JP2016054995A - Regenerative crystalline lens unit - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a regenerative crystalline lens unit completely preventing secondary cataract and functioning for a long period after the operation by replacing a native crystalline lens by a regenerative crystalline lens unit.SOLUTION: The regenerative crystalline lens unit to be inserted into a lenticular capsule after removing a part of the anterior capsule of the lens by an extracapsular extraction such as a small incision cataract surgery, integrally includes an optical part (a lens body) 4 having excellent plasticity and transparency by integral molding technique using a soft material or the like. The regenerative crystalline lens unit is placed in the lenticular capsule by energization force with high controllability by outwardly refractively inverting a stationary support part 2 at a refraction part 5 as a boundary part where a movable support part 3 and the stationary support part 2 are concatenated.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a regenerated lens lens unit that is inserted into a lens capsule after removal by an extracapsular excision in which a part of an anterior lens capsule is removed by a small incision cataract operation or the like to extract a cortex and a nucleus therein.

  Conventionally, surgical removal to insert into the lens capsule after an intraocular lens was developed in 1949 to replace the lens after the removal of the cortical lens and nucleus of the lens that had been removed by cataract. As a result of recent improvements in instruments, such as transplantation sites and the occurrence of complications, and the rapid development and spread of peripheral technologies in general, surgery has been performed safely, and the target patient's vision has been restored. ing.

  For extracapsular extraction at the time of cataract surgery, a single-focus lens type conforming to the “intraocular lens approval standard” of the Ministry of Health, Labor and Welfare and a multifocal intraocular lens were approved in 2007. In order to insert and fix the intraocular lens in the lens capsule, the shape of the type in which a support member having an elastic force is fixedly supported on the edge portion of the lens diameter which is the optical part of the intraocular lens and various types Many intraocular lenses made of materials or the like have been put into practical use, and are fixed near the equator of the lens capsule by the elastic force of the support member. However, since there is no focus adjustment power in the optical part (lens body) of the single focus lens type intraocular lens itself, when the power of the inserted lens is inappropriate, the glasses (glasses) at the power that requires focus adjustment ) Etc.

  In recent years, PMMA (polymethyl methacrylate), silicone resin, cross-linked acrylic polymer, PC hydrogel, etc., which are biocompatible with biomaterials, have been used as materials for optical parts (lens bodies). There are known multifocal intraocular lenses, colored aspherical lenses, etc., which are made of (polyvinylidene fluoride) or the like, or a lens part made of an acrylic material and a support member made of the same material. In addition, it has the clinical advantage that the anterior capsule incision at the time of surgery can be made as small as possible, allowing early recovery after surgery, and it can be deformed or folded and inserted into the lens capsule using an intraocular lens insertion device. There is provided an intraocular lens made of a soft material having excellent flexibility and transparency.

  In addition, the conventional intraocular lens can be adjusted in focus by moving the optical part (lens body) in the optical axis direction via the chin band (ciliary zonule) accompanying the contraction and relaxation of the ciliary muscle. In the concept, the optical part (lens body) is a single lens type that is a convex lens, and the optical part (lens body) is a type that consists of two concave and convex lenses, and is located in the posterior capsule part of the crystalline lens capsule. An adjustable intraocular lens has been devised in which a concave lens of a fixed lens is combined with a convex lens of a movable lens that moves in the optical axis direction.

  Moreover, the type which adjusts by the change of the curvature radius of an optical part (lens body) is devised instead of the type adjusted by the back-and-forth movement of the optical part (lens body) in the optical axis direction. This type of intraocular lens is a type called an artificial lens (balloon) that mimics the natural lens, and in the 1960s, after removal of the turbid lens cortex and nucleus from a small incision in the lens capsule, From the attempt to directly inject a viscoelastic substance into the capsular bag with an injector or the like, in recent years, research on prevention measures for substance leakage at the time of injection has been advanced. In addition, the silicone balloon (diameter is about 10 mm, film thickness is about 20 μm), the injection material is also made of the same silicone, and the mixing ratio of the two liquids can adjust the solidity and elasticity after injection. is there. In addition, a gel for preventing backflow is sealed at the end of the artificial lens (balloon).

  Prior art documents of Patent Document 4 to Patent Document 6, and the representative intraocular lens of Patent Document 4 is a structure including one or a plurality of optical members, and is a front floating type located in the anterior lens capsule. A plurality of levers for moving the lens complex to the posterior capsule are coupled to the base frame, and the other end of the lever is located at a plurality of balance points on the outer periphery of the floating lens complex. Sliding holes and the like necessary for the operation of the coupling point during vertical movement are provided.

  In conventional accommodative intraocular lenses, patent documents, and other documents, the optical part (lens body) can be swung in the radial direction and the horizontal direction from the edge part of the lens diameter, symmetrical, circumferential 3 etc. In addition, a general intraocular lens-type support member (PVDF = polyvinylidene fluoride) etc. is made of an elastic material that protrudes at a plurality of symmetrical positions, etc., and the side of the optical part (lens body) It is a multi-piece adjustable intraocular lens connected to a sliding hole provided at an edge by a fitting shaft.

Special table 2005-538086 gazette Special table 2007-512907 gazette JP 2005-533611 A US Patent Application Publication No. 2011/0071628 US Patent Application Publication No. 2011/0295368 US Patent Application Publication No. 2012/0296424

  However, in the above-described invention and the conventional accommodation intraocular lens, the optical portion (lens body) in the optical axis direction of the optical unit (lens body) is connected via a chin band (ciliary small band) accompanying the contraction and relaxation of the ciliary band muscle. For example, in terms of the function and effect of the functional mechanism of the adjustable intraocular lens disclosed in Patent Document 4, the concept of trying to achieve focus adjustment by movement is based on a third-party engineering method. It is a requirement to be proved by proper verification, etc., and these detailed explanations are omitted, but they have a detailed configuration that cannot be consistent mechanically. An important function of the intraocular lens is that it is inserted into the capsular bag of the living body and is filled with aqueous humor (specific gravity and resistance). In terms of ensuring the stability and long-term stability, the inventions in other patent documents including Patent Document 4 have problems in effectiveness in terms of physical action functions.

