: cosolvent, emulsifier, lubricant, hydrophilic coating, carry medicine, color masterbatch, ultraviolet absorber, Crosslinking agent, coupling agent, pH adjusting agent, antistatic agent, release agent, etc.) in, and it is coated in the surface of copolymer material, drug, light Absorbent, fluorescer and/or photosensitizer molecule and copolymer material strand are combined together with hydrogen bond or van der Waals interaction, Light absorber, fluorescer and/or photosensitizer are bound in the surface of copolymer material, cannot be freely accessible to blood or other body fluid In.
In another preferred scheme, in order to enhance drug, light absorber, fluorescer and/or photosensitizer molecule together Affinity between polymer material molecule, drug, light absorber, fluorescer and/or photosensitizer molecule can live not changing light Chemical modification is carried out under the premise of property;Copolymer material can also be activated, including but not limited to, at plasma Reason, sided corona treatment, flame treatment, strong acid treatment, highly basic processing etc..
Can be used for other polymerisable monomers of the invention includes: butadiene, styrene, α-methylstyrene, styrene sulphur Sour sodium, vinyltoluene, acrylonitrile, methacrylonitrile, α-chloroacrylonitrile, ethyl acrylonitrile, methyl vinyl ether, isopropyl Vinyl ethers, n-butyl vinyl ether, isobutyl vinyl ether, tert-Butyl vinyl ether, 2- ethylhexyl vinyl ether, 4- hydroxyl Butyl vinyl ether, 1,4-butanediol divinyl ether, diethylene glycol divinyl ether, vinyl esters such as, vinyl-acetic ester, alkane Hydroxyl vinyl esters of carboxylic acids, vinyl propionate, vinyl butyrate, vinyl isobutyrate base ester, caproic acid vinyl esters, 2- ethyl saccharinic acid Vinyl acetate and vinyl base ester;Allyl chloride, methallyl chloride, dichloroethylene, vinyl chloride, vinyl fluoride, difluoroethylene, Sodium vinyl sulfonate, butyl vinyl sulfonate, phenyl vinyl sulfone, methyl ethylene sulfone, N- ethenyl pyrrolidone diketone, N- Vinyl oxazolidinedione, methacrylaldehyde, acrylamide, Methacrylamide, N, N- dimethyl (methyl) acrylamide, methylol Acrylamide, N- butoxy (methyl) acrylamide, isobutoxy (methyl) acrylamide etc., etc.;Other olefinics are unsaturated Carboxylic acid and its ester such as, the dialkyl ester and trialkyl ester of binary and tricarboxylic acid (such as itaconic acid), including (the 2- second of maleic acid two Base hexyl) ester, maleic acid dibutyl ester, dimethyl fumarate, dimethyl itaconate, citraconic acid diethyl ester, aconitic acid front three Base ester, mesaconic acid diethyl ester, itaconic acid two (2- ethylhexyl) ester, itaconic acid two (2- chloroethyl) ester, maleic acid, maleic acid Acid anhydride, fumaric acid, itaconic acid;Or mixtures thereof and alkene is such as, diisobutylene, 1- octene, 1- decene, 1- hexadecylene etc.,.
In one embodiment of the present invention, drug, light absorber, fluorescer and/or photosensitizer and copolymer material are poly- When closing acquisition material of the present invention, or obtained when drug, light absorber, fluorescer and/or photosensitizer are dispersed in copolymer material When material of the present invention, material of the present invention can be prepared by the method included the following steps:
1) polymerisable monomer and optional additives such as thermal cross-linking agent, initiator, ultraviolet absorber etc. are mixed;
2) drug, light absorber, fluorescer and/or photosensitizer is added, and makes it dissolve, then polymerize.
More specifically, the material that the present invention is used to prepare ophthalmic lens can be prepared by the method included the following steps:
1) polymerisable monomer is mixed with thermal initiator, crosslinking agent and/or ultraviolet absorber;
2) drug, light absorber, fluorescer and/or photosensitizer is added, makes it dissolve;
3) 2) reaction system obtained is placed in mold;
4) it is polymerize, such as water-bath polymerization;
5) it polymerize again in drier.
In another embodiment of the present invention, when drug, light absorber, fluorescer and/or photosensitizer with surface grafting, When surface modification mode is fixed on copolymer material surface, material of the present invention can be prepared by the method included the following steps:
1) polymerisable monomer and optional additives such as crosslinking agent, thermal initiator, ultraviolet absorber etc. are mixed, then polymerize, obtains To copolymer material;
2) drug, light absorber, fluorescer and/or photosensitizer is added, and makes it dissolve, such as by drug, light absorber, fluorescence Agent and/or photosensitizer are dissolved with suitable auxiliary agent (such as polymerisable monomer), are then polymerize such as graft polymerization or surface and repaired Decorations or trans-printing.
More specifically, material of the present invention can be prepared by the method included the following steps:
1) polymerisable monomer is mixed with thermal initiator, crosslinking agent and/or ultraviolet absorber;
2) 1) reaction system obtained is transferred in mold;
4) it is polymerize, such as water-bath polymerization;
5) it polymerize again in drier;
6) drug, light absorber, fluorescer and/or photosensitizer are dissolved, for example, by drug, light absorber, fluorescer and/or light Quick dose is dissolved with suitable polymerisable monomer;
7) system of above-mentioned acquisition is polymerize again such as graft polymerization or surface modification or trans-printing.
In another embodiment of the present invention, when drug, light absorber, fluorescer and/or photosensitizer are coated with surface When mode is fixed on copolymer material surface, material of the present invention can be prepared by the method included the following steps:
1) suitable copolymer material is obtained;
2) by drug, light absorber, fluorescer and/or photosensitizer, such as by drug, light absorber, fluorescer and/or photosensitizer It is dissolved with a kind of suitable solvent, is coated in copolymer material surface.
The material that the present invention is used to prepare ophthalmic lens can be used for manufacture medical treatment device, medical detection device, Such as: for manufacture contact lens, Ortho-K, scleral contact lens, iris hooks, internal oculoscope, artificial cornea, in cornea Ring, capsular tension ring, intracorneal lens, Glaucoma Drainage valve, slow releasing carrier of medication, Ocular tamponades, eyeground filler, eye Mirror, goggles, Medical Devices lens can be used for manufacturing medical treatment device (such as when it includes therapeutic agent and/or photosensitizer The device for treating ophthalmology disease), such as the device (ophthalmic lens as treated inverse position method) for the treatment of inverse position method, or when it includes glimmering Can be used for manufacturing medical detection device when photo etching (detect resulting product can using fluorescent characteristic, in particular, ophthalmology is set It is standby, e.g., the eyeglass with fluorescent characteristic, especially ophthalmic lens, the ophthalmic lens with fluorescent characteristic, contact lens, angle Film moulding mirror, iris hooks, internal oculoscope, artificial cornea, cornea inner ring, capsular tension ring, intracorneal lens, Glaucoma Drainage Valve, slow releasing carrier of medication, Ocular tamponades, eyeground filler, glasses, goggles, Medical Devices lens, telescope, surveillance mirror Deng) etc. other Ophthalmologic apparatus or consumptive material.
The invention further relates to the materials that the present invention is used to prepare medical device (such as ophthalmic lens, particularly intraocular lens) Purposes in preparation above-mentioned apparatus or equipment (such as medical treatment device, medical detection device), such as: ophthalmic lens, especially Ground, intraocular lens, contact lens, Ortho-K, scleral contact lens, iris hooks, internal oculoscope, artificial cornea, cornea Inner ring, capsular tension ring, intracorneal lens, Glaucoma Drainage valve, slow releasing carrier of medication, Ocular tamponades, eyeground filler, eye Mirror, goggles, Medical Devices lens can be used for manufacturing medical treatment device (such as when it includes therapeutic agent and/or photosensitizer The device for treating ophthalmology disease), such as the device for the treatment of inverse position method, or can be used for manufacturing anti-optics when it includes light absorber The therapeutic device (device as treated ophthalmology disease, such as ophthalmic lens, particularly intraocular lens) of interference, or when it includes glimmering Can be used for manufacturing medical detection device when photo etching (detect resulting product can using fluorescent characteristic, in particular, ophthalmology is set It is standby, e.g., the eyeglass with fluorescent characteristic, especially ophthalmic lens, the ophthalmic lens with fluorescent characteristic, contact lens, angle Film moulding mirror, scleral contact lens, iris hooks, internal oculoscope, artificial cornea, cornea inner ring, capsular tension ring, intracorneal lens, Glaucoma Drainage valve, Ocular tamponades, eyeground filler, glasses, goggles, Medical Devices lens, is looked in the distance at slow releasing carrier of medication Mirror, surveillance mirror etc.) etc. other Ophthalmologic apparatus or consumptive material.
