Hydrogel film application

Abstract

An apparatus and method for applying a hydrogel film to a product are provided. The hydrogel film can be created by injecting a monomer solution into a mold, polymerizing the monomer solution in the mold to produce a hydrogel sheet, and cutting the hydrogel sheet to create one or more hydrogel films. The process can include applying a hydrogel film of the one or more hydrogel films to the product. Applying the hydrogel sheet to the product can include applying an adhesive to the product, placing a first edge of the hydrogel film on the adhesive on the product, and placing a second edge of the hydrogel film on the adhesive on the product.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application Serial No. 63 / 378,175, filed October 3, 2022, the entire contents of which are incorporated herein by reference.

[0002] FIELD OF THE INVENTION

[0003] The present disclosure relates to an apparatus and method for applying a hydrogel film to a product. [Background technology]

[0003]

[0004] Background Statement

[0005] One example of a product that includes one or more hydrogel films is an analyte sensor. The analyte sensor can be part of an analyte monitoring system, which can be used to monitor analyte levels, such as analyte concentrations (e.g., glucose concentrations). One type of analyte monitoring system is a continuous analyte monitoring system. Continuous analyte monitoring systems measure analyte levels throughout the day and can be very useful in managing diseases such as diabetes.

[0004]

[0006] The hydrogel film of the analyte sensor can include an analyte indicator molecule that produces a detectable characteristic (e.g., an optical characteristic) that indicates the presence and / or amount of an analyte (e.g., glucose) in a fluid (e.g., interstitial fluid) proximate to the hydrogel film. For example, the analyte indicator molecule can reversibly bind to the analyte and, upon irradiation with excitation light, emit an amount of light (e.g., fluorescent light) that indicates whether the analyte is bound. The analyte sensor can include a detector (e.g., a photodetector) that outputs a signal that indicates the detectable characteristic produced by the analyte indicator molecule (e.g., the amount of light emitted by the analyte indicator molecule).

[0005]

[0007] For products that include a hydrogel film (eg, an analyte sensor such as a glucose sensor), the product must be manufactured by forming the hydrogel into the product. Summary of the Invention

[0006]

[0008] For products including hydrogel films (e.g., analyte sensors such as glucose sensors) that are manufactured by forming a hydrogel into a product, the hydrogel film must be formed into each individual product. Additionally, if the hydrogel formed into a product is defective, the hydrogel cannot be removed from the product and the product cannot be used. Thus, conventional processes for forming hydrogels into products would be wasteful because defective hydrogels would result in discarding an otherwise fully functional, potentially expensive, product. Furthermore, in certain non-limiting embodiments, the thickness of the hydrogel formed into the product can have a preferred thickness (e.g., a hydrogel having a thickness not exceeding approximately 500 microns (approximately 0.020 inches)).

[0007]

[0009] Aspects of the present invention can provide the advantage of hydrogel films that are produced separately from a product. The separately produced hydrogel films can be inspected before application to the product, so that only successfully produced hydrogel films are applied to the product. In some aspects, the applied hydrogel film can be removable from the product so that if the applied hydrogel film fails inspection, the hydrogel film can be peeled off and another hydrogel film can be applied. In this way, a potentially expensive and otherwise fully functional product need not be discarded due to problems with the applied hydrogel film.

[0008]

[0010] Some aspects of the present invention can provide the advantage of a scalable hydrogel film production process. In some aspects, many hydrogel films can be made by manufacturing a hydrogel sheet and then cutting the hydrogel sheet into hydrogel films. In some aspects, when the hydrogel film is produced separately from the product, a larger range of hydrogel film thicknesses may be possible (compared to the thickness range possible for hydrogels formed into products).

[0009]

[0011] One aspect of the present invention can provide a process that includes injecting a monomer solution into a mold. The process can include polymerizing the monomer solution in the mold to produce a hydrogel sheet. The process can include cutting the hydrogel sheet to create one or more hydrogel films. The process can include applying one or more of the hydrogel films to a product.

[0010]

[0012] In some embodiments, the mold can include a first plate and a second plate and one or more clips configured to hold the first plate and the second plate together, and the monomer solution can be injected between the first plate and the second plate. In some embodiments, the first plate can be a glass plate, the second plate can be a stamping plate, and the one or more clips can be plastic clips. In some embodiments, the process can further include assembling the mold. In some embodiments, injecting the monomer solution into the mold can include injecting the monomer solution into an injection port of the mold.

[0011]

[0013] In some embodiments, cutting the hydrogel sheet to create one or more hydrogel films can include using a hydrogel cutting tool to divide the hydrogel sheet. In some embodiments, using the hydrogel cutting tool to cut the hydrogel sheet can include providing the hydrogel sheet between a platform of the hydrogel cutting tool and a cutout sheet, where the platform includes protrusions and the cutout sheet includes openings that mate with the protrusions of the platform. In some embodiments, using the hydrogel cutting tool to divide the hydrogel sheet can include inserting the protrusions of the platform into the openings of the cutout sheet.

[0012]

[0014] In some embodiments, applying the hydrogel sheet to the product can include applying an adhesive to the product, placing a first edge of the hydrogel film on the adhesive on the product, and placing a second edge of the hydrogel film on the adhesive on the product. In some embodiments, the adhesive can include silicone, siloxane, acrylate, cyanoacrylate, epoxy, and / or polyurethane. In some embodiments, applying the hydrogel sheet to the product can include rotating the product and pressing the hydrogel film against the product as the product rotates. The hydrogel sheet can be applied by placing the film directly over an optical window of the product and by wrapping the hydrogel film around the product.

[0013]

[0015] In some embodiments, applying the hydrogel sheet to the product can include using a hydrogel film application tool. In some embodiments, using the hydrogel film application tool can include holding the product in one or more product racks of the hydrogel film application tool and using a roller of the hydrogel film application tool to apply the hydrogel film to the product. In some embodiments, holding the product in the one or more product racks can include using one or more magnets of the hydrogel film application tool to hold the product in the one or more product racks. In some embodiments, the hydrogel film application tool can include multiple cavities for holding the product(s). In some embodiments, using a roller to apply the hydrogel film to the product can include rotating the roller 180 degrees in one of a clockwise or counterclockwise direction, and then rotating the roller 180 degrees in the other of a clockwise or counterclockwise direction.

[0014]

[0016] In some aspects, the process can further include determining whether the hydrogel film passes a test prior to applying the hydrogel film to the product, hi some aspects, determining whether the hydrogel film passes a test can include determining whether the hydrogel film contains a threshold amount of analyte indicator molecules.

[0015]

[0017] In some aspects, the process can further include determining whether the hydrogel film applied to the product passes inspection. In some aspects, the process can further include determining that the hydrogel film applied to the product does not pass inspection, removing all or a portion of the hydrogel film from the product, and applying another hydrogel film to the product.

[0016]

[0018] In some aspects, the process can further include the step of drying the product including the hydrogel film applied to the product.

