JP6616084B2 - Intraocular lens - Google Patents

Description

  The present invention relates to an intraocular lens, and more particularly to an intraocular lens that can be used for various techniques such as in-the-bag, out-the-bag, sewing fixation, and intra-scleral fixation.

  For example, when the lens becomes cloudy due to cataract, the eyesight can be recovered by a surgical procedure in which an intraocular lens, which is an artificial lens, is inserted into the eye instead of the clouded lens.

  An intraocular lens implanted in the eye during cataract surgery is constituted by an optical part (lens part) having an optical lens function instead of a crystalline lens and a support part that supports the optical part. Usually, this type of intraocular lens is housed inside the lens capsule that remains after the lens is removed. In this case, a cataract operation (in-the-bag) as shown in FIG. 1 is performed.

  When the posterior capsule (the back part of the eyeball) in the lens capsule is damaged, the lens capsule is fragile and may not be fixed in the capsule by the support portion. In that case, a cataract operation (out-the-bag) is performed in which an intraocular lens is placed in such a manner that the support portion is fitted into the ciliary groove while being placed on the corneal side as viewed from the lens capsule (FIG. 2).

  However, for example, when the sac itself has already been removed or no longer exists, a technique is known in which the support is sewn and fixed to a predetermined part of the eye with a suture. This sewing fixation mainly includes the following techniques, that is, ciliary groove sewing (FIG. 3), ciliary body flat part sewing, and sewing to the sclera.

  Under such circumstances, attention has recently been paid to a technique called “intrascleral fixation” which is different from the technique such as in-the-bag, out-the-bag, and conventional sewing (FIG. 4). The technique of intrascleral fixation is a technique of embedding the tip of the support part of the intraocular lens in the sclera.

  The content of the technique of intrascleral fixation is also described in [0004] to [0006] of Patent Document 1. For example, in [0004] of Patent Document 1, the tip of the support portion of the intraocular lens is inserted into a tunnel-shaped hole formed in the sclera in the circumferential direction, and the tunnel is not sewn by tightening the tip. It is described that an intraocular lens is supported.

  If the technique of intrascleral fixation is adopted, the intraocular lens can be placed more stably (eg, the eccentricity and inclination of the optical part can be suppressed) than the conventional technique of sewing. Are known. Hereinafter, the eccentricity and inclination of the optical unit are collectively referred to as “eccentric inclination”. In addition, when the intrascleral fixation is used, sewing is not essential, and the burden on the operator and the patient undergoing surgery can be significantly reduced.

  [0006] In Patent Document 1 [0006], as a problem, the development of an intraocular lens suitable (specialized) suitable for intrascleral fixation is insufficient by using a conventional intraocular lens. It has been pointed out.

JP 2014-14646 A

  As described in Patent Document 1, it cannot be said that the development of an intraocular lens suitable for intrascleral fixation is sufficient at present. For example, although the intraocular lens described in Patent Document 1 can be fixed as long as the tip of the support portion can be inserted into the sclera, the tip of the support portion has a folded shape. It may be difficult to pass through a tunnel formed in the sclera, which may increase the burden on the operator.

  The present inventor performs not only the description in Patent Document 1 but also a variety of commercially available intraocular lenses by performing a test (tensile test) on the assumption that intrascleral fixation has been performed, and performs intrascleral fixation. The problem at the time was identified. As a result, it was found that, when performing intrascleral fixation, the eccentric inclination of the optical part of the intraocular lens still exists as a major point to be improved. In addition, it was found that it is necessary to create an intraocular lens specialized in suppressing the eccentric inclination in performing intrascleral fixation (that is, an intraocular lens specialized in intrascleral fixation).

  On the other hand, the inventors have found that there is the following demand for an intraocular lens specialized for intrascleral fixation. Certainly, recently, attention has been paid to the difficulty of causing eccentric inclination, and the technique of intrascleral fixation is spreading. Therefore, there is a need for an intraocular lens specialized in intrascleral fixation that further increases the goodness of intrascleral fixation. However, as described above, depending on the condition of the patient's capsular bag, there are many cases where it is preferable to apply a technique other than intrascleral fixation. In that case, it is impossible for the surgeon to keep only an intraocular lens specialized for intrascleral fixation in stock. In that case, in addition to the intraocular lens specialized for intrascleral fixation, it is necessary to prepare an intraocular lens that can handle other surgical methods. If this happens, the surgeon will be burdened with stock and lack convenience. In other words, the present inventor has revealed that there is a hidden demand for an intraocular lens that can handle other surgical methods even for intraocular lenses specialized for intrascleral fixation. .

  As a result of the above, the intraocular lens capable of intrascleral fixation has seemingly contradictory performances such as "specialization of performance for intrascleral fixation" and "general versatility for a variety of surgical procedures". The inventor is urged to provide something.

