Ophthalmic device

Abstract

Provided is a novel method for manufacturing an ophthalmic device, which is suitable for the practical use of an ophthalmic device in which a dissimilar element is embedded. A method for manufacturing an ophthalmic device (10) includes a step for forming a silicone layer (40) by molding and polymerizing a silicone-containing material (32) on a surface on which a positioning surface on which a dissimilar element (12) is positioned and supported in a primary molded article (20) comprising RGP or the like, thereby embedding the dissimilar element (12) in the silicone layer (40).

Description

Technical Field

[0001] This invention relates to an implantable ophthalmic device in which conductive materials, components, and other dissimilar elements are embedded and disposed internally. Background Technology

[0002] In recent years, in addition to improving optical properties, research is also being conducted on diversifying various functions beyond optics in ophthalmic devices such as contact lenses, intraocular lenses, eyeglasses, and goggles.

[0003] For example, in contact lenses, research is underway on embedding heterogeneous components with visual, biosensor, communication, detection, and aesthetic design functions within the lens. Specifically, a smart contact lens is proposed in U.S. Patent No. 10028702 (Patent Document 1), among others.

[0004] However, in such implantable ophthalmic devices, it is difficult to put into practical use the need to integrate dissimilar components such as conductive materials and elements into the base components that make up lenses with high positional accuracy.

[0005] In this context, the patent documents that disclose inventions concerning contact lenses in which heterogeneous components are disposed internally in an embedded state include the aforementioned U.S. Patent No. 10028702 (Patent Document 1), Japanese Patent Application Publication No. 2019-530009 (Patent Document 2), and Japanese Patent No. 6636212 (Patent Document 3).

[0006] Patent document 1 discloses a method in which a first lens layer is overlapped with a second lens layer in the lens thickness direction, wherein electronic components as dissimilar elements are embedded therein, and the first lens layer is fixed to the second lens layer by means of a concave-convex interlocking structure and an adhesive structure, thereby manufacturing a contact lens.

[0007] However, the inventors have discovered through research that in the contact lenses disclosed in Patent Document 1, it is difficult to maintain the first and second lens layers in a fixed state with good precision and stability. In particular, when using a concave-convex interlocking structure to fix the first and second lens layers, it is difficult to form the interlocking portion with good dimensional accuracy. Furthermore, when using adhesives to fix the first and second lens layers, there are concerns about the negative impact of the adhesive on optical performance. Additionally, for example, when the placement of electronic components requires precision, it is difficult to maintain placement accuracy even when the first and second lens layers are combined. Moreover, the overall number of precision processes increases, making it unsuitable for mass production. Furthermore, for example, when using adhesives to fix the first and second lens layers, it is difficult to maintain adhesion within the humid environment of the eye.

[0008] Patent document 2 discloses a method for manufacturing contact lenses, wherein when using a lens blank obtained by cutting a lens material in the length direction with a rod, and cutting a contact lens from the lens blank, electronic components, which are dissimilar elements, are embedded in the length direction at predetermined intervals during the manufacturing process of the rod, thereby arranging the electronic components in each lens blank.

[0009] However, the inventors have discovered through research that in the contact lenses disclosed in Patent Document 2, when electronic components are embedded in the rod, there are problems such as the size of the electronic components negatively impacting the polymerization and molding of the rod, or difficulty in ensuring the positioning accuracy of the electronic components within the rod. Furthermore, before the lens blank is cut to a certain extent, it is difficult to accurately determine the position and orientation of the electronic components within the rod, and there are limitations in correcting the arrangement of the electronic components within the lens during the cutting process. In particular, when contact lenses are cut to fit the eyes of various users, deviations in the position of the electronic components in the lens blank become an even greater problem, thus making them unsuitable for industrial production of contact lenses.

[0010] In addition, Patent Document 3 discloses a method in which a contact lens is configured as a stacked two-layer structure, and the second layer is formed while an independent heterogeneous component is placed into a recess of a molded article formed in the first layer and positioned therein, thereby molding a contact lens in which the component is embedded.

[0011] However, the inventors have discovered through research that in the contact lenses disclosed in Patent Document 3, gaps that can be attributed to shrinkage during the molding of the second layer are easily generated around other components, resulting in a problem that makes it difficult to stably manufacture contact lenses of practical quality.

[0012] According to patent documents 1 to 3, in the prior art, for example, when manufacturing an eye device with a foreign component installed in an embedded state, there is no practical technology that can accurately position the foreign component in a specified position, prevent poor forming such as gaps, and manufacture it with good quality and stability.

[0013] Patent Document 1: US Patent No. 10028702

[0014] Patent Document 2: Japanese Patent Application Publication No. 2019-530009

[0015] Patent Document 3: Japanese Patent No. 6636212 Summary of the Invention

[0016] The problems of the prior art exemplified above are not limited to contact lenses. The objective of this invention is to solve at least one of the problems that hinder the practical application of ophthalmic devices with internally embedded heterogeneous components.

[0017] In particular, the inventors have discovered through research that, for example, the location of voids is often difficult to control. Therefore, under molding conditions that produce voids, it is unavoidable that voids will enter the optical area through which incident light passes through the cornea, potentially negatively impacting the visual effect when wearing an eye-care device. Furthermore, even when voids occur in the peripheral portion offset from the optical area, their presence reduces the strength of the eye-care device itself. This reduction in strength can easily become a fatal defect, especially in thin-walled electronic devices such as contact lenses that house electronic components. Additionally, the oxygen-permeable materials used in contact lenses and similar products allow water molecules to pass through easily. Water molecules that penetrate through these materials can form water droplets within the voids, potentially negatively impacting the embedded electronic components. This is a new problem that the inventors have observed.

[0018] Hereinafter, preferred embodiments for mastering the present invention will be described. However, the embodiments described below are illustrative and can be used in appropriate combinations. Furthermore, the multiple constituent elements described in each embodiment can be identified and used as independently as possible, and can also be used in appropriate combinations with any constituent elements described in other embodiments. Therefore, the present invention is not limited to the embodiments described below, and various other embodiments can be implemented.

[0019] The first embodiment of the present invention is as follows.

[0020] A method for manufacturing an eye-care device, characterized in that,

[0021] The manufacturing process of an ophthalmic device having at least one non-specific component embedded in it includes the following steps:

[0022] A one-piece molded article having a positioning surface for positioning the aforementioned dissimilar components is formed and polymerized using a first molding material; and

[0023] On the positioning surface of the aforementioned dissimilar component in the one-piece molded article, a silicone-containing material is molded and polymerized to form a silicone layer, thereby obtaining a composite molded article in which the dissimilar component is embedded in the silicone layer.

[0024] According to this method, with the dissimilar element positioned and supported on a one-piece molded article, a silicone layer is formed on the positioning surface of the one-piece molded article, thus enabling the internal embedding of an ophthalmic device containing the dissimilar element. Here, for the silicone-containing material constituting the silicone layer for embedding the dissimilar element, among various polymer materials used in polymerization molding, the polymerization shrinkage is sufficiently small. Therefore, the generation of voids, distortion, and reduction in dimensional accuracy around the dissimilar element during the molding and polymerization of the silicone layer can be suppressed. As a result, molding defects can be prevented, and ophthalmic devices containing embedded dissimilar elements can be manufactured stably with excellent quality.

[0025] In other words, the inventors' research revealed that when polymerizable monomers are molded and polymerized in an embedded state to form heterogeneous components, voids and other molding defects are easily generated, particularly around the heterogeneous components. Further repeated research showed that voids and other defects are easily generated along with the shrinkage during the curing of the polymeric molding material. Therefore, in this method, by using a silicone-containing material with low polymerization shrinkage in the polymeric molding material, the negative pressure generated around the embedded heterogeneous components during and after molding can be reduced. This allows for the production of ophthalmic devices with good and stable quality, suppressing the generation of voids and other defects. In particular, this method suppresses the generation of voids and other defects, which helps to solve the new problems caused by voids described in the "Summary of the Invention" section above, and has significant technical implications for the practical application of ophthalmic devices such as smart contact lenses.

[0026] Furthermore, during the manufacturing stage, when the silicone layer for embedding the foreign element is formed and polymerized, the foreign element is positioned as a one-piece molded product, thus enabling the position of the foreign element in the eye device to be set with good accuracy and stability.

[0027] In addition, by using a silicone layer as a raw material, it is easy to achieve a high oxygen permeability (Dk value), so it is easy to handle situations where high oxygen permeability is required, such as contact lenses.

[0028] The second embodiment of the present invention is as follows.

[0029] The method for manufacturing an ophthalmic device according to method 1 described above is characterized by comprising the following steps:

[0030] Another molded article is formed and polymerized by using a second molding material, which is superimposed on the aforementioned primary molded article via the aforementioned silicone layer; and

[0031] The silicone layer is formed by molding and polymerizing the silicone-containing material between opposing surfaces formed by overlapping the positioning surfaces of the other molded article and the positioning surfaces of the primary molded article where the dissimilar element is positioned.

[0032] According to this method, both sides of the silicone layer can be covered by a primary molded article and another molded article. In particular, when a molding cavity for molding and polymerizing the silicone-containing material is formed between the opposing surfaces of the primary molded article and the other molded article, the two sides of the silicone layer can be stably and tightly bonded to both the primary molded article and the other molded article. Furthermore, by forming a silicone layer with low polymerization shrinkage between the pre-formed primary molded article and the other molded article, optical distortion or mechanical residual stress caused by polymerization shrinkage can be suppressed, thereby improving the quality and stabilizing the performance of ophthalmic devices.

[0033] Especially in ophthalmic devices that constitute the optical system of the eye, it is required to minimize optical distortion in the optical region. For example, regarding contact lenses, Japanese contact lens certification standards require that rigid contact lenses must be free of distortion or interference fringes. Under these circumstances, according to this method, it has also been confirmed that in contact lenses and the like, the generation of optical distortion in the optical region can be suppressed to within the range of 0% to 20%, preferably within the range of 0% to 5%. Furthermore, the measurement of optical distortion is specified, for example, by ISO 9340:1996, and can be measured using an optical distortion meter, birefringence meter, etc.

[0034] The third embodiment of the present invention is as follows.

