CN106901871B

CN106901871B - Intraocular lens with one or more additional portions

Info

Publication number: CN106901871B
Application number: CN201510975072.2A
Authority: CN
Inventors: 不公告发明人
Original assignee: Abbott Beijing Medical Technology Co ltd
Current assignee: Abbott Beijing Medical Technology Co ltd
Priority date: 2015-12-23
Filing date: 2015-12-23
Publication date: 2021-08-24
Anticipated expiration: 2035-12-23
Also published as: CN106901871A

Abstract

The invention relates to a medical device, in particular for treating cataracts, in particular an intraocular lens for preventing and/or treating after cataract, more particularly an intraocular lens with one or more add-on parts comprising a) a main body, b) a ring shaped add-on body connected to the intraocular lens main body.

Description

Intraocular lens with one or more additional portions

Technical Field

The present invention relates to medical devices, particularly for the treatment of cataracts, particularly intraocular lenses for the prevention and/or treatment of after-cataract, and more particularly intraocular lenses having one or more additional portions.

Background

Various reasons such as aging, heredity, local nutrition disorder, immune and metabolic abnormality, trauma, poisoning, radiation and the like can cause the metabolic disorder of crystalline lens, lead to the denaturation of crystalline lens protein and generate opacity, and are called cataract, and the incidence rate and the total population number of the cataract are continuously increased along with the aging of the global population. Cataract is the first eye disease causing blindness in the world, and in 4000-4500 million blind people in the world, the number of people causing blindness due to cataract accounts for 46%. At present, 670 million cataract patients exist in China, about 130 million cataract blind people are newly increased every year, and due to cataract, blurred vision and even blindness are caused, and great life inconvenience and pain are caused to the cataract patients.

Surgical replacement of intraocular lenses is currently the most effective method for treating cataracts. However, patients after cataract surgery still face a significant problem: posterior Capsular Opacification (PCO). Posterior capsule opacification is mainly caused by proliferation, migration and fibrosis of Lens Epithelial Cells (LECs) remained after cataract surgery along the posterior capsule wall, and is the most common complication affecting vision after cataract surgery. The incidence rate of the traditional Chinese medicine is 30-50% (within 5 years) for adults, wherein 20-30% of patients lose vision again due to the posterior capsule, 43% of patients are operated again due to the posterior capsule, and the incidence rate of the child posterior capsule is 100%. Anterior capsular opacification, known as "ACO", occurs when residual crystalline epithelial cells following cataract surgery undergo cell growth along the anterior capsule wall.

In addition, there are inflammatory reactions that occur after implantation of an IOL, such as infectious endophthalmitis, uveitis, and the like. Therefore, after the artificial lens is implanted into a cataract patient, the cataract patient is treated by point medication. The eye drop is treated by hormone and non-hormone anti-inflammatory drugs to prevent postoperative uveitis and fibroplasia, and prevent acute iridocyclitis, episcleritis, allergic keratitis, macular edema, etc. And can be used in combination with ofloxacin eye drop for inhibiting bacterial conjunctivitis, keratitis, dacryocystitis, and postoperative infection. The eye drop concentration of the eye drop is periodically higher and fluctuates greatly when the eye drop is used for treating inflammation, the stable and continuous antibiosis and anti-inflammation can not be realized, the inconvenience of life is increased for patients due to the operation and the cooperation of the patients, and the burden of the patients is increased

The prior art has been directed to treatment of PCO by post-laser capsulotomy, which may produce adverse conditions, surgical complications including intraocular lens injury, post-operative intraocular pressure increase, macular edema, retinal detachment, and intraocular lens dislocation due to the destruction of the natural barrier by the incised capsule, and efforts have been made to find ways and methods to prevent PCO formation

Current methods of preventing and/or treating PCO generally start from several aspects: designing an artificial lens, improving a surgical operation mode, carrying medicine by the artificial lens, performing capsulotomy after laser and the like.

The use of sharp, square edges in the optic of an intraocular lens, such as those disclosed in U.S. patent nos. 6162249 and 6468306, has proven to be an effective method of reducing posterior capsule opacification because such designs block migration of lens epithelial cells between the posterior surface of the intraocular lens and the posterior capsule (see Buehl et al, Journal of Cataract and reflective Surgery, volume 34, 1976-1985. in recent years, there has been much work in the industry to form IOLs with sharp posterior edges to create sharp, discontinuous bends in the posterior capsule wall, such as in Nishi us patent No. 5171320, Woffinden us patent No. 5693093, CN1310625C, CN1684643, CN102711666A, CN 201888856U.

Similar designs also include patent CN1856281 which discloses an intraocular lens provided with sharp oblique edges at the periphery of the optic which extend along the arc segments defined by the junctions at the junctions between the haptics and the optic; patent CN2626458Y, careless about the omission of an intraocular lens, is characterized in that a raised step is added at the edge of the second surface of the non-optical part of a normal intraocular lens to block the migration and growth of epithelial cells, so as to prevent the capsular opacity after the intraocular lens implantation operation; CN2717403Y discloses a sigma-type intraocular lens, wherein the edge of the optical lens of the intraocular lens is designed to be a wedge shape recessed inwards, and also to be a sharp bevel edge, which is similar to the greek letter Σ in side view to prevent posterior capsule opacification and simultaneously prevent glare.

Studies in the field have also reduced the risk of posterior capsular opacification by changing the lens material design. See "acrylic intraocular lenses cause less posterior capsule opacification than PMMA, silicone IOLs" ophthalmic News, Vol.14, No. 15, p.23 (1996). And Ursell et al, "Relationship Between Intraocular Lens Biomaterials and Posterior capsular opacification" (Relationship Between Intraocular Lens Biomaterials and spatial Capsule optification. J. Caparact. Refract. Surg.,24: 352-.

In the intraocular lens drug-carrying mode, one mode carries drugs for preventing postoperative inflammation and microbial infection, and is various antibiotics, steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs, for example, patent CN2531755Y "sustained release agent carrying intraocular lens" discloses a sustained release agent carrying intraocular lens, which is perforated on an intraocular lens loop, and the hole is filled with sustained release agent drugs for preventing intraocular inflammation after intraocular lens implantation; CN104434811A discloses a drug sustained-release microsphere capable of being embedded in an artificial lens loop, which can effectively prevent and treat microorganism infection after cataract operation, antagonize inflammatory reaction, and prevent and inhibit after cataract. The other is to eliminate LEC or inhibit mitosis of epithelial cells by carrying lens epithelial cell target agents, including antimetabolite drugs and mitosis inhibitors, drug immunotoxins and cytotoxins to inhibit inflammatory responses, drugs to inhibit adhesion of cells to extracellular matrix, and drugs to induce apoptosis. Such as Bretton, U.S. patent 5620013, "method of destroying residual lens epithelial cells", U.S. patent 4918165, which teaches the use of methotrexate to prevent posterior capsular opacification; U.S. patent No. US5576345A employs taxol to prevent posterior capsular opacification and includes the following patent techniques.

In patent CN100553692C, chitosan-polyacrylic acid is used as a carrier to prepare a fluorouracil nanoparticle preparation, and a mixed coating is coated on the surface of a PMMA intraocular lens, so that the biocompatibility of the intraocular lens is increased, and PCO and ACO are prevented; CN101053680B, wherein the anti-cell proliferation medicine is coated on the artificial lens by adopting a high polymer coating material, and can slowly release the medicine to the capsular bag and the cells at the equator, inhibit the growth of crystal epithelial cells, and prevent and treat the formation of posterior capsule disorder; patent CN101269240B, discloses an intraocular lens with anti-transforming growth factor β 2 antibody membrane on the surface; CN200973766 fixes the annular drug slow-release carrier on the outer side of the equator of the artificial lens, and slowly releases the drug for inhibiting the proliferation of lens epithelial cells after being implanted, thereby preventing the occurrence of posterior capsule; patent CN103099706 discloses an intraocular lens for the prevention and/or treatment of posterior capsule opacification, which has immobilized trypsin on the surface of the lens and when implanted in the lens capsule can selectively destroy lens epithelial cells in the lens capsule.

Although these methods are theoretically suitable, the toxicity of the drug itself can cause serious complications, significant intraocular toxic side effects, poor specificity, or poor efficacy, and the conditions of too rapid drug release and unstable release, while not ensuring that all the iol epithelial cells in the capsular bag are killed, and these techniques have certain difficulties in clinical application, and any residual LECs may eventually proliferate and migrate to the iol after the agent action disappears, eventually leading to PCO.

In terms of surgical operation technology, ophthalmologists clearly see that the remaining lens body cells cause posterior capsule opacification, so that there is a constant attempt in surgery to improve the way of surgery to minimize the remaining epithelial cells, and their careful removal of all the remaining lens epithelial cells, and the development of instruments for removal has been carried out, for example: patent CN103099705A discloses a device for preventing and treating Posterior Cataract (PCO), which can selectively remove lens epithelial cells during operation, thereby preventing the occurrence of posterior capsule opacification. However, despite much effort, there is often a significant amount of epithelial cells left on the inner surface of the lens capsule because epithelial cells are illegible and often difficult to reach due to their limited location on the inner surface of the lens capsule.

In recent years, research on photodynamic therapy or photothermal therapy has also been receiving attention in the field of ophthalmology. Patent WO2013/027222 reports chlorophyll photosensitizers for the treatment of eye diseases; patent CN103083133 reports a laser photothermal treatment system for fundus diseases based on gold nanorods; patent WO97/33619 reports a method for improving vision by photodynamic therapy of the eye; WO98/25648 reports a photosensitive compound for the preparation of a photodynamic therapeutic agent for ocular diseases; WO98/25610 reports a green porphyrin-based photosensitizer drug for the treatment of secondary cataracts; in the treatment of post-cataract disorders us patent 5733276 discloses prophylactic laser treatment. According to the method, the laser is used to irradiate the lens capsule to destroy the residual lens epithelial cells; in patent CN100455276C, the surface of the artificial lens is coated with a titanium dioxide nano film, and the proliferation of lens epithelial cells is inhibited through the inhibition and oxidation of titanium dioxide photocatalyst on the cell proliferation.

However, both conventional photodynamic and photothermal therapies are limited by photosensitizers and are not widely used for treating capsular opacification after intraocular lens treatment. The photosensitizer used in the traditional photodynamic therapy and photothermal therapy comprises a photodynamic photosensitizer and a photothermal photosensitizer, and finally needs to be prepared into a liquid medicament, enters a pathological change tissue after entering blood through modes such as intravenous injection and the like, or directly enters the pathological change tissue through injection, and after treatment is finished, the photosensitizer needs to be discharged out of a body through modes such as degradation or metabolism and the like. The conventional photodynamic therapy and photothermal therapy have problems of safety, metabolism and the like of the photosensitizer, so that the selection range and the type of the photosensitizer are greatly limited. Although the toxic side effects of photodynamic therapy are small, the photosensitizers used end up in the body with some toxicity. In addition, the photosensitizer generally cannot be used alone, and needs to be acted together with other drugs or compounds to enter the human body in the form of solution, suspension or emulsion, and the compounds interacting with the photosensitizer have certain toxicity, so that the treatment risk is increased. In addition, because the photosensitizer needs to be injected into the body from the vein, and the injection speed and the removal speed are required to be high, the organs and tissues of the heart, the blood vessel and the like of a patient need to bear discomfort caused by the quick injection of the photosensitizer in the treatment process; and only when the photosensitizer passes through the pathological tissues, the laser irradiation can be started for effective treatment, so that higher requirements are put forward on the administration time and the maintenance time, and the treatment process is difficult.

In the prior art, the artificial lens is designed to prevent epithelial cells from migrating, so that the aim of preventing the posterior capsule is fulfilled, and the effect is limited. The removal of the crystalline epithelium as far as possible during the surgical procedure also reduces the incidence of posterior problems, but in practice it is difficult to completely remove the epithelium by physical means, these procedures require additional time, may increase ocular tissue damage, leading to increased damage to the aqueous humor barrier, which in turn stimulates the proliferation of residual epithelial cells; sharp-edged IOLs, while proven to inhibit PCO, still have the potential for LECs to migrate along the posterior capsule and over the IOL surface, which is particularly prone to contact and uneven forces between the periphery of the IOL and the capsular bag, such as post-operative intraocular lens rotational movement within the capsular bag; the medicine and the chemical method are very effective in removing or destroying the proliferation and migration of residual lens epithelial cells, but the medicine and the chemical method have the problems of toxic and side effects of the medicine on other tissues, damage to the epithelial cells and toxic damage to other tissues in eyes, which are still not well solved, and in addition, the medicine and the chemical method have the problems of short effective medicine concentration duration and continuous administration; both conventional photodynamic and photothermal therapies are limited by photosensitizers and are not widely used for treating capsular opacification after intraocular lens treatment. Laser posterior capsulotomy is currently the primary means of treating secondary cataracts, but also presents a range of complications including IOL damage, post-operative intraocular pressure elevation, macular cystoid edema, retinal detachment, and IOL dislocation.

Therefore, the prior art cannot well prevent the occurrence of the posterior capsule, and no effective method for preventing and treating the posterior capsule exists clinically at present.

Disclosure of Invention

The invention provides a medical device, in particular to a medical device for treating cataract, in particular to an artificial lens for preventing and/or treating after cataract, more particularly to an artificial lens with one or more additional parts, which can be combined with one or more treatment means such as sharp right-angle edge artificial lens design, artificial lens drug loading, photodynamic therapy and the like into a whole, solves the problem that epithelial cells of the artificial lens are not easy to be thoroughly removed, and can solve the technical problem of preventing and treating after cataract.

The invention relates to a medical device, in particular an intraocular lens for the prevention and/or treatment of a posterior failure, comprising:

a) an intraocular lens body portion;

b) one or more appendages on and attached to the IOL body portion, the appendages having a width of 0.05 to 3.5mm, preferably 0.1 to 1.5mm, more preferably 0.2 to 0.8mm, the appendages having a thickness of 0.01 to 2mm, preferably 0.01 to 1mm, more preferably 0.01 to 0.7mm,

wherein the inner edge of the additional part is more than 2mm away from the center of the artificial lens.

According to another embodiment of the invention, the intraocular lens body portion and the supplemental portion are physically or chemically bonded.

According to another embodiment of the invention, the physical means is selected from the group consisting of inlaying, gluing, spraying, printing, evaporation.

According to another embodiment of the invention, the chemical means is selected from the group consisting of stepwise copolymeric molding, graft modification.

According to another embodiment of the invention, the attachment portion is located on a posterior surface of the intraocular lens body portion.

