TWI758937B - Contact lenses for intraocular pressure monitoring and manufacturing method thereof - Google Patents

Abstract

The invention discloses a contact lens for intraocular pressure monitoring, comprising an outer lens layer, an adhesive layer and an inner lens layer, wherein the elastic modulus of the outer lens layer is greater than the elastic modulus of the inner lens layer, and the elastic modulus of the outer lens layer is greater than 0.8 MPa and less than 1.7 MPa, the elastic modulus of the inner lens layer is not less than 0.2 MPa and not more than 0.8 MPa, and the difference between the degree of swelling of the outer lens layer and the inner lens layer is in the range of 0% to 1%. The outer lens layer and the inner lens layer are respectively provided with a first pattern layer and a second pattern layer, wherein the second pattern layer will appear relative deviation with the fixed first pattern layer with the change of intraocular pressure to achieve the purpose of intraocular pressure monitoring.

Description

Contact lens for intraocular pressure monitoring and method of making the same

The present invention relates to a contact lens, and in particular to a contact lens for intraocular pressure monitoring.

Intraocular pressure is the balanced pressure exerted by the eyeball on the wall of the eyeball. Generally, a constant pressure is maintained in a healthy eye so that the photoreceptor optic nerve system of the retina can function normally. When the intraocular pressure rises, the eyes will be sore or see the symptoms of rainbow halo; when the situation is aggravated, there will be eye swelling, headache and other phenomena. Long-term high intraocular pressure will cause optic nerve atrophy and lesions due to compression of the optic nerve, resulting in symptoms such as decreased vision and reduced visual field, resulting in the formation of glaucoma, which is currently the main cause of acquired blindness in humans. However, in the early stage of glaucoma, there are often no obvious symptoms, so the optic nerve is often found to have lost function. Therefore, long-term IOP measurement is necessary, especially in groups with high glaucoma risk factors such as high myopia, hypertension, obesity, or a family history of glaucoma, which requires close monitoring. In addition, glaucoma patients can avoid deterioration or even blindness by monitoring the intraocular pressure for a long time.

The current methods for monitoring intraocular pressure mainly use piezoresistive tonometers or non-contact optical instruments to measure eye pressure on a regular but single-time basis, which cannot be monitored for a long time. For long-term monitoring, existing technologies can be achieved by implanting microchips or microfluidic sensors in the patient's eye, or using resistive or capacitive It is achieved by a non-invasive intraocular pressure sensing element. However, the former requires implantation of chips or sensors through ophthalmic surgery, which is of high risk; while the operating principle of the latter is to confirm the change in resistance or capacitance due to changes in intraocular pressure through a non-invasive sensing element, and through the back-end signal processing, the procedures are complicated and there are many sources of interference.

In view of this, there is a need for a new simple and suitable for long-term intraocular pressure monitoring contact lenses.

An object of the present invention is to provide a contact lens for intraocular pressure sensing for monitoring intraocular pressure changes. The eye pressure sensing contact lens of the present invention adopts the outer lens layer and the inner lens layer to be laminated. Due to the difference in tensile modulus between the inner lens layer and the outer lens layer, when wearing, the inner lens layer changes due to the intraocular pressure of the eyeball. As a result of the deformation, the pattern of the inner lens layer and the pattern of the outer lens layer are deviated, so the variation of the intraocular pressure can be evaluated by monitoring the deviation of the patterns.

The intraocular pressure sensing contact lens of the present invention comprises: an outer lens layer, the outer lens layer includes a first optical zone corresponding to the cornea area and a first peripheral area having a first pattern and corresponding to the area outside the cornea area , and the outer lens layer has a first outer surface and a first inner surface opposite to each other, the first pattern is located on the first outer surface or the first inner surface, and the stretching mold of the outer lens layer The number is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer comprising a second optical zone corresponding to the corneal region and a second peripheral region having a second pattern and corresponding to the region outside the corneal region, and The inner lens layer has an opposite second outer surface and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than that of the outer lens layer modulus and not less than 0.2MPa and not more than 0.8MPa; and an adhesive layer disposed between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and the adhesive layer and the The first inner surface of the outer lens layer is adjacent to the second outer surface of the inner lens layer to bond the outer lens layer and the inner lens layer, wherein the first pattern and the second pattern are overlapped with each other or set a deviation of a A predetermined distance or a predetermined angle d.

A preferred embodiment of the contact lens for intraocular pressure monitoring according to the present invention, wherein the tensile modulus ratio of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5, and the outer lens layer to the inner lens The difference in swelling and shrinkage of the layers is between 0% and 1%.

A preferred embodiment of the contact lens for intraocular pressure monitoring according to the present invention, wherein the first pattern is located on the first outer surface of the outer lens layer or the first inner surface adjacent to the adhesive layer, and the first pattern is located on the first outer surface of the outer lens layer or the first inner surface adjacent to the adhesive layer. Two patterns are located on the second outer surface adjacent to the inner lens layer and the adhesive layer.

According to a preferred embodiment of the contact lens for intraocular pressure monitoring of the present invention, the second inner surface of the inner lens layer directly contacts the eyeball, and when the inner lens layer is deformed with the change of intraocular pressure, the second pattern Changes also occur, and the outer lens layer is not in contact with the eyeball and has a higher tensile modulus, which is not easy to deform, so the pattern of the second pattern that causes the deformation and the pattern of the first pattern of the outer lens layer appear for The relative position deviation or angular deviation detected by the naked eye or the instrument can be used to evaluate the change of intraocular pressure.

According to a preferred embodiment of the contact lens for intraocular pressure monitoring of the present invention, the adhesive layer is for bonding the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer to maintain the outer lens The bonding between the layer and the inner lens layer and the deformation space of the inner lens layer is reserved. In another preferred embodiment of the contact lens of the present invention, the adhesive layer is outside the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer, not the first and second peripheral regions The part preferably also contains an adhesive layer, but does not completely fill the space between the outer lens layer and the inner lens layer, so as to retain the deformation space of the inner lens layer, but maintain the adhesion stability between the outer lens layer and the inner lens layer.

