Method and device for wearable contact lenses for monitoring of intraocular pressure

Abstract

To provide a method and device for wearable contact lenses for preferably monitoring an intraocular pressure.SOLUTION: A contact lens with a sensor region is described. The contact lens allows normal vision, and a concentric ring around the vision area of the lens includes one or more sensors for detecting changes in the interocular pressure of an eye. Data may be scanned using a camera, or in some embodiments, the data may be transmitted using a micro antenna located in a sensing region. The data may be analyzed using a software application on a cell phone or other computing device.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority from U.S. Provisional Application No. 62 / 780,128, entitled "Method and Devices for Wearable Contact Lenses for Monitoring Interocular Pressure," filed December 14, 2018 (Attorney Docket No. 48675-706.101), the contents of which are incorporated herein by reference in their entirety.

[0002] Field

[0003] The present disclosure relates to microfabricated sensors, and more particularly, to wearable microfluidic, optical, electronic, and electromagnetic sensors for measuring intraocular pressure (IOP) and corneal temperature. [Background technology]

[0004] background

[0005] Glaucoma is the second most common cause of blindness worldwide. It is a multifactorial disease with several risk factors, of which intraocular pressure (IOP) is the most important. IOP measurements are used for glaucoma diagnosis and patient monitoring. IOP has a wide diurnal variation and depends on body position and several other factors, therefore occasional measurements made by ophthalmologists in clinics can be insufficient and misleading.

[0006] Previously (US20160015265A1, 2018), an implantable microfluidic device that could be used for glaucoma diagnosis was proposed for intraocular pressure monitoring, and later, a wearable device was proposed to serve the same purpose (US2019 / 076021A1, 2019), however, it does not require implantation. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] US Patent Application Publication No. 2016 / 0015265 Summary of the Invention [Means for solving the problem]

[0008] The present disclosure relates to contact lenses with sensors for detecting changes in intraocular pressure (IOP) of the eye. The sensors utilize software technology in the form of a mobile device app to analyze sensor data that may be presented in visual, wireless, or thermal modalities.

[0009] In various embodiments, a contact lens can be formed from two polymer assemblies assembled together like a sandwich. The two polymer assemblies work in concert to form a single contact lens with an IOP sensor. In other embodiments, various methods of making a mold used to make a contact lens with an IOP sensor are described. In other embodiments, various forms of IOP sensors and other forms of sensors for the eye are described.

[0010] In one embodiment, there may be a method for producing a planar mold. The method involves fabricating a planar substrate from a silicon material. Creating one or more reliefs on the planar surface, which will create one or more microfluidic channels in a membrane sheet.

[0011] In an embodiment, there may be a method of producing a mold for use in fabricating contact lenses with sensors. The method involves placing a liquid material on a planar mold, the liquid material capable of changing from a liquid state to a substantially solid state. The planar mold may impart one or more microfluidic channels to the liquid material as the material transitions to a substantially solid state. The substantially solid state of the material forms a membrane sheet. A holder is then placed in the center of the membrane sheet and a portion of the membrane sheet is cut out, the portion of the membrane sheet having the microfluidic channels and the portion of the membrane sheet forming the membrane template. The membrane template is then clamped between the holder and a base assembly. The base assembly may have an opening or hole in the center. The holder may be removed from the base assembly such that the membrane template remains on the base assembly. The base assembly may then be pressed onto the curved mold such that the membrane template is pressed against the curved mold. The base assembly opening may then be filled with additional liquid material. The additional liquid material can be allowed to harden, and the resulting hardened material can form a mold having a curved surface that matches the curvature of the curved mold. The hardened mold can be separated from the curved mold.

[0012] In another embodiment, there can be a method of producing a curved mold for making contact lenses with sensors, the method involves coating a curved mold with photoresist and curing the photoresist. A pattern is then created in the photoresist. The pattern is developed and an elastomer is poured over the developed pattern. The photoresist is then cured to produce a mold.

[0013] In another embodiment, there may be a method of producing a contact lens and sensor device. The method involves forming a bottom membrane layer by coating a curved mold with a liquid elastomer and curing it. The bottom membrane layer is then treated with plasma to make the elastomer surface hydrophilic and promote adhesion of the UV-curable polymer. The elastomer surface is then coated with a UV-curable polymer and the mold is used to imprint a microfluidic layer onto the UV-curable polymer. The method also involves, as a separate process, creating a top membrane layer by pouring elastomer onto a second curved mold, curing the top membrane layer, and releasing the top membrane layer after it has cured. Then, a plasma treatment is performed on the inside of the top membrane, the inside of the top membrane is coated with a UV-curable polymer, partially cured, and the UV-curable polymer is solidified. The top membrane is then placed on a pressurized chamber, the top membrane and the bottom membrane are bonded together to form a contact lens and sensor template, and the contact lens and sensor template are cut to size. The cut forms a sharp edge on the contact lens, and a UV curable polymer is applied to the sharp edge of the contact lens to form an atraumatic edge.

[0014] In one embodiment, there can be an apparatus for measuring intraocular pressure in an eye, the apparatus including an elastomeric contact lens body and a plurality of metallized Fabry-Perot optical interference cavities, the cavities being distributed around an optical portion of the contact lens, where changes in shape and reflected light cause changes in the shape of the contact lens due to changes in intraocular pressure.

[0015] In an embodiment, there can be an apparatus for measuring intraocular pressure in an eye, the apparatus having an elastomeric contact lens body and a group of metallized cavities distributed within a sensor region of the contact lens body, the plurality of metallized cavities changing an electromagnetic resonant response characteristic upon a change in intraocular pressure, either by a change in capacitance or by a change in direct electrical contact between different portions of an antenna.

[0016] In an embodiment, there may be a device for measuring intraocular pressure (IOP) of an eye. The device may have an elastomeric contact lens body with a sensor region. There may be an embedded transmission grating within the sensor region. The grating allows external light to enter into the posterior corneal cavity. Input and output coupling gratings route the external light, and coupling conditions at the angle of incidence and wavelength of the light can be used to calculate the strain exerted on the contact lens.

[0017] In an embodiment, there can be a device for measuring intraocular pressure of an eye. The device can have an elastomeric contact lens body having a sensor region. There can be fluorescent beads embedded within the sensor region.

[0018] In an embodiment, there may be a system for determining changes in intraocular pressure over time. The system may include an elastomeric microfluidic contact lens with a sensor region. Microfluidic channels may be dispersed within the sensor region. The channels may include a density-sensitive material capable of adhering to the microfluidic walls. The system may also have an optical reader for reading changes in the density-sensitive material, where changes in density of the density-sensitive material correspond to changes in intraocular pressure of the eye. Reading the optical density changes on the walls can be used to calculate intraocular pressure. The density-sensitive material may be a dye or fluorescent beads.

