JP2000086498A - Capsule direct injection - Google Patents

Abstract

(57) [Problem] To provide a direct injection of a capsular sac which can be easily injected with an incision as small as possible, has excellent refractive index adjusting ability, and is safe for a living body. To provide. A direct injection of a capsular bag containing a hydrophilic polymer.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION The present invention relates to a direct injection of a lens capsule, which is useful as a substitute for the crystalline lens. More specifically, by being directly injected into the lens capsule after the removal of the lens parenchyma devitrified due to cataract or the like, the lens capsule is given a shape substantially corresponding to the lens before the removal, and The present invention relates to a direct injection of a capsular bag capable of imparting a refractive index adjusting ability based on a change in the shape of the lens due to tension and relaxation of the ciliary body to the injected material after injection.

[0002]

2. Description of the Related Art Conventionally, in order to correct vision after cataract surgery, eyeglasses, contact lenses, and intraocular lenses (the term "intraocular lens" as used herein means that a support is attached to a polymer material that has been polymerized and molded in advance, or A type in which a supporting portion is attached to a hydrogel of the polymer material and supported by an iris, a capsular bag, or the like) is used. Intraocular lenses, which fall into the category of artificial lens, have a better visual function than eyeglasses and contact lenses after surgery, have established surgical techniques such as ultrasonic suction surgery, and are able to leave the posterior capsule, The results are good and the complications are decreasing. Hard polymethyl methacrylate (PMMA) is used as the material of the intraocular lens, poly (2-hydroxyethyl methacrylate), poly (N-vinyl-2-pyrrolidone) is used as the soft water-containing material, and soft non-water-containing material is used. Silicone rubber, acrylic rubber, and the like have been devised as conductive materials. However, since these are all solid materials having a predetermined shape, there have been problems such as the fact that the crystalline lens does not have the refractive index adjusting ability originally possessed and the resulting incision is still large.

For the purpose of solving the above problems, various developments have been made conventionally. Such conventional techniques include: (1) by directly injecting an intraocular lens composition containing a photopolymerizable monomer and a photoinitiator into the lens capsule after the lens parenchyma is extracted, or into the lens capsule. A method of injecting the intraocular lens composition into an inserted balloon (thin film capsule) to form an intraocular lens in the lens capsule (Japanese Patent Application Laid-Open No. 2-255151); (2) extracting the lens substance After that, a balloon (a thin film capsule) is inserted, and a polymer solution, a crosslinked gel, or the like is injected into the balloon (Japanese Patent Application Laid-Open No. 1-227753).

In the prior art (1), since the solid intraocular lens is formed in the crystalline lens, there is no ability to adjust the refractive index, and an intraocular lens having a desired shape is formed. However, there are problems that sufficient visual acuity cannot be obtained, monomers and photoinitiators are absorbed into the living body and have an adverse effect, and sterilization is difficult.

[0005] Further, regarding the prior art of the above (2),
In the method of injecting a polymer solution or the like into the balloon, even if an elastomer is used as the material of the balloon, it is difficult to inflate the balloon into a shape fitted to the capsular bag, and there is a possibility that a stable visual function may not be obtained. is there. Also, to insert the balloon, the sclera, cornea,
Since it is necessary to make a large incision in the lens capsule and the like, there is a disadvantage that the invasion to the living body is increased.

[0006]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to make it possible to easily inject a drug while keeping the incision as small as possible, to have excellent refractive index adjusting ability, and to be applied to a living body. And safe and direct injection of the lens capsule.

[0007]

Means for Solving the Problems The present inventors directly inject a transparent, high-refractive-index composition containing a hydrophilic polymer into a lens capsule that has been devitrified due to cataract or the like and that has been removed. Thus, the lens capsule is given a shape substantially corresponding to the lens before the extraction, and the refractive index adjusting ability based on the shape change of the lens due to the tension-relaxation of the ciliary body which the lens originally has. Have also been found to be able to be applied to the injected material after injection. That is, the gist of the present invention relates to a direct injection of a capsular bag containing a hydrophilic polymer.