The term as used herein " alkyl " refers to containing 1 to 500 carbon atom or 1 to 100 carbon atom or 1 to 50 carbon Atom or 1 to 20 carbon atom or 1 to 10 carbon atom or 1 to 8 carbon atom, 1 to 6 carbon atom, 1 to 4 carbon atom Or the linear chain or branched chain hydrocarbon of 1 to 3 carbon atom (unless otherwise prescribed).The representative example of alkyl include but is not limited to methyl, Ethyl, n-propyl, isopropyl, normal-butyl, sec-butyl, isobutyl group, tert-butyl, n-pentyl, isopentyl, neopentyl, n-hexyl, 3- Methylhexyl, 2,2- dimethyl amyl group, 2,3- dimethyl amyl group, n-heptyl, n-octyl, n-nonyl and positive decyl, undecyl, Dodecyl, tridecyl, myristyl, pentadecyl, cetyl, heptadecyl, octadecyl, nonadecyl, 20 Alkyl.When the linking group between " alkyl " group is two other parts, then it may also be linear chain or branched chain;Example packet It includes but is not limited to-CH2-、-CH2CH2-、-CH2CH2CH(CH3)-、-CH2CH(CH2CH3)CH2-。
The term as used herein " aryl " refers to phenyl (that is, monocyclic aryl) either containing the bicyclic of at least one phenyl ring System or the aromatics that carbon atom is contained only in aromatic bicyclic system are bicyclic.Bicyclic aryl can be azulenyl (azulenyl), naphthalene Base or the phenyl for being fused to monocyclic cycloalkyl, monocyclic cycloalkenyl or monocyclic heterocycles base.The phenyl that bicyclic aryl passes through bicyclic system Any carbon atom of any carbon atom or naphthalene or azulenyl ring that contain in part is connected to parent molecular moiety.Bicyclic aryl Condensed monocyclic cycloalkyl or monocyclic heterocycles base portion point are optionally replaced by one or two oxos and/or thia group.Bicyclic aryl Representative example includes but is not limited to azulenyl, naphthalene, indane -1- base, indane -2- base, indane -3- base, indane -4- Base, 2,3- indoline -4- base, 2,3- indoline -5- base, 2,3- indoline -6- base, 2,3- indoline -7- base, Indenes -1- base, indenes -2- base, indenes -3- base, indenes -4- base, dihydronaphthalene -2- base, dihydronaphthalene -3- base, dihydronaphthalene -4- base, dihydronaphthalene -1- Base, 5,6,7,8- naphthane -1- base, 5,6,7,8- naphthane -2- base, 2,3- Dihydrobenzofuranes -4- base, 2,3- dihydrobenzo Dioxane between furans -5- base, 2,3- Dihydrobenzofuranes -6- base, 2,3- Dihydrobenzofuranes -7- base, benzo [d] [1,3] Amylene -4- base, benzo [d] [1,3] dioxole -5- base, the dilute -2- ketone -5- base of 2H- color, the dilute -2- ketone -6- of 2H- color Dilute -2- ketone -7- the base of base, 2H- color, the dilute -2- ketone -8- base of 2H- color, isoindoline -1,3- diketone -4- base, isoindoline -1,3- two Ketone -5- base, 1-Indanone -4- base, 1-Indanone -5- base, 1-Indanone -6- base, 1-Indanone -7- base, 2,3- dihydrobenzo [b] [1,4] dioxanes -5- base, 2,3- dihydrobenzo [b] [1,4] dioxanes -6- base, 3 (4H) -one-of 2H- benzo [b] [1,4] oxazines 5- base, 3 (4H) -one -6- base of 2H- benzo [b] [1,4] oxazines, 3 (4H) -one -7- base of 2H- benzo [b] [1,4] oxazines, 2H- benzene And 3 (4H) -one-8- base of [b] [1,4] oxazines, benzo [d] oxazines-2 (3H) -one-5- base, benzo [d] (3H) -one of oxazines-2-6- Base, benzo [d] oxazines -2 (3H) -one -7- base, benzo [d] oxazines -2 (3H) -one -8- base, quinazoline -4 (3H) -one -5- base, Quinazoline -4 (3H) -one -6- base, quinazoline -4 (3H) -one -7- base, quinazoline -4 (3H) -one -8- base, quinoxaline -2 (1H) - Ketone -5- base, quinoxaline -2 (1H) -one -6- base, quinoxaline -2 (1H) -one -7- base, quinoxaline -2 (1H) -one -8- base, benzo [d] thiazole -2 (3H) -one -4- base, benzo [d] thiazole -2 (3H) -one -5- base, benzo [d] thiazole -2 (3H) -one -6- base and benzene And [d] thiazole -2 (3H) -one -7- base.In certain embodiments, bicyclic aryl be fused to 5 or 6 unit monocycle naphthenic base, 5 or (i) naphthalene or (ii) benzyl ring of 6 unit monocycle cycloalkenyls or 5 or 6 unit monocycle heterocycles, wherein condensed naphthenic base, cycloalkenyl Optionally replaced by one or two groups for independently being oxo or thia with heterocyclyl groups.
The term as used herein " aryl alkyl " or refer to through alkyl group as defined herein for " alkylaryl " It is connected to the aryl group as defined herein of parent molecular moiety.The representative example of aryl alkyl includes but is not limited to benzyl Base, 2- phenylethyl, 3- phenyl propyl and 2- naphthalene -2- base ethyl.
The term as used herein " naphthenic base " refers to monocycle or bicyclic cycloalkyl loop system.Single loop system is containing 3 to 8 The cyclic hydrocarbon group of carbon atom, wherein this group can be saturated or unsaturated, it but is not aromatics.In certain embodiment party In case, group of naphthene base is fully saturated.The example of monocyclic cycloalkyl includes cyclopropyl, cyclobutyl, cyclopenta, cyclopentene Base, cyclohexyl, cyclohexenyl group, suberyl and cyclooctyl.Bicyclic cycloalkyl loop system is the monocycle or condensed bicyclic of bridge joint.Bridge The monocycle connect contains monocyclic cycloalkyl ring, and wherein the non-adjacent carbon atom of the two of monocycle passes through the Asia of one to three extra carbon atom Alkyl bridge connects (that is,-(CH2)wThe bridge joint group of form, wherein w is 1,2 or 3).The representative example of bicyclic system include but It is not limited to bicyclic [3.1.1] heptane, bicyclic [2.2.1] heptane, bicyclic [2.2.2] octane, bicyclic [3.2.2] nonane, bicyclic [3.3.1] nonane and bicyclic [4.2.1] nonane.Condensed-bicyclic alkyl ring system, which contains, is fused to phenyl, monocyclic cycloalkyl, list The monocyclic cycloalkyl ring of ring cycloalkenyl, monocyclic heterocycles base or bicyclic heteroaryl.Bridging or condensed bicyclic cycloalkyl pass through monocycle Any carbon atom contained in cycloalkyl ring is connected to parent molecular moiety.Group of naphthene base independently optionally is by one or two The group of oxo or thia replaces.In certain embodiments, condensed bicyclic cycloalkyl is to be fused to benzyl ring, 5 or 6 yuan of lists 5 or 6 unit monocycle cycloalkanes of the unit monocycle heterocycle of the unit monocycle cycloalkenyl of ring naphthenic base, 5 or 6,5 or 6 or 5 or 6 unit monocycle heteroaryls Basic ring, wherein condensed bicyclic cycloalkyl is optionally replaced by one or two groups for independently being oxo or thia.