[0019] In another embodiment, there can be a device for measuring intraocular pressure of an eye. The device can have an elastomeric contact lens with a sensor area. A liquid crystal thermometer can be embedded in the sensor area, where the liquid crystal thermometer changes color due to temperature changes in the cornea. The present invention provides, for example, the following: (Item 1) 1. A method for producing a planar mold, the method comprising: fabricating a planar substrate from the material; generating one or more reliefs on said planar substrate; Including, the one or more reliefs generate one or more microfluidic channels in the membrane sheet; The method, wherein said material is optionally made from silicon or a silicon composite material. (Item 2) 1. A method of producing a mold for use in fabricating a contact lens sensor, the method comprising: depositing a liquid material onto a planar mold, the liquid material being capable of changing from a liquid state to a substantially solid state, the planar mold imparting one or more microfluidic channels to the liquid material as the material transitions to the substantially solid state, the substantially solid state of the material forming a membrane sheet; placing a holder in the center of the membrane sheet; cutting a portion of the membrane sheet, the portion of the membrane sheet having the microfluidic channel, the portion of the membrane sheet being a membrane template; clamping the membrane template between the holder and a base assembly, the base assembly having an opening; removing the holder from the base assembly such that the membrane template remains on the base assembly; pressing the base assembly against the curved mold such that the membrane template is pressed against the curved mold; filling at least a portion of the base assembly opening with additional liquid material; hardening the liquid material such that the liquid material has a curve that matches the curved mold; Separating the curved mold from the film template. A method comprising: (Item 3) 3. The method of claim 2, wherein transitioning the liquid material to a substantially solid state involves hardening the material over a period of time. (Item 4) 3. The method according to claim 2, wherein the liquid material is a polymer. (Item 5) 3. The method according to claim 2, wherein the liquid material is an elastomeric material. (Item 6) 3. The method according to claim 2, wherein the method is a lithography process. (Item 7) 3. The method of claim 2, wherein one or both of the holder and the base assembly are configured in a substantially tubular shape. (Item 8) 8. The method of claim 7, wherein one or both of the holder and the base assembly are substantially cylindrical. (Item 9) 3. The method of claim 2, wherein one or both of the holder and the base assembly are annular rings. (Item 10) 3. The method of claim 2, wherein the membrane template substantially matches the footprint of the holder. (Item 11) 3. The method of claim 2, wherein the removal of the membrane template is performed using a laser. (Item 12) 1. A method of producing a mold for a contact lens with a sensor, the method comprising: Coating the curved mold with a photoresist; curing the photoresist; and generating a predetermined pattern in the photoresist; developing the photoresist patterned surface; and pouring an elastomer onto the predetermined pattern surface; hardening the photoresist to produce the mold. A method comprising: (Item 13) 1. A method for the production of a sensor and lens arrangement, the method comprising: forming a bottom membrane layer by coating a curved mold with a liquid elastomer; curing the bottom membrane layer; treating the bottom membrane layer with plasma to render the elastomeric surface hydrophilic and promote adhesion of a UV curable polymer; coating the bottom membrane with a UV curable polymer; imprinting a microfluidic layer onto the UV-curable polymer using an etched mold; creating a top membrane layer by pouring an elastomer onto a second curved mold; curing the top film layer; Releasing the top film layer after curing; performing a plasma treatment on the inside of the top film; coating the inside of the top membrane with a UV-curable polymer, partially curing, and solidifying the UV-curable polymer; placing the upper membrane over a pressurized chamber; bonding the top and bottom films together to form a contact lens and a sensor template; cutting the contact lens and sensor template to size, the cutting forming a sharp edge on the contact lens; applying an ultraviolet curable polymer to the steep edge of said contact lens to form an atraumatic edge; A method comprising: (Item 14) Item 14. The method of item 13, wherein creating the hydrophilic elastomeric surface further comprises curing the surface with a UV-curable polymer from the backside. (Item 15) 14. The method according to claim 13, wherein the coating is performed by rotating the mold as the material is being added onto the mold or onto a layer of polymer on the mold. (Item 16) 1. An apparatus for measuring intraocular pressure in an eye, the apparatus comprising: an elastomeric contact lens body with a sensor region; Multiple metallized Fabry-Perot optical interference cavities and Equipped with The cavities are distributed within the sensor area; A device in which the change in shape and reflected light causes a change in the shape of the contact lens due to a change in intraocular pressure. (Item 17) Item 17. The apparatus of item 16, wherein the change in the contact lens shape can be sensed remotely. (Item 18) Item 17. The apparatus of item 16, wherein the change in the contact lens shape can be sensed indirectly. (Item 19) 1. An apparatus for measuring intraocular pressure in an eye, the apparatus comprising: an elastomeric contact lens body with a sensor region; a plurality of metallized cavities distributed within a sensor region of the contact lens body; Equipped with the plurality of metallized cavities act as mechanically variable capacitors and resonant antennas within the contact lens; The device, wherein the plurality of metallized cavities change their electromagnetic resonant response characteristics upon changes in intraocular pressure, by a change in capacitance, or by a change in direct electrical contact between different portions of the antenna. (Item 20) 20. The apparatus of item 19, wherein the intraocular pressure of the eye can be sensed remotely. (Item 21) 20. The apparatus of item 19, wherein the intraocular pressure of the eye can be sensed indirectly. (Item 22) 1. An apparatus for measuring intraocular pressure (IOP) of an eye, the apparatus comprising: an elastomeric contact lens body with a sensor region; a plurality of embedded transmission gratings, the gratings allowing external light to enter into the posterior corneal cavity; a plurality of input and output coupling gratings for routing the external light; Equipped with The coupling conditions at the angle of incidence and wavelength of light can be used to calculate the distortion exerted on the contact lens. (Item 23) 23. The apparatus of claim 22, wherein the strain exerted on the contact lens can be used to determine corneal deformation due to intraocular pressure. (Item 24) 1. An apparatus for measuring intraocular pressure in an eye, the apparatus comprising: an elastomeric contact lens body having a sensor region; a plurality of fluorescent beads embedded within the sensor region; The device comprises: (Item 25) 25. The apparatus of claim 24, wherein the plurality of fluorescent beads are sized to have a diameter of 0.01 μm to 600 μm. (Item 26) 25. The apparatus of claim 24, wherein the plurality of fluorescent beads are sized to have a diameter of 0.1 μm to 400 μm. (Item 27) 25. The apparatus of claim 24, wherein the plurality of fluorescent beads are scattered within the contact lens with an average distance between the fluorescent beads of 1 μm to 10 mm. (Item 28) 25. The apparatus of claim 24, wherein the separation of the plurality of fluorescent beads varies based on changes in intraocular pressure of the eye. (Item 29) 30. The apparatus of claim 28, wherein the separation of the fluorescent beads is determined by a mobile phone app on a camera phone. (Item 30) 1. A system for determining changes in intraocular pressure over time, the system comprising: an elastomeric contact lens with a sensor area; a plurality of microfluidic channels dispersed within the sensor region, the channels comprising a density-sensitive material capable of adhering to a microfluidic wall; an optical reader for reading changes in the density sensitive material; Equipped with the change in density in the density sensitive material corresponds to a change in intraocular pressure in the eye; The system, reading the optical density changes on the wall can be used to calculate intraocular pressure. (Item 31) 31. The system of claim 30, wherein the density-sensitive material is a dye. (Item 32) 31. The system of claim 30, wherein the density-sensitive material is a bead. (Item 33) Item 31. The system of item 30, wherein the optical reader is a mobile phone. (Item 34) 31. The system of claim 30, wherein the density-sensitive material is absorbed into a surface of the microfluidic channel. (Item 35) 35. The system of claim 34, wherein the density-sensitive absorption by the microfluidic channel corresponds to changes in intraocular pressure. (Item 36) 1. An apparatus for measuring intraocular pressure in an eye, the apparatus comprising: an elastomeric contact lens with a sensor area; A plurality of liquid crystal thermometers embedded in the sensor area; Equipped with The liquid crystal thermometer changes color due to changes in temperature of the cornea. (Item 37) Item 37. The apparatus of item 36, wherein the color can be detected remotely. (Item 38) Item 37. The apparatus of item 36, wherein the color can be detected indirectly. [Brief description of the drawings]

[0020] To easily identify the discussion of any particular element or act, the most significant digit(s) in a reference number refers to the number of the figure in which that element is first introduced.

[0021] [Figure 1]FIG. 1 illustrates a planar substrate according to an embodiment 100.

[0022] [Diagram 2] FIG. 2 illustrates the application of an elastomeric material to a mold, according to an embodiment 200.

[0023] [Diagram 3] FIG. 3 illustrates curing a material according to an embodiment 300.

[0024] [Figure 4] FIG. 4 illustrates a holder according to an embodiment 400.

