Ophthalmic device

Abstract

Provided is a novel ophthalmic device manufacturing method suitable for practical implementation of an ophthalmic device in which a heterogeneous element is embedded and arranged therein.　An ophthalmic device 10 is manufactured by including a step of forming, for a primary molded article 20 made of RGP or the like, a silicone layer 40 by molding and polymerizing a silicone-containing material 32 on top of a positioning surface where a heterogenous element 12 is positioned and supported, thereby embedding the heterogenous element 12 in the silicone layer 40.

Description

Ophthalmic Devices

[0001] The present invention relates to an element-embedded ophthalmic device in which different elements such as conductive materials and elements are embedded inside.

[0002] In recent years, in the field of ophthalmic devices such as contact lenses, intraocular lenses, eyeglasses, and goggles, efforts have been made to improve the optical properties as well as to diversify various functions, not limited to optical functions.

[0003] For example, in the case of contact lenses, it is being considered to embed different elements inside the lenses, such as those with visual functions, biosensor functions, communication functions, detection functions, and appearance design functions. Specifically, a kind of smart contact lens is proposed in U.S. Patent No. 10,028,702 (Patent Document 1) and the like.

[0004] However, in such element-embedded ophthalmic devices, different elements such as conductive materials and elements must be assembled integrally and with high positional precision inside the base member that constitutes the lens, etc., making them difficult to put into practical use.

[0005] Under these circumstances, patent documents disclosing inventions relating to contact lenses having heterogeneous elements embedded therein include the above-mentioned U.S. Pat. No. 10,028,702 (Patent Document 1), Japanese Patent Laid-Open No. 2019-530009 (Patent Document 2), and Japanese Patent No. 6,636,212 (Patent Document 3).

[0006] Patent Document 1 discloses a method for manufacturing a contact lens by overlapping a first lens layer in the lens thickness direction with a second lens layer having electronic components embedded therein as heterogeneous elements, and then fixing the two together using a concave-convex fitting structure or an adhesive structure.

[0007] However, the inventors have found that the contact lens disclosed in Patent Document 1 has difficulty in maintaining the first and second lens layers in a stable and precise fixed state. In particular, when the first and second lens layers are fixed to each other using a concave-convex interlocking structure, it is difficult to form a concave-convex interlocking portion with high dimensional accuracy. Furthermore, when the first and second lens layers are fixed to each other with an adhesive, there is a concern that the adhesive may adversely affect optical performance. Furthermore, when precision is required for the placement of electronic components, for example, it is difficult to maintain the placement precision even when the first and second lens layers are combined. In addition, the large number of precision steps required overall makes the contact lens unsuitable for mass production. Furthermore, when the first and second lens layers are fixed to each other with an adhesive, it is difficult to maintain the adhesiveness in the humid environment of the eye.

[0008] Patent Document 2 discloses a method for manufacturing contact lenses in which lens blanks obtained by cutting a rod of lens material lengthwise are used, and when contact lenses are machined from the lens blanks, electronic components are embedded as heterogeneous elements at predetermined intervals lengthwise during the manufacturing process of the rod, thereby disposing electronic components in each lens blank.

[0009] However, the inventors have found that the contact lens disclosed in Patent Document 2 has problems in that, when electronic components are molded as inserts into a rod, the size of the electronic components can adversely affect the polymerization molding of the rod, and it is difficult to ensure the accuracy of positioning of the electronic components within the rod. Furthermore, it is difficult to accurately grasp the positions and orientations of the electronic components within the rod until cutting of the lens blank has progressed to a certain extent, and there are limitations to correcting the placement of the electronic components within the lens during the cutting process. In particular, when contact lenses are cut to fit the eyes of individual users, variations in the positions of the electronic components within the lens blank become even more problematic, making the contact lens unsuitable for industrial production.

[0010] Furthermore, Patent Document 3 discloses a method for molding a contact lens having a laminated two-layer structure, in which a separate, different element is inserted into a recess formed in a molded product of the first layer, and the second layer is molded in a state of being positioned, thereby forming a contact lens having the member embedded therein.

[0011] However, the inventors have found through their investigations that the contact lens disclosed in Patent Document 3 is prone to the generation of voids around the separate member, which are thought to be due to shrinkage during molding of the second layer, making it difficult to consistently produce contact lenses of a quality that is acceptable for practical use.

[0012] As can be seen from Patent Documents 1 to 3, the prior art did not provide any practical technology for, for example, when manufacturing an ophthalmic device in which heterogeneous elements are embedded, accurately positioning such heterogeneous elements in predetermined positions while preventing molding defects such as voids and producing the device stably with good quality.

[0013] US Patent No. 10,028,702 JP 2019-530009 A Japanese Patent No. 6,636,212 A

[0014] The problems of the prior art exemplified above are not limited to contact lenses, and the present invention aims to solve at least one of the problems that pose obstacles to the practical application of ophthalmic devices having heterogeneous elements embedded therein.

[0015] In particular, the inventors have found that, for example, it is generally difficult to control the location of voids, and therefore, under molding conditions that result in voids, it is inevitable that voids will enter the optical zone through which light incident on the cornea passes, thereby adversely affecting the vision of the ophthalmic device when worn. Furthermore, even if voids occur in the peripheral area outside the optical zone, the presence of such voids can lead to a decrease in the strength of the ophthalmic device itself. In particular, in thin-walled electronic devices such as contact lenses equipped with electronic components, a decrease in strength can easily become a fatal defect in the product. Furthermore, the inventors have recognized a new problem in that oxygen-permeable materials used in contact lenses, etc., are permeable to water molecules. Therefore, water molecules that penetrate the material through the permeation can form water droplets in the voids, which can adversely affect the embedded electronic components.

[0016] The following describes preferred embodiments for understanding the present invention, but the embodiments described below are merely examples and may be appropriately combined with one another. Multiple components described in each embodiment may be recognized and employed independently to the greatest extent possible, and may also be appropriately combined with any of the components described in other embodiments. Accordingly, the present invention is not limited to the embodiments described below, and various other embodiments may be realized.

[0017] A first aspect of the present invention is as follows: A method for producing an ophthalmic device having at least one heterogeneous element embedded therein, the method comprising: molding and polymerizing a primary molded article having a positioning surface for positioning the heterogeneous element using a first molding material; and molding and polymerizing a silicone-containing material on the positioning surface of the primary molded article on which the heterogeneous element is positioned to form a silicone layer, thereby obtaining a composite molded article in which the heterogeneous element is embedded in the silicone layer.

[0018] According to this aspect, a silicone layer is formed on the positioning surface of a primary molded article while a heterogeneous element is positioned and supported relative to the primary molded article, thereby realizing an ophthalmic device with a heterogeneous element embedded therein. Here, the silicone-containing material constituting the silicone layer in which the heterogeneous element is embedded has a sufficiently small polymerization shrinkage compared to various polymer materials that can be polymerized. This suppresses the generation of voids, distortion, and deterioration of dimensional accuracy around the heterogeneous element during molding and polymerization of the silicone layer. As a result, ophthalmic devices with embedded heterogeneous elements can be manufactured with high quality and without molding defects.

[0019] That is, as a result of the inventor's studies, it was found that molding defects such as voids are likely to occur, particularly around the heterogeneous elements, when a polymerizable monomer is molded and polymerized while a heterogeneous element is embedded. Further studies revealed that voids and other defects are likely to occur due to shrinkage during hardening of the polymerized molding material. Therefore, in this embodiment, by using a silicone-containing material with low polymerization shrinkage among polymerized molding materials, it was possible to reduce the negative pressure generated around the embedded heterogeneous elements during and after molding, thereby making it possible to obtain ophthalmic devices with good and stable quality in which defects such as voids are suppressed. In particular, the suppression of voids and other defects by this embodiment contributes to solving new problems caused by voids, as described in the above-mentioned "Problem to be Solved by the Invention" section, and is of great technical significance toward the practical application of ophthalmic devices such as smart contact lenses.

[0020] Furthermore, during the manufacturing stage, when the silicone layer in which the heterogeneous elements are embedded is molded and polymerized, the heterogeneous elements are positioned relative to the primary molded product, so that the position of the heterogeneous elements within the ophthalmic device can be set accurately and stably.

[0021] Furthermore, by employing a silicone layer, it becomes easier to achieve a high oxygen permeability (Dk value) for the material, making it easier to meet the requirements for high oxygen permeability characteristics, such as in contact lenses.

[0022] Aspect 2 of the present invention is as follows: The method for manufacturing an ophthalmic device according to Aspect 1, comprising the steps of: molding and polymerizing a separate molded article, which is to be superimposed on the primary molded article via the silicone layer, using a second molding material; and forming the silicone layer by molding and polymerizing the silicone-containing material between opposing surfaces of the separate molded article superimposed on the positioning surface of the primary molded article on which the different element is positioned.

[0023] According to this embodiment, both side surfaces of the silicone layer can be covered with the primary molded product and the separate molded product. In particular, a molding cavity for molding and polymerizing the silicone-containing material is formed between the opposing surfaces of the primary molded product and the separate molded product, allowing both side surfaces of the silicone layer to be stably adhered to the primary molded product and the separate molded product. Furthermore, by forming a silicone layer with small polymerization shrinkage between the preformed primary molded product and the separate molded product, optical distortion or mechanical residual stress caused by polymerization shrinkage can be suppressed, thereby improving the quality and stabilizing the performance of the ophthalmic device.

[0024] In particular, ophthalmic devices that constitute ophthalmic optical systems are required to minimize optical distortion in the optical zone. For example, with regard to contact lenses, Japan's contact lens approval standards require that hard contact lenses be free of distortion or interference fringes. Under these circumstances, it has been confirmed that, according to this embodiment, the occurrence of optical distortion in the optical zone of contact lenses and the like can be suppressed to within a range of 0 to 20%, and preferably within a range of 0 to 5%. Measurement of optical distortion is specified, for example, in ISO 9340:1996, and can be measured using an optical distortion meter, birefringence meter, or the like.

