JP7122790B1 - Manufacturing method for intraocular lens and intraocular lens support - Google Patents

Manufacturing method for intraocular lens and intraocular lens support Download PDF

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JP7122790B1
JP7122790B1 JP2022066823A JP2022066823A JP7122790B1 JP 7122790 B1 JP7122790 B1 JP 7122790B1 JP 2022066823 A JP2022066823 A JP 2022066823A JP 2022066823 A JP2022066823 A JP 2022066823A JP 7122790 B1 JP7122790 B1 JP 7122790B1
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support
intraocular lens
eye
support portion
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一夫 市川
則彦 吉田
裕人 戸田
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Chukyo Medical Co Ltd
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Abstract

【課題】支持部の先端側に折り返し部を形成しなくても、その先端側を眼内から眼外に容易に出すことができる眼内レンズを提供する。【解決手段】眼内レンズ１の支持部３の先端３１は、他の部分３２に比べて幅広の幅広部である。幅広部３１は、支持部３の先端側を眼内から眼外に出す器具に引っ掛けさせる部分である。幅広部３１は、支持部３の軸線Ｌ１を面内に含む断面において軸線Ｌ１を境にして２つの領域に分けたときに、双方の領域側に出っ張る形状に形成される。言い換えれば、幅広部３１は、軸線Ｌ１回りの全周に亘って支持部３の延設方向に交差する方向に出っ張る形状に形成される。幅広部３１の、支持部３の延設方向に直角な方向における幅が０．２ｍｍ～０．６ｍｍである。【選択図】図１[PROBLEMS] To provide an intraocular lens in which the tip side can be easily protruded from the inside of the eye to the outside of the eye without forming a folded part on the tip side of the support part. A distal end (31) of a support (3) of an intraocular lens (1) is a wide portion wider than other portions (32). The wide portion 31 is a portion for hooking the distal end side of the support portion 3 to an instrument that extends from the inside of the eye to the outside of the eye. The wide portion 31 is formed in a shape that protrudes toward both regions when a cross section including the axis L1 of the support portion 3 is divided into two regions with the axis L1 as a boundary. In other words, the wide portion 31 is formed in a shape protruding in a direction intersecting the extending direction of the support portion 3 over the entire circumference around the axis L1. The width of the wide portion 31 in the direction perpendicular to the extending direction of the support portion 3 is 0.2 mm to 0.6 mm. [Selection drawing] Fig. 1

Description

本開示は眼内レンズに関する。 The present disclosure relates to intraocular lenses.

従来より、レンズ部と、レンズ部から線状に延び出して眼球の部位に支持される支持部とを備えた眼内レンズが知られている（例えば特許文献１参照）。特許文献１に記載の眼内レンズでは、支持部としてのハプティクの先端からの一部が逆方向に折り返された折り返し部として構成されている。また、特許文献１では、支持部の折り返し部を引っ掛けて、眼内から眼外に出す医療用器具を提案している。 2. Description of the Related Art Conventionally, there has been known an intraocular lens that includes a lens portion and a support portion that linearly extends from the lens portion and is supported by the eyeball (see, for example, Patent Document 1). In the intraocular lens disclosed in Patent Literature 1, a portion from the tip of the haptic as a support portion is configured as a folded portion that is folded back in the opposite direction. In addition, Patent Literature 1 proposes a medical instrument that is pulled out of the eye from the inside of the eye by hooking the folded part of the support part.

特許第６０４５６５９号公報Japanese Patent No. 6045659

支持部の先端側に折り返し部が形成されていない場合には、その先端側を眼内から眼外に容易に出すことはできない。 If the folded portion is not formed on the distal end side of the supporting portion, the distal end side cannot be easily protruded from the inside of the eye to the outside of the eye.

本開示は、支持部の先端側に折り返し部を形成しなくても、その先端側を眼内から眼外に容易に出すことができる眼内レンズ、及び眼内レンズ支持部の製造方法を提供することを課題とする。 The present disclosure provides an intraocular lens and a method for manufacturing an intraocular lens haptic that allows the tip side of the haptic part to be easily pulled out of the eye from the inside of the eye without forming a folded part on the tip side of the haptic part. The task is to

本開示の眼内レンズは、
レンズ部と、
前記レンズ部から線状に延び出して、眼球の部位に支持される支持部とを備え、
前記支持部の先端は他の部分に比べて幅広の幅広部であり、
前記幅広部は、前記支持部の先端側を眼内から眼外に出す器具に引っ掛けさせる部分である。 The intraocular lens of the present disclosure comprises
a lens part;
a support portion linearly extending from the lens portion and supported by the eyeball portion;
The tip of the support portion is a wide portion wider than other portions,
The wide portion is a portion that hooks the distal end side of the support portion to an instrument that extends from the inside of the eye to the outside of the eye.

これによれば、支持部の先端に幅広部を有するので、支持部の先端側を眼外に出す器具にその幅広部を引っ掛けさせることができる。これにより、支持部の先端側に折り返し部を形成しなくても、その先端側を眼内から眼外に容易に出すことができる。 According to this, since the tip of the supporting part has the wide part, the wide part can be hooked to an instrument for exposing the tip side of the supporting part to the outside of the eye. As a result, the distal end side can be easily pulled out from the inside of the eye to the outside of the eye without forming a folded portion on the distal end side of the support portion.

また、本開示の眼内レンズ支持部の製造方法は、
眼内に挿入されるレンズ部に一端が接続され、他端側が眼球の部位に支持されるように用いられる、線状に延びる支持部を準備して、眼内に挿入する前に前記支持部の先端を加熱して、前記支持部の延設方向に交差する方向に出っ張る形状の熱変形部を形成する。 Further, the method for manufacturing an intraocular lens haptic of the present disclosure includes:
A support part extending linearly, one end of which is connected to the lens part to be inserted into the eye and the other end of which is used to be supported by the part of the eyeball, is prepared, and the support part is inserted into the eye before being inserted into the eye. is heated to form a thermally deformed portion protruding in a direction crossing the extension direction of the support portion.

これによれば、先端に、支持部の延設方向に交差する方向に出っ張る形状の熱変形部を有した眼内レンズ支持部を得ることができる。そして、支持部の先端側を眼外に出す器具にこの熱変形部を引っ掛けさせることができる。これにより、支持部の先端側に折り返し部を形成しなくても、その先端側を眼内から眼外に容易に出すことができる。 According to this, it is possible to obtain an intraocular lens support part having a thermally deformed part that protrudes in a direction intersecting the extending direction of the support part at the tip. Then, the heat-deformed portion can be hooked to an instrument for exposing the distal end side of the support portion to the outside of the eye. As a result, the distal end side can be easily pulled out from the inside of the eye to the outside of the eye without forming a folded portion on the distal end side of the support portion.

眼内レンズの正面図である。1 is a front view of an intraocular lens; FIG. 支持部の先端側の断面図である。It is sectional drawing of the front end side of a support part. 支持部の先端の平面図である。FIG. 4 is a plan view of the tip of the support; 支持部先端が幅広形状となっていない基本眼内レンズの正面図である。1 is a front view of a basic intraocular lens in which the distal end of a support portion does not have a wide shape; FIG. 支持部先端に熱変形部を有した眼内レンズの正面図である。1 is a front view of an intraocular lens having a thermally deformed portion at the tip of a support portion; FIG. 眼内レンズが眼内に挿入された状態を示すとともに、その眼内レンズの支持部の先端側を眼外に出すために、鑷子等の器具が眼内に挿入された状態を示す図である。FIG. 2 shows a state in which the intraocular lens is inserted into the eye, and a state in which an instrument such as tweezers is inserted into the eye in order to expose the distal end side of the support portion of the intraocular lens to the outside of the eye. . 図６のＡ部の拡大図であって、支持部先端が鑷子等の器具に引っ掛けられた状態を示す図である。FIG. 7 is an enlarged view of part A in FIG. 6 , showing a state where the distal end of the support is hooked on an instrument such as tweezers. 眼内レンズの支持部の先端側が眼外に出された状態を示す図である。FIG. 4 is a diagram showing a state in which the distal end side of the support portion of the intraocular lens is exposed to the outside of the eye; 眼外に出された支持部先端に、眼球固定用の熱変形部が形成された状態を示す図である。FIG. 10 is a diagram showing a state in which a thermally deformable portion for fixing an eyeball is formed at the tip of the supporting portion protruded outside the eye; 支持部先端の熱変形部が強膜内に埋め込まれた状態を示すとともに、眼内レンズが眼球に装着された状態を示す図である。While showing the state where the thermal deformation part of the tip of the supporting part is embedded in the sclera, it is a diagram showing the state where the intraocular lens is attached to the eyeball. 変形例１に係る支持部先端の平面図であり、２方向に出っ張る形状の支持部先端を示す図である。FIG. 10 is a plan view of the tip of the support portion according to Modification 1, and shows the tip of the support portion that protrudes in two directions. 変形例２に係る支持部先端の平面図であり、４方向に出っ張る形状の支持部先端を示す図である。FIG. 10 is a plan view of the tip of the support portion according to Modification 2, and shows the tip of the support portion that protrudes in four directions. 支持部先端が玉状に形成された眼内レンズの正面図である。1 is a front view of an intraocular lens in which the tip of a support portion is formed in a bead shape; FIG. 図１３の支持部の先端側の断面図である。FIG. 14 is a cross-sectional view of the distal end side of the support portion of FIG. 13;

