JP2839255B2 - Method for producing balloon body for intraocular lens - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to a method for manufacturing a balloon body for an intraocular lens, and in particular, can be suitably used as an intraocular lens as a lens for correcting vision after cataract surgery, etc. The present invention relates to an advantageous method of manufacturing a balloon body that can be inserted through a small incision hole and that can be closely attached and held in a capsular bag.

(Background Art) Intraocular lenses, which are used as lenses for correcting vision after cataract surgery, have been developed in recent years in Japan under many clinical experiments with the improvement of lenses and the development of surgical techniques.
Its use has been increasing, and it has been recognized that it is extremely functionally superior to conventionally used cataract glasses and contact lenses.

By the way, such an intraocular lens is generally roughly classified into an anterior chamber lens, an iris supporting lens, and a posterior chamber lens depending on a fixing portion thereof. In particular, it is said that fixation in the capsule of the lens is preferable from a place closer to a natural state.

When the intraocular lens is fixed in the capsule, it is necessary to make an incision in the sclera of the eye for insertion into the capsule and to form an incision sufficient to insert the intraocular lens. However, since such a large incision causes postoperative astigmatism, it is preferable that the intraocular lens to be inserted can be inserted even with a small incision as much as possible.

For this reason, conventionally, several proposals have been made as an intraocular lens to be inserted and fixed in such a capsule,
For example, in U.S. Pat.No. 4,449,257, a swollen lens made of a water-absorbing hydroxyethyl methacrylate-based polymer is used, which is inserted in a small dry state,
A structure has been proposed in which an aqueous humor is impregnated and swelled in the eye to form a flexible lens, but in an intraocular lens having such a structure, although it depends on the swelling rate of the material, In the case of a hydroxyethyl methacrylate-based polymer, the scleral incision is reduced to only about 4 mm.

In addition, such an intraocular lens is fixed in the capsular bag of the lens, so it must have elasticity to follow the movement of the lens, of course, it has the same shape as the lens, and it can be closely attached to the capsular bag. It is preferable that the intraocular lens is used. However, such an intraocular lens has not been provided so far, and its manufacture has been very difficult.

(Solution Problem) Under such circumstances, the object of the present invention is to form an intraocular lens which is inserted and fixed in a capsular bag by a hollow balloon having substantially the same shape as the lens. It is intended to be able to be closely attached and held in the capsule and to solve the problem of the size of the incision so that it can be inserted even from a smaller incision. It is to provide a method that can be manufactured.

The present invention has been made in view of the above problems, and is made of, among other things, an elastic elastomer that is inserted into a capsular bag to give the capsular bag a substantially corresponding shape. The hollow body in the form of an integral convex lens, which is formed so that a projection different from the convex lens shape does not occur at the peripheral edge thereof, and the film thickness of the optical part of the hollow body is 0.001 to 0.1mm, diameter 6-13mm
A predetermined light transmissive injectate is injected into the hollow body, and the hollow body is swelled in the capsular bag, thereby providing an objective intraocular lens. A balloon body is to be manufactured.

And, in the present invention, in order to advantageously obtain the balloon body for an intraocular lens as described above, (a) a corresponding one-sided shape of a hollow balloon body having a convex lens shape is provided.
Providing a mold containing two equal-diameter elastomeric balloon halves, respectively, in correspondingly shaped recesses formed in the overlapping surface; and (b) the interior of at least one of the balloon halves. Place a predetermined amount of adhesive monomer in the
(C) stacking the two mold halves coaxially so that the convex surfaces of the respective balloon halves are located outside and the peripheral portions of the balloon halves are abutted with each other; Bonding the peripheries of the butted two balloon halves by polymerizing the bonding monomer while rotating the stacked molds about a center as an axis.
This constitutes the manufacturing method.

Further, in the present invention, as another method of manufacturing the balloon for an intraocular lens, (a) stacking an elastomer balloon half which gives one side shape of a hollow balloon having a convex lens shape. Providing a first mold housed in a correspondingly shaped recess provided on the mating surface; and (b) the other half of the balloon body having the same diameter as the balloon half providing the one side shape. Prepare a second mold to make the balloon halves giving shape,
While the second mold and the first mold are coaxially overlapped with each other, a step of putting a predetermined amount of a balloon-forming monomer that produces an elastomer by polymerization in at least one of the molds, (C) a balloon that gives the other one-sided shape of the balloon body into the second mold by polymerizing the monomer while rotating the overlapped mold around the center of the balloon half. A method of forming a half body and adhering the balloon mold half body of the first mold with the peripheral part integrally at the peripheral portion thereof.