[0025] Aspect 3 of the present invention is as follows: The method for producing the ophthalmic device according to Aspect 1, comprising the steps of: forming a silicone layer by molding and polymerizing a silicone-containing material on the surface of the positioning surface on which the different elements are positioned in the primary molded article; and then molding and polymerizing a cover layer that covers the silicone layer using a second molding material.

[0026] According to this aspect, both side surfaces of the silicone layer can be covered with the primary molded product and the cover layer. Furthermore, even if a dimensional error occurs on the surface of the silicone layer, the cover layer is molded and polymerized on the surface of the silicone layer, and the cover layer formed in close contact with the surface of the silicone layer can address the dimensional error on the surface of the silicone layer.

[0027] Furthermore, according to this aspect, it is also easy to form a cover layer in a form that covers the entire silicone layer, for example, as described below in aspect 4. This makes it possible to prevent the silicone layer from being exposed to the outside by the primary molded article and the cover layer, so that even in cases where the properties of the silicone layer, such as lipid adsorption, are of concern, it is easy to avoid problems caused by such properties of the silicone layer and improve the performance of the ophthalmic device.

[0028] Aspect 4 of the present invention is as follows: The method for producing an ophthalmic device according to any one of Aspects 1 to 3, wherein the silicone layer covers the entire device in a manner that the silicone layer is not exposed to the outside.

[0029] According to this aspect, by preventing the silicone layer from being exposed to the outside as described above, it is possible to avoid problems caused by the external exposure due to the material properties of the silicone layer, such as high lipophilicity, limited care products, etc. Furthermore, even when the posterior surface of the silicone layer overlaps the cornea when worn, as in the case of contact lenses, the adsorption of the silicone material to the cornea is eliminated, and the wearing comfort can be improved.

[0030] Aspect 5 of the present invention is as follows: The method for producing an ophthalmic device according to any one of Aspects 1 to 4, wherein the positioning surface of the primary molded article has a spherical concave shape, and the primary molded article is held in a state where the spherical concave shape opens vertically upward, and the silicone-containing material is injected into the positioning surface.

[0031] According to this aspect, by making good use of the spherical-shell concave shape of the primary molded article, the silicone-containing material can be pooled on the positioning surface of the primary molded article, molded, and polymerized, making it possible to easily form a silicone layer that is in close contact with the positioning surface of the primary molded article on which the different elements are positioned. In particular, when producing contact lenses, which are a type of ophthalmic device, by forming a spherical-shell convex front surface of the lens using the primary molded article, it is possible to advantageously set a spherical-shell concave positioning surface in the primary molded article that provides the molding surface for the silicone-containing material.

[0032] A sixth aspect of the present invention is as follows: The method for producing an ophthalmic device according to any one of the first to fourth aspects, wherein the positioning surface of the primary molded article has a spherical convex shape, and the primary molded article is immersed in the stored silicone-containing material with the positioning surface facing vertically downward, thereby molding and polymerizing the silicone-containing material on the positioning surface of the primary molded article.

[0033] According to this aspect, even when a different element is positioned relative to the spherical-shell convex positioning surface of the primary molded article, it is possible to form a silicone layer that is in close contact with the positioning surface of the primary molded article. Also, when manufacturing contact lenses, which are a type of ophthalmic device, by forming a spherical-shell concave posterior surface of the lens using the primary molded article, it is possible to advantageously set a spherical-shell convex positioning surface in the primary molded article that provides the molding surface for the silicone-containing material.

[0034] A seventh aspect of the present invention is as follows: The method for manufacturing an ophthalmic device according to any one of the first to sixth aspects, further comprising: subjecting a surface layer covering the silicone layer to a finishing process by cutting.

[0035] According to this aspect, it is possible to ease production management by lowering the precision requirements during molding of the surface layer covering the silicone layer, for example, the surface formed by the primary molded product described in aspect 1, the separate molded product described in aspect 2, or the cover layer described in aspect 3. It also becomes easy to set an individual shape for such a surface layer, which makes it possible to easily provide, for example, custom-made ophthalmic devices and small-lot produced ophthalmic devices with different surface shapes.

[0036] Aspect 8 of the present invention is as follows: The method for producing an ophthalmic device according to any one of Aspects 1 to 7, wherein at least a portion of the surface layer covering the silicone layer is a molding surface formed by a molding die.

[0037] According to this aspect, forming the surface by molding can eliminate the need for post-processing after molding, making manufacturing easier and stabilizing the shape. In both the above-mentioned aspect 7 and the present aspect 8, it is not necessary to form the entire surface layer by cutting or molding. For example, the front surface may be cut and the rear surface may be a molded surface, or the molded front surface may be partially cut.

[0038] A ninth aspect of the present invention is as follows: The method for manufacturing an ophthalmic device according to any one of the first to eighth aspects, wherein the different element is positioned relative to the positioning surface of the primary molded article by adhesion.

[0039] According to this aspect, it is possible to easily position a dissimilar element relative to a primary molded product by adhering it to the primary molded product. Furthermore, by adopting the positioning of a dissimilar element by adhering according to this aspect, it is possible to, for example, make the positioning surface of the primary molded product or the cavity surface of the mold for forming the positioning surface smooth and free of unevenness or steps, and position and support the dissimilar element by adhering it to the surface. This allows the structure and shape of the cavity surface of the mold for the primary molded product and the positioning surface of the primary molded product to be simplified, compared to, for example, adopting the locking structure described in aspect 12 below, which not only facilitates manufacturing and management but also more effectively suppresses the occurrence of voids and the like during polymerization and molding of silicone-containing materials. Furthermore, adopting positioning by adhering a dissimilar element to the positioning surface of the primary molded product makes it easy to automate the positioning process. However, this aspect can also be used in conjunction with other positioning configurations, such as the locking structure described in aspect 12 below.

[0040] A tenth aspect of the present invention is as follows: The method for manufacturing an ophthalmic device according to the ninth aspect, wherein the different element is attached to the positioning surface of the primary molded article by adhering it to the positioning surface using a silicone-containing adhesive.

[0041] According to this aspect, by using a silicone-containing adhesive when positioning the heterogeneous elements, the interface between the adhesive layer and the silicone layer is suppressed, thereby reducing or avoiding any impact on optical properties, etc. Note that this aspect is not limited to an aspect in which the heterogeneous elements are positioned solely using a silicone-containing adhesive. If necessary, for example, adhesives of other compositions or the locking structure described in aspect 12 below may also be used. For example, when positioning heterogeneous elements on a primary molded product, a silicone-containing adhesive may be used in the optical region of an ophthalmic device where light rays irradiate the pupil are incident, while an adhesive other than a silicone-containing adhesive may be used in the peripheral region outside the optical region. This avoids, for example, adverse effects on optical properties due to elution of adhesive components other than silicone-based components into the silicone layer in the optical region and its surroundings, while broadening the range of adhesives available in areas far from the optical region, taking into account factors such as handleability, adhesive strength, and adhesive strength attainment time. Note that the silicone-containing adhesive is not limited in terms of the content of the silicone component, and may also be an adhesive that contains other components, such as an acrylic component.

[0042] Aspect 11 of the present invention is as follows: The method for manufacturing an ophthalmic device according to Aspect 10, wherein the different element is attached by forming the different element on the positioning surface of the primary molded article.

[0043] According to this aspect, for example, by forming the dissimilar element on the positioning surface of the primary molded product by printing (including 3D printing) or electrodeposition, the dissimilar element can be attached to the positioning surface without using an adhesive, and the attachment process can be simplified, etc. Furthermore, by forming the dissimilar element on the positioning surface, it becomes possible to attach it to the primary molded product in a tight contact state.

[0044] A twelfth aspect of the present invention is as follows: The method for manufacturing an ophthalmic device according to any one of the first to eleventh aspects, wherein an engagement structure is utilized when positioning the different element relative to the positioning surface of the primary molded product.

[0045] According to this aspect, it is possible to position the dissimilar element on the primary molded product by utilizing the relative shapes of the positioning surface and the dissimilar element, such as a concave-convex fit, a hook-like locking mechanism, etc. Note that this aspect is not limited to positioning aspects that utilize only such engagement structures, and it is also possible to position the dissimilar element on the positioning surface by also employing, for example, adhesion as described in any of the above aspects 9 to 11.

[0046] A thirteenth aspect of the present invention is as follows: The method for manufacturing an ophthalmic device according to any one of the first to ninth, eleventh, and twelfth aspects, wherein the dissimilar element is positioned relative to the positioning surface of the primary molded article without using an adhesive.

[0047] According to this aspect, the preparation and application of an adhesive is not necessary, which simplifies the manufacturing process, and there is no problem with the adhesive components leaching out into the silicone layer, the primary molded product, etc. Note that positioning of dissimilar elements without using adhesive can be achieved, for example, by forming the dissimilar elements on a positioning surface as described in aspect 11 above, by positioning using an engagement structure as described in aspect 12 above, or by welding the dissimilar elements to the primary molded product, and the specific aspect is not limited, and positioning aspects using various conventionally known techniques can be employed.

[0048] Aspect 14 of the present invention is as follows: The method for producing an ophthalmic device according to any one of Aspects 1 to 13, wherein, when obtaining the composite molded product, the silicone-containing material is inserted between the positioning surface of the primary molded product and the heterogeneous element, and the heterogeneous element is covered with the silicone layer.

