CN113655636A

CN113655636A - Contact lens for intraocular pressure monitoring

Info

Publication number: CN113655636A
Application number: CN202011300141.7A
Authority: CN
Inventors: 张美云; 张修豪; 林栢青
Original assignee: BenQ Materials Corp
Current assignee: BenQ Materials Corp
Priority date: 2020-11-19
Filing date: 2020-11-19
Publication date: 2021-11-16

Abstract

The invention discloses a contact lens for intraocular pressure monitoring, which comprises an outer lens layer, an adhesion layer and an inner lens layer, wherein the tensile modulus of the outer lens layer is greater than that of the inner lens layer, the tensile modulus of the outer lens layer is greater than 0.8MPa and less than 1.7MPa, the tensile modulus of the inner lens layer is not less than 0.2MPa and not more than 0.8MPa, and the difference of the swelling and shrinking rates of the outer lens layer and the inner lens layer is 0-1%. The outer lens layer and the inner lens layer are respectively provided with a first pattern and a second pattern, and the second pattern can generate relative deviation or angular deviation with the fixed first pattern along with the change of intraocular pressure, so that the purpose of intraocular pressure monitoring is achieved. The contact lens has wearing comfort, and can provide a simple and convenient means suitable for monitoring intraocular pressure for a long time without the cooperation of ophthalmic surgery.

Description

Contact lens for intraocular pressure monitoring

Technical Field

The present invention relates to a contact lens, and more particularly, to a contact lens for intraocular pressure monitoring.

Background

Intraocular pressure is the equilibrium pressure exerted by the eyeball on the wall of the eyeball, and generally, a constant pressure is maintained in a healthy eye to make the photosensitive optic nerve system of the retina operate normally. When the intraocular pressure is increased, the eyes will feel sour or rainbow; when the condition is aggravated, there are symptoms such as eye swelling and headache. The long-term ocular hypertension causes atrophy and pathological changes of optic nerves due to compression of the optic nerves, and further causes symptoms such as visual deterioration, visual field reduction and the like, so that glaucoma is the most main reason of the acquired blindness of human at present. However, glaucoma, which often does not produce significant symptoms at its early stage, is often found with loss of function of the optic nerve. Therefore, long-term intraocular pressure measurements are necessary, especially for populations with high risk factors for glaucoma, such as high myopia, hypertension, obesity or family history of glaucoma, to be monitored more closely. Moreover, glaucoma patients can also avoid worsening of disease and even blindness by monitoring intraocular pressure for a long time.

At present, the intraocular pressure is monitored by a piezoresistive tonometer or a non-contact optical instrument periodically but once, and cannot be monitored for a long time. If monitoring is required for a long period of time, the prior art can achieve this by implanting a microchip or microfluidic sensor in the patient's eye, or using a resistive or capacitive non-invasive intraocular pressure sensing element. However, the former requires implanting a chip or sensor by ophthalmic surgery, which is a high risk; the latter operating principle is that the non-invasive sensing element is used to confirm the resistance or capacitance change caused by the intraocular pressure change, and the back end signal processing is used, so the procedure is complicated and the interference sources are many.

In view of the foregoing, there is a need for a new contact lens for intraocular pressure monitoring that is simple and suitable for extended periods of time.

Disclosure of Invention

In view of the problems in the prior art, the present invention provides a contact lens to solve the above problems.

Therefore, the technical problem to be solved by the present invention is to provide a contact lens for intraocular pressure monitoring, which comprises: an outer lens layer including a first optical zone corresponding to a corneal region of an eyeball and a first peripheral zone having a first pattern and corresponding to a region other than the corneal region of the eyeball, the outer lens layer having a first outer surface and a first inner surface opposite to each other, and a tensile modulus of the outer lens layer being greater than 0.8MPa and less than 1.7 MPa; the inner lens layer comprises a second optical area corresponding to the cornea region of the eyeball and a second peripheral area which is provided with a second pattern and corresponds to a region outside the cornea region of the eyeball, the inner lens layer is provided with a second outer surface and a second inner surface which are opposite, the tensile modulus of the inner lens layer is smaller than that of the outer lens layer, and the tensile modulus of the inner lens layer is not less than 0.2MPa and not more than 0.8 MPa; 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, the adhesive layer being adjacent to the first inner surface of the outer lens layer and 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 are set with a deviation preset distance or a deviation preset angle.

As an optional technical solution, the ratio of the tensile modulus of the outer lens layer to the tensile modulus of the inner lens layer is greater than 1 and less than 4.5, and the difference of the swelling and shrinking rates of the outer lens layer to the tensile modulus of the inner lens layer is between 0% and 1%.

As an optional technical solution, 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 second outer surface of the inner lens layer adjacent to the adhesive layer.

As an optional technical solution, the second inner surface of the inner lens layer directly contacts with the eyeball, when the inner lens layer deforms with the change of intraocular pressure, the second pattern also changes, and the outer lens layer does not contact with the eyeball and has a high tensile modulus, and a detectable relative position deviation or angular deviation occurs between the deformed pattern of the second pattern and the first pattern of the outer lens layer, so as to evaluate the change of intraocular pressure.