  An object of the present invention is to provide an intraocular lens that is specialized in performance for intrascleral fixation and has versatility for a wide variety of surgical procedures.

  The present inventor has studied a method for solving the above-described problems, and further performed the above various tests. In the various tests, tests were performed on various known intraocular lenses. As a result, the configuration of the present invention described below has been adopted.

The first aspect of the present invention is:
A soft optical part having a lens function;
A wide soft support portion extending from the optical portion and integrally formed with the optical portion and a base end;
A hard support portion connected at the base end with the soft support portion and extended in the extending direction of the soft support portion;
With
In the intraocular lens, the maximum width of the distal end portion of the hard support portion is a narrow shape of 0.3 mm or less.
A second aspect of the present invention is the invention according to the first aspect,
The hard support portion further includes a middle base end portion connected to the wide soft support portion, and the base end portion and the narrow tip end portion are connected.
A third aspect of the present invention is the invention according to the first or second aspect,
The maximum width of the tip portion of the hard support portion is a narrow shape of 0.2 mm or less.
A fourth aspect of the present invention is the invention according to any one of the first to third aspects,
The distal end portion of the hard support portion is warped so as to face the optical portion.
A fifth aspect of the present invention is the invention according to any one of the first to fourth aspects,
The hard support portion is provided with a constriction.

  According to the present invention, it is possible to provide an intraocular lens that is specialized in performance for intrascleral fixation and also has versatility for a wide variety of surgical procedures.

It is a cross-sectional schematic diagram which shows the mode of a cataract operation (in-the-bag). It is a cross-sectional schematic diagram which shows the mode of a cataract operation (out-the-bag). It is a cross-sectional schematic diagram which shows the mode of ciliary groove sewing. It is the schematic which shows the mode of intrascleral fixation. It is the schematic which shows the intraocular lens in this embodiment, Fig.5 (a) is a top view, FIG.5 (b) is a side view. FIG. 6 is a schematic plan view showing a preferable example (warp shape) of an intraocular lens in the present embodiment. FIG. 6A is a view before inserting the intraocular lens into the lens capsule, and FIG. FIG. It is a plane schematic diagram showing a preferable example (bending) of an intraocular lens in the present embodiment. It is the schematic explaining the manufacturing method of the intraocular lens in this embodiment. It is a plane schematic diagram showing an intraocular lens (modification mode 1) in this embodiment. It is a plane schematic diagram showing an intraocular lens (modification mode 2) in this embodiment. It is a plane schematic diagram which shows the intraocular lens (modification aspect 3) in this embodiment. It is a schematic plan view showing an intraocular lens (deformation mode 4) in the present embodiment. It is a schematic plan view showing an intraocular lens (deformation mode 5) in the present embodiment.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
In the present embodiment, description will be given in the following order.
1. Intraocular lens (A) Optical part (B) Support part (B-1) Soft support part (B-2) Hard support part (B-2-1) Base end part (B-2-2) Tip part 2. Manufacturing method of intraocular lens 3. Use of intraocular lens 4. Effects of the embodiment Modified example

  In addition, about a structure which is not described below, you may employ | adopt a well-known structure suitably. In particular, the contents described in the document (Japanese Patent Laid-Open No. 2013-22273) disclosed by the present inventor may be applied to this embodiment. This document mainly mentions sewing fixing, and when performing non-sewing fixing, it is described as an in-bag in [0041] to [0046] of the document. In the first place, as shown in each figure of the document, the tip of the support part is too wide to be suitable for intrascleral fixation, and “specification of performance for intrascleral fixation” “ In order to solve the seemingly contradictory problem of “general versatility for a wide variety of surgical methods”, there are a number of opportunities for selecting the configuration of the intraocular lens described in the document from among the numerous intraocular lenses. Not yet publicly known.

  In this specification, the “tip” refers to the side away from the optical unit when viewed from the center of the optical unit, and the “base” refers to the side closer to the optical unit. Point to.

  Further, in this specification, “wide”, “medium width”, and “narrow” mean that each part in the arm-shaped support part (soft support part or hard support part, base end part or distal end part of the hard support part). The width of the part where the width is maximum is compared in each part. For example, if the cross section of each part is a rectangle, “width” refers to the length of the diagonal of the rectangle, and if the cross section of each part is an ellipse or a substantially ellipse, “width” is the major axis. If the cross section is a circle or a substantially circle, “width” refers to the diameter. “Wide”, “medium width”, and “narrow” can be rephrased as “very thick”, “medium thick”, and “very thin”.