According to another embodiment of the invention, the intraocular lens body portion has one or more grooves and the add-on portion is embedded in the groove or grooves of the intraocular lens body portion.

According to another embodiment of the invention, the additional part has a part of a drug or an active agent. In the present invention, the active agent may be any type of active agent that can be used in the present intraocular lens, which may be selected depending on the end use of the product.

According to another embodiment of the invention, the intraocular lens body portion has at least two sharp edges.

In accordance with another embodiment of the invention, the support haptics are disposed in the IOL body portion at an angle to the optic plane of the IOL; the near end of the back surface of the support loop is provided with a right-angle edge step type structure; the far end of the back surface of the support loop is provided with a right-angle edge stepped structure, wherein the thickness of the near end of the stepped structure of the back surface of the support loop is larger than that of the far end.

According to another embodiment of the present invention, the step height of the right-angled edge stepped structure at the distal end of the back surface of the support tab is 0.1 to 5mm, preferably 0.1 to 1mm, more preferably 0.2 to 0.5 mm, wherein the thickness at the proximal end of the stepped structure at the back surface of the support tab is greater than the thickness at the distal end.

According to another embodiment of the invention, the step drop of the right-angled edge stepped structure at the proximal end of the back surface of the support tab is 0.1-5 mm, preferably 0.3-3 mm, more preferably 0.5-2 mm, wherein the thickness at the proximal end of the back surface stepped structure of the support tab is greater than the thickness at the distal end.

According to another embodiment of the invention, the posterior surface of the optic of the lens body portion is a convex spherical surface having a radius of curvature in the range of 6.6 mm to 80.0 mm.

According to another embodiment of the invention, the radius of curvature of the posterior surface of the optic of the main body portion of the intraocular lens is between 17.8% and 60.0% of the radius of curvature of the anterior surface of the optic.

According to another specific embodiment of the present invention, the intraocular lens is prepared from a material comprising a copolymer prepared by copolymerizing polymerizable monomers comprising an acrylate, wherein the polymerizable monomers comprising an acrylate comprise a hydrophilic acrylate monomer and a hydrophobic acrylate monomer, wherein the molar ratio of the hydrophilic acrylate monomer to the hydrophobic acrylate monomer is 20:80-80:20, preferably 30:70-70:30, more preferably 40:60-60:40, and the material has the following properties:

a. a water content of 5 to 15wt%, preferably 6 to 13wt%, more preferably 7 to 12wt% at 35 ℃;

b. a refractive index (wet state) at 35 ℃ of 1.49 to 1.54, preferably 1.49 to 1.53, more preferably 1.50 to 1.52.

According to another embodiment of the invention, the hydrophilic acrylate monomers are chosen from acrylate monomers having a hydrophilic group, corresponding to the following formula:

wherein R is₁Is H or C_1-6Alkyl, preferably H or CH₃；

R₂Is straight-chain or branched, saturated or unsaturated C_1-20Alkyl or C_6-20Arylalkyl, or straight or C_6-20A heteroarylalkyl group;

x may be O, S or NR₄Wherein R is₄Is H, straight-chain or branched, saturated or unsaturated C_1-20Alkyl or C_6-20Arylalkyl radical, or C_6-20Heteroarylalkyl, or C_3-20A heterocyclylalkyl group;

R₃is C_nH_2n+1O_mWherein m isOr n is equal to 0 or an integer selected from more than 1 and m is less than or equal to n, or C_3-20Heterocyclylalkyl radical or C_3-20A cycloalkyl group.

According to another embodiment of the invention, the hydrophobic acrylate monomers are chosen from acrylate monomers having a hydrophobic group, corresponding to the following formula:

wherein R is₁Is H or C_1-6Alkyl, preferably H or CH₃；

R₅Is straight-chain or branched, saturated or unsaturated C_1-20Alkyl or C_6-20Arylalkyl radical, or C_6-20Heteroarylalkyl, or C_6-20Heterocyclylalkyl radical or C_3-20A cycloalkyl group;

y may be H, or Z-R₆Wherein Z, which may be present or absent, may be selected from heteroatoms such as O or S,

R₆is C_6-20Arylalkyl radical, or C_6-20A heteroarylalkyl group.

According to another embodiment of the invention, the hydrophilic acrylate monomer is selected from: hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate, vinyl pyrrolidone, ethoxyethoxyethoxyethyl methacrylate, ethoxyethoxyethoxyethyl acrylate, ethoxyethyl methacrylate, methoxyethyl acrylate, 1, 3-butanediol dimethacrylate, ethylene glycol dimethacrylate, polyethylene glycol methacrylate, polyethylene glycol 200 dimethacrylate (e.g., AGEFLEX @. PEG200 DMA), polyethylene glycol acrylate, polyethylene glycol methyl ether methacrylate, polyethylene glycol methyl ether acrylate, glycidyl methacrylate, glycidyl acrylate, acrylic acid, methacrylic acid, 2- (trifluoromethyl) acrylic acid, phenylacrylic acid, acrylamide, methacrylamide, styrene-acrylic acid, styrene-methacrylic acid, styrene-acrylic acid, styrene-methacrylic acid, styrene-acrylic, N-methylolacrylamide, N-methylolmethacrylamide, or derivatives of the above, or mixtures of the above, preferably hydroxyethyl methacrylate.

According to another embodiment of the present invention, the hydrophobic acrylate monomer is selected from the group consisting of methyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, hexyl methacrylate, hexyl acrylate, isopropyl methacrylate, isopropyl acrylate, isobutyl methacrylate, isobutyl acrylate, tert-butyl methacrylate, tert-butyl acrylate, isooctyl methacrylate, isooctyl acrylate, isodecyl methacrylate, lauryl acrylate, stearyl methacrylate, stearyl acrylate, 9-anthracenemethyl methacrylate, 9-anthracenemethyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, dimethylaminoethyl methacrylate, ethyl acrylate, butyl acrylate, hexyl methacrylate, isobutyl acrylate, and an isobutyl acrylate, and an alkyl acrylate, N, N-dimethyl methacrylamide, N-dimethyl acrylamide, N-diethylaminoethyl acrylate, N-diethylaminoethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, hexafluorobutyl acrylate, 2-perfluorodecyl ethyl methacrylate, 2- (perfluorooctyl) ethyl acrylate, pyruvyl methacrylate, pyruvyl acrylate, N-diethylaminoethyl methacrylate, N-diethylamino-ethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, 2-perfluorodecyl ethyl acrylate, 2-perfluorodecyl methacrylate, 2- (perfluorooctyl) ethyl methacrylate, pyruvyl acrylate, acetonyl acrylate, N-N, N-diethylaminoethyl acrylate, N-t-butylacrylamide, N-isopropylacrylamide, N-tetrahydrofurfuryl methacrylate, hexafluoroacrylate, N-butyl acrylate, N-butyl methacrylate, N-tetrahydrofurfuryl methacrylate, N-butyl methacrylate, hexafluorobutyl methacrylate, N-butyl methacrylate, N-hexafluorobutyl methacrylate, N-butyl acrylate, N-hexafluorobutyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, and N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-2-perfluorodecyl methacrylate, and N-butyl methacrylate, N-butyl acrylate, N-butyl, Tetrahydrofurfuryl acrylate, tetrahydrofurfuryl methacrylate, phenyl acrylate, phenylethyl methacrylate, phenylethyl acrylate, phenoxyethyl methacrylate, phenoxyethyl acrylate, benzyl methacrylate, benzyl acrylate, acetoacetoxyethyl methacrylate, acetoacetoxyethyl acrylate, diacetone acrylamide, diacetone methacrylamide, allyl methacrylate, phenoxyethyl acrylate, or derivatives of the foregoing, or mixtures thereof, preferably ethyl acrylate, phenoxyethyl acrylate.

According to another embodiment of the invention, the material for the preparation of intraocular lenses according to the invention has a glass transition temperature (dry state, determined by DSC measurements) of 10 to 35℃, preferably 15 to 30℃, more preferably 20 to 25℃.

According to another embodiment of the invention, the material for the production of an intraocular lens according to the invention has an elongation at break (wet state) >180% and a strength at break (wet state) >2.5 MPa.

According to another embodiment of the invention, the additional part further comprises at least one drug, a fluorescent agent and/or at least one photosensitizer;

wherein the drug, fluorescer and/or photosensitizer is bound to the copolymer in a manner selected from:

-the drug, fluorescer and/or photosensitizer is involved in the polymerization during the formation of the copolymer;

-drugs, fluorescent agents and/or photosensitizers are added to the copolymer material by physical dispersion during the copolymer formation process;

-drugs, fluorescers and/or photosensitizers are immobilized on the copolymer surface in a surface grafting, surface modification manner; and/or

-drugs, fluorescers and/or photosensitizers are immobilized on the copolymer surface in a surface coating manner.

Detailed Description

The body portion of the intraocular lens according to the present invention may be any form of body portion of an intraocular lens known in the art comprising an optic and at least one support haptic, wherein the optic and the support haptic are made of different materials and then molded in steps or made of the same material as a single piece. The optical component is divided into a front surface and a rear surface. The front and/or back surfaces may comprise any optical device, such as, for example, one selected from aspheric devices, multifocal devices, toric devices, non-dispersive devices, variable focus devices, optical filtering devices or various devices conventionally suitable in the art, depending on the situation and/or the requirements of the user.

According to one embodiment of the invention, the posterior surface of the main body portion of the intraocular lens is composed of a central region and a peripheral region, wherein the peripheral region may be at least 0.2mm thicker than the edges of the central region, so that a right-angled edge step-like structure is provided at the posterior surface of the support haptics near the optic. The step height of the right-angled edge stepped structure is 0.1 to 5mm, preferably 0.3 to 3 mm, most preferably 0.5 to 2 mm. The right-angled edge stepped structure is beneficial to preventing proliferation and migration of crystal epithelial cells to the rear surface of the optical component, so that the probability of rear capsule turbidity is reduced.

According to one embodiment of the invention, the support haptics of the main IOL body portion are at an angle to the plane of the optic of the IOL (which is perpendicular to the optic axis), generally at any suitable angle, preferably 1-20 degrees, and most preferably 5-10 degrees. The support tab with the angle can ensure that the optical component protrudes or moves towards the back of the eye when the intraocular lens device is subjected to the extrusion acting force of the capsule. The proximal end of the support tab (i.e., the end of the support tab near the optic) is provided with an open slot that serves as a force-transmitting fulcrum. When the supporting loop is pressed by the peripheral bag, the supporting loop can axially rotate by taking the open slot as a fulcrum, and stress is not transmitted to the optical component, so that the stability of the optical component in the eye is ensured. At the distal end of the back surface of the support tab (i.e., the end of the support tab distal from the optic), at least 1.5mm from the right-angled edge structure at the proximal end, a right-angled edge step structure is additionally provided. The step height of the step structure with the right-angled edge is 0.1-5 mm, preferably 0.1-1 mm, and most preferably 0.2-0.5 mm. The step-type structure with the right-angle edge can further prevent the proliferation and migration of epithelial cells of the crystal to the back surface, and a supporting point can be manufactured between the supporting loop and the back capsule, so that the stability of the artificial lens device in the capsule is improved. In addition, when the intraocular lens device is folded, this stepped configuration creates a space between its optical component and the support tab, thereby reducing the adhesive force therebetween, facilitating the support tab to automatically open after implantation of the intraocular lens device.

Additional components of the present invention may be made from any material known in the art to be suitable for use in the manufacture of medical devices of the present invention, particularly ophthalmic medical devices such as intraocular lenses; in particular, it is prepared from ophthalmic medical materials with suitable water content and suitable refractive index, which are suitable for manufacturing micro-incision artificial lens. Wherein the material from which the supplemental portion is made may be the same or different from the material from which the intraocular lens body is made.

According to another embodiment of the present invention, the additional portion is a main functional area, and the shape of the additional portion is not limited according to the function achieved by the present invention, and the additional portion may be any shape such as a ring, a square, a trapezoid, an interrupted or uninterrupted additional portion, a triangle, a fan, and the like, and any shape of the additional portion that can achieve the function of the present invention is within the protection scope of the present invention.

The additional part of the invention is preferably prepared from a material containing a medicine, a photosensitizer and/or a fluorescent agent, or can carry the medicine and/or the photosensitizer and/or the light filtering dye, the photosensitizer is fixed in the material of the additional part or on the surface of the material of the additional part, the edge of the additional part can form a 90-degree sharp right-angle edge with the optical surface of the optical part of the artificial lens, and the additional part can be positioned on the front surface and/or the rear surface of the optical part of the artificial lens, so that the symptoms such as front capsule opacity, rear capsule opacity, postoperative intraocular inflammation and the like can be prevented and treated.

According to another embodiment of the invention, the adjunct ingredient comprises a therapeutic agent, wherein the agent comprises a wide range of antibiotics, steroidal anti-inflammatory drugs, and non-steroidal anti-inflammatory drugs to prevent post-operative inflammation, and microbial infection. Also can be used for carrying antimetabolite and mitosis inhibitor, immunotoxin and cytotoxin for inhibiting inflammatory reaction, drug for inhibiting adhesion of cell and extracellular matrix, and apoptosis inducing drug for eliminating LEC or inhibiting mitosis of epithelial cell, and preventing and treating posterior capsule turbidity. Such as ofloxacin, ascorbic acid, aspirin, colchicine, lidocaine, nepafenac, ketorolac, bromfenac, recombinant hirudin, methotrexate, 5-fluorouracil, taxol, doxorubicin, daunorubicin, saporin, and other known or unknown drugs or compositions with similar function.

According to another embodiment of the present invention, the additional part of the present invention comprises a photosensitizer, wherein the photosensitizer is any photosensitizing dye that is activated in the wavelength range of 300 to 1100nm, preferably, the activation wavelength range is selected from 500 to 1000 nm; particularly, the activation wavelength range is selected from 600-900 nanometers; particularly, the activation wavelength range is 700-900 nm or 800-1100 nm. The photosensitizer is selected from porphyrin, porphin, chlorophyll, purpurin, fluorescein, phthalocyanine, metal phthalocyanine, indocyanine green, tricarbocyanine, nanogold, metal nanoparticles, metal oxide nanoparticles, metal sulfide nanoparticles, metal carbide nanoparticles, carbon nanotubes, graphene and the like, and a derivative product of the above compounds, or a degradation product of the above compounds, or a salt form of the above compounds, or a mixture thereof.