As another method for manufacturing the balloon for an intraocular lens, the present invention provides (a) a corresponding one-sided shape of a hollow balloon having a convex lens shape.
(B) placing a predetermined amount of a monomer for forming a balloon, which produces an elastomer by polymerization, in a mold for producing each of the balloon halves having the same diameter, and casting the monomer in a desired shape on the surface of the mold; (C) superposing the two molds on which the monomer has been cast coaxially, and (c) polymerizing the monomers while rotating the superimposed molds to form a balloon half in each mold. Forming the body and adhering the two balloon halves at the periphery are also advantageously employed.

Further, in the present invention, as another method of manufacturing the balloon body for the intraocular lens, (a) manufacturing a balloon half which gives one side shape of a hollow balloon body having a convex lens shape. A step of putting a predetermined amount of a balloon-forming monomer which generates an elastomer by polymerization into a first mold, and casting the monomer into a desired shape on the surface of the mold; and (b) a balloon which gives the one-sided shape of the one side A half mold and a diameter are equal, using a second mold mold for producing a balloon half that gives the other one-sided shape of the balloon body, a predetermined amount of a balloon-forming monomer that produces an elastomer by polymerization in the mold, And a step of laminating the first mold coaxially thereon,
(C) While rotating the stacked molds,
A step of forming a balloon half in each mold by polymerizing the two monomers, and bonding the two balloon halves at the peripheral portion is also advantageously employed. It is.

(Specific Configuration) Hereinafter, the present invention will be described more specifically with reference to the drawings.

First, FIG. 1 shows one of the hollow balloon bodies which is an object of the present invention to provide a target intraocular lens. That is, the balloon body 12 provided by this intraocular lens is
It is made of a thin film-like elastic elastomer and has a convex lens shape with a hollow inside. After the balloon body 12 is inserted into the capsular sac in a state where the gas inside the balloon body 12 is removed and reduced, the injectate 14 is inserted therein according to an injection operation using a normal catheter or the like. Injected and, as shown in FIG.
Therefore, the intraocular lens 10 effectively exhibits the function as a crystal.

By the way, a balloon body constituting such an intraocular lens 10
12 is formed using an elastomer, is inserted into the lens capsule, and is swelled into the lens capsule by injection of a predetermined injection material, so that the elongation is about 50% or more. Preferably, there is. It ’s
If the elongation percentage is less than 50%, it is impossible to swell in the sac when the injectate 14 is inserted, and the balloon material is liable to be deteriorated. It is.

In addition, such a balloon body 12, together with the implanted material 14 to be injected, is required to be made of a light-transmitting material because it functions as a crystalline lens, and in general, its transparency is Visible light transmittance (380-7
(Transmittance in the region of 80 nm): formed of a material that is about 65% or more, and furthermore, after the injection of the injectate 14, such an injectate 14 does not elute into the eye, and the material in the aqueous humor It is desirable to be formed of a material that does not absorb water so that the contents do not accumulate.

As the material of the balloon body 12 that satisfies these requirements, polyurethane, silicone rubber, segmented polyurethane, a block or graft copolymer of polysiloxane and polyurethane, and the like are advantageously used to form the desired balloon body 12. It is done.

It should be noted that the above-mentioned material forming the balloon body 12 may be added with a dye or an ultraviolet absorber as conventionally used as an additive, if necessary.

By the way, the balloon body for an intraocular lens manufactured according to the present invention has a hollow integral convex lens shape, and is formed so that a protrusion different from the convex lens shape does not occur at a peripheral portion thereof. That is, as shown in FIG. 1, it has almost the same shape as the crystalline lens. Therefore, the intraocular lens 10 can be advantageously held in a state in which the intraocular lens 10 is in close contact with the inner surface of the capsular bag 16, and the balloon body 12
Injection 14 is injected into the intraocular lens through the injection hole.
Leakage outside the 10 can be avoided well.