The term as used herein " heteroaryl " refers to bicyclic heteroaryl or bicyclic system containing at least one hetero-aromatic ring.It is single Ring heteroaryl can be 5- or 6-membered ring.5 member rings by two double bonds and one, two, three or four nitrogen-atoms and an optional oxygen or Sulphur atom composition.6 member rings are made of three double bonds and one, two, three or four nitrogen-atoms.5 or 6 unit's heteroaryls pass through in heteroaryl Any carbon atom or any nitrogen-atoms contained is connected to parent molecular moiety.The representative example of bicyclic heteroaryl includes but not It is limited to furyl, imidazole radicals, isoxazolyl, isothiazolyl, oxadiazoles base, oxazolyl, pyridyl group, pyridazinyl, pyrimidine radicals, pyrazine Base, pyrazolyl, pyrrole radicals, tetrazole radical, thiadiazolyl group, thiazolyl, thienyl, triazolyl and triazine radical.Bicyclic heteroaryl is by thick Close the bicyclic heteroaryl composition of phenyl, monocyclic cycloalkyl, monocyclic cycloalkenyl, monocyclic heterocycles base or bicyclic heteroaryl.It is bicyclic miscellaneous The fused cycloalkyl or heterocyclyl moieties of aryl group are optionally replaced by one or two groups for independently being oxo or thia.When When bicyclic heteroaryl contains condensed naphthenic base, cycloalkenyl or heterocyclic ring, then bicyclic heteroaryl group passes through bicyclic system Any carbon or nitrogen-atoms contained in monocyclic heteroaryl moiety is connected to parent molecular moiety.When bicyclic heteroaryl is to be fused to benzene When the bicyclic heteroaryl of basic ring, then bicyclic heteroaryl group is connected to mother by any carbon atom in bicyclic system or nitrogen-atoms Body molecular moiety.The representative example of bicyclic heteroaryl includes but is not limited to benzimidazolyl, benzofuranyl, benzothiophene Base, benzoxadiazole base, benzo oxa- thia di azoly, benzothiazolyl, cinnoline base, 5,6- dihydroquinoline -2- base, 5,6- bis- Hydrogen isoquinoline -1- base, furopyridyl, indazolyl, indyl, isoquinolyl, naphthyridines base, quinolyl, purine radicals, 5,6,7, 8- tetrahydroquinoline -2- base, 5,6,7,8- tetrahydroquinoline -3- base, 5,6,7,8- tetrahydroquinoline -4- base, 5,6,7,8- Tetrahydroisoquinoli- Quinoline -1- base, thienopyridine base, 4,5,6,7- tetrahydro benzo [c] [1,2,5] oxadiazoles base and 6,7- dihydrobenzo [c] [1,2, 5] oxadiazoles -4 (5H) -one base.In certain embodiments, condensed bicyclic heteroaryl is to be fused to benzyl ring, 5 or 6 yuan of lists 5 or 6 unit monocycle heteroaryls of the unit monocycle heterocycle of the unit monocycle cycloalkenyl of ring naphthenic base, 5 or 6,5 or 6 or 5 or 6 unit monocycle heteroaryls Basic ring, wherein condensed naphthenic base, cycloalkenyl and heterocyclyl groups independently optionally are the base of oxo or thia by one or two Group replaces.
The term as used herein " heteroaryl alkyl " and "-miscellaneous alkyl aryl " refer to through alkyl group as defined herein It is connected to the heteroaryl as defined herein of parent molecular moiety.The representative example of heteroaryl alkyl includes but is not limited to furan It mutters -3- ylmethyl, 1H- imidazoles -2- ylmethyl, 1H- imidazol-4 yl methyl, 1- (pyridin-4-yl) ethyl, pyridin-3-yl first Base, pyridin-4-yl methyl, pyrimidine -5- ylmethyl, 2- (pyrimidine -2-base) propyl, thiophene -2- ylmethyl and thiene-3-yl first Base.
The term as used herein " heterocycle " refers to monocyclic heterocycles or bicyclic heterocycle.Monocyclic heterocycles are 3,4,5,6 or 7 yuan Ring, the hetero atom containing at least one independently selected from O, N and S, middle ring are saturated or unsaturated, but are not aromatics.3 Or 4 member ring contain 1 be selected from O, N and S hetero atom.5 member rings can be selected from O, N containing zero or double bond and one, two or three With the hetero atom of S.6 or 7 member rings contain zero, one or two double bonds and one, two or three hetero atom selected from O, N and S.Monocycle is miscellaneous Ring is connected to parent molecular moiety by any carbon atom contained in monocyclic heterocycles or any nitrogen-atoms.The representative of monocyclic heterocycles Property example include but is not limited to azetidinyl, nitrogen heterocyclic heptyl, '-aziridino, Diazesuberane base, 1,3- bis- dislike It is alkyl, 1,3- dioxolane base, 1,3- dithiolane base, 1,3- dithianyl, imidazolinyl, imidazolidinyl, different Thiazolinyl, isothiazole alkyl, isoxazoline base, isoxazolidinyl, morpholinyl, oxadiazoline base, oxadiazoles alkyl, oxazoline Base, oxazolidinyl, piperazinyl, piperidyl, pyranose, pyrazolinyl, pyrazolidinyl, pyrrolinyl, pyrrolidinyl, tetrahydrofuran Base, tetrahydro-thienyl, Thiadiazoline base, thiadiazoles alkyl, thiazolinyl, thiazolidinyl, thio-morpholinyl, 1,1- sulfur dioxide For morpholinyl (thiomorpholine sulfone), thiapyran base and trithiane base.Bicyclic heterocycle is to be fused to phenyl, monocyclic cycloalkyl, monocycle ring The monocyclic heterocycles of alkenyl, monocyclic heterocycles or bicyclic heteroaryl.Contain in the monocyclic heterocycles part that bicyclic heterocycle passes through bicyclic system Any carbon atom or any nitrogen-atoms be connected to parent molecular moiety.The representative example of bicyclic heterocyclic radical includes but is not limited to 2,3- Dihydrobenzofuranes -2- base, 2,3- Dihydrobenzofuranes -3- base, indoline -1- base, indoline -2- base, dihydro Indoles 3- base, 2,3- dihydrobenzo thiophene -2- base, decahydroquinolyl, Decahydroisoquinolinpreparation base, octahydro -1H- indyl and octahydro benzene And furyl.Heterocyclyl groups are optionally replaced by one or two groups for independently being oxo or thia.In certain embodiments In, bicyclic heterocyclic radical is to be fused to the unit monocycle heterocycle of the unit monocycle cycloalkenyl of the unit monocycle naphthenic base of benzyl ring, 5 or 6,5 or 6,5 or 6 5 or 6 unit monocycle heterocyclic rings of base or 5 or 6 unit monocycle heteroaryls, wherein bicyclic heterocyclic radical independently optionally is by one or two The group of oxo or thia replaces.
Extention of the present invention can be degradation material, such as polycaprolactone, poly butylene succinate, polylactic acid, gather Hydroxyalkanoate, aliphatic aromatic copolyesters, polyvinyl alcohol, carbon dioxide copolymer, poly-beta-hydroxy-butyrate or it is mixed Object or its copolymer are closed, degradation material is the ideal carrier of drug, and phase sustained release position is uniform, and uniformly, slow-release time is long for amount. After degradation material is degradable, drug is discharged completely, can be -1 year for 1 week according to the difference of degradation material Time, residual epithelium cell are more thoroughly removed.After complete release, the groove in lens optical area forms similar sharp The structure on right angle side side, while having effects that prevention.When extention does not use degradation material, therapeutic active agents can To be coated not using the coating of any surface and modification technique, the surface fixed to extention disclosed in the prior art with other With optics district center is without healing potion, and removing upper cell is more targeted, and the dosage needed also accordingly reduces, to it His normal tissue cell injury is small.
In another embodiment of the present invention, extention and material of main part are selected from hydrophobic type acrylate, acrylic acid Ester hydrogel, silica gel, silicone-hydrogel, fluorine Si acrylate, polystyrene and polymethyl methacrylate, polycarbonate, poly- silicon Or mixtures thereof oxygen alkane,.