As an optional technical solution, the adhesion layer bonds the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer to maintain the bondability of the outer lens layer and the inner lens layer and to maintain the deformation space of the inner lens layer.

Alternatively, the occupied area of the adhesive layer starts from the outer edge of the first peripheral area of the outer lens layer and reaches a position where the distance extrapolated from the axis of the outer lens layer is between 10% and 95% of the diameter of the outer lens layer.

The present invention also provides a method of manufacturing a contact lens for intraocular pressure monitoring, the method comprising the steps of: providing an outer lens layer, wherein the outer lens layer comprises a first optical area corresponding to an eyeball cornea area and a first peripheral area which is provided with a first pattern and corresponds to an area outside the eyeball cornea area, the outer lens layer is provided with a first outer surface and a first inner surface which are opposite to each other, the first pattern is positioned on the first outer surface or the first inner surface, and the tensile modulus of the outer lens layer is more than 0.8MPa and less than 1.7 MPa; providing an inner lens layer, wherein the inner lens layer comprises a second optical area corresponding to an eyeball cornea area and a second peripheral area which is provided with a second pattern and corresponds to an area outside the eyeball cornea area, the inner lens layer is provided with a second outer surface and a second inner surface which are opposite, the second pattern is positioned on the second outer surface, the tensile modulus of the inner lens layer is smaller than that of the outer lens layer, and the tensile modulus of the inner lens layer is not less than 0.2MPa and not more than 0.8 MPa; 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 bonding the outer lens layer and the inner lens layer in an aligned manner, so that the bonding layer composition forms a bonding layer between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, the bonding 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 bonding layer to complete the manufacture of the contact lens for intraocular pressure monitoring; wherein, the first pattern and the second pattern are overlapped with each other or are set with a deviation preset distance or a deviation preset angle.

As an alternative solution, the manufacturing steps of the outer lens layer include: providing a first composition and a pattern colorant composition; placing the first composition into a contact lens mold, curing the first composition to form an outer lens layer body having a first outer surface and a first inner surface opposite one another; and printing the pattern pigment composition 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, thereby completing the manufacture of the outer lens layer.

As an optional technical solution, the manufacturing steps of the inner lens layer include: providing a second composition and a pattern coloring composition; placing the second composition into a contact lens mold, and curing the second composition to form an inner lens layer body having a second outer surface and a second inner surface opposite to each other; and printing the pattern pigment composition on the second outer surface of the inner lens layer body to form a second pattern on the inner lens layer body, thereby completing the manufacture of the inner lens layer.

As an optional technical solution, the ratio of the tensile modulus of the outer lens layer to the tensile modulus of the inner lens layer is greater than 1 and less than 4.5, and the difference of the swelling and shrinking rates of the outer lens layer to the tensile modulus of the inner lens layer is 0% to 1%.

Compared with the prior art, the contact lens for intraocular pressure monitoring disclosed by the invention comprises an outer lens layer, an adhesion layer and an inner lens layer, wherein the tensile modulus of the outer lens layer is greater than that of the inner lens layer, the tensile modulus of the outer lens layer is greater than 0.8MPa and less than 1.7MPa, the tensile modulus of the inner lens layer is not less than 0.2MPa and not more than 0.8MPa, and the difference between the swelling and shrinking rates of the outer lens layer and the inner lens layer is 0-1%. The outer lens layer and the inner lens layer are respectively provided with a first pattern and a second pattern, and the second pattern can generate relative deviation or angular deviation with the fixed first pattern along with the change of intraocular pressure, so that the purpose of intraocular pressure monitoring is achieved. The contact lens has wearing comfort, and can provide a simple and convenient means suitable for monitoring intraocular pressure for a long time without the cooperation of ophthalmic surgery.

The invention is described in detail below with reference to the drawings and specific examples, but the invention is not limited thereto.

Drawings

FIG. 1 is a diagram of an eyeball location corresponding to a contact lens for intraocular pressure monitoring having an optical zone and a peripheral zone, according to an embodiment of the invention.

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

FIG. 3A is a schematic drawing of a contact lens for intraocular pressure monitoring with the outer lens layer aligned with the inner lens layer according to another embodiment of the present invention;

fig. 3B is a schematic drawing of a contact lens for intraocular pressure monitoring with the outer lens layer aligned with the inner lens layer according to another embodiment of the present invention.

Fig. 4A-4C are schematic diagrams of a first pattern and a second pattern of a contact lens for intraocular pressure monitoring according to another embodiment of the present invention.

Detailed Description

In order to further understand the objects, structures, features and functions of the present invention, the following embodiments are described in detail.

In order to make the disclosure more complete and complete, the following description sets forth illustrative aspects and embodiments of the invention; it is not intended to be the only form in which the embodiments of the invention may be practiced or utilized. The embodiments disclosed below may be combined with or substituted for one another where appropriate, and additional embodiments may be added to one embodiment without further recitation or description.