[0049] According to this aspect, it is possible to embed the heterogeneous element in the ophthalmic device while covering the heterogeneous element over a wider surface with the silicone layer, thereby improving the stability of the physical environment around the heterogeneous element, and more effectively preventing molding defects such as voids caused by polymerization shrinkage near the periphery of the heterogeneous element by using a silicone-containing material with small polymerization shrinkage.

[0050] A fifteenth aspect of the present invention is as follows: The method for producing an ophthalmic device according to any one of the first to fourteenth aspects, wherein the different element is a member harder than the primary molded article.

[0051] According to this aspect, damage to the heterogeneous elements can be avoided due to the strength characteristics of the heterogeneous elements themselves, and damage to the heterogeneous elements due to polymerization shrinkage, for example, can be prevented, thereby improving the quality stability of the product. Furthermore, by arranging the heterogeneous elements in an embedded manner, it is possible to expect a reinforcing effect and improved shape stability for the ophthalmic device including the primary molded product.

[0052] Aspect 16 of the present invention is as follows: The method for manufacturing an ophthalmic device according to Aspect 15, wherein the heterogeneous element is an electrical component including a metal portion.

[0053] According to this aspect, by embedding and arranging electrical components including metal parts in the ophthalmic device of the present invention, such electrical components are covered with a primary molded product or a silicone layer, etc., which makes it possible to suppress oxidation, etc. in the electrical components including metal parts, thereby stabilizing performance and effectively preventing external leakage and electrical short circuits, etc.

[0054] Aspect 17 of the present invention is as follows: A method for producing an ophthalmic device according to any one of Aspects 1 to 16, for producing a contact lens including a scleral lens.

[0055] According to this aspect, it is possible to practically realize a contact lens as an ophthalmic device in which a heterogeneous element is embedded, which facilitates the practical realization of functional contact lenses (including smart contact lenses) that have, for example, visual functions such as a display, biosensor functions such as tear component detection, communication functions such as sending and receiving information to and from the outside, detection functions such as a motion sensor, and appearance design functions such as distinctive coloring or luminescence. Furthermore, if such functional contact lenses are made into scleral lenses, for example, the positional stabilization of the contact lens on the eye is improved, making it easier to more stably exert various functions.

[0056] Aspect 18 of the present invention is as follows: A method for manufacturing an ophthalmic device having at least one heterogeneous element embedded therein, the method comprising the steps of: molding and polymerizing a first molding material in a first molding cavity defined by a first molding die to obtain a primary molded product having a positioning surface for positioning the heterogeneous element; molding and polymerizing a second molding material in a second molding cavity defined by a second molding die to obtain a separate molded product; and molding and polymerizing a silicone-containing material between opposing surfaces of the separate molded product superimposed on the positioning surface on which the heterogeneous element is positioned in the primary molded product to form a silicone layer, thereby obtaining a composite molded product in which the heterogeneous element is embedded in the silicone layer.

[0057] According to this aspect, a primary molded product and a separate molded product are produced using a first mold and a second mold with excellent mass productivity and shape stability, and a silicone layer with a small polymerization shrinkage rate is polymerized and molded using these primary molded product and separate molded product, thereby making it possible to efficiently polymerize and mold an ophthalmic device having a silicone layer provided between the opposing surfaces of the primary molded product and the separate molded product with good and stable interfacial adhesion. Furthermore, because different elements positioned in a preformed primary molded product are embedded and disposed in the silicone layer, it is possible to embed and dispose the different elements with high positional accuracy while avoiding molding defects such as voids caused by polymerization shrinkage.

[0058] A nineteenth aspect of the present invention is as follows: A method for manufacturing an ophthalmic device having at least one heterogeneous element embedded therein, the method comprising the steps of: molding and polymerizing a first molding material in a first molding cavity defined by a first molding die to obtain a primary molded article having a positioning surface for positioning the heterogeneous element; opening the first molding die, and mating an intermediate molding die with the positioning surface side of the primary molded article remaining in the first molding die to define an intermediate molding cavity to form a silicone layer, thereby obtaining a composite molded article in which the heterogeneous element positioned with respect to the positioning surface is embedded in the silicone layer; and demolding the intermediate molding die, and mating a second molding die with the silicone layer side of the composite molded article remaining in the first molding die to form a cover layer that covers the silicone layer from the opposite side of the primary molded article.

[0059] According to this embodiment, it is possible to efficiently polymerize and mold the silicone layer and cover layer in sequence by skillfully utilizing the first mold and the primary molded article molded therein. In particular, according to this embodiment, it is possible to easily produce a configuration in which the entire surface of the silicone layer is covered with the primary molded article and the cover layer.

[0060] Aspect 20 of the present invention is as follows: The method for producing an ophthalmic device according to any one of Aspects 2, 3, 18, and 19, wherein the first molding material and the second molding material are both hard lens materials.

[0061] According to this aspect, since the primary molded article and the separate molded article or cover layer made of a hard lens material are provided on the front and rear sides of the silicone layer, respectively, the accuracy and stability of the embedding position of the different element positioned by the hard lens material can be improved, and the hard lens material can also stabilize the shape and optical properties of the ophthalmic device equipped with the silicone layer. Note that the first molding material and the second molding material may be different materials or may be the same.

[0062] A twenty-first aspect of the present invention is as follows: An ophthalmic device having at least one heterogeneous element embedded therein, the ophthalmic device comprising a silicone layer disposed in a middle portion in the thickness direction, and a front layer and a rear layer made of an oxygen-permeable hard lens material provided on both sides in the thickness direction of the silicone layer, the heterogeneous element being positioned in at least one of the front layer and the rear layer, and the heterogeneous element being embedded in the silicone layer.

[0063] According to this embodiment, even in cases where high oxygen permeability is required, such as in contact lenses, the requirement for high oxygen permeability can be met by laminating a highly oxygen-permeable silicone material in addition to the oxygen-permeable hard lens material on both the front and rear sides. Furthermore, even in cases where a heterogeneous element is embedded, since the heterogeneous element is embedded in a silicone material with low polymerization shrinkage, defects such as voids around the heterogeneous element during molding are suppressed, making it possible to consistently achieve good quality. Furthermore, when the heterogeneous element is embedded, the heterogeneous element is positioned by the front and rear layers made of hard lens material, making it possible to stably set the embedded position of the heterogeneous element with high precision.

[0064] Preferably, the front layer and rear layer in this embodiment are disposed in close contact with the silicone layer, without subsequently undergoing a swelling treatment, etc., and when disposed in close contact with the silicone layer, the front layer and rear layer including the silicone layer are given the desired shape at least in the silicone layer and the overlapping portion in close contact with the silicone layer, which prevents distortion due to subsequent treatment such as swelling, and makes it possible to more advantageously achieve stable optical properties, strength properties, etc.

[0065] Aspect 22 of the present invention is as follows: The ophthalmic device according to Aspect 21, wherein the silicone layer is entirely covered by the front layer and the rear layer.

[0066] According to this aspect, as described in the fourth aspect, the silicone layer is prevented from being exposed to the outside, and thus problems caused by the external exposure due to the material properties of the silicone layer can be avoided.

[0067] Aspect 23 of the present invention is as follows: The ophthalmic device according to Aspect 21 or 22, wherein the heterogeneous element is positioned by being attached to at least one of the front layer and the rear layer.

[0068] According to this aspect, the positioning of dissimilar elements can be performed with high precision using hard lens material, and by positioning by adhesive, the positioning of dissimilar elements can be performed reliably and easily using the simple shape of the components, etc.

[0069] Aspect 24 of the present invention is as follows: The ophthalmic device according to Aspect 23, wherein the heterogeneous element is attached to at least one of the front layer and the rear layer by being adhered with a silicone-containing adhesive.

[0070] According to this aspect, as described in the above-mentioned aspect 10, by using a silicone-containing adhesive, the interface between the adhesive layer and the silicone layer is substantially optically eliminated, thereby reducing or avoiding the influence on the optical properties, etc. of the ophthalmic device.

[0071] Aspect 25 of the present invention is as follows: The ophthalmic device according to any one of Aspects 21 to 24, wherein in a central portion outside the heterogeneous element, the thickness dimensions of the front layer and the rear layer are each equal to or less than half the thickness dimension of the silicone layer.

[0072] According to this embodiment, by reducing the thickness dimensions of the front layer and the rear layer, it is possible to more actively utilize the high oxygen permeability of the silicone layer, and therefore the present embodiment can be suitably applied to, for example, contact lenses, which require oxygen permeability for the entire ophthalmic device. Note that even in this embodiment, it is possible to, for example, not provide a silicone layer near the outer periphery of the peripheral portion outside the central portion, which is the optical region of the ophthalmic device, or to make the thickness dimension of the front layer and / or the rear layer in the peripheral portion greater than half the thickness dimension of the silicone layer, thereby advantageously ensuring the shape retention performance of the entire ophthalmic device by the hard lens material.

[0073] Aspect 26 of the present invention is as follows: The ophthalmic device according to any one of Aspects 21 to 25, wherein the total mass of the silicone layer, the front layer, and the rear layer combined is 99% or less of the total mass of the silicone layer made of the same hard lens material as the front layer.

[0074] According to this embodiment, not only is the weight of the ophthalmic device itself reduced, thereby improving the wearing comfort, but the composition ratio of the silicone layer relative to the front and rear layers made of hard lens material is ensured to a certain extent, making it possible to more significantly enjoy the characteristic effects, such as improved oxygen permeability, that come from the provision of the silicone layer.

[0075] According to the method of the present invention, it is possible to manufacture an ophthalmic device having heterogeneous elements embedded therein while realizing high positioning accuracy of the heterogeneous elements and reducing or avoiding molding defects such as voids.