[0008]

BEST MODE FOR CARRYING OUT THE INVENTION The hydrophilic polymer in the present invention is not particularly limited as long as it has hydrophilicity, that is, it has a property of dissolving in water or swelling with water. It may be a homopolymer, or a copolymer obtained by copolymerizing a hydrophilic monomer and various hydrophobic monomers for the purpose of adjusting water solubility, viscosity, and the like. These homopolymers and copolymers may be used with isocyanate compounds, epoxy compounds, endcap agents ( A modified polymer such as a polymer obtained by reacting an end-capping agent or the like or a polymer obtained by graft-polymerizing the above homopolymer or copolymer. Further, regardless of the homopolymer, copolymer, or modified polymer, as long as the polymers show compatibility with each other, a blend of two or more of these polymers may be used as the hydrophilic polymer. The hydrophilic polymer may be cross-linked as long as the predetermined viscosity can be maintained.

[0009] Such hydrophilic polymers can be used for the manufacture of direct capsular injections useful as replacements for the lens parenchyma.

As such a hydrophilic polymer, for example,
Polysaccharides such as methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, chitin and alginic acid, poly (meth) acrylic polymers, polyvinyl alcohol (PVA) polymers, polyvinylpyrrolidone (PVP) polymers, polyethylene glycol (P
Synthetic polymers such as EG) polymers.

As the poly (meth) acrylic polymer,
Poly (meth) acrylic acid, sodium poly (meth) acrylate, poly (meth) acrylamide, poly (N, N-)
Dimethyl (meth) acrylamide, poly {N-methyl (meth) acrylamide}, poly {N-ethyl (meth)
Acrylamide, poly {N-propyl (meth) acrylamide}, poly {N-isopropyl (meth) acrylamide}, poly {N-butyl (meth) acrylamide}, poly {N-acryloylmorpholine}, poly2
-Hydroxyethyl (meth) acrylate｝, poly ｛3
-Hydroxypropyl (meth) acrylate} and poly {(4-hydroxybutyl (meth) acrylate}).

As the polyvinyl alcohol-based polymer,
Vinyl acetate, vinyl butyrate, vinyl pivalate, homopolymers of vinyl esters such as vinyl versatate or saponified products of these copolymers, copolymers of the above-mentioned vinyl esters with other copolymerizable monomers And saponified compounds. Examples of the copolymerizable monomer include olefins such as ethylene, propylene, and 1-hexane;
(Meth) acrylic acid, crotonic acid, maleic acid, itaconic acid, unsaturated carboxylic acids such as maleic anhydride, salts or esters thereof; (meth) acrylamide, N-
Acrylamides such as alkyl (meth) acrylamide, N, N-dialkyl (meth) acrylamide, 2- (meth) acrylamidopropanesulfonic acid and its salts, (meth) acrylamidopropyldimethylamine and its salts; styrene; methyl vinyl ether; t Vinyl ethers such as -butyl vinyl ether; N-vinyl amides such as N-vinyl pyrrolidone, N-vinyl formamide, N-vinyl acetamide; allyl acetate, allyl chloride, allyl alcohol, allyl sulfonic acid and salts thereof, 8-hydroxy-1 An allyl compound such as octene;
Vinyl cyanides such as (meth) acrylonitrile; vinyl halides such as vinyl chloride, vinylidene chloride, vinyl fluoride, and vinylidene fluoride; and silane compounds such as vinyltrimethoxysilane. The copolymerizable amount of these copolymerizable monomers is preferably 20 mol% or less.

In the present invention, the above-mentioned polyvinyl alcohol-based polymer is added to an isocyanate compound such as methyl isocyanate, ethyl isocyanate, isopropyl isocyanate, isobutyl isocyanate, phenyl isocyanate, tolyl isocyanate and naphthyl isocyanate. A polymer obtained by reacting an epoxy compound such as epoxypropane, epoxybutane, epoxycyclohexane, or epoxyethylbenzene, or a polymer obtained by performing graft polymerization of the above-mentioned polyvinyl alcohol-based polymer with cerium ions can also be used.

As the polyvinylpyrrolidone-based polymer,
Homopolymers or copolymers of vinylpyrrolidone such as N-vinyl-2-pyrrolidone, N-vinyl-3-pyrrolidone, N-vinyl-4-pyrrolidone, and copolymerizable monomers of the above-mentioned vinylpyrrolidone and other copolymerizable monomers And the like. As the copolymerizable monomer,
The same ones as those exemplified as the vinyl ester and the copolymerizable monomer in the case of the above-mentioned polyvinyl alcohol-based polymer can be used. The copolymerizable amount of the copolymerizable monomer is preferably at most 20 mol%.