The advantages, features, and advantages of the present invention will be more readily understood by reference to the following detailed description of exemplary embodiments and the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein but, on the contrary, is provided for a person of ordinary skill in the art to so fully convey the scope of the present invention and that the present invention is defined only by the appended claims.

Unless otherwise defined, all terms (including technical and scientific terms) and terminology used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs, and terms such as those defined in commonly used dictionaries should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an overly idealized or overly formal sense unless expressly so defined herein.

Further, as used herein, the term "tensile modulus" refers to the mathematical description of the elastic deformation of a material when a force is applied to the material, and is defined as the ratio of the stress (stress) to the strain (strain) of the material after the force is applied. "swelling and shrinking ratio" refers to the ratio of the size change of a polymer in a solvent due to the entrance of solvent molecules between molecular chains.

The contact lens for intraocular pressure monitoring of the present invention is illustrated below by way of illustration. First, please refer to fig. 1 and fig. 2A to 2B. As shown in fig. 1, the contact lens 10 for intraocular pressure monitoring according to the present invention includes an optical zone 10a corresponding to a corneal region 111 of an eyeball 11 and a peripheral zone 10b corresponding to a region 113 outside the corneal region 111 of the eyeball 11. As further shown in fig. 2A, the contact lens 10 for intraocular pressure monitoring of the present invention sequentially comprises an outer lens layer 21, an adhesive layer 23, and an inner lens layer 25 directly contacting the eyeball. Wherein the outer lens layer 21 has a first optical zone 210a corresponding to the corneal region 111 and a first peripheral zone 210b corresponding to the region 113 outside the corneal region 111, and has a first outer surface 211 and a first inner surface 213 opposite to each other; the inner lens layer 25 includes a second optical zone 250a corresponding to the corneal region 111 and a second peripheral zone 250b corresponding to the region 113 outside the corneal region 111, and the inner lens layer 25 has a second outer surface 251 and a second inner surface 253 opposite to each other. As further shown in FIG. 2B, the outer lens layer 21 has a first pattern 22 for intraocular pressure monitoring at a first peripheral region 210B, and the inner lens layer 25 has a second pattern 24 for intraocular pressure monitoring at a second peripheral region 250B.

In a preferred embodiment of the present invention, the tensile modulus of the outer lens layer 21 is greater than 0.8MPa and less than 1.7MPa, the tensile modulus of the inner lens layer 25 is less than the tensile modulus of the outer lens layer 21, and the tensile modulus of the inner lens layer 25 is not less than 0.2MPa and not more than 0.8 MPa. The contact lens 10 for monitoring intraocular pressure adopts the outer lens layer 21 and the inner lens layer 25 to be overlapped, and because the tensile modulus of the inner lens layer 25 and the outer lens layer 21 is different, when the contact lens is worn, the inner lens layer 25 is deformed due to the change of intraocular pressure of an eyeball. Too low a tensile modulus for the outer lens layer 21 may not provide the outer lens layer 21 with resistance to deformation and overall contact lens 10 support; when the tensile modulus of the outer lens layer 21 is too high, the contact lens 10 hardly conforms to the curvature of the cornea, and the feeling of foreign body sensation during wearing increases. When the tensile modulus of the endoscope layer 25 is too low, the material is not easy to form independently; too high may result in insufficient deformability.

In a preferred embodiment of the present invention, the ratio of the tensile modulus of the outer lens layer 21 to that of the inner lens layer 25 is greater than 1 and less than 4.5, and the difference in the swelling and shrinking percentages is between 0% and 1%. In the range defined by the ratio of the tensile modulus of the outer lens layer 21 to the tensile modulus of the inner lens layer 25 and the difference between the expansion and contraction rates, the inner lens layer 25 of the contact lens 10 can generate a difference in deformation with the outer lens layer 21 when deformed by intraocular pressure, 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 fig. 3A and fig. 3B. FIG. 3A is a schematic diagram illustrating the alignment of an outer lens layer 321a and an 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 alignment of an outer lens layer 321B and an inner lens layer 325B of a contact lens 310B for intraocular pressure monitoring according to another embodiment of the invention. In fig. 3A, the first pattern 322a and the second pattern 324a are overlapped with each other when they are aligned initially; in fig. 3B, the pattern of the first pattern 322B and the pattern of the second pattern 324B are offset by a predetermined distance or a predetermined angle d when they are initially aligned.

With further reference to fig. 4A to 4C, the first pattern 322a and the second pattern 324A of the contact lens 310a for intraocular pressure monitoring and the first pattern 322B and the second pattern 324B of the contact lens 310B for intraocular pressure monitoring according to the embodiments of the present invention may be respectively composed of a plurality of identical or different sub-patterns, and the sub-patterns may have any shapes, such as but not limited to lines as shown in fig. 4A, concentric circles as shown in fig. 4B, geometric patterns as shown in fig. 4C, or combinations thereof, as long as the patterns of the second pattern 324A and the first pattern 322a, and the patterns of the second pattern 324B and the first pattern 322B are observed to be out of alignment or angular deviation after the endoscope sheet layer 325a or 325B is deformed according to the intraocular pressure.