[0025] [Diagram 5] FIG. 5 illustrates placing the holder on the membrane according to an embodiment 500.

[0026] [Figure 6] FIG. 6 illustrates cutting a membrane template according to an embodiment 600.

[0027] [Figure 7] FIG. 7 illustrates a base assembly according to an embodiment 700.

[0028] [Figure 8] FIG. 8 illustrates assembly of a holder and a base assembly according to an embodiment 800.

[0029] [Figure 9] FIG. 9 illustrates a curved mold according to an embodiment 900.

[0030] [Figure 10] FIG. 10 illustrates the assembly of a curved mold and a base assembly according to an embodiment 1000.

[0031] [Figure 11]FIG. 11 illustrates backfilling the membrane into the base assembly according to an embodiment 1100.

[0032] [Figure 12] FIG. 12 illustrates hardening the backfill material according to an embodiment 1200.

[0033] [Figure 13] FIG. 13 illustrates a completed mold according to embodiment 1300.

[0034] [Figure 14] FIG. 14 illustrates producing a film on a curved mold according to an embodiment 1400.

[0035] [Figure 15] FIG. 15 illustrates curing a film on a curved mold according to an embodiment 1500.

[0036] [Figure 16] FIG. 16 illustrates the energy treatment of a membrane according to an embodiment 1600.

[0037] [Figure 17] FIG. 17 illustrates drop casting a membrane according to an embodiment 1700.

[0038] [Figure 18] FIG. 18 illustrates curing the film according to an embodiment 1800.

[0039] [Figure 19] FIG. 19 illustrates steps in a method of making a lens and sensor device according to an embodiment 1900.

[0040] [Figure 20] FIG. 20 illustrates steps in a method of making a lens and sensor device according to embodiment 2000.

[0041] [Figure 21] FIG. 21 illustrates steps in a method of making a lens and sensor device according to embodiment 2100.

[0042] [Figure 22] FIG. 22 illustrates steps in a method of making a lens and sensor device according to an embodiment 2200.

[0043] [Figure 23] FIG. 23 illustrates steps in a method of making a lens and sensor device according to embodiment 2300.

[0044] [Figure 24] FIG. 24 illustrates steps in a method of making a lens and sensor device according to embodiment 2400.

[0045] [Diagram 25] FIG. 25 illustrates steps in a method of making a lens and sensor device according to embodiment 2500.

[0046] [Figure 26] FIG. 26 illustrates steps in a method of making a lens and sensor device according to embodiment 2600.

[0047] [Figure 27] FIG. 27 illustrates steps in a method of making a lens and sensor device according to embodiment 2700.

[0048] [Figure 28] FIG. 28 illustrates steps in a method of making a lens and sensor device according to embodiment 2800.

[0049] [Figure 29]FIG. 29 illustrates steps in a method of making a lens and sensor device according to an embodiment 2900.

[0050] [Diagram 30] FIG. 30 illustrates a stress model according to an embodiment 3000.

[0051] [Diagram 31] FIG. 31 illustrates a series of stress patterns according to an embodiment 3100.

[0052] [Diagram 32] FIG. 32 illustrates a cross-sectional view of a metallized cavity according to an embodiment 3200.

[0053] [Diagram 33] FIG. 33 illustrates a nanoscale patterned film according to an embodiment 3300.

[0054] [Diagram 34] FIG. 34 illustrates a stress deformation example according to embodiment 3400.

[0055] [Diagram 35] FIG. 35 illustrates a cross-sectional view of the lens and sensor area according to embodiment 3500.

[0056] [Diagram 36] FIG. 36 illustrates a shadow mask according to an embodiment 3600.

[0057] [Figure 37] FIG. 37 illustrates an assembly of top and bottom layers according to embodiment 3700.

[0058] [Figure 38] FIG. 38 illustrates an annular sensor component according to an embodiment 3800.

[0059] [Figure 39]FIG. 39 illustrates an annular sensor component with a distortion perturbation cavity, according to an embodiment 3900.

[0060] [Diagram 40] FIG. 40 illustrates a laser system for projecting onto a film according to embodiment 4000.

[0061] [Diagram 41] FIG. 41 illustrates generating a mold according to an embodiment 4100.

[0062] [Diagram 42] FIG. 42 illustrates light interaction with an optical sensor according to an embodiment 4200.

[0063] [Diagram 43] FIG. 43 illustrates a temperature sensor according to an embodiment 4300.

[0064] [Diagram 44] FIG. 44 illustrates a pressure sensor according to an embodiment 4400.

[0065] [Diagram 45] FIG. 45 illustrates a pressure sensor according to an embodiment 4500.

[0066] [Figure 46] FIG. 46 illustrates a pressure sensor according to an embodiment 4600.

[0067] [Figure 47] FIG. 47 illustrates a sensing area with a “C” shaped sensing channel, according to an embodiment 4700. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0068] Various embodiments of contact lenses and IOP sensors, various molds, and methods of making them are described herein. Contact lenses can be used for vision correction, cosmetic appearance, or without vision correction and cosmetic effects. A portion of the contact lens that may be placed over that portion of the eye through which a person (or animal) can see may be visually clear and not otherwise interfere with the vision of the eye. This central portion of the device may be referred to as the visual area. The lens area may provide the appropriate vision correction, an aesthetic color, or simply be clear.

[0069] In various embodiments, the sensor portion of the contact lens may have one or more elements embedded in the periphery of the contact lens. The periphery may be considered to be the annular space around the visual area of ​​the contact lens. The periphery area may be considered to be the sensor area.

[0070] Contact lenses with sensors can be constructed in a variety of ways. In one embodiment, it may be possible to take an existing contact lens and add a sensor area around it. In another embodiment, it may be possible to construct the visual / aesthetic lens and the sensor area at the same time.

[0071] Numerous embodiments are described herein for creating the visual and sensor areas of the top and bottom layers and then combining the two layers to form a single contact lens with the sensor. In various embodiments, there may be a mold for the top layer and a separate mold for the bottom layer. Numerous methods are described herein for creating the two layers (top and bottom) as well as for creating the two molds.

[0072] Various other embodiments are also presented on how contact lenses with sensors can have different sensors to detect and measure different aspects of the eye. Some embodiments measure IOP, some measure temperature changes, and still others measure distortions that the eye can exert on the contact lens. Various devices can be used to collect data from the sensors, including cell phones, tablets, computers, and optical sensors. The optical information can be used in a program or app to provide the user, healthcare provider, or other interested parties with an easily understandable and / or usable summary of the data collected.

[0073] In an embodiment, there may be a planar substrate such as a silicon wafer, a metal plate, or a polymer sheet, as shown in FIG. 1. The planar substrate 100 may have a relief pattern 106 or a negative mold suitable for generating or forming microfluidic structures in the material used on the mold. The planar substrate 100 may have a planar mold 104 and a relief pattern 106. The planar substrate may also have one or more flat edges 102 portions to facilitate use, handling, or separation of the planar mold 104 from the material used with the planar mold 104.

[0074] In some embodiments, more than one mold may be present on the planar substrate, and although a single mold is shown, it should be understood that any number of molds may be fabricated simultaneously on the same substrate.

[0075] Here, a process for making a mold that can be used to fabricate a contact lens with an intraocular pressure sensor is described. The process generally involves placing a liquid material on a planar mold. A liquid is generally a substance that can be deposited in liquid form and then somewhat changed to be substantially solid. When the material solidifies, it takes on the texture and shape of the planar mold. The material can solidify into a membrane. A holder can be placed on the membrane and a portion of the membrane can be cut away around the holder. The holder can have a sticky or viscous surface, so the cut away portion of the membrane will adhere to the holder when the holder is moved. The holder can then be clipped to the base assembly with a membrane section between the holder and the base assembly. Clipping the holder to the base assembly can allow the membrane to transfer onto the base assembly. The base assembly can then be pressed onto the curved mold in a manner that the membrane template is stretched over the curved mold. The base assembly may have an opening or fill port that allows the back end of the base assembly to be filled with a material that will bond to the membrane template when the membrane template is stretched over the curved mold. The added material may then be allowed to harden to solidify. When this process is complete, the curved mold may be separated from the membrane template.