[0019] In some embodiments, the process may further include applying a protective material to the hydrogel film applied to the product. In some embodiments, the protective material may be configured to reduce degradation of analyte indicator molecules in the hydrogel film. In some embodiments, the protective material may be configured to catalyze the decomposition of reactive oxygen species (ROS). In some embodiments, the protective material may include platinum, palladium, iridium, molybdenum, and / or silver. In some embodiments, the process may further include applying a second protective material to the hydrogel film applied to the product. In some embodiments, the second protective material may include iridium, palladium, silver, and / or molybdenum.

[0017]

[0020] In some aspects, the product may be a sensor.

[0021] In some embodiments, a hydrogel film of the one or more hydrogel films can be a first hydrogel film, the first hydrogel film can be applied to a first portion of a product, the first hydrogel film can include a first analyte indicator molecule configured to reversibly bind to a first analyte and emit a first emitted light in an amount indicative of the amount of the first analyte indicator molecule reversibly bound to the first analyte. In some embodiments, the process can further include applying a second hydrogel film to a second portion of the product. In some embodiments, the second hydrogel film can include a second analyte indicator molecule configured to reversibly bind to a second analyte and emit a second emitted light in an amount indicative of the amount of the second analyte indicator molecule reversibly bound to the second analyte, the second analyte can be different from the first analyte. In some embodiments, the monomer solution can be a first monomer solution, the mold can be a first mold, the hydrogel sheet can be a first hydrogel sheet, and the one or more hydrogel films can be one or more first hydrogel films. In some embodiments, the process can further include injecting a second monomer solution into the second mold, where the second monomer solution can include a second analyte indicator molecule. In some embodiments, the process can further include polymerizing the second monomer solution in the second mold to produce a second hydrogel sheet. In some embodiments, the process can further include cutting the second hydrogel sheet to create one or more second hydrogel films, where the second hydrogel film applied to the product can be one of the one or more second hydrogel films.

[0018]

[0022] Another aspect of the invention can provide a process for using a hydrogel film application tool to apply a hydrogel film to a product. The process can include holding the product in one or more product racks of the hydrogel film application tool. The process can include using rollers of the hydrogel film application tool to apply the hydrogel film to the product.

[0019]

[0023] In some embodiments, holding the product in the one or more product racks can include using one or more magnets of the hydrogel film application tool to hold the product in the one or more product racks. In some embodiments, using a roller to apply the hydrogel film to the product can include rotating the roller 180 degrees in one of a clockwise and counterclockwise direction, and then rotating the roller 180 degrees in the other of a clockwise and counterclockwise direction.

[0020]

[0024] Yet another aspect of the present invention can provide a hydrogel film application tool. The hydrogel film application tool can include one or more product racks configured to hold a product. The hydrogel film application tool can include a roller configured to apply a hydrogel film to the product.

[0021]

[0025] In some embodiments, the tool may further include one or more magnets configured to hold the product to the one or more product racks.

[0026] These and other embodiments encompassed by the systems and methods are described below in the detailed description of the invention.

[0022]

[0027] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate various non-limiting embodiments of the present invention, in which like reference numbers indicate identical or functionally similar elements. [Brief explanation of the drawings]

[0023] [Figure 1]

[0028] Figure 1A is a front view of a device including a product and one or more hydrogel films and embodying an embodiment of the present invention, and Figure 1B is a side view of a device including a product and one or more hydrogel films and embodying an embodiment of the present invention. [Figure 2A]

[0029] FIG. 1 is a perspective view of a device that includes one hydrogel film that is applied to an article and that embodies an aspect of the present invention. [Figure 2B] FIG. 1 is a perspective view of a device including two hydrogel films affixed to an article and embodying aspects of the present invention. [Figure 3]

[0030] FIG. 1 is a block diagram illustrating a device including a hydrogel film attached to a product housing, embodying aspects of the present invention. [Figure 4]

[0031] 1 is a flowchart illustrating a non-limiting example of a process for creating and applying a hydrogel film, embodying aspects of the present invention. [Figure 5]

[0032] 1 is a flowchart illustrating a non-limiting example of a process for manufacturing a hydrogel sheet, embodying aspects of the present invention. [Figure 6A]

[0033] 1A-1D illustrate steps for manufacturing a hydrogel sheet, embodying aspects of the present invention. [Figure 6B] 1A-1D illustrate steps for manufacturing a hydrogel sheet, embodying aspects of the present invention. [Figure 6C] 1A-1D illustrate steps for manufacturing a hydrogel sheet, embodying aspects of the present invention. [Figure 6D] 1A-1D illustrate steps for manufacturing a hydrogel sheet, embodying aspects of the present invention. [Figure 7]

[0034] 1 is a perspective view of a hydrogel cutting tool embodying aspects of the present invention. FIG. [Figure 8]

[0035] FIG. 1 illustrates a hydrogel film embodying aspects of the present invention. [Figure 9]

[0036] 1 is a flowchart illustrating a non-limiting example of a process for applying a hydrogel film to a product, embodying aspects of the present invention. [Figure 10A]

[0037] FIG. 1 illustrates a flat oval tip for applying adhesive to a product, embodying aspects of the present invention. [Figure 10B]

[0038] FIG. 1 illustrates an adhesive applied to a product, embodying aspects of the present invention. [Figure 10C]

[0039] 1 illustrates a spreading tool for applying adhesive to a product, embodying aspects of the present invention. [Figure 10D]

[0040] 1 is a perspective view of an adhesive application tool for applying adhesive to a product, embodying aspects of the present invention; [Figure 10E] 1 is a cross-sectional view of an adhesive application tool for applying adhesive to a product, embodying aspects of the present invention. [Figure 10F]

[0041] FIG. 1 shows a first edge of a hydrogel film disposed on an adhesive in a product embodying an aspect of the present invention. [Figure 10G]

[0042] FIG. 1 illustrates a first edge and a second edge of a hydrogel film disposed on an adhesive in a product embodying an aspect of the present invention. [Figure 11A]

[0043] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11B] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11C] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11D]

[0044] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11E] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11F] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11G] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11H] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 11I] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 12A]

[0045] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 12B] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 12C] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 12D]

[0046] 1A-1C illustrate rollers of a hydrogel film application tool embodying aspects of the present invention. [Figure 12E] 1A-1C illustrate rollers of a hydrogel film application tool embodying aspects of the present invention. [Figure 12F] 1A-1C illustrate rollers of a hydrogel film application tool embodying aspects of the present invention. [Figure 12G] 1A-1C illustrate rollers of a hydrogel film application tool embodying aspects of the present invention. [Figure 12H]

[0047] 1A-1C illustrate roller actuators of a hydrogel film application tool embodying aspects of the present invention. [Figure 12I]

[0048] 1A-1C illustrate a product platform, shaft, and mount of a hydrogel film application tool embodying aspects of the present invention. [Figure 12J]

[0049] 1A-1C illustrate a product platform, shaft, and mount of a hydrogel film application tool embodying aspects of the present invention. [Figure 12K]

[0050] 1 illustrates a product rack of a hydrogel film application tool embodying aspects of the present invention. [Figure 12L] 1 illustrates a product rack of a hydrogel film application tool embodying aspects of the present invention. [Figure 12M] 1 illustrates a product rack of a hydrogel film application tool embodying aspects of the present invention. [Figure 12N]