The contact lens 310a for intraocular pressure monitoring is superposed with the inner lens layer 325a by the outer lens layer 321 a; the contact lens 310b employs an outer lens layer 321b in superimposition with an inner lens layer 325 b. When the lens is worn, the

inner lens layers

325a and 325b are deformed due to the change of the intraocular pressure of the eyeball, so that the second pattern 324a of the inner lens layer 325a and the first pattern 322a of the outer lens layer 321a have a relative position deviation or an angular deviation which can be identified by naked eyes or detected by instruments; the second pattern 324b of the inner lens layer 325b and the first pattern 322b of the outer lens layer 321b have relative or angular deviations for visual or instrumental detection, so that the intraocular pressure change can be evaluated by monitoring the deviation.

The adhesive layer of the contact lens for intraocular pressure monitoring is used for adhering an outer lens layer and an inner lens layer. In an embodiment of the present invention, as shown in fig. 2A, the adhesive layer 23 of the contact lens 10 for intraocular pressure monitoring can be attached to the first peripheral region 210b of the first inner surface 213 of the outer lens layer 21 and the second peripheral region 250b of the second outer surface 251 of the inner lens layer 25, preferably to increase the adhesion stability and maintain the deformation space of the inner lens layer 25, and the adhesive layer 23 can be in the form of dots, stripes, 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 second outer surface 251 of the inner lens layer 25 adjacent to the adhesive layer 23.

The occupied area of the adhesive layer 23 is a position starting from the outer edge of the first peripheral area of the outer lens layer 21 and up to a diameter of the outer lens layer 21 extrapolated from the axial center of the outer lens layer 21 by a distance of 10% to 95%. The effect of fixing the outer lens layer 21 and the inner lens layer 25 is affected when the occupied area of the adhesion layer 23 is too small; an excessively large occupied area limits the rate at which the lens layer 25 deforms with changes in intraocular pressure.

It is yet another object of the present invention to provide a method of manufacturing a contact lens for intraocular pressure monitoring comprising the steps of: providing an outer lens layer 21, wherein the outer lens layer 21 includes a first optical zone 210a corresponding to the corneal region 111 and a first peripheral zone 210b having a first pattern 22 and corresponding to a region 113 outside the corneal region 111, the outer lens layer 21 has a first outer surface 211 and a first inner surface 213 opposite to each other, 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 0.8MPa and less than 1.7 MPa; providing an inner lens layer 25, wherein the inner lens layer 25 comprises a second optical zone 250a corresponding to the cornea region 111 and a second peripheral zone 250b having a second pattern 24 and corresponding to a region 113 outside the cornea region 111, the inner lens layer 25 has a second outer surface 251 and a second inner surface 253 which are opposite, the second pattern 24 is located on the second outer surface 251, the tensile modulus of the inner lens layer 25 is smaller than that of the outer lens layer 21, and the tensile modulus of the inner lens layer 25 is not less than 0.2MPa and not more than 0.8 MPa; providing an adhesive composition and printing the adhesive composition on the first inner surface 213 of the outer lens layer 21 and/or the second outer surface 251 of the inner lens layer 25; and bonding the outer lens layer 21 and the inner lens layer 25 in an aligned manner, so that the adhesive layer composition forms an adhesive layer 23 between the first inner surface 213 of the outer lens layer 21 and the second outer surface 251 of the inner lens layer 25, 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 outer lens layer 21 and the inner lens layer 25 are bonded by the adhesive layer 23, thereby completing the manufacture of the contact lens 10 for intraocular pressure monitoring; wherein the first pattern 22 and the second pattern 24 are overlapped with each other or deviated from each other by a predetermined distance or a predetermined angle d.

According to an embodiment of the manufacturing method of the present invention, the manufacturing step of the outer lens layer 21 includes: providing a first composition and a pattern colorant composition; placing the first composition into a contact lens mold (not shown), curing the first composition to form an outer lens layer body (not shown) having a first outer surface 211 and a first inner surface 213 opposite each other; the pattern colorant composition is printed on the first outer surface 211 or the first inner surface 213 of the outer lens layer body to form the first pattern 22 on the outer lens layer body, completing the manufacture of the outer lens layer 21.

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 coloring composition; placing the second composition into a contact lens mold (not shown), curing the second composition to form an inner lens layer body (not shown) having a second outer surface 251 and a second inner surface 253 opposite to each other; the pattern colorant composition is printed onto the second outer surface 251 of the inner lens layer body to form a second pattern 24 on the inner lens layer body, completing the fabrication of the inner lens layer 25.