In another embodiment of the present invention, the extention material be selected from biodegradable plastic, as polycaprolactone, Poly butylene succinate, polylactic acid, polyhydroxyalkanoates, aliphatic aromatic copolyesters, polyvinyl alcohol, carbon dioxide copolymerization Object, poly-beta-hydroxy-butyrate, or mixtures thereof or its copolymer.
In another embodiment of the present invention, it is anti-can to carry all kinds of antibiotic, steroidal for extention drug-carrying Scorching medicine and non-steroidal anti-inflammatory drugs prevent post-operation inflammatory and microorganism infection.Antimetabolitas and mitosis can also be carried Inhibitor, the drug immunotoxin for inhibiting inflammatory reaction and cytotoxin, lure at the drug for inhibiting cell and extracellular matrix adhesion Guided cell apoptosis drug come eliminate LEC or inhibit epithelial cell mitosis, prevent and treat post gelating time, degradation material In degradation process, drug is sustained.
In another embodiment of the present invention, extention can be attached with main body by adhesive, adhesive Selected from but not limited to a-cyanoacrylate class adhesive of medical, as α-cyanoacrylaten-butyl, alpha-cyanoacrylate are just pungent The mixture of ester, isobutyl alpha-cyanoacrylate and its two kinds of components or three kinds of components.
In another embodiment of the present invention, the adhesive of extention and main part is bonded selected from medical organic silicon Agent.Such as MED-1131, MED-1137, MED-1511, MED-1540, MED-1555, MED-2000, MED1- of Nusil company 4213 and the medical organic silicon adhesive with phase same-action.
In another embodiment of the present invention, the present invention prepares the material of extention and the material of preparation main part It may be the same or different, any suitable main body material selected from the material of main part comprising polymerisable monomer or preferred good biocompatibility Material.Wherein, polymerisable monomer be selected from hydrophilic polymerisable monomer or hydrophobic polymerizable monomer, can be monomer homopolymer or The copolymer of various of monomer.It can be selected from high-molecular biologic degradation material simultaneously.
In another embodiment of the present invention, the material for preparing main part be can be, but be not limited only to: above-mentioned to be suitble to Manufacture ophthalmology medical material, the glue with appropriate aqueous rate and suitable index of refraction of micro-incision medical device (such as ophthalmic lens) Original, hydrogel, silicone-hydrogel, fluorine Si acrylate, silicone, polystyrene, methyl methacrylate, siloxanes, methyl silicon oxygen Alkane, phenyl siloxane, vinylsiloxane, acrylate radical siloxane, methacrylate siloxanes or above-mentioned mixing Object.
In another embodiment of the present invention, hydrogel is selected from, including but not limited to: collagen, gelatin, angle egg White, elastin laminin, vegetable protein, netted scleroprotein and quaternized albumen etc. or poly- polysaccharide, heparin, chondroitin sulfate, hyalomitome Acid, Arabic gum, agar, Irish moss amine, pectin, guar gum and alginate etc. or modified starch, modified cellulose, carboxylic first Base starch, acetic starch, methylcellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, Carboxymethyl cellulose etc. or polyvinyl acetate, polymethyl vinyl ether, polyvinyl alcohol, polyethylene glycol, polyoxyethylene, poly- third Acrylamide (PAM), hydrolyzed polyacrylamide (HPAM)), polyvinylpyrrolidone (PVP), polyethyleneimine (PEI) or above-mentioned Blend.
In another embodiment of the present invention, the material for being used to prepare extention is also selected from biodegradable material Material, including but not limited to polycaprolactone, poly butylene succinate, polylactic acid, polyhydroxyalkanoates, aliphatic aromatic copolymerization Ester, polyvinyl alcohol, carbon dioxide copolymer, poly-beta-hydroxy-butyrate, or mixtures thereof or its copolymer.
In another embodiment of the present invention, extention includes therapeutic agent, including steroids and non-hormone resist Scorching medicine and broad-spectrum antibacterials and any mitotic drug eliminated lens epithelial cells or inhibit epithelial cell, such as oxygen Flucloxacillin, ascorbic acid, aspirin, colchicin, lidocaine, nepafenac, ketorolac, Bromfenac, lepirudin 023 ludon, Methotrexate, 5 FU 5 fluorouracil, taxol, adriamycin, daunorubicin, saponaretin and other known or unknown have The drug or composition of identity function.
In another embodiment of the present invention, extention is cricoid and including light absorber and/or photosensitizer.
In another embodiment of the present invention, the main part of ophthalmic lens of the present invention has at least two sharp edges Edge.
In another embodiment of the present invention, in main part, support loop and optical flat are at an angle;Support loop Rear surface proximal end have square edge staircase structural model;Supporting the far-end of the rear surface of loop has square edge step Formula structure, wherein the proximal end thickness of support loop rear surface staircase structural model is greater than far-end thickness.
In another embodiment of the present invention, the step of the square edge staircase structural model of loop rear surface far-end is supported Drop height is 0.1-5 millimeters, preferably 0.1-1 millimeters, 0.2-0.5 millimeters more preferable, wherein support loop rear surface step knot The proximal end thickness of structure is greater than far-end thickness.
In another embodiment of the present invention, in the platform of the square edge staircase structural model of support loop rear surface proximal end Rank drop is 0.1-5 millimeters, preferably 0.3-3 millimeters, 0.5-2 millimeters more preferable, wherein support loop rear surface staircase structural model Proximal end thickness is greater than far-end thickness.
Another preferred embodiment according to the present invention, in ophthalmic lens main part optical component and support loop be by An entirety made of same material.
Another preferred embodiment according to the present invention, medical device (such as ophthalmic lens such as intraocular lens;With it is non- Ophthalmic lens mirror etc. as built in frame eyeglasses, contact lens (contact lenses), cornea) the preceding table of optical component in main part Face and/or rear surface include optical device, for example, selected from aspherical equipment, multifocal point device, double-curved surface equipment, colourless being casually arranged with The conventional suitable various equipment in standby, zoom point device, light filter plant or this field.
Another preferred embodiment according to the present invention supports the proximal end of loop to have open slot.
The invention further relates to the methods of preparation medical device (such as ophthalmic lens) comprising following step:
(A) prepared by medical device (such as ophthalmic lens) main part:
1) main part is prepared by the above-mentioned material for being used to prepare main part;
2) light absorption area part is prepared by the above-mentioned material for being used to prepare light absorption area part;
3) it obtains and optionally contains reeded medical device (such as ophthalmic lens) main part;
(B) preparation of the extention of drug containing, light absorber, photosensitizer and/or fluorescer:
1) the above-mentioned material for being used to prepare extention is prepared into extention, it includes drug, light absorber, photosensitizers And/or fluorescer,
(C) optionally, adhesive is added.
In another embodiment of the present invention, for parent of the medical device (ophthalmic lens) between main body and extention And power, medical device (such as ophthalmic lens) main body can be activated, and including but not limited to, corona treatment, electricity Dizzy processing, flame treatment, strong acid treatment, highly basic processing etc..Or the coating in medical device (such as ophthalmic lens) body recess Primary coat paint increases the adhesive force of extention and medical device (such as ophthalmic lens) main body.
In the methods of the invention, dosage of crosslinking agent is 0.1-20 weight %, the preferably 0.5-15% of polymerisable monomer, particularly 1-5%.Ultraviolet absorber dosage is 0-10 weight %, the preferably 0-5% of polymerisable monomer, particularly 0-1%.Initiator amount is can 0.01-10 weight %, the preferably 0.01-5% of polymerized monomer, particularly 0.05%-1%.
The other optional components that can be used in the present invention include cosolvent, emulsifier, hydrophilic coating, carry medicine, color masterbatch, crosslinking It is agent, coupling agent, pH adjusting agent, antistatic agent, release agent, pigment, filler, dispersing agent, curing agent, wetting agent, defoaming agent, ultraviolet Light absorbers, antioxidant, bactericidal agent and stabilizer etc..