[0076] Various stages of the process for making a curved mold will now be described and illustrated in more detail. In an embodiment, there may be a planar substrate 212 with a planar mold 210 on one or both sides. The planar mold 210 may have a relief pattern 204. A polymeric or elastomeric material 206 may be deposited onto the planar mold 210. The planar mold 210 may be stationary or rotate 202 while the material 206 is added to the planar mold 210. The material 206 thickness may be controlled while the rotation 202 of the planar mold 210 is in progress. The speed of rotation may be controlled to select an appropriate thickness of material 206, as is well understood in the art.

[0077] In various embodiments, the planar substrate 212 may be rotated on a spindle or disk or any other mechanism as is well understood in the art. The material may be beaded in a droplet manner or flowed onto the planar mold 210. The method of adding material 206 to the planar mold 210 may depend on the type of material and the ability to control its deposition on the mold or adjust the material thickness while under rotation.

[0078] Once the material is dispensed onto the planar mold 304, it may be cured using energy 306, such as ultraviolet light, heat, or other forms of energy, as is well understood in the art. The curing time may be according to manufacturing recommendations, or may be shorter or longer. The material when cured forms a substantially solid form. By substantially solid, applicant means that the material may have areas of cured material that may retain some fluid properties. In some embodiments, the material may be partially cured. In alternative embodiments, the material may be a substance that can be converted back to a liquid, semi-liquid, or vapor state by application of energy or chemical reagents. In some embodiments, the material may be an elastomeric compound.

[0079] In some embodiments, the thickness of the membrane sheet 302 can range between 1 and 999 microns (μm). In some embodiments, the thickness of the membrane sheet 302 can range between 25 and 600 microns. In yet other embodiments, the thickness of the membrane sheet 302 can range between 50 and 500 microns.

[0080] Once the membrane material is cured, a holder 402 may be placed on the membrane sheet. The holder may be circular or an annular ring. In some embodiments, the footprint of the holder may be sized to be a particular diameter larger than the diameter of the microfluidic channel formed in the membrane sheet. In other embodiments, the holder footprint may be sized to match the outer diameter of the microfluidic channel. In some embodiments where the shape of the microfluidic channel is not irregular or may not be substantially circular, the holder may have a corresponding footprint of equal or larger size. In some embodiments where the holder may be an annular ring, the inner diameter of the annular ring may be sized such that the inner diameter exceeds the diameter of the microfluidic channel in the membrane sheet.

[0081] In various embodiments, the holder 402 can have one or more holes 404. The holes can be used to align holes in other parts to fasten the holder to another part and create an assembly. In some embodiments, the holder can have an adhesive layer 406. In certain embodiments, the adhesive layer 406 can be double-sided tape. In some embodiments, the adhesive layer 406 can be a viscous material that is affixed to the holder 402. In still other embodiments, the adhesive layer 406 can be a mechanical gripper, suction device, or other temporary mechanical fastener.

[0082] The process of making a curved mold may now proceed with placing a holder 504 at the center of the membrane sheet 502. The viscous portion (not shown) of the holder 504 faces the membrane sheet 502 such that the viscous portion may be in direct physical contact with the membrane sheet 502. The holder 504 may follow a placement orientation 506 as shown and be pressed onto the membrane sheet 502. The opening of the holder may be placed around or above the microfluidic channel 508.

[0083] Once the holder is properly in place, the membrane template may be cut from the membrane sheet. A cutting tool 602 may be used to create a cutting path 606 around the holder 604.

[0084] In various embodiments, the resection tool 602 can be a knife, a laser, or any cutting tool or device (such as an energy device) that can be used to cut the membrane template from the membrane sheet. The resection tool 602 can follow a pre-programmed path such as those generated by a computer controlled cutting tool, or it can be a mechanical device on a cam-following shaft. The membrane template can also be cut manually.

[0085] In some embodiments, the planar mold or planar substrate may be cut away when the membrane is cut away. In alternative embodiments, the cutting path does not damage the planar mold or substrate. In those embodiments in which the planar mold is not damaged, it may be reused.

[0086] In one embodiment, there can be a base assembly 702. The base assembly 702 can have one or more holes 706 in a pattern that matches the holes in the holder so that fasteners such as screws can be used to fasten the holder to the base assembly 702. The base assembly 702 can have a viscous or adhesive layer 704. The adhesive layer can be similar to those already described. The base assembly 702 can have openings so that it is shaped like a tube or hollow cylinder.

[0087] The holder 802 with the membrane template 808 facing the base assembly 804 may now be assembled. The holder 802 and base assembly 804 may be brought together via connection 806 forces with various holes 810 aligned. The holes 810 may then receive fasteners such as screws, pegs, or glue. An adhesive 812 may be placed on the connection side of the base assembly 804 so that the membrane template 808 may adhere to the base assembly 804 when the holder is separated from the combined base assembly 702.

[0088] The membrane template 808 can be of uniform thickness with an opening in the center (inside the area defined by the microfluidic channel). In an alternative embodiment, the membrane template is continuous (has no opening). In one embodiment, an annular ring of material can be used to create a sensor area that can be attached to an existing contact lens.

[0089] In some embodiments, the microfluidic channels can be oriented to face a particular direction, while in other embodiments, other fixtures can be forced to match their orientation to the combined holder and base assembly.

[0090] In various embodiments, the base assembly can be combined with a lower base assembly 904, as shown in Figure 9. The lower base assembly 904 can have a curved mold 902. The curved mold 902 can be a hemispherical or spherical mold, a partially curved mold of a particular radius and arch length or arch perimeter. In some embodiments, the curved mold 902 can be continuous in curvature up to the seam between the curved mold 902 and the lower base assembly 904.

[0091] In various embodiments, the lower base assembly 904 may also have one or more fastener holes 906. The fastener holes 906 may have the same shape and orientation as the holes in the base assembly that allow the lower base assembly 904 and the base assembly to be fastened together using screws, pegs, or other fasteners. Although screws are envisioned as a possible embodiment, the various assembled parts (holder and base assembly, base assembly and lower base assembly) may be fastened using clamps, glue, clips, or other mechanisms. The assembled parts may have a mechanical engagement such as an interference fit together or one screwed onto the other.

[0092] In various embodiments, the curved mold 902 can be made from glass, a non-adhesive material, or other surface that allows the membrane template to stretch over the curved mold and take on substantially the same radius of curvature of the curved mold without distorting the membrane template or the microfluidic channels to the point where either element cannot function.

[0093] As previously described, various embodiments may assemble the lower base assembly with the base assembly, as shown in Figure 10. In some embodiments, screws 1002 may be used as fasteners to secure the base assembly 1004 and the lower base assembly 1008. The base assembly 1004 may be oriented such that the membrane template faces the curved mold 1006 during assembly, such that the membrane template contacts the curved mold 1006 and is stretched over the curved mold 1006 when the base assembly and lower base assembly are fastened together.

[0094] In some embodiments, the film template may not be allowed to completely solidify or harden to allow the film template to better assume the shape over the curved mold 1006 .

[0095] In an embodiment, the base assembly may have a cavity 1108 or opening behind the membrane template 1110, as shown in Figure 11. In an embodiment, the cavity 1108 may be backfilled with additional material 1102 to partially or completely fill the cavity 1108 of the base assembly 1104. The membrane template 1110 acts as a barrier to prevent the backfilled material from contacting the lower base assembly 1106.