[0035] The method for manufacturing an ophthalmic device according to method 1 described above is characterized by comprising the following steps:

[0036] On the positioning surface where the aforementioned dissimilar element is positioned in the aforementioned one-piece molded article, a silicone-containing material is molded and polymerized to form a silicone layer, and then a cover layer covering the silicone layer is molded and polymerized using a second molding material.

[0037] According to this method, both sides of the silicone layer can be covered by a one-piece molded article and a cover layer. Furthermore, even assuming dimensional errors occur on the surface of the silicone layer, a cover layer is formed and polymerized on the surface of the silicone layer, thereby enabling the countermeasure against dimensional errors on the surface of the silicone layer through a cover layer formed in close contact with the surface of the silicone layer.

[0038] Furthermore, according to this method, for example as described in Method 4 below, a covering layer can easily be formed to cover the entire silicone layer. Thus, by using a one-piece molded product and a covering layer, external exposure of the silicone layer can be prevented. Therefore, even when there are concerns about the characteristics of the silicone layer, such as lipid adsorption, problems caused by these characteristics can be easily avoided, thereby improving the performance of the ophthalmic device.

[0039] The fourth method of the present invention is as follows.

[0040] The method for manufacturing an ophthalmic device according to any one of methods 1 to 3 described above is characterized in that...

[0041] The entire structure is covered in such a way that the aforementioned silicone layer is not exposed to the outside.

[0042] According to this method, as described above, external exposure of the silicone layer can be avoided, thereby preventing problems caused by external exposure due to the raw material characteristics of the silicone layer, such as high oleophilicity and limitations in care products. Furthermore, even when the posterior surface overlaps with the cornea during wear, such as with contact lenses, the adhesion of the silicone material to the cornea can be eliminated, thus improving the wearing comfort.

[0043] The fifth method of the present invention is as follows.

[0044] The method for manufacturing an ophthalmic device according to any one of methods 1 to 4 described above is characterized in that,

[0045] The positioning surface of the aforementioned one-piece molded article has a concave spherical shell shape. The one-piece molded article is held in a state where the concave spherical shell shape is open vertically upward, and the aforementioned silicone-containing material is injected into the positioning surface.

[0046] According to this method, the concave shape of the spherical shell inherent in the one-piece molded article can be cleverly utilized to leave the silicone-containing material on the positioning surface of the one-piece molded article for molding and polymerization, and a silicone layer that is closely connected to the positioning surface of the one-piece molded article with dissimilar components can be easily formed. Especially in the manufacture of contact lenses as an ophthalmic device, by forming the convex shape of the lens front surface of the one-piece molded article, the concave shape of the spherical shell positioning surface that provides the molding surface of the silicone-containing material can be advantageously set in the one-piece molded article.

[0047] The sixth embodiment of the present invention is as follows.

[0048] The method for manufacturing an ophthalmic device according to any one of methods 1 to 4 described above is characterized in that,

[0049] The positioning surface of the aforementioned one-piece molded article has a spherical convex shape. With the positioning surface facing vertically downward, the one-piece molded article is immersed in the stored silicone-containing material, thereby molding and polymerizing the silicone-containing material on the surface of the positioning surface of the one-piece molded article.

[0050] According to this method, even when a dissimilar component is positioned on a convex, spherical positioning surface of a one-piece molded article, a silicone layer that is in close contact with the positioning surface of the one-piece molded article can be formed. Furthermore, even when manufacturing a contact lens as an ophthalmic device, where a concave, spherical rear surface of the lens is formed using a one-piece molded article, a convex, spherical positioning surface providing a silicone-containing molding surface can be advantageously provided within that one-piece molded article.

[0051] The seventh embodiment of the present invention is as follows.

[0052] The method for manufacturing an ophthalmic device according to any one of methods 1 to 6 above is characterized in that,

[0053] The surface layer covering the aforementioned silicone layer is subjected to cutting-based finishing.

[0054] According to this method, the precision requirements for molding surfaces such as the silicone-covered surface layer, for example, the one-piece molded article described in Method 1, the other molded article described in Method 2, and the cover layer described in Method 3 can be reduced, thereby simplifying manufacturing management. Furthermore, it is easy to set independent shapes for the aforementioned surface layers, for example, making it easy to provide customized eye devices and small-batch production of eye devices with different surface shapes.

[0055] The eighth aspect of the present invention is as follows.

[0056] The method for manufacturing an ophthalmic device according to any one of methods 1 to 7 described above is characterized in that,

[0057] In the surface layer covering the aforementioned silicone layer, at least a portion is a molded surface based on a molding die.

[0058] According to this method, the surface is formed by molding, thereby eliminating the trouble caused by post-molding processing and achieving ease of manufacturing and shape stability. Furthermore, in either method 7 above or method 8 of this method, it is not necessary to form the entire surface layer by cutting or molding. For example, the front surface can be formed by cutting and the rear surface can be the molding surface, or the front surface after molding can be partially machined by cutting.

[0059] The following is embodiment 9 of the present invention.

[0060] The method for manufacturing an ophthalmic device according to any one of methods 1 to 8 described above is characterized in that,

[0061] When positioning the aforementioned dissimilar component relative to the aforementioned positioning surface in the aforementioned one-piece molded article, attachment is used.

[0062] According to this method, dissimilar components can be easily positioned onto a one-piece molded article using attachment. Furthermore, by employing the attachment method described herein for positioning dissimilar components, it is possible, for example, to make the positioning surface of the one-piece molded article and the mold cavity surface of the mold for molding the positioning surface smooth surfaces without unevenness or steps, and to position and support the dissimilar component in an adhered state. Therefore, compared to the locking structure described in method 12 (described later), the structure and shape of the mold cavity surface of the mold for molding the one-piece molded article and the positioning surface of the one-piece molded article can be simplified, not only facilitating manufacturing and management but also more effectively suppressing the generation of voids during the polymerization of silicone-containing materials. In addition, by employing positioning based on the attachment of dissimilar components to the positioning surface of the one-piece molded article, the aforementioned positioning process can be easily automated. Of course, in this method, other positioning structures, such as the locking structure described in method 12 (described later), can also be employed simultaneously.

[0063] The present invention provides a method 10 as follows.

[0064] The method for manufacturing an ophthalmic device according to method 9 above is characterized in that,

[0065] The dissimilar components are attached to the positioning surface of the one-piece molded article by using a silicone adhesive.

[0066] According to this method, when positioning dissimilar components, a silicone-containing adhesive is used, thereby suppressing the interface between the adhesive layer and the silicone layer and reducing or even avoiding the impact on optical properties. Furthermore, this method is not limited to positioning dissimilar components solely using a silicone-containing adhesive; it is also possible to use adhesives with other compositions simultaneously, or to simultaneously employ the locking structure described in method 12 (described later), as needed. For example, when positioning a dissimilar component relative to a one-piece molded article, a silicone-containing adhesive can be used in the optical area of ​​the ophthalmic device where illumination light enters the pupil, while an adhesive not limited to a silicone-containing adhesive can be used in the peripheral area away from the optical area. Thus, for example, it is possible to avoid negative impacts on optical properties caused by the dissolution of adhesive components other than silicone into the silicone layer in the optical area and its surroundings, while expanding the range of adhesives that can be selected in areas far from the optical area, considering operability, adhesion, and the time it takes for the adhesive strength to reach its maximum. Furthermore, silicone adhesives are not limited to a certain amount of silicone; for example, they can also be adhesives that contain other components such as acrylics.

[0067] The present invention has the following embodiment 11.

[0068] The method for manufacturing an ophthalmic device according to method 10 described above is characterized in that,

[0069] The aforementioned dissimilar component is formed on the aforementioned positioning surface in the aforementioned one-piece molded article for attachment.

[0070] According to this method, for example, dissimilar components can be formed on the positioning surface of a one-piece molded article by printing (including 3D printing), electrodeposition, etc., so that the dissimilar components can be attached to the positioning surface without the use of adhesives, and the attachment process can be simplified. In addition, by forming the dissimilar components on the positioning surface, they can also be attached to the one-piece molded article in a close-fitting state.

[0071] The present invention has the following embodiment 12.

[0072] The method for manufacturing an ophthalmic device according to any one of methods 1 to 11 described above is characterized in that,

[0073] When positioning the aforementioned dissimilar component relative to the aforementioned positioning surface in the aforementioned one-piece molded article, a snap-fit ​​structure is used.

[0074] According to this method, for example, using interlocking or hook-shaped locking mechanisms, the shape of the positioning surface and the dissimilar component can be used to position the dissimilar component in a one-piece molded product. Furthermore, this method is not limited to positioning methods that only utilize the interlocking structure as described above; it is also possible to simultaneously use, for example, the attachment described in any of methods 9 to 11 above to position the dissimilar component on the positioning surface.

[0075] The present invention provides a method 13 as follows.

[0076] The method for manufacturing an ophthalmic device according to any one of methods 1 to 9, 11, and 12 described above is characterized in that,

[0077] When positioning the aforementioned dissimilar component relative to the aforementioned positioning surface in the aforementioned one-piece molded article, the dissimilar component is positioned without using an adhesive.

[0078] According to this method, the manufacturing process can be simplified by eliminating the need for adhesive preparation and coating, and the dissolution of adhesive components into the silicone layer, the one-piece molded product, etc., is not a problem. In addition, the positioning of dissimilar components without the use of adhesives can be achieved not only by forming the dissimilar components on the positioning surface as described in method 11 above, or by positioning based on an interlocking structure as described in method 12 above, but also by welding the dissimilar components to the one-piece molded product. The specific method is not limited, and positioning methods based on various existing known technologies can be used.

[0079] The present invention provides a method 14 as follows.

[0080] The method for manufacturing an ophthalmic device according to any one of methods 1 to 13 described above is characterized in that,

[0081] When the above-mentioned composite molded article is obtained, the above-mentioned silicone-containing material is inserted between the above-mentioned positioning surface of the above-mentioned primary molded article and the above-mentioned dissimilar element, and the dissimilar element is covered with the above-mentioned silicone layer.

[0082] According to this method, dissimilar components can be embedded in ophthalmic devices while being covered by a silicone layer on a wider surface. Therefore, the stability of the physical environment surrounding the dissimilar component can be improved, and molding defects such as voids caused by polymerization shrinkage near the periphery of the dissimilar component can be prevented more effectively by using a silicone-containing material with low polymerization shrinkage.