Examples of the polyethylene glycol polymer include a homopolymer of ethylene oxide (polyethylene glycol) and a copolymer of ethylene oxide with a copolymerizable monomer such as epoxypropane, epoxybutane, epoxycyclohexane, and epoxyethylbenzene. . The copolymerizable amount of the copolymerizable monomer is 20
It is preferably at most mol%.

In the present invention, a product obtained by reacting the above-mentioned polyethylene glycol polymer with an endcapping agent (end capping agent) can also be used. Acetic acid, butyric acid, valeric acid,
Hexanoic acid, octanoic acid, decanoic acid, carboxylic acids such as benzoic acid, methanol, ethanol, isopropanol,
Examples thereof include alcohols such as butanol, hexanol, octanol, decanol, and phenol.

Above all, even when an injectable having a high hydrophilic polymer content is prepared, it has a viscosity such that it can pass through a fine injection needle, has an affinity for the living body for a long time, Polymers that are less likely to be used are preferred. Polymers that can be injected with a fine needle are preferred because they can reduce the incision in the capsular bag during injection. Such suitable hydrophilic polymers include polyvinyl alcohol polymers,
At least one polymer selected from the group consisting of a polyvinylpyrrolidone-based polymer and a polyethylene glycol-based polymer is exemplified, and a blend of a polyvinyl alcohol-based polymer and a polyvinylpyrrolidone-based polymer is more preferable.

The polyvinyl alcohol polymer is preferably a homopolymer of a vinyl ester such as vinyl acetate, vinyl butyrate, vinyl pivalate or vinyl versatate, or a saponified product of a copolymer thereof. Saponified homopolymers are more preferred. As the polyvinylpyrrolidone-based polymer, a homopolymer of N-vinyl-2-pyrrolidone is preferable, and as the polyethylene glycol-based polymer, a homopolymer of ethylene oxide (polyethylene glycol) is preferable.

The viscosity of the hydrophilic polymer is 50,0
It is preferably at most 00 cp, more preferably at most 30,000 cp, even more preferably at most 10,000 cp.

The viscosity-average degree of polymerization of the polyvinyl alcohol-based polymer is preferably 30 or more, more preferably 50 or more, and particularly preferably 70 or more, from the viewpoint of preventing absorption by the living body. In addition, the viscosity average degree of polymerization is preferably 10,000 or less, and 5,000, from the viewpoint of achieving a desired viscosity by lowering the viscosity even in an injection having a high content.
The following is more preferable, and the value of 2,000 or less is particularly preferable.
In addition, since it is necessary to maintain transparency at an environmental temperature near body temperature for a long period of time, the degree of saponification of the polyvinyl alcohol-based polymer is 50 mol% from the viewpoint of preventing phase separation that causes a decrease in transparency. More preferably, 55 mol%
The above is more preferable, and 60 mol% or more is further preferable. In addition, from the viewpoint of suppressing opacity due to an increase in crystallinity, 99.8 mol% or less is preferable, and 99.5 mol% or less.
Is more preferably, and particularly preferably 99 mol% or less.

[0021] The number average molecular weight of the polyvinylpyrrolidone-based polymer is 3,000 from the viewpoint of preventing it from being absorbed into a living body.
0 or more is preferable, 4,000 or more is more preferable,
Particularly preferred is 5,000 or more. Further, from the viewpoint of achieving a desired viscosity by lowering the viscosity even in an injection having a high content, the number average molecular weight is preferably 3,000,000 or less, more preferably 2,000,000 or less,
Particularly preferred is 1,000,000 or less.

The number average molecular weight of the polyethylene glycol-based polymer is 200
Or more is preferable, and 400 or more is more preferable. In addition, from the viewpoint of achieving a desired viscosity by lowering the viscosity even in an injection having a high content, the number average molecular weight is preferably 1,000.
It is preferably at most 000, more preferably at most 800,000, particularly preferably at most 500,000.

The blend of a polyvinyl alcohol polymer and a polyvinyl pyrrolidone polymer complements the change with time in the viscosity of the polyvinyl alcohol polymer and the decrease in transparency of the polyvinyl pyrrolidone polymer when prepared as a high-content solution. This is preferable because it can be improved in terms of quality. From the viewpoint of exhibiting the effect of the blend, the blend ratio (weight ratio) is, for example, polyvinyl alcohol-based polymer / polyvinyl pyrrolidone-based polymer = 1/99 to 9
9/1 is preferable, 3/97 to 97/3 is more preferable, and 5/95 to 95/5 is particularly preferable.