以下、本開示の実施形態を図面を参照しつつ説明する。図１に本実施形態の眼内レンズ１（Ｉｎｔｒａｏｃｕｌａｒ Ｌｅｎｓ：ＩＯＬ）を示す。眼内レンズ１は主要な構成として、レンズ部２と２つの支持部３とを備える。眼内レンズ１は、レンズ部２と支持部３とが異なる材料で形成された３ピース型の眼内レンズとして構成されている。なお、眼内レンズの種類としては、３ピース型の眼内レンズの他に、レンズ部と支持部とが同一の材料で一体で成型された１ピース型の眼内レンズもある。 Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. FIG. 1 shows an intraocular lens 1 (Intraocular Lens: IOL) of this embodiment. The intraocular lens 1 includes a lens portion 2 and two support portions 3 as main components. The intraocular lens 1 is configured as a three-piece intraocular lens in which the lens portion 2 and the support portion 3 are made of different materials. In addition to the three-piece intraocular lens, there is also a one-piece intraocular lens in which the lens portion and the support portion are integrally molded from the same material.

レンズ２部は、例えば円盤状に形成されている。レンズ部２は例えば白内障により白濁した水晶体を患者の眼から摘出（全摘出、あるいは部分摘出）した後に、眼の後房（あるいは眼後房、つまり虹彩より後ろの領域）に配置して、摘出された水晶体のレンズ機能を代行する。レンズ部２はアクリル、シリコン等の樹脂材料で形成される。また、レンズ部２は、棒状に丸めてインジェクタ等を用いて眼内に挿入できるように、可撓性（言い換えれば弾性又は柔軟性）を有した材料で形成される。 The lens part 2 is formed, for example, in a disc shape. For example, the lens part 2 is placed in the posterior chamber of the eye (or the posterior chamber of the eye, that is, the region behind the iris) after the crystalline lens that has become opaque due to cataract is removed from the patient's eye (total removal or partial removal). Substitutes the lens function of the crystalline lens. The lens portion 2 is made of a resin material such as acrylic or silicon. Also, the lens portion 2 is formed of a material having flexibility (in other words, elasticity or flexibility) so that it can be rolled into a rod shape and inserted into the eye using an injector or the like.

支持部３はレンズ部２を後房内に支持する部位である。支持部３は、レンズ部２の外周縁から線状に延び出すように設けられる。具体的には、支持部３は、レンズ部２の外周縁の２箇所から、１対のループ状（換言すれば弧形状又は脚形状又は触覚(ｈａｐｔｉｃ)形状）に延設されて、図１の正面方向から見て、レンズ部２の中心Ｏに関して点対称な形状を有する。換言すれば、支持部３は、レンズ部２の光軸に関して線対称な形状を有する。なお、レンズ部２の光軸は例えばレンズ部２の中心Ｏを通る、図１の紙面に直交する方向に延びる直線である。支持部３のループ形状は具体的には光軸に関する径方向外方に延びつつ、（特に先端側）は周方向にも延びる曲線形状である。さらに言い換えれば、支持部３の形状は、径方向外方に延びつつ、レンズ部２の側（内側）に湾曲する形状である。図１の例では、支持部３は、レンズ部２から距離が離れるにしたがって次第にレンズ部２の周方向における反時計周りの方向に変位する。 The support portion 3 is a portion that supports the lens portion 2 in the posterior chamber. The support portion 3 is provided so as to linearly extend from the outer peripheral edge of the lens portion 2 . Specifically, the support portion 3 extends from two points on the outer peripheral edge of the lens portion 2 in a pair of loop shapes (in other words, an arc shape, a leg shape, or a haptic shape). has a point-symmetrical shape with respect to the center O of the lens portion 2 when viewed from the front direction. In other words, the support portion 3 has a line-symmetrical shape with respect to the optical axis of the lens portion 2 . The optical axis of the lens portion 2 is, for example, a straight line passing through the center O of the lens portion 2 and extending in a direction perpendicular to the paper surface of FIG. Specifically, the loop shape of the support portion 3 is a curved shape that extends radially outward with respect to the optical axis and also extends in the circumferential direction (especially on the tip end side). In other words, the shape of the support portion 3 is a shape that extends radially outward and curves toward the lens portion 2 side (inward). In the example of FIG. 1 , the supporting portion 3 is gradually displaced counterclockwise in the circumferential direction of the lens portion 2 as the distance from the lens portion 2 increases.

支持部３の側方から見た形状は例えば、レンズ部２と略同一平面内に収まる形状でとすればよい。あるいは、側方から見て支持部３を、レンズ部２の外周縁から眼内の前方あるいは後方に向かって斜め方向に延びるように形成してもよい。 The shape of the support portion 3 when viewed from the side may be, for example, a shape that fits within substantially the same plane as the lens portion 2 . Alternatively, the supporting portion 3 may be formed so as to extend obliquely from the outer peripheral edge of the lens portion 2 toward the front or rear of the eye when viewed from the side.

支持部３の基端３３は例えばレンズ部２の外周縁に接続されている。支持部３の先端３１は眼球に装着されていない状態で自由端である。その先端３１は他の部分３２に比べて幅広の形状の幅広部として形成されている。なお、先端３１（幅広部）よりも先には支持部３の部位は存在しない。先端３１と他の部分３２とは同一材料で一体に形成されている。他の部分３２は、支持部３の先端３１と基端３３の間の部分であり、より具体的には、先端３１の直近の部分である。先端直近部分３２は、眼内レンズ１を眼球に装着する際に、先端３１（幅広部）とともに、強膜に形成される針穴に内側から通されて、強膜の外側に出される部分又は該針穴内に留まる部分である。また、先端直近部分３２は、図２に示すように、先端３１の裏面３１ｃとの境界部３１ｄを有する。 A proximal end 33 of the support portion 3 is connected to the outer peripheral edge of the lens portion 2, for example. The tip 31 of the support part 3 is a free end when it is not attached to the eyeball. The tip 31 is formed as a wide portion having a shape wider than the other portion 32 . Note that there is no portion of the support portion 3 beyond the tip 31 (wide portion). The tip 31 and the other portion 32 are integrally formed of the same material. The other portion 32 is the portion between the distal end 31 and the proximal end 33 of the support portion 3 , more specifically, the portion immediately adjacent to the distal end 31 . When the intraocular lens 1 is attached to the eyeball, the tip-proximal portion 32 is passed through a needle hole formed in the sclera from the inside together with the tip 31 (wide portion), and is a portion that is exposed to the outside of the sclera. It is the part that stays in the needle hole. Further, the portion 32 near the tip has a boundary portion 31d with the rear surface 31c of the tip 31, as shown in FIG.

幅広部としての先端３１は、支持部３の中心軸線Ｌ１に交差する方向に出っ張る形状に形成されている。具体的には、図２に示すように、先端３１は、支持部３の軸線Ｌ１を面内に含む断面において、軸線Ｌ１を境に２つの領域に分けたときに、双方の領域の側に出っ張る形状に形成されている。すなわち、先端３１は、図２の断面で見て、軸線Ｌ１よりも一方の領域側（右側）に出っ張る部分３１ａと、他方の領域側（左側）に出っ張る部分３１ｂとを有する。これら部分３１ａ、３１ｂの、先端直近部分３２からの出っ張り方向は互いに反対方向である。 A distal end 31 as a wide portion is formed in a shape protruding in a direction intersecting the central axis L1 of the support portion 3 . Specifically, as shown in FIG. 2, when the cross section including the axis L1 of the support portion 3 is divided into two regions with the axis L1 as a boundary, the tip 31 is located on the side of both regions. It is formed in a protruding shape. 2, the tip 31 has a portion 31a that protrudes toward one region (right side) and a portion 31b that protrudes toward the other region (left side) from the axis L1. The protruding directions of these portions 31a and 31b from the tip proximal portion 32 are opposite to each other.