  Therefore, the regenerated crystalline lens unit of the present invention adjusts the focus by moving the optical part (lens body) in the optical axis direction via the Ching band (ciliary band) accompanying the contraction and relaxation of the ciliary band muscle. Based on the concept of achieving the above, a regenerative lens lens unit based on a biomimetic technique or the like that conforms to the following requirements for “anatomy and physiology” of the lens is provided.

<Crystal>
The natural lens plays an important role as a lens that refracts incoming light and projects an image on the retina. Moreover, it not only refracts light but also absorbs ultraviolet rays that are harmful to the eyes and prevents the ultraviolet rays from reaching the retina. As a characteristic of the lens, the lens is mostly composed of water (65%) and protein (35%). There are no blood vessels or nerves, and nutrients are taken from the aqueous humor between the cornea and the lens rather than from the blood like other organs, and unwanted waste is returned to the aqueous humor.

  The lens has a thickness of 4 to 5 mm, a diameter of 9 to 10 mm, and is transparent with a shape like a meteorite, and is supported by a chin band (ciliary band) to support the lens.

<Chin belt (hair-like obi)>
The chin band (ciliary zonule) connects the ciliary body and the lens, and functions to support the lens. In addition, in cooperation with the ciliary muscle, it works to change the thickness of the crystalline lens (regulation action) when looking at the distance or near.

  When looking at distant objects, the ciliary muscles are loosened, the chin band is pulled and the lens is flattened, and when looking at nearby objects, the ciliary muscles are contracted, the chin band is loosened and the lens is It becomes a shape with roundness and thickness and increases the refractive power.

  The time taken to focus when looking at a distant object or near object is called the adjustment time. The time required to see a nearby object (adjustment tension time) is about 1 second, and the object is distant. It takes about 0.6 seconds (adjustment relaxation time).

  Normal focus adjustment in daily life requires 2.0D (diopter) or more. The natural eye exhibits sufficient adjustment power at 4.0D, with a corneal multifocality and spherical aberration, and a ritual adjustment value of 2.0D due to pupil movement and the like.

  When the refractive power of the adjusting intraocular lens is + 20D, a moving value in the optical axis direction of the optical unit (lens) needs to be about 0.75 mm in order to obtain a focusing power of about 1.0D. In order to obtain a focus adjustment force equal to or greater than D, an amount of movement of the optical unit (lens body) of at least 1.5 mm is required.

  As described above, the basic point in the “anatomy and physiology” of the lens in the biomimetic technology that can be replaced with the natural lens becomes a requirement of the regenerative lens lens unit of the present invention. Even in documents other than patent documents, it is established from the technical viewpoint in terms of the focus adjustment force (the amount of movement of the optical unit in the optical axis direction), which is a basic requirement for an adjustable intraocular lens. The first stage, which is the initial stage of the practical application verification process in the verification of the effectiveness of the biological function after surgery, which is the main purpose of providing the adjustable intraocular lens, even in the literature on whether or not to do so The basic requirements have not been fully met, even without clinical validation through animal experiments.

  In addition, after surgery, the lens epithelial cells proliferate and cause two types of subsequent cataracts: fibrous turbidity and degenerative turbidity, and long-term maintenance of the elasticity and transparency of the lens capsule. In particular, fibrotic secondary cataracts can reduce the elasticity of the capsular bag and have a significant impact on accommodation. It has also been reported that conventional accommodative intraocular lenses are less effective in preventing these secondary cataracts. Therefore, the most important problem of the present invention is the biocompatibility of the physiological action of the aqueous humor (liquid between the cornea and the lens) and the insert (compatible product of the biocompatible material). Extraction and solution of issues that can provide a regenerative lens lens unit that functions long term after surgery by replacing the natural lens with the regenerative lens lens unit of the present invention with biomimetic technology, for example, to prevent secondary cataract Overcoming.

  The present invention is an annular tension via a chin band (ciliary zonule) accompanying the contraction and relaxation of the ciliary muscles in solving the problems of the above prior art, etc., by moving the optical part (lens body). It is possible to replace the lens with a natural lens in consideration of all foreseeable problems with biomimetic technology etc. based on the `` anatomy and physiology '' requirements of the lens that is the basis of the concept of achieving focus adjustment. An object is to provide a reproduction lens unit.

  In order to achieve the above-mentioned object, the present invention inserts a part of the anterior lens capsule into the lens capsule after the removal by extracapsular excision in which the cortex and nucleus are removed by a small incision wound cataract operation or the like. The present invention relates to a reproduction lens unit.

  The regenerated lens lens unit of the present invention is an embodiment in which the anterior lens capsule of the lens capsule and the lens epithelium are excised about 5 mm in diameter and contact the vicinity of the anterior capsulotomy incision, the equator, and the inner wall of the posterior capsule. Is provided. The regenerated lens lens unit is fixed to the inner wall surface of the lens capsule with an urging force with a constant tension, and the opening edge of the fixing support portion and the opening near the incision edge of the lens capsule are in close contact with each other. Movable support part equipped with an optical part (lens body) that adjusts the focus by moving in the direction of the optical axis via the annular tension vector of the chin-striped band (ciliary small band) accompanying the contraction and relaxation of the striated muscle A one-piece type accommodation intraocular lens or a multi-piece type accommodation intraocular lens, characterized by a foldable type accommodation intraocular lens that is inserted into a lens capsule after the regenerated crystalline lens is deformed or folded.

  In one conventional patent document or the like, a portion referred to as a front floating lens complex corresponds to the movable support portion of the present invention, but the movable portion support portion of the flexible material having the elastic force of the present invention and The fixed support part is formed by a boot-type integral molding method in which a refracting part that becomes a hinge action part is provided at a position that becomes a boundary part where the fixed support part is connected, and is refracted (folded) by the refracting part (hinge action). The basic structure formed in the embodiment of the present invention is formed so as to maintain a stable urging force at a correlated constant tension for a long time in a mode of being mounted in the lens capsule.