  In the present embodiment, reference is made to the width in plan view for the purpose of illustrating the case where the cross section of each part is substantially rectangular. Moreover, although it is how to measure the width | variety in this embodiment, the outer side of a support part (a side far from the curve center of a support part) which opposes the arbitrary points inside a support part (side near the curve center of a support part). The distance between these points (the distance between points X and X ′ in FIG. 5 described later). As another measurement method, from an arbitrary point on the inner side of the support portion (side closer to the center of curvature of the support portion) like a point Y or a point Z of the support portion in FIG. It is the distance between the closest part (point Y ′ and point Z ′) on the side farther from the center of curvature.

<1. Intraocular lens 1>
As shown in FIG. 5, the intraocular lens 1 in this embodiment is roughly provided with an optical unit 2 having a lens function and a support unit 3 that supports the optical unit 2. FIG. 5 is a schematic view showing the intraocular lens 1 in the present embodiment, in which FIG. 5 (a) is a plan view and FIG. 5 (b) is a side view.
Hereinafter, each configuration will be described with reference to FIG.

(A) Optical part 2
The optical unit 2 is a relatively soft portion having a lens function, and is formed in a convex lens shape having a circular shape in plan view. The diameter of the optical unit 2 may be set to any size as long as it is a size suitable for inserting the intraocular lens 1 into the lens capsule in the eye. To describe a specific dimension setting example, the diameter D of the optical unit 2 is preferably set in a range of 5 mm to 7 mm, and more preferably set to 7 mm. By using the optical part 2 having a relatively large aperture when fixing the intraocular lens 1 in the eye, the influence of the eccentric inclination can be reduced as compared with the case of the optical part 2 having a small aperture.

  What is necessary is just to set the thickness of the optical part 2 according to a desired refractive index. The optical unit 2 is made of a soft material that allows the optical unit 2 to be folded. The term “foldable” described here is used to mean that the intraocular lens 1 including the optical unit 2 can be folded in at least two. Therefore, the soft material constituting the optical unit 2 is a material having a high degree of flexibility enough to fold the optical unit 2. Specifically, for example, soft materials such as silicone resin, acrylic resin, hydrogel, and urethane resin can be used.

(B) Support part 3
The support part 3 is formed in a state extending outward from the outer peripheral part of the optical part 2. The support unit 3 supports the optical unit 2 when the intraocular lens 1 is inserted into the eye. Two support portions 3 are formed on one intraocular lens 1. Each support portion 3 draws an arc in a counterclockwise direction in the drawing from a portion where an axis passing through the center C of the optical portion 2 (indicated by a one-dot chain line in the figure) intersects the outer peripheral portion of the optical portion 2. It extends to. Each support part 3 has the following common structure.

  The support part 3 extends in an arm shape outward from the outer peripheral part of the optical part 2. In addition, the support part 3 extends from the optical part 2 and is integrally formed at the base end with the optical part 2, and a wide soft support part 31 is connected to the soft support part 31 at the base end and is softly supported. And a hard support portion 32 extended in the extending direction of the portion 31. Specifically, the main part of the support part 3 is composed of a soft support part 31, and the tip part excluding this is composed of a hard support part 32. In addition, as an intention using the expression “the hard support portion 32 extends in the extending direction of the soft support portion 31”, the tip of the support portion 3 is not J-shaped as described in Patent Document 1. It is what you point. In other words, even when the hard support portion 32 is extended in a direction not greatly deviating from the extending direction of the soft support portion 31 even in a preferable example described later (the tip portion 32b has a warped shape). If there is, it belongs to this embodiment.

  The outer surface of the support part 3 describes a smoothly continuous arc from the soft support part 31 to the hard support part 32. The soft support portion 31 and the hard support portion 32 are sectioned using the arc line as a boundary line when an arc line having a radius R is drawn from the center C of the optical unit 2. That is, the portion inside the arc line having the radius R is the soft support portion 31, and the portion outside the arc line having the radius R is the hard support portion 32.

  In addition, although the example which provides the two support parts 3 is given in this embodiment, you may form the three or more support parts 3. FIG. Further, in the present embodiment, the two support portions 3 have the same configuration and are arranged so as to be point-symmetric when viewed from the center C of the optical portion 2. For this reason, the reference numerals in the figure are attached only to one support part 3.

(B-1) Soft support 31
The soft support portion 31 is configured to be elastically deformable in the radial direction of the optical portion 2. The soft support portion 31 extends in a slender shape as a whole, and the material constituting the soft support portion 31 also has appropriate flexibility. Specifically, the soft support portion 31 is integrally formed of the same soft material as that of the optical portion 2 described above. Here, “integral molding” means that the optical part 2 and the soft support part 31 are integrally formed from the same member, and the optical part 2 and the soft support part 31 are separately formed. It is not formed as a member and connected.