[0076] As mentioned above, ophthalmic devices in which heterogeneous elements are embedded have unique circumstances that make them prone to void formation. Not only do the voids that form have a negative impact on vision, but the resulting reduction in the strength of the entire ophthalmic device can easily result in a fatal product defect. Furthermore, there is concern that the formation of water droplets in the voids will have a negative impact on the heterogeneous elements. Therefore, the present invention, which can achieve the effect of suppressing voids and the like in ophthalmic devices in which heterogeneous elements are embedded, has great technical significance.

[0077] In addition, in the ophthalmic device of the present invention, the use of a front layer and / or a rear layer made of a hard lens material ensures the positioning accuracy of the heterogeneous elements, and the silicone layer enables high oxygen permeability.

[0078] FIG. 1 is a process explanatory diagram illustrating a manufacturing process of a contact lens as an ophthalmic device according to a first embodiment of the present invention; FIG. 1 is an explanatory diagram illustrating the molding of a primary molded product using a first mold during the manufacturing of the contact lens as the first embodiment shown in FIG. 1; FIG. 3 is an explanatory diagram illustrating the state in which an embedding member, as a different element, has been positioned relative to the primary molded product shown in FIG. 3; FIG. 5 is a process explanatory diagram illustrating the manufacturing process of a contact lens as an ophthalmic device according to a second embodiment of the present invention; FIG. 5 is an explanatory diagram illustrating the molding of a primary molded product using a first mold during the manufacturing of the contact lens as the second embodiment shown in FIG. 5; FIG. 7 is an explanatory diagram illustrating the state in which an embedding member, as a different element, has been positioned relative to the primary molded product shown in FIG. 7;

[0079] In order to clarify the present invention in more detail, the present invention will be described below based on embodiments with reference to the drawings.

[0080] 1-2, which illustrates a first embodiment, shows an overview of a method for manufacturing a contact lens 10 as an ophthalmic device according to the present invention. In this embodiment, the contact lens 10 is manufactured by subjecting the lens material to a multi-stage molding process, including a first molding step involving molding and polymerization of a first hard lens material, a second molding step involving molding and polymerization of a silicone-containing material, and a third molding step involving molding and polymerization of a second hard lens material, thereby positioning and disposing the embedding member 12 as a different element therein.

[0081] More specifically, in the first molding step, as shown in FIGS. 1(a)-(c), a primary molded product 20 is formed by molding a first molding material 18 in a first molding cavity 16 defined by a first mold 14.

[0082] In this embodiment, a lens front surface mold having a concave molding surface 22 as a cavity forming surface that provides a lens front surface consisting of a substantially spherical crown-shaped convex surface is used as the first molding die 14. In addition, a support surface molding die 26 is used as the molding die that is mated with this first molding die 14 to cooperate with the first molding die 14 to define the first molding cavity 16.

[0083] The support surface mold 26 has a generally spherical crown-shaped convex molding surface 24 as a cavity-forming surface. The primary molded product 20 molded in the first molding cavity 16 defined by the first molding die 14 and the support surface mold 26 will constitute the spherical shell-shaped front lens layer of the desired contact lens 10.

[0084] The materials of the first mold 14 and the support surface mold 26 are not limited. Preferably, a resin mold is used rather than a metal mold. Specific examples include polypropylene, polyethylene, polystyrene, polycarbonate, polyethylene terephthalate, polyamide, polyacetal, polyvinyl chloride, and other thermoplastic resins that can generally be used as mold materials. The materials of both molds may be the same, but different materials or surface properties may also be used.

[0085] Furthermore, the molding material (first molding material) 18 of the primary molded product 20 molded in the first molding cavity 16 is selected depending on the desired ophthalmic device, and is not limited to any particular material. In this embodiment, any of a variety of contact lens materials can be used depending on the properties required of the target contact lens 10, and known monomers and the like can be used as polymerizable compositions for molding contact lenses.

[0086] For illustrative purposes, various conventionally known hard contact lens materials (hard lens materials) can be used. For example, a hard contact lens material made of a polymerizable composition consisting of methyl (meth)acrylate (MMA) or the like as the main component can also be used. Preferably, however, a highly oxygen-permeable hard contact lens material (RGP) obtained from a polymerizable composition consisting of a siloxane-containing monomer, a fluorine-containing monomer, a styrene-based monomer, or the like as the main component is used.

[0087] 1(a), for example, a predetermined amount of the first molding material 18 is poured into the concave molding surface 22 of the first mold 14, which is open upward, and then the convex molding surface 24 of the support surface mold 26 is inserted to close the mold. The first molding material 18 can then be cured by polymerization using a known method such as heating, irradiation with ultraviolet light or the like, or a combination of these.

[0088] In this way, the primary molded article 20 molded using the first molding die 14 and the support surface molding die 26 has the embedding member 12 supported in a positioned state against the spherical crown concave surface (upper surface in FIG. 1(d)), as shown in FIG. 1(d). For this reason, in this embodiment, the positioning surface that positions and supports the embedding member 12 is formed by the spherical crown concave surface of the primary molded article 20. Note that, as shown in the figure, it is desirable to assemble the embedding member 12 to the primary molded article 20 after the molds are opened and the support surface molding die 26 is removed, and the primary molded article 20 is supported by the first molding die 14.

[0089] Furthermore, the embedding member 12 is not specifically limited, and any component for imparting a specific function to the contact lens 10 can be used. Specifically, electronic components such as sensors, cameras, projectors, batteries, antennas, and computing devices for realizing a smart contact lens can be used as the embedding member 12. The material of the embedding member 12 is also not limited, and it may contain at least a portion of metal, resin, ceramics, etc. The embedding member 12 is also not limited in terms of function, and may exhibit, for example, chemical or electrical functions such as sensors and cameras, mechanical functions such as reinforcement and retention of a specific shape, biological or medical functions such as drug administration, and design or aesthetic functions such as coloring and patterning, all of which may be combined as needed. It goes without saying that the specific size, shape, and number of the embedding member 12 are not specifically limited.

[0090] If there is a concern that the embedding member 12 may have an adverse optical effect on the ocular optical system, it is desirable to set the position of the embedding member 12 so as to avoid the portion where the optical region is formed. Specifically, it is desirable to set the position of the engaging portion 30 so that the embedding member 12 is disposed in the outer periphery and not in the central portion of the contact lens, which is the transmission path of light rays entering the pupil.

[0091] However, depending on the type of embedding member 12, a part or the whole of the embedding member 12 may be disposed in the central portion, such as a projector or an extremely small component that displays information visible to the wearer of the contact lens 10. The central portion of the contact lens 10 may be provided with a vision correction function, as required, similar to known contact lenses.

[0092] Furthermore, the support of the embedding member 12 in a positioned state relative to the primary molded article 20 may be any structure that can hold the embedding member 12 in a predetermined position when molding the silicone layer, which will be described later. The specific support structure is not limited, and it is also possible to position and support the embedding member 12 relative to the primary molded article 20 in an affixed state, including by adhesion, welding, printing, or the like.

[0093] 1(a) and 1(b), a concave-convex engaging portion is provided on the convex molding surface 24 of the support surface molding die 26, and thereby, as shown in an enlarged view in Fig. 3, an engaging portion 30 is formed for positioning and / or holding the embedding member 12 relative to the concave surface of the primary molded product 20. In this embodiment, such engaging portion 30 is made into a fitting recess, so that the embedding member 12 is fitted into the engaging portion 30 to be positioned and held, as shown in an enlarged view in Fig. 4.

[0094] The recessed engaging portion 30 in which the embedding member 12 as in this embodiment is positioned by fitting or locking can be set appropriately according to the shape and size of the embedding member 12, and is not limited to any particular type. In this embodiment, the embedding member 12 and the engaging portion 30 are formed in an annular shape extending in the circumferential direction, but it is also possible to use, for example, an independent recessed engaging portion 30 formed partially on the periphery and the embedding member 12 that is fitted and held therein.

[0095] Then, as shown in Figure 1(e), with the embedding member 12 positioned and placed at a predetermined position in the primary molded article 20, a second molding step is carried out by molding and polymerizing a silicone-containing material 32. In this second molding step, an intermediate mold 34 is mated with the first mold 12 in place of the support surface mold 26 that was removed from the first mold 14 leaving the primary molded article 20, thereby defining a silicone molding cavity 36. Then, as shown in Figure 2(f), the silicone-containing material 32 is molded in the silicone molding cavity 36 in which the primary molded article 20 remains, thereby forming an intermediate molded article 38 with the embedding member 12 embedded.

[0096] In this second molding step, the embedding member 12 is supported by the primary molded product 20, so that the embedding member 12 can be set at a predetermined position within the silicone molding cavity 36. Then, the silicone molding cavity 36 is filled with the silicone-containing material 32 to mold the silicone layer 40, which is the intermediate layer, to form an intermediate molded product 38 as a molded product with the embedding member 12 inserted.

[0097] In this intermediate molded product 38, the embedding member 12 may be inserted in an embedded state, that is, completely embedded inside the silicone layer 40, or the intermediate molded product 38 may be covered by the primary molded product 20, which is the front lens layer of the contact lens 10, or a cover layer, which will be described later, which is the rear lens layer, so that the intermediate molded product 38 is partially exposed or protrudes from the silicone layer 30. In other words, it is desirable that the embedding member 12 be embedded in a manner that avoids direct exposure on the front or rear surface of the contact lens 10.

[0098] 4(b), in this embodiment, a silicone molding cavity 36 is also formed on the surface of the embedding member 12 where it is superimposed on the primary molded product 20, with a gap-like region extending between the embedding member 12 and the primary molded product 20. The silicone-containing material 32 is then spread to this gap-like region, so that the surface of the embedding member 12, preferably almost the entirety, is covered with the silicone layer 40 in a substantially embedded state.