[0083] The present invention provides the following method 15.

[0084] The method for manufacturing an ophthalmic device according to any one of methods 1 to 14 described above is characterized in that,

[0085] As the aforementioned dissimilar component, a part that is harder than the aforementioned one-piece molded product is used.

[0086] According to this method, damage to the foreign components can be avoided by utilizing the inherent strength characteristics of the foreign components themselves. For example, damage to foreign components that occur during polymerization shrinkage can also be prevented, thereby improving the quality stability of the product. Furthermore, by embedding and configuring foreign components, it is also expected to enhance the strengthening effect and improve the shape stability of ophthalmic devices that include one-piece molded parts.

[0087] The present invention provides a method 16 as follows.

[0088] The method for manufacturing an ophthalmic device according to method 15 described above is characterized in that,

[0089] The aforementioned dissimilar components are electrical components that include metal parts.

[0090] According to this method, electrical components including metal parts are embedded in the eye device involved in this invention, thereby covering the electrical components with a one-piece molded product, a silicone layer, etc., which can suppress oxidation in the electrical components including metal parts, thereby stabilizing performance, or effectively prevent leakage current, electrical short circuits, etc. to the outside.

[0091] The present invention provides a method 17 as follows.

[0092] The method for manufacturing an ophthalmic device according to any one of methods 1 to 16 described above is characterized in that,

[0093] Used to manufacture contact lenses, including scleral lenses.

[0094] According to this method, it is possible to practically implement contact lenses as ophthalmic devices by embedding heterogeneous components. Therefore, it becomes easier to practically implement functional contact lenses (including smart contact lenses) that possess visual functions such as display integration, biosensor functions such as tear composition detection, communication functions such as information transmission and reception, detection functions such as motion sensors, and aesthetic design functions such as color rendering and light emission. Furthermore, by designing such functional contact lenses as, for example, scleral lenses, the stability of the contact lens position on the eye is improved, thereby facilitating more stable performance of various functions.

[0095] The present invention provides an embodiment 18 as follows.

[0096] A method for manufacturing an ophthalmic device, comprising embedding at least one heterogeneous component in the ophthalmic device, characterized by the following steps:

[0097] The first molding material is molded and polymerized by the first molding cavity defined by the first molding mold to obtain a one-time molded product with a positioning surface for positioning the above-mentioned dissimilar components.

[0098] The second molding material is molded and polymerized in a second molding cavity defined by a second molding die to obtain another molded product; and

[0099] Between the opposing surfaces formed by overlapping the positioning surfaces of the other molded article and the primary molded article where the dissimilar element is positioned, a silicone-containing material is molded and polymerized to form a silicone layer, thereby obtaining a composite molded article in which the dissimilar element is embedded in the silicone layer.

[0100] According to this method, a primary molded article and another molded article are manufactured using a first molding die and a second molding die, exhibiting excellent mass production and shape stability. These primary and second molded articles are then used to polymerize a silicone layer with low polymerization shrinkage. This allows for efficient and stable polymerization of an ophthalmic device with a silicone layer between the opposing surfaces of the primary and second molded articles, achieving good interfacial adhesion. Furthermore, dissimilar components positioned within the pre-formed primary molded article are embedded in the silicone layer, preventing molding defects such as voids caused by polymerization shrinkage and enabling the embedding of dissimilar components with high positional accuracy.

[0101] The present invention provides a method 19 as follows.

[0102] A method for manufacturing an ophthalmic device, comprising embedding at least one heterogeneous component in the ophthalmic device, characterized by the following steps:

[0103] The first molding material is molded and polymerized by the first molding cavity defined by the first molding mold to obtain a one-time molded product with a positioning surface for positioning the above-mentioned dissimilar components.

[0104] The first molding mold is opened, and an intermediate molding cavity is defined by closing the intermediate molding mold with the positioning surface of the primary molded article remaining in the first molding mold. Silicone-containing material is then molded and polymerized to form a silicone layer, thereby obtaining a composite molded article in which the aforementioned dissimilar component positioned on the positioning surface is embedded in the silicone layer; and

[0105] The intermediate molding mold is removed, and the second molding material is molded and polymerized by closing the second molding mold with the silicone layer side of the composite molded article remaining in the first molding mold to form a cover layer covering the silicone layer from the opposite side of the primary molded article.

[0106] According to this method, the silicone layer and the capping layer can be polymerized sequentially and efficiently using a first molding die and a primary molded article formed therein. In particular, according to this method, it is also possible to easily manufacture the silicone layer in such a way that the primary molded article and the capping layer cover the entire surface of the silicone layer.

[0107] The following is embodiment 20 of the present invention.

[0108] The method for manufacturing an ophthalmic device according to any one of methods 2, 3, 18, and 19 above is characterized in that,

[0109] Both the first molding material and the second molding material are rigid lens materials.

[0110] According to this method, a primary molded article and another molded article or cover layer made of rigid lens material are respectively provided on the front and rear surfaces of the silicone layer. Therefore, the accuracy and stability of the embedding position of the positioned heterogeneous component can be improved by using the aforementioned rigid lens material. Furthermore, the shape and optical characteristics of the ophthalmic device with the silicone layer can also be stabilized by using the rigid lens material. In addition, the first molding material and the second molding material can be different materials or the same material.

[0111] The following is embodiment 21 of the present invention.

[0112] An ophthalmic device is an ophthalmic device in which at least one heterogeneous component is embedded, characterized in that...

[0113] In contrast to the silicone layer disposed in the middle portion in the thickness direction, front and rear layers made of oxygen-permeable rigid lens material are provided on both sides in the thickness direction.

[0114] The aforementioned heterogeneous element is positioned in at least one of the front layer and the rear layer, and the heterogeneous element is embedded in the silicone layer.

[0115] According to this method, even in applications requiring high oxygen permeability, such as contact lenses, a highly oxygen-permeable silicone material is layered in addition to the oxygen-permeable rigid lens material on both the front and back sides, thereby meeting the overall requirement for high oxygen permeability. Furthermore, even in the case of a dissimilar element embedding structure, the dissimilar element is embedded in a silicone material with low polymerization shrinkage, thus suppressing defects such as voids around the dissimilar element during molding, thereby consistently achieving good quality. Moreover, during the embedding of dissimilar elements, the dissimilar element is positioned by the front and back layers made of rigid lens material, thus enabling highly precise and stable positioning of the dissimilar element.

[0116] Furthermore, preferably, the front and rear layers of this method are disposed in close contact with the silicone layer, without subsequent swelling treatment or the like. When disposed in close contact with the silicone layer, the front and rear layers, including the silicone layer, are given the target shape at least in the silicone layer and the overlapping portion in close contact with the silicone layer. This prevents distortions caused by subsequent swelling treatments, thereby more advantageously achieving stable optical and strength properties.

[0117] The following is embodiment 22 of the present invention.

[0118] The ophthalmic device according to method 21 described above is characterized in that,

[0119] The aforementioned silicone layer is entirely covered by the aforementioned front layer and the aforementioned rear layer.

[0120] According to this method, as described in Method 4 above, external exposure of the silicone layer can be avoided, thereby avoiding problems caused by external exposure due to the raw material characteristics of the silicone layer.

[0121] The following is embodiment 23 of the present invention.

[0122] The ophthalmic device according to method 21 or 22 described above is characterized in that,

[0123] The aforementioned heterogeneous element is positioned by being attached to at least one of the aforementioned front layer and the aforementioned rear layer.

[0124] According to this method, it is possible to accurately position dissimilar components using rigid lens materials and to position them by bonding, thereby enabling reliable and easy positioning of dissimilar components with simple component shapes.

[0125] The present invention has the following embodiment 24.

[0126] The ophthalmic device according to method 23 described above is characterized in that,

[0127] The aforementioned dissimilar components are bonded to at least one of the aforementioned front layer and the aforementioned rear layer by a silicone adhesive.

[0128] According to this method, as described in Method 10 above, by using a silicone-containing adhesive, the interface between the adhesive layer and the silicone layer can be optically substantially eliminated, thereby reducing or even avoiding the impact on the optical characteristics of eye devices.

[0129] The present invention provides a method 25 as follows.

[0130] The ophthalmic device described in any one of methods 21 to 24 above is characterized in that,

[0131] In the portion of the material that is off-center from the aforementioned heterogeneous element, the thickness of the front layer and the rear layer is less than 1 / 2 of the thickness of the silicone layer.

[0132] According to this method, the thickness of the front and rear layers is kept relatively small, thereby allowing for more efficient utilization of the high oxygen permeability of the silicone layer. Therefore, it is also preferably applicable to, for example, contact lenses requiring high oxygen permeability as an overall ophthalmic device. Furthermore, in this method, for example, the silicone layer can be omitted from the periphery of the peripheral portion offset from the central portion of the optical area of ​​the ophthalmic device, or the thickness of the front and / or rear layers in the peripheral portion can be greater than half the thickness of the silicone layer. This allows for advantageous assurance of shape retention performance as an overall ophthalmic device through the use of rigid lens materials.

[0133] The following is embodiment 26 of the present invention.

[0134] The ophthalmic device described according to any one of methods 21 to 25 above is characterized in that,

[0135] The total mass of the aforementioned silicone layer, the aforementioned front layer, and the aforementioned rear layer is less than 99% of the total mass when the silicone layer is made of the same rigid lens material as the front layer.

[0136] According to this method, not only is the wearing comfort improved due to the lightweight design of the eye device itself, but the composition ratio of the silicone layer relative to the front and back layers made of rigid lens material is also exceptionally well ensured to a certain extent. Furthermore, the improved oxygen permeability and other properties brought about by the silicone layer can be enjoyed more significantly.

[0137] According to the method of the present invention, it is possible to manufacture ophthalmic devices with embedded foreign components while achieving high positioning accuracy of foreign components and reducing or even avoiding poor forming such as gaps.