より具体的には、先端３１は、例えば軸線Ｌ１回りの全周に亘って軸線Ｌ１（支持部３の延設方向）に交差する方向に出っ張る形状に形成されている。図３は先端３１の平面図であり、換言すれば先端３１を軸線Ｌ１の方向から見た図である。支持部３の軸線Ｌ１と先端３１との交点Ｐを先端中心とする。図３に示すように、先端３１は、先端中心Ｐ回りの全周に亘って先端直近部分３２から径方向外方に出っ張っている。また、先端３１は、図３の方向から見て、例えば先端中心Ｐを中心とした円形に形成されてよい。なお、先端３１は、図３の方向から見て、楕円形、多角形（正方形、長方形など）など円形以外の形状に形成されてもよい。 More specifically, the distal end 31 is formed in a shape protruding in a direction intersecting the axis L1 (extending direction of the support portion 3) over the entire circumference around the axis L1, for example. FIG. 3 is a plan view of the tip 31, in other words, a view of the tip 31 viewed from the direction of the axis L1. The point of intersection P between the axis L1 of the support portion 3 and the tip 31 is defined as the center of the tip. As shown in FIG. 3 , the tip 31 protrudes radially outward from the tip proximal portion 32 over the entire circumference around the tip center P. As shown in FIG. Further, the tip 31 may be formed, for example, in a circular shape around the tip center P when viewed from the direction of FIG. 3 . Note that the tip 31 may be formed in a shape other than a circle, such as an ellipse, a polygon (square, rectangle, etc.) when viewed from the direction of FIG.

また、図３に示すように、先端中心Ｐを通る、支持部３の軸線Ｌ１に直交する基準線Ｌ０を定義し、先端中心Ｐから軸線Ｌ１に直交する方向Ｒ（径方向）を基準線Ｌ０に対する角度θで表すとする。先端３１は、角度θが０°～３６０°の全範囲に出っ張る形状に形成されている。すなわち、先端３１は、角度θが０°となる方向と、１８０°となる方向の双方に出っ張っている。加えて、先端３１は、角度θが９０°の方向と２７０°の方向にも出っ張っている。 Further, as shown in FIG. 3, a reference line L0 passing through the tip center P and perpendicular to the axis L1 of the support portion 3 is defined, and a direction R (radial direction) perpendicular to the axis L1 from the tip center P is defined as the reference line L0. be represented by the angle θ with respect to The tip 31 is formed in a shape that protrudes over the entire range of the angle θ from 0° to 360°. That is, the tip 31 protrudes in both the direction in which the angle θ is 0° and the direction in which the angle θ is 180°. In addition, the tip 31 also protrudes in the direction where the angle θ is 90° and the direction where the angle θ is 270°.

図２に示すように、先端３１の、軸線Ｌ１（支持部３の延設方向）に直角な方向における幅Ａは、先端直近部分３２の、軸線Ｌ１に直角な方向における幅Ｂよりも大きい。具体的には、幅Ａは例えば０．２ｍｍ～０．６ｍｍである。この範囲であれば、支持部３の先端側を眼内から眼外に出す際に強膜に形成する針穴を小さくできる。また、鑷子等の器具（支持部３の位置を制御する器具）を用いて、先端３１を眼内から眼外に出すときに、その器具に先端３１を引っ掛けやすくでき、換言すれば、先端３１を器具に引っ掛けて眼外に出す最中に、器具から支持部３（先端３１）が外れてしまうのを抑制できる。仮に幅Ａが０．２ｍｍより小さい場合には、鑷子等の器具に先端３１を引っ掛けるのが困難となる。また、仮に幅Ａが０．６ｍｍより大きい場合には、先端３１を眼内から眼外に出すために強膜に形成する針穴が大きくなってしまう。 As shown in FIG. 2, the width A of the tip 31 in the direction perpendicular to the axis L1 (extending direction of the support portion 3) is larger than the width B of the tip proximal portion 32 in the direction perpendicular to the axis L1. Specifically, the width A is, for example, 0.2 mm to 0.6 mm. Within this range, the needle hole formed in the sclera when the distal end side of the support portion 3 is pulled out of the eye can be made smaller. In addition, when using an instrument such as tweezers (an instrument for controlling the position of the support portion 3) to move the tip 31 from the inside of the eye to the outside of the eye, the tip 31 can be easily hooked on the instrument. It is possible to prevent the support part 3 (tip 31) from coming off the instrument while the eye is hooked on the instrument and pulled out of the eye. If the width A is less than 0.2 mm, it will be difficult to hook the tip 31 to an instrument such as tweezers. Further, if the width A is larger than 0.6 mm, the needle hole formed in the sclera becomes large in order to extend the tip 31 from the inside of the eye to the outside of the eye.

先端直近部分３２の幅Ｂは先端３１の幅Ａよりも小さい。具体的には、幅Ｂは例えば０．２ｍｍより小さい。 The width B of the tip-proximal portion 32 is smaller than the width A of the tip 31 . Specifically, the width B is smaller than 0.2 mm, for example.

また、先端３１の、先端直近部分３２からの、軸線Ｌ１に直角な方向への出っ張り量Ｃ（図２参照）は例えば０．１ｍｍ以上に設定される。０．１ｍｍ以上であれば、鑷子等の器具に先端３１を引っ掛けやすい。また、図２において、先端３１を、軸線Ｌ１を境に２つの部分３１ａ、３１ｂに分けたときに、一方の部分３１ａの出っ張り量Ｃと、他方の部分３１ｂの出っ張り量Ｃは互いに同じでもよいし、異なっていてもよい。さらに、軸線Ｌ１回りの全周に亘って同じ出っ張り量Ｃでもよいし、軸線Ｌ１回りの位置に応じて出っ張り量Ｃが変化してもよい。 Also, the protrusion amount C (see FIG. 2) of the tip end 31 in the direction perpendicular to the axis L1 from the tip proximal portion 32 is set to, for example, 0.1 mm or more. If it is 0.1 mm or more, the tip 31 can be easily hooked on an instrument such as tweezers. In FIG. 2, when the tip 31 is divided into two parts 31a and 31b along the axis L1, the protrusion amount C of one part 31a and the protrusion amount C of the other part 31b may be the same. and may be different. Further, the protrusion amount C may be the same over the entire circumference around the axis L1, or the protrusion amount C may vary depending on the position around the axis L1.

また、先端３１（幅広部）の、軸線Ｌ１の方向における幅Ｄ（図２参照）は例えば２ｍｍ以下としてよい。これによれば、鑷子等の器具に先端３１を引っ掛けて眼内から眼外に出す際に、強膜に形成した針穴に、先端３１を入れやすくできる。また、幅Ｄは例えば０．１ｍｍ以上としてよい。これによれば、先端３１を鑷子等の器具に引っ掛けたときに、先端３１が、後述の角度φ（図２参照）が大きくなる方向に変形して、先端３１が器具から外れてしまうの抑制できる。 Also, the width D (see FIG. 2) of the distal end 31 (wide portion) in the direction of the axis L1 may be, for example, 2 mm or less. According to this, the tip 31 can be easily inserted into the needle hole formed in the sclera when the tip 31 is hooked on an instrument such as tweezers and pulled out of the eye. Moreover, the width D may be set to 0.1 mm or more, for example. According to this, when the tip 31 is hooked on an instrument such as tweezers, the tip 31 is deformed in a direction that increases the angle φ (see FIG. 2) described later, and the tip 31 is prevented from coming off the instrument. can.