According to another embodiment of the present invention, the intraocular lens further comprises a filter dye selected from compounds having a filtering function in a specific wavelength range, for example, the further comprises a blue light absorber selected from compounds having a selective filtering function for blue light in a wavelength range of 400 to 500 nm. Preferably a yellow dye compound with a molecular structural formula containing azo groups. More preferred are yellow dye compounds containing a polymerizable group selected from vinyl, allyl, butenyl, ethynyl, acryloxy, methacryloxy, acrylamido, methacrylamido, vinyl ether, and the like.

Because the additional part of the artificial lens comprises the medicine, the photosensitizer and/or the fluorescent agent or the medicine, the photosensitizer and/or the fluorescent agent is fixed on the additional part, the artificial lens can play a role in prevention after being implanted, and can receive laser treatment without performing operation once the tissue or the part suffers from diseases; more particularly, the material provided by the invention has the effect of repeated action, and after one laser treatment is finished, because the photosensitizer is not eliminated and still exists in a diseased region, when the region has secondary disease or multiple times, the material can receive the laser treatment again or multiple times without injecting the photosensitizer, and has repeatability of treatment. Specifically, the artificial lens for preventing and/or treating after cataract contains photosensitizer, and after the artificial lens is implanted into the eye of a patient in cataract operation, the photosensitizer is activated under the condition of selected laser extraocular irradiation, and the active oxygen with cytotoxicity or high-temperature heat can be generated to kill lens epithelial cells in the lens capsule, so that the effect of preventing or treating after cataract is achieved. In particular, the supplemental intraocular lens of the present invention contains a photosensitizer with a photothermal effect. The additional part with photothermal effect is combined with the lens body part by physical means or chemical means, wherein the physical means is selected from casting, embedding, bonding, spraying, printing and evaporation; the chemical mode is selected from stepwise copolymerization molding and grafting modification. The artificial lens can kill the epithelial cells of the posterior capsule lens under the irradiation of laser with selected wavelength (such as 300-. Particularly, since the lens epithelial cells are generated along the periphery of the optical zone to cause the posterior capsule and the photosensitizer area is also positioned at the periphery of the lens optical zone, when the artificial lens is subjected to photothermal therapy, the artificial lens can kill residual lens epithelial cells, does not damage normal cells of tissues in other areas, and has small side effect. More particularly, since the photosensitizer region is located at the periphery of the optical region without touching the optical imaging region of the lens, the lens has a visible light transmittance consistent with that of a normal intraocular lens, no light energy is lost, the visual perception of a patient in any scene state is not affected, and no glare condition exists.

The body portion and/or the attachment portion of the present invention may be made from any material known in the art to be suitable for use in the manufacture of medical devices of the present invention, particularly ophthalmic medical devices such as intraocular lenses. Particularly preferably, the material is prepared from ophthalmic medical materials with proper water content and proper refractive index, which are suitable for manufacturing the micro-incision artificial lens, and is prepared by copolymerizing acrylate monomers, wherein the acrylate monomers comprise hydrophilic acrylate monomers and hydrophobic acrylate monomers, the molar ratio of the hydrophilic monomers to the hydrophobic monomers is 20:80-80:20, preferably 30:70-70:30, more preferably 40:60-60:40, and the material has the following properties:

a. a water content at 35 ℃ of 5 to 15 wt.%, preferably 6 to 13 wt.%, more preferably 7 to 12 wt.%, even 8 to 11 wt.%, especially 9 to 11 wt.%;

The hydrophilic acrylate monomer is selected from acrylate monomers with hydrophilic groups, and accords with the following formula:

R₁is H or C_1-6Alkyl, preferably H or CH₃；

R₃is C_nH_2n+1O_mWherein m or n is equal to 0 or an integer selected from greater than 1, and m.ltoreq.n, or C_3-20Heterocyclylalkyl radical or C_3-20A cycloalkyl group.

The hydrophilic acrylate in the present invention is an acrylate having a hydrophilic group, and is selected from, for example, hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate, vinylpyrrolidone, ethoxyethoxyethoxyethyl methacrylate, ethoxyethoxyethoxyethoxyethyl acrylate, ethoxyethyl acrylate, methoxyethyl methacrylate, methoxyethyl acrylate, 1, 3-butanediol dimethacrylate, ethylene glycol dimethacrylate, polyethylene glycol methacrylate, polyethylene glycol 200 dimethacrylate (e.g., AGEFLEX @ PEG200 DMA), polyethylene glycol acrylate, polyethylene glycol methyl ether methacrylate, polyethylene glycol methyl ether acrylate, glycidyl methacrylate, glycidyl acrylate, acrylic acid, methacrylic acid, acrylic acid, methacrylic acid, acrylic acid, and acrylic acid, and acrylic acid, and acrylic acid, 2- (trifluoromethyl) acrylic acid, phenylacrylic acid, acrylamide, methacrylamide, N-methylolacrylamide, N-methylolmethacrylamide, or derivatives of the aforementioned substances, or mixtures of the aforementioned substances. Hydroxyethyl methacrylate is preferred.

The hydrophobic acrylate monomer is selected from acrylate monomers with hydrophobic groups, and the formula is shown in the specification:

R₁is H or C_1-6Alkyl, preferably H or CH₃；

R₆is C_6-20Arylalkyl radical, or C_6-20A heteroarylalkyl group.

The hydrophobic acrylate in the present invention is an acrylate having a hydrophobic group, and is selected from, for example, methyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, hexyl methacrylate, hexyl acrylate, isopropyl methacrylate, isopropyl acrylate, isobutyl methacrylate, isobutyl acrylate, tert-butyl methacrylate, tert-butyl acrylate, isooctyl methacrylate, isooctyl acrylate, isodecyl methacrylate, lauryl acrylate, stearyl methacrylate, stearyl acrylate, 9-anthracenemethyl methacrylate, 9-anthracenemethyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, dimethylaminoethyl methacrylate, ethyl acrylate, butyl methacrylate, isobutyl acrylate, tert-butyl methacrylate, tert-butyl acrylate, isooctyl methacrylate, isooctyl acrylate, isodecyl methacrylate, lauryl acrylate, stearyl methacrylate, stearyl acrylate, 9-anthracenemethyl methacrylate, and ethyl methacrylate, N, N-dimethyl methacrylamide, N-dimethyl acrylamide, N-diethylaminoethyl acrylate, N-diethylaminoethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, hexafluorobutyl acrylate, 2-perfluorodecyl ethyl methacrylate, 2- (perfluorooctyl) ethyl acrylate, pyruvyl methacrylate, pyruvyl acrylate, N-diethylaminoethyl methacrylate, N-diethylamino-ethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, 2-perfluorodecyl ethyl acrylate, 2-perfluorodecyl methacrylate, 2- (perfluorooctyl) ethyl methacrylate, pyruvyl acrylate, acetonyl acrylate, N-N, N-diethylaminoethyl acrylate, N-t-butylacrylamide, N-isopropylacrylamide, N-tetrahydrofurfuryl methacrylate, hexafluoroacrylate, N-butyl acrylate, N-butyl methacrylate, N-tetrahydrofurfuryl methacrylate, N-butyl methacrylate, hexafluorobutyl methacrylate, N-butyl methacrylate, N-hexafluorobutyl methacrylate, N-butyl acrylate, N-hexafluorobutyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, and N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-2-perfluorodecyl methacrylate, and N-butyl methacrylate, N-butyl acrylate, N-butyl, Tetrahydrofurfuryl acrylate, tetrahydrofurfuryl methacrylate, phenyl acrylate, phenylethyl methacrylate, phenylethyl acrylate, phenoxyethyl methacrylate, phenoxyethyl acrylate, benzyl methacrylate, benzyl acrylate, acetoacetoxyethylmethacrylate, acetoacetoxyethylacrylate, diacetoneacrylamide, diacetoneamethacrylamide, allyl methacrylate, phenoxyethyl acrylate, or derivatives of the foregoing, or mixtures thereof. Preferably ethyl acrylate and/or phenoxyethyl acrylate.

The material for preparing the artificial lens of the invention also comprises one or more additives such as a cross-linking agent, an ultraviolet absorbent, a blue light absorbent and the like if necessary.

The material for preparing the artificial lens of the invention can contain a cross-linking agent, wherein the cross-linking agent is selected from polymerizable monomers with two or more than two functionalities, and comprises the following components: ethylene glycol dimethacrylate, ethylene glycol diacrylate, butylene glycol dimethacrylate, butylene glycol diacrylate, hexanediol dimethacrylate, hexanediol diacrylate, diethylene glycol dimethacrylate, diethylene glycol diacrylate, triethylene glycol dimethacrylate, triethylene glycol diacrylate, polyethylene glycol dimethacrylate, polyethylene glycol diacrylate, trimethylolpropane triacrylate, trimethylolpropane trimethacrylate, bisphenol A glycerol dimethacrylate, bisphenol A glycerol diacrylate, pentanediol dimethacrylate, methacrylic anhydride, acrylic anhydride, N '-methylenebisacrylamide, N' -methylenebismethacrylamide, propylene glycol dimethacrylate, ethylene glycol dimethacrylate, propylene glycol dimethacrylate, ethylene glycol dimethacrylate, ethylene glycol dimethacrylate, and ethylene glycol dimethacrylate, and a copolymer, each, Divinylbenzene, or derivatives of the foregoing, or mixtures of the foregoing. Ethylene glycol dimethacrylate is preferred.

The material for manufacturing an intraocular lens according to the present invention may contain an ultraviolet absorber, wherein the ultraviolet absorber is selected from compounds having a highly efficient absorption function for ultraviolet rays having a wavelength range of 380 nm or less. Benzophenone compounds and/or benzotriazole compounds with high safety are preferable. More preferably, the benzophenone-based compound and/or the benzotriazole-based compound contains a polymerizable group selected from a vinyl group, an allyl group, a butenyl group, an ethynyl group, an acryloyloxy group, a methacryloyloxy group, an acrylamido group, a methacrylamido group, a vinyl ether group, and the like.

The material for preparing the artificial lens can contain a blue light absorbent, wherein the blue light absorbent is selected from compounds with selective filtering function on blue light with the wavelength range of 400-500 nm. Preferably a yellow dye compound with a molecular structural formula containing azo groups. More preferred are yellow dye compounds containing a polymerizable group selected from vinyl, allyl, butenyl, ethynyl, acryloxy, methacryloxy, acrylamido, methacrylamido, vinyl ether, and the like.

According to another embodiment of the present invention, the material for the preparation of intraocular lenses according to the present invention is obtained by polymerization of hydrophobic acrylate monomers and hydrophilic acrylate monomers, optionally with additives such as cross-linking agents, UV absorbers, blue-light absorbers, etc. Wherein the polymerization mode is selected from bulk polymerization, and a free radical bulk polymerization mode is preferred. The radical polymerization initiator may be selected from radical polymerization initiators commonly used in the art, and/or peroxy initiators, preferably selected from dilauroyl peroxide, bis (4-tert-butylcyclohexyl) peroxydicarbonate, dihexadecyl peroxide dicarbonate, ditetradecyl peroxydicarbonate, azobisisobutyronitrile, azobisisovaleronitrile, azobisisoheptonitrile, dicumyl peroxide, benzoyl peroxide, 2, 5-dimethyl-2, 5-di (tert-butylperoxy) hexane, 2-ethylhexyl tert-butylperoxycarbonate, tert-amyl peroxy-2-ethylhexanoate, tert-amyl peroxy (2-ethylhexyl) carbonate, 2, 5-dimethyl-2, 5-bis (2-ethylhexanoate peroxy) hexane, hexane, 2, 5-dimethyl-2, 5-di-tert-butylperoxy-3-hexyne, tert-butyl peroxy (2-ethylhexanoate), 1-di-tert-butylperoxycyclohexane, tert-butyl neodecanoate peroxypivalate, tert-butyl 2-ethylbutaneperoxycarboxylate, 1-di-tert-butylperoxy-3, 3, 5-trimethylcyclohexane, 3,6, 9-triethyl-3, 6, 9-trimethyl-1, 4, 7-triperoxonane, bis (3,5, 5-trimethylhexanoyl) peroxide, 1,3, 3-tetramethylbutyl peroxy-2-ethylhexanoate, tert-butylperoxy-3, 5, 5-trimethylhexanoate, tert-butylhydroperoxide, Di-tert-butane peroxide, tert-butyl peroxybenzoate, tert-butyl peroxyisopropyl formate, bis (2-ethylhexyl) peroxydicarbonate, tert-butyl peroxyacetate, hydroxy cumene peroxide, diisopropylbenzene hydroperoxide, tert-butyl cumene peroxide, tert-amyl hydroperoxide, or mixtures thereof. Azobisisobutyronitrile is preferred.

The material for preparing the artificial lens has moderate water content, provides necessary lubricity and flexibility for the artificial lens suitable for micro-incision surgery, and does not cause serious negative influence on the refractive index and the mechanical property of the artificial lens. Therefore, the material (for example, the material for preparing the artificial lens) has the saturated water content of 5-15wt%, preferably 6-13wt%, more preferably 7-12wt%, even 8-11wt% and especially 9-11wt% under the condition of simulating the human eye (physiological saline at 35 ℃).

The material for preparing the artificial lens has moderate refractive index, is processed into the artificial lens with the same diopter, can be thinner, and is more suitable for micro-incision implantation operation; and simultaneously, the dispersion effect caused by overhigh refractive index is overcome, so that glare generated after the artificial lens is implanted is avoided. Therefore, the refractive index of the material (such as the material for preparing the artificial lens) in the state of simulating human eyes (physiological saline at 35 ℃) is selected from 1.49-1.54, preferably 1.49-1.53, and more preferably 1.50-1.52.

The material for preparing the artificial lens has special mechanical properties, is a hard material in a dry room temperature or below, and can be processed into the artificial lens; and is soft in a wet state (after complete hydration) room temperature or a simulated human eye (35 ℃) environment, can be folded to enter the human eye capsular bag through a narrow passage, can be automatically and slowly restored to the original shape of the artificial lens, and can keep a stable working state in the capsular bag. Therefore, the dry glass transition temperature of the material (such as the material for preparing the artificial lens) is selected from 10-35 ℃, preferably 15-30 ℃, and more preferably 20-25 ℃; the material (such as the material for preparing the artificial lens) has moderate mechanical strength, the elongation at break of the material in a wet state (after complete hydration) room temperature environment is at least 180 percent, and the breaking strength is at least 2.5 MPa, so that the requirement of micro-incision operation implantation can be met, the situations of loop folding, fracture and the like of the artificial lens in the implantation process are avoided, and the safety in the operation is ensured.