[0138] As mentioned above, especially for ophthalmic devices with embedded foreign components, there is a special situation where gaps are easily generated. These gaps not only negatively affect visual effects but also easily lead to a decrease in the overall strength of the ophthalmic device, becoming a fatal product defect. Furthermore, ophthalmic devices with embedded foreign components present a special issue of concerns that water droplets generated within the gaps may negatively affect the foreign components. Therefore, the present invention, which can suppress gaps and other defects in ophthalmic devices with embedded foreign components, is of great technical significance.

[0139] Furthermore, in the ophthalmic device of the present invention, the use of anterior and / or posterior layers made of rigid lens material ensures the positioning accuracy of heterogeneous elements and enables high oxygen permeability through the silicone layer. Attached Figure Description

[0140] Figure 1 This is a process description diagram illustrating the manufacturing process of a contact lens, which is an ophthalmic device according to the first embodiment of the present invention.

[0141] Figure 2 It continues Figure 1 The process diagram.

[0142] Figure 3 It is used for Figure 1 The diagram shown illustrates the molding process of a one-time molded article during the manufacture of a contact lens according to the first embodiment.

[0143] Figure 4 This indicates that the embedded component, which is a dissimilar element, is positioned in... Figure 3 The diagram shows the state of a one-piece molded product.

[0144] Figure 5 This is a process illustration diagram illustrating the manufacturing process of a contact lens, which is an ophthalmic device according to the second embodiment of the present invention.

[0145] Figure 6 It continues Figure 5 The process diagram.

[0146] Figure 7 It is used for Figure 5 The diagram shown illustrates the molding process of a single-piece contact lens manufactured using a first molding die, as an example of the second embodiment.

[0147] Figure 8This indicates that the embedded component, which is a dissimilar element, is positioned in... Figure 7 The diagram shows the state of a one-piece molded product.

[0148] Figure 9 This is a process illustration diagram illustrating the manufacturing process of a contact lens, which is an ophthalmic device according to the third embodiment of the present invention.

[0149] Figure 10 It continues Figure 9 The process diagram.

[0150] Figure 11 This is a process description diagram illustrating the manufacturing process of a contact lens, which is an ophthalmic device according to the fourth embodiment of the present invention.

[0151] Figure 12 It continues Figure 11 The process diagram.

[0152] Figure 13 This is a cross-sectional view illustrating a contact lens, which is an ophthalmic device according to the fifth embodiment of the present invention.

[0153] Figure 14 This is a process description diagram illustrating the manufacturing process of a contact lens, which is an ophthalmic device according to the sixth embodiment of the present invention. Detailed Implementation

[0154] Hereinafter, in order to illustrate the present invention in more detail, embodiments will be described with reference to the accompanying drawings.

[0155] A. First implementation method ( Figure 1-4 )

[0156] First, in the description of the first embodiment Figure 1-2 The diagram shows an outline of a method for manufacturing a contact lens 10, which is an ophthalmic device according to the present invention. In this embodiment, the contact lens 10, in which an implantation component 12, which is internally positioned and disposed, is manufactured by a molding process comprising a first molding process based on a first rigid lens material, a second molding process based on a silicone-containing material, and a third molding process based on a second rigid lens material.

[0157] More specifically, in the first molding process, such as Figure 1 As shown in (a)-(c), the first molding material 18 is molded in the first molding cavity 16 defined by the first molding mold 14 to form a one-piece molded product 20.

[0158] In this embodiment, the first molding die 14 is a lens front surface die having a concave molding surface 22 that provides a lens front surface formed by a convex surface of approximately spherical crown shape as the mold cavity forming surface. Furthermore, the support surface molding die 26 is used as the molding die that closes with the first molding die 14 to define the first molding cavity 16.

[0159] The support surface forming mold 26 has a generally spherical crown-shaped convex forming surface 24 as the mold cavity forming surface. The one-piece molded article 20, which is formed in the first forming cavity 16 defined by the first forming mold 14 and the support surface forming mold 26, forms the spherical convex shape of the front surface layer of the lens in the target contact lens 10.

[0160] Furthermore, the materials of the first molding die 14 and the support surface molding die 26 are not limited. Resin molding dies are preferred over metal molding dies. Specifically, thermoplastic resins such as polypropylene, polyethylene, polystyrene, polycarbonate, polyethylene terephthalate, polyamide, polyoxymethylene, and polyvinyl chloride can typically be used as mold materials. The two molding dies can also be made of the same material, or they can be made of different materials and have different surface properties.

[0161] Furthermore, the molding material (first molding material) 18 of the one-piece molded article 20 molded in the first molding cavity 16 is selected according to the eye device being targeted and is not limited thereto. In this embodiment, various contact lens materials can be used according to the characteristics required for the contact lens 10 being targeted, and known monomers or the like can be used as polymeric components for contact lens molding.

[0162] By way of reference, various rigid contact lens materials (rigid lens materials) known in the past can be used. For example, rigid contact lens materials composed mainly of polymeric components such as methyl methacrylate (MMA) can also be used. However, it is preferable to use rigid contact lens materials (RGP) with high oxygen permeability obtained by using polymeric components such as siloxane monomers, fluorine monomers, and styrene monomers as the main components.

[0163] Furthermore, when molding a one-piece article 20 using such a first molding material 18, for example, Figure 1 As shown in (a), after a predetermined amount of first molding material 18 is injected relative to the concave molding surface 22 that opens upwards in the first molding die 14, the convex molding surface 24 of the support surface molding die 26 is brought in and the die is closed. Afterwards, the first molding material 18 can be subjected to polymerization-based curing treatment by known methods such as heating, irradiation with ultraviolet light, or combinations thereof.

[0164] In a one-piece molded article 20 formed using a first molding die 14 and a support surface molding die 26, such as Figure 1 As shown in (d), the embedding component 12 is supported on the concave surface of the spherical cap in a positioned state. Figure 1 (d) Upper surface). Therefore, in this embodiment, the positioning surface for positioning and supporting the embedding component 12 is formed by the concave surface of the one-piece molded article 20. Furthermore, as shown in the figure, the assembly of the embedding component 12 to the one-piece molded article 20 is preferably performed in a state where the support surface molding mold 26 is removed by mold opening and the one-piece molded article 20 is supported by the first molding mold 14.

[0165] Furthermore, the embedding component 12 is not specifically limited. For example, any component used to impart specific functions to the contact lens 10 can be used. Specifically, electronic components such as sensors, cameras, projectors, batteries, antennas, and computing devices used in smart contact lenses can be used as the embedding component 12. The material of the embedding component 12 is also not limited; it can be made of metal, resin, ceramic, etc., at least in part. The function of the embedding component 12 is also not limited. For example, it can be combined and perform functions as needed, such as chemical or even electrical functions (e.g., sensors, cameras), mechanical functions (e.g., reinforcement, shape retention), biological or even medical functions (e.g., drug delivery), and aesthetic or design functions (e.g., coloring, patterning). Moreover, it goes without saying that the specific size, shape, and number of the embedding component 12 are not limited.

[0166] Furthermore, regarding the implantation component 12, in cases of concern about negative optical effects on the eye's optical system, it is preferable to position the implantation component 12 away from the portion forming the optical area. Specifically, it is preferable to position the engaging portion 30 such that the implantation component 12 is disposed on the outer periphery, so as to avoid the central portion that forms the transmission path of light entering the pupil in the contact lens.

[0167] Of course, depending on the type of embedding component 12, a portion or all of the projector that allows the wearer of the contact lens 10 to visually recognize and display information, or other extremely small components, may also be positioned in the central portion. Furthermore, similar to conventional contact lenses, vision correction functions may be provided in the central portion of the contact lens 10 as needed.

[0168] Furthermore, regarding the support of the embedded component 12 in its positioned state relative to the one-piece molded article 20, it is sufficient as long as the embedded component 12 can be held in a predetermined position during the molding of the silicone layer, which will be described later. The specific support structure is not limited; for example, the embedded component 12 can be positioned and supported on the one-piece molded article 20 in an adhered state, including bonding, welding, printing, etc.

[0169] For example, such as Figure 1 As shown in (a) and (b), a concave-convex engaging forming portion is provided on the convex forming surface 24 of the support surface forming mold 26, thereby, as Figure 3 As shown in the enlarged view, a locking portion 30 is formed on the concave surface of the one-piece molded article 20 for positioning and / or retaining the embedding component 12. In this embodiment, the locking portion 30 is used as a fitting recess, thereby achieving the desired fit. Figure 4 As shown in the enlarged view, the embedding component 12 is embedded in the engaging portion 30 and thus positioned and held.

[0170] Furthermore, the recessed engaging portion 30, which positions the embedding component 12 through fitting or locking as in this embodiment, can be appropriately set according to the shape and size of the embedding component 12 and is not limited thereto. In this embodiment, the embedding component 12 and the engaging portion 30 are formed in a ring shape extending circumferentially, but for example, a recessed engaging portion 30 formed locally in the circumferential direction and an embedding component 12 fitted and held therewith can also be used.

[0171] Moreover, such as Figure 1 As shown in (e), with the embedding component 12 positioned at a predetermined location on the one-piece molded article 20, a second molding process based on the molding and polymerization of the silicone-containing material 32 is performed. In this second molding process, instead of leaving the one-piece molded article 20, the support surface molding mold 26 is removed from the first molding mold 14, and the intermediate molding mold 34 is closed with the first molding mold 12, thereby defining the silicone molding cavity 36. Then, as... Figure 2 As shown in (f), silicone material 32 is molded in silicone molding cavity 36 where primary molded part 20 remains, thereby forming intermediate molded part 38 in which embedded part 12 is embedded.

[0172] In the second molding process described above, the embedding component 12 is supported on the primary molded article 20, thereby enabling the embedding component 12 to be positioned at a predetermined location within the silicone molding cavity 36. Furthermore, the silicone molding cavity 36 is filled with a silicone-containing material 32, and the silicone layer 40, which serves as an intermediate layer, is molded to form an intermediate molded article 38, which is a molded article in which the embedding component 12 is embedded.

[0173] Furthermore, in the aforementioned intermediate molded article 38, the implantation component 12 can be embedded in the silicone layer 40 in a completely embedded state, and the intermediate molded article 38 can also be partially exposed or protruding from the silicone layer 30 while being covered by the primary molded article 20, which serves as the front surface layer of the contact lens 10, and the cover layer, which serves as the rear surface layer of the contact lens (described later). That is, the implantation component 12 is preferably implanted in a manner that avoids direct exposure on the front and rear surfaces of the contact lens 10.