[0096] In an embodiment, a curing agent elastomeric material, such as polydimethylsiloxane (or PDMS), may be applied onto the backside of the membrane template 1110. The elastomeric material may then be drained. Once the elastomeric material is drained, the backside cavity 1108 may be filled with a material, such as a premixed elastomeric material. The curing agent may improve the bonding of the elastomeric material layer after curing.

[0097] After the material is added into the cavities of the base assembly, it may be cured as shown in FIG. 12. The base assembly 1202 and lower base assembly 1204 may remain fastened while energy 1206 is applied to the freshly poured mold 1208 of material behind the membrane template 1210. The energy may be of any type suitable for curing the material within the cavities of the base assembly 1202. Some non-limiting examples include ultraviolet (UV) light, heat, visible and non-visible light energy, or other materials such as chemical curing agents. The assembled base and lower base combination may be placed in a chamber such as an oven or light chamber for the curing process. In one embodiment, the energy 1206 is shown radiating from a single direction, but it should be understood that the energy may originate from one or more point sources or may originate from an energy source and indirectly reach the mold 1208 and cure it, as in the case of an oven chamber.

[0098] A cross-sectional view of a mold 1302 formed into a base assembly 1304 and a membrane template 1306 is shown in Figure 13. The mold 1302 can be separate from the lower base assembly and can be used in an imprint process to make contact lenses and IOP sensing devices.

[0099] An alternative method of making contact lens and IOP sensor molds is now described. In various embodiments, there may be a curved mold that may be coated with photoresist. The photoresist may then be cured for a period of time. The curing time may be greater than, less than, or equal to the amount of time normally used for photoresist materials. When the photoresist reaches a suitable cured state, a pattern may be generated on the surface of the photoresist, and the pattern may be developed to produce one or more reliefs or other features for the creation of microfluidic channels. An elastomeric compound may then be poured over the patterned surface and cured to produce the contact lens and IOP sensor molds.

[0100] In one embodiment, the bottom membrane layer may be fabricated by drop casting 1406 a thin layer of elastomeric material 1402 (such as premixed PDMS) onto a curved mold 1408, as shown in Figure 14. The curved mold 1408 may be located or affixed to a lower base assembly 1404. The curved mold may be a glass hemisphere, sphere, or other suitable material. The elastomeric material may be a photoresist material.

[0101] In certain embodiments, the elastomeric film 1502 may be cured by the application of energy 1504. In various embodiments, the energy 1504 may be thermal energy (heat), ultraviolet light, or other curing energy. In some alternative embodiments, the elastomeric film 1502 may be cured by exposing it to a curing compound. The elastomeric film 1502 thickness may be controlled by the composition of the material used for the film, the viscosity, or the spinning process prior to curing.

[0102] In an embodiment, the elastomer layer may be treated with plasma 1602 to improve bonding of a subsequent UV curable polymer layer. A lower base assembly 1606 with a curved mold serves as a substrate for the membrane and photoresist layer 1604 during plasma 1602 treatment. The plasma 1602 may be used to create a pattern in the photoresist.

[0103] In one embodiment, the elastomeric compound 1702 can be drop cast 1712 to form a PDMS film 1714 (or other suitable material), as shown in Figure 17. The PDMS can be drop cast 1712 onto the curable polymer layer 1704 with another film 1706 layer underneath. The lower base assembly 1708 can be rotated in either direction as the curable elastomeric compound 1702 is spin coated 1710 onto the curable polymer layer 1704.

[0104] In some embodiments, the PDMS membrane 1714 can be between 0.01 microns and 999 microns. In some embodiments, the PDMS membrane 1714 can be between 1 and 300 microns. In yet other embodiments, the membrane can be between 10 and 50 microns.

[0105] In one embodiment, the curable polymer layer 1804 may be cured using ultraviolet light 1810 projected through an opening 1812 in the lower base assembly 1808. The ultraviolet light 1810 may shine through the film 1802 and the curved mold 1806 (which may be partially or mostly transparent to the ultraviolet light). When the curing process is complete, the mold may be finished.

[0106] In an embodiment, there may be a thin bottom PDMS membrane 1910 with a partially cured UV curable polymer layer 1906, which may be drop cast 1908 by an applicator to form a second layer of UV curable polymer 1904, as shown in Figure 19. In an embodiment, the membrane 1910 may have a base elastomer 1902 layer, a first UV curable polymer layer 1906, and a second layer of UV curable polymer 1904. The membrane 1910 may be formed on a curved mold supported by a base assembly 1912.

[0107] In one embodiment, as shown in Figure 20, a curved mold 2004 may be brought into contact with the previously described assembly and a controlled pressure 2002 may be applied to perform the imprinting step. The layer 2006 may be partially cured by ultraviolet light 2008 while the two components are in contact.

[0108] In one embodiment, a PDMS unpatterned membrane 2106, prepared as previously described, can be peeled off from a curved mold 2102, which can be supported by a base assembly 2104, as shown in FIG.

[0109] In one embodiment, the PDMS membrane 2204 can be flipped upside down and placed onto a cylindrical holder 2206, as shown in Figure 22. The upside-down membrane 2204 can be pressed into the holder 2206 using a suitable force 2202.

[0110] In one embodiment, the concave side of the PDMS membrane 2304 may be exposed to a plasma 2302 to promote adhesion of the UV-curable polymer layer, as shown in Figure 23. The membrane 2304 may be held in place by a membrane holder 2306.

[0111] In one embodiment, an applicator can be used to drop cast UV curable resin 2402 into the concave side of the curved membrane 2304, as shown in Figure 24. The membrane holder 2406 can be rotated 2408 to spin coat the resin onto the membrane.

[0112] In an embodiment, as shown in Figure 25, there may be a pressure cap 2504 with a gas port 2502 and a window 2512. The window 2512 may be transparent to ultraviolet light and / or other forms of optical energy. A membrane 2508 may be attached to a holder 2510. The membrane may have a layer 2506 of ultraviolet curable resin that has been partially cured.

[0113] In an embodiment, a retaining ring 2602 may be attached from the top of the assembly of Fig. 25 to hermetically seal the pressure chamber and hold the PDMS membrane 2604 in place, as shown in Fig. 26. The retaining ring 2602 may hold the membrane 2604 in approximately place without causing distortion in the plane that may cause deformation of the membrane. The UV curable resin may be slightly cured using UV light 2606 to maintain partial adhesive properties.

[0114] In one embodiment, two assemblies of the device with a top membrane 2702 and a bottom membrane 2704 can be brought into contact by the application of pressure 2706, as shown in FIG.

[0115] In one embodiment, a top layer 2802 and a bottom layer 2804 may be bonded together using ultraviolet light 2806, as shown in Figure 28. Pressure 2808 may be applied to the two layers while the ultraviolet bonding is occurring.

[0116] In an embodiment, a contact lens with an IOP sensor 2906 may be exposed by removing the top mold assembly, as shown in FIG. Exposing the contact lens with the IOP sensor 2906 may allow a punch cutter 2904 to be centered over the lens. Application of force 2902 may separate the contact lens with the IOP sensor 2906 from the curved mold assembly 2908.

[0117] In another embodiment, after bonding, the top mold can be removed to allow access for a cylindrical punch cutter. The assembled lens can be cut using the punch and removed from the curved mold. The lens can then be filled with detection fluid, made hydrophilic, and ready for use.

[0118] We now proceed to describe various methods for measuring intraocular pressure based on the optical changes of a metal-insulator-metal cavity upon strain.

[0119] An exemplary model of strain distribution in an elastomeric contact lens is shown in FIG. 30. As can be seen, the von Mises stress pattern is shown with a scale of stress to the left of the image. The image is a computer generated image of an actual contact lens, according to one embodiment. Distortion can be seen near the edge of the contact lens.