[0051] 1 illustrates a product rack of a hydrogel film application tool embodying aspects of the present invention. [Figure 13]

[0052] 1 is a flowchart illustrating a non-limiting example of a process for applying a hydrogel film to a product, embodying aspects of the present invention. [Figure 14A]

[0053] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 14B] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 14C] 1A-1C illustrate a hydrogel film application tool embodying aspects of the present invention. [Figure 15]

[0054] 1 is a flowchart illustrating a non-limiting example of a process for applying a hydrogel film to a product, embodying aspects of the present invention. [Figure 16]

[0055] 10A-10C show experimental results of repeatability and reproducibility testing of a device including a hydrogel film applied to a product, embodying aspects of the present invention. [Figure 17]

[0056] 1A-1D show experimental results of functionality testing of devices including hydrogel films applied to products after sterilization, embodying aspects of the present invention. [Figure 18A]

[0057] FIG. 1 shows test results of stability testing on hydrogel films formed on products. [Figure 18B] FIG. 1 shows test results of a stability study on a hydrogel film applied to a product, embodying an aspect of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0024]

[0058] 1A and 1B are front and side views, respectively, of a device 100 according to some embodiments. In some embodiments, the device 100 can include an article 101 and one or more hydrogel films 409 attached to the article 101. In some embodiments, the hydrogel film 409 can include a network polymer material. In some embodiments, the network polymer material can be a three-dimensional network. In some embodiments, the polymer material can be a hydrophilic polymer material. In some embodiments, the polymer material can include cross-linked polymer chains.

[0025]

[0059] In some embodiments, device 100 can be an implant. In some embodiments, device 100 can be a sensor (e.g., an analyte sensor, such as, but not limited to, a glucose sensor). In some embodiments, as shown in FIGS. 2A and 2B, device 100 can be a miniature, fully subcutaneously implantable sensor that performs one or more measurements indicative of an analyte (e.g., glucose) level in a first medium (e.g., interstitial fluid) of a living animal (e.g., a living human). However, this is not required, and in some alternative embodiments, device 100 can be a partially implantable (e.g., transcutaneous) sensor or a fully external sensor. Similarly, it is not required that device 100 be a sensor, and it is not required that device 100 be implantable. In some sensor embodiments, as shown in FIG. 2B, device 100 can include multiple hydrogel films 409 (e.g., to create a multi-array platform). 2B, the plurality of hydrogel films 409 can include a first hydrogel film 409 attached to a first portion of the device 100 and a second hydrogel film 409 attached to a second portion of the device 100. In some embodiments of the plurality of hydrogel films 409, different analyte detection moieties can be polymerized into the hydrogel film 409 and attached to specific portions of the device 101 (e.g., over specific photodiodes), thereby providing for an increased biological range of analyte detection by the device 101.

[0026]

[0060] In some aspects, as shown in FIGS. 2A and 2B , the product 101 can include a housing 406 (i.e., a body, shell, capsule, or container), which can be rigid and biocompatible. In one non-limiting embodiment, the housing 406 can be a silicone tube. However, this is not required, and in some other aspects, various materials and / or shapes can be used for the housing 406. In some embodiments, the product 101 can include a transparent optical resonator. In some aspects, the transparent optical resonator can be formed from a suitable optically transparent polymeric material, such as, for example, an acrylic polymer (e.g., polymethyl methacrylate (PMMA)), a polyolefin (e.g., polypropylene (PP)), polyurethane, and / or polysiloxane / silicone and copolymers thereof. However, this is not required, and in other embodiments, various materials can be used for the transparent optical resonator.

[0027]

[0061] 2A and 2B, the one or more hydrogel films 409 can be affixed (e.g., glued) to the housing 406. In some embodiments, the housing 406 can include one or more cutouts or recesses, and the one or more hydrogel films 409 can be disposed (partially or entirely) in the cutouts or recesses. In some embodiments, the one or more hydrogel films 409 can be porous, allowing an analyte (e.g., glucose) in a first medium (e.g., interstitial fluid) to diffuse into the one or more hydrogel films 409.

[0028]

[0062] In some aspects, device 100 may include a communication interface for transmitting information (e.g., measurement data, such as, for example, light measurements and / or temperature measurements) and / or receiving information (e.g., commands). In some aspects, the communication interface of device 100 may include an antenna for wireless communication. In some alternative aspects (e.g., transcutaneous aspects), the communication interface may include a wired connection. In some aspects (e.g., wireless aspects), as shown in FIGS. 2A and 2B, the communication interface of device 100 may include inductor 517, which may be, for example, a ferrite-based micro-antenna. In some aspects, as shown in FIG. 2A, inductor 517 may include conductor 518 in the form of a coil and magnetic core 519. In some aspects, core 519 may be, for example, without limitation, a ferrite core. In some embodiments, inductor 517 may be connected to circuitry (e.g., an application-specific integrated circuit (ASIC)) of device 100 housed within housing 406 of product 101.

[0029]

[0063] 2A and 2B, the analyte sensor 100 can include one or more substrates 516. In some non-limiting embodiments, the substrate 516 can be a circuit board (e.g., a printed circuit board (PCB) or a flexible PCB) to which one or more of the circuit components (e.g., analog and / or digital circuit components) can be mounted or otherwise attached. However, in some alternative aspects, the substrate 516 can be a semiconductor substrate.

[0030]

[0064] In some embodiments, product 101 may include one or more light sources (e.g., one or more of the light sources mounted on or fabricated within substrate 516) and / or one or more photodetectors (e.g., photodiodes, phototransistors, photoresistors, or other photosensitive elements). In some embodiments, one or more photodetectors may be mounted on or fabricated within substrate 516.

[0031]

[0065] 3, one or more hydrogel films 409 can include indicator molecules 311. In some embodiments, indicator molecules 311 can be fluorescent indicator molecules (e.g., having the chemical name 9-[N-[6-(4,4,5,5,-tetramethyl-1,3,2-dioxaborolano(-3-)trifluoromethyl)benzyl]-N-[3-(methacrylamido)propylamino]methyl]-10-[N-[6-(4,4,5,5,-tetramethyl-1,3,2-dioxaborolano)-3-(trifluoromethyl)benzyl]-N-[2-(carboxyethyl)amino]methyl]anthracene sodium salt) or light-absorbing non-fluorescent indicator molecules. In some embodiments, the indicator molecule 311 can reversibly bind to an analyte (e.g., glucose, oxygen, a cardiac marker, low density lipoprotein (LDL), high density lipoprotein (HDL), or triglycerides). When the indicator molecule 311 binds to the analyte, the indicator molecule can become fluorescent, in which case the indicator molecule 311 can absorb (or be excited by) excitation light 329 and emit light 331. When no analyte is bound, the indicator molecule 311 can only be weakly fluorescent.

[0032]

[0066] 3, device 100 (e.g., product 101 of device 100) can include a light source 303, which may be, for example, a light emitting diode (LED) or other light source that emits radiation including radiation over a wavelength range that interacts with indicator molecules 311. In other words, light source 303 can emit excitation light 329 that is absorbed by indicator molecules 311 in hydrogel film 409. In some embodiments, light source 303 can be contained within housing 406 of product 101. In some embodiments, light source 303 can be mounted on or fabricated within substrate 516.