The inventor of the present invention finds that the material for preparing the intraocular lens of the present invention can be finally obtained by selecting and proportioning monomers, and has the comprehensive properties as described above, and simultaneously has the following properties:

b. a refractive index (wet state) at 35 ℃ of 1.49 to 1.54, preferably 1.49 to 1.53, more preferably 1.50 to 1.52. The molar ratio of the hydrophilic monomer to the hydrophobic monomer in the material (such as the material for preparing the artificial lens) is 20:80-80:20, preferably 25:75-75:25, preferably 30:70-70:30, preferably 35:65-65:35, preferably 40:60-60:40, more preferably 45: 55-55: 45, and even about 50: 50.

the material for the manufacture of an intraocular lens according to the invention, in particular for the manufacture of the add-on part, may further comprise at least one drug, a fluorescent agent and/or at least one photosensitizer.

According to another embodiment of the present invention, when the material used to make the intraocular lens of the present invention comprises a fluorescent agent, the fluorescent agent is immobilized within or on the surface of the final material. The fluorescent agent is stably combined in the final material, and at the moment, the fluorescence of the material can be utilized, medical detection can be performed, specifically, the material can fluoresce under a slit lamp light source or a Pentro microscope, an ophthalmologist can clearly and clearly judge the adaptability of the material and a cornea, and the material does not stain the cornea when contacting the cornea, and an exogenous cornea fluorescence staining agent is thoroughly eliminated, so that the material is used for medical detection without adding any additional reagent (including the fluorescent agent).

According to another embodiment of the present invention, when the material for manufacturing an intraocular lens of the present invention comprises a photosensitizer, the photosensitizer is fixed inside or on the surface of the final material, the material is surgically implanted into a diseased site, and when the diseased site needs to be treated, laser light of a selected wavelength is irradiated thereto; when treatment is complete, only the laser needs to be removed. Since the photosensitizer is bound in or on the material and can not freely enter other tissues of the human body through blood or other body fluid, the toxicity of the photosensitizer per se can be ignored, and the selection range of the photosensitizer is not limited. Particularly, the material provided by the invention can be implanted into tissues or parts possibly suffering from diseases in advance along with other eye operations, on one hand, the material can play a role in prevention, and on the other hand, when the tissues or the parts suffer from diseases, the material can receive laser treatment without carrying out operations again; more particularly, the material provided by the invention has the effect of repeated action, and after one laser treatment is finished, because the photosensitizer is not eliminated and still exists in a diseased region, when the region has secondary disease or multiple times, the material can receive the laser treatment again or multiple times without injecting the photosensitizer, and has repeatability of treatment.

In the material for preparing the artificial lens, when the copolymer prepared by copolymerizing the acrylate monomers is used as a copolymer material and further comprises at least one drug, fluorescent agent and/or at least one photosensitizer, the combination mode of the drug, fluorescent agent and/or photosensitizer and the copolymer material is selected from the following groups:

-the drug, fluorescer and/or photosensitizer participate in the polymerization during the formation of the copolymer material;

-the drug, fluorescent agent and/or photosensitizer is added to the copolymer material by physical dispersion during the molding of the copolymer material;

the medicine, fluorescent agent and/or photosensitizer are fixed on the surface of the copolymer material in a surface grafting and surface modification mode; and/or

The drugs, fluorescent agents and/or photosensitizers are immobilized on the surface of the copolymer material in a surface-coating manner.

When (1) the drug, fluorescer and/or photosensitizer is bound to the copolymer material in a manner such that the drug, fluorescer and/or photosensitizer participates in the polymerization during the formation of the copolymer material, the drug, fluorescer and/or photosensitizer comprises a material of polymerizable monomers.

When (2) the drug, fluorescent agent and/or photosensitizer is incorporated with the copolymer material in a manner such that the drug, fluorescent agent and/or photosensitizer is added to the copolymer material by physical dispersion during the formation of the copolymer material, the drug, fluorescent agent and/or photosensitizer may be any suitable drug, fluorescent agent and/or photosensitizer, optionally including polymerizable monomers.

When (3) the drug, fluorescent agent and/or photosensitizer is bound to the copolymer material in such a manner that the drug, fluorescent agent and/or photosensitizer is immobilized on the surface of the molded copolymer material in a surface grafting, surface modification manner, the copolymer material is a molded material, but contains a polymerizable group on the surface of the copolymer material.

The polymerizable group herein may be, for example: vinyl, allyl, butene, acryloxy, methacryloxy, acrylamido, methacrylamido, vinyl ether, alkynyl, hydroxyl, mercapto, amino, imino, carboxyl, acid anhydride, aldehyde, isocyanate, siloxane, epoxy, ring nitrogen, and the like.

When (4) the drug, fluorescent agent and/or photosensitizer is bound to the copolymer material in such a manner that the drug, fluorescent agent and/or photosensitizer is fixed to the surface of the molded copolymer material in a surface coating manner, the copolymer material is a molded material.

In one embodiment of the present invention, the inventive fluorescer is selected from: fluorescein (sodium), cyanine fluorescent dye, fluorescein isothiocyanate, rhodamine substance with fluorescence property, lanthanide chelate with fluorescence property, Phycoerythrin (PE), substance which generates fluorescence after enzyme action such as polymethacrylic chlorophyll protein (PerCP), propidium iodide and other derivatives which have emission wavelength at 300-850 nm and are modified or modified based on the above fluorescent agent, or fluorescent agent formed by reasonably loading the above compounds into nanometer materials, or mixtures thereof.

In one embodiment of the present invention, the photosensitizer of the present invention is selected from a photodynamic type photosensitizer or photothermal type photosensitizer. The photosensitizer is any photosensitizer with the wavelength range of 300-1100 nanometers of an activated laser light source. Preferably, the wavelength range of the laser light source is selected from 500-1000 nanometers; preferably, the wavelength range of the laser light source is selected from 600-900 nanometers; preferably, the wavelength range of the laser light source is 700-900 nm or the wavelength range of the laser light source is 800-1100 nm.

In one embodiment of the present invention, the material containing the photodynamic photosensitizer is irradiated by laser with a selected wavelength (e.g., 300-1100 nm), and the photosensitizer in the material is excited to generate active oxygen with cytotoxicity, so that cells at a diseased region can be killed, and a therapeutic effect is achieved.

In another embodiment of the present invention, the material containing photo-thermal photosensitizer is irradiated by laser with selected wavelength (e.g. 300-1100 nm), the photosensitizer in the material is excited, and the light energy is converted into heat, so that the ambient temperature is raised to kill the cells of the diseased tissue. When the temperature of a diseased tissue area reaches 43 ℃, the synthesis of DNA, RNA and protein can be inhibited, and the safety limit of normal cells is 45 ℃, so that in the preferred scheme, the material containing the photo-thermal photosensitizer can generate heat under the irradiation of laser, and the temperature is increased by 4-20 ℃; in a more preferable scheme, the material containing the photo-thermal photosensitizer can generate heat under laser irradiation, so that the ambient temperature is increased by 6-12 ℃; in a more preferable scheme, the material containing the photo-thermal photosensitizer can generate heat under laser irradiation, so that the ambient temperature is increased by 8-10 ℃. E.g., elevated temperature greater than 38 ℃, greater than 39 ℃, preferably greater than 40 ℃, preferably greater than 41 ℃, preferably greater than 42 ℃, preferably greater than 43 ℃, preferably greater than 44 ℃, preferably greater than 45 ℃, preferably greater than 46 ℃, preferably greater than 47 ℃, preferably greater than 50 ℃, and less than 55 ℃, preferably greater than 56 ℃, preferably greater than 57 ℃, preferably greater than 58 ℃, preferably greater than 59 ℃, preferably greater than 60 ℃, preferably greater than 61 ℃, preferably greater than 62 ℃, preferably greater than 63 ℃, preferably greater than 64 ℃, preferably greater than 65 ℃, and preferably less than 66 ℃, preferably less than 65 ℃, preferably less than 64 ℃, preferably less than 63 ℃, preferably less than 62 ℃, preferably less than 61 ℃, preferably less than 60 ℃, preferably less than 59 ℃, preferably less than 58 ℃, preferably less than 57 ℃, preferably less than 56 ℃, preferably less than 55 ℃, preferably less than 54 ℃, preferably less than 53 ℃, preferably less than 52 ℃, preferably less than 51 deg.C, preferably less than 50 deg.C, preferably less than 49 deg.C, preferably less than 48 deg.C, preferably less than 47 deg.C, preferably less than 46 deg.C.

In another embodiment of the present invention, the photosensitizer suitable for use in the present invention is selected from the group consisting of porphyrin, metalloporphyrin, porphine, chlorophyll, purpurin, fluorescein, phthalocyanine, metallophthalocyanine, indocyanine green, tricarbocyanine, nanogold particles, metal nanoparticles, metal oxide nanoparticles, metal sulfide nanoparticles, metal carbide nanoparticles, carbon nanotubes, graphene, and the like, and a derivative product of the above compounds, or a degradation product of the above compounds, or a salt form of the above compounds. In a preferred embodiment, the photosensitizer is selected from the group consisting of indocyanine (monomethylcyanine), indocyanine (trimethycyanine), indocyanine (pentamethylcyanine), indocyanine (heptamethicyanine), tricarbocyanine dye, benzindole hemicyanine dye, indocyanine squaraine dye, phthalocyanine, chlorophyll derivatives, pheophytin, pheophorbide a and derivatives thereof, chlorin e6 and derivatives thereof, purpurin 18, chlorin p6 and derivatives thereof, chlorin e4 and derivatives thereof, chlorin f and derivatives thereof, protoporphyrin and derivatives thereof, benzopheophorbide, metalloporphyrin, hematoporphyrin derivatives (HpD), pormhodium, carcinomaton (PSD-007), nano gold, nano tungsten oxide, nano copper sulfide, nano iron oxide, nano nickel carbide, nano molybdenum oxide and other water-soluble or fat-soluble derivatives modified or modified based on the photosensitizer.

In another embodiment of the present invention, the photosensitizer can be a photosensitizer with a wavelength range of 400-600 nm of the activated laser light source, such as fluorescein; the photosensitizer can be a photosensitizer with the wavelength range of 600-750 nm of an activated laser light source, such as purpurin 18; the photosensitizer can be a photosensitizer with the wavelength range of 700-900 nm of an activated laser light source, such as indocyanine green (ICG); the photosensitizer can be activated laser light source photosensitizer with wavelength range of 800-1100 nm, such as nanogold.

In another embodiment of the present invention, the drug, fluorescer and/or photosensitizer may contain reactive groups in the molecular structure, such as: hydroxyl, sulfydryl, amino, imino, carboxyl, acid anhydride, aldehyde group, isocyanate group, siloxane group, epoxy group, ring nitrogen group and the like can perform grafting reaction with groups on the side chain of the copolymer material molecule, the photosensitizer molecule is bonded with the copolymer material molecule chain in a covalent bond mode, and the photosensitizer is fixed in the copolymer material or on the surface of the copolymer material and can not freely enter blood or other body fluid.

In one embodiment of the present invention, when the drug, fluorescer and/or photosensitizer contains a polymerizable group in the molecular structure, for example: vinyl, allyl, butene, acryloxy, methacryloxy, acrylamido, methacrylamido, vinyl ether, alkynyl, hydroxyl, mercapto, amino, imino, carboxyl, anhydride, aldehyde, isocyanate, siloxane, epoxy, cyclic nitrogen, etc., may be copolymerized with a polymerizable monomer of a copolymer material, molecules of a drug, a fluorescent agent and/or a photosensitizer are present in a molecular chain of the copolymer material in the form of covalent bonds, and the drug, the fluorescent agent and/or the photosensitizer are immobilized in the copolymer material, so that toxicity of the drug, the fluorescent agent and/or the photosensitizer itself may be ignored.

In another embodiment of the present invention, when the drug, the fluorescent agent and/or the photosensitizer are dispersed in the copolymer material by blending or doping, the drug, the fluorescent agent and/or the photosensitizer molecules are bonded to the molecular chains of the copolymer material by hydrogen bonds or van der waals force, and the drug, the fluorescent agent and/or the photosensitizer molecules are bound in the copolymer material and cannot freely enter blood or other body fluids.

In another embodiment of the present invention, when the drug, fluorescent agent and/or photosensitizer is immobilized on the surface of the copolymer material in a surface-grafted, surface-modified manner, the copolymer material is selected from polymerizable copolymer materials, preferably comprising polymerizable groups with good biocompatibility on the surface, such as: vinyl, allyl, butene, acryloxy, methacryloxy, acrylamide, methacrylamide, vinyl ether, alkynyl, hydroxyl, mercapto, amino, imino, carboxyl, anhydride, aldehyde, isocyanate, siloxane, epoxy, cyclic nitrogen, etc., wherein the drug, fluorescer and/or photosensitizer may undergo a grafting reaction with a copolymer material that is covalently bound to the drug, fluorescer and/or photosensitizer molecules, the drug, fluorescer and/or photosensitizer being immobilized within or on the copolymer material and likewise not being free to enter blood or other body fluids.

In another preferred embodiment, the drug, fluorescer and/or photosensitizer is dispersed in other auxiliary agents (such as cosolvent, emulsifier, lubricant, hydrophilic coating, drug loading, color masterbatch, ultraviolet absorbent, cross-linking agent, coupling agent, pH regulator, antistatic agent, release agent, etc.) in a dissolving, suspending, emulsifying manner, etc. manner, and is coated on the surface of the copolymer material, the drug, fluorescer and/or photosensitizer molecules are combined with the molecular chain of the copolymer material by hydrogen bond or van der Waals force, and the fluorescer and/or photosensitizer is bound on the surface of the copolymer material and can not freely enter blood or other body fluids.

In another preferred embodiment, the drug, fluorescer and/or photosensitizer molecules may be chemically modified without changing the photoactivity in order to enhance the affinity between the drug, fluorescer and/or photosensitizer molecules and the molecules of the copolymeric material; the copolymer material may also be subjected to an activation treatment including, but not limited to, plasma treatment, corona treatment, flame treatment, strong acid treatment, strong base treatment, and the like.