[0099] Furthermore, in this embodiment, the central portion that forms the optical zone of the contact lens 10, located on the inner periphery of the engaging portion 30 of the first mold 14, is formed in a spherical shell shape that extends with a substantially constant thickness throughout, thereby preventing any size differences or portions with varying thickness from being formed in the optical zone, thereby improving and uniforming the optical characteristics.

[0100] Here, various conventionally known silicone-containing lens materials can be used as the molding material for the silicone layer 40 in which the embedding member 12 is embedded. For example, silicone-containing hydrous or non-hydrous soft contact lens materials obtained from polymerizable compositions composed of silicone-containing monomers, silicone-containing macromers, etc. are preferably used.

[0101] Such a silicone-containing material 32 can minimize the degree of volumetric shrinkage associated with polymerization compared to common hard lens materials, particularly compared to the aforementioned RGP that constitutes the primary molded product 20. Specifically, according to the inventor's investigations, contact lenses 10 having an embedding member 12 embedded therein are prone to molding defects such as voids, which adversely affect the visibility and strength of the contact lens 10, and furthermore, the formation of water droplets in the voids adversely affects the embedding member 12. In response to these problems, the use of a silicone-containing material 32 as the lens material for embedding the embedding member 12 can reduce the negative pressure generated around the embedding member 12, thereby suppressing the occurrence of defects such as voids. As a result, contact lenses 10 having an embedding member 12 embedded therein can be consistently manufactured with excellent quality.

[0102] Furthermore, during polymerization molding of the silicone-containing material 32, the embedding member 12 is positioned and supported by the primary molded product 20 made of RGP or the like. By making the primary molded product 20 harder than the silicone layer 40, the embedding member 12 can be positioned firmly, stably, and accurately.

[0103] Furthermore, because high oxygen permeability can be achieved in the silicone layer 40, it is possible to set high oxygen permeability for the entire contact lens 10, including the primary molded article 20 that constitutes the front and rear lens layers, and the cover layer described below. That is, by forming the interior of the lens with a silicone layer 40 that has high oxygen permeability (Dk value), it is possible to reduce the thickness of the primary molded article 20 and the cover layer, and this, in turn, enables high oxygen permeability for the contact lens 10. Furthermore, by forming the primary molded article 20 and the cover layer from RGP, it is possible to further improve the oxygen permeability of the contact lens 10.

[0104] Next, as shown in FIG. 2( g ), the intermediate mold 34 is removed by opening the mold, and then, as shown in FIG. 2( h ), a third molding step is carried out by molding and polymerizing a second molding material 44 to form a cover layer 46 that constitutes the posterior surface of the contact lens 10 as shown in FIG. 2( i ).

[0105] In this third molding step, a second molding die 50 is fitted to the first molding die 12 in place of the intermediate molding die 34 that was removed from the first molding die 14 leaving the intermediate molding product 30 behind, thereby defining a second molding cavity 52. ​​Then, a second molding material 44 is molded in the second molding cavity 52 in which the intermediate molding product 30 remains, thereby molding a cover layer 46 that covers the entire back surface side of the silicone layer 40.

[0106] The second mold 50 defining the second molding cavity 52 has a generally spherical crown-shaped convex molding surface 54 as the cavity-forming surface. The cover layer 46 molded in the second molding cavity 52 defined between the mating surfaces of the first mold 12 and the second mold 50 and with the intermediate molded product 38 placed in an insert state will constitute the spherical-shell concave posterior layer of the lens in the intended contact lens 10.

[0107] The intermediate molding die 34 and the second molding die 50 can be made of the same materials as those of the first molding die 14, and there are no restrictions on the materials, nor are there any restrictions on the specific shapes and structures of each part, including the cavity forming surface.

[0108] The molding material (second molding material) 44 of the cover layer 46 molded in the second molding cavity 52 is selected depending on the intended ophthalmic device and is not limited to any particular material. In this embodiment, any of a variety of contact lens materials can be used depending on the properties required of the target contact lens 10, and for example, RGP or the like can be suitably used, similar to the first molding material 18 described above.

[0109] 1(h)-(i), for example, a predetermined amount of the first molding material 18 is injected from above into the intermediate molded product 38 that is placed in an insert state on the upwardly opening concave molding surface 22 of the first molding die 14, and then the convex molding surface 54 of the second molding die 50 is inserted and the mold is closed. Thereafter, as in the molding of the primary molded product 20 using the above-described first molding material 18, the second molding material 44 can be subjected to a curing treatment by polymerization using a known method such as heating, irradiation with light such as ultraviolet light, or a combination thereof.

[0110] In this way, the cover layer 46 is formed integrally with the intermediate molded product 38 in a tightly adhered state, and the desired contact lens 10 is formed as shown in Figure 2(j), and then demolded.

[0111] The contact lens 10 obtained in this manner has a structure in which the embedding member 12 is embedded, but molding defects such as voids that occur during molding are reduced or prevented, resulting in good quality.

[0112] Furthermore, the primary molded article 20 made of a highly oxygen-permeable hard contact lens material or the like and the cover layer 46 are provided in such a way that the silicone layer 40 with the embedding members 12 embedded therein is sandwiched from the front and back of the lens, preventing exposure of the silicone layer 40 to the lens surface. This also makes it possible to avoid problems due to the material properties of the silicone layer 40, such as its ability to adsorb lipids or to adsorb to the cornea.

[0113] Furthermore, since the embedding member 12 is positioned and set by the primary molded product 20 made of hard contact lens material or the like, the embedding position of the embedding member 12 can be set with high accuracy and stability.

[0114] Furthermore, even if some sink marks or the like occur on the molding surface of the silicone layer 40 during polymerization molding, practical problems such as sink marks can be avoided because they are covered by the cover layer 46 molded on the molding surface of the silicone layer 40. In other words, by allowing such sink marks on the molding surface of the silicone layer 40, it is possible to more effectively prevent voids inside the silicone layer 40.

[0115] From this perspective, it is also desirable to perform surface treatments such as laser irradiation or application of a release agent on the molding surface of the intermediate mold 34, which forms the molding surface of the silicone layer 40, as needed to improve releasability from the silicone layer 40. The cavity-forming surfaces of the molds employed in this embodiment may be subjected to various treatments as needed. For example, surface property adjustment treatments such as plasma treatment, UV irradiation, corona discharge, laser irradiation, and surfactant application can be performed to increase or decrease adhesion to the molding materials 18, 26. Furthermore, when molding various molding materials using various molds such as the first mold 14, support surface mold 26, intermediate mold 34, and second mold 50, the temperature can be controlled by heating or cooling each mold as needed to adjust adhesion to the molding material.

[0116] In this embodiment, the front surface (convex spherical crown surface) of the contact lens 10 is formed by the primary molded product 20 that supports the embedding member 12 in a positioned state. However, it is also possible to form the rear surface (concave spherical crown surface) of the contact lens 10 by the primary molded product that supports the embedding member 12 in a positioned state. Such an embodiment is shown below as a second embodiment.

[0117] B. Second Embodiment (FIGS. 5-8) An outline of a method for manufacturing a contact lens 10 according to a second embodiment is shown in FIG. 5-6. Like the first embodiment, this embodiment also manufactures a contact lens 10 having an embedding member 12 positioned therein as a different element through a multi-stage molding process, including a first molding step involving molding and polymerization of a first hard lens material, a second molding step involving molding and polymerization of a silicone-containing material, and a third molding step involving molding and polymerization of a second hard lens material. In this embodiment, corresponding components and the like to those in the first embodiment are designated by corresponding reference numerals and have the same names, and detailed description thereof will be omitted.

[0118] First, in the first molding step, as shown in Figures 5(a) to (c), a first molding material 18 made of RGP or the like is molded in a first molding cavity 16 defined by a first molding die 14 and a support surface molding die 26 to form a primary molded product 20' in which the embedding member 12 is positioned.

[0119] Unlike the primary molded article 20 in the first embodiment, which constitutes the lens front surface, the primary molded article 20' in this embodiment has a spherical crown-shaped concave surface which constitutes the lens rear surface of the contact lens 10. As shown in Fig. 7, an engaging portion 30 having a stepped surface for engagement is formed in the spherical crown-shaped convex surface of the primary molded article 20', and as shown in Fig. 8, the embedding member 12 is supported in a positioned state by this engaging portion 30. That is, in this embodiment, the positioning surface which positions and supports the embedding member 12 is constituted by the spherical crown-shaped convex surface of the primary molded article 20'.

[0120] In the subsequent second molding step, as shown in FIGS. 5(d) to 6(f), a silicone-containing material 32 is molded in a silicone molding cavity 36 defined by the first mold 14, with the primary molded article 20' remaining on the molding surface, and the intermediate mold 34, to form a silicone layer 40 that covers the spherical crown-shaped convex surface of the primary molded article 20'.

[0121] As a result, the silicone layer 40 is molded while the primary molded article 20′, with the embedding member 12 supported in a positioned state, is inserted, forming an intermediate molded article 38. In this intermediate molded article 38, similar to the first embodiment, one surface of the primary molded article 20′ (the surface opposite to the first molding die 14) is covered over substantially the entirety with the silicone layer 40, and the embedding member 12 is embedded in the silicone layer 40.

[0122] In the subsequent third molding step, as shown in FIGS. 6(g)-(h), a cover layer 46' that covers the spherical crown-shaped convex surface of the silicone layer 40 is formed by molding a second molding material 44 made of RGP or the like in a second molding cavity 52 defined by the first molding die 14 and the second molding die 50, with the intermediate molding product 38 remaining on the molding surface.

[0123] As a result, the cover layer 46' is molded with the intermediate molded product 38 inserted, and this cover layer 46 will constitute the spherical convex front surface layer of the target contact lens 10.