In addition, as for the size of the balloon body 12, first, the thickness t of the optical part, in other words, the central part near the center through which light passes, is considerably reduced to 0.001 to 0.1 mm. Therefore, if the gas (air) inside is removed, the balloon body can be folded small and can be inserted into the capsular bag even from a smaller incision.
If the film thickness is less than 0.001 mm, the film is easily broken. If the film thickness is more than 0.1 mm, it is difficult to insert the film into the capsule, and it is difficult to conform to the shape of the capsule within the capsule. In particular, such a film thickness is 0.00
About 5 to 0.05 mm is preferable. In addition, such a balloon body 12
It is desirable that the film thickness of the optical part except for the peripheral part of the above is substantially uniform, but it is preferable that the central part is slightly thinned.

Further, the diameter of the balloon body 12 (M in FIG. 1)
Is between 6 and 13 mm, which is approximately equal to the diameter of the capsule when injected and injected into the lens capsule. Furthermore, the thickness (L in FIG. 1) is preferably 2 to 6 mm, and is approximately equal to the thickness of the capsule when inserted into the capsule and injected.

The thickness (T in FIG. 1) at the outer peripheral edge of the convex lens shape of the balloon body 12 is preferably 1.1 to 4.0 times the thickness of the optical part (near the center) of the balloon body 12: t. However, this is because the thickness of the outer peripheral edge is slightly increased, so that the intraocular lens 10
Is to maintain the shape of the lens in the shape of the crystalline lens.

On the other hand, an injectate injected into the balloon body 12 as described above
14 is to expand the balloon body 12 into the capsular bag 16 and make it approximately the same size as the lens, thereby forming the intraocular lens 10 that functions as the lens,
Light-transmissive fluids, particularly transparent liquids, are desirable, and generally those having a refractive index of 1.36 or more are suitably used, and the viscosity thereof does not make it difficult to inject into the balloon body 12. Thus, less than about 300,000 centipoise will be advantageously used.

Examples of the injectate 14 having such properties include cellulose, chitin, alginic acid, a solution or cross-linked gel of a polysaccharide such as hyaluronic acid or a derivative thereof, polyacrylic acid, polyacrylamidopropyl sulfonic acid,
A solution of a synthetic polymer electrolyte such as polystyrene sulfonic acid,
Examples thereof include solutions of water-soluble oligomers such as hydroxyethyl methacrylate, N-vinylpyrrolidone, and polyvinyl alcohol, silicone oils, and silicone gels. These components can be injected or gelled in the balloon 12. As a result, it is accommodated in the balloon body 12. The injection amount of such an injection material 14 is used to fill the volume of the crystalline lens, and is usually about 0.1 to 0.3 ml.

When the balloon body 12 is set as an intraocular lens 10 in a capsular bag of the lens (see FIG. 2),
First, through the incision as small as possible provided at a predetermined portion of the sclera 20 located around the cornea 18 so as not to damage the iris 22 etc. The part is removed. On the other hand, a catheter is inserted into the balloon body 12, and the air in the balloon body 12 is removed, and the balloon body 12 is folded.

Then, the balloon body 12 into which the catheter has been inserted.
However, it is inserted into the capsular bag 16 through the incision in the sclera and further through the incision in the capsule. Next, a predetermined injectate 14 is injected into the balloon body 12 through a catheter, so that the balloon body 12 is inflated so as to be in close contact with the entire inside of the capsular bag 16 and the intraocular lens is inflated. It is set at 10, and is fixed in the capsule.

Thereafter, when the injection of the injectate 14 is completed, the catheter is withdrawn from the balloon body 12 and the incision in the sclera is sutured, whereby the intraocular lens is formed.
2 will be worn as shown in FIG. 2, but if the catheter is withdrawn, the balloon
Since the is in close contact with the capsular bag 16, the injectate does not leak from the inlet.

In addition, the balloon body 12 (the intraocular lens 10)
In addition to being closely adhered and fixed over the entire inside of the inside 16, the thinness of the film thickness allows the intraocular lens 10 to follow the movement of the capsule well, and is similar to a natural eye. Adjustment of visual acuity becomes possible, and thus the intraocular lens 10 effectively functions as an artificial crystalline lens.

By the way, such an intraocular lens balloon body is advantageously manufactured according to any of the following manufacturing methods.