Other polymerizable monomers that can be used in the present invention include: butadiene, styrene, alpha-methylstyrene, sodium styrenesulfonate, vinyltoluene, acrylonitrile, methacrylonitrile, alpha-chloroacrylonitrile, ethacrylonitrile, methyl vinyl ether, isopropyl vinyl ether, n-butyl vinyl ether, isobutyl vinyl ether, tert-butyl vinyl ether, 2-ethylhexyl vinyl ether, 4-hydroxybutyl vinyl ether, 1, 4-butanediol divinyl ether, diethylene glycol divinyl ether, vinyl esters such as vinyl acetate, vinyl alkanoate, vinyl propionate, vinyl butyrate, vinyl isobutyrate, vinyl hexanoate, vinyl 2-ethylhexanoate, and vinyl decanoate; allyl chloride, methallyl chloride, ethylene dichloride, vinyl chloride, vinyl fluoride, vinyl difluoride, sodium vinylsulfonate, butyl vinylsulfonate, phenyl vinylsulfone, methyl vinylsulfone, N-vinyl pyrrolidinone, N-vinyl oxazolidinedione, acrolein, acrylamide, methacrylamide, N-dimethyl (meth) acrylamide, methylolacrylamide, N-butoxy (meth) acrylamide, isobutoxy (meth) acrylamide, and the like; other ethylenically unsaturated carboxylic acids and esters thereof such as the dialkyl and trialkyl esters of di-and tricarboxylic acids (e.g., itaconic acid, and the like) including di (2-ethylhexyl) maleate, dibutyl maleate, dimethyl fumarate, dimethyl itaconate, diethyl citraconate, trimethyl aconitate, diethyl mesaconate, di (2-ethylhexyl) itaconate, di (2-chloroethyl) itaconate, maleic acid, maleic anhydride, fumaric acid, itaconic acid; and olefins such as diisobutylene, 1-octene, 1-decene, 1-hexadecene, and the like, or mixtures thereof.

In one embodiment of the present invention, when the drug, the fluorescent agent and/or the photosensitizer is polymerized with the copolymer material to obtain the material of the present invention, or when the drug, the fluorescent agent and/or the photosensitizer is dispersed in the copolymer material to obtain the material of the present invention, the material of the present invention may be prepared by a method comprising the steps of:

1) mixing the polymerizable monomer with optional additives such as thermal crosslinkers, initiators, ultraviolet absorbers, and the like;

2) drugs, fluorescent agents and/or photosensitizers are added and dissolved, followed by polymerization.

More specifically, the material for manufacturing an intraocular lens of the present invention can be prepared by a method comprising the steps of:

1) mixing a polymerizable monomer with a thermal initiator, a crosslinking agent and/or an ultraviolet absorber;

2) adding medicine, fluorescent agent and/or photosensitizer to dissolve;

3) placing the reaction system obtained in the step 2) in a mould;

4) carrying out polymerization, such as water bath polymerization;

5) the polymerization was carried out again in the dryer.

In another embodiment of the present invention, when the drug, fluorescent agent and/or photosensitizer is immobilized on the surface of the copolymer material in a surface grafting, surface modification manner, the material of the present invention can be prepared by a method comprising the following steps:

1) mixing a polymerizable monomer with optional additives such as a cross-linking agent, a thermal initiator, an ultraviolet absorber and the like, and then polymerizing to obtain a copolymer material;

2) the drug, fluorescer and/or photosensitizer is added and dissolved, for example by dissolving the drug, fluorescer and/or photosensitizer with suitable auxiliaries (e.g. polymerizable monomers) and then subjected to polymerisation such as graft polymerisation or surface modification or transfer printing.

More specifically, the material of the present invention can be prepared by a process comprising the steps of:

2) transferring the reaction system obtained in 1) into a mold;

4) carrying out polymerization, such as water bath polymerization;

5) polymerizing again in the dryer;

6) dissolving the drug, fluorescent agent and/or photosensitizer, e.g., dissolving the drug, fluorescent agent and/or photosensitizer with a suitable polymerizable monomer;

7) the system obtained as described above is polymerized again, for example by graft polymerization or surface modification or transfer printing.

In another embodiment of the present invention, when the drug, fluorescent agent and/or photosensitizer is immobilized in a surface coating manner on the surface of the copolymer material, the material of the present invention can be prepared by a method comprising the steps of:

1) obtaining a suitable copolymer material;

2) the drug, fluorescer and/or photosensitizer, for example, is dissolved in a suitable solvent and coated onto the surface of the copolymer material.

The materials of the invention for the preparation of intraocular lenses can also be used for the manufacture of medical treatment devices, medical examination devices, for example: for making contact lenses, orthokeratology lenses, iris retractors, intraocular lenses, artificial corneas, intracorneal rings, capsular tension rings, intracorneal lenses, glaucoma drainage valves, drug delivery vehicles, intraocular fillers, fundus fillers, eyeglasses, goggles, medical device lenses or, when they contain a therapeutic agent and/or a photosensitizer, for making medical treatment devices (e.g., devices for treating ophthalmic diseases), such as devices for treating posterior disorders (e.g., intraocular lenses for treating posterior disorders), or, when they contain a fluorescent agent, for making medical detection devices (so that the resulting article can be detected using fluorescent properties, in particular, ophthalmic devices, such as lenses having fluorescent properties, in particular, ophthalmic lenses, intraocular lenses, orthokeratology lenses, iris retractors, intraocular lenses, artificial corneal inserts, capsular tension rings, intraocular lenses, glaucoma drainage valves, drug delivery devices, drug delivery vehicles, intraocular fillers, ocular inserts, ophthalmic devices, ocular inserts, devices, ocular inserts, devices, ophthalmic devices, or ocular inserts, devices, intracorneal rings, capsular bag tension rings, intracorneal lenses, glaucoma drainage valves, drug delivery vehicles, intraocular fillers, fundus fillers, eyeglasses, goggles, medical device lenses, telescopes, scopes, etc.), among other ophthalmic devices or consumables.

The invention also relates to the use of the material for the preparation of an intraocular lens according to the invention for the preparation of a device or apparatus (such as a medical treatment device, a medical examination device) as described above, for example: intraocular lens, contact lens, orthokeratology lens, iris retractor, intraocular lens, keratoprosthesis, intracorneal ring, capsular tension ring, intracorneal lens, glaucoma drainage valve, drug delivery vehicle, intraocular filler, fundus filler, eyeglasses, goggles, medical device lens or when it contains a therapeutic agent and/or a photosensitizer it may be used to manufacture a medical treatment device (e.g., a device for treating an ophthalmic disease), such as a device for treating a posterior cataract, or when it contains a fluorescent agent it may be used to manufacture a medical detection device (so that the resulting article may be detected using a fluorescent property, in particular, an ophthalmic device, such as a lens having a fluorescent property, in particular, an ophthalmic lens, an intraocular lens having a fluorescent property, a contact lens, an orthokeratology lens, an iris retractor, an intraocular lens, an artificial cornea, an intracorneal ring, a capsular tension ring, an intracorneal lens, an intraocular lens, an artificial cornea, an intraocular lens, a corneal intraocular lens, an intraocular lens, a corneal tension ring, an intraocular lens, a corneal contact lens, a method of treating a method of treating a method of treating a disease, a method of treating a method of treating a disease, a method of treating a disease, a method of treating a method of a disease, a method of treating a method of a disease, a method of treating a disease, a method of treating a method of treating a disease, a method of treating a disease, a method of treating a method of treating a disease, a patient, a disease, Glaucoma drainage valves, drug slow-release carriers, intraocular fillers, fundus fillers, glasses, goggles, medical device lenses, telescopes, scopes, etc.) and other ophthalmic devices or consumables.

The term "alkyl" as used herein refers to a straight or branched chain hydrocarbon containing from 1 to 500 carbon atoms or from 1 to 100 carbon atoms or from 1 to 50 carbon atoms, or from 1 to 20 carbon atoms, or from 1 to 10 carbon atoms, or from 1 to 8 carbon atoms, from 1 to 6 carbon atoms, from 1 to 4 carbon atoms, or from 1 to 3 carbon atoms (unless otherwise specified). Representative examples of alkyl groups include, but are not limited to, methyl, ethyl, n-propyl, isopropyl, n-butyl, sec-butyl, isobutyl, tert-butylButyl, n-pentyl, isopentyl, neopentyl, n-hexyl, 3-methylhexyl, 2-dimethylpentyl, 2, 3-dimethylpentyl, n-heptyl, n-octyl, n-nonyl and n-decyl, undecyl, dodecyl, tridecyl, tetradecyl, pentadecyl, hexadecyl, heptadecyl, octadecyl, nonadecyl, eicosyl. When an "alkyl" group is a linking group between two other moieties, it may also be straight or branched; examples include, but are not limited to-CH₂-、-CH₂CH₂-、-CH₂CH₂CH(CH₃)-、-CH₂CH(CH₂CH₃)CH₂-。

The term "aryl" as used herein refers to a phenyl group (i.e., a monocyclic aryl group) or an aromatic bicyclic ring system containing at least one phenyl ring or containing only carbon atoms in the aromatic bicyclic ring system. The bicyclic aryl group can be azulenyl (azulenyl), naphthyl, or phenyl fused to a monocyclic cycloalkyl, monocyclic cycloalkenyl, or monocyclic heterocyclyl. The bicyclic aryl is attached to the parent molecular moiety through any carbon atom contained within the phenyl portion of the bicyclic system or any carbon atom of the naphthyl or azulenyl ring. The fused monocyclic cycloalkyl or monocyclic heterocyclyl portion of the bicyclic aryl is optionally substituted with one or two oxo and/or thia groups. Representative examples of bicyclic aryl groups include, but are not limited to, azulenyl, naphthyl, indan-1-yl, indan-2-yl, indan-3-yl, indan-4-yl, 2, 3-indolin-5-yl, 2, 3-indolin-6-yl, 2, 3-indolin-7-yl, inden-1-yl, inden-2-yl, inden-3-yl, inden-4-yl, dihydronaphthalen-2-yl, dihydronaphthalen-3-yl, dihydronaphthalen-4-yl, dihydronaphthalen-1-yl, 5,6,7, 8-tetrahydronaphthalen-1-yl, 5,6,7, 8-tetrahydronaphthalen-2-yl, 2, 3-dihydrobenzofuran-4-yl, 2, 3-dihydrobenzofuran-5-yl, 2, 3-dihydrobenzofuran-6-yl, 2, 3-dihydrobenzofuran-7-yl, benzo [ d ] [1,3] dioxol-4-yl, benzo [ d ] [1,3] dioxol-5-yl, 2H-chromen-2-on-6-yl, 2H-chromen-2-on-7-yl, 2H-chromen-2-on-8-yl, isoindolin-1, 3-diketo-4-yl, isoindolin-1, 3-diketo-5-yl, inden-1-keto-4-yl, inden-1-keto-5-yl, inden-1-keto-6-yl, inden-1-keto-7-yl, 2, 3-dihydrobenzo [ b ] [1,4] dioxan-5-yl, 2, 3-dihydrobenzo [ b ] [1,4] dioxan-6-yl, 2H-benzo [ b ] [1,4] oxazine 3(4H) -one-5-yl, 2H-benzo [ b ] [1,4] oxazine 3(4H) -one-6-yl, 2H-benzo [ b ] [1,4] oxazine 3(4H) -one-7-yl, 2H-benzo [ b ] [1,4] oxazin-3 (4H) -on-8-yl, benzo [ d ] oxazin-2 (3H) -on-5-yl, benzo [ d ] oxazin-2 (3H) -on-6-yl, benzo [ d ] oxazin-2 (3H) -on-7-yl, benzo [ d ] oxazin-2 (3H) -on-8-yl, quinazolin-4 (3H) -on-5-yl, quinazolin-4 (3H) -on-6-yl, quinazolin-4 (3H) -on-7-yl, quinazolin-4 (3H) -on-8-yl, quinoxalin-2 (1H) -on-5-yl, Quinoxaline-2 (1H) -on-6-yl, quinoxaline-2 (1H) -on-7-yl, quinoxaline-2 (1H) -on-8-yl, benzo [ d ] thiazol-2 (3H) -on-4-yl, benzo [ d ] thiazol-2 (3H) -on-5-yl, benzo [ d ] thiazol-2 (3H) -on-6-yl and benzo [ d ] thiazol-2 (3H) -on-7-yl. In certain embodiments, a bicyclic aryl is (i) a naphthyl or (ii) a phenyl ring fused to a 5 or 6 membered monocyclic cycloalkyl, 5 or 6 membered monocyclic cycloalkenyl or 5 or 6 membered monocyclic heterocyclyl, wherein the fused cycloalkyl, cycloalkenyl and heterocyclyl groups are optionally substituted with one or two groups independently oxo or thia.

The term "arylalkyl," or "alkylaryl," as used herein, refers to an aryl group, as defined herein, appended to the parent molecular moiety through an alkyl group, as defined herein. Representative examples of arylalkyl groups include, but are not limited to, benzyl, 2-phenylethyl, 3-phenylpropyl, and 2-naphthalen-2-ylethyl.

The term "cycloalkyl" as used herein refers to a monocyclic or bicyclic cycloalkyl ring system. Monocyclic systems are cyclic hydrocarbon groups containing from 3 to 8 carbon atoms, where such groups may be saturated or unsaturated, but are not aromatic. In certain embodiments, the cycloalkyl group is fully saturated. Examples of monocyclic cycloalkyl groups include cyclopropyl, cyclobutyl, cyclopentyl, cyclopentenyl, cyclohexyl, cyclohexenyl, cycloheptyl, and cyclooctyl. Bicyclic cycloalkyl ring systems are bridged monocyclic or fused bicyclic rings. Bridged monocyclic rings contain a monocyclic cycloalkyl ring in which two non-adjacent carbon atoms of the monocyclic ring are connected by an alkylene bridge of one to three additional carbon atoms (i.e., - (CH)₂)_w-a bridging group of the form, whichWherein w is 1,2 or 3). Representative examples of bicyclic ring systems include, but are not limited to, bicyclo [3.1.1]Heptane, bicyclo [2.2.1]Heptane, bicyclo [2.2.2]Octane, bicyclo [3.2.2]Nonane, bicyclo [3.3.1]Nonanes and bicyclo [4.2.1]Nonane. Fused bicyclic cycloalkyl ring systems contain a monocyclic cycloalkyl ring fused to a phenyl, monocyclic cycloalkyl, monocyclic cycloalkenyl, monocyclic heterocyclyl or monocyclic heteroaryl. The bridged or fused bicyclic cycloalkyl is connected to the parent molecular moiety through any carbon atom contained within the monocyclic cycloalkyl ring. The cycloalkyl group is optionally substituted with one or two groups independently oxo or thia. In certain embodiments, the fused bicyclic cycloalkyl is a 5 or 6 membered monocyclic cycloalkyl ring fused to a phenyl ring, a 5 or 6 membered monocyclic cycloalkyl, a 5 or 6 membered monocyclic cycloalkenyl, a 5 or 6 membered monocyclic heterocyclyl or a 5 or 6 membered monocyclic heteroaryl, wherein the fused bicyclic cycloalkyl is optionally substituted with one or two groups independently oxo or thia.