[0033]

[0067] In some embodiments, as shown in FIG. 3 , the device 100 can include one or more photodetectors 305 (e.g., photodiodes, phototransistors, photoresistors, or other photosensitive elements). In some embodiments, the one or more photodetectors 305 can be contained within the housing 406 of the product 101. In some embodiments, the one or more photodetectors 305 can be mounted on or fabricated within the substrate 516. In some embodiments, the one or more photodetectors 305 can be sensitive to light 331 (e.g., fluorescent light) emitted by the indicator molecules 311, such that a signal generated by the one or more photodetectors 305 in response thereto indicates the amount of light 331 emitted by the indicator molecules 311 and, therefore, the amount of analyte of interest (e.g., glucose). In some embodiments, the excitation light 329 can have a different wavelength than the emission light 331.

[0034]

[0068] In some embodiments of the plurality of hydrogel films 409, the plurality of hydrogel films 409 can include indicator molecules 311 that reversibly bind to the same analyte and, upon illumination with excitation light 329, emit an amount of emission light 331 indicative of the level of the analyte in a first medium (e.g., interstitial fluid) of the living animal. In some alternative embodiments of the plurality of hydrogel films 409, one of the hydrogel films 409 can include a first indicator molecule 311 that reversibly binds to a first analyte (e.g., one of glucose, oxygen, a cardiac marker, LDL, HDL, or triglycerides) and, upon illumination with excitation light 329, emits an amount of emission light 331 indicative of the amount of first indicator molecule 311 that has reversibly bound to the first analyte, which amount can indicate the level of the first analyte in the first medium of the living animal. In some of these alternative embodiments of the plurality of hydrogel films 409, another of the hydrogel films 409 can include a second indicator molecule 311 that reversibly binds to a second analyte (e.g., another one of glucose, oxygen, a cardiac marker, LDL, HDL, or triglycerides) and, upon irradiation with excitation light 329, emits an amount of emission light 331 indicative of the amount of second indicator molecule 311 that has reversibly bound to the second analyte, which amount can indicate the second analyte level in the first medium of the living animal.

[0035]

[0069] 4 is a flowchart illustrating a process 400 for creating and applying a hydrogel film 409 according to some embodiments. In some embodiments, the process 400 can include a step 402 of manufacturing a hydrogel sheet 612. FIG. 6D shows an example of a hydrogel sheet 612 that can be manufactured in step 402 according to some embodiments.

[0036]

[0070] 5 is a flow chart illustrating a process 500 for manufacturing a hydrogel sheet 612. In some embodiments, the process 500 can be performed at step 402 of the process 400 shown in FIG.

[0037]

[0071] 5, process 500 may include step 502 of assembling a mold 600. In some embodiments, as shown in FIG. 6A, mold 600 may include a first plate 602 and a second plate 604 and one or more clips 606 configured to hold first plate 602 and second plate 604 together (e.g., with first plate 602 over second plate 604). In some embodiments, first plate 602 may be a glass plate, second plate 604 may be a stamped plate (e.g., a stamped metal plate), and / or one or more clips 606 may be plastic clips. In some embodiments, mold 600 may include an injection port 608. In some embodiments, as shown in FIG. 6A, injection port 608 may include a needle 609. In some embodiments, needle 609 may be a flat-tip needle (e.g., a 30-gauge flat-tip needle). In some embodiments, including an injection port 608 in the assembled mold 600 can make it easier to fill the mold 600 with the monomer solution 610 .

[0038]

[0072] In some embodiments, the second plate 604 can include a raised edge (e.g., around the periphery of the second plate 604). In some embodiments, the raised edge of the second plate 604 can contact the first plate 602 when the first plate 602 and the second plate 604 are held together by one or more clips 606. In some embodiments, the first plate 602 and the second plate 604 can be spaced apart from one another (e.g., other than at the raised edge of the second plate 604) such that a gap exists between the first plate 602 and the second plate 604 when the first plate 602 and the second plate 604 are held together by one or more clips 606. In some embodiments, the amount of separation between the first plate 602 and the second plate 604 can correspond to the desired thickness of the hydrogel sheet 612 produced by the mold 600.

[0039]

[0073] 5, the process 500 can include step 504 of injecting a monomer solution 610 into a mold 600. In some embodiments, as shown in FIG. 6B, the monomer solution 610 can be injected between a first plate 602 and a second plate 604. In some embodiments, injecting the monomer solution 610 into the mold 600 in step 504 can include injecting the monomer solution 610 into an injection port 608 of the mold 600. In some embodiments, the monomer solution 610 can be injected into a gap between the first plate 602 and the second plate 604 of the mold 600.

[0040]

[0074] In some embodiments, as shown in Figure 6C, injection port 608 can be removed from mold 600 after monomer solution 610 has been injected into mold 600. In some embodiments, as shown in Figure 6C, after monomer solution 610 has been injected into mold 600, one additional clip 606 (or multiple clips 606) can be added to mold 600 (e.g., so that clips 606 on all sides of mold 600 hold first plate 602 and second plate 604 together).

[0041]

[0075] 5, the process 500 can include a step 506 of polymerizing the monomer solution 610 in the mold 600 to produce a hydrogel sheet 612. In some embodiments, the step 506 can include curing the monomer solution 610.

[0042]

[0076] 5, process 500 can include step 508 of removing hydrogel sheet 612 from mold 600. In some embodiments, as shown in FIG. 6D, step 508 can include removing one or more clips 606 from mold 600. In some embodiments, step 508 can include removing hydrogel sheet 612 from between first plate 602 and second plate 604.

[0043]

[0077] In some embodiments, as shown in FIG. 5, the process 500 can include a step 510 of washing the hydrogel sheet 612 .

[0078] 5, the process 500 can include a step 512 of inspecting the hydrogel sheet 612. In some embodiments, if the hydrogel sheet 612 does not pass inspection, all or a portion of the hydrogel sheet 612 can be discarded.

[0044]

[0079] Returning to process 400, in some embodiments, as shown in Figure 4, process 400 can include step 404 of cutting a hydrogel sheet 612 to create one or more hydrogel films 409. Figure 8 shows an example of a hydrogel film 409 cut from a hydrogel sheet 612, according to some embodiments.

[0045]

[0080] In some embodiments, cutting the hydrogel sheet 612 to create one or more hydrogel films 409 in step 404 can include using a hydrogel cutting tool 700 to divide the hydrogel sheet 612. In some embodiments, as shown in FIG. 7 , the hydrogel cutting tool 700 can include a platform 702 and a cutout sheet 704. In some embodiments, the platform 702 can include a protrusion 706. In some embodiments, the cutout sheet 704 can include an opening 708 that mates with the protrusion 706 of the platform 702. In some embodiments, using the hydrogel cutout tool 700 to divide the hydrogel sheet 612 in step 404 can include providing the hydrogel sheet 612 between the platform 702 and the cutout sheet 704, as shown in FIG. 7 . In some embodiments, using the hydrogel cutting tool 700 to divide the hydrogel sheet 612 can include inserting the protrusion 706 of the platform 702 into the opening 708 of the cutout sheet 704. In some embodiments, step 404 can include removing one or more hydrogel films 409 from the hydrogel cutting tool 700 .

