Technical field
[0001]
The present invention is, toric intraocular lens, a method of manufacturing the intraocular lens insertion device and toric intraocular lens.
BACKGROUND
[0002]
Intraocular lens to be inserted as a substitute for the lens for correcting the replacement or refraction of human turbid crystalline lens in cataract has been put to practical use. If a patient with corneal astigmatism undergo cataract surgery, there is a case where correction of astigmatism intraocular lenses, called toric intraocular lens is inserted. The toric intraocular lens after insertion into a patient's eye, it is necessary to match the toric axis of the astigmatic axis and the intraocular lens of the patient's cornea.
[0003]
　Conventionally, a toric intraocular lens, a plurality of circular dots aligned linearly have been subjected as a mark showing the toric axis (steepest meridian or weak principal meridian). Toric intraocular lens comprises a lens body having a predetermined refractive power, coupled to the lens body, the lens body and a support portion for retaining in the eye, the mark showing the toric axis is supported at the lens body applied around the joint between the parts (for example, Patent Document 1).
CITATION
Patent Document
[0004]
Patent Document 1: Japanese Patent No. 5771907
Summary of the Invention
Problems that the Invention is to Solve
[0005]
　Mark indicating the toric axis is formed by printing or uneven shape on the front surface of the toric axis of the lens body (astigmatic axis). However, marks printed on the lens body is likely to be mistaken such a line caused in the lens of the patient. Also, the mark formed by the circular or spherical shape the lens body is likely to be mistaken like the air bubbles mixed into the eye during surgery. Further, if the pupil is small cases, IOL (Intraocular Lens) is marked for insertion on the backside of the pupil as seen from the operator may not be able to observe only one. In this case, it can not be recognized accurately toric axis is circular or spherical shape of the mark. Further, the portion where the mark is applied with rough surface, by scattering light by the rough surface, to vary the appearance for the operator in a portion where the mark of the lens body is not subjected a portion has been subjected In some cases. However, light scattered by the rough surface, and is easy to become stray light, which may affect the patient's visual function.
[0006]
　The disclosure of technology has been made in view of the above circumstances, and its object is to provide a toric intraocular lens to improve the visibility of the toric axis.
Means for Solving the Problems
[0007]
　Toric intraocular lens of the present disclosure, there is provided a toric intraocular lens having a lens body that astigmatic axis is provided, on the optical surface of the lens body is formed with a mark indicating the astigmatic axis, an upper surface of the optical surface in view circumferential length of the radial length and the lens body of the lens body in the outer dimensions of the marks are different from each other. Thereby, the mark is different from state of light reflection at the boundary between the optical surface after the toric intraocular lens is inserted into a patient's eye, the surgeon even if not visible only a part of the mark, the operator can identify the astigmatic axis based on the mark. Also, it could be mistaken as bubbles mark is mixed into the eye is reduced.
[0008]
　Said toric intraocular lens is first at least one edge of the contour of the mark of the axis extending in the radial direction of the lens body in the mark may be configured without an arc circle. Further, the mark may be configured as a convex portion formed on the front surface of the recess or a lens body formed on the rear surface of the lens body. Moreover, the radius dimension of the mark edges rounded chamfer in the lens body of a section along a plane parallel to the optical axis of the lens body may be 0.1mm or smaller dimensions. Further, the edges may be made to have been configured with the slope of the optical surface and the mark. Or peripheral portion of the mark may be changed stepwise brightness. Thus, the surgeon for appearance and appearance of the light reflection is different between the optical portion other than the mark and the mark, visibility of the mark of the lens body is improved.
[0009]
　Further, the mark may be configured to have an inclined surface adjacent to the edge of the lens body of a section along a plane parallel to the optical axis of the lens body. Further, a surface roughness value 20nm or smaller than that of the mark, the surface roughness of the optical surface may be a surface roughness different from configuration of the mark. Further, the toric intraocular lens, a toric intraocular lens group consisting of refracting power of different toric intraocular lenses of the lens body is formed in each toric intraocular lenses toric intraocular lens, mark, with respect to the position of the support portion of the toric intraocular lens may be configured to provided at a fixed position regardless of the refractive power of the lens body. Further, the mark is, with respect to the position of the support portion of the toric intraocular lens may be configured to provided at a fixed position regardless of the refractive power of the lens body.
[0010]
　Alternatively, the toric intraocular lens into the intraocular lens insertion device for insertion into the eye of a patient, said toric intraocular lens may be accommodated in advance. Further, the method of manufacturing the toric intraocular lens, using a mold indicator for providing a constant position the position of the mark showing the astigmatic axis with respect to the position of the support portion of the toric intraocular lens is attached, it may be configured to polymerize the resin constituting the lens body. Also, the index of the resin type may be a recess, the surface roughness of the indicators of resin type, may be configured to be different from the surface roughness of the portion other than the indicator.
Effect of the invention
[0011]
　According to the present disclosed technology, it is possible to provide a toric intraocular lens to improve the visibility of the toric axis.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012]
[1] Figure 1 (a), (b) , (c) is a diagram showing a schematic configuration of a toric intraocular lens in one embodiment.
[2] Figure 2 (a), (b) is a diagram showing the schematic configuration of the intraocular lens insertion device according to one embodiment.
FIG. 3 is a diagram showing a schematic configuration of the nozzle body in one embodiment.
[4] FIG. 4 (a), (b) is a diagram showing the schematic configuration of the positioning member in one embodiment.
[5] FIG. 5 (a), (b) is a diagram showing a schematic configuration of a plunger in one embodiment.
[6] FIG. 6 (a), (b) is a schematic diagram showing the forming of bulk intraocular lens in one embodiment.
[7] FIG. 7 (a), (b) is a schematic diagram showing the forming of bulk intraocular lens in one embodiment.
[8] FIG. 8 (a), (b) is a diagram showing a schematic configuration of a bulk intraocular lens in one embodiment.
[9] FIG. 9 is a schematic diagram showing the forming of bulk intraocular lens in one embodiment.
[10] FIG. 10 (a), (b) is a schematic diagram showing the forming of bulk intraocular lens in one embodiment.
[11] FIG. 11 (a) ~ (d) are views showing a schematic configuration of a mark toric intraocular lens in one embodiment.
[12] FIG. 12 (a) ~ (c) is a diagram showing an example of Cornsweet illusion.