The invention further relates in the method for the effects of phototherapy for treating ophthalmology disease of Laser Driven, wherein this is only used only in this method The prepared Medical Devices (such as ophthalmic lens) of invention can be carried out.Specifically, for example, only by tool of the present invention There are the medical device (such as ophthalmic lens) (photosensitizer is added without additional) of photosensitizer, under laser equipment, treatment needed for irradiating Position, the Medical Devices as prepared by the present invention have photosensitizer, and photosensitizer is activated, and has cytotoxicity by generating Active oxygen, or generate high warm, lens epithelial cells in lens capsule can be killed, reach prevention or treatment late coming is white The effect of cataract or glaucoma.
It can be seen that Medical Devices prepared by material of the present invention and the present invention thoroughly get rid of exogenous photosensitizer (without taking photosensitizer etc. in advance), the method for the present invention have non-without adding any additional reagent (including photosensitizer) The advantages such as invasion, nontoxicity, high efficiency, repeatability.
Detailed description of the invention
Fig. 1 illustrates the plan view for the intraocular lens that extention is annular, wherein (a) is main body;(b) annular is attached Add part.
Fig. 2 illustrates the sectional view for the intraocular lens that extention is annular.
Fig. 3 illustrates the rear surface and its sectional view that extention is incorporated into intraocular implants' phosphor bodies, and wherein Fig. 3 (a) shows Example annulus is located at crystal rear surface;Fig. 3 (b) illustrates the sectional view that annulus is located at crystal rear surface.
Fig. 4 illustrates the front surface and its sectional view that extention is incorporated into intraocular lens, and wherein Fig. 4 (a) is illustrated Annulus is located at crystal front surface;Fig. 4 (b) illustrates the sectional view that annulus is located at crystal front surface.
Fig. 5 illustrates extention and is incorporated in intraocular implants' phosphor bodies rear surface and its sectional view with embedded mode, wherein Fig. 5 (a) illustrates annulus and is fixed on rear surface with embedded mode;Fig. 5 (b) illustrates annulus and is fixed on rear surface with embedded mode Sectional view.
It is intermittent circle that Fig. 6, which illustrates extention shape,.
It is intermittent sector that Fig. 7, which illustrates extention shape,.
The shape that Fig. 8 illustrates extention is polygon, and the specific example of light absorption closed loop is formed around optics area.
Fig. 9 illustrates intraocular lens' specific example of optics area edge coating light absorber, and wherein dash area is to apply Cover the part of light absorber.
Figure 10 illustrates mold diagrammatic cross-section, and wherein A chamber is optics area, and B chamber is edge and support section.
Figure 11 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area It is preceding recessed rear convex;The junction on annulus and the forward and backward surface of crystal and main surface shape are coincide, non-flanged step.
Figure 12 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area It is preceding recessed rear convex;Annulus forms step structure in crystal rear surface, and step drop is 0.05mm.
Figure 13 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area For equal concave-concaves;Annulus is respectively formed step structure on the forward and backward surface of crystal, and step drop is 0.005mm.
Figure 14 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area For etc. biconvexs;Annulus forms step structure in crystal rear surface, and step drop is 0.15mm.
Figure 15 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area It is put down after close to lordosis;Annulus forms step structure in crystal front surface, and step drop is 0.3mm.
Figure 16 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area It is recessed after close to preceding put down;Annulus forms step structure in crystal rear surface, and step drop is 0.4mm.
Figure 17 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area It is recessed after lordosis;Annulus forms step structure in crystal rear surface, and step drop is 0.001mm.
Figure 18 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area It is recessed after lordosis;Annulus forms step structure in crystal rear surface, and step drop is 0.005mm.
Figure 19 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area For the biconvexs such as not;Annulus forms step structure in crystal rear surface, and step drop is 0.01mm.
Figure 20 illustrates extention annulus and a kind of combination of intraocular lens, wherein intraocular implants' bulk optics area For the biconvexs such as not;Annulus forms step structure in crystal rear surface, and step drop is 1.0mm.
Figure 21 illustrates light absorption area Refractive Index of Material >=optics area Refractive Index of Material of intraocular lens, and light is incident Having a common boundary to intraocular implants' bulk optics area and uptake zone not will cause total reflection phenomenon, and reduces light and be incident to aqueous humor from uptake zone Incidence angle, avoid secondary total reflection.
Specific embodiment
The synthesis of embodiment 1-6 material of main part
Embodiment 1-6 illustrates the monomer composition of material of main part synthesis, and with molar percent, all embodiments in table 1 are all It prepares in the following manner, all monomers are purified through vacuum distillation.It, can respectively according to corresponding ratio mix monomer in beaker The additives such as the addition initiator for the property selected and light absorber, stir and filter, and are transferred in special mold.It is above-mentioned The various vessel and mold arrived used in implementation process will be through over cleaning, drying and disinfection before use.
It is passed through nitrogen in monomer solution into mold, and is under nitrogen protection sealed mold, then by mold It is put into the water-bath of set temperature and carries out polymerization reaction at least 24 hours, then mold is transferred in the baking oven of set temperature and is continued Keep the temperature 24 hours (note: the set temperature of baking oven should be higher than that the set temperature of water-bath).It will take out molding polymer in a mold Cooled to room temperature, or the blank for being cut into required size and shape is carried out to it while hot, with alcohols solvent in certain temperature Finally blank is placed in vacuum oven dried under set temperature with removing remaining small molecule within the lower extraction of degree at least 24 hours The material of main part of the present invention can be obtained in night.
Embodiment 1 2 3 4 5 6
EA 70 60.5 26 46
EMA 27.5
MMA 17.5 97.5
HEMA 80 40 40
POEA 30
ST 36
KH570 10
AIBN 0.2 0.15 0.2 0.15 0.12 0.12
EGDMA 2 2 2 3 3.5 3.5
EA: ethyl acrylate
EMA: ethyl methacrylate
MMA: methyl methacrylate
HEMA: hydroxyethyl methacrylate
POEA: acrylic acid -2- phenoxy ethyl
ST: styrene
KH570:3- (methacryloxypropyl) propyl trimethoxy silicane
AIBN: azodiisobutyronitrile
EGDMA: ethylene glycol dimethacrylate.
Embodiment extention synthesis mode Monomer Formations
Embodiment 7-13 schematically illustrates the synthesizing formula of cyclic annular treatment part material, with molar percent.The molding for the treatment of part Mode is selected from cutting method, cast molding, spraying, method of molding.
Embodiment 7 8 9 10 11 12 13
EA 70 70 60.5 26 46
EMA 27.5 27.5
MMA 17.5 97.5
HEMA 80 40 40
POEA 30
ST 36
KH570 10
AIBN 0.2 0.2 0.15 0.2 0.15 0.12 0.12
EGDMA 2 2 2 2 3 3.5 3.5
Purpurin 18 0.01 0.01 0.01
Indoles simple cyanine 0.01
IR780 0.02 0.02
IR783 0.01
Embodiment 14: adhesion mode prepares peripheral treatment part intraocular lens
A the artificial lens body part in peripheral treatment part) is processed using 1 material prepared of embodiment, is to pass through turning process Processing, is divided into the brilliant base that thickness is about 3 mm, diameter is about 16 mm for prepared polymer material.In single-point diamond vehicle Bed (OPTOFORM) machine-shaping intraocular lens, molding intraocular lens have the main diameter of 6mm, and main body has therapeutic type recessed Slot, interior edge are 2.2mm away from intraocular lens center, and width 0.2mm, depth is the groove of 0.1mm, intraocular implants after molding The polished dielectric polish of body.
B) according to the formula of embodiment 8, treatment part material is prepared in such a way that material of main part is molding in glass plate, Treatment part material mechanical is then processed into wide 0.2mm using cutting method, with a thickness of the treatment part of 0.1mm.
C) by step A) preparation with reeded main part under oxygen atmosphere, with vacuum plasma machine, 100w Power under handle 1 minute, silicone adhesive MED-2000 is then coated in groove, by treatment part obtained by step B) It is embedded into the groove of main part, being placed in makes adhesive sufficiently dry for 3 hours in 60 DEG C of baking ovens, obtains periphery with treatment part Intraocular lens.