[0124] 6(i), the contact lens 10 of this embodiment obtained in this manner has substantially the same structure as the contact lens 10 obtained in the first embodiment. That is, the silicone layer 40 is enclosed and sandwiched between the thin, spherical-crown-shaped cover layer 46 that constitutes the front surface of the lens and the thin, spherical-crown-shaped primary molded product 20' that constitutes the rear surface of the lens, and the embedding member 12 is embedded in the silicone layer 40 while being positioned with high precision by the primary molded product 20' made of RGP or the like.

[0125] Therefore, the method for manufacturing the contact lens 10 according to this embodiment can also achieve all of the same effects as those of the first embodiment.

[0126] In the first and second embodiments described above, a first molding step is performed to form the primary molded articles 20, 20' that support the embedding member 12 in a positioned state, followed by a second molding step to form a silicone layer 40 on the surface of the primary molded articles 20, 20', and then a third molding step to form a cover layer 46, 46' on the surface of the silicone layer 40. Alternatively, the primary molded articles 20, 20' and the cover layers 46, 46' that constitute the front and rear lens surfaces may be molded separately in the first and second molding steps, and then the silicone layer 40 may be molded between the opposing surfaces of the primary molded articles 20, 20' and the cover layers 46, 46' in the subsequent third molding step, thereby embedding the embedding member 12, which is positioned and supported by the primary molded articles 20, 20' and / or the cover layers 46, 46', in the silicone layer 40. Such aspects are shown below as third and fourth embodiments.

[0127] C. Third Embodiment (FIGS. 9-10) An outline of a method for manufacturing contact lens 10 according to a third embodiment is shown in FIGS. 9-10. Note that in this embodiment, the same components as those in the first embodiment are designated by the same reference numerals and names, and detailed description thereof will be omitted.

[0128] 9(a)-9(d), a first molding material 18 is molded in a first molding cavity 16 defined by a first molding die 14 and a support surface molding die 26 to form a primary molded product 20 in which the embedding member 12 is positioned. As in the first embodiment, this primary molded product 20 is made of RGP or the like, and constitutes a lens front surface layer having a thin spherical crown shape as a whole.

[0129] 9(e) to 10(g), in the second molding step, a second molding material 44 made of RGP or the like is injected into an intermediate mold 34 having a spherical-crown concave molding surface, and a second mold 50 having a convex molding surface 54 is mated with the second molding material 44 to form a cover layer 46. As in the first embodiment, this cover layer 46 is made of RGP or the like, and constitutes a lens posterior surface layer having a thin spherical-crown shape overall.

[0130] Here, the formation of the primary molded product 20 in the first molding step and the formation of the cover layer 46 in the second molding step can be performed in any order and can also be performed in parallel using independent equipment. The primary molded product 20 and / or the cover layer 46 may also be formed in advance and stocked. In this embodiment, the cover layer 46 formed from the second molding material 44 is a separate molded product formed separately from the primary molded product 20 that positions and supports the embedding member 12.

[0131] Then, in the third molding step, as shown in Figures 10(h)-(j), the silicone-containing material 32 is molded in the silicone molding cavity 36 in which the primary molded article 20 and the cover layer 46 are placed in an insert state, to form the silicone layer 40 between the opposing surfaces of the primary molded article 20 and the cover layer 46.

[0132] Specifically, the first molding die 14, with the primary molded article 20 with the embedding member 12 positioned and left on the concave molding surface 22, is opened upward and the silicone-containing material 32 is injected therein. Then, the second molding die 50, with the cover layer 46 left on the convex molding surface 54, is mated from above with the first molding die 14 to define a silicone molding cavity 36, in which the silicone-containing material 32 is molded and polymerized.

[0133] As a result, the embedding member 12, which is positioned and supported by the primary molded product 20 and arranged between the opposing surfaces of the primary molded product 20 and the cover layer 46, is embedded and arranged in an embedded state with almost the entire surface covered by the silicone layer 40.

[0134] Even in the method for molding contact lens 10 according to this embodiment, molding defects such as reduced pressure during polymerization of silicone-containing material 32 and resulting voids are suppressed, and the silicone layer 40 can be accurately adhered to the primary molded article 20 and cover layer 46, making it possible to stably manufacture good-quality contact lenses 10 with the embedding member 12 embedded therein. Furthermore, the positioning accuracy of the embedding member 12 can be ensured well and stably by the primary molded article 20 made of RGP or the like, and effects similar to those of the first embodiment described above can be achieved.

[0135] D. Fourth Embodiment (FIGS. 11-12) An outline of a method for manufacturing a contact lens 10 according to a fourth embodiment is shown in FIGS. 11-12. Note that in this embodiment, the same components as those in the second embodiment are designated by the same reference numerals and names, and detailed description thereof will be omitted.

[0136] 11(a)-11(d), a primary molded product 20' is formed by molding a first molding material 18 in a first molding cavity 16 defined by a first molding die 14 and a support surface molding die 26, thereby positioning and disposing the embedding member 12. This primary molded product 20' is made of RGP or the like, as in the second embodiment, and constitutes a lens posterior surface layer having a thin spherical crown shape as a whole.

[0137] 11(e) to 12(g), in the second molding step, a second molding material 44 made of RGP or the like is injected into a second mold 50 having a spherical-crown concave molding surface, and the mold is then mated with an intermediate mold 34 having a convex molding surface, and a cover layer 46' is formed by molding the second molding material 44. This cover layer 46' as a separate molded product is made of RGP or the like, as in the second embodiment, and constitutes a lens front surface layer having a thin spherical-crown shape as a whole.

[0138] Here, the formation of the primary molded product 20' in the first molding step and the formation of the cover layer 46' in the second molding step can be performed in any order, and can also be performed in parallel using independent equipment. Also, the primary molded product 20' and / or the cover layer 46' can be formed in advance and stored.

[0139] Thereafter, in the third molding step, as shown in Figures 12(h)-(j), the silicone-containing material 32 is molded in the silicone molding cavity 36 in which the primary molded article 20' and the cover layer 46' are placed in an insert state, to form the silicone layer 40 between the opposing surfaces of the primary molded article 20' and the cover layer 46'.

[0140] Specifically, the second mold 50, with the cover layer 46' remaining on its concave molding surface, is opened upward and the silicone-containing material 32 is injected therein. The first mold 14, with the primary molded article 20' remaining on its convex molding surface 22', is then mated from above with the second mold 50 to define the silicone molding cavity 36, in which the silicone-containing material 32 is molded and polymerized.

[0141] As a result, the embedding member 12, which is positioned and supported by the primary molded product 20' and arranged between the opposing surfaces of the primary molded product 20' and the cover layer 46', is embedded and arranged in an embedded state in which it is almost entirely covered with the silicone layer 40.

[0142] Even in the method for molding contact lens 10 according to this embodiment, molding defects such as reduced pressure during polymerization of silicone-containing material 32 and resulting voids are suppressed, and the silicone layer 40 can be accurately adhered to the primary molded article 20' and cover layer 46', making it possible to stably manufacture the desired contact lens 10 of good quality, in which the embedding member 12 is embedded. Furthermore, the positioning precision of the embedding member 12 can be ensured satisfactorily and stably by the primary molded article 20' made of RGP or the like, and effects similar to those of the above-mentioned embodiments can be achieved.

[0143] E. Fifth Embodiment (FIG. 13) In the contact lens 10 of each of the above-described embodiments, the silicone layer 40 covering the embedding member 12 is covered on both the front and rear sides with a front lens layer and a rear lens layer (20, 20', 46, 46') made of RGP or the like, thereby preventing exposure of the silicone layer 40 to the lens surface. Thus, exposing the silicone layer 40 to the lens surface is desirable in consideration of the properties of the silicone layer 40, such as lipid adsorption. Furthermore, if the silicone layer 40 is softer than the front and rear lens layers (20, 20', 46, 46') made of RGP or the like, it is desirable from the standpoint of shape stability and, ultimately, optical stability of the contact lens 10 to keep the silicone layer 40 completely enclosed and not exposed to the surface.

[0144] Looking at the contact lens 10 of each of the above-described embodiments from this perspective, the front and rear surfaces of the lens are each composed of a primary molded article 20, 20' and a cover layer 46, 46', each of which is a single-structure molded body. However, at the lens edge, on the outer periphery of the silicone layer 40, there is an interface between the primary molded article 20, 20' and the cover layer 46, 46', with an overlapping structure. Therefore, there is a risk that the silicone layer 40 may be accessible from the outside at this interface.

[0145] In particular, in the second and fourth embodiments, the silicone layer 40 is formed by molding and polymerizing the silicone-containing material 32 between the opposing overlapping surfaces of the primary molded articles 20, 20' and the cover layers 46, 46'. Therefore, when molding conditions including molding dimensional errors due to polymerization shrinkage and the like and mold clamping force are taken into consideration, it is desirable to anticipate the risk that the silicone layer 40 will be formed extending to the outer periphery of the edge portion through gaps between the overlapping surfaces in the outer periphery of the primary molded articles 20, 20' and the cover layers 46, 46'.

[0146] Therefore, in the contact lens 10 of this embodiment, as shown in Figure 13, an edge coating layer 60 is provided that covers the entire edge of the contact lens 10, thereby covering the entire overlapping surface at the outer periphery of the primary molded articles 20, 20' and the cover layers 46, 46'.

[0147] By providing such an edge covering layer 60, it is possible to prevent external influences on the silicone layer 40 through the boundary surface between the primary molded article 20, 20' and the cover layer 46, 46', and it is possible to more reliably prevent risks due to external exposure of the silicone layer 40, thereby improving and stabilizing quality.