  Since the above configuration is adopted, when the intraocular lens 1 receives an external force toward the center C of the optical unit 2 through the hard support portion 32 when performing the in-the-bag or out-the-bag, the soft support is performed according to the external force. The part 31 can be elastically deformed in a direction approaching the optical part 2. Conversely, when the intraocular lens 1 receives an external force that moves away from the center C of the optical part 2 through the hard support part 32 during sewing fixation or intrascleral fixation, the soft support part 31 optically follows the external force. It can be elastically deformed in a direction away from the portion 2.

  The soft support portion 31 has a base end portion 32a (base portion) that is wide at the bottom of the mountain, and is connected to the optical portion 2 at the widest portion. Further, the soft support portion 31 extends from the wide base end portion 32a so as to draw a circular arc obliquely outward. The tip portion (the portion on the side opposite to the root portion) of the soft support portion 31 is formed to be slightly wider. Note that the width of the soft support portion 31 is gradually reduced from the base end portion 32a of the soft support portion 31 to the distal end portion.

(B-2) Hard support part 32
The hard support part 32 is made of a material having a hardness different from that of the optical part 2 and the soft support part 31 described above. Specifically, the hard support portion 32 is made of a hard material harder than the soft support portion 31. As a hard material applied to the hard support portion 32, any material can be used as long as it can guarantee a strength enough to prevent the portion from being broken even if the suture is tied to the hard support portion 32. Specifically, for example, a hard resin material such as PMMA (polymethyl methacrylate) can be used. The end of the hard support portion 32 is slightly rounded so as not to damage the eyeball tissue even if it contacts the eyeball tissue. Moreover, the soft support part 31 and the hard support part 32 which comprise the support part 3 are structurally integrated only by the material of each site | part differing.

  The hard support portion 32 includes a medium-width base end portion 32a connected to the wide soft support portion 31 and a narrow end (in other words, an ultrafine shape) having a maximum width of 0.3 mm or less. Part 32b.

(B-2-1) Base end portion 32a
The base end portion 32a constituting the hard support portion 32 is a portion connecting the soft support portion 31 described above and the distal end portion 32b having a narrow shape which will be described later, which is another portion constituting the hard support portion 32. There is a portion for smoothly changing the width when viewed from the entire support portion 3. Specifically, based on the role of gradually narrowing the hard support portion 32 toward the distal end side by changing the curvature of the inner curvature while keeping the curvature of the outer curvature of the support portion 3 as it is. The end 32a bears.

(B-2-2) Tip portion 32b
The tip portion 32 b is a portion located at the tip of the hard support portion 32. The maximum width of the tip 32b is 0.3 mm or less, and has a narrow shape (in other words, an ultrafine shape). In the present embodiment, in addition to the various configurations described above (particularly, integral molding of the soft optical portion 2 and the soft support portion 31), the hard tip end portion 32b has a narrow shape, thereby achieving various synergies. An effect is obtained. Details will be described below.

  First, if the maximum width of the tip 32b is 0.3 mm or less, the tip 32b can be easily inserted into the sclera when performing intrascleral fixation. For example, a tunnel-like hole formed in the sclera in the circumferential direction is used in the present embodiment by using a method similar to that described in Patent Literature 1 [0004] and [0029] to [0034]. Insert the tip 32b. In that case, if the maximum width of the distal end portion 32b is a very narrow shape of 0.3 mm or less, the ease of insertion of the distal end portion 32b into the tunnel-shaped hole portion is remarkably improved, and the surgical procedure by the operator is improved. The burden is significantly reduced.

  In addition, it is surprisingly high in terms of stability after intrascleral fixation, that is, in terms of difficulty in causing an eccentric inclination. When the intraocular lens 1 is fixed by the tip portions 32b of the two support portions 3, the optical portion 2 in which the tip portion 32b is suspended in a very thick shape is considered to be a very thin tip portion 32b. It is considered that the optical unit 2 is more stably disposed than the optical unit 2 to be hung. However, since the intraocular lens 1 in the present embodiment is a lens specialized for a specific situation of intrascleral fixation, there are some aspects in which such a conventional idea is not valid. More specifically, in intrascleral fixation, the intraocular lens 1 is placed under a certain special situation in which the distal end portion 32b is sandwiched between meat layers constituting the sclera. As a result, the narrow end portion 32b is more easily wrapped in the meat layer than the wide end portion 32b. As a result, even if the maximum width of the distal end portion 32b is 0.3 mm or less, it is possible to effectively suppress the occurrence of the eccentric inclination in the scleral fixation because the shape is extremely narrow in other words. Moreover, as described above, the ease of inserting the tip 32b into the tunnel-shaped hole is greatly improved.

  Also, if the tip 32b has a very narrow shape with a maximum width of 0.3 mm or less, it can be combined with the various configurations described above to achieve a technique other than intrascleral fixation, ie, in-the-bag, out-the- It also has a positive effect in various techniques such as bag and sewing fixation.