According to a preferred embodiment of the present invention, the contact lens for intraocular pressure monitoring as described above, wherein the occupied area of the adhesive layer starts from the outer edge of the first peripheral area of the outer lens layer and ends at the outer edge of the outer lens layer. The axis of the lens layer is extrapolated from a position between 10% and 95% of the diameter of the outer lens layer.

Another object of the present invention is to provide a method of manufacturing a contact lens for intraocular pressure monitoring, comprising the steps of: providing an outer lens layer, the outer lens layer comprising a first optical zone corresponding to the corneal region and a the first pattern and corresponding to the first periphery of the area other than the corneal area of the eyeball area, and the outer lens layer has a first outer surface and a first inner surface opposite to each other, the first pattern is located on the first outer surface or the first inner surface, and the stretching of the outer lens layer The modulus is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer is provided, the inner lens layer contains a second optical zone corresponding to the corneal region and a second peripheral region having a second pattern and corresponding to the region outside the corneal region , and the inner lens layer has an opposite second outer surface and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than that of the outer lens layer The tensile modulus is not less than 0.2MPa and not more than 0.8MPa; an adhesive layer composition is provided, and the adhesive layer composition is printed on the first inner surface of the outer lens layer and/or the inner lens layer. the second outer surface; and aligning the outer lens layer and the inner lens layer, so that the adhesive layer composition forms an adhesive layer on the first inner surface of the outer lens layer and the first inner surface of the inner lens layer Between two outer surfaces, and the adhesive layer is adjacent to the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, the outer lens layer and the inner lens layer are bonded by the adhesive layer The lens layer completes the manufacture of the contact lens for intraocular pressure monitoring; wherein, the first pattern and the second pattern are overlapped with each other or offset by a predetermined distance or a predetermined angle d.

According to a preferred embodiment of the present invention, the method for manufacturing a contact lens for intraocular pressure monitoring as described above, wherein the manufacturing steps of the outer lens layer include: providing a first composition and a pattern colorant composition; The first composition is placed in a contact lens mold, the first composition is cured to form an outer lens layer body, the outer lens layer body has a first outer surface and a first inner surface opposite to each other; and the The pattern colorant composition is printed on the first outer surface or the first inner surface of the outer lens layer body to form a first pattern on the outer lens layer body, and the fabrication of the outer lens layer is completed.

According to a preferred embodiment of the present invention, the above-mentioned method for manufacturing a contact lens for intraocular pressure monitoring, wherein the manufacturing step of the inner lens layer comprises: providing a second composition and a pattern colorant composition; The second composition is placed in a contact lens mold, and the second composition is cured to form an inner lens layer body, the inner lens layer body having a second outer surface and a second inner surface opposite to each other; to and printing the pattern colorant composition on the second outer surface of the inner lens layer body to form a second pattern on the inner lens layer body to complete the manufacture of the inner lens layer.

According to a preferred embodiment of the present invention, in the method for manufacturing a contact lens for intraocular pressure monitoring as described above, the steps of curing the first and second compositions may be heat curing, light curing or microwave curing, respectively.

According to the method for manufacturing a contact lens for intraocular pressure monitoring according to a preferred embodiment of the present invention, the printing methods of the first pattern and the second pattern can be inkjet printing, laser printing, Pad printing or transfer printing.

According to a preferred embodiment of the present invention, the method for manufacturing a contact lens for intraocular pressure monitoring as described above, the printing of the adhesive layer is inkjet printing, laser printing, pad printing ( pad printing) or transfer printing.

According to a preferred embodiment of the present invention, in the method for manufacturing a contact lens for intraocular pressure monitoring as described above, the outer lens layer and the inner lens layer are aligned and adhered so that the pattern of the first pattern and the pattern of the second pattern are The patterns overlap or are set to deviate by a predetermined distance or a predetermined angle d.

The above summary is intended to provide a simplified summary of the disclosure to provide the reader with a basic understanding of the disclosure. This summary is not an exhaustive overview of the disclosure, and it is not intended to identify key/critical elements of embodiments of the invention or to delineate the scope of the invention. After referring to the following embodiments, those with ordinary knowledge in the technical field to which the present invention pertains can easily understand the basic spirit of the present invention, as well as the technical means and implementation aspects adopted by the present invention.

10, 310a, 310b: Contact lenses for intraocular pressure monitoring

10a: Optical Zone

10b: Surrounding area

11: Eyeballs

111: Corneal area of the eye

113: Area outside the cornea area of the eye

21, 321a, 321b: outer lens layer

210a: First Optical Zone

210b: First peripheral area

211: First outer surface

213: First inner surface

22, 322a, 322b: the first pattern

23: Adhesive layer

24, 324a, 324b: the second pattern

25, 325a, 325b: inner lens layer

250a: Second Optical Zone

250b: Second Perimeter

251: Second outer surface

253: Second inner surface

d: Set the distance or angle of the deviation

1 is a schematic diagram of a contact lens 10 having an optical zone 10a and a peripheral zone 10b for intraocular pressure monitoring corresponding to the position of the eyeball 11 according to an embodiment of the present invention.

2A to 2B are a schematic cross-sectional view and a top view of a contact lens 10 for intraocular pressure monitoring drawn according to an embodiment of the present invention, respectively.

3A is a schematic diagram of the alignment of the outer lens layer 321a and the inner lens layer 325a of the contact lens 310a used for intraocular pressure monitoring according to another embodiment of the present invention; FIG. 3B is drawn according to another embodiment of the present invention. A schematic diagram of the alignment of the outer lens layer 321b and the inner lens layer 325b of the contact lens 310b used for intraocular pressure monitoring.