[13] FIG. 13 (a) ~ (c) is a diagram showing a schematic configuration of a mark toric intraocular lens in a modified example.
[14] FIG. 14 (a), (b) is a diagram showing a schematic configuration of a mark toric intraocular lens in a modified example.
DESCRIPTION OF THE INVENTION
[0013]
　Hereinafter, with reference to the drawings will be described embodiments of the present invention.
[0014]
　Figure 1 is a diagram showing a schematic configuration of a toric intraocular lens 2 according to the present embodiment. 1 (a) is a plan view and FIG. 1 (b) is a side view, FIG. 1 (c) is an enlarged view of the vicinity of the mark. In addition, between 1 (a) and FIG. 1 (b), the orientation of the toric intraocular lens 2 is not compatible. Further, FIG. 1 (c) is a diagram in top view when viewed mark from the rear side of the opposite side, that intraocular lens 1 and (a). Toric intraocular lens 2 is a so-called one-piece supporting portion and the lens portion are integrally molded of the same material, the material of the lens is an acrylic material flexible. Toric intraocular lens 2, a lens body 2a having a predetermined refractive power, coupled to the lens body 2a, and a long plate-like two supporting portions 2b for holding the lens body 2a in the eye provided. Lens body 2a and the supporting portion 2b is formed of a flexible resin material. Also, the lens body 2a and the support portion 2b, and are connected to one another via a joint 2e.
[0015]
　As shown in FIG. 1 (b), joint portions 2e are formed to protrude from the lens outer peripheral surface tangentially provided in contact around the periphery and a predetermined range of the lens body 2a. Further, in the present embodiment, the vicinity of the outer edge portion of the optical surface of the lens body 2a, a pair of marks 2d that face each other across the optical axis O of the lens body 2a is applied. Mark above 1.5mm from the optical axis O, preferably the desired position or more away 2.0 mm. Imaginary line connecting the marks and 2d, the first represents axis (e.g. weak principal meridian) line perpendicular to the line of the imaginary in the optical axis O of the lens body 2a of the lens body 2a is a second axis (e.g. strong principal meridian) represents a. Thus, the operator, after a toric intraocular lens 2 is inserted into a patient's eye, so that the weak principal meridian direction indicating mark 2d of patient's cornea the strong principal meridian direction and the lens body 2a coincide, toric it is possible to adjust the position of the intraocular lens 2. It should be noted, will be described in detail later in the configuration of the mark 2d.
[0016]
　In the present embodiment, within the intraocular lens insertion device 1 to be described later, one of the support portion 2b of the two supporting portions 2b is a rear side of the lens body 2a, the front side of the other support portion 2b lens body 2a as arranged, toric intraocular lens 2 is set on the stage 12. Note that the front supporting portion supporting portion disposed on the front side of the lens body 2a, a supporting portion arranged on the rear side of the lens body 2a and the rear support portion.
[0017]
　Toric intraocular lens 2 in this embodiment, embossing is applied to the support portion 2b. Thus, when by the plunger 30 of the pressing movement of the toric intraocular lens 2, the orientation of the toric intraocular lens 2 can be stabilized. Specifically, for example, by the plunger 30 when the toric intraocular lens 2 is pressed and moved, toric intraocular lens by appropriate frictional force is generated between the inner wall surface of the support portion 2b and the nozzle body 10 2 There can be prevented so as not to rotate with the nozzle body 10.. In addition, by embossing it is applied to the support portion 2b, when a toric intraocular lens 2 is folded in the nozzle body 10, may be supporting portion 2b is prevented so as not stick to the lens body 2a . Further, in the present embodiment, as shown in FIG. 1 (b), the peripheral portion of the lens body 2a toric intraocular lens 2, that is, in connection portion between the lens body 2a and the supporting portion 2b, optical with lens body 2a is reduce the center thickness of the lens by providing a curvature smaller optical surface 2c so as to alleviate the tilt of the surface, the cross-sectional area of ​​the lens also reduced, thereby realizing a thin lens shape. Here, the optical surface 2c may be a flat shape.
[0018]
　In the range where the joint 2e is in contact with the outer periphery of the lens body 2a, the optical section diameter of the front, because that is only slightly larger minute processing margin than other ranges, the optical portion in front slightly oval has a shape (non-circular). Further, the rear optical unit is also in the range of joint 2e is in contact with the outer periphery of the lens body 2a, has become larger optic diameter about 10% compared to other ranges, i.e., the optical lens surface in the joint 2e there is a function to have part of the as. Thus widely effective range of the lens a little in a predetermined size to be defined for the lens body 2a. Generally, the optical portion diameter of the lens body 2a in the range not contacting the joint 2e is 7.0mm from 5.5 mm.
[0019]
　Figure 2 shows a schematic configuration of the intraocular lens insertion device 1 for use in insertion into the eye of the toric intraocular lens of the present embodiment. 2 (a) is a plan view of the IOL injection instrument 1 in the case where the lid opening stage lid 13, FIG. 2 (b) side of the intraocular lens insertion device 1 in the case of closing the stage cover portion 13 It shows a view. The nozzle body 10 of the intraocular lens insertion device 1 is a cylindrical member of the cross-section substantially rectangular, and the rear end portion 10b which is largely opened on one side of the end portion, the insertion tube which is narrowed in an end portion of the other side and a nozzle portion 15 and the tip portion 10a of the parts 100. As shown in FIG. 2 (b), the tip portion 10a is opened obliquely. Plunger 30 is inserted into the nozzle body 10 is reciprocable.
[0020]
　In the following description, forward a direction from the rear end 10b to the distal end portion 10a of the nozzle body 10, the rear direction and the opposite direction, upward direction near side in FIG. 2 (a), the downward direction and the opposite direction , the vertically upward direction from the sheet surface left, the opposite direction to the right in FIG. 2 (b). In this case, the upper on the front side optical axis of the lens body 2a to be described later, the optical axis rear lower lens body 2a, the front side in the pressing direction forward by the plunger 30, the rear side pressing by the plunger 30 It corresponds to the direction the rear.
[0021]
　In the vicinity of the rear end portion 10b of the nozzle body 10, protruding in a plate shape, the user hold unit 11 for applying a finger when pressing the plunger 30 in the distal end side of the nozzle body 10 is provided integrally. Further, the rear side of the nozzle portion 15 of the nozzle body 10, a stage unit 12 to set the toric intraocular lens 2 is provided. The stage unit 12 is adapted to open to the upper side of the nozzle body 10 by lid opening stage lid 13. Further, the stage unit 12, the positioning member 50 is attached from the lower side of the nozzle body 10. This positioning member 50, toric intraocular lens 2 is positioned stably in the stage unit 12 before use (during transport).