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

One or more hydrophilic monomers such as Glycidyl Methacrylate (GMA), 2-hydroxyethyl acrylate (HEMA), N-vinyl pyrrolidone (NVP), N-dimethyl acrylamide (DMA), methacrylic acid (MAA), hexafluoroisopropyl methacrylate (HFMA), and the like may be used in the first and second compositions suitable for forming the outer lens layer 21 and the inner lens layer 25 of the present invention. Suitable cross-linking agents in the composition of the lens layer may be, for example, Glycerol Dimethacrylate (GDMA), Ethylene Glycol Dimethacrylate (EGDMA), trimethylolpropane triacrylate (TMPTA), tetraethylene glycol dimethacrylate (TrEGDMA), triethylene glycol dimethacrylate (TEGDMA), trimethylolpropane trimethacrylate (TMPTMA), polyethylene glycol dimethacrylate (PEGDMA), vinyl methacrylate, ethylenediamine dimethylacrylamide, glycerol dimethacrylate, triallyl isocyanurate, triallyl cyanurate, or combinations thereof, with their polymer chains being cross-linked to adjust the strength to produce a lens layer having a tensile modulus and a swell-shrink ratio in the range required for the lens layer of the present invention. Suitable initiators in the aqueous gel composition may be thermal initiators or photo initiators. The thermal initiator may be, for example, but not limited to, Azobisisoheptonitrile (ADVN), 2 '-Azobisisobutyronitrile (AIBN), 2' -azobis (2, 4-dimethyl) valeronitrile, 2 '-azobis, 2' -azobis (2-methyl-butyronitrile), or benzoyl peroxide; the photoinitiator may include, but is not limited to, 2,4, 6-trimethylbenzoyl-diphenylphosphine oxide, 2-hydroxy-2-methylphenylpropane-1-one, ethyl 2,4, 6-trimethylbenzoylphenylphosphonate, or 2, 2-diethoxyacetophenone, and the like.

The foregoing methods of producing the outer lens layer 21 and the 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 molding method.

According to an embodiment of the production method of the present invention, the aforementioned curing procedure refers to curing (e.g., crosslinking or polymerization) by heating, light irradiation such as UV irradiation, ion irradiation (e.g., γ -ray or X-ray irradiation), microwave irradiation, or the like.

According to the embodiment of the manufacturing method of the present invention, the first pattern 22 and the second pattern 24 may be printed by using a known printing technique, which may be, but is not limited to, inkjet printing (inkjet printing), laser printing (laser printing), pad printing (pad printing), or transfer printing (transfer printing). Wherein the first pattern 22 can be printed to the first outer surface 211 or the first inner surface 213 of the outer lens layer 21 and the second pattern 24 is printed to the second outer surface 251 of the inner lens layer 25, preferably the first pattern 22 is printed to the first inner surface 213 of the outer lens layer 21 and the second pattern 24 is printed to the second outer surface 251 of the inner lens layer 25.

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 a hydrophilic monomer, a tackifier or a crosslinking agent and an initiator. Suitable hydrophilic monomers, crosslinking agents and initiators are those described above for the preparation of the hydrogel composition, and suitable viscosity-increasing agents are polyvinylpyrrolidone or modified polyvinylpyrrolidone prepared by polymerizing vinylacetamide monomer, vinylpyrrolidone monomer and 2-hydroxyethyl methacrylate monomer and reacting with 2-isocyanatoethyl (meth) acrylate. According to the embodiment of the manufacturing method of the present invention, the adhesive layer 23 can be printed by using known printing techniques, such as but not limited to inkjet printing (inkjet printing), laser printing (laser printing), pad printing (pad printing) or transfer printing (transfer printing), and the number of times of repetitive printing can be increased according to the adhesion or wetting condition of the adhesive layer 23.

According to the embodiment of the manufacturing method of the present invention, the outer lens layer 21 and the inner lens layer 25 are bonded by alignment, and a bonding method with high alignment precision and controlled bonding failure (for example, bonding bubbles or internal contamination) can be selected, and the bonding method can be, but is not limited to, manual bonding, jig bonding or automatic equipment bonding. More specifically, one of the first pattern 22 and the second pattern 24 is selected as a reference, and the pattern distribution range of the unselected pattern is overlapped and attached at a known position relative to the pattern distribution range of the reference pattern, so that the pattern distribution range of the first pattern 22 is overlapped or deviated from the pattern distribution range of the second pattern 24 by a known distance or angle.

The colorant composition suitable for the first pattern 22 and the second pattern 24 of the present invention comprises at least a hydrophilic monomer, an adhesive resin, a colorant, an initiator and a crosslinking agent. The hydrophilic monomer, initiator and crosslinking agent used in the colorant can be the same as those of the above-mentioned hydrogel composition. Suitable adhesive resins may be, for example, polyurethane resins, acrylic resins or phenolic resins. Suitable colorants can be organic or inorganic dyes. The organic dye may 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 are not limited to, black iron oxide, brown iron oxide, yellow iron oxide, red iron oxide, titanium dioxide, and the like.

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

Examples

Preparation example 1: preparation of a hydrogel composition for forming the 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 (available from Croda International PLC, UK) and 0.4053 g of Azobisisobutyronitrile (AIBN) were mixed in 0.5936 g of glycerin and stirred for about 2 hours, and then the resultant was filtered to obtain a hydrogel composition for forming an outer lens layer.