4A-4C are schematic diagrams of the first patterns 322a and 322b and the second patterns 324a and 324b of the contact lens 310 for intraocular pressure monitoring drawn according to another embodiment of the present invention.

In order to make the description of the disclosure of the present invention more detailed and complete, the following provides an illustrative description for the embodiments and specific embodiments of the present invention; but this is not the only form of implementing or using the specific embodiments of the present invention. The embodiments disclosed below can be combined or substituted with each other under beneficial circumstances, and other embodiments can also be added to one embodiment without further description or explanation.

The advantages, features and technical means of achieving the present invention will be more easily understood by being described in more detail with reference to the exemplary embodiments, and the present invention may be implemented in different forms, so it should not be construed as limited to the embodiments set forth herein. On the contrary, to those skilled in the art, the provided embodiments will make the present disclosure more thorough, complete and complete to convey the scope of the present invention, and the present invention will only be covered by the appended claims. definition.

Unless otherwise defined, all terms (including technical and scientific terms) and proper nouns used hereinafter have substantially the same meaning as commonly understood by those skilled in the art to which this invention belongs, and, for example, Those terms defined by the dictionary used should be construed to have meanings consistent with those in the relevant art, and should not be construed in an overly idealized or overly formal meaning unless clearly defined hereinafter.

Furthermore, the term "tensile modulus" as used herein refers to a mathematical description of the elastic deformation of a material when a force is applied to it, and is defined as the ratio of stress to the strain of the material after being subjected to the force. "Swelling and shrinkage ratio" refers to the ratio of the size change of a polymer substance in a solvent due to the entry of solvent molecules into the molecular chains.

The contact lens for intraocular pressure monitoring of the present invention will be described below by way of diagrams. First, please refer to FIG. 1 and FIGS. 2A-2B. As shown in FIG. 1 , the contact lens 10 for intraocular pressure monitoring of the present invention includes an optical zone 10a corresponding to the corneal region 111 of the eyeball 11 and a peripheral region 10b corresponding to the region 113 outside the corneal region 111 of the eyeball 11 . As also shown in FIG. 2A , the contact lens 10 for intraocular pressure monitoring of the present invention sequentially includes an outer lens layer 21 , an adhesive layer 23 and an inner lens layer 25 directly contacting the eyeball. The outer lens layer 21 includes a first optical zone 210a corresponding to the corneal area 111 and a first peripheral area 210b corresponding to the area 113 outside the cornea area 111, and the outer lens layer has a first outer lens opposite to each other. surface 211 and a first inner surface 213; the inner lens layer 25 includes a second optical zone 250a corresponding to the corneal area 111 and a second peripheral area 250b corresponding to the area 113 outside the corneal area 111, and the inner lens layer 25 has a second outer surface 251 and a second inner surface 253 opposite to each other. Further as shown in FIG. 2B , the outer lens layer 21 and the inner lens layer 25 respectively have a first pattern 22 and a second pattern 24 for intraocular pressure monitoring in the first peripheral area 210b and the second peripheral area 250b.

In a preferred embodiment of the present invention, the tensile modulus of the outer lens layer 21 is greater than 0.8 MPa and less than 1.7 MPa, and the tensile modulus of the inner lens layer 25 is smaller than the tensile modulus of the outer lens layer 21 and not less than 0.2 MPa and not more than 0.8MPa. The contact lens 10 used for intraocular pressure monitoring adopts the outer lens layer 21 and the inner lens layer 25 to be superimposed. Due to the difference in tensile modulus between the inner lens layer 25 and the outer lens layer 21, when wearing, the inner lens layer 25 will The eyeball's intraocular pressure changes and deforms. When the tensile modulus of the outer lens layer 21 is too low, it cannot provide the outer lens layer 21 with resistance to deformation and the support of the contact lens 10 as a whole; When the tensile modulus of the 25 layers of the inner lens is too low, the material cannot be formed independently; if it is too high, the deformability is insufficient.

In a preferred embodiment of the present invention, the tensile modulus ratio of the outer lens layer 21 to the inner lens layer 25 is greater than 1 and less than 4.5, and the difference in expansion and shrinkage is between 0% and 1%. Within the defined range of the ratio of tensile modulus and the difference between the expansion and shrinkage ratios of the outer lens layer 21 to the inner lens layer 25, the inner lens layer 25 of the contact lens 10 can interact with the outer lens layer when the eyeball is deformed due to intraocular pressure. 21 produces a difference in deformation, and the outer lens layer 21 and the inner lens layer 25 can be well bonded by the adhesive layer 23 without peeling.

Next, please refer to FIGS. 3A and 3B . 3A is a schematic diagram illustrating the alignment of the outer lens layer 321a and the inner lens layer 325a of a contact lens 310a for intraocular pressure monitoring according to another embodiment of the present invention; FIG. 3B is a schematic diagram illustrating another embodiment of the present invention. A schematic diagram of the alignment of the outer lens layer 321b and the inner lens layer 325b of the contact lens 310b for pressure monitoring. In FIG. 3A, the first pattern 322a and the second pattern 324a overlap each other during the initial alignment; in FIG. 3B, the pattern of the first pattern 322b and the pattern of the second pattern 324b are set to a predetermined deviation during the initial alignment distance or a predetermined angle d.

Further referring to FIGS. 4A-4C , the patterns of the first patterns 322a and 322b and the second patterns 324a and 324b suitable for the contact lenses 310a and 310b for intraocular pressure monitoring according to embodiments of the present invention may be the same or different, respectively. It is composed of sub-graphics, and the appearance of the sub-graphics is not limited, such as but not limited to lines as shown in FIG. 4A , or concentric circles as shown in FIG. 4B , or geometric patterns as shown in FIG. 4C , or the like. Combination, as long as the inner lens layer 325a or 325b deforms with the change of intraocular pressure, it can be observed that the patterns of the second patterns 324a and 324b and the patterns of the first patterns 322a and 322b produce relative positional deviation or angular deviation respectively.