[0022]
　That is, in the intraocular lens insertion device 1, at the time of manufacture, in a state where the stage cover portion 13 is the positioning member 50 is opened cover is attached to the stage 12, toric intraocular lens 2 on the stage 12, the optical axis the front side is set to be the top. Then, it shipped after being closed the stage cover portion 13, is sold. Furthermore, in use, the user, by inserting the stage portion 12 of the needle of a syringe which lubricant filled for toric intraocular lens from the needle hole 20a of the insertion portion 20 to inject the lubricant. Then, the user removes the positioning member 50 while still closing the stage cover portion 13, then pushing the plunger 30 on the distal end side of the nozzle body 10.
[0023]
　Thus, pressing the toric intraocular lens 2 by the plunger 30, after moving to the nozzle section 15, a toric intraocular lens 2 is released into the eye from the tip 10a. The nozzle body 10 in the intraocular lens insertion device 1, the plunger 30, the positioning member 50 is formed of a resin such as polypropylene material. Polypropylene has a proven track record in medical equipment, reliability such as chemical resistance is also high material.
[0024]
　Further, a part of the stage cover portion 13 is formed a confirmation window 17 by a thin portion. Incidentally, either the degree of the thin portion of the check window portion 17 at the stage the lid 13 be suitably determined based on the visibility of the toric intraocular lens material and the confirmation window 17 to form a stage cover portion 13 Bayoi. Further, by forming the check window portion 17, it can be expected the effect of reducing shrinkage during molding of the stage cover portion 13.
[0025]
　The Figure 3 shows a plan view of the nozzle body 10. In the nozzle body 10 as described above, toric intraocular lens 2 is set on the stage 12. The toric intraocular lens 2 is released from the pressed the tip portion 10a in this state by the plunger 30. Incidentally, inside the nozzle body 10 has a through hole 10f of the through hole 10c and the rear end side of the distal end side of the cross-sectional shape changes is provided in accordance with a change in the outer shape of the nozzle body 10. Through holes 10c is part to become pores of the movement path when the intraocular lens 2 is pressed and moved, the through-hole 10f is a hole plunger 30 is inserted. Then, when the toric intraocular lens 2 is released, the toric intraocular lens 2 is deformed in accordance with a change in the cross-sectional shape of the through hole 10c of the nozzle body 10, the incision formed in the patient's eye It is released after having deformed easily form enters.
[0026]
　The tip portion 10a, the upper region of the nozzle portion 15 is cut obliquely so that the front of the lower region, a so-called bevel cut shape. Although described later in detail of the tip of the nozzle portion 15 of this embodiment, the cut shape obliquely the tip section 10a, as viewed from the lateral direction may be linearly obliquely cut and, to have a bulge on the outside, i.e. may be cut obliquely so that the curved shape.
[0027]
　The stage 12, the stage groove 12a having a width slightly greater than the diameter of the lens body 2a toric intraocular lens 2 is formed. Longitudinal dimension of the stage groove 12a is set larger than the maximum width dimension including a support portion 2b extending on either side of the toric intraocular lens 2. Further, the bottom surface of the stage groove 12a, a mounting surface of the toric intraocular lens set surface 12b is formed. Vertical position of the set surface 12b, rather than the height position of the bottom surface of the through hole 10f of the nozzle body 10 is set upward, it is connected by a sloping bottom face 10d and the set surface 12b and the bottom surface of the through-hole 10f .
[0028]
　It is formed integrally with the stage 12 and the stage cover portion 13. Stage lid 13 has a longitudinal dimension equivalent to the stage portion 12. Stage lid 13, the side surface of the stage 12 are connected by a thin plate-like connecting part 14 formed extending to the stage cover portion 13 side. Connecting portion 14 is bendable formed at the central portion, the stage cover portion 13 can be closed overlap from above the stage unit 12 by bending the connecting portion 14.
[0029]
　In stage lid 13, the set surface 12b which faces when closing, and reinforce the stage cover portion 13, the rib 13a for stabilizing the position of the toric intraocular lens 2, and 13b, upper plunger 30 guide protrusions 13c of the guide is provided for. Further, the stage cover portion 13, the needle hole 20a of the toric intraocular lens 2 as an insertion hole for injecting a syringe hyaluronic acid in the stage 12 before the operation of inserting the intraocular provided. The needle hole 20a, when closed stage cover portion 13 is a hole for connecting the toric intraocular lens 2 housed in the outside stage portion 12 of the stage 12. The user inserts the syringe needle from the needle hole 20a before the operation of inserting the toric intraocular lens 2, and supplies the hyaluronic acid is a viscoelastic material to the desired location within the stage portion 12.
[0030]
　Below the set surface 12b of the stage 12, the positioning member 50 is provided detachably. Figure 4 shows a schematic configuration of the positioning member 50. 4 (a) shows a plan view of the positioning member 50, FIG. 4 (b) shows a left side view of the positioning member 50. The positioning member 50 is configured separately from the nozzle body 10, there is a pair of side wall portions 51, 51 are connected by a connecting portion 52 structure. The lower end of the side wall portion 51, the holding portion 53 that extends extends outward is formed.
[0031]
　Then, the inside of the side wall portions 51, 51, the first placement portion 54 protruding upward, the second mounting portion 63 is formed. Further, on the outer peripheral side of the upper end face of the first mounting portion 54, the first positioning portion 55 is formed to protrude. Further, on the upper end face of the second mounting portion 63, the second positioning portions 64 of the pair of positioning the lens body 2a and the support portion 2b of the intraocular lens 2 is formed to protrude. A first positioning portion 55 spaced the length of the second positioning portion 64 is set slightly larger than the diameter of the lens body 2a of the intraocular lens 2.
[0032]
　In addition, the inside of the side wall portions 51 and 51, the third mounting portion 56, 56 of the pair of protruding upward is formed. The first mounting portion 54, the second mounting portion 63, the height of the upper surface of the third mounting portion 56, 56 are respectively turned equally. Furthermore, the outer part in the top surface of the third mounting portion 56, third positioning portions 57 and 57 to further protrude upward throughout the lateral direction of the third mounting portion 56, 56 are formed . Separation length of the inner each other of the third positioning portion 57 is set slightly larger than the diameter of the lens body 2a of the intraocular lens 2.