[0148] The material of the edge coating layer 60 is not particularly limited, and various materials other than silicone-containing materials can be used. Preferably, a lens material similar to that of the primary molded products 20, 20' and the cover layers 46, 46' can be used. However, the edge coating layer 60 does not affect the optical properties as long as it does not extend into the optical zone, so there is no need to consider the optical properties of the lens. On the other hand, the edge coating layer 60 can be formed on the surface of the contact lens 10 over an area extending into the optical zone, or it may be formed as an integrated structure that wraps around the entire surface of the contact lens 10.

[0149] F. Sixth Embodiment (FIG. 14) In the contact lens 10 of each of the above-described embodiments, the embedding members 12 are assembled to and supported in a positioned state by the primary molded articles 20, 20' constituting either the front lens layer or the rear lens layer, and are thereby disposed in an embedded state within the silicone layer 40. As described above, the specific type, shape, size, structure, and number of such embedding members 12 are not limited, but by employing both the primary molded article 20 constituting the front lens layer and the primary molded article 20' constituting the rear lens layer as primary molded articles that support the embedding members 12 in a positioned state, it is also possible to dispose the embedding members 12 in an embedded state within the silicone layer 40 from both the front lens side and the rear lens side.

[0150] One specific example is shown as a sixth embodiment in Fig. 14. In this embodiment, the same reference numerals are used to designate the same components as those in the third and fourth embodiments, and detailed descriptions thereof will be omitted.

[0151] 14(a)-(b), a primary molded product 20' in which the embedding member 12' is positioned is formed by molding using a first mold 14' and a support surface mold (not shown). This primary molded product 20' is made of RGP or the like, as in the fourth embodiment, and constitutes a lens posterior layer having a thin spherical crown shape as a whole.

[0152] As in the fourth embodiment, the embedding member 12' is positioned and supported relative to the engaging portion 30' of the primary molded article 20'. The embedding member 12' can be positioned and supported relative to the primary molded article 20' by fitting or locking the embedding member 12' into the engaging portion 30' as in the fourth embodiment. However, in this embodiment, in addition to the positioning by the fitting structure, the embedding member 12' is superimposed on the primary molded article 20' and adhered with the adhesive layer 62, thereby positioning and fixing the embedding member 12'. When the adhesive layer 62 is used to position and support the embedding member 12', it is not necessary to employ a geometrical engaging structure for the embedding member 12', such as a concave-convex or hook-shaped structure, in the primary molded article 20'; the primary molded article 20' can also be formed with a smooth surface.

[0153] The specific composition of the adhesive 62 is not limited, and may be selected from various conventionally known adhesives taking into consideration the required characteristics and materials of the contact lens 10. A silicone-containing adhesive is preferably used. The silicone-containing adhesive may be any of room-temperature curing, heat curing, addition reaction curing, one-component, or two-component types, and modified silicone adhesives may also be used. Furthermore, since the positioning support of the embedding member 12' on the primary molded product 20' only needs to be sufficient to hold the embedding member 12' in a predetermined position within the molding cavity during molding of the silicone layer 40, a silicone-based sealant or adhesive may also be used. The silicone-containing adhesive 62 in this embodiment (the present invention) is interpreted to include silicone-containing sealants, adhesives, and the like.

[0154] 14(c), in parallel with this first molding step, a second molding step is performed using a first molding die 14 and a support surface molding die (not shown) to form a primary molded product 20 in which the embedding member 12 is positioned. As in the third embodiment, this primary molded product 20 is made of RGP or the like, and constitutes a lens front surface layer having a thin spherical crown shape as a whole.

[0155] Then, similarly to the third embodiment, the embedding member 12 is positioned and supported by the engaging portion 30 of the primary molded article 20. Note that an adhesive structure can also be used to position and support the embedding member 12 relative to the primary molded article 20, but in this embodiment, the embedding member 12 is positioned and supported relative to the primary molded article 20 by fitting into the engaging portion 30, similarly to the third embodiment.

[0156] Thereafter, as shown in Figures 14(d)-(f), the silicone-containing material 32 is molded in a manner substantially similar to the third and fourth embodiments to form the contact lens 10 in which the embedding members 12, 12' are embedded within the silicone layer 40.

[0157] Specifically, the first molding die 14, with the primary molded product 20 with the embedding member 12 positioned and left on the concave molding surface, is opened upward and the silicone-containing material 32 is injected therein. Then, the first molding die 14', with the primary molded product 20' with the embedding member 12' positioned and left on the convex molding surface, is mated from above with the first molding die 14 to define a silicone molding cavity 36, within which the silicone-containing material 32 is molded and polymerized.

[0158] As a result, the silicone-containing material 32 is molded in the silicone molding cavity 36 in which the two primary molded articles 20, 20' are placed in an inserted state, and a silicone layer 40 is formed between the opposing surfaces of the primary molded articles 20 and 20'. Inside this silicone layer 40, the embedding members 12, 12', which are positioned and supported by the primary molded articles 20, 20' and arranged between the opposing surfaces of the two primary molded articles 20, 20', are embedded and arranged in an embedded state, almost entirely covered by the silicone layer 40 (in this embodiment, arranged so as to overlap each other in the front-to-back direction of the lens).

[0159] Even with the method for molding contact lens 10 according to this embodiment, it is possible to stably manufacture contact lens 10 of good quality, in which embedding members 12, 12' are embedded and positioned with good positioning accuracy, as in the above-mentioned embodiments, while avoiding defects such as voids.

[0160] In particular, in this embodiment, the embedding members 12, 12' can be positioned and supported by the primary molded product 20 constituting the front lens layer and the primary molded product 20' constituting the rear lens layer, and can be disposed in an embedded state within the silicone layer 40, so it is possible to ensure an even greater degree of freedom in setting the number, arrangement and positions of the embedding members 12, 12' to be embedded and disposed within the silicone layer 40.

[0161] Furthermore, by positioning the embedding member 12' relative to the primary molded product 20' using an adhesive structure that uses the adhesive 62, it is possible to simplify the surface shape of the primary molded product 20'. Furthermore, by using the silicone-containing adhesive 62, the silicone layer 40 that is subsequently molded and polymerized is integrated with the adhesive 62, making it possible to substantially eliminate the interface between the silicone layer 40 and the adhesive 62.

[0162] Although several specific embodiments of the present invention have been described above, the present invention should not be construed as being limited by the specific descriptions in these embodiments.

[0163] For example, the contact lens 10 with the embedding member 12 inserted therein can be provided as a well-known soft contact lens or hard contact lens that is worn superimposed on the cornea, but can also be provided as a scleral lens that is worn with the lens edge positioned on the sclera outside the cornea. With a scleral lens, the size of the area that covers the sclera can be set arbitrarily, and for example, when covering a wide area of ​​the sclera, the outer peripheral shape of the lens edge may be non-circular. For example, when it is desired to accurately position the embedding member 12 on the eyeball when worn, a scleral lens or the like that minimizes movement on the eyeball when worn is preferable.

[0164] Furthermore, contact lenses 10 with an embedding member 12 inserted therein tend to have a large lens thickness, and in such cases, it is desirable to ensure sufficient oxygen permeability in the contact lens, not only when worn continuously over multiple days but also when used daily. The contact lenses 10 according to the above-described embodiments employ a silicone layer 40 made of a silicone-based material with high oxygen permeability, such as a silicone-containing (meth)acrylate monomer or a silicone-containing macromer, making it easy to ensure high oxygen permeability. In particular, the use of RGP for the front and rear lens layers ensures the positioning accuracy of the embedding member, while further improving the oxygen permeability of the contact lens 10.

[0165] In particular, by making the thickness of the silicone layer 40 greater than the thicknesses of the front and rear lens layers in the central portion of the lens that is positioned on the cornea when worn, it is possible to impart higher oxygen permeability to the contact lens 10. More preferably, in the central portion away from the embedding member, the thicknesses of the front and rear lens layers are each set to be no more than half the thickness of the silicone layer 40. Alternatively, it is desirable that the total mass of the silicone layer 40, the front and rear lens layers combined is no more than 99%, and more preferably no more than 97.5%, of the total mass if the silicone layer 40 were made of the same hard lens material as the front and rear lens layers.

[0166] More specifically, when considering the oxygen permeability of typical RGPs, satisfying the recommended level of oxygen permeability (Dk value) for daily use becomes difficult with an RGP lens material having a Dk value of around 100 when the maximum central lens thickness exceeds 0.4 mm, and becomes difficult with an RGP lens material having a Dk value of around 170 when the maximum central lens thickness exceeds 0.7 mm. Therefore, for contact lenses 10 with a maximum central lens thickness of greater than 0.4 mm or greater than 0.7 mm, depending on the lens material, it is particularly important to employ a laminated structure such as that of the embodiments having a silicone layer 40. Furthermore, in the central portion of the contact lens 10, it is effective to keep the total thickness of the front and rear lens layers made of RGP to 0.4 mm or less or 0.7 mm or less depending on the lens material, and it is desirable to actively ensure the lens thickness required for embedding the embedding member 12 with the silicone layer 40.

[0167] In the peripheral portion of the contact lens 10, particularly the outer peripheral portion where the lens thickness is thinner, the outer peripheral portion may be located away from the cornea in a scleral lens or other scleral lens, and therefore there is almost no problem with oxygen permeability. Therefore, the contact lens 10 may have a single structure of RGP material consisting of a front lens layer and / or a rear lens layer without a silicone layer 40 sandwiched therebetween.