The contact lenses 310a and 310b used for intraocular pressure monitoring use outer lens layers 321a and 321b to overlap with inner lens layers 325a and 325b respectively. When wearing, the inner lens layers 325a and 325b change due to changes in the intraocular pressure of the eyeball. Deformation occurs, causing the second patterns 324a and 324b of the inner lens layers 325a and 325b and the first patterns 322a and 322b of the outer lens layers 321a and 321b, respectively, to have relative positional deviation or angular deviation that can be recognized by the naked eye or detected by an instrument. Therefore, Changes in intraocular pressure can be assessed by monitoring the amount of deviation.

The adhesive layer of the contact lens for intraocular pressure monitoring of the present invention is used for adhering the outer lens layer and the inner lens layer. In an embodiment of the present invention, as shown in FIG. 2A , the adhesive layer 23 of the contact lens 10 used for intraocular pressure monitoring can adhere to the first peripheral region 210 b of the first inner surface 213 of the outer lens layer 21 and the inner lens The second peripheral region 250b of the second outer surface 251 of the layer 25 is preferably used to increase the adhesive stability and maintain the deformation space of the inner lens layer 25. The adhesive layer 23 can be in the shape of dots, lines, regular or irregular geometric shapes Distributed between the inner lens layer 25 and the outer lens layer 21 . As shown in FIG. 2B , the first pattern 22 can be located on the first outer surface 211 of the outer lens layer 21 or the first inner surface 213 adjacent to the adhesive layer 23 , and the second pattern 24 can be located on the inner lens layer 25 and the adhesive layer 23 is connected to the second outer surface 251.

The occupied area of the adhesive layer 23 starts from the outer edge of the first peripheral area of the outer lens layer 21 and ends at the outer lens with an extrapolation distance from the axis of the outer lens layer 21 ranging from 10% to 95% The location of the diameter of layer 21 . If the occupied area of the adhesive layer 23 is too small, the effect of fixing the outer lens layer 21 and the inner lens layer 25 will be affected; if the occupied area is too large, the deformation ratio of the inner lens layer 25 with the change of intraocular pressure will be limited.

Another object of the present invention is to provide a method of manufacturing a contact lens for intraocular pressure monitoring, comprising the steps of: providing an outer lens layer 21 containing a first optical zone corresponding to the corneal region 111 of the eyeball 210a and a first peripheral area 210b having the first pattern 22 and corresponding to the area 113 outside the cornea area 111 of the eyeball, and the outer lens layer 21 has a first outer surface 211 and a first inner surface 213 opposite to each other, the The first pattern 22 is located on the first outer surface 211 or the first inner surface 213, and the tensile modulus of the outer lens layer 21 is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer 25 is provided, the inner lens layer 25 The layer 25 includes a second optical zone 250a corresponding to the corneal area 111 and a second peripheral area 250b having the second pattern 24 and corresponding to the area 113 outside the corneal area 111, and the inner lens layer 25 has an opposite first optical zone 250b. Two outer surfaces 251 and a second inner surface 253, the second pattern 24 is located on the second outer surface 251, and the tensile modulus of the inner lens layer 25 is smaller than the tensile modulus of the outer lens layer 21, and not less than 0.2MPa and not more than 0.8MPa; provide an adhesive layer composition, and print the adhesive layer composition on the first inner surface 213 of the outer lens layer 21 and/or the first inner surface of the inner lens layer 25 Two outer surfaces 251; with and aligning the outer lens layer 21 and the inner lens layer 25 , so that the adhesive layer composition forms an adhesive layer 23 on the first inner surface 213 of the outer lens layer 21 and the first inner surface 213 of the inner lens layer 25 Between the two outer surfaces 251 , the adhesive layer 23 is adjacent to the first inner surface 213 of the outer lens layer 21 and the second outer surface 251 of the inner lens layer 25 , and the adhesive layer 23 is used for bonding The outer lens layer 21 and the inner lens layer 25 complete the manufacture of the contact lens 10 for intraocular pressure monitoring; wherein, the first pattern 22 and the second pattern 24 overlap each other or are offset by a predetermined distance or a predetermined angle d.

According to an embodiment of the manufacturing method of the present invention, the manufacturing steps of the outer lens layer 21 include: providing a first composition and a pattern colorant composition; placing the first composition in a contact lens mold (not shown). ), curing the first composition to form an outer lens layer body (not shown), the outer lens layer body having a first outer surface 211 and a first inner surface 213 opposite to each other; and the pattern color The material composition is printed on the first outer surface 211 or the first inner surface 213 of the outer lens layer body to form a first pattern 22 on the outer lens layer body, and the fabrication of the outer lens layer 21 is completed.

According to an embodiment of the manufacturing method of the present invention, the manufacturing steps of the inner lens layer 25 include: providing a second composition and a pattern colorant composition; placing the second composition in a contact lens mold (not shown) , the second composition is cured to form an inner lens layer body (not shown), the inner lens layer body has a second outer surface 251 and a second inner surface 253 opposite to each other; and the pattern colorant The composition is printed on the second outer surface 251 of the inner lens layer body to form a second pattern 24 on the inner lens layer body, and the fabrication of the inner lens layer 25 is completed.

According to an embodiment of the manufacturing method of the present invention, the aforementioned first and second compositions for forming the outer lens layer 21 and the inner lens layer 25 can be formed by curing a hydrogel composition or a silicone hydrogel composition. The hydrogel composition includes, for example, but not limited to, hydrophilic monomers, cross-linking agents, and initiators. The silicone hydrogel composition may include, for example, but not limited to, polysiloxane macromers, hydrophilic monomers, cross-linking agents, and initiators.