[0033]
　In addition, the inside of the side wall portions 51 and 51, a fourth mounting portion 58 in which a part of the front support portion of the support portion 2b of the intraocular lens 2 is placed is formed. The fourth positioning portion 59 protrudes further upward from the fourth mounting portion 58 is formed. The fourth positioning portion 59 a part of the front support portion abuts. Then, the inside of the side wall portions 51 and 51, the fifth mounting portion 60 in which a part of the rear support portion of the support portion 2b of the intraocular lens 2 is placed is formed. Further, the fifth positioning portion 61 which protrudes further upward from the fifth mounting portion 60 is formed. The fifth positioning portion 61 a part of the rear support portion abuts.
[0034]
　Incidentally, as shown in FIG. 4 (b), the height of the upper surface of the fifth mounting portion 60 and the fifth positioning unit 61, than the height of the upper surface of the first through fourth mounting portion and the first to fourth positioning portion It is provided so as also low. On the other hand, on the outside of the side wall portions 51 and 51, is provided rotation prevention wall 62 for preventing unwanted rotation when removing the positioning member 50.
[0035]
　The set surface 12b of the nozzle body 10, set surface through hole 12c penetrating the set surface 12b in the thickness direction is formed. The outer shape of the set surface through hole 12c is slightly larger substantially similar shape to the shape viewed first to fifth mounting portion and the first to fifth positioning portion of the positioning member 50 from the upper side. Then, when the positioning member 50 is attached to the nozzle body 10, first to fifth mounting portion and the first to fifth positioning part is inserted from the lower side of the set surface 12b on the set surface through holes 12c, set surface protruding above the 12b.
[0036]
　Then, when the intraocular lens 2 is set to the set surface 12b is the outer peripheral bottom face of the lens body 2a is, first setting portion 54, the second mounting portion 63, the third mounting portion 56, 56 It is placed on the upper surface. The lens body 2a is first positioning portion 55, the second positioning unit 64, the position is regulated with respect to (horizontal direction in sets face 12b) horizontally by the third positioning portion 57. Furthermore, two support portions 2b of the intraocular lens 2 and the fourth mounting portion 58, respectively, are placed on the upper surface of the fifth mounting portion 60. Moreover, two supporting portion 2b, the fourth positioning portion 59, respectively, is restricted in position with respect to the horizontal direction by the fifth positioning portion 61.
[0037]
　It shows a schematic configuration of the plunger 30 in FIG. Plunger 30 has a slightly larger front-rear length than the nozzle body 10. Then, the working portion 31 of the base and the distal end side of the cylindrical shape and a rectangular rod-shaped and is formed from the base and the rear end side of the insertion portion 32.. The action part 31 is configured to include a cylindrical portion 31a which is a cylindrical shape and a thin plate-like flat portion 31b extending in the lateral direction of the cylindrical portion 31a. Figure 5 (a) shows the central axis CX of the working portion 31 of the plunger 30 (columnar portion 31a). Here, the tip of the plunger 30 is generally from 0.5 mm 2.0 mm width (thickness). This case from thin plunger strength becomes weak, it is impossible to stably extruded lens. If thicker than this, in turn increases the incision for inserting an intraocular lens into the eye, astigmatism called induced astigmatism is likely to adversely affect the generated visual function.
[0038]
　The tip portion of the working portion 31, the cutout portion 31c is formed. The notch 31c, as can be seen from FIG. 5 (b), are formed in a groove shape that penetrates in the lateral direction open in the downward direction of the action part 31. Moreover, as can be seen from FIG. 5 (b), the groove wall on the distal end side of the cutout portion 31c is formed in the inclined surface directed downward to take to go to the tip end of the working portion 31.
[0039]
　Further, in the longitudinal direction in the vicinity of middle and proximal of the left and right flat portions 31b, the slit 31d, 31f are formed. Slits 31d, 31f are formed to be substantially L-shape consisting of notches and extending into the notches and the longitudinal direction to stretch the flat portion 31 in the lateral direction. Also, the flat portion 31b, the movable piece 31e by slits 31d, 31f are formed, 31 g is formed. Movable piece 31e, 31 g, when the plunger 30 moves the nozzle body 10, so that the cylindrical portion 31a is located at the center in the lateral direction of the nozzle body 10, functions of the so-called axial deviation prevention. In this embodiment, two pairs of the movable piece 31e, but 31g are formed, may be formed only one pair or three pairs or more.
[0040]
　Insertion portion 32 is generally has a substantially H-shaped cross section, dimensions of the horizontal direction and the vertical direction is set slightly smaller than the through hole 10f of the nozzle body 10. Further, the rear end of the insertion portion 32, a disc-shaped pressing plate portion 33 extending in the vertical and horizontal direction is formed.
[0041]
　The front side of the portion from the center of the longitudinal direction of the insertion portion 32, toward the upper side of the insertion portion 32 protrudes elastically by vertically movable pawl portion 32a of the material of the plunger 30 is formed. Then, when the plunger 30 is inserted into the nozzle body 10, the locking hole 10e and the pawl portion 32a shown in FIG. 3 provided in the thickness direction in the upper surface of the nozzle body 10 is engaged by this the relative positions of the nozzle body 10 and the plunger 30 in the initial state are determined. The formation position of the claw portion 32a and the engaging hole 10e is in engagement, the tip of the working portion 31 is positioned on the rear side of the lens body 2a toric intraocular lens 2 is set on the stage 12, lens notch 31c of the support portion 2b of the rear side of the main body 2a is set to be positioned on the support in a location from below. Also in the insertion portion 32, the slits 31d, similarly to 31f, a slit of a substantially L-shape consisting of a notch extending into the notches and the longitudinal direction extending in the lateral direction may be formed. Thus slit formed in the insertion portion 32, perform the function of axial misalignment prevention of the plunger 30.
[0042]
　Next, a method for manufacturing the intraocular lens of the present embodiment.