また、図２に示すように、先端３１は、先端直近部分３２側に向いた裏面３１ｃを有する。裏面３１ｃは、鑷子等の器具に引っ掛けられることを想定した引掛想定面である。裏面３１ｃは平面に形成されてもよいし、曲面に形成されてもよい。図２の断面で見て、裏面３１ｃと、先端直近部分３２との成す角度φは例えば１５°以上１６０°以下に設定される。この範囲であれば、鑷子等の器具を裏面３１ｃに引っ掛けやすい。角度φが仮に１５°未満又は１６０°より大きい場合には、器具と裏面３１ｃとの引っ掛かりが困難となる。角度φは、好ましくは４５°以上１３５°以下に設定され、より好ましくは６０°以上１２０°以下に設定されてよい。図２の例では、角度φが９０°に設定された例を示している。なお、角度φは、図２の断面で見て、裏面３１ｃと先端直近部分３２との境界部３１ｄでの裏面３１の傾きを示す接線と、境界部３１ｄでの先端直近部分３２の傾きを示す接線との成す角度としてよい。 Further, as shown in FIG. 2, the tip 31 has a back surface 31c facing the tip proximal portion 32 side. The back surface 31c is a surface that is assumed to be hooked by an instrument such as tweezers. The back surface 31c may be formed flat or curved. As seen in the cross section of FIG. 2, the angle φ between the rear surface 31c and the portion 32 near the tip end is set to, for example, 15° or more and 160° or less. Within this range, it is easy to hook an instrument such as tweezers to the back surface 31c. If the angle φ is less than 15° or greater than 160°, it becomes difficult to catch the instrument with the back surface 31c. The angle φ is preferably set between 45° and 135°, and more preferably between 60° and 120°. The example in FIG. 2 shows an example in which the angle φ is set to 90°. 2, the angle φ indicates the tangential line indicating the inclination of the rear surface 31 at the boundary 31d between the rear surface 31c and the tip proximal portion 32 and the inclination of the tip proximal portion 32 at the boundary 31d. It may be an angle formed with a tangent line.

また、図２において、先端３１を、軸線Ｌ１を境に２つの部分３１ａ、３１ｂに分けたときに、一方の部分３１ａの角度φと、他方の部分３１ｂの角度φは互いに同じでもよいし、異なっていてもよい。さらに、軸線Ｌ１回りの全周に亘って同じ角度φでもよいし、軸線Ｌ１回りの位置に応じて角度φが変化してもよい。 2, when the tip 31 is divided into two portions 31a and 31b with the axis L1 as a boundary, the angle φ of one portion 31a and the angle φ of the other portion 31b may be the same, can be different. Further, the angle φ may be the same over the entire circumference around the axis L1, or the angle φ may vary depending on the position around the axis L1.

なお、一方の支持部３の先端３１の形状と、他方の支持部３の先端３１の形状とは互いに同じ形状としてよい。なお、図２では、先端３１の断面形状の一例として長方形断面を示しているが、四角形以外の多角形状、曲線を含む形状など、他の断面形状でもよい。 The shape of the tip 31 of one support portion 3 and the shape of the tip 31 of the other support portion 3 may be the same shape. Note that FIG. 2 shows a rectangular cross section as an example of the cross-sectional shape of the distal end 31, but other cross-sectional shapes such as a polygonal shape other than a square, a shape including a curve, and the like may be used.

支持部３は、棒状に丸めてインジェクタ等を用いて眼内に挿入できるように、可撓性（言い換えれば弾性又は柔軟性）を有した材料で形成される。また、支持部３は、加熱されることで溶けて（熱変形して）、支持部３の延設方向（軸線Ｌ１）に交差する方向に出っ張る形状の玉（熱変形部）を形成する材料で形成される。具体的には、支持部３は例えばＰＶＤＦ（ポリフッ化ビニリデン）等の樹脂材料で形成される。また、支持部３はレンズ部２とは異なる材料で形成されてよい。この場合、レンズ部２と支持部３とは別体で形成された後に接着剤等で接合されてよい。 The support part 3 is formed of a material having flexibility (in other words, elasticity or flexibility) so that it can be rolled into a rod shape and inserted into the eye using an injector or the like. In addition, the support portion 3 is made of a material that melts (thermally deforms) when heated to form a ball (thermally deformed portion) protruding in a direction intersecting the extension direction (axis L1) of the support portion 3. formed by Specifically, the support portion 3 is made of a resin material such as PVDF (polyvinylidene fluoride). Moreover, the support portion 3 may be formed of a material different from that of the lens portion 2 . In this case, the lens portion 2 and the support portion 3 may be formed separately and then joined with an adhesive or the like.

支持部３及びその先端３１（幅広部）は例えば成型により形成されてよい。または、支持部３の先端３１は以下に示すように、加熱処理により形成されてもよい。この場合、先ず、支持部３の基となる一対の基本支持部１１（図４参照）を準備する。このとき、一対の基本支持部１１の各基端がレンズ部２に接続された基本眼内レンズ１０（図４参照）を準備してもよいし、レンズ部２から分離された基本支持部１１を準備してもよい。レンズ部２から分離された基本支持部１１を準備した場合には、後述の加熱処理で支持部１１の先端に熱変形部１３（図５参照）を形成した後に、レンズ部２と支持部１１（図１の支持部３に相当）とを接合すればよい。 The support portion 3 and its distal end 31 (wide portion) may be formed by molding, for example. Alternatively, the tip 31 of the support portion 3 may be formed by heat treatment as described below. In this case, first, a pair of basic support portions 11 (see FIG. 4) that serve as the base of the support portion 3 are prepared. At this time, a basic intraocular lens 10 (see FIG. 4) in which each base end of a pair of basic support parts 11 is connected to the lens part 2 may be prepared, or the basic support parts 11 separated from the lens part 2 may be prepared. may be prepared. When the basic support portion 11 separated from the lens portion 2 is prepared, the lens portion 2 and the support portion 11 are assembled after forming the thermally deformed portion 13 (see FIG. 5) at the tip of the support portion 11 by heat treatment, which will be described later. (corresponding to the support portion 3 in FIG. 1).

基本支持部１１の先端１２は他の部分と同等の幅に形成されており、言い換えれば、先端１２は幅広形状又は出っ張り形状となっていない。基本支持部１１は、先端１２以外は、図１の支持部３と同様の形状であり、すなわち、曲線状（具体的には弧形状又は触覚(ｈａｐｔｉｃ)形状）に延びる形状を有する。 The tip 12 of the basic support portion 11 is formed to have the same width as the other portions, in other words, the tip 12 does not have a wide shape or a protruding shape. The base support 11 has the same shape as the support 3 of FIG.

基本支持部１１は、加熱されることで溶けて（熱変形して）、基本支持部１１の延設方向に交差する方向に出っ張る形状の熱変形部を形成する材料で形成されている。具体的には例えば、基本支持部１１はＰＶＤＦ（ポリフッ化ビニリデン）等の樹脂材料で形成されている。 The basic support portion 11 is made of a material that melts (thermally deforms) when heated to form a thermally deformed portion that protrudes in a direction intersecting the extending direction of the basic support portion 11 . Specifically, for example, the basic support portion 11 is made of a resin material such as PVDF (polyvinylidene fluoride).

次に、基本眼内レンズ１０又は基本支持部１１を眼内に挿入する前に、加熱器具（医療用焼灼器具（アキュテンプ）など）を用いて、各基本支持部１１の先端１２を加熱により溶かす（熱変形させる）。基本支持部１１は、溶けるに伴い、先端に、支持部１１の延設方向に交差する方向に出っ張る形状の熱変形部１３（図５参照）を形成しつつ、徐々に縮んでいく。また、縮んでいくに伴い、徐々に熱変形部１３が大きくなる。そして、この熱変形部１３が目標の大きさ又は形状になったときに加熱を終了する。図５において、加熱終了時の熱変形部１３が図１の先端３１（幅広部）に相当する。加熱終了時の支持部１１が図１の支持部３に相当する。加熱終了時の眼内レンズ１０が図１の眼内レンズ１に相当する。以上により、幅広形状の先端３１を有した眼内レンズ支持部３を得ることができる。 Next, before inserting the basic intraocular lens 10 or the basic support 11 into the eye, a heating instrument (such as a medical cauterizer (Accutane)) is used to melt the tip 12 of each basic support 11 by heating. (heat deformed). As the basic support portion 11 melts, it gradually shrinks while forming a thermally deformed portion 13 (see FIG. 5) projecting in a direction intersecting the extension direction of the support portion 11 at its tip. In addition, the heat-deformed portion 13 gradually becomes larger as it shrinks. Heating is terminated when the thermally deformed portion 13 reaches a target size or shape. In FIG. 5, the thermally deformed portion 13 at the end of heating corresponds to the tip 31 (wide portion) in FIG. The support portion 11 at the end of heating corresponds to the support portion 3 in FIG. The intraocular lens 10 at the end of heating corresponds to the intraocular lens 1 in FIG. As described above, the intraocular lens support part 3 having the wide distal end 31 can be obtained.