[0046]

[0081] 7, the platform 702 can include 60 protrusions 706, the cutout sheet 704 can include 60 openings 708, and the hydrogel cutting tool 700 can cut 60 hydrogel films 409 from the hydrogel sheet 612. However, this is not required, and in some alternative embodiments, the hydrogel cutting tool 700 can include a different number of protrusions 706, can include a different number of openings 708, and can cut a different number (e.g., 2, 4, 12, 20, 64, 100, 120, 200, etc.) of hydrogel films 409 from the hydrogel sheet 612.

[0047]

[0082] In some embodiments, step 404 may include washing the hydrogel film 409 (e.g., before applying the hydrogel film 409 to the product 101). However, this is not required, and in some alternative embodiments, step 404 may not include washing the hydrogel film 409, and an unwashed hydrogel film 409 may be applied to the product 101.

[0048]

[0083] 4, process 400 may include step 406, in which the hydrogel film 409 (e.g., the hydrogel film 409 cut from the hydrogel sheet 612 in step 404) passes an inspection (e.g., before applying the hydrogel film 409 to the product 101). In some embodiments, determining whether the hydrogel film 409 passes the inspection may include determining whether the hydrogel film 409 contains a threshold amount of indicator molecules 311 (e.g., analyte indicator molecules). In some embodiments, determining whether the hydrogel film 409 passes the inspection may include determining whether the amount of free monomer remaining in the monomer solution 610 exceeds a threshold amount, and if so, determining that polymerization of the monomer solution 610 (e.g., in step 506) was not performed correctly. In some embodiments, if the hydrogel film 409 fails the inspection, the hydrogel film 409 may be removed from process 400 and discarded.

[0049]

[0084] 4, the process 400 can include step 408 of applying a hydrogel film 409 to the product 101. In some embodiments, the hydrogel film 409 can be applied to the product 101 using a manual process. In some alternative embodiments, the hydrogel film 409 can be applied to the product 101 using a hydrogel film application tool (e.g., the hydrogel film application tool 1100 shown in FIGS. 11A-11C, the hydrogel film application tool 1150 shown in FIGS. 11D-11I, the hydrogel film application tool 1200 shown in FIGS. 12A-12O, or the hydrogel film application tool 1400 shown in FIGS. 14A-14C).

[0050]

[0085] 9 is a flow chart illustrating a process 900 for applying a hydrogel film 409 to a product 101. In some embodiments, the process 900 can be performed at step 408 of the process 400 shown in FIG. 4. In some embodiments, the process 900 can be a manual process for applying the hydrogel film 409 to the product 101.

[0051]

[0086] 9, process 900 can include step 902 of applying adhesive 1002 to product 101. In some embodiments, as shown in FIG. 10A, adhesive 1002 can be applied using tip 1004. In some embodiments, tip 1004 can be a flat tip (e.g., a flat oval tip, such as an 18-G flat oval tip). In some embodiments, adhesive 1002 can be applied to housing 406 of product 101, as shown in FIG. 10B.

[0052]

[0087] In some alternative embodiments, as shown in FIG. 10C , adhesive 1002 may be applied to product 101 using a spreading tool 1003. In some embodiments, spreading tool 1003 may be made from a soft material, such as, but not limited to, rubber. In some embodiments, spreading tool 1003 may spread adhesive 1002 over a defined area of ​​product 101 using a soft surface 1007 that is pressed against the surface of product 101. In some embodiments, spreading tool 1003 may be integrated with a dispensing needle 1005. In some embodiments, needle 1005 may dispense droplets of adhesive 1002. In some embodiments, spreading tool 1003 may move over product 101 (or product 101 may rotate) to spread adhesive 1002 on product 101. In some embodiments, dispensing and / or positioning of adhesive 1002 may be achieved by an automated system.

[0053]

[0088] 10D and 10E, an adhesive application tool 1050 may be used to apply adhesive 1002 to product 101. In some embodiments, adhesive application tool 1050 may include a motor 1052, one or more drive shafts 1054, one or more first rollers 1056, one or more second rollers 1057, and one or more holders 1060. In some embodiments, product 101 may be placed in one or more slots 1058 in one or more holders 1060. In some embodiments, product 101 in one or more slots 1058 may be placed on one or more rollers 1056 and one or more second rollers 1057. In some embodiments, first roller 1056 and second roller 1057 may be, for example, without limitation, cylindrical rollers. In some embodiments, first roller 1056 and second roller 1057 may be, for example, without limitation, rubber rollers. In some embodiments, adhesive 1002 can be applied to one or more first rollers 1056 (e.g., on top of one or more rollers 1056) and / or one or more first rollers 1056 can be partially immersed in a pool of adhesive 1002. In some embodiments, one or more first rollers 1056 can rotate and apply adhesive 1002 to product 101. In some embodiments, one or more second rollers 1057 can rotate and remove excess adhesive from product 101. In some embodiments, as shown in FIG. 10E , adhesive application tool 1050 can include a lip 1061 that can act as a wiper to remove excess adhesive from one or more second rollers 1057. In some embodiments, as shown in FIG. 10E, the adhesive application tool 1050 can include one or more depressions 1062 in which excess adhesive from the one or more first rollers 1056 and / or one or more second rollers 1057 can accumulate.In some embodiments, the first roller 1056 and the second roller 1057 can rotate a set number of times to turn the product 101, after which the product 101 is removed from the adhesive application tool 1050. In some embodiments, the rollers 1056 and 1057 can apply a precise amount of adhesive 1002 to the product 101 and remove excess adhesive through the rotational motion of the first roller 1056 and the second roller 1057 and the use of the edges 1061.

[0054]

[0089] 9, process 900 can include step 904 of placing a first edge (e.g., a leading edge) of hydrogel film 409 on product 101. In some embodiments, as shown in FIG. 10F, step 904 can include placing the first edge of hydrogel film 409 on adhesive 1002 on product 101. In some embodiments, adhesive 1002 can be a biocompatible adhesive. In some embodiments, adhesive 1002 can include cyanoacrylate. In some embodiments, adhesive 1002 can include octyl-cyanoacrylate, N-butyl-cyanoacrylate, and / or 2-ethylcyanoacrylate. In some embodiments, adhesive 1002 can additionally or alternatively include silicone, siloxane, acrylate, epoxy, and / or polyurethane.

[0055]

[0090] 9, the process 900 can include a step 906 of rotating the product 101. In some embodiments, the step 906 can include pressing the hydrogel film 409 against the product 101 as the product 101 rotates.

[0056]

[0091] 9, process 900 can include step 908 of placing a second edge (e.g., a trailing edge) of the hydrogel film 409 on the product 101. In some embodiments, as shown in FIG. 10G, step 908 can include placing the second edge of the hydrogel film 409 on adhesive 1002 on the product 101. In some embodiments, step 908 can include ensuring that the seam between the first edge and the second edge of the hydrogel film 409 is flat (e.g., no protruding edges).