[0043]
　With reference to FIGS. 6-10, will be described in detail the process of manufacturing bulk intraocular lens 3e underlying intraocular lens according to the present embodiment. The Figure 6 shows a schematic view of a molding resin mold 20 in the bulk intraocular lens 3e. Molding resin mold 20 is made of a resin upper mold 115 and the resin lower mold 117.. Bulk resin upper mold 115 is coupled to the resin lower mold 117, the original intraocular lens 3 by filling the soft material in the clearance formed between the resin upper mold 115 and the resin lower die 117 in its forming an intraocular lens 3e. 6 (a) is a sectional view showing a state in which the resin upper mold 115 and the resin lower die 117 is separated. 6 (b) is a sectional view showing a state during molding bulk intraocular lens 3e by combining the upper mold 115 and lower mold 117. Bulk intraocular lens 3e is provided with a front lens body 3g and the front supporting portion 3h. It will be described later in detail before the lens body 3g and the front supporting portion 3h.
[0044]
　As shown in FIG. 6 (a), the resin upper mold 115 includes a optical front surface forming portion 115a for forming the front surface of the lens body 3a of bulk intraocular lens 3e, the front surface of the areas of the support portion 3a and a support portion front forming portion 115b for molding. Resin lower die 117, the support portion rear surface molding portion for molding the optical rear surface molding portion 117a for forming the optical portion rear surface, the rear surface of the areas of the support portion 3a of the lens body 3a of bulk intraocular lens 3e and a 117b. The resin lower die 117, the outer wall portion 117c for enabling binding to the resin upper mold 115 is provided over the entire circumference of the outer periphery thereof are provided.
[0045]
　Resin upper mold 115 and the resin lower die 117 is formed by injection molding, a general-purpose resin material is used as a material. The plastic resin is preferably excellent in solvent resistance which does not cause deformation by the raw material monomer of the lens material as a resin material, polyethylene, or may be a polyolefin resin of the polymerization vessel such as polypropylene. It may also be formed with acrylic resin, nylon resin, such as PMMA.
[0046]
　When manufacturing the intraocular lens 3 using an injection molding resin mold 120 described above, first, as shown in FIG. 6 (a), the resin lower mold 117, and supplies the raw material monomer 110 of lens material . Is not particularly limited may be those commonly used in intraocular lenses for this raw material monomer 110. Also, it is known thermal polymerization initiators as polymerization initiator may be used a photopolymerization initiator, and the like. Further, by applying or colored ultraviolet absorbing ability to the UV type intraocular lens 3, polymerizable UV absorber as a copolymer component, or the like may be used polymerizable dye.
[0047]
　Then, as shown in FIG. 6 (b), thereby coupling the resin upper mold 115 and the resin lower mold 117 by way to push-fit the resin upper mold 115 to the inside of the outer wall portion 117c of the resin lower mold 117. Thereby, the optical front surface molding portion 115a of the resin upper mold 115, a portion of the raw material monomer 100 in the gap surrounded by the optical rear surface molding portion 117a of the resin lower die 117 corresponds to the lens body 3a is filled, also, resin material monomer 110 is a portion corresponding to the supporting portion 3b is filled in the gap surrounded by the support portion forming portion 117b of the support portion forming part 115b and the resin lower die 117 of the upper die 115.
[0048]
　Then, the polymerization inside the molding resin mold 120 material monomer 110 filled in the gap between the resin upper mold 115 and the resin lower die 117. As the method of polymerization, for example, the temperature was raised at a temperature range of stepwise or continuously 25 120 ° C., it may be used thermal polymerization to complete the polymerization in several tens of hours to several hours. Further, for example, photopolymerization or the polymerization is carried out by irradiating light having a wavelength corresponding to the absorption of the activated photoinitiators such as ultraviolet or visible light, it may be used a combination of a thermal polymerization and a photopolymerization . Note that this time, intracisternal carrying out the polymerization, or the room an atmosphere of inert gas such as nitrogen or argon, and may be polymerized at atmospheric pressure or under pressure.
[0049]
　Then, in the present embodiment, the polymerization of the raw material monomer 110 is completed, as shown in FIG. 7 (a), from the state where the resin upper mold 115 and the resin lower die 117 is attached, FIG. 7 (b as shown in), to remove the resin upper mold 115. Thus bulk intraocular lens 3e is exposed to be described later. At that time, the bulk intraocular lens 3e are generally considered likely to remain higher resin lower mold 117 side of the contact area. That is, by removing the resin upper mold 115, in a state where the resin lower die 117 and the bulk intraocular lens 3e are integrated, bulk intraocular lens 3e is exposed.
[0050]
　Bulk intraocular lens 3e, as shown in FIG. 8 (a), has a substantially disc-like shape, and the lens body 3g before the group of the lens body 3a, before a group of the support portion 3b supporting portion it is that a 3h. Intraocular lens 3 is obtained by machining along the bulk intraocular lens 3e to the contour of the intraocular lens 3 shown by the broken line in FIG. 8 (a).
[0051]
　Next, steps for obtaining the intraocular lens 3 by adding machined bulk intraocular lens 3e. In this embodiment, as shown in FIG. 7 (b), from the state where the resin lower die 117 and the bulk intraocular lens 3e are integrated, coating the upper surface of the bulk intraocular lens 3e 9 200 covered with such to secure the bulk intraocular lens 3e. Thereafter, as shown in FIG. 10 (a), (b), to obtain the shape of the intraocular lens 3 using a milling (shaping) method with the surface of the fixed bulk intraocular lens 3e conventionally. Therefore when the cutting chips is prevented from adhering as foreign to the product, or blowing air (cold air) to the lens at the time of milling, cutting oil (eg good water-soluble propylene glycol) it has been made to apply a there. Thereafter, by removing the coating material 200, it is possible to obtain a desired intraocular lens 3. Incidentally, the coating material 200 can eliminate the risk of adhesion of cutting chips and dust produced when cutting out the intraocular lens 3, as long as it can improve the quality of the time of manufacturing the intraocular lens 3. As the coating material 200 can be utilized, for example, sealant and liquid wax agent.
[0052]
　Further, as shown in FIG. 7 (b), without having to remove the resin upper mold 115, the processing may be performed with the resin upper mold 115 and the resin lower die 117 and the bulk intraocular lens 3e.
[0053]
　Obtained by also polymerized using the resin under type 117 having a toric marks indicating resin upper mold 115 and the toric surface and astigmatic axis, as previously described the case of producing a toric intraocular lens. However, in the case of toric intraocular lens, the relationship between the positions of the support portion toric marks is very important, when the positional relationship is not appropriate, the lens is broken or during insertion, extrusion behavior during insertion not because of the adverse effect on surgery or become stable, the resin lower mold 117 used in this case is provided in the step before the step of indicators to perform polymerization for positioning when trimmed .