  For example, in the case of an in-the-bag, the intraocular lens 1 is inserted into the capsular bag, and the support portion 3 is fitted near the equator of the capsular bag. At this time, if the maximum width of the tip 32b is 0.3 mm or less, the support 3 is very easily and stably fitted in the vicinity of the equator of the lens capsule. This leads to the stable placement of the optical unit 2 in the intraocular lens 1 and, in turn, makes it difficult for eccentric tilt to occur.

  Further, in the case of an out-the-bag, the support portion 3 is fitted into the ciliary groove, so that, as in the case of the in-the-bag, the maximum width of the tip end portion 32b is 0.3 mm or less and the shape is extremely narrow. The support part 3 fits very easily and stably. This leads to the stable placement of the optical unit 2 in the intraocular lens 1 and, in turn, makes it difficult for eccentric tilt to occur.

Further, in the case of fixing by sewing, if the width of the distal end portion 32b is a very narrow shape of 0.3 mm or less, it is convenient when sewing each tissue of the eye and the distal end portion 32b.
For example, if the maximum width of the distal end portion 32b is large, the eye tissue must be sutured in a wide range according to the width of the distal end portion 32b, which increases the burden on the patient. .
Further, if the maximum width of the tip end portion 32b is 0.3 mm or less, the tip end portion 32b can be locally sewn tightly, and the sewing thread will not easily come off. On the contrary, when the maximum width of the tip end portion 32b is large, it is difficult to collect the winding portions at one place when the sewing thread is wound around the tip end portion 32b, and the tip end portion 32b cannot be locally stitched.

  In addition, the specific position of the front-end | tip part 32b in this embodiment may be arbitrary as long as it is a distance which can perform intrascleral fixation from the forefront of the hard support part 32. FIG. To give a preferred example, in the portion of the hard support 32 from the front end to at least 5 mm, more preferably at least 7 mm, more preferably at least 10 mm, and preferably from the front end to 15 mm, It is preferable that the maximum width of the tip portion 32b is 0.3 mm or less.

  As described above, various special effects can be obtained by combining the tip 32b of the present embodiment with the various configurations described above.

  By the way, in addition to the above-mentioned effect, another synergistic effect can be obtained by adopting a preferable shape of the tip portion 32b. The preferable shape is a shape in which the distal end portion 32b is warped toward the optical unit 2 (FIG. 6A). In other words, the tip 32b is warped toward the optical unit 2 as compared to the portion of the support 3 up to the tip 32b. Hereinafter, this shape is simply referred to as a “warped shape”. As for the degree of “warp” in the present embodiment, the warp is closer to the optical unit 2 than the original curved shape of the base end portion 32a, and the outer curve of the support portion 3 due to the warp is warped. It is less than 90 ° (preferably 45 ° or less, more preferably 30 ° or less). That is, the J-shape as described in Patent Document 1 is not included in the “warp” in the present embodiment.

  Here, the reason why the warp shape is adopted for the distal end portion 32b is that the intraocular lens 1 of the present embodiment is applied to the in-the-bag. For example, when the in-the-bag technique is adopted, the intraocular lens 1 is pressed by the lens capsule, and pressure is transmitted from the vicinity of the equator of the lens capsule to the distal end portion 32b. Then, as shown in FIG. 6B, a portion having a warped shape at the distal end portion 32b is deformed along the lens capsule. That is, by inserting the intraocular lens 1 into the capsular bag, the contact area between the capsular bag and the support unit 3 can be increased, and the intraocular lens 1 (optical unit 2) can be stably disposed. As a result, the occurrence of the eccentric inclination can be more efficiently suppressed. Note that this deformation is possible because the tip 32b has a very narrow shape with a maximum width of 0.3 mm or less.

  Note that the specific position of the warped shape in the present embodiment is, as a preferred example, a portion from the most distal end of the hard support portion 32 to at least 3 mm, more preferably at least 5 mm, and even more preferably at least It is preferable that a 7 mm portion, and preferably a 10 mm portion from the forefront, be warped.

Another preferred shape is to provide a constriction at the tip 32b (FIG. 7). Here, the term “bundling” refers to a state in which the width is wider on both sides of the portion to be constricted and the portion to be constricted is relatively narrow. By forming the constriction, when the sewing is adopted when the intraocular lens 1 is inserted, the sewing thread is hardly detached by performing the sewing at the constricted portion.
Note that the constriction mentioned here may be formed by narrowing the width of the portion to be constricted, or the constriction may be formed by providing a wide portion on both sides of the constricted portion. In addition, although the example in which the constriction is formed on the distal end portion 32b has been described, it may be formed on the proximal end portion 32a. If it is advantageous to sew in the vicinity of the distal end portion 32b according to the technique, a constriction may be formed in the distal end portion 32b. Further, it is preferable to provide the constriction on the inner side of the curve in terms of facilitating the surgical procedure, but it may be provided on the outer side of the curve or on both sides.