Embodiment 15: spraying method prepares peripheral treatment part intraocular lens
A extention intraocular lens' main part in periphery) is processed using 1 material prepared of embodiment, is to pass through turning process Processing, is divided into the brilliant base that thickness is about 3 mm, diameter is about 16 mm for prepared polymer material.In single-point diamond vehicle Bed (OPTOFORM) machine-shaping intraocular lens, molding intraocular lens have the main diameter of 6.5mm, and main body has therapy section Parting groove, interior edge are 2.1mm away from intraocular lens center, and width 0.8mm, depth is the groove of 0.1mm, people after molding The polished dielectric polish of work crystalline lens.
B) by step A) preparation with reeded main part under oxygen atmosphere, with vacuum plasma machine, 100w Power under handle 1 minute, improve surface cover performance
C the formula in extention formulation Example 10) is done into pre-polymerization, performed polymer is fitted into spray gun.Intraocular lens' main part Divide and carries out covering treatment in addition to groove part.Spray amount is controlled, is solidified after being sprayed to performed polymer, in 90 DEG C of baking ovens overnight, Obtain periphery extention intraocular lens.
Embodiment 16: casting mode prepares periphery extention intraocular lens
A extention intraocular lens' main part in periphery) is processed using 1 material prepared of embodiment, is to pass through turning process Processing, is divided into the brilliant base that thickness is about 3 mm, diameter is about 16 mm for prepared polymer material.In single-point diamond vehicle Bed (OPTOFORM) machine-shaping intraocular lens, molding intraocular lens have the main diameter of 6mm, and main body has extention Type groove, interior edge are 2.1mm away from intraocular lens center, and width 0.2mm, depth is the groove of 1mm, artificial crystalline substance after molding The polished dielectric polish of shape body.
B the formula materials in embodiment 10) are done into pre-polymerization under azodiisobutyronitrile initiation, in three-necked flask, 88 DEG C poly- It closes 1 hour, stops stirring when system becomes viscous.
C performed polymer obtained by step B)) is injected into step A by syringe) groove of intraocular lens' main part It is interior, make to fill up groove, lies in a horizontal plane in solidification in 90 DEG C of vacuum drying ovens and overnight, obtain periphery extention intraocular lens.
Embodiment 17: the preparation of appendix load sharing medicine intraocular lens
A extention intraocular lens' main part in periphery) is processed using 1 material prepared of embodiment, is to pass through turning process Processing, is divided into the brilliant base that thickness is about 3 mm, diameter is about 16 mm for prepared polymer material.In single-point diamond vehicle Bed (OPTOFORM) machine-shaping intraocular lens, molding intraocular lens have the main diameter of 6.5mm, and main body has appendix Parting groove, interior edge are 2.5mm away from intraocular lens center, and width 0.2mm, depth is the groove of 0.02mm, after molding The polished dielectric polish of intraocular lens.
B) Ofloxacin is dissolved into chloroform, is added in the chloroform soln of polylactic acid, mixed liquor is concentrated.
C step A is injected by micro syringe after) being concentrated) prepared by intraocular lens' main part groove in, set In in 45 DEG C of vacuum drying oven, dry organic solvent obtains the intraocular lens of periphery appendix load sharing medicine.
Embodiment 18
In 250ml beaker, a kind of light absorber carbon black is added to commercially available one pack system or two-component silicon rubber in 2% ratio In colloid system (the MED-6820 trade mark of Nusil company), bubble is stirred and removed, one kind is obtained and contains light absorber Silica gel coatings, its further solidify before have certain mobility, surface coat by way of with existing artificial crystalline substance Shape body combines and forms photo-absorption region.Silica gel coatings containing light absorber further solidify, and inhale light after paint solidification molding It receives agent to lock firmly into silica gel material, to guarantee the long-time stability after implantation.
Embodiment 19
The Silica gel coatings containing light absorber obtained by embodiment 18 carry out the edge of commercially available intraocular lens uniform Coating, wherein intraocular lens are silica gel type intraocular lens, the Tecnis Z9001 intraocular lens of AMO company.Then The Silica gel coatings that edge coating contains light absorber are further solidified, by the Nusil MED- containing 2% content carbon black component 6820 are transferred in 100 DEG C or more baking ovens and solidify 30 minutes or more.After solidification, light absorber can not only be securely locked It in silica gel material, and can combine closely with intraocular lens' basis material, be formed at intraocular lens edge and absorb light Area.It so obtains and is coated with the intraocular lens containing light absorber Silica gel coatings, it is existing to eliminate the bad optics such as dazzle, ghost As.
Embodiment 20
The Silica gel coatings containing light absorber obtained by embodiment 18, to the edge or optical section of commercially available intraocular lens Equatorial region uniformly coated, wherein intraocular lens are silica gel type intraocular lens, SI60NB Canon Staar The KS-3 intraocular lens of company.Then the Silica gel coatings that edge coating contains light absorber are further solidified, 2% will be contained The Nusil MED-6820 of content carbon black component, which is transferred in 100 DEG C or more baking ovens, to be solidified 30 minutes or more.After solidification, not only Light absorber can be locked firmly into silica gel material, and can combined closely with intraocular lens' basis material, Intraocular lens edge, which is formed, absorbs light area.What is so obtained is coated with the intraocular lens containing light absorber Silica gel coatings, Eliminate the bad optical phenomena such as dazzle, ghost.
Embodiment 21
These kind of monomer is hybridly prepared into the phenylethyl acrylate of intraocular lens monomer solution 100g:70 mole% (PEA), the acrylic acid butanediol ester (BDDA) of the methacrylic acid phenyl chlorocarbonate (PEMA) of 30 mole%, 3 mole%;Then, Add 0.06% purpurine 18(Purpurin 18).By light absorber purpurine 18(Purpurin 18) and monomer solution It is uniformly mixed, then, the direct molded ring for light absorption area.The artificial crystalline substance being coated with containing light absorber so obtained Shape body eliminates the bad optical phenomena such as dazzle, ghost.
Embodiment 22
If embodiment 21 obtains the monomer solution 100g containing light absorber, then the monomer solution containing light absorber is added The AIBN of initiator 0.1% and the 2- acryloxy -5- methylphenyl benzotriazole of ultraviolet absorber 0.5%, injection such as Fig. 9 The intracavitary heating copolymerization molding of the A in mold illustrated, obtains intraocular implants' bulk optics area.Monomer containing light absorber is molten 2- acryloxy -5- methylphenyl benzotriazole the injection of the AIBN and ultraviolet absorber 0.5% of initiator 0.1% is added in liquid To form the light absorption area of intraocular lens and support button loop component, it is in due course after copolymerization starts to heat for the intracavitary copolymerization of B in mold The baffle device between two chamber of A-B is removed, the component for keeping B intracavitary can exist in polymerization process with the optical member adhesion in A chamber It is formed together composite structure.It fully opens mold after completion polymerization forming and can be obtained and contain the artificial of light absorption function at edge Crystalline lens, wherein fringe region can absorb harmful scattering light, to eliminate the bad optical phenomena such as dazzle, ghost.
Embodiment 23
By the contact glass material of the Definitive of commercially available intraocular lens Contamac company, by turnery processing mode, Contain the intraocular lens of groove structure in the periphery of preparation optical bodies part.Then will contain light obtained in embodiment 22 to inhale It is perfused after receiving the AIBN of agent monomer solution addition initiator 0.1% to groove, forms light absorption area after polymerization forming.
Embodiment 24
By ethyl methacrylate (EMA, 33g), styrene acrylate (PEA, 23g), phenoxyethyl acrylate (POEA, 39g), ethyl acrylate (EA, 5g), purpurine 18(Purpurin 18) 0.05% preparation contain the hydrophobic of light absorber ingredient Property esters of acrylic acid optical absorption coating, add the 2- acryloyl of the light absorber 0.5% containing polymerizable unsaturated carbon-carbon double bond Oxygroup -5- methylphenyl benzotriazole, then irradiation makes system start polymerization reaction, obtains containing in a kind of molecular chain structure The light absorber material of light absorption group, i.e., a kind of thick liquid 100g containing 0.05% purpurine 18, this system are in one kind Non-fully cured state has certain mobility, then solidifies again.Coated by various surfaces and cured mode with Existing intraocular lens or other ophthalmic lens products combine and form photo-absorption region, realize the absorption to harmful scattering light Effect.