The term "heteroaryl" as used herein refers to a monocyclic heteroaryl or bicyclic ring system containing at least one heteroaromatic ring. The monocyclic heteroaryl group may be a 5 or 6 membered ring. The 5-membered ring consists of two double bonds and one, two, three or four nitrogen atoms and optionally one oxygen or sulfur atom. The 6-membered ring consists of three double bonds and one, two, three or four nitrogen atoms. The 5-or 6-membered heteroaryl is connected to the parent molecular moiety through any carbon atom or any nitrogen atom contained within the heteroaryl. Representative examples of monocyclic heteroaryl groups include, but are not limited to, furyl, imidazolyl, isoxazolyl, isothiazolyl, oxadiazolyl, oxazolyl, pyridyl, pyridazinyl, pyrimidinyl, pyrazinyl, pyrazolyl, pyrrolyl, tetrazolyl, thiadiazolyl, thiazolyl, thienyl, triazolyl, and triazinyl. Bicyclic heteroaryls consist of a monocyclic heteroaryl fused to a phenyl, monocyclic cycloalkyl, monocyclic cycloalkenyl, monocyclic heterocyclyl or monocyclic heteroaryl. The fused cycloalkyl or heterocyclyl portion of the bicyclic heteroaryl group is optionally substituted with one or two groups independently oxo or thia. When the bicyclic heteroaryl contains a fused cycloalkyl, cycloalkenyl, or heterocyclyl ring, then the bicyclic heteroaryl group is attached to the parent molecular moiety through any carbon or nitrogen atom contained within the monocyclic heteroaryl portion of the bicyclic ring system. When the bicyclic heteroaryl is a monocyclic heteroaryl fused to a phenyl ring, then the bicyclic heteroaryl group is connected to the parent molecular moiety through any carbon or nitrogen atom within the bicyclic ring system. Representative examples of bicyclic heteroaryls include, but are not limited to, benzimidazolyl, benzofuranyl, benzothienyl, benzooxadiazolyl, benzoxathiooxadiazolyl, benzothiazolyl, cinnolinyl, 5, 6-dihydroquinolin-2-yl, 5, 6-dihydroisoquinolin-1-yl, furopyridinyl, indazolyl, indolyl, isoquinolyl, naphthyridinyl, quinolinyl, purinyl, 5,6,7, 8-tetrahydroquinolin-2-yl, 5,6,7, 8-tetrahydroquinolin-3-yl, 5,6,7, 8-tetrahydroquinolin-4-yl, 5,6,7, 8-tetrahydroisoquinolin-1-yl, thienopyridinyl, 4,5,6, 7-tetrahydrobenzo [ c ] [1,2,5] oxadiazolyl, and 6, 7-dihydrobenzo [ c ] [1,2,5] oxadiazol-4 (5H) -one. In certain embodiments, a fused bicyclic heteroaryl is a 5 or 6 membered monocyclic heteroaryl ring fused to a phenyl ring, a 5 or 6 membered monocyclic cycloalkyl, a 5 or 6 membered monocyclic cycloalkenyl, a 5 or 6 membered monocyclic heterocyclyl or a 5 or 6 membered monocyclic heteroaryl, wherein the fused cycloalkyl, cycloalkenyl and heterocyclyl groups are optionally substituted with one or two groups independently oxo or thia.

The terms "heteroarylalkyl" and "-alkylheteroaryl" as used herein, refer to a heteroaryl, as defined herein, appended to the parent molecular moiety through an alkyl group, as defined herein. Representative examples of heteroarylalkyl groups include, but are not limited to, furan-3-ylmethyl, 1H-imidazol-2-ylmethyl, 1H-imidazol-4-ylmethyl, 1- (pyridin-4-yl) ethyl, pyridin-3-ylmethyl, pyridin-4-ylmethyl, pyrimidin-5-ylmethyl, 2- (pyrimidin-2-yl) propyl, thiophen-2-ylmethyl, and thiophen-3-ylmethyl.

The term "heterocyclyl" as used herein refers to a monocyclic heterocycle or a bicyclic heterocycle. Monocyclic heterocycle is a 3, 4,5,6 or 7 membered ring containing at least one heteroatom independently selected from O, N and S, wherein the ring is saturated or unsaturated, but is not aromatic. The 3 or 4 membered ring contains 1 heteroatom selected from O, N and S. The 5-membered ring may contain zero or one double bond and one, two or three heteroatoms selected from O, N and S. The 6 or 7 membered ring contains zero, one or two double bonds and one, two or three heteroatoms selected from O, N and S. The monocyclic heterocycle is attached to the parent molecular moiety through any carbon atom or any nitrogen atom contained within the monocyclic heterocycle. Representative examples of monocyclic heterocycles include, but are not limited to, azetidinyl, azepanyl, aziridinyl, diazepanyl, 1, 3-dioxanyl, 1, 3-dioxalanyl, 1, 3-dithiolanyl, 1, 3-dithianyl, imidazolinyl, imidazolidinyl, isothiazolinyl, isothiazolidinyl, isoxazolinyl, isoxazolidinyl, morpholinyl, oxadiazolinyl, oxadiazolidinyl, oxazolinyl, oxazolidinyl, piperazinyl, piperidinyl, pyranyl, pyrazolinyl, pyrazolidinyl, pyrrolinyl, pyrrolidinyl, tetrahydrofuranyl, tetrahydrothienyl, thiadiazolinyl, thiazolinyl, thiazolidinyl, thiomorpholinyl, 1-thiomorpholinyl (thiomorpholinyl sulfone), thiopyranyl, and trithianyl. A bicyclic heterocycle is a monocyclic heterocycle fused to a phenyl, monocyclic cycloalkyl, monocyclic cycloalkenyl, monocyclic heterocycle, or monocyclic heteroaryl. The bicyclic heterocycle is attached to the parent molecular moiety through any carbon atom or any nitrogen atom contained within the monocyclic heterocycle portion of the bicyclic ring system. Representative examples of bicyclic heterocyclic groups include, but are not limited to, 2, 3-dihydrobenzofuran-2-yl, 2, 3-dihydrobenzofuran-3-yl, indolin-1-yl, indolin-2-yl, indolin-3-yl, 2, 3-dihydrobenzothien-2-yl, decahydroquinolinyl, decahydroisoquinolinyl, octahydro-1H-indolyl, and octahydrobenzofuranyl. The heterocyclyl group is optionally substituted with one or two groups which are independently oxo or thia. In certain embodiments, bicyclic heterocyclyl is a 5 or 6 membered monocyclic heterocyclyl ring fused to a phenyl ring, a 5 or 6 membered monocyclic cycloalkyl, a 5 or 6 membered monocyclic cycloalkenyl, a 5 or 6 membered monocyclic heterocyclyl or a 5 or 6 membered monocyclic heteroaryl, wherein the bicyclic heterocyclyl is optionally substituted with one or two groups independently oxo or thia.

The additional part of the invention can be degradable materials, such as polycaprolactone, poly butylene succinate, polylactic acid, polyhydroxyalkanoate, aliphatic aromatic copolyester, polyvinyl alcohol, carbon dioxide copolymer, poly-beta-hydroxybutyrate, or a mixture thereof, or a copolymer thereof, the degradable materials are ideal carriers of medicines, and the sustained-release position is uniform, the amount is uniform, and the sustained-release time is long. When the degradable material is completely degraded, the medicine is completely released, and can last for 1 week to 1 year according to the difference of the degradable material, so that residual epithelial cells can be more completely removed. When the lens is completely released, the groove in the optical area of the lens forms a structure similar to a sharp right-angled square edge, and has a prevention effect. When the additional portion is not made of degradable material, the therapeutic agent can be fixed to the surface of the ring by any surface coating and modification techniques disclosed in the prior art, unlike other coatings, the center of the optical zone is free of therapeutic agent, which is more targeted for removal of the upper cells, and the required dose is correspondingly reduced, with less damage to other normal tissue cells.

In another embodiment of the present invention, the additional part and the host material are selected from hydrophobic acrylates, acrylate hydrogels, silica gels, silica hydrogels, fluorosilicone acrylates, polystyrene and polymethylmethacrylate, polycarbonate, polysiloxane, or mixtures thereof.

In another embodiment of the present invention, the additional part material is selected from biodegradable plastics, such as polycaprolactone, polybutylene succinate, polylactic acid, polyhydroxyalkanoates, aliphatic aromatic copolyesters, polyvinyl alcohol, carbon dioxide copolymers, poly-beta-hydroxybutyrate, or mixtures thereof, or copolymers thereof.

In another embodiment of the present invention, the additional part may carry drugs, may carry various types of antibiotics, steroidal anti-inflammatory drugs, and non-steroidal anti-inflammatory drugs, and prevents post-operative inflammation, and microbial infection. Also can carry antimetabolites and mitosis inhibitors, drugs for inhibiting inflammatory reaction, immunotoxins and cytotoxins, drugs for inhibiting adhesion of cells and extracellular matrix, and drugs for inducing apoptosis to eliminate LEC or inhibit mitosis of epithelial cells, prevent and treat posterior capsule opacification, and slowly release drugs in the degradation process of degradable materials.

In another embodiment of the present invention, the attachment portion and the body may be attached by an adhesive selected from, but not limited to, alpha-cyanoacrylate based medical adhesives, such as n-butyl alpha-cyanoacrylate, n-octyl alpha-cyanoacrylate, isobutyl alpha-cyanoacrylate, and mixtures of two or three thereof.

In another embodiment of the present invention, the adhesive of the attachment portion to the intraocular lens body portion is selected from medical grade silicone adhesives. Such as MED-1131, MED-1137, MED-1511, MED-1540, MED-1555, MED-2000 and MED1-4213 of Nusil company and medical organic silicon adhesive with the same function.

In another embodiment of the present invention, the material for making the additional part of the present invention may be the same or different from the material for making the main part, and is selected from a host material comprising a polymerizable monomer or preferably any suitable host material with good biocompatibility. Wherein, the polymerizable monomer is selected from hydrophilic polymerizable monomers or hydrophobic polymerizable monomers, and can be homopolymers of monomers or copolymers of a plurality of monomers. And can be selected from high molecular biodegradable materials.

In another embodiment of the present invention, the material for preparing the main body portion may be, but is not limited to: the above ophthalmic medical material having a suitable water content and a suitable refractive index suitable for the production of a micro-incision intraocular lens, collagen, hydrogel, silicone hydrogel, fluorosilicone acrylate, silicone, polystyrene, methyl methacrylate, silicone, methyl siloxane, phenyl siloxane, vinyl siloxane, acrylate-based siloxane, methacrylate-based siloxane, or a mixture thereof.

In another embodiment of the present invention, the hydrogel is selected from, but not limited to: collagen, gelatin, keratin, elastin, vegetable protein, reticulin, quaternized protein, and the like, or polysaccharides, heparin, chondroitin sulfate, hyaluronic acid, gum arabic, agar, carrageenan, pectin, guar gum, alginate, and the like, or modified starch, modified cellulose, carboxymethyl starch, starch acetate, methyl cellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, and the like, or polyvinyl acetate, polymethyl vinyl ether, polyvinyl alcohol, polyethylene glycol, polyethylene oxide, Polyacrylamide (PAM), Hydrolyzed Polyacrylamide (HPAM)), polyvinylpyrrolidone (PVP), Polyethyleneimine (PEI), or a blend thereof.

In another embodiment of the present invention, the material used to prepare the additional moiety may also be selected from biodegradable materials including, but not limited to, polycaprolactone, polybutylene succinate, polylactic acid, polyhydroxyalkanoates, aliphatic aromatic copolyesters, polyvinyl alcohol, carbon dioxide copolymers, poly-beta-hydroxybutyrate, or mixtures or copolymers thereof.

In another embodiment of the invention, the additional portion comprises therapeutic agents, including hormonal and non-hormonal anti-inflammatory agents and broad spectrum antibacterial agents and any agent that eliminates lens epithelial cells or inhibits mitosis of epithelial cells, such as ofloxacin, ascorbic acid, aspirin, colchicine, lidocaine, nepafenac, ketorolac, bromfenac, recombinant hirudin, methotrexate, 5-fluorouracil, taxol, doxorubicin, daunorubicin, saporin, and other known or unknown drugs or compositions with similar function.

In another embodiment of the invention, the additional moiety is cyclic and comprises a photosensitizer.

In another embodiment of the invention, the intraocular lens body portions of the invention have at least two sharp edges.

In another embodiment of the invention, the support haptics are at an angle to the optic plane of the intraocular lens in the body portion of the intraocular lens; the near end of the back surface of the support loop is provided with a right-angle edge step type structure; the far end of the back surface of the support loop is provided with a right-angle edge stepped structure, wherein the thickness of the near end of the stepped structure of the back surface of the support loop is larger than that of the far end.

In another embodiment of the invention, the step height of the right angle edge stepped structure at the distal end of the back surface of the support tab is from 0.1 to 5mm, preferably from 0.1 to 1mm, more preferably from 0.2 to 0.5 mm, wherein the thickness at the proximal end of the back surface stepped structure of the support tab is greater than the thickness at the distal end.

In another embodiment of the invention, the step drop of the right angle edge stepped structure at the proximal end of the back surface of the support tab is 0.1-5 mm, preferably 0.3-3 mm, more preferably 0.5-2 mm, wherein the thickness at the proximal end of the back surface stepped structure of the support tab is greater than the thickness at the distal end.

In accordance with another preferred embodiment of the present invention the optic and the support haptics of the intraocular lens body portion are formed as a unitary body from the same material.

According to another preferred embodiment of the present invention, the anterior and/or posterior surfaces of the optic in the body portion of the intraocular lens comprise an optical device, such as, for example, a device selected from the group consisting of an aspheric device, a multifocal device, a toric device, a non-dispersive device, a variable focus device, an optical filtering device, or any of a variety of devices conventionally suitable in the art.

According to another preferred embodiment of the invention, the proximal end of the support tab has an open slot.

The present invention also relates to a method of making a medical device (e.g., an intraocular lens) comprising the steps of:

(A) (intraocular lens) body part preparation:

1) obtaining a body portion prepared from the material for preparing the body portion;

2) preparing an intraocular lens body portion comprising a groove;

(B) preparation of rings containing drugs, photosensitizers and/or fluorescers:

1) the above-mentioned material for preparing the additional part is prepared to obtain the additional part which contains medicine, photosensitizer and/or fluorescent agent,

(C) optionally, a binder is added.