[0120] In various embodiments, various stress situations can be demonstrated as shown in Figure 31. A cross section 3102 of an unstressed cavity lens is shown at the top of the drawing page. In another embodiment, a stressed cavity pattern 3104 is shown in the center. The bottom illustrates cavities 3106 that have been stressed until they are caused to collapse.

[0121] In one embodiment, a cross-sectional view of a metallized elastomeric rectangular cavity is shown. The cavity 3202 may be coated or surrounded by a thin metal film 3206 strip sandwiched between elastomer layers 3204. This design forms an interference structure whose optical properties depend sensitively on the deformation of the cavity.

[0122] An alternative view of a thin metal film is shown in FIG. 33. In one embodiment, a cavity 3310 is surrounded by a patterned metal film 3302 and a thin metal film 3306. The two metal films can be sandwiched between a pair of elastomer layers 3304. The patterned metal film 3302 can be a nanoscale patterned metal film. The pattern can be useful for tuning optical properties such as optical resonance and angular response. Periodic or quasi-periodic metal patterns with characteristic dimensions ranging from 1 nanometer to 10 micrometers can be used. The size and pattern of the structures can be optimized to improve the optical response at a particular wavelength and angle incidence.

[0123] In one embodiment, a cross-section of a metallized elastomeric rectangular cavity and its deformation under applied stress is shown in Figure 34. Stress vectors are shown in the horizontal plane, causing the cavity to pull on the sides and contract along the top and bottom. The elastomeric layer provides a flexible medium that can withstand various stress and strain forces without damaging the material. The top and bottom arrows illustrate the vectors of light waves entering and exiting the lens to read the level of force, stress, or strain on the contact lens.

[0124] A cross-sectional view of an embodiment of a contact lens is shown in Figure 35. In one embodiment, a contact lens 3506 has a viewing area 3502 and a sensing area 3504. The viewing area may be generally transparent and substantially free of microfluidic structures, sensors, or other elements that may adversely affect vision. The sensing area 3504 may include sensors that respond to changes in the eye's IOP, sensors that detect stress or strain based on the shape of the eye, etc.

[0125] In an embodiment, there may be a metal-insulator-metal (MIM) cavity in the sensing region 3504. The MIM cavity may detect changes in the IOP of the eye and change shape in response to the change in IOP. The shape change may advance or recede a fluid-air interface in the microfluidic channel, which may be read by an optical sensor.

[0126] In another embodiment, there may be a metallization procedure for a contact lens with an IOP sensor, as shown in FIG. 36. In an embodiment, a lower base assembly 3608 may hold a curved mold 3604. The curved mold may have a bottom membrane 3606, a UV curable layer 3614, and a metal layer 3612 as shown. Metal deposition 3602 may occur through a shadow mask 3610 to deposit metal on the metal layer 3612. In some embodiments, deposition may be done by evaporation or sputtering. In other embodiments, the metal layer may be laid down on the membrane without a shadow mask 3610, and instead may be EDM (electrical discharge machining) or micromachined into a specific pattern.

[0127] In various embodiments, the bottom film 3606 and the UV curable layer 3614 can be any similarly described layers herein.

[0128] In an embodiment, the assembly of the various layers is shown in FIG. 37. In an embodiment, the holder 3704 may have a pressurized cap 3702 with air access holes 3714. The top membrane 3706 may have a UV curable resin layer 3708 and a metal layer 3718. The lower base assembly 3712 may have a thin bottom membrane 3710 which may include a second metal layer 3720, a UC UV curable layer 3722, and a bottom membrane 3724. The thin bottom membrane 3710 composition may be placed on a curved mold on the lower base assembly 3712. The top and bottom membranes may be pressed together, bonded, and formed into an elastomeric contact lens with an optical strain sensor.

[0129] In one embodiment, the contact lens 3810 may have a series of metallized cavities 3802. A cross-sectional view is shown with a metallized layer 3808, metallized cavities 3806, and the contact lens 3810. In this embodiment, distortions caused by changes in the eye's IOP may perturb the cavities and modify the electromagnetic resonance of the ring-shaped metallized cavities 3802, causing the ring to act as a remote sensing antenna. In one embodiment, the lens may sense intraocular pressure through remote radio frequency measurements, similar to an RF-ID chip readout.

[0130] In another embodiment, a contact lens 3902 may have a metallized region 3904 with a cavity 3906, as shown in FIG. 39. Changes in the IOP of the eye may perturb the cavity 3906 into distortion. The alteration of the cavity may modify the electromagnetic resonance of the metallized region 3904 to act as a remote sensing antenna. In this embodiment, the lens may be used to sense changes in intraocular pressure through remote radio frequency resonance measurements, similar to the readout of an RFID chip.

[0131] In one embodiment, a cross-sectional view of a metallized region 3904 is shown. The cross-sectional view shows a single cavity 3910 and metallized layers 3908 on two of the sides of the cavity. The cavity is embedded in a contact lens 3912. While this embodiment shows two sides of the cavity with metallized layers, it should be understood that the cavity may have metallized layers on anywhere from one to four sides. The cavity may not be a regular polygon and may have a circular cross-section. In such cases, the cavity may have any portion of the circumference of the cross-section metallized to achieve similar results as described herein.

[0132] In yet another embodiment, there is an alternative method of making a curved mold 4002, as shown in Figure 40. In one embodiment, a curved mold 4002 can be coated with photoresist 4006. A laser projection system 4012 can be used to define a microfluidic channel pattern 4008 directly on the curved mold 4002 with the photoresist 4006 by UV exposure 4010.

[0133] In some embodiments, the polymer layer may be made of a photodefinable polymer such as SU8. The microfluidic channels may form concentric rings that are "C" rings around the sensor area with switchback corners to provide a continuous channel going around the periphery.

[0134] In some embodiments, the microfluidic sensor may use an air reservoir. The height of the air reservoir may be between 1 micron and 1 mm. In some other embodiments, the height of the air reservoir may be between 5 and 500 microns. In yet other embodiments, the height of the air reservoir may be between 10 and 200 microns.

[0135] In some embodiments, an air reservoir may also be provided. In some embodiments, the air reservoir may have a width of 1 μm to 10 mm. In other embodiments, the width may be from 10 microns to 1 mm. In yet other embodiments, the width of the air reservoir may be from about 30 microns to 200 microns.

[0136] In some embodiments, the number of liquid reservoir channels can be between about 1 and 1,000,000. In some other embodiments, the number of liquid reservoir channels can be between about 1 and 100. In still other embodiments, the number of liquid reservoir channels can be between about 1 and 20.

[0137] In another embodiment for making a mold, the top side of a curved mold 4110 with the microfluidic pattern 4102 can be turned into a mold by filling the top opening of the holder 4104 with elastomer 4106. A cylindrical housing 4108 contains the elastomer 4106, and the elastomer 4106 can be allowed to harden. The curved mold 4110 can be attached to a lower base assembly 4112.

[0138] An alternative method and device for measuring IOP can be seen in the embodiment shown in FIG. 42. In this embodiment, light 4210 entering the eye can pass through a contact lens 4202 placed on the cornea 4208. Some incoming light 4210 passes through a transmission grating for input light 4212 and output light 4206. The input light 4212 can be diffracted internally and pass through the cornea 4208 or the posterior corneal cavity (beyond the iris) and outcoupled back as an output signal or light 4204 exiting the eye. The exiting light 4204 can be imaged using a conventional color or spectrally resolved camera system in terms of intensity and position to extract distortion-related perturbations of the lens and cornea.

[0139] In yet another embodiment, a contact lens 4302 may have one or more microfluidic features 4304 and an embedded liquid crystal pattern 4306, as shown in FIG. 43. In some embodiments, the embedded liquid crystal pattern 4306 may generate a color palette that can be detected by a camera, such as those on a cell phone or tablet. The color palette may be read out and compared to an optical thermometer array 4308. The liquid crystal optical thermometer array 4308 may be used to measure temperature based on different spots with varying color transition temperatures. A contact lens 4302 with microfluidic features 4304 or other optical features may now complement independent measurements by using the embedded liquid crystal pattern 4306. An image of the lens may yield the device temperature.