  The maximum width of the tip 32b is preferably 0.2 mm or less. If the maximum width of the tip 32b is narrowed, the effects listed above are further increased. The lower limit is not particularly specified as long as the above effect can be obtained, but may be any, but if exemplified, 0.1 mm or more and 0.15 mm or more may be mentioned. Further, the distal end portion 32b may gradually decrease in width toward the forefront within a range of 0.3 mm or less, or may have a predetermined constant width of 0.3 mm or less.

As an example of the dimensions of the modes shown in FIGS. 5 and 7, the total length of the intraocular lens 1 is 13.5 mm, and the width of the distal end portion of the soft support portion 31 is 0 from the proximal end (base) to the distal end. The width gradually decreases from 0.5 mm to 0.4 mm, and the width of the tip 32b of the hard support portion 32 is 0.1 mm. Further, the horizontal distance between the geometric center of the optical unit 2 and the distal end portion 32b in a state where the outer shapes of the base end portions (bases) of the two soft support portions 31 are aligned in the vertical direction is set to 1 mm.
Further, when viewed in cross section, the width of the distal end portion 32b of the hard support portion 32 is 0.1 mm, and the width of the base end portion (base) of the soft support portion 31 is 0.15 mm.

<2. Manufacturing method of intraocular lens 1>
Then, the manufacturing method of the intraocular lens 1 which concerns on this embodiment is demonstrated. The manufacturing method of the intraocular lens 1 can be considered mainly divided into three steps. Hereinafter, it demonstrates according to the flow of a process.

(First step)
First, as shown in FIG. 8A, an annular hard material portion 100 is obtained by a known molding method using, for example, PMMA (hard material). A circular hole 110 is formed in the center of the hard material portion 100.

  Next, as shown in FIG. 8B, a raw material liquid 200 that becomes, for example, soft acrylic (soft material) after polymerization is injected into the circular hole 110 of the hard material portion 100 to complete the polymerization. Thereby, the soft material portion 250 having a circular shape in plan view is formed inside the hard material portion 100. As a result, the lens material 300 having a structure in which the hard material portion 100 and the soft material portion 250 are integrated is obtained.

(Second step)
Next, as shown in FIG. 8C, the surface shape of the lens material 300 is adjusted to match the surface shapes of the optical unit 2 and the support unit 3. Specifically, by performing surface forming processing on the front and back surfaces of the lens material 300 using a precision lathe device, the convex curved surface of the optical unit 2, the slope of the base portion of the support unit 3, and other flat surfaces are obtained. In addition, the surface shape of the lens material 300 is adjusted. Thereby, a disk-shaped intermediate member (processed product of lens material) 350 reflecting the shape of the front and back surfaces of the intraocular lens 1 is obtained.

(Third step)
Next, the outer shape of the intermediate member 350 is adjusted according to the outer shapes of the optical unit 2 and the support unit 3. Specifically, an unnecessary portion as the intraocular lens 1 is removed from the intermediate member 350 by performing an outer shape process such as a milling process on the intermediate member 350. Thereafter, polishing is performed on necessary portions.

  In the method for manufacturing the intraocular lens 1 according to the present embodiment, as shown in FIG. 8, a disk-shaped intermediate member 350 reflecting the front and back surfaces of the intraocular lens 1 from a rotationally symmetric disk-shaped lens material 300. Then, the intraocular lens 1 is formed. By using the rotationally symmetric disk-shaped lens material 300, the eccentric inclination can be effectively suppressed. This is because the intraocular lens 1 manufactured by the above manufacturing method has higher symmetry than the case where the support unit 3 is formed as a separate member from the optical unit 2 and the support unit 3 is attached to the optical unit 2. In this case, for example, when the two support portions 3 are provided to face each other with the optical portion 2 interposed therebetween, when the two support portions 3 are pulled away (that is, when sewn or fixed in the sclera), the balance is good. The support part 3 can be pulled, and the stability of the optical part 2 pulled by the support part 3 is greatly improved. The same applies to the case where the two support portions 3 are pressed toward each other (that is, in the case of the in-the-bag and out-the-bag).

<3. Usage of intraocular lens 1>
Next, a method for using the intraocular lens 1 according to the present embodiment will be described. The form of use of the intraocular lens 1 exists depending on the type of surgical procedure. Conventional in-the-bag, out-the-bag, and sewing fixing techniques are left to the publicly-known literature or the literature disclosed by the present inventor, and in this embodiment, intrascleral fixation The case of performing is described. However, the basic scleral immobilization technique is the same as that described in [0004] and [0029] to [0034] of Patent Document 1. That is, a scleral incision is formed from one location below the scleral half-layer valve in the sclera, and an intrascleral tunnel is formed in the circumferential direction about the visual axis.
On the other hand, the intraocular lens 1 is inserted into the eye by an injector or the like through an incision formed in the cornea, for example. At that time, the distal end portion 32b of the one support portion 3 is partially exposed to the outside from the incision of the cornea.