Preparation example 2: preparation of a silicone hydrogel composition for forming the 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. 20 g of α -butyl- ω - [3- (2,2- (dimethylol) butoxy) propyl ] polydimethylsiloxane were weighed out accurately and added dropwise to the flask over about 1 hour. After 12 hours of reaction, an additional 0.0025 g of dibutyltin dilaurate and 7.2 g of polyethylene glycol monomethacrylate were weighed out and added dropwise to the flask over about 1 hour. After 12 hours of reaction, the product formed was washed with a large amount of water and then dehydrated and filtered. Next, the methylene chloride 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. 20 g of the silicone compound are weighed out accurately and added dropwise to a round-bottomed flask over about 1 hour. After 12 hours of reaction, an additional 0.0025 g of dibutyltin dilaurate and 14.4 g of polyethylene glycol monomethacrylate were weighed out and added dropwise to the flask over about 1 hour. After 12 hours of reaction, the product formed was washed with a large amount of water and then dehydrated and filtered. Next, the methylene chloride solvent was removed from the product to obtain second polymethylsiloxane macromers.

41.8 grams of the first siloxane, 6.3 grams of the second siloxane macromers, 0.52 grams of Azobisisoheptonitrile (ADVN), 35.2 grams of N-vinylpyrrolidone (NVP), 14.6 grams of 2-hydroxyethyl methacrylate (HEMA), 0.3 grams of hexafluoroisopropyl methacrylate (HFMA), 0.6 grams of trimethylolpropane trimethacrylate (TMPTMA), and 0.68 grams of 2- [3- (2H-benzotriazol-2-yl) -4-hydroxyphenyl ] ethyl 2-methacrylate were mixed in 2 grams 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 a hydrogel composition for forming an endoscope sheet.

66.3964 g of 2-hydroxyethyl methacrylate (HEMA), 0.2989 g of Ethylene Glycol Dimethacrylate (EGDMA) solvent, 0.0735 g of TWEEN80 (available from Croda International PLC, UK) and 0.3983 g of Azobisisobutyronitrile (AIBN) were mixed and stirred in 7.9688 g of glycerin for about 2 hours, and then the resultant was subjected to monomer filtration to obtain a water gel composition for forming an endoscope sheet layer.

Preparation example 4: preparing a silicon hydrogel composition for forming an endoscope sheet layer.

First and second polymethylsiloxane macromolecules were prepared in the same manner as in preparation example 2.

After 39.8 grams of the first siloxane macro-block, 11.3 grams of the second siloxane macro-block, 0.5 grams of Azobisisoheptonitrile (ADVN), 33.5 grams of N-vinyl pyrrolidone (NVP), 14.0 grams of 2-hydroxyethyl methacrylate (HEMA), 0.3 grams of hexafluoroisopropyl methacrylate (HFMA), and 0.60 grams of 2- [3- (2H-benzotriazol-2-yl) -4-hydroxyphenyl ] ethyl 2-methacrylate were mixed in 2 grams of ethanol and stirred for about 1 hour, a silicone hydrogel composition for forming an endoscope sheet was formed.

Preparation example 5: preparation of the adhesive layer composition.

55.152 g of 2-hydroxyethyl methacrylate (HEMA), 1.809 g of N-vinyl pyrrolidone (NVP), 1.809 g of methacrylic acid, 0.904 g of ethylene glycol dimethacrylate (EDGMA), 0.904 g of trimethylolpropane methacrylate triacrylate (TMPTMA), 36.172 g of polyvinylpymetrozine and 0.995 g of 5329 (from Sigma-Aldrich) were mixed and stirred with a high speed stirrer for about 60 minutes, followed by addition of photoinitiator 1.583 g of 1173 (from BASF, Germany) and 0.678 g of 819 (from Sigma-Aldrich, Germany) and stirred for 30 minutes to form an adhesive layer composition.

Preparation example 6: preparation of a pattern coloring 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-propanone (trade name UV-1173, available from BASF, Taiwan, China) and 37.6 g of a Black pigment (trade name Sicovit Black 85E172, available from BASF, Germany) were put into a ball mill (equipment name RETSCH PM400) and ground to form a pattern pigment composition.

Example 1: preparation of hydrogel contact lenses for intraocular pressure monitoring.

The aqueous gel composition for forming an outer lens layer formed in preparation example 1 was quantitatively dropped into a polypropylene mold, and after curing was performed at 80 ℃ for 5 hours, curing was performed at 115 ℃ for 2 hours. And after the polymerization reaction is finished, soaking the model and the lens body in ethanol for 1 hour, and taking out the formed outer lens layer body, wherein the outer lens layer body is provided with a first outer surface and a first inner surface which are opposite. And adhering the pigment composition with the same pattern as the first pattern on the printing plate by using a pad printing rubber head in a pad printing mode, and printing the pigment composition on the first inner surface of the inner arc side of the outer lens layer to perform photopolymerization reaction so as to form the water gel outer lens layer with the first pattern.