The refractive index of the lens capsule direct injection of the present invention is determined by the deformation of the lens caused by the tension and relaxation of the ciliary body.
From the viewpoint of producing a desired change in the refractive index, 1.340
Or more is preferable, and 1.345 or more is more preferable.
Particularly preferred is 350 or more.

The direct injection of the capsular bag of the present invention is preferably low in viscosity even though the content of the hydrophilic polymer is high, in order to reduce the incision of the capsular bag. From the viewpoint of enabling the use of an injection needle with a smaller diameter, the viscosity of the lens capsule direct injection is preferably 50,000 cp or less, and 30,000 cp or less.
0 cp or less is more preferable, and 10,000 cp or less is particularly preferable. When an injection having such a viscosity is injected into the capsular bag, the injection formed by injection of the injection can change its shape due to tension and relaxation of the ciliary body. Therefore, the injectable composition of the present invention is a suitable composition capable of imparting refractive index adjusting ability to such an injectable substance.

The direct injection of the lens capsule of the present invention preferably has a visible light transmittance of 50% or more, more preferably 55% or more, and more preferably 60% or more from the viewpoint of transparency. Particularly preferred. In addition, from the viewpoint of securing a sufficient visual function, it is preferably 50% or more.

[0027] The content of the hydrophilic polymer in the lens capsule direct injectable composition of the present invention is not particularly limited as long as the desired performance is exhibited. For example, from the viewpoint of exhibiting a desired refractive index in the lens capsule direct injection, the content is preferably 1% by weight or more, more preferably 3% by weight or more, and particularly preferably 5% by weight or more of the lens capsule direct injection. . In addition, from the viewpoint of ease of injection and suppression of changes in viscosity and transparency over time, the content is 9% of that of the lens capsule direct injection.
0 wt% or less is preferable, 85 wt% or less is more preferable, and 80 wt% or less is particularly preferable.

The direct injection of the capsular bag of the present invention is preferably an aqueous solution or a gel of the above-mentioned hydrophilic polymer. Examples of the solvent for dissolving or swelling the hydrophilic polymer to prepare an aqueous solution or gel include water, physiological saline, an intraocular perfusion solution, an intraocular washing solution, and the like.

The direct injection of the capsular bag of the present invention may optionally contain additives other than the hydrophilic polymer as long as the performance is not impaired. For example, coloring agents such as dyes, UV absorbers, antioxidants, stabilizers, surfactants, sequestering agents, defoaming agents, nutrients such as glucose, sodium chloride, potassium chloride, calcium chloride, magnesium sulfate, hydrogen carbonate Inorganic compounds such as sodium, sodium hydrogen phosphate, and boric acid; and eye tissue protective agents such as oxyglutathione. The compounding of the substance can be carried out, for example, by using a preparation containing the substance in advance when preparing a lens capsule direct injection using a hydrophilic polymer as a raw material. In this case, examples of the preparation include physiological saline, an intraocular perfusion solution, an intraocular washing solution, and the like. Above all, physiological saline and intraocular perfusate having isotonic buffering action on the living body are generally preferred, and have a composition close to the aqueous humor composition and have an isotonic buffering action, such as cataract surgery, glaucoma surgery, and vitreous body. An intraocular perfusion solution, which is a preparation that is perfused at the time of intraocular surgery to protect or wash eye tissues, is more preferable.

The method for preparing the lens capsule direct injection of the present invention is not particularly limited, and a method in which a hydrophilic polymer is dissolved in water together with an additive if desired, and a method in which the hydrophilic polymer is dissolved in an aqueous solution in which the hydrophilic polymer is dissolved in advance. Any of a method of dissolving the additive as desired, a method of dissolving the hydrophilic polymer in an aqueous solution in which the additive is dissolved in advance as needed, and a method of previously dissolving the hydrophilic polymer in a preparation having a desired effect may be used. It is preferable to prepare under the condition that the hydrophilic polymer and the additive are not denatured. In addition, the prepared lens capsule direct injection agent is prepared aseptically in consideration of direct injection into the lens capsule, or used by performing a predetermined sterilization operation before lens capsule injection. Considering that denaturation must not occur after preparation, aseptic preparation or sterilization before use, the lens capsule direct injection is preferably provided in a vial bottle, and is sealed in an injection cartridge. More preferably, it is provided in a state where it is provided.