[0174] In addition, in this embodiment, from Figure 4 As can be seen from (b), on the overlapping side of the embedding component 12 and the one-piece molded article 20, a silicone molding cavity 36 is also formed through a gap-like region extending between the embedding component 12 and the one-piece molded article 20. Moreover, the silicone-containing material 32 is filled into the aforementioned gap-like region, so that the surface of the embedding component 12, preferably substantially entirely, is covered by the silicone layer 40 in a substantially embedded state.

[0175] Furthermore, in this embodiment, the central portion of the optical region of the contact lens 10, located on the inner periphery of the engaging portion 30 in the first molding die 14, is formed with a spherical shape that expands with a substantially constant thickness. This avoids large steps or variations in thickness within the optical region, thereby improving and homogenizing the optical properties.

[0176] Here, the molding material for the silicone layer 40, to which the embedding component 12 is embedded, can be any silicone-containing lens material known in the past. For example, preferably, a silicone-containing aqueous or non-aqueous soft contact lens material obtained from a polymeric composition composed of silicone-containing monomers, silicone-containing macromolecular monomers, etc., can be used.

[0177] Compared to conventional rigid lens materials, especially RGP lenses like the one-piece molded article 20, this silicone-containing material 32 can suppress the degree of volume shrinkage accompanying polymerization. That is, according to the inventors' research, in contact lenses 10 with the implantation component 12 embedded, there is a particular problem: poor forming, such as voids, is easily generated, which negatively affects the visual effect and strength of the contact lens 10, and the formation of water droplets within the voids negatively affects the implantation component 12. To address these problems, silicone-containing material 32 is used as the lens material for embedding the implantation component 12, thereby reducing the negative pressure generated around the implantation component 12 and suppressing the formation of voids and other defects. As a result, contact lenses 10 with the implantation component 12 can be manufactured with excellent quality and stability.

[0178] Furthermore, during the polymerization and molding of the silicone-containing material 32, the embedding component 12 is positioned and supported by a one-piece molded article 20 made of RGP or the like. The one-piece molded article 20 is made harder than the silicone layer 40, thereby enabling the embedding component 12 to be positioned firmly, stably, and with good precision.

[0179] Furthermore, high oxygen permeability can be achieved in the silicone layer 40, thus the overall oxygen permeability of the contact lens 10, including the one-piece molded article 20 constituting the front and back layers of the lens and the cover layer described later, can also be set to be high. That is, by using a silicone layer 40 with high oxygen permeability (Dk value) to form the interior of the lens, and in conjunction with reducing the thickness of the one-piece molded article 20 and the cover layer, high oxygen permeability of the contact lens 10 can be achieved. In addition, by using RGP (Rubber Gas Permeable) to form the one-piece molded article 20 and the cover layer, the oxygen permeability of the contact lens 10 can be further improved.

[0180] Next, as Figure 2 As shown in (g), after removing the intermediate molding die 34 by opening the mold, as... Figure 2 As shown in (h), the third molding process is performed through the molding and polymerization of the second molding material 44, thereby achieving the desired result. Figure 2 As shown in (i), a cover layer 46 is formed that constitutes the rear surface of the contact lens 10.

[0181] In the aforementioned third molding process, instead of leaving the intermediate molded product 30, the intermediate molded mold 34 is removed from the first molding mold 14, and the second molding mold 50 is closed with the first molding mold 12, thereby defining the second molding cavity 52. ​​Then, within the second molding cavity 52 where the intermediate molded product 30 remains, the second molding material 44 is molded to form the cover layer 46 covering the entire back side of the silicone layer 40.

[0182] The second molding die 50, which defines the second molding cavity 52, has a generally spherical crown-shaped convex molding surface 54 as the cavity forming surface. The cover layer 46, which is molded in the second molding cavity 52, which is located between the mating surfaces of the first molding die 12 and the second molding die 50 and in an embedded state, forms a concave spherical lens rear surface layer in the target contact lens 10.

[0183] Furthermore, the intermediate molding die 34 and the second molding die 50 described above can be made of the same material as the first molding die 14 described above, and the material is not limited. In addition, the specific shape and structure of each part including the mold cavity forming surface are not limited.

[0184] Furthermore, the molding material (second molding material) 44 of the cover layer 46 molded in the second molding cavity 52 is selected based on the target eye device and is not limited thereto. In this embodiment, various contact lens materials can be used depending on the characteristics required for the target contact lens 10, such as RGP (Rubber Gel Permeable) material, similar to the first molding material 18 described above.

[0185] During the formation of the cover layer 46 based on the second molding material 44, for example, Figure 1 As shown in (h)-(i), after a predetermined amount of first molding material 18 is injected from above onto the intermediate molded article 38, which is disposed in an embedded state on the concave molding surface 22 of the first molding mold 14 facing upward, the convex molding surface 54 of the second molding mold 50 is brought in and the mold is closed. Subsequently, similar to the molding of the primary molded article 20 using the first molding material 18 described above, the second molding material 44 can be subjected to polymerization-based curing treatment by known methods such as heating, irradiation with ultraviolet light, or combinations thereof.

[0186] In this way, the covering layer 46 is integrally formed on the intermediate molded part 38 in a close-fitting state, thereby achieving... Figure 2 As shown in (j), a contact lens 10 is formed as the target and then delaminated.

[0187] In the contact lens 10 obtained in this way, although the structure in which the embedding component 12 is embedded is adopted, the molding defects such as gaps during molding are reduced or even prevented, thus achieving good quality.

[0188] Furthermore, by clamping and embedding the silicone layer 40, in which the embedding component 12 is disposed, and by providing a one-piece molded product 20 and a cover layer 46 made of a rigid contact lens material with high oxygen permeability, the silicone layer 40 can be prevented from being exposed to the lens surface. Therefore, adverse conditions caused by the material characteristics of the silicone layer 40, such as lipid adsorption and corneal adsorption, can also be avoided.

[0189] Furthermore, since the implantation component 12 is positioned and set by a one-piece molded product 20 made of rigid contact lens material or the like, the implantation position of the implantation component 12 can be set with good accuracy and stability.

[0190] Furthermore, even if slight shrinkage marks or other defects occur on the molding surface during the polymerization of the silicone layer 40, they are covered by the cover layer 46 formed on the molding surface of the silicone layer 40, thus avoiding practical problems such as shrinkage marks. In other words, by allowing shrinkage marks on the molding surface of the silicone layer 40, voids inside the silicone layer 40 can be prevented more effectively.

[0191] From the above perspective, it is also preferable to perform surface treatments such as laser irradiation and mold release agent coating on the molding surface of the intermediate molding die 34, which constitutes the molding surface of the silicone layer 40, to improve the demolding properties with the silicone layer 40. Furthermore, various treatments can be performed on the mold cavity forming surfaces of the molding dies used in this embodiment as needed. For example, surface property adjustment treatments such as plasma treatment, UV irradiation, corona discharge, laser irradiation, and surfactant coating can be performed to improve or reduce the adhesion with the molding materials 18 and 26. In addition, when molding various molding materials using various molding dies such as the first molding die 14, the support surface molding die 26, the intermediate molding die 34, and the second molding die 50, the temperature can be managed by heating or cooling each molding die as needed, thereby adjusting the adhesion with the molding material.

[0192] However, in this embodiment, the front surface (a convex, crown-shaped surface) of the contact lens 10 is formed by a one-piece molded article 20 that supports the embedding member 12 in a positioning state. Conversely, the rear surface (a concave, crown-shaped surface) of the contact lens 10 can also be formed by a one-piece molded article that supports the embedding member 12 in a positioning state. Hereinafter, the above method will be shown as a second embodiment.

[0193] B. Second implementation method ( Figure 5-8 )

[0194] The outline of the manufacturing method of the contact lens 10 according to the second embodiment is as follows: Figure 5-6 As shown. Similar to the first embodiment, this embodiment also manufactures a contact lens 10 with an implantation component 12, which is internally positioned and disposed, via a molding process comprising a first molding process based on molding and polymerization of a first rigid lens material, a second molding process based on molding and polymerization of a silicone-containing material, and a third molding process based on molding and polymerization of a second rigid lens material. Furthermore, corresponding reference numerals are used for components in this embodiment that correspond to those in the first embodiment, and the same names are used, thus omitting detailed descriptions.

[0195] First, in the first molding process, such as Figure 5 As shown in (a)-(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 mold 14 and a support surface molding mold 26 to form a one-piece molded product 20′ for positioning and arranging the embedded component 12.

[0196] The one-piece molded article 20′ of this embodiment differs from the one-piece molded article 20 constituting the front surface of the lens in the first embodiment, and has a spherical concave surface constituting the rear surface of the contact lens 10. Furthermore, as... Figure 7 As shown, a locking portion 30 with a stepped surface for locking is formed on the spherical convex surface of the one-piece molded article 20′, and so on. Figure 8 As shown, the embedding component 12 is supported in a positioning state by the engaging portion 30. That is, in this embodiment, the positioning surface that positions and supports the embedding component 12 is formed by the convex surface of the one-piece molded article 20′.

[0197] In the next second molding process, such as Figure 5 (d)- Figure 6 As shown in (f), silicone material 32 is molded in the silicone molding cavity 36 defined by the first molding mold 14 and the intermediate molding mold 34, which are used to mold the primary molded article 20′, thereby forming a silicone layer 40 covering the crown-shaped convex surface of the primary molded article 20′.

[0198] Thus, the primary molded article 20', which is supported in a positioning state with the embedding component 12, is molded with the silicone layer 40 in an embedded state, thereby forming an intermediate molded article 38. In the intermediate molded article 38, similarly to the first embodiment, one side of the primary molded article 20' (the side opposite to the first molding die 14) is substantially entirely covered by the silicone layer 40, and the embedding component 12 is embedded in the silicone layer 40.

[0199] In the subsequent third molding process, such as Figure 6 As shown in (g)-(h), a second molding material 44 made of RGP or the like is molded in a second molding cavity 52 defined by a first molding mold 14 and a second molding mold 50, in which the intermediate molded product 38 is left on the molding surface, thereby forming a cap-shaped convex covering layer 46′ covering the silicone layer 40.