  The present invention can be molded by a boot-type integral molding method in which a bending portion serving as a hinge action portion is provided at a position that becomes a boundary portion where the movable support portion and the fixed support portion are joined by a flexible material having elasticity. As a manufacturing process advantage that is a basic structure, a one-piece type that has a structure in which an optical part frame and an optical part (lens body) are integrally formed on a movable support part according to an embodiment of the present invention. It is an adjustable intraocular lens.

  Further, it is molded by a boot-type integral molding method in which a refracting portion serving as a hinge working portion is provided at a position where a movable supporting portion and a fixed supporting portion are connected in a flexible material having elasticity according to the present invention. In the basic structure, the movable support unit in which the optical unit frame and the optical unit (lens body) are integrally molded is another example, for visual acuity adjustment such as the appropriate power of the target patient, In order to respond flexibly, the optical part frame can be adapted to a multi-piece type adjustable intraocular lens type in which a locking groove capable of attaching / detaching an optical part (lens body) is provided.

  Further, the reproducing lens unit of the present invention is molded by a boot-type integral molding method in which a refracting portion is provided at a position where a movable portion supporting portion and a fixed portion are joined by a flexible material having elasticity. In the embodiment of the present invention, the basic structure formed by refraction inversion (folding) at the refracting portion is an optical portion on the rear surface side in the configuration of two optical portions (lens bodies). The concave lens of the lens body is integrally molded at the position of the refracting portion (hinge action) of the basic structure, and an optical portion frame having a locking groove that allows the front optical portion (lens body) to be attached and detached is provided. A type that is configured to fit a convex lens of an optical unit (lens body) at an appropriate power of a symmetric patient with a movable support unit is also included.

  In the urging force of the connecting part in the conventional patent document, the shape, setting position, material, etc. of the connecting part may be a Chin band (ciliary zonule) that is generated when the aforementioned ciliary muscle contracts or relaxes. The basic concept of achieving focus adjustment cannot be realized by the persistence of the tension with an appropriate annular tension via) and the movement of the optical part (lens body) in the optical axis direction. Therefore, the reproduction lens unit of the present invention has a structure in each component that enables the realization of the effectiveness of the functional mechanism that can be replaced with the natural lens with high precision and biomimetic technology. .

  According to this, the reproduction lens unit of the present invention includes a movable support unit having an optical unit (lens body) serving as a focus adjustment function unit and a fixed support unit fixed to the inner wall surface of the lens capsule. In order for the unit to be inserted into the capsular bag and fixed in a stable position, an urging force having a certain tension is required at the anterior capsulotomy wound edge portion, the equator portion, and the posterior capsule portion. Therefore, in order to obtain a structure that exerts an effective urging force to the corresponding part, a refracting part having a hinge action is provided at a position where the movable supporting part and the fixed supporting part are connected to each other, and the refracting part is provided. Is formed by reversing the refraction (folding) in the embodiment of the present invention. In addition, in a mode of being arranged on the bottom surface of the posterior capsule portion and each of the front capsule incision wound edge portion in the other embodiments, in the vicinity of the incision wound edge portion of the anterior lens capsule and on the equator portion and the posterior capsule portion. Stable fixation can be achieved by the urging force having a high controllability function. In addition, the effective hinge action at the refracted part has good extensibility, including around the equator part of the lens capsule, and stable and stable action over a long period of time after insertion. Can suppress the development of subsequent cataract.

  In addition, since the movable support unit including the optical unit (lens body) that adjusts the focus by moving in the optical axis direction requires stable planar movement when the movable support unit moves back and forth, the optical unit frame is required. A support leg portion is provided in the vertical direction of the inner side surface of the rim. Further, since the optical part frame of the movable support part is bent in parallel and synchronously, a bending groove is also provided at a position close to the optical part frame.

  In addition, in order to move the optical part (lens body) in a stable manner in cooperation with the annular tension vector via the chin band (ciliary zonule) that occurs when the ciliary muscle contracts or relaxes. In addition, bending of a plurality of notched grooves having a bending action in the circumferential direction equally in the direction perpendicular to the inner side surface of the optical part frame, which is integrally formed at the tip opening of the movable support portion described above. Support legs are provided with auxiliary grooves. The support leg is provided with a V-shaped groove bent portion that synchronizes and bends with the auxiliary bending groove above the support leg. A plurality of elastic refractions arranged with a circumferentially equal bending action in the direction perpendicular to the inner surface of the opening edge of the fixed support part movable in contact with the side wall of the bent part of the V-shaped groove Protruding ribs are formed.

  In addition, it is a numerical value that is required for the deformation of the lens, and passively the cyclic tension vector through the Chin band (ciliary zonule) that occurs when the ciliary muscle of about 1,500 mg contracts or relaxes. The pressing force due to the refractive protrusion-like ribs is inserted into the side wall portion of the V-shaped groove bending portion of the movable support portion in the form of a bending urging force, and the optical movable portion is structured by a contact movable action structure with little pressure loss. In order to obtain a focus adjustment force of 2.0D or more, the support leg portion that is equally divided into the circumference in the vertical direction of the inner side surface of the frame has a movement amount of the optical unit (lens body) of at least 1.5 mm or more. It has a structure that forms a secured bending operation locus.

  In addition, the fixed support that comes into contact with the inner wall surface of the lens capsule with a constant urging force is an annular tension vector via a chin band (ciliary zonule) that occurs when the ciliary muscle contracts or relaxes. Compared with the anterior capsule and the posterior capsule in the vicinity of the equator of the effective position to obtain the urging force for effective operation of the movement specified amount of the optical part (lens body) on the movable support side in cooperation with The horizontal band bend and rhombic cutout window with a reduced cross-sectional area are provided, and the inner wall of the lens capsule and the anterior capsule incisional wound are always applied by the biasing force restricted by the horizontal band bend. A stable biasing force near the edge can be obtained.