The term "direct" in the direct injection of the capsular bag of the present invention means that the injection is not directly into the balloon inserted into the capsular bag but directly into the capsular bag.
Therefore, the method of using the direct injection of the capsular bag of the present invention is preferably a method of removing the lens parenchyma that has lost its function due to cataract or the like, and then injecting directly into the capsular bag using an injection needle. The smaller the injection needle used, the smaller the incision in the capsular bag is. For example, the injection needle is preferably thinner than 16G, more preferably thinner than 18G, and particularly preferably thinner than 20G. Since the injection of the present invention has a low viscosity, the injection operation can be easily performed using such a small diameter injection needle. After injecting the lens capsule direct injection, the incision may be closed with a biocompatible patch, plug, adhesive or the like so that the injection does not leak. Thus, the use of the direct injection of the capsular bag of the present invention also provides a method for correcting visual acuity, in which the capsular bag is directly injected into the lens capsule after the lens parenchyma is removed, such as after cataract surgery.

[0032]

EXAMPLES The present invention will be described below in more detail with reference to examples and the like, but the present invention is not limited thereto.
In the following examples, the viscosity, refractive index, and visible light transmittance of the lens capsule direct injection were measured or evaluated as follows.

Viscosity of lens capsule direct injection: The viscosity of the injection obtained before injection and the injection extracted 6 months after injection obtained in the following example was measured using an E-type viscometer attached to a thermostat at 35 ° C. VISCONIC EH made by TOKIMEC
D), and the rate of change in the viscosity of the injection before and after excision of the rabbit lens capsule was determined by the following formula.

[0034]

(Equation 1)

Refractive index of the lens capsule direct injection: The refractive index of the lens capsule direct injection before and after extraction obtained in the following example was measured with a refractometer attached to a thermostat at 35 ° C. (Abago refraction manufactured by Atago). And the rate of change of the refractive index of the injection before and after the extraction of the rabbit lens capsule was determined by the following formula.

[0036]

(Equation 2)

Visible light transmittance of the lens capsule direct injection: The visible light transmittance of the lens capsule direct injection obtained before and after removal obtained in the following example was left for a while in a thermostat at 35 ° C. , Take out immediately and use the haze meter (T
(TC-H / CL manufactured by OKYO DENSHOKU: measurement wavelength: 380 to 780 nm), and the change rate of visible light transmittance of the injection before and after excision of the rabbit lens capsule was determined by the following formula.

[0038]

(Equation 3)

Example 1 As a hydrophilic polymer, polyvinyl alcohol (PVA4
05: Kuraray / viscosity average polymerization degree 500, saponification degree 82
(Mol%) was dissolved in 85 parts by weight of physiological saline (manufactured by Otsuka Pharmaceutical Co., Ltd.) to prepare a solution for lens capsule direct injection. The viscosity of this injection is 200 cp and the refractive index is 1.35.
8. The visible light transmittance was 99%.

After the injection was sealed in a cartridge for injection, it was sterilized in an autoclave. This injection was injected into the capsular bag of a rabbit from which the lens parenchyma had been removed using a 22G injection needle, and the incision was plugged. The incision in the lens capsule was 1 mm or less. Six months later, the rabbit lens was excised,
Observation with the naked eye showed no tissue abnormality such as leakage of the injection, wrinkling, tearing, inflammation, and adhesion of the lens capsule, and physical properties of the injection were almost the same as before injection. The viscosity, the refractive index, and the visible light transmittance were measured by the above-described methods, and the change was evaluated. The results are shown in Table 1 below together with observations.

Example 2 Poly (N-vinyl-2-pyrrolidone) (K-15: manufactured by Gokyo Sangyo / average molecular weight 10,000 as a hydrophilic polymer)
0) 40 parts by weight were dissolved in 60 parts by weight of Opegaard MA (manufactured by Senju Pharmaceutical) to prepare a solution-like direct injection of the capsular bag. The viscosity of this filler is 370 cp and the refractive index is 1.41.
0, the visible light transmittance was 87%.