  With the scleral half-layer valve opened, the distal end portion 32b of the other support portion 3 inserted into the eye is pulled out from the posterior chamber through a scleral incision with an instrument such as forceps, and the lower part of the scleral half-layer valve To expose outside the eye. Then, the distal end portion 32b exposed to the outside of the eye is inserted into the intrascleral tunnel formed above with a tool such as forceps. When the above procedure is complete, the two scleral half-layer valves are closed. According to the above procedure, the intrascleral tunnel tightens the support part 3 to restrain and hold the support part 3 in the intrascleral tunnel, and the intraocular lens 1 is fixed in the eye without sewing. It should be noted that the intrascleral fixation can be fixed without sewing, but it does not deny that it is sewn. In order to make the fixation firm, it is possible to carry out several stitches.

<4. Advantages of the embodiment>
According to this embodiment, in addition to the effects listed above, the following effects can be obtained.

  When performing intrascleral fixation, it is possible to provide an intraocular lens 1 that is specialized in suppressing the eccentric inclination that is a major problem for intrascleral fixation (that is, an intraocular lens 1 specialized in intrascleral fixation).

  For the surgeon, if only the intraocular lens 1 according to the present embodiment specialized for intrascleral fixation is possessed as an inventory, it is possible to cope with surgical procedures other than intrascleral fixation. Then, the burden on the stock is reduced for the surgeon, and convenience is improved. As a result, even the intraocular lens 1 specialized for intrascleral fixation can satisfy the hidden demand for the intraocular lens 1 that can handle other surgical methods.

  Furthermore, by using the intraocular lens 1 according to the present embodiment, even when an operation method other than intrascleral fixation is applied, deformation of the lens capsule itself can be suppressed, and the optical unit 2 of the intraocular lens 1 can be suppressed. Can be suppressed.

  As described above, according to the present embodiment, it is possible to provide an intraocular lens 1 that is specialized in performance for intrascleral fixation and also has versatility for a wide variety of surgical procedures.

<5. Modification>
The technical scope of the present invention is not limited to the above-described embodiments, and includes various modifications and improvements as long as the specific effects obtained by the constituent elements of the invention and combinations thereof can be derived.

(Base end 32a and tip 32b)
In this embodiment, the case where the base end part 32a and the front-end | tip part 32b are integrally molded by the same hard material was described. On the other hand, a configuration in which the distal end portion 32b is formed as a separate member and the distal end portion 32b is connected to the proximal end portion 32a later may be employed. Similarly, for the base end portion 32 a, the base end portion 32 a may be connected to the soft support portion 31 later. Or you may connect the hard support part 32 which united the base end part 32a and the front-end | tip part 32b to the soft support part 31 later.
Moreover, although the example which provided the base end part 32a was given in this embodiment, the structure of connecting the front-end | tip part 32b directly to the soft support part 31 may be employ | adopted.

(The warped shape of the tip 32b)
In the present embodiment, the warped shape of the distal end portion 32b is given as a preferred modification to the present invention. On the other hand, the “warp shape” described above can be an independent invention. As shown again, when the in-the-bag technique is adopted, the intraocular lens 1 is compressed by the lens capsule, and when pressure is transmitted from the vicinity of the equator of the lens capsule to the tip 32b, In some cases, the arrangement becomes unstable and an eccentric inclination occurs (problem). Therefore, as shown in FIG. 6B, a warp shape is provided at the tip 32b (means). Then, the warped portion is deformed so as to follow the lens capsule, and the intraocular lens 1 is inserted into the lens capsule so that the contact area between the lens capsule and the support portion 3 can be increased. The optical part 2) can be stably arranged, and as a result, the occurrence of the eccentric inclination can be more efficiently suppressed (effect). At this time, for example, each of the two support portions 3 is connected to the optical portion 2 only at one end.

The above configuration is summarized as follows.
"An optical part with a lens function,
A support portion extending from the optical portion and connected to the optical portion only at one end;
With
The intraocular lens in which the tip of the support part is warped toward the optical part as compared with the part up to the tip of the support part. "

(Deformation of intraocular lens 1)
Hereinafter, the deformation | transformation aspect of the intraocular lens 1 is demonstrated for every figure using FIGS. The contents without special mention are the same as in the above embodiment.