[0140] In another embodiment, an alternative feature for contact lenses is shown in FIG. 44. In an embodiment, the solution may be mixed with beads or dyes that have low binding affinity. As the intraocular pressure changes throughout the day, the dye may bind to the channel walls in which the solution resides. The longer the channel walls are exposed to the dye, the darker or more intense the staining on the walls. Based on the residence time, the maximum, average, and standard deviation of intraocular pressure may be calculated from a color correlation map (shown with a spectrum from dark to light).

[0141] In yet another embodiment, additional features for contact lenses with sensors are shown in FIG. 45. In one embodiment, the microchannels of the lens can be filled with red dye (or beads). The red dye (or beads) can be withdrawn after an incubation period. The dye can leave a red residue through the channel with the dye bound to the channel walls. Later, a solution with blue dye can be loaded into the channel for intraocular pressure measurement. Imaging methods can be used to read out color correlations through the channel for red and blue colors. Using correlation algorithms, it can be possible to calculate the maximum, average, and standard deviation of intraocular pressure throughout the day and night.

[0142] In another embodiment, beads can be embedded in a contact lens as shown in FIG. 46. The fluorescent beads can have a diameter of 10 nm to 1 mm. In some embodiments, the diameter can be 1 to 250 microns. In yet other embodiments, the diameter of the beads can be 20 to 100 microns. The beads can be placed in a contact lens. The contact lens can be made of a transparent elastic material. The beads can be located using a variety of coupling techniques, using an excitation source such as ultraviolet or blue or green LED light, and using a camera with an emission band base filter, or a smartphone adapter with the same components. The beads can be located with high accuracy by fitting the point spread function to a 2-D Gaussian function, and the distance between the beads can be determined with micrometer accuracy using such data processing. As the intraocular pressure changes, the lens can stretch or compress, and the relative position of the beads can change due to the change in the curvature of the eye. The distortion on the contact lens can be determined for each bead pair, and the overall pressure change can be accurately calculated.

[0143] In some embodiments, the distance between the beads may be between 1 micron and 10 cm. In other embodiments, the distance between the beads may be between 10 microns and 1 mm. In yet other embodiments, the distance between the beads may be between 50 and 500 microns.

[0144] In an embodiment, a C-shaped sensing channel 4704 may be used instead of one or more annular ring channels, as shown in FIG. 47. The sensing channel 4704 may have a fill port for adding liquid and a reporting channel 4702 for indicating the level of intraocular pressure the eye is experiencing. An air reservoir 4706 provides air and forms a gas-air interface in the microfluidic channel 4710. A scale 4712 may be present on the sensing area. In an embodiment, the scale may be viewed using a camera, such as on a cell phone, and an image may indicate the level of IOP according to the location of the liquid-gas interface on the microfluidic channel 4710.

[0145] Advantages of the present disclosure include, but are not limited to, a robust process for the creation of a highly sensitive wearable contact lens sensor that requires no power or circuitry and can be remotely monitored by a simple camera such as those found on a cell phone.

[0146] Various aspects of the disclosure are now provided.

[0147] 1. An aspect of a method for producing a planar mold, the method comprising:

[0148] fabricating a planar substrate from the material;

[0149] Producing one or more reliefs on a planar substrate;

[0150] wherein the one or more reliefs generate one or more microfluidic channels in the membrane sheet;

[0151] The material is optionally made of silicon or a silicon composite material; method.

[0152] 2. An aspect of a method for producing a mold for use in fabricating a contact lens sensor, the method comprising:

[0153] depositing a liquid material onto a planar mold, the liquid material being capable of changing from a liquid state to a substantially solid state, the planar mold imparting one or more microfluidic channels to the liquid material as the material transitions to the substantially solid state, the substantially solid state of the material forming a membrane sheet;

[0154] placing a holder in the center of the membrane sheet;

[0155] Cutting out a portion of a membrane sheet, the portion of the membrane sheet having a microfluidic channel and the portion of the membrane sheet being a membrane template;

[0156] Clamping the membrane template between a holder and a base assembly, the base assembly having an opening;

[0157] removing the holder from the base assembly such that the membrane template remains on the base assembly;

[0158] pressing the base assembly against a curved mold such that the membrane template is pressed against the curved mold;

[0159] filling at least a portion of the base assembly opening with additional liquid material;

[0160] hardening the liquid material such that the liquid material has a curve that matches the curved mold;

[0161] Separating the curved mold from the membrane template; and A method comprising:

[0162] 3. The method of aspect 2, wherein transitioning the liquid material to a substantially solid state involves hardening the material over a period of time.

[0163] 4. The method of aspect 2, wherein the liquid material is a polymer.

[0164] 5. The method of aspect 2, wherein the liquid material is an elastomeric material.

[0165] 6. The method of aspect 2, wherein the method is a lithographic process.

[0166] 7. The method of aspect 2, wherein one or both of the holder and base assembly are configured in a substantially tubular shape.

[0167] 8. The method of aspect 7, wherein one or both of the holder and the base assembly are substantially cylindrical.

[0168] 9. The method of aspect 2, wherein one or both of the holder and base assembly are annular rings.

[0169] 10. The method of aspect 2, wherein the membrane template substantially conforms to the footprint of the holder.

[0170] 11. The method of aspect 2, wherein the removal of the membrane template is performed using a laser.

[0171] 12. An aspect of a method of producing a mold for a contact lens with a sensor, the method comprising:

[0172] Coating the curved mold with a photoresist;

[0173] hardening the photoresist; and

[0174] Creating a predetermined pattern in a photoresist;

[0175] developing the photoresist patterned surface;

[0176] Pouring an elastomer onto a predetermined pattern surface;

[0177] hardening the photoresist to produce a mold; A method comprising:

[0178] 13. An aspect of a method for the production of a sensor and lens arrangement, the method comprising:

[0179] forming a bottom membrane layer by coating a curved mold with a liquid elastomer;

[0180] curing the bottom membrane layer;

[0181] treating the bottom membrane layer with plasma to render the elastomeric surface hydrophilic and promote adhesion of the ultraviolet curable polymer;

[0182] coating the bottom membrane with a UV-curable polymer;

[0183] imprinting a microfluidic layer onto a UV-curable polymer using the etched mold;

[0184] creating a top membrane layer by pouring an elastomer onto a second curved mold;

[0185] curing the top film layer;

[0186] Releasing the top film layer after curing;

[0187] performing a plasma treatment on the inside of the top film;

[0188] coating the inside of the top membrane with an ultraviolet curable polymer and partially curing and solidifying the ultraviolet curable polymer;

[0189] placing an upper membrane over the pressurized chamber;

[0190] bonding the top and bottom films together to form a contact lens and a sensor template;

[0191] cutting the contact lens and the sensor template to size, the cutting forming a sharp edge on the contact lens;

[0192] applying an ultraviolet light curable polymer to the steep edge of the contact lens to form an atraumatic edge; A method comprising:

[0193] 14. The method of aspect 13, wherein creating a hydrophilic elastomeric surface further comprises curing the surface with an ultraviolet-curable polymer from the backside.

[0194] 15. The method of aspect 13, wherein the coating is performed by rotating the mold as the material is being added onto the mold or onto a layer of polymer on the mold.

[0195] 16. An aspect of a device for measuring intraocular pressure in an eye, the device comprising:

[0196] an elastomeric contact lens body with a sensor region;

[0197] a plurality of metallized Fabry-Perot optical interference cavities, the cavities being distributed within the sensor area;

[0198] wherein the change in shape and reflected light causes a change in the shape of the contact lens due to a change in intraocular pressure. Device.