After the injection was sealed in an injection cartridge, it was sterilized in an autoclave. The injection was injected with a 24G injection needle into the capsular bag of a rabbit from which the lens was removed, and the incision was plugged. The incision in the lens capsule was 1 mm or less. Six months later, the rabbit lens was excised,
Observation with the naked eye revealed no tissue abnormality such as leakage of the injection, wrinkling, tearing, inflammation, and adhesion of the lens capsule, and physical properties of the injection were almost the same as before injection. The viscosity, the refractive index, and the visible light transmittance were measured by the above-described methods, and the change was evaluated. The results are shown in Table 1 below together with observations. In addition, opeguard MA is an intraocular perfusion solution, and its composition is as follows. 1 mL
Per glucose 1.5mg, NaCl 6.6mg,
KCl 0.36 mg, CaCl ₂ 0.18 mg, M
An aqueous solution containing 0.3 mg of gSO ₄ and 2.1 mg of NaHCO ₃ .

Example 3 As a hydrophilic polymer, polyethylene glycol (PEG) was used.
# 1000: 60 parts by weight of Wako / Average molecular weight 1,000) was dissolved in 40 parts by weight of purified water (manufactured by Otsuka Pharmaceutical Co., Ltd.) to prepare a solution-like direct injection of lens capsule. The viscosity of this filler is 440 cp, the refractive index is 1.442, and the visible light transmittance is 9
7%.

After the injection was sealed in a cartridge for injection, autoclave sterilization was performed. The injection was injected with a 24G injection needle into the capsular bag of a rabbit from which the lens was removed, and the incision was plugged. The incision in the lens capsule was 1 mm or less. Six months later, the rabbit lens was excised,
Observation with the naked eye showed no tissue abnormality such as leakage of the injection, wrinkling, tearing, inflammation, and adhesion of the lens capsule, and physical properties of the injection were almost the same as before injection. The viscosity, the refractive index, and the visible light transmittance were measured by the above-described methods, and the change was evaluated. The results are shown in Table 1 below together with observations.

[0045]

[Table 1]

Example 4 Polyvinyl alcohol (PVA2) was used as a hydrophilic polymer.
05: Kuraray / viscosity average degree of polymerization 500, saponification degree 88
Mol.) 20 parts by weight, poly (N-vinyl-2-pyrrolidone) (K-30: manufactured by Gokyo Sangyo / average molecular weight 10,000)
0) 20 parts by weight were dissolved in 60 parts by weight of Opegaard MA (manufactured by Senju Pharmaceutical Co., Ltd.) to prepare a lens capsule direct injection. The viscosity of this injection was 700 cp, the refractive index was 1.411, and the visible light transmittance was 93%.

After the injection was sealed in a cartridge for injection, autoclave sterilization was performed. The injection was injected with a 24G injection needle into the capsular bag of a rabbit from which the lens was removed, and the incision was plugged. The incision in the lens capsule was 1 mm or less. Six months later, the rabbit lens was excised,
Observation with the naked eye showed no tissue abnormality such as leakage of the injection, wrinkling, tearing, inflammation, and adhesion of the lens capsule, and physical properties of the injection were almost the same as before injection. The viscosity, the refractive index, and the visible light transmittance were measured by the above-described methods, and the change was evaluated. The results are shown in Table 2 below together with observations.

Example 5 As a hydrophilic polymer, 35 parts by weight of sodium itaconate copolymerized polyvinyl alcohol (KL-504, manufactured by Kuraray / viscosity average degree of polymerization 400, itaconic acid copolymerization rate 1 mol%, saponification degree 75 mol%) was used. Physiological saline (Otsuka Pharmaceutical) 6
It was dissolved in 5 parts by weight to prepare a gel-like lens capsular direct injection. The viscosity of this filler is 8800 cp and the refractive index is 1.
403, the visible light transmittance was 82%.

After the injection was sealed in a cartridge for injection, autoclave sterilization was performed. This injection was injected into the capsular bag of a rabbit from which the lens parenchyma had been removed using a 22G injection needle, and the incision was plugged. The incision in the lens capsule was 1 mm or less. Six months later, the rabbit lens was excised,
Observation with the naked eye showed no tissue abnormality such as leakage of the injection, wrinkling, tearing, inflammation, and adhesion of the lens capsule, and physical properties of the injection were almost the same as before injection. The viscosity, the refractive index, and the visible light transmittance were measured by the above-described methods, and the change was evaluated. The results are shown in Table 2 below together with observations.

