Intraocular lens of dynamically changeable Jiao and preparation method thereof
Technical field
The present invention relates to a kind of hydrophobic polyacrylate intraocular lens and preparation method thereof, particularly relate to hydrophobic polyacrylate intraocular lens of a kind of dynamically changeable Jiao and preparation method thereof.
Background technology
Natural lens in human eye is water white transparency and very soft crystalline lens when the baby of just birth, along with the increase at age, the change of external condition, under impact as key elements such as ultraviolet radiation, this natural lens will become more and more harder and become coloured crystalline lens, when people live more than 50 to threescores, there is people's intra-ocular lens of about 30 percent will become brown color and muddiness, to such an extent as to cannot see completely, when this happens, this natural lens (i.e. cataractous lens) goes have to displacement with an artificial crystalline lens, thus recover the eye eyesight of cataract patient.
A typical intraocular lens is made up of optical crystal and support arm, wherein lens optics focused ray to optic nerve makes it to see object and the effect of arm is to support its Optical Region, make Optical Region be positioned at the center of ophthalmic, thus can effectively focus on.
Optical Region and the support arm of intraocular lens can be made up of commaterial, also can be made from a variety of materials, the intraocular lens be made up of commaterial, namely the single-piece crystalline lens that it has often been said, namely the intraocular lens be made up of different materials is the three-member type crystalline lens that it has often been said, embodiment is at United States Patent (USP) 4,997,442 and United States Patent (USP) 5,217, have corresponding report in 491, above-mentioned patent is all make Optical Region by softer optical material and arm regions made by harder material.
Conventional monofocal intraocular lens can provide the vision correcting of a conventional distance, but can not provide an effective varifocal vision correcting.That is, it can not provide one see far away and see the effect that closely can provide its vision correcting.Unique monofocal intraocular lens can be made to reach see far to see closely can make to work, a pair of glasses must be brought again or select multi-focused intraocular lens to replace cataractous lens.But each distance can only have some light to be focused on optic nerve, and also there is other side effect.Therefore, people start to design novel varifocal intraocular lens, as United States Patent (USP) 4,409,691, and United States Patent (USP) 5,674,282,5,496,366,6,197,059 and 6,387,126, United States Patent (USP) 6,178,878 and United States Patent (USP) 6,406,494.
The varifocal intraocular lens of above-mentioned design, be all softer by material, the silica gel material that refractive index is lower is made.Because the refractive index of silica gel material is lower, the crystalline lens made is thicker, its crystalline lens within the eye in pouch the distance of movement limited, make it varifocal optical strength change limited.Simultaneously silica gel material forms fiber and the cataractous probability of secondary be also height relative to hydrophobic polyacrylate.Therefore, the varifocal crystalline lens be made up of silica gel after in implantation human eye, only has groups of people can have varifocal function, and this part people occupies and transplants percentage ratio in total number of persons also along with the growth of Implantation Time has the trend reduced gradually.Therefore, intraocular lens of new dynamically changeable Jiao and preparation method thereof is provided to provide.
Summary of the invention
Technical problem to be solved by this invention is to provide intraocular lens of a kind of hydrophobic polyacrylate dynamically changeable Jiao and preparation method thereof, have that matter is soft, refractive index is high, the feature of crystal book, such crystalline lens will implant the ophthalmic of people by a very little side mouth, such crystalline lens can provide larger movable distance at human body ophthalmic simultaneously, thus larger optical strength change is provided, realize better dynamically changeable burnt.
The present invention solves the problems of the technologies described above the intraocular lens that the technical scheme adopted is to provide a kind of dynamically changeable Jiao, comprises central transparent light guide district and supports hands arm; Wherein, flexible concertina district is provided with between described central transparent light guide district and support arm.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, described central transparent light guide district is made up of hydrophobic polyacrylate material, described support arm and flexible concertina district are made up of silica gel material or hydrophobic polyacrylate material or hydrophilic polyacrylic ester hydrated gums material, and described support arm is identical with the thickness in flexible concertina district.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, in described hydrophobic polyacrylate material containing polymerisable medium-sized can interlinkage molecule or can interlinkage group.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, described can interlinkage group be (CH2CH) (CH
3)
2si-O-group, (CH
3)
2hsi-O-group, methacryl group, acryloyl group or ethenylphenyl group; Described polymerisable interlinkage molecule is ethylene glycol dimethacrylate diester, dimethacrylate propylene glycol diesters, dimethacrylate butanediol diester, dimethacrylate hexanediol diester, diacrylate ethylene glycol diester, diacrylate propylene glycol diesters, diacrylate butanediol diester, diacrylate hexanediol diester, 1,4-divinylbenzene or 1,3-divinylbenzene.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, described hydrophobic polyacrylate material is formed by alkyl acrylate and the copolymerization of alkyl methacrylate derivant, or is formed by alkyl acrylate, alkyl methacrylate and styrene or cinnamic derivant copolymerization.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, containing UV absorbent in described hydrophobic polyacrylate material, containing benzophenone or benzotriazole group in described UV absorbent; Described central transparent light guide district and support arm contain blue-light absorbers.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, containing hydrophilic monomer in described hydrophilic polyacrylic ester hydrated gums material, described hydrophilic monomer is methacrylic acid 2-hydroxyethyl ester, acrylic acid 2-hydroxyethyl ester, methacrylic acid 3-hydroxy-propyl ester, acrylic acid 3-hydroxy-propyl ester, methacrylic acid 4-hydroxybutyl ester, acrylic acid 4-hydroxybutyl ester, acrylic acid N, N-dimethylformamide, methacrylate N, N-dimethylformamide, acrylic acid N, N-diethylamide buserelin or methacrylic acid N, N-diethylamide.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, the surface in described central transparent light guide district is sphere, aspheric surface or Tuo Neike optical surface, and the rear and front end in described flexible concertina district is provided with restriction protrusion, and the height of described restriction protrusion is 0.5 millimeter ~ 1.0 millimeters.