Referring first to FIG. 3, there is shown a simplified process diagram illustrating one technique for advantageously producing the balloon body 12 according to the present invention.

In FIG. 3, reference numeral 24a denotes a mold having a recess 26a for giving one side shape of the balloon body 12. That is, the concave portion 26a has a shape that gives the shape of one surface of the balloon body 12 (the outer surface of the balloon half), and actually corresponds to one surface of the convex lens shape, that is, the one surface shape of the crystalline lens. And such a mold 24a
In, the balloon half 28a is formed by a general molding method, injection molding method, spin casting method, or the like,
By arranging the separately formed balloon half 28a in the recess 26a of the mold 24a, the mold 24a containing the balloon half 28a is prepared (third).
FIG. (A)).

Further, by the same operation, a mold 24b is prepared in which the balloon half 28b is accommodated in the recess 26b giving the other one-sided shape of the balloon body 12. The recesses 26a and 26b of the molds 24a and 24b have at least the same diameter.

In addition, as a material of the balloon halves 28a and 28b,
The materials used for the balloon body 12 as described above are preferably applied, and usually, the monomers thereof are polymerized by heat or ultraviolet rays to form the balloon halves 28a and 28b. In addition, as the material of the molds 24a and 24b, generally, metal or plastic is used, and when ultraviolet polymerization is performed, light transmissive plastic is preferably used.

Next, a predetermined amount of the bonding monomer 30 is placed in at least one of the recesses of the molds 24a and 24b. Naturally, the adhesive monomer 30 is selected to have an adhesive property to the balloon halves 28a and 28b, and to maintain the properties of the balloon body to be manufactured, the one having an elongation of about 50% or more is required. It is preferably adopted. Specific examples of such a monomer include a thermosetting or ultraviolet-curing monomer such as silicone or urethane. Permeability is not a particular concern.

Then, 2 which accommodates the balloon halves 28a and 28b respectively
One mold 24a, 24b is placed such that after the adhesive monomer 30 is placed, the convex surfaces of the respective balloon halves 28a, 28b are located on the outside and the balloon halves 28a, 28b
(See FIG. 3 (b)).

Under this condition, the stacked molds 24
a, 24b are integrally rotated about a single axis (symmetric axis: O) at a predetermined number of revolutions, so that the adhesive monomer 30 is centrifugally applied to the joints at the peripheral edges of the balloon halves 28a, 28b. It is collected and polymerized under the action of heat or ultraviolet light to form the adhesive layer 32, and the balloon halves 28a, 28b are joined at their peripheral edges (see FIG. 3 (c)). In this way, the balloon body 12 for an intraocular lens is advantageously manufactured according to the present invention.

Next, another method for advantageously producing a balloon body according to the present invention will be described with reference to FIG.

First, reference numeral 34 denotes a first mold provided with a recess 36 for giving a one-sided shape of the balloon body similarly to the molds 24a and 24b. Like the recesses 26a and 26b, the recess 36 also has one surface of a convex lens shape, that is, a concave surface corresponding to the one-sided shape of the crystalline lens.

Then, for such a mold 34, similarly to the above, the balloon half 38 is formed on site by a general molding method, injection molding method, spin casting method, or the like,
The separately molded balloon half 38 is fitted,
The first mold 34 in which the balloon half 38 is accommodated is prepared (see FIG. 4 (a)).

On the other hand, a second mold 42 having a recess 40 for providing the other one-sided shape of the balloon body 12 is prepared. In addition,
The recesses 36,0 of the first and second molds 34,42 have at least the same diameter.

As the material of the balloon half 38, the material used for the balloon body 12 as described above is preferably applied, and usually, those monomers are polymerized by heat or ultraviolet rays to form the balloon half 38. Becomes In addition, as the material of the molds 34 and 42, generally, metal or plastic is used, and when ultraviolet polymerization is performed, light transmissive plastic is preferably used.

Next, a predetermined amount of the monomer 44 for forming a balloon is put into the recess 40 of the second mold 42. In addition, as the balloon-forming monomer 44,
In general, monomers of the materials used for the balloon body described above are preferably applied. However, the balloon-forming monomer 44
Must have an adhesive property to the balloon half 38, and among them, a thermosetting or ultraviolet curable monomer such as silicone or urethane is preferably used.