One or more hydrophilic monomers, such as glycidyl methacrylate (GMA), 2- Hydroxyethyl ester (HEMA), N-vinylpyrrolidone (NVP), N,N-dimethylacrylamide (DMA), methacrylic acid (MAA), hexafluoroisopropyl methacrylate (HFMA), etc. . Suitable cross-linking agents in the composition of the lens layers may be, for example, glycerol dimethacrylate (GDMA), ethylene glycol dimethacrylate (EGDMA), trimethylolpropane triacrylate (TMPTA), tetra Ethylene glycol dimethacrylate (TrEGDMA), triethylene glycol dimethacrylate (TEGDMA), trimethylolpropane trimethacrylate (TMPTMA), polyethylene glycol dimethacrylate (PEGDMA) ), vinyl methacrylate, ethylenediamine dimethyl acrylamide, glycerol dimethacrylate, triallyl isocyanurate, triallyl cyanurate, or a combination of the above to make it high The molecular chains are interlaced and combined to adjust the strength, so as to prepare the lens layer with the required tensile modulus and expansion and shrinkage ratio of the lens layer of the present invention. Suitable initiators in the hydrogel composition may be thermal initiators or photoinitiators. The thermal initiator can be, for example, but not limited to, azobisisoheptanenitrile (ADVN), 2,2'-azobisisobutyronitrile (AIBN), 2,2'-azobis(2,4-bis(2,4-bis) Methyl)valeronitrile, 2,2'-azobis, 2,2'-azobis(2-methyl-butyronitrile), or benzyl peroxide; photoinitiators may include, but Not limited to 2,4,6-trimethylbenzyl-diphenylphosphine oxide, 2-hydroxy-2-methylphenylpropan-1-one, 2,4,6-trimethylbenzyl ethyl phenylphosphonate, or 2,2-diethoxyacetophenone, etc.

The foregoing methods of producing outer lens layer 21 and inner lens layer 25 using contact lens mold molding are generally well known to those skilled in the art. The manufacturing method of the present invention is not limited to any particular mold forming method.

According to one embodiment of the manufacturing method of the present invention, the aforementioned curing procedure refers to curing (eg, UV radiation, ion radiation (eg, γ-ray or X-ray radiation), microwave radiation, etc.) by heating, light irradiation, etc. (eg, cross-linking or polymerization).

According to an embodiment of the manufacturing method of the present invention, the printing of the first pattern 22 and the second pattern 24 can be performed by using known printing techniques, such as inkjet printing, laser printing, but not limited to. printing), pad printing or transfer printing. The first pattern 22 can be printed on the first outer surface 211 or the first inner surface 213 of the outer lens layer 21, while the second pattern is printed on the first outer surface 211 or the first inner surface 213 of the outer lens layer 21. Brush onto the second outer surface 251 of the inner lens layer 25 , preferably the first pattern 22 is printed on the first inner surface 213 of the outer lens layer 21 , and the second pattern 24 is printed on the first inner surface 213 of the inner lens layer 25 . Two outer surfaces 251 .

The adhesive composition suitable for the adhesive layer 23 of the outer lens layer 21 and the inner lens layer 25 of the present invention may comprise at least one hydrophilic monomer, a tackifier, a cross-linking agent and an initiator. Suitable hydrophilic monomers, cross-linking agents and initiators are the same as those used in the preparation of the hydrogel composition, and the suitable tackifier is polyvinylpyrrolidone or modified polyvinylpyrrolidone, wherein the modified polyvinylpyrrolidone Pyrrolidone, which is composed of vinylacetamide monomer, vinylpyrrolidone monomer and 2-hydroxyethyl methacrylate monomer after polymerization reaction, and (meth)acrylic acid-2-isocyanatoethyl ester produced by the reaction. According to an embodiment of the manufacturing method of the present invention, the printing of the adhesive layer 23 can be performed by using known printing techniques, which can be, but are not limited to, inkjet printing, laser printing, pad printing (pad printing) or transfer printing (transfer printing), it is also possible to increase the number of printing repetitions depending on the adhesion or wetting conditions or conditions on the printing of the adhesive layer 23

According to an embodiment of the manufacturing method of the present invention, the alignment and bonding of the outer lens layer 21 and the inner lens layer 25 can be selected with high alignment accuracy and can control poor bonding (for example, bonding air bubbles or internal dirt) The bonding method can be, but not limited to, manual bonding, jig bonding or automatic equipment bonding. More specifically, one of the first pattern 22 or the second pattern 24 is selected as a reference, and the pattern distribution range of the unselected pattern is overlapped with a known position relative to the pattern distribution range of the reference pattern, so that the first pattern The pattern of the pattern 22 overlaps or deviates from the distribution range of the pattern of the second pattern 24 by a known distance or angle.

The colorant composition suitable for the first and second patterns 22 and 24 of the present invention comprises at least one hydrophilic monomer, one adhesive resin, one colorant, initiator and crosslinking agent. The hydrophilic monomers, initiators and cross-linking agents used in the colorant can be those of the aforementioned hydrogel composition. Suitable adhesive resins may be, for example, polyurethane resins, acrylic resins or phenolic resins. Suitable colorants may be organic or inorganic dyes. The organic dye can be, for example, but not limited to, C.I.Reactive Yellow 14, C.I.Reactive Orange 7, C.I.Reactive Red 23. C.I. Reactive Blue 19. Inorganic dyes can be, for example, but not limited to, black iron oxide, brown iron oxide, yellow iron oxide, red iron oxide, titanium dioxide, and the like.

The following examples are used to further illustrate the present invention, but the present invention is not limited thereto.

Example

Preparation Example 1: Preparation of Hydrogel Composition for Forming Outer Lens Layer

67.6648 g of 2-hydroxyethyl methacrylate (HEMA), 1.6408 g of ethylene glycol dimethacrylate (EDGMA) solvent, 0.0749 g of TWEEN80 (purchased from Croda International PLC, UK), 0.4053 g of azodiisobutylene Nitrile (AIBN) was mixed in 0.5936 g of glycerol as a catalyst and stirred for about 2 hours, and the product was filtered to obtain a hydrogel composition for forming an outer lens layer.