[0057]

[0092] 4 using a hydrogel film application tool 1100 shown in FIGS. 11A-11C. In some embodiments, the hydrogel film 409 can be applied to the product 101 in step 408 of the process 400 shown in FIG. 4. In some embodiments, the hydrogel film application tool 1100 can include a housing 1102 (e.g., a cylindrical housing), a structure 1104 in the housing 1102, and a base 1112. In some embodiments, the structure 1104 can include one or more magnets 1106. In some embodiments, the one or more magnets 1106 can be configured to align the product 101 in a particular orientation (e.g., with the window of the product 101 facing down). In some embodiments, the structure 1104 can include one or more magnets 1106 on one side of the product 101 and one or more magnets 1106 on the other side of the product 101. In some embodiments, the housing 1102 can include one or more openings 1110. In some embodiments, the structure 1104 can include one or more clips 1108 configured to interact with one or more openings 1110 and to lock the structure 1104 and one or more magnets 1106 in a down position, as shown in Figure 11A. In some embodiments, releasing the one or more clips 1108 can result in the structure 1104 moving to the up position shown in Figure 11B, thereby releasing the product 101 from the one or more magnets 1106.

[0058]

[0093] 11A and 11B, the housing 1102 can be configured to extend into and be held in place by the base 1112. In some embodiments, the base 1112 can include a fillet 1116 (see FIG. 11C). In some embodiments, the fillet 1116 can ensure proper orientation of the housing 1102 and the structure 1104 within the base 1112. In some embodiments, the base 1112 can include a recess 1118 (e.g., a rounded recess) configured to hold the product 101. In some embodiments, the base 1112 can include one or more recesses 1120 (e.g., a rounded recess) configured to curve the hydrogel film 409 along the product 101. In some embodiments, the base 1112 can include one or more ridges 1122 configured to reduce (or prevent) the hydrogel film 409 from sticking to the base 1112 (e.g., suction sticking).

[0059]

[0094] In some alternative embodiments, the hydrogel film 409 may be applied to the product 101 in step 408 of the process 400 shown in FIG. 4 using a hydrogel film application tool 1150 shown in FIGS. 11D-11I. In some embodiments, the hydrogel film application tool 1150 may include a housing 1152 (e.g., a cylindrical housing), a structure 1154 in the housing 1152, a base 1158, and / or a holder 1160. In some embodiments, the housing 1152 may include a slot 1153. In some embodiments, the structure 1154 may include one or more magnets 1156. In some embodiments, the structure 1154 may be movable in the housing 1152 between a raised position, as shown in FIG. 11D, and a lowered position, as shown in FIG. 11E.

[0060]

[0095] 11E, product 101 can be placed in slot 1153 of housing 1152. In some embodiments, one or more magnets 1156 can hold product 101 in place in slot 1153 when structure 1154 is in the lowered position as shown in FIG. 11E. In some embodiments, one or more magnets 1156 can be configured to align product 101 in a particular orientation (e.g., with the window of product 101 facing down). In some embodiments, structure 1154 can include one or more magnets 1156 on one side of product 101 and one or more magnets 1156 on the other side of product 101.

[0061]

[0096] 11F, the housing 1152 can be aligned with the base 1158, and the housing 1152 and structure 1154 can be lowered at least partially into the base 1158. In some embodiments, the base 1158 can include a fillet 1161 (see FIGS. 11D and 11E). In some embodiments, the fillet 1161 can ensure proper orientation of the housing 1152 and structure 1154 within the base 1158. In some embodiments, the base 1158 can include a recess 1159 (e.g., a rounded recess) configured to hold the product 101. In some embodiments, as shown in FIGS. 11D and 11E, the base 1158 can include one or more recesses 1163 (e.g., rounded recesses) configured to curve the hydrogel film 409 along the product 101. 11F, the product 101 can be positioned within the recess 1159 when the housing 1152 and structure 1154 are lowered into the base 1158. In some embodiments, at least a first edge of the hydrogel film 409 can be affixed to the product 101 when the product 101 is positioned within the recess 1159. In some embodiments, as shown in FIG. 11F, the base 1158 can be configured such that the product 101 extends from the base 1158 when the product 101 is positioned within the recess 1159.

[0062]

[0097] 11G, the holder 1160 can slide onto the portion of the product 101 that extends from the base 1158. In some embodiments, the holder 1160 can be used to grip the product 101 within the recess 1159 of the base 1158. In some embodiments, the holder 1160 can be made from a slightly flexible material, allowing for easier handling of the product 101. In some embodiments, the holder 1160 can be used to rotate the product 101 to wrap the hydrogel film 409 around the product 101 and / or press the product 101 against the hydrogel film 409 for application of the hydrogel film 409. In some embodiments, the housing 1152 and structure 1154 can be detachable from the base 1158, as shown in FIG. 11H. 11H, the holder 1160 can hold the product 101 in place in the recess 1159 of the base 1158 when the housing 1152 and the structure 1154 are removed from the base 1158. In some embodiments, the holder 1160 can be used to remove the product 101 from the base 1152, as shown in FIG.

[0063]

[0098] In some alternative embodiments, the hydrogel film 409 may be applied to the product 101 in step 408 of the process 400 shown in FIG. 4 using a hydrogel film application tool 1200 shown in FIGS. 12A-12N. In some embodiments, as shown in FIGS. 12A-12C, the hydrogel film application tool 1200 may include a base 1210. In some embodiments, as shown in FIGS. 12A and 12B, the hydrogel film application tool 1200 may include one or more product racks 1202 configured to hold the product 101. In some embodiments, as shown in FIGS. 12A and 12B, the tool 1200 may further include one or more magnets 1204 configured to hold the product 101 to the one or more product racks 1202. In some embodiments, the one or more product racks 1202 may be removable (e.g., held in place by set screws), allowing for easy cleaning of the one or more product racks 1202.

[0064]

[0099] 12A-12C, the hydrogel film application tool 1200 can include a roller 1206 configured to apply the hydrogel film 409 to the product 101. In some embodiments, the roller 1206 can be initially positioned below the product 101, as shown in FIG. 12A. In some embodiments, the roller 1206 can be in this position when the product 101 is placed in one or more product racks 1202. In some embodiments, to apply the hydrogel film 409 to the product 101, the roller 1206 can be moved (e.g., rotated) approximately 180 degrees in one direction (e.g., clockwise) from its initial position to apply the hydrogel film 409 to one side of the product 101, as shown in FIG. 12B. In some embodiments, the roller 1206 can then rotate in the opposite direction (e.g., counterclockwise) back to the initial position and then rotate approximately 180 degrees from the initial position, as shown in Figure 12C, to apply the hydrogel film 409 to the other side of the product 101. In some embodiments, the hydrogel film application tool 1200 can include mechanical stops configured to prevent the roller 1206 from moving more than approximately 180 degrees in one direction (relative to the initial position) and from moving more than 180 degrees in the other direction (relative to the initial position).