Thus, after the balloon-forming monomer 44 is placed in the recess 40 of the second mold 42, the balloon half 38
The first mold 34 that accommodates
4 are coaxially superimposed so that the convex surfaces of the recesses 36, 40 are located on the outside and the peripheral edges of the recesses 36, 40 coincide (FIG. 4 (b)). )
reference).

Then, under such a state, the superposed molds 34 and 42 are integrally rotated around a uniaxial axis (symmetric axis: O) at a predetermined rotational speed, and the balloon forming monomer 44 is controlled while controlling the rotational speed. Are almost uniformly spread in the recess 40 of the second mold 42 by the action of the centrifugal force. At that time, the monomer is polymerized under the action of heat or ultraviolet light to form a balloon half 46 that gives the other one-sided shape of the balloon body, and at the same time, it is placed in the upper first mold 34. The peripheral portion of the accommodated balloon half 38 is polymerized and adhered, thereby forming the balloon half.
38 and 46 are integrated (see FIG. 4 (c)).
Thus, the balloon body 12 for an intraocular lens is favorably manufactured according to the present invention.

Furthermore, another method for advantageously producing a balloon body according to the invention will be described with reference to FIG.

First, reference numeral 50a denotes a mold having a recess 52a for providing a single-sided shape of the balloon body similar to the molds 24a and 24b. Then, the balloon-forming monomer 54a is cast into the balloon half-shape on the surface of the recess 52a in the mold 50a (FIG. 5 (a)).
reference). As a method of such casting, the balloon-forming monomer is placed in the recess 52a, and the mold 50a is rotated.
A method of casting by the action of centrifugal force or the like will be adopted.

Also, for the mold 50b provided with the recess 52b giving the other one-sided shape of the balloon body 12, as described above,
The balloon-forming monomer 54b is cast. The recesses 52a, 52b of the two molds 50a, 50b have at least the same diameter.

Then, the molds 50a and 50b are superposed coaxially such that the convex surfaces of the respective recesses 52a and 52b are located outside and the peripheral portions of the recesses coincide with each other (fifth embodiment). Fig. (B).

Incidentally, as the balloon-forming monomers 54a and 54b, monomers of the material used for the balloon body as described above are preferably adopted.However, since the molds 50a and 50b are overlapped in the up-down or left-right direction or the like, some degree Viscosity is required, and specifically, is preferably about 100 cps or more. 100c
If it is less than ps, the optical surface may not be formed when the mold is set and rotated. Therefore, there is no problem if a monomer having a high viscosity is used as the monomer, but a monomer having a low viscosity is predominantly used by increasing its viscosity by polymerization to some extent (prepolymer). As a material of the molds 50a and 50b, a metal or a plastic is generally used, and when ultraviolet polymerization is performed, a light-transmitting plastic is preferably used.

Under this condition, the stacked molds 50
a, 50b are integrally rotated about a single axis (symmetry axis: O) at a predetermined number of rotations, and the number of rotations is controlled so that the shape of the balloon half is maintained. Thus, at the same time as the balloon-forming monomers 54a and 54b are polymerized, the balloon-forming monomers 54a and 54b cast in the respective recesses 52a and 52b are polymerized and adhered at the peripheral edge thereof, Balloon half 56a, 56b
Are formed and integrated (see FIG. 5 (c)).
Thus, the balloon body 12 for an intraocular lens is favorably manufactured according to the present invention.

Still another method of advantageously producing a balloon body according to the present invention will be described with reference to FIG.

First, reference numeral 60 denotes a first mold provided with a recess 62 for providing a single-sided shape of the balloon body similar to the molds 24a, 24b and the like. In the mold 60, the balloon-forming monomer 64 is cast in the shape of a balloon half on the surface of the recess 62 (see FIG. 6 (a)). As a method for such casting, the balloon-forming monomer 64 is
, The mold 60 is rotated, and the casting is performed by the action of the centrifugal force.

Also, a recess that gives the other one-sided shape of the balloon body
A second mold 68 with 66 is prepared. Note that at least the diameters of the recesses 62, 66 of the first and second molds 60, 68 are made equal.