  In addition, the optical unit (lens body) can move stably in cooperation with the annular tension vector via the chin band (ciliary band) that occurs when the ciliary muscle contracts or relaxes. Thus, the above-described effective devices and the like for the purpose of providing the regenerated crystalline lens of the present invention have been made. In particular, even if the density (specific gravity, resistance), etc., of the aqueous humor after important insertion surgery, etc., the appropriate action of the aqueous humor will be prevented by the regenerated lens lens unit inserted, which will prevent the occurrence of secondary cataract. As a regenerative crystalline lens unit that does not become an obstacle, a device that gives effectiveness to each functional component is also provided.

  For example, the regenerative lens lens unit of the present invention is movable in the capsular bag with the soft material having the elastic force of the present invention in a device that works effectively even in the density filled with aqueous humor after insertion surgery. An embodiment of the present invention is obtained by reversing the refraction (folding) at the refraction part by a boot-type integral molding method in which a refraction part as a hinge action part is provided at a position where the part support part and the fixed part are connected to each other. The bending action grooves of the movable support part and the fixed support part inscribed in the inner wall of the lens capsule are provided with an optical part with a stable biasing action, which is a great advantage of the basic structure formed in the ciliary body. When the muscle contracts or relaxes, the ratio of the annular tension vector generated through the chin band (ciliary zonule) directly from the passive fixed support part to which the stress is transmitted is fixed to the fixed part. Is 1, the movable part side is 2 They are arranged in a number.

  According to this, on the inner surface of the tip of the fixed support part, the pressure of the elastic bent projection-shaped rib placed on the circumference is equally divided by the highly efficient grouping vector, the V-shape of the passive part on the movable support part side In the groove bent portion, the same number, but in order for the optical portion (lens body) of the movable support portion that operates synchronously with the stress to move stably in parallel, the passive stress in the V-shaped groove bent portion is further reduced. The arrangement ratio is efficient with respect to the support leg portion provided with the bending grooves of the plurality of cutout grooves having a bending action that operate stably on the circumference.

Since this invention is comprised as mentioned above, there exists an effect described below.
According to the present invention, a flexible material having elasticity is formed by a boot-type integral molding method in which a refracting portion serving as a hinge acting portion is provided at a position where the movable supporting portion and the fixed supporting portion are connected. The regular hinge that is refracted (folded) at the refracting portion and is refracted (folded) at the refracting portion in the basic structure formed in each embodiment of the present invention. The urging force having a stable action is fixed to the inner wall surface of the lens capsule with the urging force having a constant tension. It also has an optical unit (lens body) that enables focus adjustment by moving in the direction of the optical axis via the annular tension of the chin band (ciliary small band) that accompanies contraction and relaxation of the ciliary band muscle. , Movable with one-piece type adjustable intraocular lens having an integral movable support part and an optical part frame having a locking structure that allows the optical part (lens body) to be attached and detached, adjusted at the power of the target patient A multi-piece adjustable intraocular lens for the support can be provided. In addition, it is possible to provide a regenerative crystalline lens unit that is a characteristic of a soft material with elasticity and can be applied to a foldable adjustable intraocular lens that is deformed or folded and inserted into the eye. It becomes.

  In addition, a refraction part formed by a boot-type integral molding method using a flexible material with elasticity at the position where the movable support part and the fixed support part provided with the optical part (lens body) are connected. In the form formed in each embodiment of the present invention (folded back), the refractive part of the regenerated lens lens unit inserted in the lens capsule is the front capsule part, the equator part, and the back capsule part, By being connected to a stable position with an urging force with a constant tension that is connected in a connected manner, the aqueous humor is prevented from being retained even at the post-operative period when the aqueous humor is filled and inserted. The onset of secondary cataracts and the like can be prevented by the regenerated lens unit.

  In addition, the mold structure is very simple and inexpensive because it is a processing method of the basic structure that is molded by the boot mold integral molding method with a flexible material whose movable support part and fixed support part have elasticity. Yes, it can be easily manufactured even with shapes that cannot be manufactured with special injection molds or technologies.

  Further, in the above-described boot mold integral molding method, the movable side (core) in the mold molding structure is reversed (folded) at the refracting portion of the molded product when released from the fixed portion (cavity), A mold structure that is formed in the embodiment of the present invention and can be taken out can be easily manufactured, and modeling with a 3D printer or the like dedicated to a soft material is also possible.

The (a) perspective view of the reproduction | regeneration lens lens unit of this invention, (b) The partial cross section figure of the aspect inserted in the crystalline lens capsule in embodiment. (A) Sectional drawing of the original form aspect of lens integral molding at the time of shaping | molding in 1st Embodiment, (b) The half sectional view formed in the implementation shape. FIG. 6 is a half cross-sectional view of (a) the optical unit (convex lens) at the front side position and (b) the rear side position in the first embodiment. Sectional drawing of the original form aspect of the integral molding at the time of (a) shaping | molding in 2nd Embodiment, and (b) Sectional drawing formed to the implementation shape. The partial sectional view of insertion in the lens capsule of the (a) front side position which fitted the lens body in 2nd Embodiment, and (b) back side position. 5A is a cross-sectional view of an original form of an optical part (concave lens) lens-integrated molding at the time of molding in a third embodiment of the present invention, and FIG. FIG. 6A is a half cross-sectional view of (a) a front side position in which a convex lens body is fitted on the front side, and (b) a rear surface position of an optical unit (concave lens) in a third embodiment of the present invention. (A) Perspective view in other embodiment of this invention, (b) Half sectional view formed to embodiment. The other embodiment of this invention WHEREIN: (a) Sectional drawing of an original pattern aspect, and (b) The half sectional view formed in the implementation shape. In another embodiment of the present invention, (a) a half-sectional view in which an optical part (balloon) is fitted on the front side in the inserted state in the lens capsule, and (b) an aspect after the curvature of the optical part is changed A cross-sectional view at. In the lens capsule according to another embodiment of the present invention, (a) the half-sectional view in which the optical part (balloon) is fitted on the front side in the inserted state, and (b) another aspect after the curvature change. FIG. (A) Sectional drawing of the normal body of the optical part (balloon) single-piece | unit in other embodiment of this invention, (b) Sectional drawing of the aspect after curvature change.