[0065]

[0100] In some embodiments, the hydrogel film application tool 1200 can include one or more roller actuators 1208 (e.g., one or more geared rollers) configured to move (e.g., rotate) the rollers 1206 relative to the product 101. In some embodiments, the one or more roller actuators 1208 can allow manual control of the movement of the rollers 1206 relative to the product 101. In some embodiments, the one or more roller actuators 1208 can cause movement of the rollers 1206 relative to the product 101 by applying a radial force to the hydrogel film 409 without pulling. In some embodiments, as shown in FIG. 12H , the one or more roller actuators 1208 can include one or more grips on their periphery, which can make it easier to use the one or more roller actuators 1208 manually. In some alternative embodiments, the hydrogel film application tool 1200 can include one or more motors for motorized movement of the rollers 1206.

[0066]

[0101] In some embodiments, as shown in FIGS. 12D-12G, roller 1206 may include notches or slots 1212. In some embodiments, slot 1212 may allow roller 1206 to be easily removed (e.g., for cleaning). In some embodiments, slot 1212 may have a width of 0.3175 cm (1 / 8 inch). In some embodiments, slot 1212 may allow roller 1206 to slide in and / or be removed without disassembly of the main assembly. In some embodiments, a screw may hold roller 1206 in place.

[0067]

[0102] 12I and 12J, the hydrogel film application tool 1200 can include one or more mounts 1214 and one or more shafts 1216 connecting the product rack 1202 to the mount 1214. While the shaft 1216 is shown in FIG. 12I as having a circular cross-section, this is not required, and in some alternative embodiments, one or more of the shafts 1216 can have a cross-section having a different shape (e.g., an oval, square, diamond, or rectangular cross-section). In some embodiments, a shaft with a non-circular cross-section can improve alignment. In some embodiments, the product rack 1202 can be slid out of the mount 1214 for removal (e.g., after removing one or more screws), and a new product rack 1202 can be slid in.

[0068]

[0103] In some embodiments, as shown in FIGS. 12K and 12M, one or more product stands 1202 can include slots 1220 configured to receive products 101. In some embodiments, as shown in FIGS. 12K-12N, one or more product stands 1202 can include one or more magnet holes 1218, each configured to hold a magnet 1204. In some embodiments, the magnets 1204 can be secured in place in the magnet holes 1218. In some embodiments, as shown in FIGS. 12K and 12N, one or more magnet holes 1218 can be adjacent to the slots 1220. In some alternative embodiments, as shown in FIGS. 12M and 12N, one or more magnet holes 1218 can be drilled from the front. In some embodiments, one or more product stands 1202 can comprise stainless steel and / or can be cleaned with a cleaning solution (e.g., acetone).

[0069]

[0104] 13 is a flow chart illustrating a process 1300 for applying a hydrogel film 409 to a product 101. In some embodiments, the process 1300 can be performed at step 408 of the process 400 shown in FIG. 4. In some embodiments, the process 1300 can apply the hydrogel film 409 to the product 101 using a hydrogel film application tool (e.g., the hydrogel film application tool 1200 shown in FIGS. 12A-12N).

[0070]

[0105] In some embodiments, as shown in FIG. 13 , process 1300 can include step 1302 of applying adhesive 1002 to product 101. In some embodiments, as shown in FIG. 10A , adhesive 1002 can be applied using tip 1004. In some embodiments, tip 1004 can be a flat tip (e.g., a flat oval tip, such as an 18-G flat oval tip). In some alternative embodiments, as shown in FIG. 10C , adhesive 1002 can be applied using a spreading tool 1003, which can be integrated with a dispensing needle 1005. In some alternative embodiments, as shown in FIGS. 10D and 10E , adhesive 1002 can be applied using an adhesive application tool 1050. In some embodiments, adhesive 1002 can be applied to housing 406 of product 101, as shown in FIG. 10B .

[0071]

[0106] 13, the process 1300 may include a step 1304 of holding the product 101 in one or more product racks 1202 of the hydrogel film application tool 1200. In some embodiments, holding the product in the one or more product racks 1202 in step 1304 may include using one or more magnets 1204 of the hydrogel film application tool 1200 to hold the product 101 in the one or more product racks 1202.

[0072]

[0107] 13, the process 1300 can include a step 1306 of using a roller 1206 of a hydrogel film application tool 1200 to apply the hydrogel film 409 to the product 101. In some embodiments, using the roller 1206 to apply the hydrogel film 409 to the product 101 can include rotating the roller 180 degrees in one of a clockwise and counterclockwise direction (e.g., as shown in FIG. 12B), and then rotating the roller 180 degrees in the other of a clockwise and counterclockwise direction (e.g., as shown in FIG. 12C).

[0073]

[0108] In some alternative embodiments, the hydrogel film 409 may be applied to the product 101 in step 408 of the process 400 shown in FIG. 4 using a hydrogel film application tool 1400 shown in FIGS. 14A-14C. In some embodiments, as shown in FIG. 14A, the hydrogel film application tool 1400 can include a first edge application tool 1401 and a film wrapping tool 1406. In some embodiments, the first edge application tool 1401 can include a housing 1402 (e.g., a cylindrical housing) and a structure 1404 in the housing 1402. In some embodiments, the housing 1402 and the structure 1404 can be similar to the housing 1152 and the structure 1154, respectively, of the hydrogel film application tool 1150 shown in FIGS. 11D and 11E.

[0074]

[0109] In some embodiments, the housing 1402 can include a slot 1403. In some embodiments, the structure 1404 can include one or more magnets 1405. In some embodiments, the structure 1404 can be movable in the housing 1402 between a raised position and a lowered position (see FIGS. 11D and 11E, respectively). In some embodiments, the product 101 can be disposed in the slot 1403 of the housing 1402, and at least in the lowered position, the one or more magnets 1405 can hold the product 101 in place in the slot 1403 (see FIG. 11E). In some embodiments, the one or more magnets 1405 can be configured to align the product 101 in a particular orientation (e.g., with the window of the product 101 facing down). In some embodiments, the structure 1404 can include one or more magnets 1405 on one side of the product 101 and one or more magnets 1405 on the other side of the product 101. In some embodiments, as shown in FIG. 14A, a first edge application tool 1401 can be used to place the product 101 onto a film wrapping tool 1406.

[0075]

[0110] In some embodiments, the film winding tool 1406 can include a film winding ramp 1408, a slider 1410, and / or a moving tool 1412. In some embodiments, the hydrogel film 409 can be placed on the film winding ramp 1408. In some embodiments, the hydrogel film 409 can be placed on the film winding ramp 1408. In some embodiments, the product 101 can be placed on the hydrogel film on the film winding ramp 1408 by the first edge application tool 1401. In some embodiments, placing the product 1010 on the hydrogel film 409 on the film winding ramp 1408 can apply a first edge of the hydrogel film 409 to the product 101. In some embodiments, the film winding tool 1406 can include one or more alignment mechanisms for precise placement of the product 101 on the first edge application tool 1401 onto the hydrogel film 409 on the film winding ramp 1408.