[0054]
　While checking the indicator, is set to the shape processing apparatus, processing by performing, in toric lenses to be produced, the position of the mark with respect to the position of the support portion can be manufactured without variation by the lens. This is because it can be operated on the lens have the same sense even vary for the operator to perform an operation many times, it is possible to obtain stable results. Although toric intraocular lens spherical equivalent power (power) and 300 or more kinds by the combination of the cylinder power may be present, and mark at the same position regardless of the size of their power is applied Being, in cataract surgery that requires different power of the lens, can be operative in the same sense, it is possible to obtain stable results. When setting the shaping unit may be mechanically controlled so that the indicator is set to the same position.
[0055]
　It will now be described indicators for performing alignment. Indicator 117d for positioning the FIG. 10 (a), an area that does not form a toric lens (b), the extension of the toric axis showing plan position of the toric marks toric surface (3i) in a front view It is provided so as to come to the top. Simultaneous machining and may be, adjusting the orientation of the mold forming the mold and the toric surface forming an index when molding the resin lower mold 117 when it is processing the toric surface of the resin lower die 117 in may be realized, it can be easily provided.
[0056]
　Indicator 117d for alignment may be disposed at a position capable of observing and detection in the polymerised state. This is, in the state after polymerization, the surface forming the lens is due to the inability to observe the indicator is sandwiched resin upper mold 115 and the resin lower die 117. Therefore, the outer wall portion 117c of FIG. 9 the indicator (peripheral portion of the upper surface of the resin mold 117) or, preferably provided on the opposite surface of (index 117d) to the surface to form a lens as shown in FIG. 10 (a) . The shape of the resin mold in this embodiment is an example, may be changed as needed. For example, the surface of the outer wall portion 117c are oblique with respect to the optical axis of the intraocular lens may be in a horizontal in order to facilitate detecting the index (perpendicular to the optical axis of the intraocular lens). It is also possible to increase the width of the outer wall portion 117c.
[0057]
　Further, the index 117d is preferably a concave shape, as shown in Figure 10 (a). This is because, while the convex part is contacted to the surface where the index of the resin lower mold 117 is formed, by rotating the resin lower mold 117 centering on the optical axis of the optical surface, the position of the convex part matches the index This is because it is possible to exactly fit the time. In this way, it is possible to detect the mechanical orientation is toric marks (orientation of toric axis). At this time, the convex part is configured with an elastic body, may be height along the surface shape of the resin lower die 117 in contact is changed when the region other than the recess are in contact. The detection of the concave portion may be performed in a non-contact manner using a laser interference or the like.
[0058]
　Recess to index may be a non-through holes in the through hole, it is to consider the non-through molding and processing conditions resin type is common. For non-penetrating, the bottom surface of the recess may be on the surface of different roughness and portions other than the concave portion. Because if the resin lower die 117 which has a high transparency resin serving as a material is large, there is a case where the detection of the index position becomes somewhat difficult, and metrics bottom, by be different roughness and around, such as a laser while irradiating with light, to rotate the resin lower mold 117 centering on the optical axis of the optical surface, because the scattering intensity of the irradiated reflection light is changed, it is easy to detect the indication position, as a result, the direction of the toric axis it can be easily detected. Moreover, it obtains a luminance difference of the optical surface and the mark by performing image processing by capturing by the CCD camera or the like, may detect the orientation of the toric axis. If the index conversely convex, since in many cases be conveyed on the lens surface to be processed, a convex shape will be inclined to interfere with the transport lane and the lens receiving jig of the lens. This inclination is to affect the machining accuracy, or require complex processes to avoid tilt, resulting in or costly.
[0059]
　In the present embodiment, since a method of providing a toric surface on the resin lower mold 117 is provided with the indication in the resin lower mold 117, depending on the configuration of the preparation and toric lenses, be provided with indicators resin upper mold 115 good.
[0060]
　Figure 11 (a) ~ (d), shows a schematic configuration of a mark 2d formed in the lens body 2a toric intraocular lens 2 in this embodiment. 11 (a) is a partial enlarged view of the lens body 2a toric intraocular lens 2 in FIG. 11 (b). In the present embodiment, marks 2d is a recess formed in the surface 2g of the lens body 2a. In FIG. 11 (b), it shows a marked 2d in the top view of the lens body 2a schematically. As shown in FIG. 11 (b), the shape of the mark 2d edge 2h in top view of the lens body 2a is elliptical having no arc of a circle. Further, the major axis 2j and the short axis 2k of elliptic edge 2h perpendicular in the center of gravity 2i mark 2d, the length of the major axis 2j and the short axis 2k are different. Axis in the present embodiment, the long axis 2j is an axis extending (direction perpendicular to the optical axis O in the lens body 2a) radially of the lens body 2a, the minor axis 2k is extending in the circumferential direction of the lens body 2a it is. Note that the length axis 2j is an example of the first shaft and (eg weak principal meridian) corresponds to (substantially coincides), the minor axis 2k corresponds to the direction of an example of a second axis (e.g., strong principal meridian). By thus mark 2d is formed, when the toric intraocular lens 2 is inserted into a patient's eye, the surgeon can reduce any potential for false marks 2d bubbles such as.
[0061]
　Further, at both ends of the long axis 2j, the edge 2h not circle portion is formed. For example, if the perfect circle section to the edge 2h at both ends of the long axis 2j are formed, the operator can not verify only the circle portion of the mark 2d in the inserted toric intraocular lens into the eye of a patient , surgeon, only the circle portion not possible to determine the astigmatic axis extends in any direction. On the other hand, the mark and 2d edge 2h no circle portion, i.e. by the structure without an arc circle, operator, even if you can not check only near one end portion of the long axis 2j, of the partial it is possible to determine the direction of the astigmatic axis based on the shape of the edge 2h.