Next, after a predetermined amount of the balloon-forming monomer 70 is placed in the recess 66 of the second mold 68, the balloon-forming monomer 64 is cast into the first mold 60.
However, on the second mold 42 on which the balloon-forming monomer 70 is placed, such that the convex surfaces of the respective recesses 62 and 66 are located outside and the peripheral edges of the recesses coincide with each other, They are superposed coaxially (FIG. 6 (b)
reference).

As the balloon-forming monomers 64 and 70, monomers of the materials used for the balloon body as described above are preferably applied. Since the mold 60 is superimposed on the mold 68 from above, the balloon-forming monomer 64 needs to have a certain degree of viscosity, specifically, a viscosity of about 100 cps or more, as in FIG. It is preferable to have one. If it is less than 100 cps, the optical surface may not be formed when the mold is set and rotated. Therefore, there is no problem if a high-viscosity monomer is used, but a low-viscosity monomer which has been polymerized to some extent and has increased viscosity is mainly used. Also,
As a material of the molds 60 and 68, generally, metal or plastic is used, and when ultraviolet polymerization is performed, light transmissive plastic is preferably used.

Under this condition, the stacked molds 6
0,68 are integrally rotated around a single axis (symmetric axis: O) at a predetermined number of revolutions, and rotated so that the balloon-forming monomer 64 in the first mold 60 is maintained in the shape of a balloon half. While the number is controlled, the balloon-forming monomer 70 is spread almost uniformly in the recess 66 of the second mold 68 by the action of centrifugal force. At this time, under the action of heat or ultraviolet light, the balloon-forming monomers 64 and 70 are polymerized, and at the same time, at the peripheral portion of the balloon-forming monomer 64 cast into the upper first mold 60. The balloon-forming monomer 70 is adhered to the balloon half 72,7.
4 are formed and integrated (see FIG. 4 (c)). Thus, the balloon body 12 for an intraocular lens is favorably manufactured according to the present invention.

Above, several techniques for advantageously producing the intraocular lens balloon according to the present invention have been described. By adopting such techniques, the intraocular lens balloon according to the present invention can be easily and at low cost. It becomes possible to manufacture.

In addition, when polymerizing an adhesive monomer or a balloon-forming monomer, generally, heat polymerization and ultraviolet polymerization are suitably employed. In particular, heat polymerization is usually performed for 5 minutes to 24 hours at room temperature to 150 ° C., and ultraviolet polymerization is usually performed for 10 seconds to 10 minutes using a normal light source such as a high pressure mercury lamp. At the length of The rotation speed of the mold is usually 100 to 10000 rpm, and is appropriately selected depending on the method of manufacturing the balloon body, the viscosity of the monomer used, and the like.

As the shape of the mold, various shapes other than those shown in FIGS. 3 to 6 are used. For example, as shown in FIG.
8 so that it is easy to overlap
0, male-female fitting mechanism 8 consisting of outer peripheral concave portion 82 of mold 78
4 can also be adopted. However, even if the male and female fitting mechanism 84 is not provided, there is no problem as long as the respective balloon half body forming surfaces are matched by a jig or the like.

And, to the extent that it does not adversely affect the optical part of the balloon body, in order to slightly increase the thickness of a part thereof,
A recess of predetermined depth and width in a part of the recess 86 of the mold 78
88 can be provided. Such molds 76, 78
By forming the balloon body by using, the thickness of a part of the balloon body can be increased, and the thick film portion is used, for example, for insertion of a catheter for injecting an injectate, and the catheter is used. When the balloon body is pulled out, it is possible to give an effect of giving the balloon body a self-sealing property.

Further, when forming a balloon body having a diameter smaller than the diameter of the capsule, as shown in FIG. 8, in order to fit the balloon body to the shape of the capsule, recesses 94, 96 of the molds 90, 92 are formed. It is also possible to make the joint of the balloon halves slightly cylindrical in shape, with the peripheral edge being cylindrical vertical surfaces 98,98.

Further, in order to reduce the generation of burrs and the like at the joint portion of the balloon halves, as shown in FIG.
In this case, the joining between the molds 100 and 104 can be linear joining.

Further, if a mold that can set a catheter for injecting the infusate is used, such a catheter is set in the mold at the time of forming the balloon body, and at the same time when the balloon body is formed, the catheter is placed in the balloon body. It can also be inserted and arranged in the.