Preparation Example 2: Preparation of Silicone Hydrogel Composition for Forming Outer Lens Layer

4.44 g of isophorone diisocyanate, 0.0025 g of dibutyltin dilaurate as catalyst and 40 ml of dichloromethane were added to a round bottom flask and stirred under nitrogen atmosphere. Accurately weigh 20 grams of α-butyl-ω-[3-(2,2-(dimethylol)butoxy)propyl]polydimethylsiloxane and add it dropwise over about 1 hour in a round bottom bottle. After 12 hours of reaction, 0.0025 g of dibutyltin dilaurate and 7.2 g of polyethylene glycol monomethacrylate were additionally weighed and added dropwise to a round-bottomed flask over a period of about 1 hour. After 12 hours of reaction, a large amount of water was added to wash the formed product, and then the product was dehydrated and filtered. Next, the dichloromethane solvent was removed from the product to obtain a first polydimethylsiloxane macro.

8.88 g of isophorone diisocyanate, 0.0025 g of dibutyltin dilaurate as catalyst, and 40 ml of dichloromethane were added to a round bottom flask and stirred under nitrogen atmosphere. Accurately weigh 20 grams of the polysiloxane compound and add it dropwise to a round bottom bottle over a period of about 1 hour. After 12 hours of reaction, 0.0025 g of dibutyltin dilaurate and 14.4 g of polyethylene glycol monomethacrylate were additionally weighed and added dropwise to a round-bottomed flask over a period of about 1 hour. After 12 hours of reaction, a large amount of water was added to wash the formed product, which was then dehydrated and filtered. Next, the dichloromethane solvent was removed from the product to obtain a second polymethylsiloxane macro.

41.8 grams of the first siloxane, 6.3 grams of the second siloxane giant, 0.52 grams of azobisisoheptanenitrile (ADVN), 35.2 grams of N-vinylpyrrolidone (NVP), 14.6 grams of methacrylic acid 2- Hydroxyethyl ester (HEMA), 0.3 g of hexafluoroisopropyl methacrylate (HFMA), 0.6 g of trimethylolpropane trimethacrylate (TMPTMA), 0.68 g of 2-[3-(2H-benzotri] Azol-2-yl)-4-hydroxyphenyl]ethyl 2-methacrylate was mixed in 2 g of ethanol and stirred for about 1 hour to form a silicone hydrogel composition for forming the outer lens layer .

Preparation Example 3: Preparation of Hydrogel Composition for Forming Inner Lens Layer

66.3964 g of 2-hydroxyethyl methacrylate (HEMA), 0.2989 g of ethylene glycol dimethacrylate (EGDMA) solvent, 0.0735 g of TWEEN80 (purchased from Croda International PLC, UK), 0.3983 g of azodiisobutyl Nitrile (AIBN) was mixed in 7.9688 g of glycerol as a catalyst and stirred for about 2 hours, and the product was subjected to monomer filtration to obtain a hydrogel composition for forming an inner lens layer.

Preparation Example 4: Preparation of Silicone Hydrogel Composition for Forming Inner Lens Layer

A first polymethylsiloxane macrobody and a second polymethylsiloxane macrobody were prepared in the same manner as in Preparation Example 2.

39.8 grams of the first siloxane macro, 11.3 grams of the second siloxane macro, 0.5 grams of azobisisoheptanenitrile (ADVN), 33.5 grams of N-vinylpyrrolidone (NVP), 14.0 grams of methacrylic acid 2-Hydroxyethyl ester (HEMA), 0.3 g of hexafluoroisopropyl methacrylate (HFMA), 0.60 g of 2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl The base 2-methacrylate was mixed in 2 grams of ethanol and stirred for about 1 hour to form a silicone hydrogel composition for forming the inner lens layer.

Preparation Example 5: Preparation of Adhesive Layer Composition

55.152 g of 2-hydroxyethyl methacrylate (HEMA), 1.809 g of N-vinylpyrrolidone (NVP), 1.809 g of methacrylic acid, 0.904 g of ethylene glycol dimethacrylate (EDGMA), 0.904 g of methyl Trimethylolpropane triacrylate acrylate (TMPTMA), 36.172 grams of polyvinyl bipyridone, 0.995 grams of 5329 (purchased from Sigma-Aldrich) were mixed and stirred with a high-speed agitator for about 60 minutes before adding light starter 1.583 g of 1173 (purchased from BASF, Germany) and 0.678 g of 819 (purchased from Sigma-Aldrich, Germany) were stirred for 30 minutes to form an adhesive layer composition.

Preparation Example 6: Preparation of Pattern Colorant Composition

6.5 g of 2-hydroxyethyl methacrylate (HEMA), 4.5 g of N,N'-diethylacrylamide (DMA), 2.0 g of 2-hydroxy-2-methyl-1-phenyl-1- Acetone (trade name UV-1173, purchased from Taiwan BASF company) and 37.6 grams of black pigment (trade name Sicovit Black 85E172, purchased from Germany BASF company) were put into a ball mill (apparatus name RETSCH PM400) for grinding to form a pattern Color composition.

Example 1: Preparation of hydrogel contact lenses for intraocular pressure monitoring

The water gel composition for forming the outer lens layer formed in Preparation Example 1 was quantitatively dropped into a polypropylene mold, and cured at 80° C. for 5 hours, and then cured at 115° C. for 2 hours. After the polymerization reaction is completed, the mold and the lens body are soaked in ethanol for 1 hour, and then the formed outer lens layer body is taken out. The outer lens layer body has opposite first outer surfaces and first inner surfaces. And use the pad printing method to stick the above-mentioned color material composition with the same pattern as the first pattern on the printing plate with the pad printing glue head, and stamp it on the first inner surface of the inner arc side of the outer lens layer, and carry out light treatment. After the polymerization reaction, a water-gel outer lens layer with a first pattern is formed.