[0200] Thus, the intermediate molded article 38 is molded with a cover layer 46' in an embedded state, and the cover layer 46 forms a spherical convex front surface layer of the lens in the target contact lens 10.

[0201] Also Figure 6 As shown in (i), the contact lens 10 obtained in this embodiment has essentially the same structure as the contact lens 10 obtained in the first embodiment. That is, the silicone layer 40 is encapsulated by sandwiching the two sides by a thin-walled, spherical cap-shaped cover layer 46 constituting the front surface of the lens and a thin-walled, spherical cap-shaped one-piece molded article 20' constituting the rear surface of the lens. In addition, the embedding component 12 is precisely positioned and embedded in the silicone layer 40 within the one-piece molded article 20' made of RGP or the like.

[0202] Therefore, in the manufacturing method of the contact lens 10 according to this embodiment, the same effects as those in the first embodiment described above can be achieved.

[0203] However, in the first and second embodiments described above, after the first molding process of forming the one-piece molded articles 20, 20' that support the embedding component 12 in a positioning state, a second molding process is performed to form a silicone layer 40 on the surface of the one-piece molded articles 20, 20', followed by a third molding process to form a cover layer 46, 46' on the surface of the silicone layer 40. In contrast, in the first and second molding processes, the one-piece molded articles 20, 20' and the cover layers 46, 46' that constitute the front and rear surfaces of the lens are formed respectively. In the subsequent third molding process, the silicone layer 40 is formed between the opposing surfaces of the one-piece molded articles 20, 20' and the cover layers 46, 46', thereby enabling the embedding component 12, which is positioned and supported by the one-piece molded articles 20, 20' and / or the cover layers 46, 46', to be embedded in the silicone layer 40. Hereinafter, the above methods will be shown as the third and fourth embodiments.

[0204] C. Third implementation method ( Figure 9-10 )

[0205] The outline of the method for manufacturing the contact lens 10 according to the third embodiment is as follows: Figure 9-10 As shown. Furthermore, the corresponding reference numerals and names are used for the components in this embodiment that correspond to those in the first embodiment, thus omitting detailed descriptions.

[0206] First, the first molding process is the same as the process described in the first embodiment above, such as... Figure 9 As shown in (a)-(d), the first molding material 18 is molded within the first molding cavity 16 defined by the first molding die 14 and the support surface molding die 26, thereby forming a one-piece molded article 20 for positioning and arranging the embedded component 12. Similar to the first embodiment, this one-piece molded article 20 is formed from RGP or the like and constitutes a lens front surface layer having a thin wall and a spherical shape as a whole.

[0207] In addition, in the second molding process, such as Figure 9 (e)- Figure 10 As shown in (g), a second molding material 44 made of RGP or the like is injected into an intermediate molding die 34 having a molding surface with a concave shape, and the second molding die 50 having a convex molding surface 54 is closed to mold the second molding material 44, thereby forming a cover layer 46. Similar to the first embodiment, this cover layer 46 is formed of RGP or the like, constituting a lens rear surface layer that has a thin wall and a spherical shape as a whole.

[0208] Here, the formation sequence of the primary molded article 20 based on the first molding process and the formation sequence of the cover layer 46 based on the second molding process are different, and they can also be performed simultaneously using independent equipment. Furthermore, the primary molded article 20 and / or the cover layer 46 can be pre-formed and stored. In this embodiment, the cover layer 46 formed from the second molding material 44 is a separate molded article formed separately from the primary molded article 20 that positions and supports the embedding component 12.

[0209] Then, in the third molding process, such as Figure 10 As shown in (h)-(j), a silicone-containing material 32 is molded in a silicone molding cavity 36 in which a primary molded article 20 and a cover layer 46 are arranged in an embedded state, thereby forming a silicone layer 40 between the opposing surfaces of the primary molded article 20 and the cover layer 46.

[0210] Specifically, a first molding die 14, in which the embedded component 12 is positioned, is left on the concave molding surface 22 and opens upwards, and silicone material 32 is injected into it. Then, in a silicone molding cavity 36 defined by a second molding die 50, in which the cover layer 46 is left on the convex molding surface 54, the silicone material 32 is molded and polymerized.

[0211] Thus, the embedded component 12, positioned and supported by the one-piece molded article 20 and disposed between the opposing surfaces of the one-piece molded article 20 and the cover layer 46, is embedded in a state in which it is substantially entirely covered by the silicone layer 40.

[0212] Even with the molding method of the contact lens 10 according to this embodiment, molding defects such as reduced pressure during the polymerization of the silicone material 32 and the resulting voids can be suppressed, and the silicone layer 40 can be precisely and tightly bonded to the primary molded article 20 and the cover layer 46. Therefore, the contact lens 10 with the implantation component 12 can be manufactured with good quality and stability. In addition, the positioning accuracy of the implantation component 12 can also be well and stably ensured by the primary molded article 20 made of RGP or the like, achieving the same effect as the first embodiment described above.

[0213] D. Fourth Implementation Method ( Figure 11-12 )

[0214] The outline of the manufacturing method of the contact lens 10 according to the fourth embodiment is as follows: Figure 11-12 As shown. Furthermore, the corresponding reference numerals and names are used for the components in this embodiment that correspond to those in the second embodiment, thus omitting detailed descriptions.

[0215] First, the first molding process is the same as that in the second embodiment described above, such as... Figure 11 As shown in (a)-(d), the first molding material 18 is molded within the first molding cavity 16 defined by the first molding die 14 and the support surface molding die 26 to form a one-piece molded article 20' for positioning and arranging the embedded component 12. Similar to the second embodiment, this one-piece molded article 20' is formed from RGP or the like and constitutes a lens rear surface layer having a thin wall and a spherical shape as a whole.

[0216] In addition, in the second molding process, such as Figure 11 (e)- Figure 12 As shown in (g), a second molding material 44 made of RGP or the like is injected into a second molding die 50 having a concave molding surface, and an intermediate molding die 34 having a convex molding surface is closed to mold the second molding material 44, thereby forming a cover layer 46'. Similarly to the second embodiment, the cover layer 46', as another molded product, is formed of RGP or the like, constituting a lens front surface layer that has a thin wall and a spherical shape as a whole.

[0217] Here, the formation of the primary molded article 20′ based on the first molding process and the formation of the cover layer 46′ based on the second molding process can also be performed in different sequences, using independent equipment simultaneously. Alternatively, the primary molded article 20′ and / or the cover layer 46′ can be pre-formed and stored.

[0218] Then, in the third molding process, such as Figure 12 As shown in (h)-(j), a silicone-containing material 32 is molded in a silicone molding cavity 36 in which a primary molded article 20′ and a cover layer 46′ are arranged in an embedded state, and a silicone layer 40 is formed between the opposing surfaces of the primary molded article 20′ and the cover layer 46′.

[0219] Specifically, the second molding die 50, in which the cover layer 46' is left on the concave molding surface, opens upwards and injects silicone-containing material 32 into it. Then, the silicone-containing material 32 is molded and polymerized in the silicone molding cavity 36 defined by the first molding die 14, in which the primary molded article 20' is left on the convex molding surface 22', and the second molding die 50 is closed from above.

[0220] Thus, the embedded component 12, positioned and supported by the one-piece molded article 20′ and disposed between the opposing surfaces of the one-piece molded article 20′ and the cover layer 46′, is embedded in a state in which it is substantially entirely covered by the silicone layer 40.

[0221] Even with the molding method of the contact lens 10 according to this embodiment, molding defects such as reduced pressure during the polymerization of the silicone material 32 and the resulting voids can be suppressed, ensuring a precise and tight bond between the silicone layer 40, the primary molded article 20', and the cover layer 46'. Therefore, the contact lens 10 with the implantation component 12 can be manufactured with good quality and stability. Furthermore, the positioning accuracy of the implantation component 12 can also be well and stably ensured by the primary molded article 20' made of RGP or the like, achieving the same effects as the embodiments described above.

[0222] E. Fifth Implementation Method ( Figure 13 )

[0223] In the contact lens 10 of the above embodiments, the silicone layer 40 covering the implantation component 12 is covered by a lens front surface layer and a lens back surface layer (20, 20′, 46, 46′) made of RGP or the like, thereby preventing the silicone layer 40 from being exposed to the lens surface. Thus, considering the characteristics of the silicone layer 40 such as lipid adsorption, exposure of the silicone layer 40 to the lens surface is preferable. Furthermore, assuming that the silicone layer 40 is softer than the lens front surface layer and lens back surface layer (20, 20′, 46, 46′) made of RGP or the like, it is more preferable from the viewpoint of the shape stability and even the optical stability of the contact lens 10 to have the silicone layer 40 completely enclosed and not exposed to the surface.

[0224] From the above perspective, the contact lens 10 of each embodiment is constructed by a single-piece molded article 20, 20' and a cover layer 46, 46', respectively, formed from a molded body with a single structure. However, at the lens edge, on the outer periphery of the silicone layer 40, there is a boundary surface with an overlapping structure between the single-piece molded articles 20, 20' and the cover layers 46, 46'. Therefore, it can be considered that there is a risk of contact with the silicone layer 40 from the outside at the aforementioned boundary surface.

[0225] 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 surfaces formed by overlapping the one-piece molded articles 20, 20′ and the cover layers 46, 46′. Therefore, if molding conditions such as molding dimensional errors caused by polymerization shrinkage and mold clamping force are also taken into consideration, it is preferable to assume that the silicone layer 40 is formed through the gap between the overlapping surfaces of the one-piece molded articles 20, 20′ and the outer peripheral portions of the cover layers 46, 46′, and the outer peripheral end extending to the edge portion.

[0226] Therefore, in the contact lens 10 of this embodiment, as Figure 13As shown, by providing an edge covering layer 60 that covers the edge of the contact lens 10 around the entire circumference, the structure becomes a structure that covers the overlapping surface of the outer periphery of the one-piece molded articles 20, 20′ and the covering layers 46, 46′.