Hereinafter, the present invention will be described in detail based on illustrated embodiments.
FIG. 1 to FIG. 12 are block diagrams of the reproduction lens unit 1, and the first, second, and third embodiments, and other embodiments, the reproduction lens lens. The unit 1 includes an integrated molding of the optical part (lens body) 4 and a removable optical part (lens body) 4 in the concept of realizing focus adjustment by moving the optical part in the optical axis direction. Aspects of the embodiment in the boot-type integral molding method using a soft material having elasticity, provided with a refracting part 5 serving as a hinge acting part at a position where the supporting part 3 is connected to the fixed supporting part 2 And is inserted into the lens capsule ST.

  Further, the refracting portion 5 of the hinge acting portion is a position that becomes a boundary portion between the movable support portion 3 and the fixed support portion 2 in order to develop a correlative biasing force by integral molding with a soft material having elasticity. Thus, the structure is formed by reversing the refraction (folding) and forming the structure formed in the aspect of the embodiment. In addition, it is a clinical advantage that enables the post-operative small incision site SnC to be as small as possible and allows early recovery after surgery. As flexible biomaterials (biocompatibility) that can be inserted into ST and have excellent elasticity and transparency, silicone resins, crosslinked acrylic polymers, hydrogels, PC group-containing urethane materials, etc. It becomes all the moldings.

  As shown in FIG. 1 (a), the regenerated lens lens unit 1 is inserted into the lens capsule ST after removing the cortex and nucleus from the anterior capsule small incision wound portion SnC of the lens capsule Sn. ), The regenerated crystalline lens unit 1 has an optical portion (lens body) with an annular tension vector Ft via a chin band (ciliary small band) Zt that accompanies contraction and relaxation of the ciliary muscle Mt. ) 4 in the direction of the optical axis is a structure for achieving focus adjustment.

  As shown in FIG. 2 (a), the regenerated crystalline lens 1 is the original form of the boot-type integral molding with a soft material having elasticity in the first embodiment, and the constituent parts in the present invention are shown in FIG. As shown in FIGS. 2 (a) and 2 (b), it is formed on the front and back surfaces of the molding surface, and the optical part (lens body) 4 is integrally molded at the front end opening of the movable support part 3. It is integrally formed on the radial surface of the optical part frame 4X. In addition, the refraction is reversed (folded) in the direction indicated by the arrow FF in FIG. 2A where the refraction unit 5 is provided at the position where the movable support unit 3 and the fixed support unit 2 are connected to each other. It is the structure which becomes the aspect formed in embodiment of invention.

  Further, bending of a plurality of notch grooves having a bending action in the circumferential direction equally in the direction perpendicular to the inner side surface of the optical part frame 4X provided by integral molding at the front end opening of the movable support part 3 An auxiliary groove 5a, a V-shaped refracting groove 5b, and an optical part refracting groove 5e are arranged, and a V-shaped groove bending part 5V is arranged. The V-shaped groove bending part 5V is formed by a support leg 5Y. The refraction part 5 and the fixed support part 2 are connected.

  Further, in the vertical direction of the inner side surface of the front end opening edge of the fixed support portion 2 described above, there is a refractive action groove 6v that operates in contact with the side wall of the V-shaped groove bent portion 5V at equal circumferences. A plurality of elastic refractive protruding ribs 6 are formed.

  Further, the extensibility of the lens capsule around the equator portion is good, and the fixation is performed by equally dividing the circumference in the vertical direction of the inner surface of the opening edge of the fixed support portion 2 connected to the movable support portion 3 and the refracting portion 5. A plurality of rhombic cutout windows 2w are arranged on the equator portion 2z of the support portion 2. Further, the equator portion 2z further reduces the cross-sectional area in the vicinity of the equator portion 2z of the fixed support portion 2 as compared with the anterior capsule portion Fr and the posterior capsule portion Re in order to enhance controllability of the bending action. The changed horizontal belt bending portion 2K is provided on the inner wall surface, and the regenerative lens lens unit 1 is tensioned on the inner wall surface of the lens capsule ST by a synergistic action synchronized with the urging force having a constant tension of the refracting portion 5. It is arranged to be maintained continuously.

  As shown in FIGS. 3A and 3B, the elastic bent protrusion-like rib 6L is provided to support the V-shaped groove bent portion 5V provided in the front direction of the support leg portion 5Y of the movable support portion 3. The optical contact frame 4X is always flat in the direction of the optical axis in cooperation with the annular tension vector Ft of the chin band (ciliary small band) Zt by the fitting contact operation with little transmission loss in the inter-part operation. The required movement amount MST required to obtain a focus adjustment force of 2.0D or more by the combined biasing action of the structure in the orbit to adjust the focus with efficient pressing while maintaining the property is 1.5 mm or more The amount of movement of the optical unit (lens body) 4 is ensured.

  In addition, since it is necessary to maintain the tension by the biasing force to the anterior capsular incision wound part SnC after the insertion into the intracapsular ST, it is efficient while maintaining the optical part frame 4X in the optical axis direction while maintaining flatness. The opening edge portion of the fixed support portion 2 that becomes the biasing force direction surface of the elastic bending protrusion-like rib 6L in the biasing action that adjusts the focal point of the specified movement amount MST by pressing is divided equally around the circumference. Further, a torus groove (annular groove) 2c perpendicular to the slit 2d is provided in the horizontal direction near the opening of the fixed support portion 2 in the horizontal direction. In addition, the torus groove (ring groove) 2c of the optical frame 4X is formed on the wall surface of the lens capsule ST of the reproduction lens unit 1 where the aqueous humor moves from the anterior capsule portion Fr to the equator portion 2z and the posterior capsule portion Re. It becomes the arrangement which becomes the fluid action.