Then, the colorant composition is transferred to another polypropylene mold in the same pattern as the second pattern, and a photopolymerization reaction is performed to form the second pattern. Then, the hydrogel composition for forming an endoscope layer formed in preparation example 3 was quantitatively dropped into a polypropylene mold and cured under conditions of 80 deg.C/5 hr and 115 deg.C/2 hr. And after the polymerization reaction is finished, soaking the model and the lens in ethanol for 1 hour, and taking out the formed endoscope sheet layer body, wherein the endoscope sheet layer body is provided with a second outer surface and a second inner surface which are opposite, and a second pattern is formed on the second outer surface to form the water gel endoscope sheet layer with the second pattern.

The resulting hydrogel outer lens layer and hydrogel inner lens layer were subjected to tensile modulus and swelling and shrinking ratio tests, respectively, according to the measurement methods described later, and the results are shown in table 1.

The printing plate is then provided with a loop of adhesive material distributed relative to the outer lens layer starting at the outer edge of the first peripheral region of the outer lens layer and ending at a position that is extrapolated from the axis of the outer lens layer by a distance of 20% of the diameter of the outer lens layer. The pad printing method is used, the pad printing glue head is used for sticking the material of the adhesion layer, the outer edge of the first peripheral area of the outer lens layer is aligned, and the first inner surface of the water gel outer lens layer is stamped. And (3) selecting the first pattern on the outer lens layer as a reference, and adhering the inner lens layer and the outer lens layer of the water gel after the pattern distribution of the second pattern on the lens layer of the water gel is overlapped with the pattern distribution of the first pattern by utilizing precise alignment lamination to obtain the composition of the water gel lens layer.

After the composition of the hydrogel lens layer is polymerized by illumination, the curing and the jointing of the adhesion layer can be completed. It was then subjected to a hydration procedure and sterilized at 121 ℃ for 30 minutes to form a hydrogel contact lens for intraocular pressure monitoring.

The hydration procedure is as follows:

(a) the hydrogel lens layer composition was removed after 1 hour of immersion in 80% alcohol:

(b) soaking in 90% alcohol for 1 hr;

(c) heating with pure water at 80 deg.C for 1 hr; and

(d) equilibrate in buffer for 12 hours.

Example 2: and (3) preparing a silica hydrogel contact lens for intraocular pressure monitoring.

The outer lens layer and the inner lens layer were prepared as in example 1, but instead, the silicone hydrogel composition for forming the outer lens layer of preparation example 2 was used to form the silicone hydrogel outer lens layer having the first pattern, and the silicone hydrogel composition for forming the inner lens layer of preparation example 4 was used to form the silicone hydrogel inner lens layer having the second pattern.

The obtained silicone-hydrogel outer lens layer and silicone-hydrogel inner lens layer were subjected to tensile modulus and swelling and shrinking ratio tests, respectively, according to the measurement methods described later, and the results are listed in table 1.

Next, a lens layer composition was prepared in the same manner as in example 1, except that the above-described silicone adhesive outer lens layer having the first pattern and the silicone adhesive inner lens layer having the second pattern were used to form a silicone adhesive contact lens for intraocular pressure monitoring.

Tensile modulus test

The lenses were hydrated according to the following hydration procedure:

(a) taking out the silicon hydrogel lens layer composition after soaking in 80% alcohol for 1 hour:

(b) soaking in 90% alcohol for 1 hr;

(c) heating with pure water at 80 deg.C for 1 hr; and

(d) equilibrate in buffer for 12 hours.

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

Swelling shrinkage test of swelling

The lens was subjected to a caliber size test in a contact lens measuring projector, giltern (manufactured by Optimec ltd. in england) to obtain the lens caliber. The lens will then be hydrated according to the following hydration procedure:

(a) the lenses were taken out after 1 hour of immersion in 80% alcohol:

(b) soaking in 90% alcohol for 1 hr;

(c) heating with pure water at 80 deg.C for 1 hr; and

(d) equilibrate in buffer for 12 hours.

And (3) measuring the caliber of the hydrated lens by using a contact lens measuring projector Chiltern, and testing the caliber to obtain the hydrated caliber of the lens. Calculating the swelling shrinkage ratio of the swelling by using the following formula:

swelling and shrinkage rate (after hydration lens caliber-lens caliber)/lens caliber x 100 (%)

Table 1: tensile modulus and swell-shrink ratio measurement results for lens layers of examples 1 and 2:

in addition, the contact lenses for intraocular pressure monitoring according to examples 1 and 2 did not cause displacement between lens layers after hydration, and did not cause delamination when rubbed with a hand. When the lens is worn, the lens layer deforms along with the change of the intraocular pressure, so that the deviation which can be identified by naked eyes or detected by an instrument appears after the pattern of the second pattern is compared with the pattern of the first pattern.

In summary, the contact lens for intraocular pressure monitoring disclosed in the present invention comprises an outer lens layer, an inner lens layer and an adhesive layer. The outer lens layer contains first pattern, and the scope lamellar contains the second pattern, and wherein outer lens layer and scope lamellar have the tensile modulus and the swelling and shrinking rate scope of definition, make the scope lamellar produce deformation along with the intraocular pressure change when wearing, cause the second pattern appear with first pattern relative position deviation or angular deviation for the monitoring observation, and possess and wear the travelling comfort, can be under the cooperation of need ophthalmic surgery, provide the means simple and convenient and be fit for monitoring the intraocular pressure for a long time.