[0227] By setting the aforementioned edge covering layer 60, it is possible to prevent external influences from the boundary between the one-piece molded articles 20, 20′ and the covering layers 46, 46′ on the silicone layer 40, and to more reliably prevent the risks caused by external exposure of the silicone layer 40, thereby achieving quality improvement and stabilization.

[0228] Furthermore, the material of the edge covering layer 60 is not particularly limited, and various materials other than silicone-containing materials can be used. Preferably, it can be the same lens material as the one-piece molded articles 20, 20', and the cover layers 46, 46'. Of course, as long as the edge covering layer 60 does not affect the optical area, it will not affect the optical properties, so there is no need to consider the optical properties of the lens. On the other hand, the aforementioned edge covering layer 60 can also be formed on the surface of the contact lens 10 within the area affecting the optical area, or it can be formed as an integral structure that covers the entire surface of the contact lens 10 in a wrapping manner.

[0229] F. Sixth Implementation Method ( Figure 14 )

[0230] In the contact lens 10 of the above embodiments, the implantation component 12 is assembled and supported in a positioning state on a single-molded product 20, 20' constituting either the front surface layer or the back surface layer of the lens, thereby being disposed in an implanted state within the silicone layer 40. As described above, the specific type, shape, size, structure, and quantity of the implantation component 12 are not limited. However, by using a single-molded product constituting the front surface layer of the lens 20 and a single-molded product constituting the back surface layer of the lens 20' as the single-molded product supporting the implantation component 12 in a positioning state, the implantation component 12 can be disposed in an implanted state within the silicone layer 40 from both the front surface side and the back surface side of the lens.

[0231] One specific method is taken as the sixth implementation method. Figure 14 Examples are shown below. Furthermore, the corresponding reference numerals and names are used for components in this embodiment that correspond to those in the third and fourth embodiments, thus omitting detailed descriptions.

[0232] First, the first molding process is the same as the first molding process in the fourth embodiment described above, such as... Figure 14As shown in (a)-(b), a one-piece molded article 20' for positioning and arranging the embedded component 12' is formed by molding based on the first molding die 14' and the support surface molding die (not shown). Similar to the fourth embodiment, this one-piece molded article 20' is formed from RGP or the like and constitutes a lens rear surface layer having a thin wall and a spherical shape as a whole.

[0233] Furthermore, similar to the fourth embodiment, the embedding component 12' is supported in a positioning state on the engaging portion 30' of the one-piece molded article 20'. In addition, the support of the embedding component 12' in the positioning state relative to the one-piece molded article 20' can also be achieved by the embedding component 12' engaging and locking onto the engaging portion 30', as in the fourth embodiment. However, in this embodiment, in addition to positioning based on the engaging structure, the embedding component 12' is overlapped and bonded to the one-piece molded article 20' by the adhesive layer 62, thereby also utilizing adhesive-based positioning for fixation. Furthermore, when the embedding component 12' is positioned and supported using the adhesive layer 62, it is not necessary to simultaneously employ engaging structures with concave-convex shapes, hook shapes, etc., on the one-piece molded article 20', and the one-piece molded article 20' can be formed with a smooth surface shape.

[0234] Furthermore, the specific composition of adhesive 62 is not limited. Considering the required characteristics and materials of contact lens 10, various conventionally known adhesives can be selectively used, with silicone-containing adhesives being preferred. Silicone-containing adhesives can be any type, such as room temperature curing type, heat curing type, addition reaction curing type, single-component type, or two-component type, and modified silicone adhesives are also preferred. Additionally, the positioning support for the embedded component 12' to the one-piece molded article 20' only needs to be sufficient to hold the embedded component 12' in a predetermined position within the molding cavity during the molding of the silicone layer 40. Therefore, silicone-based sealants and adhesives can also be used. In this embodiment (the present invention), silicone-containing adhesive 62 should be interpreted as including silicone-containing sealants, adhesives, etc.

[0235] like Figure 14 As shown in (c), in parallel with this first molding process, a second molding process is performed to form a one-piece molded article 20 for positioning and arranging the embedded component 12 by molding based on the first molding mold 14 and the support surface molding mold (not shown). Similar to the third embodiment, this one-piece molded article 20 is formed from RGP or the like and constitutes a lens front surface layer having a thin wall and a spherical shape as a whole.

[0236] Furthermore, similar to the third embodiment, the embedding component 12 is supported in a positioning state on the engaging portion 30 of the one-piece molded article 20. In addition, regarding the positioning support of the embedding component 12 relative to the one-piece molded article 20, an adhesive structure can also be used, but in this embodiment, similar to the third embodiment, the embedding component 12 is positioned and supported on the one-piece molded article 20 by fitting relative to the engaging portion 30.

[0237] After that, as Figure 14 As shown in (d)-(f), in substantially the same manner as in the third and fourth embodiments, the silicone-containing material 32 is molded to form a contact lens 10 in which the embedding components 12, 12' are embedded within the silicone layer 40.

[0238] Specifically, a first molding die 14, in which the positioning and placement of the embedded component 12 is left on the concave molding surface, opens upwards and injects silicone material 32 into it. Then, within the silicone molding cavity 36 defined by the first molding die 14', in which the positioning and placement of the embedded component 12' is left on the convex molding surface, the silicone material 32 is molded and polymerized.

[0239] Thus, within the silicone molding cavity 36 containing two primary molded articles 20 and 20' arranged in an embedded state, the silicone-containing material 32 is molded, forming a silicone layer 40 between the opposing surfaces of the primary molded articles 20 and 20'. Inside the silicone layer 40, the embedding components 12 and 12', which are positioned and supported by the primary molded articles 20 and 20' respectively and arranged between the opposing surfaces of the two primary molded articles 20 and 20', are embedded in a substantially completely encapsulated state covered by the silicone layer 40.

[0240] Even with the molding method of the contact lens 10 according to this embodiment, it is possible to avoid defects such as gaps and to manufacture the contact lens 10 with good quality and good positioning accuracy by consistently avoiding defects such as gaps and having the mounting components 12, 12' embedded in it.

[0241] In particular, in this embodiment, the embedded components 12 and 12' can be supported in a positioning state and disposed in an embedded state within the silicone layer 40 by the one-piece molded article 20 constituting the front surface layer of the lens and the one-piece molded article 20' constituting the rear surface layer of the lens, respectively. Therefore, the number, arrangement method, and placement position of the embedded components 12 and 12' disposed in the silicone layer 40 can be set more freely.

[0242] Furthermore, by using the adhesive structure of adhesive 62 to position the embedded component 12′ relative to the one-piece molded article 20′, the surface shape of the one-piece molded article 20′ can be simplified. Moreover, by using silicone adhesive 62, the silicone layer 40 that is subsequently molded and polymerized can be integrated with adhesive 62, thereby making the boundary between the silicone layer 40 and adhesive 62 substantially disappear.

[0243] The above describes several specific embodiments of the present invention, but the present invention is not to be interpreted in a limited way by the specific descriptions in the above embodiments.

[0244] For example, the contact lens 10 with the implantation component 12 embedded can provide well-known soft contact lenses or rigid contact lenses that are worn overlapping on the cornea, but it can also provide a scleral lens with the lens edge located on the sclera outside the cornea. In a scleral lens, the size of the area covering the sclera can be arbitrarily set; for example, in the case of covering a large area of ​​the sclera, the outer peripheral shape of the lens edge can also be non-circular. For example, when it is desirable to accurately position the implantation component 12 on the eyeball while wearing, a scleral lens that minimizes movement on the eyeball while wearing is preferred.

[0245] Furthermore, in contact lenses 10 with embedded insertion components 12, the lens thickness tends to increase. In such cases, whether worn for multiple consecutive days or assumed for daily use, it is preferable to ensure sufficient oxygen permeability in the contact lens. Here, in the contact lenses 10 described in the above embodiments, a silicone layer 40 composed of silicone-based materials with high oxygen permeability, such as silicone (meth)acrylate monomers or silicone macromolecular monomers, is used, thereby easily ensuring high oxygen permeability. In particular, using RGP (Rubber Gel Permeable) as the front and back surface layers of the lens ensures the positioning accuracy of the insertion components and further improves the oxygen permeability of the contact lens 10.

[0246] In particular, in the central portion of the lens located on the cornea when worn, the thickness of the silicone layer 40 is greater than that of the front and back surface layers of the lens, thereby enabling the contact lens 10 to have higher oxygen permeability. More preferably, in the central portion offset from the implantation component, the thickness of the front and back surface layers of the lens is less than or equal to the thickness of the silicone layer 40. Alternatively, it is preferable that the total mass of the silicone layer 40, the front and back surface layers of the lens is less than or equal to the total mass of the silicone layer 40 when it is made of the same rigid lens material as the front and back surface layers of the lens, which is 99% or less, more preferably less than or equal to 97.5%.

[0247] Here, we will examine the issue more specifically. Considering the typical oxygen permeability of RGP lenses, it is difficult to achieve the recommended oxygen permeability (Dk value) level for everyday use using a single-layer RGP structure when the maximum lens thickness in the central portion exceeds 0.4 mm for RGP lens materials with a Dk value around 100. Similarly, it is difficult to achieve the same level of oxygen permeability (Dk value around 170) when the maximum lens thickness in the central portion exceeds 0.7 mm for RGP lens materials. Therefore, depending on the lens material, it is more significant to adopt a layered structure as described in the various embodiments with the silicone layer 40 for contact lenses 10 with a maximum lens thickness in the central portion greater than 0.4 mm or greater than 0.7 mm. Furthermore, it is effective to keep the combined thickness of the front and back surface layers of the RGP lens in the central portion of the contact lens 10 below 0.4 mm or 0.7 mm, depending on the lens material. Preferably, the silicone layer 40 actively ensures the lens thickness required for the embedding of the implantation component 12.

[0248] Furthermore, in the peripheral portion of the contact lens 10, especially the outer peripheral portion where the lens thickness decreases, the lens may deviate from the cornea to the outer periphery in a scleral lens, and there is almost no problem with oxygen permeability. Therefore, it can also be a single structure of RGP material consisting of the front surface layer and / or the back surface layer of the lens without the silicone layer 40 sandwiched in.