In another embodiment of the present invention, the intraocular lens body may be subjected to an activation treatment for affinity between the intraocular lens body and the add-on portion, including but not limited to, plasma treatment, corona treatment, flame treatment, strong acid treatment, strong base treatment, and the like. Or the bottom painting is coated in the groove of the artificial lens main body, so that the adhesion force of the additional part and the artificial lens main body is increased.

In the process of the present invention, the crosslinking agent is used in an amount of 0.1 to 20% by weight, preferably 0.5 to 15%, in particular 1 to 5%, based on the polymerizable monomers. The UV absorbers are used in amounts of from 0 to 10% by weight, preferably from 0 to 5% by weight, in particular from 0 to 1% by weight, based on the polymerizable monomers. The initiators are used in amounts of from 0.01 to 10% by weight, preferably from 0.01 to 5%, in particular from 0.05% to 1%, based on the polymerizable monomers.

Other optional components useful in the present invention include cosolvents, emulsifiers, hydrophilic coatings, drug loading, color concentrates, crosslinkers, coupling agents, pH adjusters, antistatic agents, mold release agents, pigments, fillers, dispersants, curing agents, wetting agents, defoamers, uv absorbers, antioxidants, biocides, and stabilizers, among others.

The invention also relates to a method for treating ophthalmic diseases with laser-driven phototherapy, wherein the method can be carried out using only the medical device (intraocular lens) prepared according to the invention. Specifically, for example, only by using the intraocular lens with a photosensitizer (without adding a photosensitizer additionally) according to the present invention, the site to be treated is irradiated under a laser device, and since the medical device prepared according to the present invention has the photosensitizer, the photosensitizer is activated, and the lens epithelial cells in the lens capsule can be killed by generating active oxygen with cytotoxicity or generating high-temperature heat, so as to achieve the effect of preventing or treating the after-cataract.

Therefore, the material and the medical equipment prepared by the method completely get rid of exogenous photosensitizer (photosensitizer does not need to be taken in advance and the like), and the method does not need to add any additional reagent (including the photosensitizer), and has the advantages of non-invasiveness, no toxicity, high efficiency, repeatability and the like.

Drawings

FIG. 1 illustrates a plan view of an intraocular lens with an annular appendage, wherein (a) is the body; (b) an annular additional portion.

Figure 2 illustrates a cross-sectional view of an intraocular lens with an additional portion in the shape of a ring.

FIG. 3 illustrates the attachment of an add-on portion to the posterior surface of an intraocular lens body and a cross-sectional view thereof, wherein FIG. 3 (a) illustrates a circular ring on the posterior lens surface; fig. 3 (b) illustrates a cross-sectional view of the ring at the rear surface of the crystal.

FIG. 4 illustrates the attachment of an additional portion to the anterior surface of an intraocular lens and a cross-sectional view thereof, wherein FIG. 4 (a) illustrates a circular ring on the anterior surface of the lens; fig. 4 (b) illustrates a cross-sectional view of the ring at the front surface of the wafer.

FIG. 5 illustrates an inset manner of attachment to the posterior surface of the IOL body and a cross-sectional view thereof, wherein FIG. 5 (a) illustrates the ring inset manner secured to the posterior surface; fig. 5 (b) is a sectional view illustrating that the ring is fixed to the rear surface in an embedded manner.

Fig. 6 illustrates the additional portion being in the shape of a discontinuous circle.

Fig. 7 illustrates the additional portion in the shape of a discontinuous sector.

Detailed Description

1. An intraocular lens comprising

a) A body portion;

2. The intraocular lens according to the preceding item, wherein the body portion and the add-on portion of the intraocular lens are physically or chemically bonded.

3. Intraocular lens according to any one of the preceding claims, wherein the physical means is selected from the group consisting of casting, inlay, gluing, spraying, printing, evaporation.

4. Intraocular lens according to any one of the preceding claims, wherein the chemical means is selected from the group consisting of fractional copolymeric molding, graft modification.

5. The intraocular lens according to any one of the preceding claims, wherein the add-on portion is a ring-shaped add-on portion.

6. The intraocular lens according to any one of the preceding claims wherein the supplemental portion is located on a posterior surface of the intraocular lens body portion.

7. The intraocular lens according to any one of the preceding claims, wherein the intraocular lens body portion has one or more grooves, the add-on portion being embedded in the intraocular lens body portion grooves.

8. An intraocular lens according to any one of the preceding claims wherein the additional portion has an additional drug-loaded or active agent-bearing portion.

9. The intraocular lens according to any one of the preceding claims wherein the optic posterior surface of the body portion is a convex spherical surface and has a radius of curvature in the range of 6.6 mm to 80.0 mm.

10. The intraocular lens according to any one of the preceding claims wherein the radius of curvature of the optic posterior surface of the body portion is 17.8% to 60.0% of the radius of curvature of the optic anterior surface.

11. The intraocular lens according to any one of the preceding claims, wherein the intraocular lens is prepared from a material comprising a copolymer prepared by copolymerization of a polymerizable monomer comprising an acrylate, wherein the polymerizable monomer comprising an acrylate comprises a hydrophilic acrylate monomer and a hydrophobic acrylate monomer, wherein the molar ratio of the hydrophilic acrylate monomer to the hydrophobic acrylate monomer is 20:80-80:20, preferably 30:70-70:30, more preferably 40:60-60:40, said material having the following properties:

12. The intraocular lens according to any one of the preceding claims, wherein the hydrophilic acrylate monomer is selected from the group of acrylate monomers having a hydrophilic group according to the following formula:

wherein R is₁Is H or C_1-6Alkyl, preferably H or CH₃；

13. The intraocular lens according to any one of the preceding claims, wherein the hydrophobic acrylate monomer is selected from the group of acrylate monomers having a hydrophobic group, corresponding to the following formula:

wherein R is₁Is H or C_1-6Alkyl, preferably H or CH₃；

R₆is C_6-20Arylalkyl radical, or C_6-20A heteroarylalkyl group.

14. The intraocular lens according to any one of the preceding claims wherein the hydrophilic acrylate monomer is selected from the group consisting of: hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate, vinyl pyrrolidone, ethoxyethoxyethoxyethyl methacrylate, ethoxyethoxyethoxyethyl acrylate, ethoxyethyl methacrylate, methoxyethyl acrylate, 1, 3-butanediol dimethacrylate, ethylene glycol dimethacrylate, polyethylene glycol methacrylate, polyethylene glycol 200 dimethacrylate (e.g., AGEFLEX @. PEG200 DMA), polyethylene glycol acrylate, polyethylene glycol methyl ether methacrylate, polyethylene glycol methyl ether acrylate, glycidyl methacrylate, glycidyl acrylate, acrylic acid, methacrylic acid, 2- (trifluoromethyl) acrylic acid, phenylacrylic acid, acrylamide, methacrylamide, styrene-acrylic acid, styrene-methacrylic acid, styrene-acrylic acid, styrene-methacrylic acid, styrene-acrylic, N-methylolacrylamide, N-methylolmethacrylamide, or derivatives of the above, or mixtures of the above, preferably hydroxyethyl methacrylate.

15. An intraocular lens according to any one of the preceding claims wherein the hydrophobic acrylate monomer is selected from the group consisting of methyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, hexyl methacrylate, hexyl acrylate, isopropyl methacrylate, isopropyl acrylate, isobutyl methacrylate, isobutyl acrylate, tert-butyl methacrylate, tert-butyl acrylate, isooctyl methacrylate, isooctyl acrylate, isodecyl methacrylate, lauryl acrylate, stearyl methacrylate, stearyl acrylate, 9-anthracenemethyl methacrylate, 9-anthracenemethyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, dimethylaminoethyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, butyl methacrylate, hexyl methacrylate, isopropyl methacrylate, isobutyl methacrylate, and an alkyl acrylate, N, N-dimethyl methacrylamide, N-dimethyl acrylamide, N-diethylaminoethyl acrylate, N-diethylaminoethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, hexafluorobutyl acrylate, 2-perfluorodecyl ethyl methacrylate, 2- (perfluorooctyl) ethyl acrylate, pyruvyl methacrylate, pyruvyl acrylate, N-diethylaminoethyl methacrylate, N-diethylamino-ethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, 2-perfluorodecyl ethyl acrylate, 2-perfluorodecyl methacrylate, 2- (perfluorooctyl) ethyl methacrylate, pyruvyl acrylate, acetonyl acrylate, N-N, N-diethylaminoethyl acrylate, N-t-butylacrylamide, N-isopropylacrylamide, N-tetrahydrofurfuryl methacrylate, hexafluoroacrylate, N-butyl acrylate, N-butyl methacrylate, N-tetrahydrofurfuryl methacrylate, N-butyl methacrylate, hexafluorobutyl methacrylate, N-butyl methacrylate, N-hexafluorobutyl methacrylate, N-butyl acrylate, N-hexafluorobutyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, and N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-2-perfluorodecyl methacrylate, and N-butyl methacrylate, N-butyl acrylate, N-butyl, Tetrahydrofurfuryl acrylate, tetrahydrofurfuryl methacrylate, phenyl acrylate, phenylethyl methacrylate, phenylethyl acrylate, phenoxyethyl methacrylate, phenoxyethyl acrylate, benzyl methacrylate, benzyl acrylate, acetoacetoxyethyl methacrylate, acetoacetoxyethyl acrylate, diacetone acrylamide, diacetone methacrylamide, allyl methacrylate, phenoxyethyl acrylate, or derivatives of the foregoing, or mixtures thereof, preferably ethyl acrylate, phenoxyethyl acrylate.

16. Intraocular lens according to any one of the preceding claims, which has a glass transition temperature (dry state, as determined by DSC testing) in the range of 10-35 ℃, preferably 15-30 ℃, more preferably 20-25 ℃.

17. Intraocular lens according to any one of the preceding claims, which has an elongation at break (wet) >180% and a strength at break (wet) >2.5 MPa.

18. The intraocular lens according to any one of the preceding claims, wherein the supplemental portion further comprises at least one drug, a fluorescent agent and/or at least one photosensitizer;

19. The intraocular lens according to any one of the preceding claims, wherein the appendage is ring-shaped and comprises a photosensitizer.

The invention also relates to the following technical scheme:

1. the artificial lens processing method comprises the following steps of but is not limited to: cutting, compression molding, injection molding, centrifugal casting, 3D printing, and the like.

3. Methods of sterilizing the intraocular lens include, but are not limited to: moist heat sterilization, irradiation sterilization, ethylene oxide sterilization, and the like.

4. The host polymeric material of the ophthalmic medical device according to item 1 may be a hydrogel.

5. The hydrogel material according to item 4, including but not limited to: collagen, gelatin, keratin, elastin, vegetable protein, reticulin, quaternized protein, and the like, or polysaccharides, heparin, chondroitin sulfate, hyaluronic acid, gum arabic, agar, carrageenan, pectin, guar gum, alginate, and the like, or modified starch, modified cellulose, carboxymethyl starch, starch acetate, methyl cellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, and the like, or polyvinyl acetate, polymethyl vinyl ether, polyvinyl alcohol, polyethylene glycol, polyethylene oxide, Polyacrylamide (PAM), Hydrolyzed Polyacrylamide (HPAM), polyvinylpyrrolidone (PVP), Polyethyleneimine (PEI), and the like.

6. The drug, photosensitizer and/or fluorescent agent annular additional part area is distributed at the periphery of the crystal optical area, and the cross section shape of the additional part is not limited and can be square, rectangle, trapezoid or other irregular shapes.

7. The concentration (or mass fraction) of the medicine, the photosensitizer and/or the fluorescent agent in the additional part material can be reasonably controlled, and active oxygen or high-temperature heat generated under the irradiation of laser with selected wavelength can effectively kill cells at a pathological change part, so that normal cells are kept from being lost; meanwhile, the influence of the photosensitizer on the use performance of the original material needs to be reduced to the minimum degree.

8. The ophthalmic medical device according to item 1, which is irradiated with the laser light of the selected wavelength one or more times, and each irradiation of the photosensitizer is activated to generate active oxygen or high-temperature heat, thereby providing the medical device with a repeatable laser treatment.

EXAMPLE 1 host Material Synthesis

Examples 1-6 illustrate the monomer composition for the synthesis of the host material, and all of the examples in Table 1 were prepared in the following manner, and all monomers were purified by distillation under reduced pressure. Respectively mixing the monomers in a beaker according to the corresponding proportion, optionally adding additives such as an initiator, a light absorber and the like, fully and uniformly stirring, filtering, and transferring into a special mold. The various utensils and molds used in the above-described implementation process are cleaned, dried and sterilized before use.

Introducing nitrogen into the monomer solution in the mold, sealing the mold under the protection of the nitrogen, putting the mold into a water bath with a set temperature for polymerization reaction for at least 24 hours, and transferring the mold into an oven with the set temperature for continuously keeping the temperature for 24 hours (note: the set temperature of the oven is higher than the set temperature of the water bath). And taking out the polymer formed in the mold, naturally cooling to room temperature, or cutting the polymer into blanks with required size and shape while the polymer is hot, extracting for at least 24 hours at a certain temperature by using an alcohol solvent to remove residual micromolecules, and finally drying the blanks at a set temperature in a vacuum drying oven overnight to obtain the material of the main body part of the invention.

Examples	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: 2-Phenoxyethyl acrylate

ST styrene

KH 570: 3- (methacryloyloxy) propyltrimethoxysilane

AIBN azobisisobutyronitrile

EGDMA ethylene glycol dimethacrylate.

EXAMPLES additional part Synthesis mode monomer formulation

Examples 8-13 illustrate the formulation of the materials for the annular attachment portion. The additional portion may be formed in a manner selected from the group consisting of cutting, casting, spraying, molding, and the like.

Examples	8	9	10	11	12	13
							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
Purpurin-18	0.01		0.01			0.01
							IR780		0.02			0.02
IR783				0.01

Example 14: adhesion mode for preparing artificial lens of peripheral additional part

A) The material prepared in example 1 was used to process the peripheral additional part of the main body of the intraocular lens by cutting the prepared polymer material into blanks having a thickness of about 3 mm and a diameter of about 16 mm. And (2) processing and molding the artificial lens on a single point diamond lathe (OPTOFORM), wherein the molded artificial lens has a main body diameter of 6mm, the main body is provided with an additional part-shaped groove, the inner edge is 2.2mm away from the center of the artificial lens, the width is 0.2mm, the depth is 0.1mm, and the molded artificial lens is polished by a polishing medium.

B) The additional part material was prepared by molding the body material in a glass plate according to the formulation of example 8, and then machined into an additional part having a width of 0.2mm and a thickness of 0.1mm by cutting.