(Examples) Next, several examples of manufacturing a balloon for an intraocular lens based on the manufacturing method according to the present invention will be described.

Example 1 A balloon for an intraocular lens was manufactured according to the method shown in FIG. That is, first, the RTV is placed in the recess of the mold mold (first) made of PMMA, which gives the one-sided shape of the balloon body.
(Room temperature curing type) Silicon monomer: 5 mg was dropped, and the mold was heated to 70 ° C. and heated while rotating at 1300 rpm to polymerize and form a balloon half. In the same operation, a balloon half was formed in another mold, and 2 mg of silicon monomer was dropped into the recess of the mold (second) in which the balloon half was formed. Next, the second mold was overlaid with the first mold having the balloon half attached thereto, and the
Heated at 70 ° C. for 30 minutes while rotating at 00 rpm. Thereafter, when the balloon body was detached from the mold, the two balloon halves were completely adhered to form an intraocular lens body having a diameter of about 10 mm and a film thickness of 0.01 to 0.02 mm.

Example 2 A balloon for an intraocular lens was manufactured according to the method shown in FIG. That is, first, 5 mg of a two-part room temperature curable polyurethane prepolymer: 5 mg is dropped into a recess of a brass mold to give a one-sided shape of the balloon body, and while rotating the mold at 1200 rpm, 140 The temperature was raised to ℃ and heated to polymerize and form a balloon half. next,
On top of another mold mold for balloon half
Prepolymer of liquid room temperature-curable polyurethane: 8 mg was dropped, and the mold with the balloon half attached thereto was superimposed on this mold, and rotated at 1700 rpm from room temperature to 140 ° C. for 60 minutes. The polymerization operation was performed by raising the temperature and heating. Thereafter, when the balloon body was separated from the mold, the two balloon halves were completely adhered to each other to form a balloon body for an intraocular lens having a diameter of about 10 mm and a film thickness of 0.01 to 0.02 mm.

Example 3 A balloon for an intraocular lens was manufactured according to the method shown in FIG. That is, first, 5 mg of an ultraviolet-curable silicone monomer is dropped into a recess of a PMMA mold that gives a one-sided shape of the balloon body.
By spinning at 00 rpm, an unpolymerized balloon half was formed. Next, into the mold of another mold for manufacturing a balloon half, ultraviolet curable silicone monomer: 7 mg was dropped, and the mold was quickly overlapped with this mold, while rotating at 1600 rpm, UV light was applied for 5 minutes. Thereafter, when the balloon body formed from the mold was released, the two balloon halves were completely adhered to form a balloon body for an intraocular lens having a diameter of about 10 mm and a film thickness of 0.01 to 0.02 mm. Was.

As described above, the configuration of the present invention has been described in detail with reference to the embodiments of the present invention, but the present invention is not to be construed as being limited to only such specific configurations and examples. The present invention can be embodied in embodiments in which various changes, modifications, improvements, and the like are made based on the knowledge of those skilled in the art, and any such embodiments may be implemented without departing from the spirit of the present invention. It is needless to say that the same is also included in the scope of the present invention.

(Effect of the Invention) As is clear from the above description, the intraocular lens using the balloon obtained according to the present invention can be suitably used for correcting vision after cataract surgery, and such The balloon body can be inserted in a small folded state from the small incision opening of the haptic and capsular sac, and has an integral convex lens shape almost the same shape as the lens, with a convex lens on the periphery. Since the projection is formed so as not to have a projection different from the shape, it is possible to closely contact and hold the inner surface of the capsular bag. In addition to the fact that the balloon body for an intraocular lens is in close contact with and held in the capsular bag, its thinness allows it to follow the movement of the capsule well, resulting in visual acuity similar to that of a natural eye. It allows for adjustment and thus functions effectively as an artificial lens.

Moreover, if the method of manufacturing a balloon for an intraocular lens according to the present invention is employed, the balloon for an intraocular lens can be manufactured easily and at low cost.