The intraocular lens of above-mentioned dynamically changeable Jiao, wherein, described hydrophobic polyacrylate index of refraction 22 DEG C time is 1.48 ~ 1.56, and Shore hardness is 45 ~ 85, and glassy state temperature is less than 18 DEG C.
The present invention also provides the process for manufacturing intraocular lenses of a kind of dynamically changeable Jiao for solving the problems of the technologies described above, comprise the steps: a) to prepare hydrophobic polyacrylate artificial intraocular lenses coarse-grain sheet; B) by the circular disk like crystalline lens that the hydrophobic polyacrylate coarse-grain sheet prepared cutting is prepared into containing Optical Region, after clean by polishing, hydrophobic polyacrylate monocrystal is cut into above; C) polymerisable silica gel or hydrophobic polyacrylate material is put in arm regions part, by adding thermosetting transparent light guide district of central authorities and supporting hands arm; D) in above-mentioned crystal, introduce illumination polymerisable little, medium-sized molecule, then by the method for illumination, hardened in central transparent light guide district and the coupling part supported between arm, make it further Cross-linked and form harder flexible concertina district; E) micromolecule adopting alcohols solvent removing not to be polymerized or medium-sized molecule, obtain described hydrophobic polyacrylate artificial intraocular lenses coarse-grain sheet after drying.
The present invention contrasts prior art following beneficial effect: the intraocular lens of dynamically changeable Jiao provided by the invention is first intraocular lens be prepared from by hydrophobic polyacrylate material, the crystalline lens comparatively book that its refractive index is high, make, side mouth used during implant into body is less, also relatively large in the movable distance of human body ophthalmic, thus larger optical strength change is provided, realize better dynamically zoom.Meanwhile, the plasticity of hydrophobic polyacrylate material is better, and the recovery time in human eye is 5 seconds to 30 seconds.Because recovery time is longer, recovery power is little, can not destroy pouch.
Accompanying drawing explanation
Fig. 1 is intraocular lens's structural representation of a kind of dynamically changeable Jiao of the present invention, and wherein, Figure 1A is Facad structure schematic diagram, and Figure 1B is side structure schematic diagram;
Fig. 2 is intraocular lens's structural representation of the second dynamically changeable Jiao of the present invention, and wherein, Fig. 2 A is Facad structure schematic diagram, and Fig. 2 B is side structure schematic diagram;
Fig. 3 is intraocular lens's structural representation of the third dynamically changeable Jiao of the present invention, and wherein, Fig. 3 A is Facad structure schematic diagram, and Fig. 3 B is side structure schematic diagram;
Fig. 4 is intraocular lens's structural representation of the 4th kind of dynamically changeable Jiao of the present invention, and wherein, Fig. 4 A is Facad structure schematic diagram, and Fig. 4 B is side structure schematic diagram;
Fig. 5 is intraocular lens's structural representation of the 5th kind of dynamically changeable Jiao of the present invention, and wherein, Fig. 5 A is Facad structure schematic diagram, and Fig. 5 B is side structure schematic diagram.
In figure:
1 flexible concertina district of central transparent light guide district 23 supports arm
4 hole 5 projections
Detailed description of the invention
Below in conjunction with drawings and Examples, the invention will be further described.
Fig. 1 is intraocular lens's structural representation of a kind of dynamically changeable Jiao of the present invention.
Refer to Fig. 1, the intraocular lens of dynamically changeable Jiao provided by the invention comprises central transparent light guide district 1 and supports arm 3; Wherein, flexible concertina district 2 is provided with between central transparent light guide district 1 and support arm 3.The rear and front end in flexible concertina district 2 can be provided with restriction protrusion 5.