[0168] Furthermore, in the contact lens 10 of the above embodiment, the front and rear surfaces of the silicone layer 40 are covered with a lens front layer and a lens rear surface made of RGP or the like, preventing direct contact of the silicone layer 40 with the biological surface (cornea and eyelid) when worn. Therefore, while achieving excellent oxygen permeability with the silicone layer 40, it is possible to avoid a decrease in wearing comfort due to the water repellency and adhesiveness to the biological surface of the silicone layer 40, and to achieve a good wearing comfort of the lens based on the hydrophilicity and lubricity of the RGP or the like with the biological body. However, in cases such as scleral lenses, where the central portion of the lens rises above the corneal surface when worn and a tear film is formed, thereby preventing direct contact between the posterior surface of the lens and the corneal surface, the silicone layer 40 can be exposed to the surface even in the central portion of the posterior surface of the lens, and such an embodiment can be adopted without causing any major problems.

[0169] Furthermore, in the contact lens 10 of the above embodiment, the embedding member 12, which was manufactured separately, was assembled into the first molding dies 14, 14', but it is sufficient that the embedding member 12 is disposed in a positioned state relative to the first molding dies 14, 14'. For example, a part or the whole of the embedding member 12 may be formed on the surface of the first molding die 14 by printing, plating, or the like, so that the embedding member 12 is positioned and supported by the first molding die 14 at the same time as it is formed. It is also possible to place the embedding member 12 in the molding cavity of the first molding die 14 and fix the surface of the embedding member 12 to the first molding die 14 when the first molding die 14 is being molded, or to partially insert the embedding member 12 into the first molding die 14 and fix it there; alternatively, it is possible to provide a metal plate that is partially insert-fixed to the first molding die 14 and form the embedding member 12 on the surface of the metal plate by plating or sputtering, or to mechanically fix a separately prepared embedding member 12 to the metal plate by caulking, etc.

[0170] In addition, in the contact lens 10 of the above embodiment, both the front and rear surfaces of the lens are molded surfaces, but it is also possible to perform finishing processing by cutting on at least one of the front or rear surfaces of the lens, either partially or entirely.

[0171] Furthermore, although the above embodiment illustrates an example of application of the present invention to contact lenses, the present invention is not limited to contact lenses, and can be applied to ophthalmic devices such as intraocular lenses, eyeglasses, and goggles.

[0172] Although not listed here, the present invention can be implemented in various forms with various changes, modifications, improvements, etc. made based on the knowledge of those skilled in the art, and it goes without saying that all such embodiments are included within the scope of the present invention as long as they do not deviate from the spirit of the present invention.

[0173] REFERENCE SIGNS LIST 10 Contact lens 12 Embedding member 12' Embedding member (sixth embodiment) 14 First molding mold 14' First molding mold (sixth embodiment) 16 First molding cavity 18 First molding material 20 Primary molded product 20' Primary molded product (second, fourth, sixth embodiments) 22 Concave molding surface (first molding mold) 22' Convex molding surface (second, fourth, sixth embodiments) 24 Convex molding surface (member support surface molding mold) 24' Concave molding surface (second, fourth, sixth embodiments) 26 Support surface molding mold 30 Engagement portion 30' Engagement portion (sixth embodiment) 32 Silicone-containing material 34 Intermediate molding mold 36 Silicone molding cavity 38 Intermediate molding product 40 Silicone layer 44 Second molding material 46 Cover layer 46' Cover layer (second and fourth embodiments) 50: Second mold 52: Second mold cavity 54: Convex molding surface (second mold) 60: Edge coating layer 62: Adhesive

Claims

1. A method for producing an ophthalmic device having at least one heterogeneous element embedded therein, comprising: a step of molding and polymerizing a primary molded article having a positioning surface for positioning the heterogeneous element using a first molding material; and a step of molding and polymerizing a silicone-containing material on the positioning surface of the primary molded article on which the heterogeneous element is positioned to form a silicone layer, thereby obtaining a composite molded article in which the heterogeneous element is embedded in the silicone layer.

2. A method for manufacturing an ophthalmic device as described in claim 1, comprising the steps of: molding and polymerizing a separate molded article, which is overlaid on the primary molded article via the silicone layer, using a second molding material; and forming the silicone layer by molding and polymerizing the silicone-containing material between opposing surfaces of the separate molded article overlaid on the positioning surface on which the different elements are positioned in the primary molded article.

3. A method for manufacturing an ophthalmic device as described in claim 1, comprising the steps of: forming a silicone layer by molding and polymerizing a silicone-containing material on the surface of the positioning surface on which the heterogeneous element is positioned in the primary molding; and then molding and polymerizing a cover layer that covers the silicone layer using a second molding material.

4. The method for manufacturing an ophthalmic device according to any one of claims 1 to 3, wherein the silicone layer covers the entire surface in a manner that the silicone layer is not exposed to the outside.

5. A method for manufacturing an ophthalmic device according to any one of claims 1 to 4, wherein the positioning surface of the primary molded product has a spherical shell concave shape, the primary molded product is held in a state where the spherical shell concave shape opens vertically upward, and the silicone-containing material is injected into the positioning surface.

6. A method for producing an ophthalmic device according to any one of claims 1 to 4, wherein the positioning surface of the primary molded product has a spherical shell convex shape, and the primary molded product is immersed in the stored silicone-containing material with the positioning surface facing vertically downward, thereby molding and polymerizing the silicone-containing material on the positioning surface of the primary molded product.

7. The method for producing an ophthalmic device according to any one of claims 1 to 6, further comprising the step of subjecting a surface layer covering the silicone layer to a finishing process by cutting.

8. The method for producing an ophthalmic device according to any one of claims 1 to 7, wherein at least a portion of a surface layer covering the silicone layer is made into a molding surface by a molding die.

9. The method for manufacturing an ophthalmic device according to any one of claims 1 to 8, wherein the dissimilar element is positioned relative to the positioning surface of the primary molded product by adhesion.

10. The method for producing an ophthalmic device according to claim 9, wherein the different element is attached to the positioning surface of the primary molded product by adhering with a silicone-containing adhesive.

11. The method for producing an ophthalmic device according to claim 9, wherein the dissimilar element is attached by forming it on the positioning surface of the primary molding.

12. The method for manufacturing an ophthalmic device according to any one of claims 1 to 11, wherein an engagement structure is utilized in positioning the dissimilar element relative to the positioning surface of the primary molded product.

13. A method for manufacturing an ophthalmic device according to any one of claims 1 to 9, 11 and 12, wherein the dissimilar element is positioned relative to the positioning surface of the primary molded product without using an adhesive.

14. A method for manufacturing an ophthalmic device according to any one of claims 1 to 13, wherein, when obtaining the composite molded product, the silicone-containing material is inserted between the positioning surface of the primary molded product and the heterogeneous element, and the heterogeneous element is covered with the silicone layer.

15. The method for manufacturing an ophthalmic device according to any one of claims 1 to 14, wherein the different element is a member harder than the primary molded product.

16. The method for manufacturing an ophthalmic device according to claim 15, wherein the dissimilar elements are electrical components including metal portions.

17. A method for producing an ophthalmic device according to any one of claims 1 to 16 for producing a contact lens, including a scleral lens.

18. A method for manufacturing an ophthalmic device having at least one heterogeneous element embedded therein, comprising the steps of: molding and polymerizing a first molding material in a first molding cavity defined by a first molding die to obtain a primary molded product having a positioning surface for positioning the heterogeneous element; molding and polymerizing a second molding material in a second molding cavity defined by a second molding die to obtain a separate molded product; and molding and polymerizing a silicone-containing material between opposing surfaces of the separate molded product superimposed on the positioning surface on which the heterogeneous element is positioned in the primary molded product to form a silicone layer, thereby obtaining a composite molded product in which the heterogeneous element is embedded in the silicone layer.

19. A method for producing an ophthalmic device having at least one heterogeneous element embedded therein, comprising the steps of: molding and polymerizing a first molding material in a first molding cavity defined by a first molding die to obtain a primary molded product having a positioning surface for positioning the heterogeneous element; opening the first molding die, and mating an intermediate molding die with the positioning surface side of the primary molded product remaining in the first molding die to form a silicone layer by molding and polymerizing a silicone-containing material in an intermediate molding cavity defined by mating the intermediate molding die with the positioning surface side of the primary molded product remaining in the first molding die to obtain a composite molded product in which the heterogeneous element positioned with respect to the positioning surface is embedded in the silicone layer; and demolding the intermediate molding die, and mating a second molding die with the silicone layer side of the composite molded product remaining in the first molding die to form a cover layer that covers the silicone layer from the opposite side of the primary molded product by molding and polymerizing a second molding material in a second molding cavity defined by mating the second molding die with the silicone layer side of the composite molded product remaining in the first molding die.

20. A method for manufacturing an ophthalmic device according to any one of claims 2, 3, 18 and 19, wherein the first molding material and the second molding material are both hard lens materials.

21. An ophthalmic device having at least one heterogeneous element embedded therein, comprising a silicone layer disposed in the middle in the thickness direction, and a front layer and a rear layer made of an oxygen-permeable hard lens material provided on either side in the thickness direction of the silicone layer, the heterogeneous element being positioned in at least one of the front layer and the rear layer, and the heterogeneous element being embedded in the silicone layer.

22. The ophthalmic device of claim 21, wherein the entire silicone layer is covered by the front layer and the rear layer.

23. An ophthalmic device according to claim 21 or 22, wherein the dissimilar element is positioned by means of attachment to at least one of the front layer and the rear layer.

24. The ophthalmic device of claim 23, wherein the dissimilar element is affixed to at least one of the front layer and the rear layer by bonding with a silicone-containing adhesive.

25. An ophthalmic device according to any one of claims 21 to 24, wherein in a central portion outside the heterogeneous elements, the thickness dimensions of the front layer and the rear layer are both less than or equal to half the thickness dimension of the silicone layer.

26. An ophthalmic device according to any one of claims 20 to 24, wherein the total mass of the silicone layer, the front layer and the rear layer combined is 99% or less of the total mass when the silicone layer is made of the same hard lens material as the front layer.

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