In addition, the above-mentioned color material composition is transferred onto another polypropylene mold with the same pattern as the second pattern, and photopolymerization is performed to form a second pattern. Next, the hydrogel composition for forming the inner lens layer formed in Preparation Example 3 was quantitatively dropped into the polypropylene mold and cured under the curing conditions of 80°C/5 hours and 115°C/2 hours. After the polymerization reaction is completed, the mold and the lens are soaked in ethanol for 1 hour, and then the formed inner lens layer body is taken out. The inner lens layer body has an opposite second outer surface and a second inner surface, and the second pattern is formed on the On the second outer surface, a water-gel inner lens layer with a second pattern is formed.

The obtained water-gel outer lens layer and water-gel inner lens layer were respectively tested for tensile modulus and expansion and contraction ratio according to the measurement methods described later. The results are listed in Table 1.

Next, there is a ring-shaped adhesive material on the printing plate, the distribution size of which is relative to the outer lens layer, starting from the outer edge of the first peripheral region of the outer lens layer, and finally extending from the axis of the outer lens layer to a distance of 20 % of the diameter of the outer lens layer. Using a pad printing method, the adhesive layer material is adhered with a pad printing glue head, the outer edge of the first peripheral region of the outer lens layer is aligned, and the first inner surface of the water-gel outer lens layer is stamped. Select the first pattern on the outer lens layer as a reference, and use precise alignment and lamination to make the pattern distribution of the second pattern on the inner lens layer of the water glue overlap with the pattern distribution of the first pattern, and then adhere the inner and outer lens layers of the water glue. A water gel lens layer composition is obtained.

After the water-gel lens layer composition is polymerized by light, curing and lamination of the adhesive layer can be completed. It was then subjected to a hydration procedure and sterilized at 121°C for 30 minutes to form a hydrogel contact lens for intraocular pressure monitoring.

The hydration procedure is as follows: (a) soaking in 80% alcohol for 1 hour to take out the water-gel lens layer composition: (b) soaking in 90% alcohol for 1 hour; (c) heating in 80°C pure water for 1 hour; and ( d) Equilibrate in buffer solution for 12 hours.

Example 2: Preparation of silicone hydrogel contact lenses for intraocular pressure monitoring

The outer lens layer and the inner lens layer were prepared as in Example 1, but the silicone hydrogel composition for forming an outer lens layer of Preparation Example 2 was used instead to form a silicone water gel outer lens layer with a first pattern. , and the silicone hydrogel composition for forming an inner lens layer of Preparation Example 4 is used to form a silicone hydrogel inner lens layer with a second pattern.

The obtained silicone hydrogel outer lens layer and the silicone hydrogel inner lens layer were tested for tensile modulus and expansion and shrinkage respectively according to the measurement methods described later. The results are shown in Table 1.

Next, the lens layer composition was prepared as in Example 1, except that the above-mentioned silicone hydrogel outer lens layer with the first pattern and the silicone hydrogel inner lens layer with the second pattern were used to form a silicon hydrogel for intraocular pressure monitoring. Hydrogel contact lenses.

Tensile modulus test

The lenses were hydrated according to the following hydration procedure: (a) soaked in 80% alcohol for 1 hour to take out the silicone hydrogel lens layer composition: (b) soaked in 90% alcohol for 1 hour; (c) heated in 80 ℃ pure water for 1 hour and (d) equilibrated in buffer solution for 12 hours.

After hydration, test slices with a width of 10 mm were cut from the central portion of the lens. Immerse the test sections in the buffer conditions specified in ISO18369-3 Section 4.7 at 25°C for 2 hours. At an ambient temperature of 20±5°C and a humidity of 55%±10%, the aqueous solution on the surface of the test piece was quickly removed with a long-fiber cloth, and the tensile rate was set using the testing instrument AI-3000 (manufactured by Gotech Testing Machine Inc., Taiwan). 10mm/min for tensile test. The tensile modulus is determined from the initial slope of the stress-strain curve.

Swell and shrink ratio test

The lens was measured by a contact lens measuring projector Chiltern (manufactured by Optimec Ltd., UK), and the aperture size test was carried out to obtain the lens aperture. Next, the lens will be hydrated according to the following hydration procedure: (a) soaked in 80% alcohol for 1 hour to take out the lens: (b) soaked in 90% alcohol for 1 hour; (c) heated in 80°C pure water for 1 hour and (d) equilibrated in buffer solution for 12 hours.

After hydration, the contact lens was used to measure the projector Chiltern, and the aperture size was tested to obtain the aperture of the lens after hydration. Use the following formula to calculate the expansion and shrinkage ratio: Swelling and shrinkage ratio = (lens diameter after hydration - lens diameter) / lens diameter × 100 (%)

Table 1: Measurement results of tensile modulus and expansion/shrinkage ratio of the lens layers of Examples 1 and 2:

In addition, the contact lenses used for intraocular pressure monitoring of Examples 1 and 2 did not appear to be displaced between the lens layers after hydration, and the interlayer peeling phenomenon did not appear when rubbed by hand. When wearing, the inner lens layer will be deformed with the change of intraocular pressure, resulting in the deviation of the pattern of the second pattern and the pattern of the first pattern, which can be recognized by the naked eye or detected by the instrument.

To sum up, the contact lens for intraocular pressure monitoring disclosed in the present invention includes an outer lens layer, which includes a first pattern, an inner lens layer, which includes a second pattern and an adhesive layer, wherein the outer lens layer includes a first pattern and an inner lens layer. The lens layer and the inner lens layer have a defined range of tensile modulus and expansion and contraction ratio, so that the inner lens layer can be deformed with the change of intraocular pressure during wearing, resulting in the relative position deviation of the second pattern and the first pattern or The angular deviation is used for monitoring and observation, and it is comfortable to wear, which can provide a simple and suitable means for monitoring intraocular pressure for a long time without the cooperation of ophthalmic surgery.