The intraocular lens of dynamically changeable Jiao provided by the invention places in ophthalmic pouch in migration process, under the supporting role supporting arm 3, transparent light guide district 1 of central authorities is positioned at the center of ophthalmic, when muscle compression with when relaxing, lenticular central transparent light guide district 1 is made to move forward and backward to reach the regulating action of its optical strength, support the design of arm 3 and shape also may with patent 5,6742,82 is similar even identical.Support on arm 3 and can be provided with hole 4, the height of restriction protrusion 5 is preferably 0.5 millimeter ~ 1.0 millimeters, and central transparent light guide district 1 outer surface is sphere, aspheric surface or Tuo Neike (Torric) optical surface.Concrete shape and size can regulate according to human eye size shape, and central transparent light guide district 1 as in Figure 1 and Figure 2 outer surface is aspheric surface, and central transparent light guide district 1 outer surface in Fig. 3 and Fig. 4 is sphere.The rear and front end in flexible concertina district 2 can not have restriction protrusion 5 yet, as shown in Figure 5.
Transparent light guide district 1 of central authorities is made up of the hydrophobic polyacrylate material of high index of refraction, and the scope of its refractive index is 1.450-1.560, and the ranges of indices of refraction selected or rather should at 1.500-1.550.Supporting arm 3 and be preferably hydrophobic polyacrylate, also can be strengthen rigid silica gel material and hydrophilic polyacrylate hydrated gums material.2, flexible concertina district is soft silicon glue material, the polyacrylate material of soft hydrophobic polyacrylate material and flexible hydrophilic.Due to soft silicon glue material, its good springiness, the response time is corresponding short; Hydrophilic polyacrylate hydrated gums material is also good springiness, and the response time is short, but water content is higher, and the water in crystalline lens is easy to exchange with the aqueous solution in tissue.
Implanting varifocal intraocular lens when ophthalmic, when its Optical Region moves forward and backward, can be forward movable, also can be backward movable.The rear and front end in flexible concertina district 2 is provided with restriction protrusion 5, to stop its lenticular further reach, and flees from a pouch.
The optical material that this crystalline lens is selected simultaneously is the hydrophobic polyacrylate of high index of refraction, and it is 1.500 to 1.550 that this material has refractive index.Therefore, the lenticular thinner thickness be prepared from by this material, moving area when luminescent crystal moves forward and backward is much bigger for the crystalline lens material of other low-refraction.Its varifocal intensity can reach 2.00 to 4.00.This lenticular design is simultaneously compared to the hydrophobic polyacrylate crystalline lens of other routine difference large less than what.Therefore, this crystalline lens can implant the ophthalmic of its human body easily from an extra small side mouth, and meanwhile, in this lenticular production technology, what difference more conventional sphere and aspheric surface do not have, thus easily commercialization.
The process for manufacturing intraocular lenses of dynamically changeable Jiao provided by the invention is as follows:
Step is a): the preparation of hydrophobic polyacrylate coarse-grain sheet
In the wolf bottle of 3 liters, put into previously prepared good hydrophobic acrylic acid's ester small molecule monomer mixed liquor, pass into nitrogen to remove the air dissolved in solution, after about 60 minutes, under nitrogen pressure, transferred in previously prepared good mould by this small molecule monomer mixed solution, at high temperature make and be about 10.5 inches long and 9.5 inches wide, thickness is about the flaky material of 3 millimeter.Then by lamellar coarse crystal material, cut into the circular coarse-grain sheet of various diameter; Until all flat crystal materials are cut into circular coarse crystal.
The circular coarse crystal of well cutting is put into extraction equipment, extracts with alcohols solvent, to remove the micromolecule and medium-sized little polymerizable molecular that do not have to be polymerized.Then at high temperature carry out drying to remove small molecule solvent.
Step b): the preparation of the thick artificial intraocular lenses of single-piece hydrophobic polyacrylate
With DAC or Optoform cutting machine, by the circular disk like wafer that the hydrophobic polyacrylate coarse-grain sheet prepared above cutting is prepared into containing Optical Region.Then the circular disk like wafer of well cutting is carried out polishing to remove tool marks, then this crystal is placed on milling machine and carries out excision forming hydrophobic polyacrylate monocrystal.
Step c): the preparation of the burnt hydrophobic polyacrylate artificial intraocular lenses of dynamically changeable
By hydrophobic polyacrylate monocrystal outside Optical Region 5.5mm-6.5mm place by Optical Region and arm support district cutter all or part of separately, the single-piece crystal separated is put into the mould of the burnt crystal of dynamically changeable, the free radical of the amount of putting into or the polymerisable silica gel material of illumination or supersoft polyacrylate material (hydrophobic or hydrophilic material) are at high temperature or make the intraocular lens of dynamically changeable Jiao under illumination condition.
Steps d): last removing by alcohols solvent at 50 DEG C does not have the micromolecule of complete interlinkage or medium-sized molecule, obtains nontoxic, the intraocular lens of biophasic dynamically changeable Jiao after drying.
Although the present invention discloses as above with preferred embodiment; so itself and be not used to limit the present invention, any those skilled in the art, without departing from the spirit and scope of the present invention; when doing a little amendment and perfect, therefore protection scope of the present invention is when being as the criterion of defining with claims.