図１の眼内レンズ１は、例えば白内障により白濁した水晶体を全摘出あるいは部分摘出した後の眼内の後房（眼後房）に、強膜内固定の手法で（縫着なしで）固定される。以下、図６～図１０を参照して、眼内レンズ１を眼内に装着（固定）する手順の一例を説明する。眼内レンズ１を装着する前提として、水晶体が全摘出又は部分摘出されているものとする。先ず、例えば角膜１００（図６参照）の輪部（換言すれば縁部又は外周部）に切開創を形成して、その切開創から、眼内レンズ１を、棒状に丸めた状態で注射器型のインジェクタ（眼内レンズ挿入器）により、眼内に挿入する。このとき、眼内レンズ１を、虹彩１０２（図６参照）よりも後方の領域（つまり後房）に挿入する。 The intraocular lens 1 in FIG. 1 is fixed (without suturing) to the posterior chamber of the eye (posterior chamber of the eye) after total or partial removal of the crystalline lens that has become opaque due to cataract, for example, by intrascleral fixation. be done. An example of the procedure for mounting (fixing) the intraocular lens 1 in the eye will be described below with reference to FIGS. 6 to 10. FIG. As a prerequisite for wearing the intraocular lens 1, it is assumed that the crystalline lens has been completely or partially removed. First, for example, an incision is formed in the limbus (in other words, the edge or the outer periphery) of the cornea 100 (see FIG. 6), and the intraocular lens 1 is rolled into a rod from the incision and inserted into a syringe-like shape. It is inserted into the eye using an injector (intraocular lens inserter). At this time, the intraocular lens 1 is inserted into the region behind the iris 102 (see FIG. 6) (that is, the posterior chamber).

次に、眼内レンズ１の支持部３の先端側を強膜１０１（図６参照）の外側に引き出す。具体的には、図６に示すように、眼内レンズ１が挿入された後房と眼球の外側とが導通するよう、針で強膜１０１に穴（トンネル）１０１ａを形成する。針穴１０１ａを形成する位置は虹彩１０２よりも後方の位置であり、具体的には例えば、毛様体皺襞部１０３よりも前方の毛様溝１０４の位置としてよい。また、各支持部３ごとの穴１０１ａを形成する。このとき、視軸に関して対称な強膜１０１の２箇所に穴１０１ａを形成する。 Next, the tip side of the support portion 3 of the intraocular lens 1 is pulled out to the outside of the sclera 101 (see FIG. 6). Specifically, as shown in FIG. 6, a hole (tunnel) 101a is formed in the sclera 101 with a needle so that the posterior chamber into which the intraocular lens 1 is inserted and the outside of the eyeball are connected. The position where the needle hole 101 a is formed is the position behind the iris 102 , specifically, it may be the position of the ciliary groove 104 in front of the ciliary fold 103 . Also, a hole 101a is formed for each support portion 3. As shown in FIG. At this time, two holes 101a are formed in the sclera 101 symmetrically with respect to the visual axis.

そして、一方の支持部３の先端側を一方の穴１０１ａ（以下、第１の針穴という）から外側に引き出し、他方の支持部３の先端側を他方の穴１０１ａ（以下、第２の針穴という）から外側に引き出す。具体的には、支持部３の先端側を眼内から眼外に出すための棒状の器具２００を、第１の針穴１０１ａから後房に挿入する。器具２００は例えば先端に鈎を有する有鈎鑷子など、先端に、支持部３の先端３１を引っ掛けることが可能な引掛部２０２（図７参照）を有する。器具２００が鑷子の場合には、器具２００の先端には先端３１を挟んで把持する挟持部２０１（図７参照）を有する。そして、器具２００で一方の支持部３の先端側を把持させる。このとき、図７に示すように、器具２００の先端の引掛部２０２に、支持部３の先端３１（幅広部）の裏面３１ｃを引っ掛けさせる。その後、器具２００を、第１の針穴１０１ａから眼外に引き出す。これに伴い、支持部３の先端３１からの一部が第１の針穴１０１ａから眼外に引き出される。 Then, the tip side of one support portion 3 is pulled out from one hole 101a (hereinafter referred to as the first needle hole), and the tip side of the other support portion 3 is pulled out from the other hole 101a (hereinafter referred to as the second needle hole). hole) to the outside. Specifically, a rod-shaped instrument 200 is inserted into the posterior chamber through the first needle hole 101a to extend the distal end side of the support portion 3 from the inside of the eye to the outside of the eye. The instrument 200 has a hooking part 202 (see FIG. 7) at its tip, such as forceps with hooks having a hook at its tip, on which the tip 31 of the support part 3 can be hooked. When the instrument 200 is tweezers, the tip of the instrument 200 has a clamping portion 201 (see FIG. 7) for clamping the tip 31 therebetween. Then, the distal end side of one support portion 3 is gripped by the instrument 200 . At this time, as shown in FIG. 7, the rear surface 31c of the tip 31 (wide portion) of the support portion 3 is hooked on the hook portion 202 at the tip of the instrument 200 . After that, the instrument 200 is pulled out of the eye through the first needle hole 101a. Along with this, part of the support portion 3 from the tip 31 is pulled out of the eye through the first needle hole 101a.

同様にして、器具２００を第２の針穴１０１ａから後房に挿入し、その器具２００で他方の支持部３の先端３１からの一部を第２の針穴１０１ａから眼外に引き出す。図８は、両方の支持部３の先端側が強膜１０１の外側に引き出された状態を示している。この状態では、レンズ部２は後房に留まっている。 Similarly, the instrument 200 is inserted into the posterior chamber through the second needle hole 101a, and the instrument 200 is used to pull out part of the other support portion 3 from the distal end 31 through the second needle hole 101a. FIG. 8 shows a state in which the tip sides of both support parts 3 are pulled out of the sclera 101 . In this state, the lens portion 2 remains in the posterior chamber.

その後、眼外に出された支持部３の先端３１（幅広部）をハサミで切断する。その後、加熱器具（医療用焼灼器具（アキュテンプ）など）を用いて、幅広部３１を切断した後の支持部３の先端を加熱により溶かす（熱変形させる）。支持部３は、溶けるに伴い、先端に、支持部１１の延設方向に交差する方向に出っ張る形状の熱変形部３４（図９参照）を形成しつつ、徐々に縮んでいく。また、縮んでいくに伴い、徐々に熱変形部３４が大きくなる。そして、この熱変形部３４が目標の大きさ又は形状になったときに加熱を終了する。熱変形部３４の大きさは、例えば当初の先端３１（幅広部）よりも大きいとしてよい。これによれば、熱変形部３４を強膜１０１に埋め込んで支持させたときに、強膜１０１から熱変形部３４が抜けてしまうのを抑制できる。 Thereafter, the distal end 31 (wide portion) of the supporting portion 3 exposed outside the eye is cut off with scissors. Thereafter, using a heating instrument (medical cautery instrument (Accutane), etc.), the distal end of the support portion 3 after the wide portion 31 has been cut is melted (thermally deformed) by heating. As the support portion 3 melts, it gradually shrinks while forming a thermally deformed portion 34 (see FIG. 9) projecting in a direction intersecting the extending direction of the support portion 11 at the tip. In addition, the thermally deformed portion 34 gradually becomes larger as it shrinks. Heating is terminated when the thermally deformed portion 34 reaches a target size or shape. The size of the thermally deformed portion 34 may be larger than, for example, the initial tip 31 (wide portion). According to this, when the thermally deformed portion 34 is embedded in the sclera 101 and supported, it is possible to prevent the thermally deformed portion 34 from coming off from the sclera 101 .

また、一方の支持部３の先端に熱変形部３４が形成されるまでは、他方の支持部３に対する当初の先端３１の切断及び加熱処理は行わないとしてよい。これによれば、他方の支持部３の先端３１（幅広部）がストッパとなることで、一方の支持部３に熱変形部３４を形成している最中に、他方の支持部３の先端側が眼内に引き戻されてしまうのを抑制できる。そして、一方の支持部３の先端に熱変形部３４を形成した後に、他方の支持部３の先端３１をハサミで切断して、切断後の先端を加熱により熱変形させることで、他方の支持部３の先端にも熱変形部３４を形成させる。 Also, until the thermally deformed portion 34 is formed at the tip of one of the support portions 3, the initial cutting and heat treatment of the tip 31 of the other support portion 3 may not be performed. According to this, the tip 31 (wide portion) of the other support portion 3 serves as a stopper, so that the tip of the other support portion 3 can be displaced while the thermally deformed portion 34 is being formed in the one support portion 3 . It is possible to prevent the side from being pulled back into the eye. Then, after forming the thermally deformed portion 34 at the tip of one support portion 3, the tip 31 of the other support portion 3 is cut with scissors, and the cut tip is thermally deformed by heating to support the other. A thermally deformed portion 34 is also formed at the tip of the portion 3 .