Although the present invention has been disclosed as above with examples, it is not intended to limit the present invention. Anyone skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection of the present invention The scope shall be determined by the scope of the appended patent application.

10: Contact lenses for intraocular pressure monitoring

10a: Optical Zone

10b: Surrounding area

21: Outer lens layer

210a: First Optical Zone

210b: First peripheral area

211: First outer surface

213: First inner surface

22: The first pattern

23: Adhesive layer

24: Second pattern

25: inner lens layer

250a: Second Optical Zone

250b: Second Perimeter

251: Second outer surface

253: Second inner surface

Claims (10)

A contact lens for intraocular pressure monitoring, comprising: an outer lens layer, the outer lens layer includes a first optical zone corresponding to the cornea area and a first peripheral area having a first pattern and corresponding to the area outside the cornea area, and the outer lens layer has an opposite to each other a first outer surface and a first inner surface, the first pattern is located on the first outer surface or the first inner surface, and the tensile modulus of the outer lens layer is greater than 0.8 MPa and less than 1.7 MPa; an inner lens layer, the inner lens layer includes a second optical zone corresponding to the cornea area and a second peripheral area having a second pattern and corresponding to the area outside the cornea area, and the inner lens layer has an opposite first optical zone Two outer surfaces and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than the tensile modulus of the outer lens layer, and is not less than 0.2MPa and not greater than 0.8MPa; and an adhesive layer disposed between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and the adhesive layer and the first inner surface of the outer lens layer and the inner lens the second outer surface of the layer is adjacent to bond the outer lens layer and the inner lens layer; Wherein, the first pattern and the second pattern are overlapped with each other or offset by a predetermined distance or a predetermined angle. The contact lens of claim 1, wherein the ratio of tensile modulus of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5, and the expansion and shrinkage ratios of the outer lens layer to the inner lens layer are different Values are between 0% and 1%. The contact lens of claim 1, wherein the first pattern is located on the first outer surface of the outer lens layer or the first inner surface adjacent to the adhesive layer, and the second pattern is located on the inner lens layer The second outer surface is adjacent to the adhesive layer. According to the contact lens of claim 1, the second inner surface of the inner lens layer directly contacts the eyeball, and when the inner lens layer is deformed with changes in intraocular pressure, the second pattern also changes, and the outer lens layer is deformed. The layer is not in contact with the eyeball and has a high tensile modulus, which is not easy to deform, so the pattern of the second pattern that causes the deformation and the first pattern of the outer lens layer have a detectable relative position deviation or angular deviation. , which can be used to assess changes in intraocular pressure. The contact lens of claim 1, wherein the adhesive layer is for bonding the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer to maintain the combination of the outer lens layer and the inner lens layer and retain the deformation space of the inner lens layer. The contact lens of claim 5, wherein the occupied area of the adhesive layer starts from the outer edge of the first peripheral area of the outer lens layer, and extends from the axis of the outer lens layer 21 to a distance of 10 % to 95% of the diameter of the outer lens layer 21. A method of manufacturing a contact lens for intraocular pressure monitoring, comprising the steps of: An outer lens layer is provided, the outer lens layer includes a first optical zone corresponding to the cornea area and a first peripheral area having a first pattern and corresponding to the area outside the cornea area, and the outer lens layer has mutually opposite a first outer surface and a first inner surface, the first pattern is located on the first outer surface or the first inner surface, and the tensile modulus of the outer lens layer is greater than 0.8 MPa and less than 1.7 MPa; An inner lens layer is provided, the inner lens layer includes a second optical zone corresponding to the cornea region and a second peripheral region having a second pattern and corresponding to the region outside the cornea region, and the inner lens layer has an opposite The second outer surface and a second inner surface, the second pattern is located on the second outer surface, and the tensile modulus of the inner lens layer is smaller than the tensile modulus of the outer lens layer, and is not less than 0.2MPa and not more than 0.8MPa; providing an adhesive layer composition, and printing the adhesive layer composition on the first inner surface of the outer lens layer and/or the second outer surface of the inner lens layer; and aligning the outer lens layer and the inner lens layer, so that the adhesive layer composition forms an adhesive layer between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and The adhesive layer is adjacent to the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, and the outer lens layer and the inner lens layer are bonded by the adhesive layer to complete the application. Manufacture of contact lenses for intraocular pressure monitoring; Wherein, the first pattern and the second pattern are overlapped with each other or offset by a predetermined distance or a predetermined angle. The method of manufacturing a contact lens for intraocular pressure monitoring as claimed in claim 7, wherein the manufacturing step of the outer lens layer comprises: providing a first composition and a pattern colorant composition; placing the first composition into a contact lens mold, and curing the first composition to form an outer lens layer body having a first outer surface and a first inner surface opposite to each other; and The pattern colorant composition is printed on the first outer surface or the first inner surface of the outer lens layer body to form a first pattern on the outer lens layer body, and the fabrication of the outer lens layer is completed. The method of manufacturing a contact lens for intraocular pressure monitoring as claimed in claim 7, wherein the manufacturing step of the inner lens layer comprises: providing a second composition and a pattern colorant composition; placing the second composition into a contact lens mold, curing the second composition to form an inner lens layer body, the inner lens layer body having a second outer surface and a second inner surface opposite to each other; and The pattern colorant composition is printed on the second outer surface of the inner lens layer body to form a second pattern on the inner lens layer body, and the production of the inner lens layer is completed. The method of manufacturing a contact lens for intraocular pressure monitoring as claimed in any one of claims 7 to 9, wherein the tensile modulus ratio of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5, and The difference between the expansion and shrinkage of the outer lens layer and the inner lens layer is 0% to 1%.

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