[0199] 17. The device of aspect 16, wherein the change in contact lens shape can be sensed remotely.

[0200] 18. The device of aspect 16, wherein the change in contact lens shape can be sensed indirectly.

[0201] 19. An aspect of a device for measuring intraocular pressure in an eye, the device comprising:

[0202] an elastomeric contact lens body with a sensor region;

[0203] a plurality of metallized cavities distributed within the sensor region of the contact lens body;

[0204] a plurality of metallized cavities acting as mechanically variable capacitors and resonant antennas within the contact lens;

[0205] The plurality of metallized cavities change their electromagnetic resonant response characteristics upon changes in intraocular pressure, either by a change in capacitance or by a change in direct electrical contact between different portions of the antenna. Device.

[0206] 20. The device of aspect 19, wherein the intraocular pressure of the eye can be sensed remotely.

[0207] 21. The device of aspect 19, wherein the intraocular pressure of the eye can be sensed indirectly.

[0208] 22. An aspect of a device for measuring intraocular pressure (IOP) of an eye, the device comprising:

[0209] an elastomeric contact lens body with a sensor region;

[0210] a plurality of embedded transmission gratings, the gratings allowing external light to enter into the posterior corneal cavity;

[0211] a plurality of input and output coupling gratings for routing external light;

[0212] and the coupling conditions at the angle of incidence and wavelength of light can be used to calculate the distortion exerted on the contact lens. Device.

[0213] 23. The device of aspect 22, wherein the distortion exerted on the contact lens can be used to determine corneal deformation due to intraocular pressure.

[0214] 24. An aspect of a device for measuring intraocular pressure in an eye, the device comprising:

[0215] an elastomeric contact lens body having a sensor region;

[0216] a plurality of fluorescent beads embedded within the sensor region; The device comprises:

[0217] 25. The device of aspect 24, wherein the plurality of fluorescent beads are sized to have a diameter of 0.01 μm to 600 μm.

[0218] 26. The device of aspect 24, wherein the plurality of fluorescent beads are sized to have a diameter of between 0.1 μm and 400 μm.

[0219] 27. The device of aspect 24, wherein the multiple fluorescent beads are scattered within the contact lens with an average distance between the fluorescent beads of 1 μm to 10 mm.

[0220] 28. The device of aspect 24, wherein the separation of the multiple fluorescent beads varies based on changes in intraocular pressure in the eye.

[0221] 29. The device of aspect 28, wherein the separation of the fluorescent beads is determined by a mobile phone app on a camera-equipped mobile phone.

[0222] 30. An aspect of a system for determining changes in intraocular pressure over time, the system comprising:

[0223] an elastomeric contact lens with a sensor area;

[0224] a plurality of microfluidic channels dispersed within the sensor region, the channels comprising a density-sensitive material capable of adhering to a microfluidic wall;

[0225] an optical reader for reading the changes in the density sensitive material;

[0226] a change in density of the density sensitive material corresponds to a change in intraocular pressure of the eye;

[0227] The system reading the optical density changes on the wall can be used to calculate intraocular pressure.

[0228] 31. The system of aspect 30, wherein the density-sensitive material is a dye.

[0229] 32. The system of aspect 30, wherein the density-sensitive material is a bead.

[0230] 33. The system of aspect 30, wherein the optical reader is a mobile phone.

[0231] 34. The system of aspect 30, wherein the density-sensitive material is absorbed into a surface of the microfluidic channel.

[0232] 35. The system of aspect 34, wherein density-sensitive absorption by the microfluidic channel corresponds to changes in intraocular pressure.

[0233] 36. An aspect of a device for measuring intraocular pressure in an eye, the device comprising:

[0234] an elastomeric contact lens with a sensor area;

[0235] A plurality of liquid crystal thermometers embedded in the sensor area, the liquid crystal thermometers changing color due to a change in temperature of the cornea; The device comprises:

[0236] 37. The device of aspect 36, wherein the color can be detected remotely.

[0237] 38. The device of aspect 36, wherein the color can be detected indirectly.

Claims

1. 1. A method for the production of contact lenses and sensor devices, the method comprising: forming a bottom membrane layer by coating a curved mold with a liquid elastomer; curing the bottom membrane layer; treating the bottom membrane layer with plasma to render the elastomeric surface hydrophilic and promote adhesion of UV or thermal curable polymers; coating said bottom membrane with said UV or thermal curable polymer; imprinting a microfluidic layer onto said UV or thermal curable polymer using an etched mold; creating a top membrane layer by pouring an elastomer onto a second curved mold; curing the top film layer; Releasing the top film layer after curing; performing a plasma treatment on the inside of the top film; coating the inside of the top membrane with the UV or heat curable polymer, partially curing, and solidifying the UV or heat curable polymer; placing the upper membrane over a pressurized chamber; bonding the top and bottom membranes together to form a contact lens and a sensor template, the sensor template comprising a plurality of cavities between the bottom and top membrane layers, the plurality of cavities being surrounded by a thin metal film; cutting the contact lens and sensor template to size, the cutting forming a sharp edge on the contact lens; applying a UV or heat curable polymer to the steep edge of the contact lens to form an atraumatic edge; A method comprising:

2. The method of claim 1, wherein the creation of a hydrophilic elastomeric surface further comprises curing the surface from the back side with a UV or thermosetting polymer.

3. The method of claim 1 , wherein the coating is performed by rotating the mold as the material is being added onto the mold or a layer of polymer on the mold.

4. The method of claim 1, wherein the plurality of cavities comprises a plurality of metallized Fabry-Perot optical interference cavities, the cavities being distributed around the optical portion of the contact lens.

5. The method of claim 1 , further comprising sandwiching a patterned metal film and a thin metal film between the bottom membrane layer and the top membrane layer.

6. further comprising incorporating a series of metallized cavities between the bottom film layer and the top film layer; The method of claim 1 , wherein the metallized cavity produces electromagnetic resonance under strain.

7. 10. The method of claim 1, further comprising adding a solution into the microfluidic layer, the solution being mixed with beads or dyes having low binding affinity.

8. The method of claim 7, wherein the beads are fluorescent beads, the fluorescent beads having a diameter between 0.01 μm and 600 μm.

9. The method further includes a method for producing the etched mold, The method for producing the etched mold comprises: depositing a liquid material onto a planar mold, the liquid material capable of changing from a liquid state to a substantially solid state, the planar mold imparting one or more microfluidic channels to the liquid material as the material transitions to the substantially solid state, the substantially solid state of the material forming a membrane sheet; placing a holder in the center of the membrane sheet; cutting a portion of the membrane sheet, the portion of the membrane sheet having the microfluidic channel, the portion of the membrane being a membrane template; clamping the membrane template between the holder and a base assembly, the base assembly having an opening; removing the holder from the base assembly such that the membrane template remains on the base assembly; pressing the base assembly against the curved mold such that the membrane template is pressed against the curved mold; filling at least a portion of the base assembly opening with additional liquid material; hardening the liquid material such that the liquid material has a curve that matches the curved mold; Separating the curved mold from the film template. The method of claim 1 , comprising:

10. The method further includes a method for producing the etched mold, the method comprising: Coating the curved mold with a photoresist; curing the photoresist; and generating a predetermined pattern in the photoresist; developing the photoresist patterned surface; and pouring an elastomer onto the predetermined pattern surface; hardening the photoresist to produce the mold. The method of claim 1 , comprising:

11. The method of claim 1 , further comprising arranging sensor regions around a viewing region of the contact lens.

12. The method of claim 1 , wherein imprinting the microfluidic layer further comprises imprinting a fluid reservoir and an air reservoir.

13. The method of claim 1, wherein each of the plurality of cavities has at least a deformable top side and a deformable bottom side.

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