その後、図１０に示すように、各支持部３の先端の熱変形部３４を、針穴１０１ａ内に押し込むことで、強膜１０１内に埋め込む。これにより、支持部３が強膜１０１で固定（支持）される。 After that, as shown in FIG. 10, the thermally deformed portion 34 at the tip of each support portion 3 is pushed into the needle hole 101a to be embedded in the sclera 101. Then, as shown in FIG. Thereby, the support portion 3 is fixed (supported) by the sclera 101 .

以上により、眼内レンズ１は眼内に装着される。この状態では、虹彩１０２の後ろの位置にレンズ部２が配置される。 As described above, the intraocular lens 1 is installed in the eye. In this state, the lens unit 2 is arranged behind the iris 102 .

以下、本実施形態の効果を説明する。本実施形態では、支持部３の先端３１が幅広部として構成されるので、その先端３１を眼内から眼外に出す際に、鑷子等の器具２００（図６、図７参照）に先端３１を引っ掛けることができる。これにより、支持部３の先端３１からの一部を簡単に眼外に出すことができる。また、先端３１を眼外に引き出した後に、眼内に引き戻されてしまうのを抑制できる。 The effects of this embodiment will be described below. In this embodiment, since the distal end 31 of the support portion 3 is configured as a wide portion, when the distal end 31 is pulled out of the eye, the distal end 31 is held by an instrument 200 such as tweezers (see FIGS. 6 and 7). can be hooked. Thereby, a part from the tip 31 of the support part 3 can be easily put out of the eye. In addition, it is possible to prevent the distal end 31 from being pulled back into the eye after being pulled out of the eye.

また、先端３１は、図２の断面で見て、軸線Ｌ１よりも一方の領域側（右側）に出っ張る部分３１ａと、他方の領域側（左側）に出っ張る部分３１ｂとを有するので、鑷子等の器具２００で先端３１を挟むように把持できる。これにより、先端３１を眼外に引き出す途中で、先端３１が器具２００から外れてしまうのを抑制できる。 2, the distal end 31 has a portion 31a that protrudes toward one region (right side) and a portion 31b that protrudes toward the other region (left side) from the axis L1. The instrument 200 can be grasped so as to pinch the tip 31 . This can prevent the tip 31 from coming off the instrument 200 while the tip 31 is being pulled out of the eye.

さらに、先端３１は、支持部３の軸線Ｌ１回りの全周に亘って軸線Ｌ１に交差する方向に出っ張る形状に形成されるので、器具２００の先端の引掛部２０２（図７参照）が、器具２００の軸線回りのどの向きにあったとしても、その引掛部２０２に、支持部３の先端３１を引っ掛けることができる。 Furthermore, since the tip 31 is formed in a shape protruding in a direction intersecting the axis L1 over the entire circumference of the support portion 3 around the axis L1, the hook portion 202 (see FIG. 7) at the tip of the instrument 200 can be attached to the instrument. The tip 31 of the support portion 3 can be hooked on the hook portion 202 in any direction around the axis of the support portion 200 .

また、先端３１の、支持部３の延設方向（軸線Ｌ１の方向）に直角な方向における幅が０．２．ｍｍ～０．６ｍｍであるので、強膜１０１に形成する針穴１０１ａ（図６参照）の径を小さくできるとともに、器具２００で先端３１を眼外に引き出す最中に、先端３１が器具２００から外れてしまうのを抑制できる。 Further, the width of the tip 31 in the direction perpendicular to the extending direction of the support portion 3 (the direction of the axis L1) is 0.2. mm to 0.6 mm, the diameter of the needle hole 101a (see FIG. 6) formed in the sclera 101 can be made small, and while the tip 31 is being pulled out of the eye with the instrument 200, the tip 31 is removed from the instrument 200. You can prevent it from coming off.

また、図２の断面で見て、先端３１（出っ張り部）の裏面３１ｃと、先端直近部分３２との成す角度φが１５°以上１６０°以下であるので、器具２００に裏面３１ｃを引っ掛けやすくできる。 2, the back surface 31c of the distal end 31 (protruding portion) forms an angle φ of 15° or more and 160° or less, so that the back surface 31c can be easily hooked to the instrument 200. .

また、支持部３は、加熱により、支持部３の延設方向に交差する方向に出っ張る形状の熱変形部を形成する材料で形成されるので、眼外に引き出した先端３１を切断した後に、その先端３１とは大きさ及び支持部３上の位置が異なる、強膜１０１に固定するための熱変形部３４（図９、図１０参照）を形成できる。 In addition, since the support part 3 is formed of a material that forms a thermally deformed part that protrudes in a direction intersecting the extending direction of the support part 3 by heating, after cutting the tip 31 pulled out of the eye, A thermal deformable portion 34 (see FIGS. 9 and 10) for fixing to the sclera 101 can be formed, which differs in size and position on the support 3 from its tip 31 .

なお、本開示は上記実施形態に限定されず種々の変更が可能である。例えば、図３では、支持部３の先端３１が、先端中心Ｐ回りの全周に亘って先端直近部分３２から径方向外方に出っ張る例を示した。しかし、これに限定されず、図３の先端３１に代えて、例えば図１１又は図１２に示す先端３５、３６でもよい。なお、図１１、図１２は、変形例に係る支持部３の先端３５、３６の平面図であり、支持部３の軸線の方向から先端３５、３６を見た図である。 It should be noted that the present disclosure is not limited to the above embodiments, and various modifications are possible. For example, FIG. 3 shows an example in which the tip 31 of the support portion 3 protrudes radially outward from the portion 32 near the tip over the entire circumference around the center P of the tip. However, the present invention is not limited to this, and instead of the tip 31 of FIG. 3, for example, tips 35 and 36 shown in FIG. 11 and 12 are plan views of tips 35 and 36 of the support portion 3 according to the modification, and views of the tips 35 and 36 from the axial direction of the support portion 3. FIG.

図１１、図１２の先端３５、３６は、先端中心Ｐ回りの周方向に間隔をあけて複数の出っ張り部３５ａ、３５ｂ、３６ａ～３６ｄを有する。具体的に言えば、図１１の先端３５は、先端中心Ｐ回りの周方向に等間隔（換言すれば１８０°間隔）に２つの出っ張り部３５ａ、３５ｂを有する。これら２つの出っ張り部３５ａ、３５ｂは、図１１の方向から見て、先端直近部分３２から径方向外方かつ互いに反対方向に出っ張る。換言すれば、２つの出っ張り部３５ａ、３５ｂから構成される先端３５は、支持部３の軸線を面内に含む断面（図１１の破線Ｌ２で先端３５を切った断面、図示外）において、軸線を境に２つの領域に分けたときに、双方の領域の側に出っ張る形状に形成されている。 The tips 35 and 36 of FIGS. 11 and 12 have a plurality of protrusions 35a, 35b, 36a-36d spaced apart in the circumferential direction around the center P of the tip. Specifically, the tip 35 in FIG. 11 has two projecting portions 35a and 35b at equal intervals (in other words, 180° intervals) in the circumferential direction around the center P of the tip. These two protruding portions 35a and 35b protrude radially outward and in opposite directions from the tip proximal portion 32 when viewed from the direction of FIG. In other words, the tip 35 composed of the two protruding portions 35a and 35b has an axial line in a cross section including the axis of the support portion 3 (a cross section obtained by cutting the tip 35 along the broken line L2 in FIG. 11, not shown). When divided into two regions with the .

先端３５は、互いに反対方向に２つの出っ張り部３５ａ、３５ｂを有するので、上記実施形態と同様に、鑷子等の器具で、２つの出っ張り部３５ａ、３５ｂを引掛けながら、先端３５を眼外に出すことができる。 Since the tip 35 has two projecting portions 35a and 35b in mutually opposite directions, the tip 35 is pulled out of the eye while hooking the two projecting portions 35a and 35b with an instrument such as forceps as in the above embodiment. can take out.