Embodiment 25
Hydrophobic acrylic acid's esters optical absorption coating containing light absorber ingredient identical with embodiment 24 is obtained, to commercially available The MZ60BD(PMMA of intraocular lens Alcon company) edge uniformly coated.Then the coating of edge coating is added Heat makes coating and intraocular lens' basis material form the mode for being intertwined combination, is formed and absorbed at intraocular lens edge Light area absorbs harmful scattering light, to realize the absorption to harmful scattering light.
Embodiment 26
Hydrophobic acrylic acid's esters optical absorption coating containing light absorber ingredient identical with embodiment 24 is obtained, is injected into So that system is carried out polymerization forming reaction in mold by way of ultraviolet irradiation, makes 18 molecule of purpurine with light absorption function It can participate in the polymerization process of monomer and be anchored in polymer molecule chain structure, finally obtain the template with optical absorption characteristics Then artificial crystalline lens material is first processed into blank, further turnery processing mode is processed into the annulus with following sizes:
Annulus inner edge diameter: 5mm
Annular width: 0.6mm
Annulus thickness: 0.3mm.
Embodiment 27
By the phenylethyl acrylate (PEA) of 70 mole% of monomer solution, the methacrylic acid phenyl chlorocarbonate of 30 mole% (PEMA), the acrylic acid butanediol ester (BDDA) of 3 mole% amounts to 100g, prepares the hydrophobicity propylene containing light absorber ingredient Esters of gallic acid optical absorption coating,;It is hybridly prepared into intraocular lens' monomer solution, adds the purpurine 18 of light absorber 0.05% (Purpurin 18).It by the AIBN of light absorber and monomer solution and initiator 0.1%, is uniformly mixed, injects ring structure The mold of component, ultraviolet irradiation make system carry out polymerization forming reaction, participate in 18 molecule of purpurine with light absorption function The polymerization process of monomer and be anchored in polymer molecule chain structure, finally obtaining a kind of has optical absorption characteristics and as implemented The annulus of 26 size of example.
Embodiment 28
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 11.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.43 material, diopter be -10D, optics district center with a thickness of 0.1mm, front surface radius of curvature are -3.66mm, and rear surface radius of curvature is -6mm, optical area diameter 3.0mm, optics area side Edge is with a thickness of 0.23mm, and body rim is with a thickness of 0.30mm.The inner edge of crystal peripheral groove is apart from lens centre 1.50mm, groove Width is 3.5mm, and groove penetrates the front surface and rear surface of crystal, depth of groove 0.30mm.The inner edge diameter of annulus is 3.0mm, annular width 3.5mm, annulus is with a thickness of 0.3mm.In this example, crystal optics area is preceding recessed rear convex;Annulus and The junction on the forward and backward surface of crystal and main surface shape are coincide, and step drop is 0mm.
Embodiment 29
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 12.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.47 material, and diopter is+6D, optics district center with a thickness of 0.1mm, Front surface radius of curvature is -8.19mm, and rear surface radius of curvature is -6.0mm, optical area diameter 2.0mm, optics area edge thickness Spending (body rim thickness) is 0.08mm.The inner edge of crystal peripheral groove is apart from 1.0 mm of lens centre, recess width 0.80mm, groove are opened in lens rear surface, do not penetrate front surface, depth of groove 0.01mm.The inner edge diameter of annulus is 2.0mm, annular width 0.80mm, annulus is with a thickness of 0.06mm.In this example, crystal optics area is preceding recessed rear convex;Annulus Step structure is formed in crystal rear surface, step drop is 0.05mm.
Embodiment 30
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 13.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.50 material, diopter be -25D, optics district center with a thickness of 0.2mm, front surface radius of curvature are -13.13, and rear surface radius of curvature is 13.13mm, optical area diameter 4.5mm, optics area Edge thickness (body rim thickness) is 0.59mm.The inner edge of crystal peripheral groove is apart from lens centre 2.25mm, recess width For 1.5mm, groove penetrates the front surface and rear surface of crystal, depth of groove 0.59mm.The inner edge diameter of annulus is 4.5mm, Annular width is 1.5mm, and annulus is with a thickness of 0.0.60mm.In this example, crystal optics area is to wait concave-concaves;Annulus is in crystal Forward and backward surface is respectively formed step structure, and step drop is 0.005mm.
Embodiment 31
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 14.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.52 material, diopter be+36D, optics district center with a thickness of 1.0mm, front surface radius of curvature are 10.16, and rear surface radius of curvature is -10.16mm, optical area diameter 4.2mm, optics area Edge thickness is 0.56mm, and body rim is with a thickness of 0.50mm.The inner edge of crystal peripheral groove is recessed apart from lens centre 2.1mm Groove width is 0.05mm, and groove is opened in lens rear surface, does not penetrate front surface, depth of groove 0.2mm.The inner edge diameter of annulus For 4.2mm, annular width 0.05mm, annulus is with a thickness of 0.35mm.In this example, crystal optics area be etc. biconvexs;Annulus Step structure is formed in crystal rear surface, step drop is 0.15mm.
Embodiment 32
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 15.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.51 material, diopter be+10D, optics district center with a thickness of 0.5mm, front surface radius of curvature are 17.92, and rear surface radius of curvature is -600mm, optical area diameter 6.5mm, optics area side Edge is with a thickness of 0.19mm, and body rim is with a thickness of 0.15mm.The inner edge of crystal peripheral groove is apart from lens centre 3.25mm, groove Width is 0.1mm, and groove is opened in lens rear surface, does not penetrate front surface, depth of groove 0.1mm.The inner edge diameter of annulus is 6.5mm, annular width 0.1mm, annulus is with a thickness of 0.4mm.In this example, crystal optics area is put down close to after lordosis;Circle Ring forms step structure in crystal front surface, and step drop is 0.3mm.
Embodiment 33
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 16.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.53 material, diopter be -18D, optics district center with a thickness of 0.1mm, front surface radius of curvature are -5244.15mm, and rear surface radius of curvature is 10.8mm, and optical area diameter is 6.0 mm, light School district edge thickness is 0.53mm, and body rim is with a thickness of 0.10mm.The inner edge of crystal peripheral groove is apart from lens centre 3.0 Mm, recess width 0.5mm, groove are opened in lens rear surface, do not penetrate front surface, depth of groove 0.05mm.Annulus it is interior Edge diameter is 6.0mm, and annular width 0.5mm, annulus is with a thickness of 0.45mm.In this example, crystal optics area is close to preceding It is recessed after flat;Annulus forms step structure in crystal rear surface, and step drop is 0.4mm.
Embodiment 34
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 17.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.56 material, diopter be+30D, optics district center with a thickness of 1.5mm, front surface radius of curvature are 4.82mm, and rear surface radius of curvature is 13mm, and optical area diameter is 6.0 mm, optics area side Edge is with a thickness of 0.80mm, and body rim is with a thickness of 0.6mm.Apart from lens centre 3.0mm, groove is wide for the inner edge of crystal peripheral groove Degree is 1.2mm, and groove is opened in lens rear surface, does not penetrate front surface, depth of groove 0.7mm.The inner edge diameter of annulus is 6mm, annular width 1.2mm, annulus is with a thickness of 0.701mm.In this example, crystal optics area is recessed after lordosis;Annulus exists Crystal rear surface forms step structure, and step drop is 0.001mm.
Embodiment 35
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 18.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.50 material, diopter be -25D, optics district center with a thickness of 0.9mm, front surface radius of curvature are 6.84, and rear surface radius of curvature is 3.3mm, optical area diameter 6.5mm, optics area edge With a thickness of 2.81mm, body rim is with a thickness of 0.55mm.Apart from lens centre 3.25mm, groove is wide for the inner edge of crystal peripheral groove Degree is 0.2mm, and groove is opened in lens rear surface, does not penetrate front surface, depth of groove 2mm.The inner edge diameter of annulus is 6.5mm, annular width 0.2mm, annulus is with a thickness of 2.005mm.In this example, crystal optics area is recessed after lordosis;Annulus Step structure is formed in crystal rear surface, step drop is 0.005mm.