[0249] Furthermore, in the contact lens 10 of the above embodiment, the front and rear surfaces of the silicone layer 40 are covered by a lens front surface layer and a lens rear surface layer made of RGP or the like, preventing direct contact between the silicone layer 40 and the biological surface (cornea, eyelid) during wear. Therefore, excellent oxygen permeability can be achieved through the silicone layer 40, and the reduction in wearing comfort caused by the hydrophobicity of the silicone layer 40 and its adhesion to the biological surface can be avoided. A good lens wearing comfort is achieved based on the hydrophilicity and lubricity of RGP or the like. Of course, in cases such as scleral lenses, where the central portion of the lens floats above the corneal surface to form a tear film during wear, thus preventing direct contact between the lens rear surface and the corneal surface, the silicone layer 40 can also be exposed in the central portion of the lens rear surface without causing significant problems.

[0250] Furthermore, in the contact lens 10 of the above embodiment, the separately manufactured implantation component 12 is assembled into the first molding molds 14 and 14'. However, the implantation component 12 only needs to be positioned in the first molding molds 14 and 14'. For example, a portion or the entire implantation component 12 can be formed on the surface of the first molding mold 14 by printing, plating, or the like, thereby positioning and supporting it in the first molding mold 14 while forming the implantation component 12. Alternatively, the implantation component 12 can be disposed in the molding cavity of the first molding mold 14, and the surface of the implantation component 12 can be fixed to the first molding mold 14 during molding, so that the implantation component 12 partially enters the first molding mold 14 and is fixed therein. Alternatively, a metal plate can be partially embedded and fixed to the first molding mold 14, and the implantation component 12 can be formed relative to the surface of the metal plate by plating, sputtering, or the like. Or, a separately prepared implantation component 12 can be mechanically fixed to the metal plate by riveting or the like.

[0251] In addition, in the contact lens 10 of the above embodiment, both the front surface and the back surface of the lens are molded surfaces, but for example, at least one of the front and back surfaces of the lens can also be partially or entirely finished by cutting.

[0252] Furthermore, while the above embodiments illustrate the application of the present invention to contact lenses, the present invention is not limited to contact lenses. For example, it can also be applied to intraocular lenses, eyeglasses, goggles, and other ophthalmic devices.

[0253] Other examples are not listed here, but the present invention can be implemented in various ways with modifications, alterations, improvements, etc., based on the knowledge of those skilled in the art. Furthermore, it goes without saying that such implementation methods are included within the scope of the present invention as long as they do not depart from the spirit of the present invention.

[0254] Explanation of reference numerals in the attached figures

[0255] 10…contact lens; 12…implantation component; 12′…implantation component (sixth embodiment); 14…first molding die; 14′…first molding die (sixth embodiment); 16…first molding cavity; 18…first molding material; 20…one-piece molded article; 20′…one-piece molded article (second, fourth, and sixth embodiments); 22…concave molding surface (first molding die); 22′…convex molding surface (second, fourth, and sixth embodiments); 24…convex molding surface (component support surface molding die); 24′…concave molding surface (component support surface molding die); Surface (second, fourth, and sixth embodiments); 26…support surface molding die; 30…engaging part; 30′…engaging part (sixth embodiment); 32…silicone-containing material; 34…intermediate molding die; 36…silicone molding cavity; 38…intermediate molded product; 40…silicone layer; 44…second molding material; 46…covering layer; 46′…covering layer (second and fourth embodiments); 50…second molding die; 52…second molding cavity; 54…convex molding surface (second molding die); 60…edge covering layer; 62…adhesive.

Claims

1. A method for manufacturing an ophthalmic device, characterized in that, The manufacturing process of an ophthalmic device having at least one non-specific component embedded in it includes the following steps: A one-piece molded article having a positioning surface for positioning the dissimilar element is formed and polymerized using a first molding material; and On the positioning surface where the heterogeneous element is positioned in the one-piece molded article, a silicone-containing material is molded and polymerized to form a silicone layer, thereby obtaining a composite molded article in which the heterogeneous element is embedded in the silicone layer.

2. The method for manufacturing an ophthalmic device according to claim 1, characterized in that, It includes the following processes: Another molded article is formed and polymerized by using a second molding material, which is superimposed on the primary molded article via the silicone layer; and The silicone layer is formed by molding and polymerizing the silicone-containing material between opposing surfaces formed by overlapping the positioning surfaces of the other molded article and the positioning surfaces of the dissimilar element in the primary molded article.

3. The method for manufacturing an ophthalmic device according to claim 1, characterized in that, It includes the following processes: On the positioning surface where the heterogeneous element is positioned in the one-piece molded article, a silicone-containing material is molded and polymerized to form a silicone layer, and then a cover layer covering the silicone layer is molded and polymerized by a second molding material.

4. The method for manufacturing an ophthalmic device according to any one of claims 1 to 3, characterized in that, The entire structure is covered in such a way that the silicone layer is not exposed to the outside.

5. The method for manufacturing an ophthalmic device according to any one of claims 1 to 4, characterized in that, The positioning surface of the one-piece molded article has a concave spherical shell shape. The one-piece molded article is held in a state where the concave spherical shell shape is open vertically upward, and the silicone-containing material is injected into the positioning surface.

6. The method for manufacturing an ophthalmic device according to any one of claims 1 to 4, characterized in that, The positioning surface of the one-piece molded article has a spherical convex shape. With the positioning surface facing vertically downward, the one-piece molded article is immersed in the stored silicone-containing material, thereby molding and polymerizing the silicone-containing material on the surface of the positioning surface of the one-piece molded article.

7. The method for manufacturing an ophthalmic device according to any one of claims 1 to 6, characterized in that, The surface layer covering the silicone layer is subjected to cutting-based finishing.

8. The method for manufacturing an ophthalmic device according to any one of claims 1 to 7, characterized in that, In the surface layer covering the silicone layer, at least a portion is a molded surface based on a molding die.

9. The method for manufacturing an ophthalmic device according to any one of claims 1 to 8, characterized in that, When positioning the dissimilar component relative to the positioning surface in the one-piece molded article, attachment is used.

10. The method for manufacturing an ophthalmic device according to claim 9, characterized in that, The dissimilar components are attached to the positioning surface of the one-piece molded article by using a silicone adhesive.

11. The method for manufacturing an ophthalmic device according to claim 9, characterized in that, The dissimilar element is formed on the positioning surface in the one-piece molded article for attachment.

12. The method for manufacturing an ophthalmic device according to any one of claims 1 to 11, characterized in that, When positioning the dissimilar component relative to the positioning surface in the one-piece molded article, a snap-fit ​​structure is used.

13. The method for manufacturing an ophthalmic device according to any one of claims 1 to 9, 11, and 12, characterized in that, When positioning the dissimilar component relative to the positioning surface in the one-piece molded article, the dissimilar component is positioned without the use of adhesive.

14. The method for manufacturing an ophthalmic device according to any one of claims 1 to 13, characterized in that, When the composite molded article is obtained, the silicone-containing material is inserted between the positioning surface of the primary molded article and the foreign component, and the foreign component is covered with the silicone layer.

15. The method for manufacturing an ophthalmic device according to any one of claims 1 to 14, characterized in that, The heterogeneous component is made of a material harder than the one-piece molded product.

16. The method for manufacturing an ophthalmic device according to claim 15, characterized in that, The heterogeneous component is an electrical component that includes a metal portion.

17. A method for manufacturing an ophthalmic device according to any one of claims 1 to 16, characterized in that, Used to manufacture contact lenses, including scleral lenses.

18. A method for manufacturing an ophthalmic device, characterized in that, It includes the following processes: The first molding material is molded and polymerized by the first molding cavity defined by the first molding mold to obtain a one-time molded product with a positioning surface for positioning the dissimilar component; The second molding material is molded and polymerized in the second molding cavity defined by the second molding mold to obtain another molded product; as well as Between the opposing surfaces formed by overlapping the positioning surfaces of the other molded article and the primary molded article where the dissimilar element is positioned, a silicone-containing material is molded and polymerized to form a silicone layer, thereby obtaining a composite molded article in which the dissimilar element is embedded in the silicone layer.

19. A method for manufacturing an ophthalmic device, characterized in that, It includes the following processes: The first molding material is molded and polymerized by the first molding cavity defined by the first molding mold to obtain a one-time molded product with a positioning surface for positioning the dissimilar component; The first molding mold is opened, and the intermediate molding cavity is defined by side-closing the intermediate molding mold with the positioning surface of the primary molded product remaining in the first molding mold. The silicone-containing material is molded and polymerized to form a silicone layer, thereby obtaining a composite molded product in which the heterogeneous element positioned on the positioning surface is embedded in the silicone layer. as well as The intermediate molding mold is removed, and the second molding material is molded and polymerized by making the second molding mold close to the silicone layer side of the composite molded article remaining in the first molding mold, thereby forming a cover layer covering the silicone layer from the opposite side of the primary molded article.

20. The method for manufacturing an ophthalmic device according to any one of claims 2, 3, 18, and 19, characterized in that, Both the first molding material and the second molding material are rigid lens materials.

21. An ophthalmic device, characterized in that, is an ophthalmic device in which at least one heterogeneous element is embedded, In contrast to the silicone layer located in the middle portion of the thickness direction, front and rear layers made of oxygen-permeable rigid lens material are provided on both sides of the thickness direction. The heterogeneous element is positioned in at least one of the front layer and the rear layer, and the heterogeneous element is embedded in the silicone layer.

22. The ophthalmic device according to claim 21, characterized in that, The silicone layer is entirely covered by the front layer and the rear layer.

23. The ophthalmic device according to claim 21 or 22, characterized in that, The heterogeneous element is positioned by attaching it to at least one of the front layer and the rear layer.

24. The ophthalmic device according to claim 23, characterized in that, The heterogeneous element is attached to at least one of the front layer and the rear layer by bonding with a silicone adhesive.

25. The ophthalmic device according to any one of claims 21 to 24, characterized in that, In the portion of the heterogeneous element that is off-center, the thickness of the front layer and the rear layer is less than 1 / 2 of the thickness of the silicone layer.

26. The ophthalmic device according to any one of claims 20 to 24, characterized in that, The total mass of the silicone layer, the front layer, and the rear layer is less than 99% of the total mass of the rigid lens material when the silicone layer is made of the same material as the front layer.

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