また、図１２の先端３６は、先端中心Ｐ回りの周方向に等間隔（換言すれば９０°間隔）に４つの出っ張り部３６ａ～３６ｄを有する。第１の出っ張り部３６ａと第２の出っ張り部３６ｂとは、図１２の方向から見て、先端直近部分３２から径方向外方かつ互いに反対方向に出っ張る。第１、第２の出っ張り部３６ａ、３６ｂは、支持部３の軸線を面内に含む断面（図１２の破線Ｌ３で先端３６を切った断面、図示外）において、軸線を境に２つの領域に分けたときに、双方の領域の側に出っ張る形状に形成されている。 Further, the tip 36 of FIG. 12 has four projecting portions 36a to 36d at equal intervals (in other words, at intervals of 90°) in the circumferential direction around the center P of the tip. The first protruding portion 36a and the second protruding portion 36b protrude radially outward and in opposite directions from the tip proximal portion 32 when viewed from the direction of FIG. The first and second protruding portions 36a and 36b are divided into two regions with the axis as a boundary in a cross section including the axis of the support portion 3 (a cross section obtained by cutting the tip 36 along the broken line L3 in FIG. 12, not shown). When divided into two regions, it is formed in a shape that protrudes toward both regions.

第３の出っ張り部３６ｃと第４の出っ張り部３６ｄとは、図１２の方向から見て、先端直近部分３２から径方向外方かつ互いに反対方向に出っ張る。第３、第４の出っ張り部３６ｃ、３６ｄは、支持部３の軸線を面内に含む断面（図１２の破線Ｌ４で先端３６を切った断面、図示外）において、軸線を境に２つの領域に分けたときに、双方の領域の側に出っ張る形状に形成されている。 The third protruding portion 36c and the fourth protruding portion 36d protrude radially outward from the tip proximal portion 32 and in mutually opposite directions when viewed from the direction of FIG. The third and fourth protruding portions 36c and 36d are divided into two regions with the axis as a boundary in a cross section including the axis of the support portion 3 (a cross section obtained by cutting the tip 36 along the broken line L4 in FIG. 12, not shown). When divided into two regions, it is formed in a shape that protrudes toward both regions.

先端３６は、互いに異なる４方向に出っ張る形状に形成されるので、上記実施形態と同様に、鑷子等の器具で、４つの出っ張り部３６ａ～３６ｄのいずれかを引掛けながら、先端３６を眼外に出すことができる。特に、先端３６は、互いに反対方向に出っ張る出っ張り部の組み合わせとして、第１、第２の出っ張り部３６ａ、３６ｂからなる第１の組み合わせと、第３、第４の出っ張り部３６ｃ、３６ｄからなる第２の組み合わせとを有するので、鑷子等の器具でより一層引っ掛けやすくできる。すなわち、上記第１の組み合わせを器具に引っ掛けさせることもできるし、上記第２の組み合わせを器具に引っ掛けさせることもできる。 Since the tip 36 is formed in a shape protruding in four directions different from each other, the tip 36 is pulled out of the eye while hooking any one of the four protrusions 36a to 36d with an instrument such as tweezers as in the above embodiment. can be sent to In particular, the distal end 36 has protrusions protruding in directions opposite to each other. Since it has a combination of 2, it can be more easily hooked with an instrument such as tweezers. That is, the first combination can be hooked to the instrument, and the second combination can be hooked to the instrument.

また、上記実施形態では、支持部３の先端３１側を眼外に引き出した後にその先端３１を切断した例を示した。しかし、これに限定されず、眼外に引き出した先端３１（幅広部）を切断せずに、その先端３１（幅広部）をそのまま眼球の部位（強膜内等）に固定させてもよい。すなわち、先端３１（幅広部）を、鑷子等の器具に引っ掛けさせる部分と、眼球の部位に支持（固定）させる部分との兼用部分として構成してもよい。 Moreover, in the above-described embodiment, an example is shown in which the tip 31 is cut after the tip 31 side of the support portion 3 is pulled out of the eye. However, the present invention is not limited to this, and the tip 31 (wide portion) pulled out of the eye may be fixed directly to the part of the eyeball (inside the sclera, etc.) without being cut. That is, the distal end 31 (wide portion) may be configured as a portion that is used both as a portion to be hooked on an instrument such as tweezers and as a portion to be supported (fixed) on the eyeball.

また、上記実施形態では、支持部の個数が２つの例を示したが、３つ以上でもよい。また、有水晶体眼内レンズ（ＩＣＬ、眼内コンタクトレンズ）に本開示を適用してもよい。 Moreover, in the above-described embodiment, an example in which the number of supporting portions is two has been shown, but the number may be three or more. The present disclosure may also be applied to a phakic intraocular lens (ICL, intraocular contact lens).

また、図１３の眼内レンズ２０のように、支持部３の先端３７が玉状（換言すれば球状）であってもよい。なお、図１３において、図１の眼内レンズ１と同様の構成には同一の符号を付している。先端３７は全体が曲面状に形成されている。また、先端３７は真球状に形成されてもよいし、向きによって径が変化する球状（例えば、軸線Ｌ１に直角な方向における径と軸線Ｌ１の方向における径とが異なる楕円球状）に形成されてもよい。 Moreover, like the intraocular lens 20 of FIG. 13, the tip 37 of the support part 3 may be spherical (in other words, spherical). In addition, in FIG. 13, the same code|symbol is attached|subjected to the structure similar to the intraocular lens 1 of FIG. The tip 37 is formed in a curved shape as a whole. In addition, the tip 37 may be formed in a true sphere, or formed in a sphere whose diameter changes depending on the direction (for example, an elliptical sphere whose diameter in the direction perpendicular to the axis L1 differs from that in the direction of the axis L1). good too.

玉状の先端３７は、支持部３の他の部分３２よりも、軸線Ｌ１に交差する方向に幅広の形状に形成される。つまり、先端３７も幅広部として構成される。玉状の先端３７は、図１～図３の先端３１と同様に、支持部３の軸線Ｌ１を面内に含む断面（図１４参照）において軸線Ｌ１を境にして２つの領域に分けたときに、双方の領域の側に出っ張る形状に形成される。また、先端３７は、支持部３の軸線Ｌ１回りの全周に亘って支持部３の延設方向に交差する方向に出っ張る形状に形成される。さらに、玉状の先端３７の直径（言い換えれば、先端３７の、軸線Ｌ１に直角な方向における幅）は、図２の先端３１の幅Ａと同様に、例えば０．２ｍｍ～０．６ｍｍとしてよい。また、先端３７の、軸線Ｌ１の方向における幅は、先端３７の、軸線Ｌ１に直角な方向における幅と異なっていてもよく、例えば、図２の先端３１の幅Ｄと同様に、０．１ｍｍ以上２ｍｍ以下としてよい。また、図１４の断面で見て、先端３７の裏面３７ａ（他の部分３２との境界部３７ｂ近傍の面）と、他の部分３２との成す角度α（図１４参照）が例えば１５°以上１６０°以下である。角度αは、境界部３７ｂでの先端３７（裏面３７ａ）の傾き（接線）Ｌ５と、境界部３７ｂでの他の部分３２の傾き（接線）Ｌ６との成す角度とすればよい。 The ball-shaped tip 37 is formed in a shape wider than the other portion 32 of the support portion 3 in the direction intersecting the axis L1. That is, the tip 37 is also configured as a wide portion. 1 to 3, the ball-shaped tip 37 is divided into two regions with the axis L1 as a boundary in a cross section (see FIG. 14) including the axis L1 of the support portion 3. In addition, it is formed in a shape protruding to the side of both regions. Further, the distal end 37 is formed in a shape protruding in a direction intersecting the extending direction of the support portion 3 over the entire circumference of the support portion 3 around the axis L1. Furthermore, the diameter of the beaded tip 37 (in other words, the width of the tip 37 in the direction perpendicular to the axis L1) may be, for example, 0.2 mm to 0.6 mm, similar to the width A of the tip 31 in FIG. . Also, the width of the tip 37 in the direction of the axis L1 may differ from the width of the tip 37 in the direction perpendicular to the axis L1, for example, 0.1 mm, similar to the width D of the tip 31 in FIG. It may be more than 2 mm or less. 14, the angle α (see FIG. 14) formed by the rear surface 37a of the tip 37 (the surface near the boundary 37b with the other portion 32) and the other portion 32 is, for example, 15° or more. 160° or less. The angle α may be the angle formed by the inclination (tangent line) L5 of the tip 37 (back surface 37a) at the boundary portion 37b and the inclination (tangent line) L6 of the other portion 32 at the boundary portion 37b.