In the embodiment shown in FIG. 9, the hard support portion 32 is formed relatively long. This makes it easier to perform a surgical procedure when performing intrascleral fixation.
In this example, the total length of the intraocular lens 1 is 13.5 mm, the width of the distal end portion of the soft support portion 31 is 0.4 mm, and the width of the distal end portion 32b of the hard support portion 32 is 0.13 mm. Further, the horizontal distance between the geometric center of the optical unit 2 and the distal end portion 32b in a state where the outer shapes of the base end portions (bases) of the two soft support portions 31 are aligned in the vertical direction is set to 4.2 mm.
In addition, in the aspect described hereafter including this example, the above-described constriction is provided inside the curved shape of the hard support portion 32.

In the embodiment shown in FIG. 10, conversely, the hard support portion 32 is formed relatively short. In this way, the technique of the in-the-bag can be facilitated while specializing in intrascleral fixation.
In this example, the total length of the intraocular lens 1 is 13.5 mm, the width of the distal end portion of the soft support portion 31 is 0.4 mm, and the width of the distal end portion 32b of the hard support portion 32 is 0.13 mm. The horizontal distance between the geometric center of the optical unit 2 and the distal end portion 32b in a state where the outer shapes of the base end portions (bases) of the two soft support portions 31 are aligned in the vertical direction is 3.4 mm.

In the embodiment shown in FIG. 11, the base end portion (base) of the soft support portion 31 is made relatively narrow and the base end portion 32a of the hard support portion 32 is provided with a warp shape at the tip end portion 32b as described above. Is formed relatively long. The effects described above can be obtained with respect to the warped shape. In addition, it has a beneficial effect when performing in-the-bag techniques. After the support part 3 is folded and the intraocular lens 1 is inserted into the crystalline lens capsule, when the intraocular lens 1 is deployed, the initial deployment direction of the support part 3 can be set to the horizontal direction. Can be deployed properly.
In this example, the total length of the intraocular lens 1 is 13.5 mm, the width of the distal end portion of the soft support portion 31 is 0.43 mm, the width of the distal end portion 32b of the hard support portion 32 is 0.13 mm, and the distal end of the constricted vicinity The width close to the portion 32b is 0.147 mm. Further, the horizontal distance between the geometric center of the optical unit 2 and the distal end portion 32b in a state where the outer shapes of the base end portions (bases) of the two soft support portions 31 are aligned in the vertical direction is set to 3.1 mm.

The mode shown in FIG. 12 is based on the mode shown in FIG. In addition, the width of the distal end portion 32b of the hard support portion 32 is made relatively wide. By carrying out like this, the intensity | strength of the support part 3 can be improved and the possibility of the failure | damage of the support part 3 during an operation method can be reduced.
In this example, the total length of the intraocular lens 1 is 13.5 mm, the width of the distal end portion of the soft support portion 31 is 0.43 mm, and the width of the distal end portion 32 b of the hard support portion 32 is 0.16 mm. Further, the horizontal distance between the geometric center of the optical unit 2 and the distal end portion 32b in a state where the outer shapes of the base end portions (bases) of the two soft support portions 31 are aligned in the vertical direction is set to 3.2 mm.

In the embodiment shown in FIG. 13, the width of the distal end portion 32 b of the hard support portion 32 is further increased from the embodiment shown in FIG. 12. Therefore, the possibility of breakage of the support portion 3 during the surgical procedure can be further reduced.
In this example, the width of the tip end portion 32b of the hard support portion 32 is 0.18 mm, and other dimensions are the same as those shown in FIG.

DESCRIPTION OF SYMBOLS 1 ......... Intraocular lens 2 ......... Optical part 3 ......... Support part 31 ... Soft support part 32 ... Hard support part 32a ... Base end part 32b ... Tip part

Claims (5)

A soft optical part having a lens function;
A wide soft support portion extending from the optical portion and integrally formed with the optical portion and a base end;
A hard support portion connected at the base end with the soft support portion and extended in the extending direction of the soft support portion;
With
The maximum width of the tip portion of the hard supporting section Ri following narrow shape der 0.3 mm,
The hard support portion further includes a middle base end portion connected to the wide soft support portion, and the base end portion is a portion connecting the soft support portion and the hard support portion. An intraocular lens in which the hard support portion is narrowed toward the distal end side by changing the curvature of the inside of the portion . The intraocular lens according to claim 1, wherein the hard support portion is narrowed toward the distal end side by changing a curvature inside the proximal end portion while keeping a curvature outside the proximal end portion constant.   The intraocular lens according to claim 1 or 2, wherein a maximum width of the distal end portion of the hard support portion is a narrow shape of 0.2 mm or less.   The intraocular lens according to claim 1, wherein the distal end portion of the hard support portion is warped toward the optical portion.   The intraocular lens according to claim 1, wherein the hard support portion is provided with a constriction.