Embodiment 36
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 19.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.53 material, diopter be+20D, optics district center with a thickness of 1.5mm, front surface radius of curvature are 15.73, and rear surface radius of curvature is -25mm, optical area diameter 3.0mm, optics area side Edge is with a thickness of 1.38mm, and body rim is with a thickness of 0.5mm.Apart from lens centre 1.5mm, groove is wide for the inner edge of crystal peripheral groove Degree is 0.15mm, and groove is opened in lens rear surface, does not penetrate front surface, depth of groove 1.0mm.The inner edge diameter of annulus is 3.0mm, annular width 0.15mm, annulus is with a thickness of 1.01mm.In this example, crystal optics area is the biconvexs such as not;Annulus Step structure is formed in crystal rear surface, step drop is 0.01mm.
Embodiment 37
Step 1: processing one has the artificial lens of peripheral groove, as shown in figure 20.
Step 2: light absorption area annulus is combined with optics area.
Intraocular lens are made of refractive index of 1.56 material, diopter be+20D, optics district center with a thickness of 1.5mm, front surface radius of curvature are 25.18mm, and rear surface radius of curvature is -20mm, optical area diameter 2.0mm, optics area Edge thickness is 1.46mm, and body rim is with a thickness of 0.4mm.The inner edge of crystal peripheral groove is apart from lens centre 1.0mm, groove Width is 1.0mm, and groove penetrates the rear surface of crystal, depth of groove 1.0mm.The inner edge diameter of annulus is 2.0mm, and annulus is wide Degree is 1.0mm, and annulus is with a thickness of 2.0mm.In this example, crystal optics area is the biconvexs such as not;Annulus is in crystal rear surface shape At step structure, step drop is 1.0mm.
Embodiment 38: there are the intraocular lens comprising light absorber in optic edge
Intraocular lens are made of refractive index of 1.48 hydrophobic acrylic acid's ester, have improvement L button loop, overall diameter 13.0mm, light Department of the Chinese Academy of Sciences diameter 6.0mm, optics area edge is with a thickness of 0.25mm.It is measured through ultraviolet-visible spectrophotometer, the intraocular implants Body measures in normal saline solution, transmitance >=90% of the optics area in 300nm~1100nm spectral region.In intraocular lens Optics area edge, uniformly coating is added to the silica gel material of 2% carbon black.Carbon black has the ability for absorbing visible light radiation, Material addition 2% carbon black after, measured through ultraviolet-visible spectrophotometer, 300nm-1100nm band spectrum transmitance≤ 0.6%.It can be seen that most spectral energies are absorbed by light absorber.Intraocular lens obtained are (on optical section side Edge have the therapy component comprising light absorber) implantation human eye after, in the biggish situation of pupil, some light is oblique with wide-angle It is incident upon intraocular lens edge, the optics area edge coated with carbon black light absorber carries out the scattering light for being incident to edge abundant It absorbs, is incident to human eye by way of intraocular lens' edge reflections almost without any light, eliminate dazzle, ghost to obtain The effect of the bad optical phenomena such as shadow.
Embodiment 39: the intraocular lens with light absorption area and the extention containing photosensitizer
Intraocular lens are made of refractive index of 1.50 hydrophobic acrylic acid's ester, have improvement L button loop, overall diameter 13.0mm, light Department of the Chinese Academy of Sciences diameter 6.0mm, optics area edge is with a thickness of 0.30mm.In the optics area edge of intraocular lens, in the Nusil of 100g The carbon black of 2g is added in the silica gel material of MED-6820, is coated uniformly on after mixing away from intraocular lens center 2.75mm Place, is embedded in the appendix cyclotomy of a wide 0.1mm, thickness 0.20mm by way of inlaying from the rear surface of intraocular lens Ring, the extention are added to the indocyanine green of 0.06g in by such as monomer solution of the 100g of embodiment 21.In intraocular implants Body implantation human eye initial stage makes extention due to the photo-thermal effect of indocyanine green using the laser irradiation extention 5s of 808nm 9 DEG C of heating, leads to cell protein denaturation, directly contributes cell death, kill the lens epithelial cells being in contact with it, thus Prevent the generation of rear hair style cataract.After intraocular lens' implantation, due to the light absorption area of lens edge coating, it can absorb The rim ray of large angle incidence prevents Night Glare phenomenon from generating.

Claims (10)

1. a kind of ophthalmic lens, especially intraocular lens comprising:
A) ophthalmic lens main part, wherein the main part includes optics area and optionally one or more light absorptions area, Wherein light absorption area includes light absorber;
B) optionally, it is one or more include active agent extentions, be located in ophthalmic lens main part and with Ophthalmic lens main part is connected, extention width be 0.05 to 3.5mm, preferably 0.1 to 1.5mm, more preferable 0.2 to 0.8mm;Extention is with a thickness of 0.01 to 2mm, preferably 0.01 to 1mm, more preferable 0.01 to 0.7mm, wherein extention Centre distance of the interior edge away from ophthalmic lens be greater than 2mm,
Wherein, the ophthalmic lens include at least one of light absorption area and extention.
2. according to the ophthalmic lens of preceding claims 1, wherein light absorption area and/or extention include drug, light absorber, Fluorescer and/or photosensitizer.
3. the light absorption area comprising light absorber is located at optics area edge according to the ophthalmic lens of any one of preceding claims And/or the equatorial region of optical section.
4. edge is greater than or equal to away from optics district center distance in light absorption area according to the ophthalmic lens of any one of preceding claims 1.0mm, preferably greater than or equal to 2.1mm, more preferably equal to or greater than 2.25mm.
5. light absorber included in light absorption area is to 300 ~ 1100nm according to the ophthalmic lens of any one of preceding claims Light in wave-length coverage has absorption, the preferably visible light of 400 ~ 700nm.
6. wherein ophthalmic lens main part has one or more recessed according to the ophthalmic lens of any one of preceding claims Slot, extention and/or light absorption area are embedded into ophthalmic lens main part groove.
7. according to the ophthalmic lens of any one of preceding claims, wherein ophthalmic lens are intraocular lens, in main part, Supporting the proximal end of the rear surface of loop has square edge staircase structural model;And/or the far-end of the rear surface of support loop has Square edge staircase structural model, wherein the proximal end thickness of support loop rear surface staircase structural model is greater than far-end thickness, light is inhaled It receives area to agree with optics area joining place shape with ophthalmic lens surface, distal end of the extention from optics area is higher by ophthalmic lens master Body portion forms edge step structure, and step drop is 0.001 ~ 1.0mm, preferred 0.005 ~ 0.4mm, it is furthermore preferred that 0.01 ~0.3mm。
8. according to the ophthalmic lens of any one of preceding claims, wherein included in the light absorption area and/or extention The combination of drug, light absorber, fluorescer and/or photosensitizer and light absorption area and/or extention material (for example, copolymer) Mode is selected from:
Drug, light absorber, fluorescer and/or photosensitizer are joined in light absorption area and/or extention material forming process With polymerize;
Drug, light absorber, fluorescer and/or photosensitizer are in the light absorption area and/or extention material forming process In be added in copolymer material by physical dispersion;
Drug, light absorber, fluorescer and/or photosensitizer are fixed on the light absorption in a manner of surface grafting, surface modification Area and/or extention material surface;And/or
Drug, light absorber, fluorescer and/or photosensitizer are fixed on the light absorption area and/or attached with surface coating method Add some materials surface.
9. medical device, it includes the ophthalmic lens according to any one of preceding claims.
10. being prevented according to the ophthalmic lens of any one of preceding claims 1-8 and according to the medical device of preceding claims 9 Migration, epithelial cell proliferation, the generation for preventing post gelating time, prevention inverse position method and the bad optical phenomena of reduction of epithelial cell Aborning application.
CN201710507219.4A 2017-06-28 2017-06-28 ophthalmic lens Pending CN109124826A (en)

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