While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow.

The present invention is capable of other embodiments, and various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention.

Claims

1. A contact lens for intraocular pressure monitoring, comprising:

an outer lens layer including a first optical zone corresponding to a corneal region of an eyeball and a first peripheral zone having a first pattern and corresponding to a region other than the corneal region of the eyeball, the outer lens layer having a first outer surface and a first inner surface opposite to each other, and a tensile modulus of the outer lens layer being greater than 0.8MPa and less than 1.7 MPa;

the inner lens layer comprises a second optical area corresponding to the cornea region of the eyeball and a second peripheral area which is provided with a second pattern and corresponds to a region outside the cornea region of the eyeball, the inner lens layer is provided with a second outer surface and a second inner surface which are opposite, the tensile modulus of the inner lens layer is smaller than that of the outer lens layer, and the tensile modulus of the inner lens layer is not less than 0.2MPa and not more than 0.8 MPa; 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, the adhesive layer being adjacent to the first inner surface of the outer lens layer and 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 are set with a deviation preset distance or a deviation preset angle.

2. The contact lens of claim 1, wherein the ratio of the tensile modulus of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5, and the difference in the swell-shrink ratio of the outer lens layer to the inner lens layer is between 0% and 1%.

3. The 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 second outer surface of the inner lens layer adjacent to the adhesive layer.

4. The lens of claim 1, wherein the second inner surface of the inner lens layer directly contacts the eye, the second pattern changes when the inner lens layer deforms in response to a change in intraocular pressure, the outer lens layer does not contact the eye and has a high tensile modulus, and the change in intraocular pressure is evaluated by detecting a relative or angular deviation between the deformed second pattern and the first pattern of the outer lens layer.

5. The contact lens of claim 1, wherein the adhesive layer bonds the first peripheral region of the outer lens layer and the second peripheral region of the inner lens layer to maintain the bonding between the outer lens layer and the inner lens layer and to maintain a deformation space of the inner lens layer.

6. The lens of claim 5 wherein the occupied area of the adhesive layer begins at the outer edge of the first peripheral region of the outer lens layer and reaches a location that is between 10% and 95% of the diameter of the outer lens layer extrapolated from the axial center of the outer lens layer.

7. A method of manufacturing a contact lens for intraocular pressure monitoring, comprising the steps of:

providing an outer lens layer, wherein the outer lens layer comprises a first optical area corresponding to an eyeball cornea area and a first peripheral area which is provided with a first pattern and corresponds to an area outside the eyeball cornea area, the outer lens layer is provided with a first outer surface and a first inner surface which are opposite to each other, the first pattern is positioned on the first outer surface or the first inner surface, and the tensile modulus of the outer lens layer is more than 0.8MPa and less than 1.7 MPa;

providing an inner lens layer, wherein the inner lens layer comprises a second optical area corresponding to an eyeball cornea area and a second peripheral area which is provided with a second pattern and corresponds to an area outside the eyeball cornea area, the inner lens layer is provided with a second outer surface and a second inner surface which are opposite, the second pattern is positioned on the second outer surface, the tensile modulus of the inner lens layer is smaller than that of the outer lens layer, and the tensile modulus of the inner lens layer is not less than 0.2MPa and not more than 0.8 MPa;

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

the outer lens layer and the inner lens layer are attached in an aligned mode, so that the adhesion layer composition forms an adhesion layer between the first inner surface of the outer lens layer and the second outer surface of the inner lens layer, the adhesion 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 adhered through the adhesion layer, and the manufacturing of the contact lens for intraocular pressure monitoring is completed;

8. The method of manufacturing a contact lens for intraocular pressure monitoring of claim 7 wherein the step of manufacturing the outer lens layer comprises:

providing a first composition and a pattern colorant composition;

placing the first composition into a contact lens mold, curing the first composition to form an outer lens layer body having a first outer surface and a first inner surface opposite one another; and

printing the pattern pigment composition 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, thereby completing the manufacture of the outer lens layer.

9. The method of manufacturing a contact lens for intraocular pressure monitoring according to claim 7, wherein the manufacturing step of the inner lens layer comprises:

providing a second composition and a pattern coloring composition;

placing the second composition into a contact lens mold, and curing the second composition to form an inner lens layer body having a second outer surface and a second inner surface opposite to each other; and

printing the pattern pigment composition on the second outer surface of the inner lens layer body to form a second pattern on the inner lens layer body, thereby completing the manufacture of the inner lens layer.

10. The method of manufacturing a contact lens for intraocular pressure monitoring according to any of claims 7 to 9 wherein the ratio of the tensile modulus of the outer lens layer to the inner lens layer is greater than 1 and less than 4.5 and the difference in the swell-shrink ratio of the outer lens layer to the inner lens layer is between 0% and 1%.