[0050]

[Table 2]

Comparative Example 1 100 parts by weight of a methacrylic acid ester (X-22-174DX: manufactured by Shin-Etsu Chemical Co., Ltd.) having polydimethylsiloxane (average number of repeating dimethylsiloxane: 60) as a photopolymerizable monomer, and a photoinitiator Was mixed with 1 part by weight of acetophenone (manufactured by Wako) to prepare an injection material.
After the injection material was sealed in an injection cartridge, it was injected into the capsular bag of a rabbit from which the lens material had been removed using a 22G injection needle, and the incision was plugged. Irradiate with halogen light,
The monomer was cured. 1 mm incision in lens capsule
It was below. Six months later, the rabbit lens was excised and observed with the naked eye. As a result, the fluidity of the lens was lost due to the hardening of the monomer, and the lens formed in this example showed tension-relaxation of the ciliary body. It was clear that the shape could not be changed with. Inflammation, which is thought to be due to unpolymerized monomers or photoinitiators, was also observed in the lens epithelium. In addition, in this example, the injection | pouring material before injection | pouring was a polymerizable monomer composition, and after injection | pouring, it polymerizes and turns into a polymer, Therefore, the measurement of the viscosity, refractive index, and visible light transmittance was not performed. The observations are shown in Table 3 below.

Comparative Example 2 A silicone tube was attached to a silicone balloon.
Is inserted into the lens capsule of a rabbit with the lens parenchyma removed.
HEALON using a catheter from one side
Made by Macia: 10 mL of sodium hyaluronate per mL
mg, NaCl 8.5 mg, Na_TwoHPO_Four・ 2H_TwoO
 0.28 mg, NaH_TwoPO_Four・ H _TwoO 0.04m
hydrogel containing 1 g; viscosity 8700 cp, refractive index 1.
336, 95% visible light transmittance). Into the eye
5 mm incision in sclera and capsular bag when balloon is inserted
That was all I had to do. Six months later, rabbit crystal
The body was removed and observed with the naked eye.
It was clear that sufficient visual function was not obtained.
It was easy. The viscosity, refractive index,
The visible light transmittance was measured, and the change was evaluated.
The results are shown in Table 3 below together with observations.

[0053]

[Table 3]

From the results shown in Tables 1 and 2, since the capsular capsules of Examples 1 to 5 have sufficiently small viscosities, they correspond to changes in the shape of the capsular bag due to tension and relaxation of the ciliary body after injection. Can be deformed. Moreover, since the injection of the present invention has a high refractive index, it has been clarified that an injection formed after injection of the injection of the present invention has a refractive index adjusting ability inherent to the crystalline lens. Furthermore, there is no change in composition or physical properties due to metabolism in the living body, and it maintains transparency for a long time and has affinity with the living body, so it is useful as a substitute for the lens parenchyma directly injected into the lens capsule I understood. Furthermore, since the direct injection of the capsular bag of the present invention can be injected from a small-diameter injection needle, the injection operation is easy and the incision of the capsular bag can be reduced.

[0055]

EFFECT OF THE INVENTION The direct injection of the capsular bag of the present invention is a composition which has high stability and safety, is easy to apply to an affected area, and exhibits an ability to adjust the refractive index after application. Useful as a replacement for the lens parenchyma that is injected directly into

 ──────────────────────────────────────────────────続 き Continuing from the front page (72) Inventor Mototsugu Nishishin 840 Shijo-cho, Kashihara-shi, Nara F-term (reference) 4C076 AA11 AA12 BB24 CC10 DD23D DD23E DD24D DD24E DD25D DD25E DD67A EE06A EE16A EE11A FF11 4C086 AA02 FA02 FA03 MA01 MA04 MA06 MA58 NA14 ZA33

Claims (6)

[Claims] 1. A lens capsular direct injection containing a hydrophilic polymer. 2. The injectable according to claim 1, wherein the content of the hydrophilic polymer is 1 to 90% by weight. 3. The injection according to claim 1, which has a viscosity of 50,000 cp or less. 4. The injection according to claim 3, which has a refractive index of 1.340 or more and a visible light transmittance of 50% or more. 5. The polymer according to claim 1, wherein the hydrophilic polymer is at least one polymer selected from the group consisting of a polyvinyl alcohol polymer, a polyvinyl pyrrolidone polymer and a polyethylene glycol polymer.
Injection according to item. 6. The injectable according to claim 1, wherein the hydrophilic polymer contains a polyvinyl alcohol-based polymer and a polyvinylpyrrolidone-based polymer.