[Brief description of the drawings]

FIG. 1 is an explanatory sectional view showing an example of a balloon body for an intraocular lens which is an object of the present invention, and FIG. 2 shows an intraocular lens using the balloon body obtained according to the present invention in a capsular bag. It is sectional explanatory drawing which shows the state which mounted | worn. And
3 (a) to 3 (c) to 6 (a) to 6 (c) are simplified process explanatory views showing different examples of a method for advantageously producing an intraocular lens balloon according to the present invention. It is. 7 to 9 are cross-sectional views showing different examples of a mold used when manufacturing a balloon body for an intraocular lens according to the present invention. 10: intraocular lens, 12: balloon body 14: injectate, 16: capsular bag 18: cornea, 20: sclera 22: iris 24a, 24b, 50a, 50b, 76, 78, 90, 92, 100, 104: mold 26a, 26b , 36, 40, 52a, 52b, 62, 66, 86, 94, 96: recess 28a, 28b, 38, 46, 56a, 56b, 72, 74: balloon half 30: adhesive monomer, 32: adhesive layer 34, 60: First mold 42, 68: Second mold 44, 54a, 54b, 64, 70: Balloon-forming monomer

──────────────────────────────────────────────────続 き Continued on front page (58) Field surveyed (Int. Cl. ⁶ , DB name) A61F 2/16 A61L 27/00

Claims (5)

(57) [Claims] 1. Two elastomer balloon halves of equal diameter, each providing a corresponding one-sided shape of a hollow balloon body exhibiting a convex lens shape, are respectively accommodated in correspondingly shaped recesses formed in the superposed surface. Preparing a mold, placing a predetermined amount of an adhesive monomer inside at least one of the balloon halves, and holding the two molds accommodating the balloon halves together with the convex surface of each balloon half. A step of coaxially overlapping the balloon halves so as to be positioned on the outside and abutting the peripheral portions of the balloon halves, and while rotating the overlapped mold around the center of the balloon half, Bonding the peripheral edges of the butted two balloon halves by polymerizing the bonding monomer. Method for producing intraocular lenses balloon body to. 2. A first mold is prepared in which an elastomer balloon half which gives one side shape of a hollow balloon body having a convex lens shape is accommodated in a correspondingly shaped recess provided on a superimposed surface. A step of preparing a second mold for producing a balloon half providing the other one-sided shape of the balloon half having the same diameter as the balloon half providing the one-sided shape; A step of placing a predetermined amount of a balloon-forming monomer that produces an elastomer by polymerization in at least one of the molds while superimposing the first mold coaxially, and centering the balloon half. By polymerizing the monomer while rotating the overlapped mold as an axis, the balloon body is placed in the second mold. While forming a balloon halves to give the other single-sided shape,
Adhering the superimposed first mold-shaped balloon halves integrally at a peripheral portion thereof, comprising the steps of: 3. A predetermined amount of a balloon-forming monomer, which produces an elastomer by polymerization, is placed in a mold for producing each of the balloon halves having the same diameter, which gives a corresponding one-sided shape of a hollow balloon having a convex lens shape. Casting the monomer on the mold surface in a desired shape; and coaxially overlapping the two molds on which the monomer has been cast; and rotating the overlapped molds while rotating the molds. Forming a balloon half in each of the molds by polymerizing the monomer, and bonding the two balloon halves at the peripheral edge thereof. Production method. 4. A predetermined amount of a monomer for forming a balloon which produces an elastomer by polymerization is put into a first mold for producing a balloon half which gives one side shape of a hollow balloon having a convex lens shape. Casting the monomer in a desired shape on the surface; and a second mold for producing a balloon half that has the same diameter as the balloon half that provides the one-sided shape and that provides the other one-sided shape of the balloon body. Using a mold, placing a predetermined amount of a balloon-forming monomer that produces an elastomer by polymerization in the mold, and superimposing the first mold coaxially thereon; and rotating the superimposed mold. While the above 2
Forming a balloon half in each of the molds by polymerizing the two monomers, and bonding the two balloon halves at the peripheral edge thereof. Manufacturing method. 5. An integral convex lens shaped hollow formed of a stretchable elastomer, wherein the intraocular lens balloon is inserted into the capsular bag to give the capsular bag a substantially corresponding shape. The optical element of the hollow body has a thickness that is formed so that a projection different from the shape of the convex lens does not occur on the periphery thereof.
A predetermined light-transmitting injectable material having a diameter of 0.001 to 0.1 mm and a diameter of 6 to 13 mm is injected into the hollow body, and the hollow body is swelled in the capsular bag. (1) to (4), which provide a lens.
The production method according to any one of the above.