[0062]
　Further, a mark 2d in cross-sectional side view of the lens body 2a in FIG. 11 (c) shows schematically. As shown in FIG. 11 (c), mark 2d has a bottom surface 2m, and an inclined surface 2n leading from the edge 2h the bottom 2m. Further, at the edge 2h of marks 2d, the surface 2g of the lens body 2a and the inclined surface 2n forms an edge. Further, in FIG. 11 (d), it shows a partial enlarged view of the edge 2h of marks 2d shown in FIG. 11 (c). In the cross section of the lens body 2a by a plane parallel to the optical axis of the lens body 2a (portion comprising marks 2d), also referred to as the dimensions of the size or the corner radius dimension (corner R radius R of rounding chamfered edges 2h. That corner a radial dimension of the structural occurring rounded portion of the part.) is equal to or less than a predetermined value. Thus, when the refraction direction in the light of each surface transmitted through the inclined surface 2n and light passing through the rear face 2g is a rapidly changing that the boundary edges 2h, the surgeon saw marks 2d, edge 2h and it can be visually recognized ellipse of which the inclined surface 2n. In the present embodiment, the predetermined value is 0.1mm or less (0.1mm or less dimension than), the angle of the inclined surface 2n and the rear 2g is smaller slope shape greater than 180 degrees than 90 degrees, the operator who is considered to be clearness in different colors and an inclined surface 2n of the rear 2g marked 2d. When actually manufacturing a toric lens having a toric marks shown in FIG. 6, the aphakic eye insert the IOL into the optical system simulating and enters the transmitted light from the cornea side and observe the retina side, If the angle of the rear 2g and the inclined surface 2n of 150 degrees or more, it was not possible to recognize the boundary. Therefore, I thought it is not actually recognize the patient even if it is inserted into the eye, is desirable as intraocular lenses.
[0063]
　The peripheral portion of the mark 2d in (e.g. inclined surface 2n), may be stepwise brightness changes. In this case, the so-called Cornsweet illusion, surgeon stepwise as a boundary edge 2h and the inclined surface 2n (peripheral portion) which brightness changes, the bottom 2m of light and mark 2d to transmit rear 2g It looks bright one light transmitted light and may be other light appear dark. From this reason, a mark 2d within the above arrangement, the operator is considered to be easily visible in different colors or brightness and a bottom surface 2m of the rear surface 2g and mark 2d.
[0064]
　Here, referring to FIG. 12 (a) ~ (c), will be described Cornsweet illusion about. 12 (a), the entire area on the right side of the center of the edge appears slightly brighter than the left. Figure 12 (b), the horizontal axis represents the position of the region shown in FIG. 12 (a), showing the vertical axis graph luminance (brightness) at each position. As the graph of FIG. 12 (b), the brightness of the left and right areas are actually the same. FIG. 12 (c), among the areas shown in FIG. 12 (a), shows a diagram of a case where blackened boundary portions of the left and right areas (edges). As shown in FIG. 12 (c), both visible at the same brightness when hide areas of the center, including the edge. Thus, even with the same brightness, when having an edge in the boundary portion, it is affected by the brightness gradient of the edge portion, to be perceived is known as brightness different on both sides of the edge.
[0065]
　Utilizing the effect of this illusion, the optical surface and mark the boundaries of the lens, by constituting such state or brightness of the light reflected changes, it is possible to change the brightness recognized by the optical surface marked , made mark is easy to recognize. This illusion occurs when having a slope of brightness at the boundary. Therefore, the optical surface and mark the boundaries of the lens, or the edge portion and a sharp shape as in this embodiment, a roughness that is changed stepwise at the periphery of the mark, the light reflected by the edge is the most bright or looks, by the brightness of the light reflected at the periphery of the mark brightness with a gradient by varying stepwise is achieved, it can be generated effectively illusion, recognizing mark It tends to be.
[0066]
　Further, the bottom surface 2m and the inclined surface 2n of the mark 2d is desirably smooth surface. If the bottom surface 2m and the inclined surface 2n configured as rough surface, concerns affecting the patient's visual function light scattered by the bottom surface 2m and the inclined surface 2n becomes the stray light is generated. On the other hand, in the present embodiment, since the bottom surface 2m and the inclined surface 2n is formed as a smooth surface, the bottom surface 2m and the inclined surface 2n, there is no concern that cause unnecessary scattered light to the patient's visual function. Here, the smooth surface is a surface which is roughened in a range which can be regarded a bottom 2m and the inclined surface 2n substantially specular. As an example, (is Ra, arithmetic mean roughness) when the roughness of the optical surface other than the mark 2d was Ra 5 nm or less (5 nm or smaller value), the bottom surface 2m and the inclined surface of the mark 2d of the lens body 2a When the roughness of the 2n and Ra 20 nm or less (20 nm or smaller value), without fear causing unnecessary scattered light to the patient's visual function, it is possible to improve the visibility of the mark 2d. More preferably, the roughness of the bottom surface 2m and the inclined surface 2n of the mark 2d and Ra 10 nm or less. Further, the Ra at the optical surface marked bottom 2m may be provided or more difference 5 nm.
[0067]
　Furthermore, while the surface 2g of the lens body 2a is formed as an optical surface of the convex marks 2d is formed as a concave optical surface. That is, in the surface 2g of the lens body 2a, it can be said that the curvature difference generated between the optical portion other than the mark 2d and mark 2d have contributed to the improvement of the visibility of the mark 2d. Furthermore, so-called Hollow Face illusion, the operator recognizes when toric intraocular lens 2 is inserted into the eye of a patient, a concave mark 2d formed on the surface 2g of the lens body 2a, as a convex surface. Thus, even when forming a mark 2d to face 2g of the lens body 2a, the operator it is possible to recognize the mark 2d as a mark of the convex surface.
[0068]
　Above is the description of the present embodiment, the configuration such as the above toric intraocular lens or intraocular lens insertion instrument is not limited to the above embodiments, the technical idea and the identity of the present invention various modifications are possible within the scope not lost. For example, in the above description, the shape of the edge 2h and bottom 2m of marks 2d has an elliptical shape other elliptical, oval, or the like may be polygon having short and long sides, such as rectangular. Further, in the above embodiments, the mark 2d, but the surface 2g formed in the recess of the lens body 2a, the convex portion formed on the front surface 2f of the lens body 2a may be instead of the mark 2d. Also, the mark 2d is composed of a bottom surface 2m and the inclined surface 2n may constitute an inclined surface 2n and bottom 2m curved. Moreover, concave shape through hole of the indicators 17d, the non-through holes, grooves, notches, may be any shape such as, an alternative to a concave shape, for example paints, printing or index by methods such as surface roughening it may be created. Further, intraocular lenses subjected to the mark of the present invention may not be one-piece lens, another material supporting portion and the lens portion, such as composed of members, may be a so-called three-piece type intraocular lens.