Next, a second embodiment will be described.
In accordance with the functionality and operation of the basic structure shown in FIGS. 1 to 3 in the first embodiment, the elastic force is shown in FIG. FIG. 4 (b) shows a configuration of a prototype of a boot-type integral molding with a soft material having a shape formed in an embodiment of the present invention and inserted into a crystalline lens. Further, as shown in FIG. 4 to FIG. 5, the optical unit (lens body) 4 is integrally formed on the circumferential inner ring surface of the distal end opening of the optical unit frame 4X at the part where the optical unit (lens body) 4 is integrally molded. Not the part (lens body) 4 but a locking groove 4D for fitting the edge of the convex lens 4a suitable for the power of the symmetric patient is provided.

  FIG. 5 (a) shows a convex lens 4a of the optical part (lens body) in which the reproducing crystalline lens unit 1 of the present invention is inserted into the crystalline lens capsule in a front side (near vision) mode. In addition, as shown in FIG. 5 (b), in cooperation with the annular tension vector Ft via the chin band (ciliary small band) Zt generated when the ciliary muscle Mt contracts or relaxes, A convex lens 4a is fitted in a locking groove 4D provided in the optical part frame 4X, which is integrally formed with the movable support part 3, and the focus is adjusted with a specified movement amount MST in the optical axis direction. It becomes the side (far vision) mode.

  Further, the convex lens 4a provided in the circumferential inner ring surface of the optical frame 4X and fitted into the locking groove 4D is deformed or folded after the regenerative crystalline lens unit 1 is inserted into the crystalline lens capsule ST, and then into the crystalline lens capsule. Wearable with a foldable adjustable intraocular lens to be inserted.

Next, a third embodiment will be described.
As shown in FIGS. 6 (a) and 6 (b), the functions of the basic components of the first embodiment (FIGS. 1 to 3) and the second embodiment (FIGS. 4 to 5) are described. FIG. 6 (a) is a soft material having elasticity in conformity with the properties and functions, and the component parts in the original mold aspect and the aspect of the third embodiment of the present invention are formed on the front and back surfaces of the molding surface. The concave part 4b of the optical part (lens body) is integrally formed at the position of the refracting part 5 serving as a fixed part on the rear surface side in the configuration where the optical part (lens body) is a two-concave lens structure. Is formed. Further, as shown in FIG. 6 (a), the refraction part 5 at the rear end of the edge part of the concave lens 4b is refracted (turned back) in the illustrated arrow direction FF, and the embodiment of the present invention. It becomes the structure which becomes the aspect formed in.

  Further, as shown in FIG. 6B, the movable portion which is formed by integral molding at the position of the above-mentioned refracting portion 5 and is refracted (turned back) at the position of the rear end of the edge portion of the concave lens 4b. A locking groove 4D into which a front optical part (lens body) is fitted is provided on the circumferential inner ring surface of the tip opening of the optical part frame 4X integrally formed with the support part 3.

  In the second and third embodiments of the regenerated crystalline lens unit 1 of the present invention, the front side to be fitted in the locking groove 4D provided on the circumferential inner ring surface of the optical part frame 4X described above. It is a type that is adjusted by changing the convex lens 4a of the optical part (lens body) and the radius of curvature of the optical part (lens body), but it is possible to fit an artificial lens (balloon) 4c similar in shape to the natural crystalline lens, although not shown.

Explanation of the focus adjustment mechanism of the human eye and the operation of the reproduction lens unit 1 of the present invention.
The idea of “focus adjustment by moving the optical part in the optical axis direction through the chin band (ciliary zonule) accompanying the contraction and relaxation of ciliary muscles” In the near vision, when the ciliary muscle contracts, the distance from the center increases and the chin band (ciliary zonule) loosens. Increases and the refractive power increases. In distance vision, when the ciliary muscle Mt relaxes, the ciliary muscle Mt spreads outward to increase its length, and the chin band (ciliary zonule) is pulled outward, and the lens Follows and is pulled outward, reducing the refractive power to reduce the thickness.

  Thus, with respect to the natural regulation mechanism, as shown in Fig. (7a), in the half cross-sectional view of the near vision state, it cooperates with the annular tension vector Ft of the chin band (ciliary small band) Zt In the near vision (the ciliary muscles itch, the chin band is loosened and the lens is rounded and thick) which is not pushed down in the direction of moving the focal point of the movable support 3 in the direction of the optical axis. In the aspect, the convex lens 4a is in a position on the front capsule portion Fr side.

  Further, as shown in FIG. 7B, the movable support portion 3 is moved in the optical axis direction in cooperation with the annular tension vector Ft of the chin band (ciliary small band) Ct in a half sectional view in the distance view state. In the state in which the lens lens unit 1 is pushed down in the direction in which the focal point moves, the regenerative lens unit 1 operates in such a manner that the ciliary muscle is loosened and the chin band is pulled to flatten the lens. It moves to the concave lens 4b side formed by integral molding on the part Re side.

Next, another embodiment (claim 8) will be described.
In the first embodiment and the second embodiment described above, in the basic structure of the boot-type integral molding of the soft material having elastic force, the bending portion 5 is refracted at the position on the anterior capsule small incision wound SnC side. Another embodiment in the form formed in the embodiment after being (folded) is shown in FIG. 8 (a) and FIG. 8 (b). Further, as shown in FIG. 8B, in the aspect in which the reproduction lens unit 1 formed in the embodiment of the present invention is mounted in the lens capsule ST, the optical unit (lens body) has a two-sheet configuration. The optical part (lens body) located on the front side is similar to the shape of the crystalline lens, and includes a locking groove BF into which the artificial lens (balloon) 4c is fitted and a concave lens 4b of the optical part (lens body) located on the rear surface side. It consists of a locking groove BR to be locked.

  Next, as shown in FIG. 9A, the constituent parts in the original form of the boot mold integrated molding are formed on the front and back of the molding surface by a soft material having elasticity. Further, the movable support portion 3 is a refraction portion 5 having a hinge action, and is refracted (turned back) in the direction indicated by the arrow FF so that the movable support portion 3 is formed on the inner surface of the fixed support portion 2 as shown in FIG. The fitting locking groove 3 recess which fits the fitting tip 3 projection of the support rib 3L is formed at the portion where the shape is maintained so as to be the mode.