先端３７は、例えば図４、図５と同様に形成されてよい。すなわち、先端に幅広部としての玉が形成されていない基本支持部を準備して、その基本支持部の先端を加熱により溶かす（熱変形させる）ことで、玉状の先端３７を形成する。図１３、図１４の構成でも上記実施形態と同様の効果が得られる。 The tip 37 may be formed similarly to FIGS. 4 and 5, for example. That is, a basic support portion having no ball as a wide portion at the tip is prepared, and the tip of the basic support portion is melted (thermally deformed) by heating to form the ball-shaped tip 37.例文帳に追加The configurations of FIGS. 13 and 14 also provide the same effect as the above embodiment.

また、上記実施形態では、図１又は図１３の眼内レンズ１、２０の支持部３を強膜内で固定する例を示した。しかし、これに限定されず、眼内レンズ１、２０は、例えば、白内障により白濁した水晶体核を摘出した後に、水晶体の嚢内に固定されてもよい。この場合、支持部３はそのループ形状に沿って水晶体嚢の内面に接触する形で水晶体嚢に支持される。また、この場合、眼内レンズ１、２０を水晶体の嚢内に装着させる際に、支持部３の位置を制御する器具（鑷子等）に、支持部３の先端の幅広部３１、３５、３６、３７（図１、図１１、図１２、図１３参照）を引っ掛けながら、嚢内での眼内レンズ１、２０（レンズ部２及び支持部３）の位置を調整してよい。 Moreover, in the above embodiment, an example in which the supporting portion 3 of the intraocular lens 1, 20 of FIG. 1 or 13 is fixed within the sclera was shown. However, it is not limited to this, and the intraocular lenses 1 and 20 may be fixed in the capsule of the lens, for example, after the nucleus of the lens clouded by cataract is removed. In this case, the support part 3 is supported by the lens capsule along the loop shape so as to contact the inner surface of the lens capsule. Further, in this case, when the intraocular lenses 1 and 20 are mounted in the capsule of the crystalline lens, the wide portions 31, 35, 36, 36, 36, 31, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 38, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36, 36 37 (see FIGS. 1, 11, 12, and 13), the position of the intraocular lens 1, 20 (lens portion 2 and haptic portion 3) within the capsule may be adjusted.

このように、図１、図１３の眼内レンズ１、２０は強膜内固定と水晶体嚢内の固定のいずれにも用いることができる眼内レンズとして構成されている。なお、幅広部３１、３５、３６、３７（図１、図１１、図１２、図１３参照）は、支持部３の先端側を強膜内で固定する場合に鑷子等の器具に引っ掛けさせる部分として機能し、支持部３が水晶体嚢内に固定される場合には、必ずしも鑷子等の器具に引っ掛けられなくてもよい。 In this manner, the intraocular lenses 1 and 20 of FIGS. 1 and 13 are configured as intraocular lenses that can be used for both intrascleral fixation and intracapsular fixation. The wide portions 31, 35, 36, and 37 (see FIGS. 1, 11, 12, and 13) are portions to be hooked on an instrument such as forceps when the distal end side of the support portion 3 is fixed within the sclera. When the support part 3 is fixed in the capsular bag, it does not necessarily have to be hooked on an instrument such as tweezers.

１、２０ 眼内レンズ
２ レンズ部
３ 支持部
３１、３５、３６、３７ 支持部の先端（幅広部）
１３ 熱変形部
Reference Signs List 1, 20 intraocular lens 2 lens portion 3 support portion 31, 35, 36, 37 tip of support portion (wide portion)
13 Thermally deformed part

Claims (11)

レンズ部と、
前記レンズ部から線状に延び出して、眼球の部位に支持される支持部とを備え、
前記支持部の先端は他の部分に比べて幅広の幅広部であり、
前記幅広部は、前記支持部の先端側を眼内から眼外に出す器具に引っ掛けさせる部分であり、
前記幅広部は、前記支持部の軸線を面内に含む断面において前記軸線を境にして２つの領域に分けたときに、双方の前記領域の側に出っ張る形状に形成される、
眼内レンズ。 a lens part;
a support portion linearly extending from the lens portion and supported by the eyeball portion;
The tip of the support portion is a wide portion wider than other portions,
The wide portion is a portion for hooking the distal end side of the support portion to an instrument that extends from the inside of the eye to the outside of the eye ,
The wide portion is formed in a shape that protrudes toward both regions when a cross section including the axis of the support portion is divided into two regions with the axis as a boundary.
intraocular lens. 前記幅広部は前記他の部分の側に向いた裏面を有し、 The wide portion has a back surface facing the other portion,
前記裏面は前記器具に引っ掛けさせる部分である請求項１に記載の眼内レンズ。 2. The intraocular lens according to claim 1, wherein said back surface is a portion to be hooked on said instrument. 前記幅広部は、前記支持部の基端と前記先端の間の部分である前記他の部分の軸線回りの全周に亘って前記支持部の延設方向に交差する方向に前記他の部分から出っ張る形状に形成される請求項１に記載の眼内レンズ。 The wide portion extends from the other portion in a direction intersecting the extending direction of the support portion over the entire circumference around the axis of the other portion, which is a portion between the base end and the tip end of the support portion. 2. The intraocular lens of claim 1, wherein the intraocular lens is formed in a protruding shape. 前記幅広部の、前記支持部の延設方向に直角な方向における幅は０．２ｍｍ～０．６ｍｍである請求項１に記載の眼内レンズ。 The intraocular lens according to claim 1, wherein the wide portion has a width of 0.2 mm to 0.6 mm in a direction perpendicular to the extending direction of the support portion. 前記幅広部の、前記他の部分からの、前記軸線に直角な方向への出っ張り量は０．１ｍｍ以上である請求項１に記載の眼内レンズ。 2. The intraocular lens according to claim 1, wherein the amount of protrusion of the wide portion from the other portion in the direction perpendicular to the axis is 0.1 mm or more. 前記幅広部の、前記軸線の方向における幅は０．１ｍｍ以上２ｍｍ以下である請求項１に記載の眼内レンズ。 2. The intraocular lens according to claim 1, wherein the wide portion has a width of 0.1 mm or more and 2 mm or less in the axial direction. 前記支持部は、加熱により、前記支持部の延設方向に交差する方向に出っ張る形状の熱変形部を形成する材料で形成される請求項１に記載の眼内レンズ。 2. The intraocular lens according to claim 1, wherein the support section is made of a material that forms a thermally deformed section that protrudes in a direction intersecting the extending direction of the support section by heating. 前記支持部の軸線を面内に含む断面で見て、前記幅広部の裏面と、前記支持部の前記他の部分との成す角度が１５°以上１６０°以下である請求項１に記載の眼内レンズ。 2. The eye according to claim 1, wherein an angle between the rear surface of the wide portion and the other portion of the support is 15° or more and 160° or less when viewed in a cross section including the axis of the support in the plane. inner lens. 前記幅広部が玉状である請求項１に記載の眼内レンズ。 2. The intraocular lens of claim 1, wherein said wide portion is spherical. 前記幅広部は前記器具としての鑷子に引っ掛けさせる部分である請求項１に記載の眼内レンズ。 2. The intraocular lens according to claim 1, wherein said wide portion is a portion to be hooked on forceps as said instrument. 眼内に挿入されるレンズ部に一端が接続され、他端側が眼球の部位に支持されるように用いられる、線状に延びる支持部を準備して、眼内に挿入する前に前記支持部の先端を加熱して、前記支持部の延設方向に交差する方向に出っ張る形状の熱変形部を形成し、
前記熱変形部は、前記支持部の軸線を面内に含む断面において前記軸線を境にして２つの領域に分けたときに、双方の前記領域の側に出っ張る形状に形成される、
眼内レンズ支持部の製造方法。 A support part extending linearly, one end of which is connected to the lens part to be inserted into the eye and the other end of which is used to be supported by the part of the eyeball, is prepared, and the support part is inserted into the eye before being inserted into the eye. heating the tip of the support portion to form a thermally deformed portion protruding in a direction intersecting the extending direction of the support portion ;
The thermal deformation portion is formed in a shape that protrudes toward both regions when a cross section including the axis of the support portion is divided into two regions with the axis as a boundary.
A method for manufacturing an intraocular lens haptic.
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