[0069]
　Figure 13 (a) ~ (c), instead of the rear face 2g to form marks 2d of the lens body 2a, showing the schematic configuration of a mark 2p formed on the front surface 2f of the lens body 2a. 13 (a) is a partial enlarged view of the lens body 2a toric intraocular lens 2 in FIG. 1 (b). Mark 2p is a convex portion formed on the front surface 2f of the lens body 2a. In FIG. 13 (b), it shows a marked 2p in the top view of the lens body 2a schematically. As shown in FIG. 13 (b), the shape of the edge 2q mark 2p is elliptical. That is, intersect at the center of gravity 2r mark 2p, the minor axis 2t extending in the circumferential direction of the long axis 2s and lens body 2a extending in the radial direction of the lens body 2a, the length of the major axis 2s and the short axis 2t, respectively different. Further, at both ends of the long axis 2s, at the edge 2q not circle portion is formed.
[0070]
　Further, the mark indicating the 2p in side cross-sectional view of the lens body 2a schematically in FIG. 13 (c). As shown in FIG. 13 (c), mark 2p has an inclined surface 2v leading from the upper surface 2u and edge 2q on the upper surface 2u. Further, at the edge 2q mark 2p, the front 2f of the lens body 2a and the inclined surface 2v form an edge. Therefore, by forming a mark 2p is a convex portion on the front surface 2f of the lens body 2a, similarly to the case of forming the mark 2d to face 2g of the lens body 2a, the surgeon, the front 2f and mark 2p it can be said that is easily visible in a different color.
[0071]
　With another aspect of changing the state of light reflection at the boundary between the mark and the optical unit, as shown in FIG. 14 (a), the slope portion 4c only the boundary between the optical portion 4a and the mark 4b on the optical surface of the lens body may be used as the shape, as shown in FIG. 14 (b), without providing a significant step in the boundary between the optical unit 5a and the mark 5d on the optical surface of the lens body, the edge 5b of the mark 5d mark 5d roughness between may be provided with a transition portion 5c which changes stepwise.
[0072]
　It will be described a modification of the index for alignment. In this modification, the toric surface recesses φ2.0mm to resin mold the lower die is provided on the periphery of the optical surface of the opposite side. Outline processing the recess as an indicator was carried out. Also, to prepare a resin-type without the index as a control, were compared alignment accuracy. If not provided an index, since the polymerization conditions can not grasp the astigmatic axis, marked with a once telecentric transmission illumination, after looking for toric marks on the optical surface under a microscope, the resin lower mold its position in permanent marker there was a need to put a. Set the machine to the mark indicator were trimmed. As a result, it was possible to better to have a recess of the resin under type φ2.0mm to suit precisely position. In the present embodiment detects an indicator visually, was set in a processing machine manually to detect mechanical indicator, by setting the mechanical machine, easily to be able to more accurately aligned It can be assumed.
[0073]
　Meanwhile, for the detection of toric axis, in a case where a so-called D-cut shape portion of, for example, a resin type not index, sometimes the position of the D-cut is asymmetrical with respect to the flow of the resin, the resin flow there is a possibility that becomes defective molding occurs poor. However, there is no change even if the inspection of the optical surface using an interferometer in the present embodiment, it was confirmed that never molding defects caused by the index.
DESCRIPTION OF SYMBOLS
[0074]
1 intraocular lens insertion
2 toric intraocular lens
2a lens body
2d, 2p mark

The scope of the claims
[Requested item 1]
　A toric intraocular lens having a lens body that astigmatic axis is provided,
　wherein the optical surface of the lens body, the which mark indicating the astigmatic axis is formed,
　in the top view of the optical surface, of the mark the lens the radial length of the main body and the lens circumferential length of the body in the external dimensions are different
toric intraocular lens, characterized in that.
[Requested item 2]
　Toric eye of claim 1, wherein at least one end the mark edge contour of the first axis extending in a radial direction of the lens body in the mark, no arc of circle, which is characterized in that to the inner lens.
[Requested item 3]
　The mark, the lens is a concave portion formed on the rear surface of the body, toric intraocular lens according to claim 1 or 2, characterized in that.
[Requested item 4]
　The mark, the lens is a convex portion formed on the front surface of the main body, toric intraocular lens according to claim 1 or 2, characterized in that.
[Requested item 5]
　The lens radius dimension of the rounded beveled edge of the mark in the cross section of the lens body by a plane parallel to the optical axis of the body is 0.1mm or less dimensions than, claim 3 or 4, characterized in that toric intraocular lens according to.
[Requested item 6]
　The mark is toric according to any one of claims 3 to 5, wherein the lens has an inclined surface adjacent to said edge in the cross section of the lens body by a plane parallel to the optical axis of the body, it is characterized by intraocular lens.
[Requested item 7]
　A surface roughness values ​​20nm or smaller than that of the mark, the surface roughness of the optical surface different from the surface roughness of the mark, it to any one of claims 1 6, characterized in toric intraocular lens described.
[Requested item 8]
　The toric intraocular lens, the lens toric intraocular lens formed consisting of refracting power of different toric intraocular lens body,
　each toric intraocular lens of the toric intraocular lens, wherein the mark, the relative position of the support portion of the toric intraocular lens, according to any one of claims 1 to 7, wherein said lens is provided at a fixed position irrespective of the power of the main body, characterized in that toric intraocular lens.
[Requested item 9]
　The toric intraocular lens according to the intraocular lens insertion device for insertion into a patient's eye to any one of claims 1 to 8, wherein the toric intraocular lens is retracted in advance, and characterized in that IOL injection instrument for.
[Requested item 10]
　A method of manufacturing a toric intraocular lens according to any one of claims 1 to 8,
　in a fixed position the position of the mark indicating the astigmatic axis relative to the position of the support portion of the toric intraocular lens by using a mold index is attached for providing, polymerizing resin constituting the lens body
manufacturing method of the toric intraocular lens, characterized in that.
[Requested item 11]
　Method for producing a toric intraocular lens according to claim 10, wherein the indication of the resin type is concave.
[Requested item 12]
　The surface roughness of the index of the resin type is different from the surface roughness of the portion other than the index, method of manufacturing toric intraocular lens according to claim 10, characterized in that.