  Further, as shown in FIG. 9B, the artificial lens (balloon) 4C of the optical part (lens body) fitted in the front-side locking groove BF is a meteorite-shaped balloon made of silicone (diameter is about 10 mm, The injection material is also made of the same silicone, and the solidity after injection can be adjusted by the mixing ratio of the two liquids, and the refractive index can be adjusted by changing the curvature. In addition, it is also applicable to a foldable type adjustable intraocular lens that is deformed or folded and inserted into the eye.

  Next, as shown in FIG. 10 (a), in the form formed in the embodiment of the present invention and mounted in the capsular bag ST, it is in close contact with the edge of the anterior capsular small incision wound portion SnC of the capsular bag ST. An annular tension vector Ft is applied to the refracted portion 5 that is refracted (turned back) at the position where the ciliary muscle Mt contracts or relaxes via a Chin band (ciliary small band) Zt. Then, the fulcrum Fu1 and the force point (the force applied point) in the mechanism in which an annular uniform stress is applied to the peripheral edge 4cP of the artificial lens (balloon) 4c in the locking groove BF into which the artificial lens (balloon) 4c is fitted. Action point) It is composed of a mechanism based on the principle action of the lever provided with Ac1. The mechanical relationship between the fulcrum part (Fu1) and the applied point (action point) Ac1 with the annular tension vector Ft part via the chin band (ciliary zonal) Zt as a force point due to the lever action is The effect of the uniform stress in the ring 4cP of the artificial lens (balloon) 4c is about 1: 3 force amplification (about 3 times).

  Further, as shown in FIG. 10 (b), the engaging groove portion BF into which the artificial lens (balloon) 4c located on the front side is fitted expresses the refractive power at the curvature change Le of the artificial lens (balloon) 4c. The mechanism part of the lever principle is provided, and the artificial lens (balloon) 4c is pressed by pressing the peripheral edge 4cP of the front and back surfaces of the artificial lens (balloon) 4c concentrically with a uniform stress. The content substance So of the lens is concentrated and raised in the center, and the curvature change Le of the lens body with roundness and thickness is made.

  In addition, the pressure action on the edge 4cP that causes the curvature change Le by concentrating the center of the content substance So of the artificial lens (balloon) 4c is an optical part (lens body) located on the rear surface side. In adjusting the focus with the concave lens 4b, the delay action of Fu1 and Ac2 on the target surface of Fu1 and Ac1 action, and the synchronization action and the limitation of the action face of Fu1 and Ac1 are designed to set the thickness of the support rib 3L. It is a possible component above.

  11 (a) and 11 (b), the artificial lens (balloon) 4c is fitted on the front side, and the convex lens body 4a is fitted on the rear surface side. 11 (b), the one side part of the front side of the peripheral lens part 4cP of the artificial lens (balloon) 4c on the front side is pressed by the uniform stress of the ring of the application point (action point) Ac1 to Although the content substance So of the crystalline lens (balloon) 4c is concentrated and raised in a semicircular shape around the center, the curvature changes Le to become a lens body with a fullness and thickness. It has a structure that allows selection and combination of optical parts (lens bodies) in accordance with visual acuity adjustment.

  12 (a) and 12 (b) are cross-sectional views of the artificial lens (balloon) 4c alone, and the surface layer member Sf of the optical part (lens body) is a medical material silicone elastic film (film thickness is about 20 μm). ) Between the front and back silicone elastic membranes of the surface layer member Sf, the flat ring-shaped holding core material Sr made of the same silicone is crimped and fixed by the flat surface portion and the flange portion Sfe, and injected into the inside. Content material So is provided with a conventional injection tube and closed with a backflow prevention plug or gel enclosure to prevent leakage, but the content of refractive index designated silicone oil mixing in this embodiment The injection of the substance So is carried out with an injector (thin needle-like needle), etc., and even when pierced and filled, the puncture part is suppressed by the holding core material Sr having closing properties such as viscoelasticity. It becomes possible. In addition, with the injection volume of the content substance So, filling with a high accuracy is possible even for a quantitative mixing ratio of about two-thirds, which affects the refractive index adjustment range.

  In addition, since the artificial lens (balloon) 4c in the present embodiment has a simple structure with the above-described configuration, it does not need to be manufactured by a conventional special injection mold technology or the like, and the surface layer member Sf and the holding core. The material Sr can be molded using standard materials made of medical silicone, etc., and the structure that enables high-precision control of tension adjustment and injection pressure of contents in required specifications in terms of optical characteristics. It is.

  In the first to third embodiments of the reproducing lens unit 1 and other embodiments of the present invention, the optical unit (lens body) is always kept flat in the optical axis direction while maintaining efficiency. The fixed support portion 2 and the movable support portion 3 in the basic structure formed in the configuration of the boot-type integral molding with a soft material having elastic force in order to perform the prescribed movement are equally divided in the circumference. It is necessary to arrange a plurality of parts connected to each other, and the embodiment of the present invention is very small. In consideration of processing problems at the actual size, the fixed support part 2 preferably has a circumference of about eight equal parts. However, it is not limited to the above-described embodiment and other embodiments, the configuration of the fixed support portion 2 and the movable support portion 3, the increase and decrease of the number, the shape (including the notch portion) and the material, Design changes can be made without departing from the scope of the present invention.