C) Treating the main body part with the groove prepared in the step A) for 1 minute by using a vacuum plasma machine under the oxygen atmosphere and the power of 100w, then coating an organic silicon adhesive MED-2000 in the groove, embedding the additional part prepared in the step B) into the groove of the main body part, and putting the main body part in an oven at 60 ℃ for 3 hours to fully dry the adhesive to obtain the artificial lens with the additional part on the periphery.

Example 15: spray coating method for preparing artificial lens with peripheral additional part

A) The material prepared in example 1 was used to process the peripheral additional part of the main body of the intraocular lens by cutting the prepared polymer material into blanks having a thickness of about 3 mm and a diameter of about 16 mm. The intraocular lens is processed and molded by a single point diamond lathe (OPTOFORM), the molded intraocular lens has a main body diameter of 6.5mm, the main body is provided with an additional part-shaped groove, the distance from the inner edge to the center of the intraocular lens is 2.1mm, the width of the groove is 0.8mm, the depth of the groove is 0.1mm, and the molded intraocular lens is polished by a polishing medium.

B) Treating the main body part with the groove prepared in the step A) for 1 minute under the oxygen atmosphere and the power of 100w by using a vacuum plasma machine, so as to improve the surface adhesion performance

C) An additional part of the formulation of formulation example 10 was prepolymerized and the prepolymer was charged into a spray gun. The intraocular lens body portion is masked except for the recessed portion. Controlling the spraying amount, spraying the prepolymer, and curing in an oven at 90 ℃ overnight to obtain the peripheral additional part of the intraocular lens.

Example 16: casting for making peripheral add-on intraocular lenses

A) The material prepared in example 1 was used to process the peripheral additional part of the main body of the intraocular lens by cutting the prepared polymer material into blanks having a thickness of about 3 mm and a diameter of about 16 mm. And (2) processing the molded intraocular lens on a single point diamond lathe (OPTOFORM), wherein the molded intraocular lens has a main body diameter of 6mm, the main body is provided with an additional part-shaped groove, the distance from the inner edge to the center of the intraocular lens is 2.1mm, the width of the groove is 0.2mm, the depth of the groove is 1mm, and the molded intraocular lens is polished by a polishing medium.

B) The formulation of example 10 was prepolymerized under azodiisobutyronitrile initiation and polymerized in a three-neck flask at 88 ℃ for 1 hour, and stirring was stopped when the system became viscous.

C) And B), injecting the prepolymer obtained in the step B) into the groove of the main body part of the intraocular lens in the step A) through an injector to fill the groove, horizontally placing the groove in a vacuum oven at 90 ℃ for curing overnight, and obtaining the intraocular lens with the additional part on the periphery.

Example 17: preparation of additional part drug-loaded intraocular lens

A) The material prepared in example 1 was used to process the peripheral additional part of the main body of the intraocular lens by cutting the prepared polymer material into blanks having a thickness of about 3 mm and a diameter of about 16 mm. The intraocular lens is machined and molded on a single point diamond lathe (OPTOFORM), the molded intraocular lens has a main body diameter of 6.5mm, the main body is provided with an additional part-shaped groove, the distance from the inner edge to the center of the intraocular lens is 2.5mm, the width of the groove is 0.2mm, the depth of the groove is 0.02mm, and the molded intraocular lens is polished by a polishing medium.

B) Dissolving ofloxacin into trichloromethane, adding into trichloromethane solution of polylactic acid, and concentrating the mixed solution.

C) After concentration, injecting the concentrated solution into the groove of the main body part of the artificial lens prepared in the step A) through a micro-injector, placing the artificial lens in a vacuum oven at 45 ℃, and drying the organic solvent to obtain the artificial lens with the medicine loaded on the peripheral additional part.

Claims

1. An intraocular lens comprising

a) The body part is provided with a plurality of grooves,

b) one or more appendages on and attached to the intraocular lens body portion, the appendages having a width of 0.05 to 3.5mm and the appendages having a thickness of 0.01 to 2mm,

wherein the distance from the inner edge of the additional part to the center of the artificial lens is more than 2mm,

wherein the additional moiety has a photosensitizer and/or a fluorescent agent immobilized thereon, the fluorescent agent and/or the photosensitizer being bound to the copolymer from which the additional moiety is made in a manner selected from the group consisting of:

-a fluorescent agent and/or a photosensitizer participate in the polymerization during the formation of said copolymer; and/or

-fluorescent and/or photosensitive agents are fixed on the surface of the copolymer in a surface grafting and surface modification manner.

2. The intraocular lens of claim 1, wherein the body portion and the appendage portion of the intraocular lens are physically or chemically bonded.

3. The intraocular lens according to claim 2 wherein the physical means is selected from the group consisting of casting, embedding, bonding, spraying, printing, and evaporation.

4. The intraocular lens according to claim 2 wherein the chemical means is selected from the group consisting of fractional copolymerization molding, graft modification.

5. The intraocular lens according to claim 1 or 2, wherein the appendage is a ring-shaped appendage.

6. The intraocular lens according to claim 1 or 2 wherein the supplemental portion is located on a posterior surface of the intraocular lens body portion.

7. The intraocular lens according to claim 1 or 2 wherein the intraocular lens body portion has one or more grooves and the supplemental portion is embedded in the intraocular lens body portion grooves.

8. The intraocular lens according to claim 1 or 2 wherein the additional portion has an additional drug-loaded or additive-loaded portion.

9. The intraocular lens according to claim 1 or 2 wherein the optic posterior surface of the body portion is a convex spherical surface and has a radius of curvature in the range of 6.6 mm to 80.0 mm.

10. The intraocular lens according to claim 1 or 2 wherein the radius of curvature of the optic posterior surface of the body portion is 17.8% to 60.0% of the radius of curvature of the optic anterior surface.

11. The intraocular lens according to claim 1 or 2, wherein the intraocular lens is prepared from a material comprising a copolymer prepared by copolymerization of a polymerizable monomer comprising an acrylate, wherein the polymerizable monomer comprising an acrylate comprises a hydrophilic acrylate monomer and a hydrophobic acrylate monomer, wherein the molar ratio of the hydrophilic acrylate monomer to the hydrophobic acrylate monomer is from 20:80 to 80:20, the material having the following properties:

a. the water content is 5-15wt% at 35 ℃;

b. the wet state refractive index at 35 ℃ is 1.49-1.54.

12. The intraocular lens according to claim 11 wherein the hydrophilic acrylate monomer is selected from the group consisting of acrylate monomers having a hydrophilic group according to the formula:

wherein R is₁Is H or C_1-6An alkyl group;

x is O, S or NR₄Wherein R is₄Is H, straight-chain or branched, saturated or unsaturated C_1-20Alkyl or C_6-20Arylalkyl radical, or C_6-20Heteroarylalkyl, or C_3-20A heterocyclylalkyl group;

13. The intraocular lens according to claim 11 wherein the hydrophobic acrylate monomer is selected from the group consisting of acrylate monomers having a hydrophobic group according to the formula:

wherein R is₁Is H or C_1-6An alkyl group;

R₅is straight-chain or branched, saturated or unsaturated C_1-20Alkyl or C_6-20Arylalkyl radical, or C_6-20Heteroaryl alkyl radicalOr C_6-20Heterocyclylalkyl radical or C_3-20A cycloalkyl group;

y is H, or Z-R₆Wherein Z, present or absent, is selected from a heteroatom,

R₆is C_6-20Arylalkyl radical, or C_6-20A heteroarylalkyl group.

14. The intraocular lens according to claim 11 wherein the hydrophilic acrylate monomer is selected from the group consisting of: hydroxyethyl methacrylate, hydroxyethyl acrylate, hydroxypropyl methacrylate, hydroxypropyl acrylate, vinyl pyrrolidone, ethoxyethoxyethyl methacrylate, ethoxyethoxyethoxyethyl acrylate, ethoxyethyl methacrylate, methoxyethyl acrylate, 1, 3-butanediol dimethacrylate, ethylene glycol dimethacrylate, polyethylene glycol methacrylate, polyethylene glycol 200 dimethacrylate, polyethylene glycol acrylate, polyethylene glycol methyl ether methacrylate, polyethylene glycol methyl ether acrylate, glycidyl methacrylate, glycidyl acrylate, acrylic acid, methacrylic acid, 2- (trifluoromethyl) acrylic acid, phenylacrylic acid, acrylamide, methacrylamide, N-methylolacrylamide, N-methylol-acrylamide, N-methylol-2-propenoic acid, N-methylol-2-methylol-propenoic acid, N-methylol-2-propenoic acid, N-2-methylol-propene, N-propenoic acid, N-methylol-propenoic acid, N-2-methylol-propenoic acid, N-methylol-propenoic acid, N-2-olmethyl-propenoic acid, N-2-one, and N-one, N-methylolmethacrylamide, or mixtures of the above.

15. The intraocular lens according to claim 11 wherein the hydrophobic acrylate monomer is selected from the group consisting of methyl methacrylate, ethyl acrylate, butyl methacrylate, butyl acrylate, hexyl methacrylate, hexyl acrylate, isopropyl methacrylate, isopropyl acrylate, isobutyl methacrylate, isobutyl acrylate, tert-butyl methacrylate, tert-butyl acrylate, isooctyl methacrylate, isooctyl acrylate, isodecyl methacrylate, lauryl acrylate, stearyl methacrylate, stearyl acrylate, 9-anthracenemethyl methacrylate, 9-anthracenemethyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, dimethylaminoethyl methacrylate, ethyl acrylate, butyl acrylate, hexyl methacrylate, isopropyl methacrylate, isobutyl, N, N-dimethyl methacrylamide, N-dimethyl acrylamide, N-diethylaminoethyl acrylate, N-diethylaminoethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, hexafluorobutyl acrylate, 2-perfluorodecyl ethyl methacrylate, 2- (perfluorooctyl) ethyl acrylate, pyruvyl methacrylate, pyruvyl acrylate, N-diethylaminoethyl methacrylate, N-diethylamino-ethyl methacrylate, N-tert-butylacrylamide, N-tert-butylmethacrylamide, N-isopropylacrylamide, N-isopropylmethacrylamide, tetrahydrofurfuryl methacrylate, tetrahydrofurfuryl acrylate, trifluoroethyl methacrylate, trifluoroethyl acrylate, hexafluorobutyl methacrylate, 2-perfluorodecyl ethyl acrylate, 2-perfluorodecyl methacrylate, 2- (perfluorooctyl) ethyl methacrylate, pyruvyl acrylate, acetonyl acrylate, N-N, N-diethylaminoethyl acrylate, N-t-butylacrylamide, N-isopropylacrylamide, N-tetrahydrofurfuryl methacrylate, hexafluoroacrylate, N-butyl acrylate, N-butyl methacrylate, N-tetrahydrofurfuryl methacrylate, N-butyl methacrylate, hexafluorobutyl methacrylate, N-butyl methacrylate, N-hexafluorobutyl methacrylate, N-butyl acrylate, N-hexafluorobutyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, and N-butyl acrylate, N-butyl methacrylate, N-butyl acrylate, N-2-perfluorodecyl methacrylate, and N-butyl methacrylate, N-butyl acrylate, N-butyl, Tetrahydrofuran acrylate, tetrahydrofuran methacrylate, phenyl acrylate, phenylethyl methacrylate, phenylethyl acrylate, phenoxyethyl methacrylate, phenoxyethyl acrylate, benzyl methacrylate, benzyl acrylate, acetoacetoxyethylmethacrylate, acetoacetoxyethylacrylate, diacetoneacrylamide, diacetone methacrylamide, allyl methacrylate, phenoxyethyl acrylate, or mixtures thereof.

16. Intraocular lens according to claim 1 or 2, which has a dry glass transition temperature of 10-35 ℃ as determined by DSC testing.

17. Intraocular lens according to claim 1 or 2, which has an elongation at break in wet state of >180% and a strength at break in wet state of >2.5 MPa.

18. The intraocular lens according to claim 1 or 2, wherein the appendage is ring-shaped and comprises a photosensitizer.

19. The intraocular lens according to claim 1 or 2, wherein the additional portion has sharp cathetuses.

20. The intraocular lens according to claim 1 wherein the appendage width is 0.1 to 1.5 mm.

21. The intraocular lens according to claim 1 wherein the appendage width is 0.2 to 0.8 mm.

22. The intraocular lens according to claim 1 wherein the additional portion is 0.01 to 1mm thick.

23. The intraocular lens according to claim 1 wherein the additional portion is 0.01 to 0.7mm thick.

24. The intraocular lens according to claim 11, wherein the molar ratio of the hydrophilic acrylate monomer to the hydrophobic acrylate monomer is from 30:70 to 70: 30.

25. The intraocular lens according to claim 11, wherein the molar ratio of the hydrophilic acrylate monomer to the hydrophobic acrylate monomer is from 40:60 to 60: 40.

26. The intraocular lens according to claim 11 wherein the water content at 35 ℃ is 6-13 wt%.

27. The intraocular lens according to claim 11 wherein the water content at 35 ℃ is 7-12 wt%.

28. The intraocular lens according to claim 11 wherein the refractive index in the wet state at 35 ℃ is from 1.49 to 1.53.

29. The intraocular lens according to claim 11, wherein the refractive index in the wet state at 35 ℃ is from 1.50 to 1.52.

30. The intraocular lens according to claim 12, wherein R₁Is H or CH₃。

31. The intraocular lens of claim 13, whereinR₁Is H or CH₃。

32. The intraocular lens according to claim 13 wherein Z is selected from O or S.

33. The intraocular lens according to claim 14 wherein the hydrophilic acrylate monomer is selected from the group consisting of: hydroxyethyl methacrylate.

34. The intraocular lens according to claim 15 wherein the hydrophobic acrylate monomer is selected from the group consisting of ethyl acrylate, phenoxyethyl acrylate.

35. The intraocular lens according to claim 16, having a dry glass transition temperature of 15 to 30 ℃ as measured by DSC.

36. The intraocular lens according to claim 16, having a dry glass transition temperature of 20 to 25 ℃ as measured by DSC.

37. A medical device comprising the intraocular lens of any one of the preceding claims.

38. Use of a material for the preparation of an intraocular lens according to any one of the preceding claims 1 to 36 for the preparation of a medical treatment device for the treatment of ophthalmic diseases.

39. A method of manufacturing an intraocular lens according to any one of the preceding claims 1 to 36, comprising the steps of providing a) a body portion as defined in any one of the preceding claims 1 to 36 and providing b) one or more additional portions as defined in any one of the preceding claims 1 to 36.