DESCRIPTION OF SYMBOLS 1 ... Regenerated crystalline lens 2 ... Fixed support part 2c ... Torus groove (ring ring groove)
2d ... Slit 2K ... Horizontal belt bending part 2w ... Rectangular cutout window 2z ... Equator part 3 ... Moving support part 3L ... Support rib 3 convex ... Fitting tip Part 3 concave ... fitting locking groove 4 optical part (lens body)
4a ... convex lens 4b ... concave lens 4c ... artificial lens (balloon)
4Cp: Edge 4D: Locking groove 4X: Optical part frame 5: Refraction part 5a ... Bending auxiliary groove 5b ... V-shaped refraction groove 5e ... Optical part refraction groove 5V ... V-shaped groove bending part 5Y ... Support leg part
Fr ・ ・ ・ Anterior capsule
Re: posterior capsule
MST ・ ・ ・ Regular displacement 6L ・ ・ ・ Ribular elastic protrusion 6v ・ ・ ・ Refractive action groove
Zt ... Chin belt (hair-like band)
Ft ... annular tension vector
BF ... Locking groove
ST ... Lens capsule
SnC ・ ・ ・ Small incision in the anterior capsule
FF ... arrow direction Fu1 ... fulcrum part Fu2 ... fulcrum part Ac1 ... force point (action point)
Ac2 ... Force point (point of action)
Le ... curvature change
So ・ ・ ・ Content
Sf ・ ・ ・ Surface material
Sr: Holding core
Sfe ・ ・ ・ Flange

Claims (10)

  A regenerative lens lens unit that is inserted into the lens capsule after removal by extracapsular extraction to remove the cortex and nucleus inside the lens capsule by small incision wound cataract surgery, etc., and inserted into the lens capsule Then, the flexibility and transparency in the concept of achieving focus adjustment by moving the optical part in the optical axis direction through the chin band (ciliary zonule) accompanying the contraction and relaxation of the ciliary muscle It is made of a soft material that is superior to the above, and the movable support part with the optical part (lens body) that is a component of the adjustable intraocular lens is connected to the fixed support part at the refraction part that becomes the hinge action part. A regenerated crystalline lens unit characterized in that it is formed in an embodiment of the present invention by a reversal (folding) of refraction at the refraction part, which is a basic structure formed by a very simple integral molding method.   The basic structure of the regenerated lens lens unit according to claim 1, wherein the fixed support portion is integrally formed with the movable support portion even in a gap in the lens capsule having a certain individual difference in the target patient. In the refraction part at the position that becomes the boundary part of the lens, it is connected to the anterior capsule incision edge, the equator part, and the posterior capsule part of the lens capsule wall surface by the synchronous action with the urging force action that is reversed (folded) In the aspect formed in the embodiment of the present invention, maintaining the biasing force having high correlation and control functionality, the effect of regenerating lens function in the long term after the insertion into the lens capsule Regenerative lens lens unit featuring a lasting structure.   The basic structure of the regenerated lens lens unit according to claim 1 and claim 2, wherein the ring is formed through a chin band (ciliary zonule) generated when the ciliary muscle contracts or relaxes. In order to move the optical part (lens body) of the optical part frame provided in the movable support part in the direction of the optical axis stably in cooperation with the tension vector, it is perpendicular to the inner side surface of the edge of the optical part frame. The elastic bent protrusion-like ribs are arranged in a circumferentially equal part and provided in the support leg, and are moved in contact with the operation part of the V-shaped groove bending part and pressed. In order to obtain a focus adjustment force of 2.0D or more, the movable support portion is provided in a direction perpendicular to the inner surface and has a small transmission loss due to the contact movable action of the pressing force and the support leg portion of the movable support portion. It is a structure that ensures the amount of movement in the optical axis direction of the optical part (lens body) of at least mm. Regenerative crystalline lens unit characterized by   4. A one-piece adjustable intraocular lens according to claim 1, 2, and 3, wherein the movable support part is integrally formed with the optical part (lens body). A regenerative crystalline lens unit comprising:   The basic structure of the regenerated crystalline lens according to any one of claims 1, 2, and 3, wherein an optical unit frame is integrated with the movable support unit in order to flexibly cope with the appropriate power of the target patient. A regenerative crystalline lens characterized by a multi-piece type adjustable intraocular lens having a locking groove that is detachable by fitting an optical part (lens body) to the inner edge of the opening formed by molding Lens unit.   The basic structure of the regenerated crystalline lens according to claim 1, claim 2, and claim 3, wherein the concave lens of the optical part (lens body) on the rear surface side in a two-lens configuration is integrally molded at the time of molding. In the original form, it is formed with a structure integrally formed on the back surface of the refracting part (hinge action part) that becomes the boundary part between the movable support part and the fixed support part, and is integrated with the movable support part on the front side. The multi-piece type adjustment according to claim 5, wherein the optical part frame formed by molding is provided with an engaging groove that is detachable by fitting the optical part (lens body). Regenerative crystalline lens unit characterized by compounding with sexual intraocular lens.   7. A regenerative lens unit according to claim 1, wherein the lens unit is a foldable type that is deformed or folded by a one-piece type adjustable intraocular lens and a multi-piece type adjustable intraocular lens and inserted into a lens capsule. A regenerative crystalline lens unit characterized by being an adjustable intraocular lens, and capable of cataract surgery or the like using a small incision in a part of the anterior lens capsule.   3. A basic structure of a reproduction lens unit according to claim 1 or 2, wherein a lock is mounted to mount an artificial lens (balloon) of a type to be adjusted by a change in the radius of curvature of an optical part (lens body). In the groove, the pressing force of the passive part of the annular tension vector through the chin band (ciliary zonule) accompanying the contraction and relaxation of the ciliary muscle is used to amplify the force by the lever action between the constituent members. A regenerative crystalline lens unit characterized by a structure that adjusts the focus by changing the radius of curvature of the optical part (lens body).   The basic structure of the regenerated lens lens unit and the artificial lens (balloon) processing method according to any one of claims 1 to 8 can be manufactured by conventional injection mold technology or mold structure restrictions. Reproducing crystalline lens unit, which can be manufactured easily and inexpensively even for shapes that cannot be handled.   The basic method of forming the basic structure of the regenerated crystalline lens unit is that the structure has a very simple unfolded shape and can be applied to other than the modeling method (manufacturing method) described in claims 1 to 8. For example, ophthalmic examination The original medical examination data of the symmetric patient by the device, especially the lens related information etc. is converted into 3D data for modeling and reflected in the 3D design etc. A regenerative crystalline lens unit characterized in that it does not require an injection mold or the like, and can be shaped (manufacturing method) adapted with high accuracy to the size of the lens capsule of each symmetrical patient.

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