[0076]

[0111] In some embodiments, the hydrogel film 409 can be applied to the product 101 by rolling the product 101 along a path in the film wrapping ramp 1408 (with or without the aid of magnetic force). In some embodiments, the film wrapping ramp 1408 can have a slope steep enough that gravity alone can roll the product 101 down the film wrapping ramp 1408 and onto the hydrogel film 409 for application of the hydrogel film 409 to the product 101. In some alternative embodiments, as shown in FIG. 14B , the film wrapping tool 1406 can include a slider 1410 (in addition to or as an alternative to the slope of the film wrapping ramp 1408) that can be used to roll the product 101 down the film wrapping ramp 1408 and onto the hydrogel film 409 for application of the hydrogel film 409 to the product 101. In some embodiments, the slider 1410 can include one or more magnets 1411 that urge the product 101 down the film wrapping ramp 1408 as the slider 1410 is moved.

[0077]

[0112] 14B and 14C, the film wrapping tool 1406 can include a transfer tool 1412 that can be used to transfer the product 101 off the film wrapping ramp 1408 after application of the hydrogel film 409 to the product 101. In some embodiments, the transfer tool 1412 can transfer the product 101 off the end of the film wrapping ramp 1408 and / or release the product 101 to another location for further processing (e.g., inspection, cleaning, and / or drying). In some embodiments, at the end of the film wrapping ramp 1408, the product 101 can slide into the transfer tool 1412.

[0078]

[0113] 14C, the transfer tool 1412 can include a structure 1413 and a plunger 1414. In some embodiments, the structure 1413 can include a slot 1416. In some embodiments, the plunger 1414 can include a magnet 1420. In some embodiments, the magnet 1420 on the plunger 1414 can pull the product 101 from the film wrapping ramp 1408 into the slot 1416 in the structure 1413. In some embodiments, the plunger 1414 can be retracted (e.g., with the aid of a spring (not shown)) and the product 101 can be released (e.g., into the slot of a dryer).

[0079]

[0114] 15 is a flow chart illustrating a process 1500 for applying a hydrogel film 409 to a product 101. In some embodiments, the process 1500 can be performed at step 408 of the process 400 shown in FIG. 4. In some embodiments, the process 1500 can apply the hydrogel film 409 to the product 101 using a hydrogel film application tool (e.g., the hydrogel film application tool 1400 shown in FIGS. 14A-14C).

[0080]

[0115] In some embodiments, as shown in FIG. 15, process 1500 can include step 1502 of applying adhesive 1002 to product 101. In some embodiments, as shown in FIG. 10A, adhesive 1002 can be applied using tip 1004. In some embodiments, tip 1004 can be a flat tip (e.g., a flat oval tip, such as an 18-G flat oval tip). In some alternative embodiments, as shown in FIG. 10C, adhesive 1002 can be applied using a spreading tool 1003, which can be integrated with a dispensing needle 1005. In some alternative embodiments, as shown in FIGS. 10D and 10E, adhesive 1002 can be applied using an adhesive application tool 1050. In some embodiments, adhesive 1002 can be applied to housing 406 of product 101, as shown in FIG. 10B.

[0081]

[0116] In some embodiments, as shown in FIG. 15, the process 1500 can include a step 1504 of placing the hydrogel film 409 on the film wrapping ramp 1408 of the hydrogel film application tool 1400 .

[0082]

[0117] 15, the process 1500 can include a step 1506 of placing the product 101 on the hydrogel film 409 on the film wrapping ramp 1408. In some embodiments, a first edge application tool 1401 can be used to place the product 101 on the hydrogel film 409. In some embodiments, the product 101 can be placed on the hydrogel film 409 such that a first edge of the hydrogel film 409 is applied to the product 101.

[0083]

[0118] 15, the process 1500 can include a step 1508 of rolling the product 101 (e.g., using a slider 1410) onto the hydrogel film 409 at the film wrapping ramp 1408 (e.g., down). In some embodiments, rolling the product 101 down the film wrapping ramp 1408 onto the hydrogel film 409 can affix the hydrogel film 409 to the product 101.

[0084]

[0119] In some embodiments, as shown in FIG. 15, the process 1500 can include a step 1510 of transferring the product 101 having the hydrogel film 409 applied thereto from the film wrapping ramp 1408 (e.g., using a transfer tool 1412).

[0085]

[0120] 4, the process 400 can include step 410 of inspecting the hydrogel film 409. In some embodiments, step 410 can include determining whether the hydrogel film 409 applied to the product 101 passes the inspection. In some embodiments, as shown in FIG. 4, if it is determined that the hydrogel film 409 does not pass the inspection, the process 400 can proceed to step 411, where all or a portion of the hydrogel film 409 is peeled off from the product 101, and then return to step 408 to apply another hydrogel film 409 to the product 101. In some embodiments, as shown in FIG. 4, if it is determined that the hydrogel film 409 passes the inspection, the process 1300 can proceed to step 412.

[0086]

[0121] In some embodiments, step 412 includes drying the product 101, including the hydrogel film 409 applied thereto. In some embodiments, as shown in FIG. 4, the process 400 may include step 414 of applying (e.g., sputtering or dip coating) a protective material to the hydrogel film 409 applied to the product 101. In some embodiments, the protective material may be configured to reduce degradation of analyte indicator molecules in the hydrogel film 409. In some embodiments, the protective material may be configured to catalyze the decomposition of reactive oxygen species (ROS). In some embodiments, the protective material may include platinum, palladium, iridium, molybdenum, and / or silver.

[0087]

[0122] 4, the process 400 may additionally or alternatively include a step 416 of applying a second protective material to the hydrogel film 409 applied to the product 101. In some embodiments, the second protective material may include iridium and / or molybdenum.

[0088]

[0123] 4, process 400 may include step 418 of inspecting device 100 including product 101 and applied hydrogel film 409. In some embodiments, inspection may include, for example, without limitation, electrical testing (e.g., circuitry of product 101). In some embodiments, process 400 may include step 420 of rinsing and drying device 100 as shown in FIG. 4. In some embodiments, process 400 may include step 422 of inspecting device 100 (e.g., a final inspection including, for example, a visual inspection). In some embodiments, if device 100 fails inspection at step 418 or step 422, it may be removed from process 400. In some embodiments, if device 100 passes inspection at steps 418 and 422, one or more devices 100 may be consolidated and / or packaged.

[0089]

[0124] In some embodiments, the same amount of monomer solution 610 used to form hydrogel films 409 on 100 products 101 by conventional methods can be used (e.g., in step 402 of process 400) to manufacture 40 hydrogel sheets 612, each of which can be cut into 60 sheets (e.g., in step 404 of process 400) to create 2400 hydrogel films 409. Thus, process 400 for creating and applying hydrogel films 409 can be more efficient than conventional methods of forming hydrogel films on products 101.

[0090]

[0125] In some embodiments of a plurality of hydrogel films 409, steps 408 and 410 (and step 411, if necessary) of process 400 may be repeated for each of the plurality of hydrogel films 409. In some embodiments of a plurality of hydrogel films 409, each of the plurality of hydrogel films 409 may be the same. However, this is not required, and in some alternative embodiments of a plurality of hydrogel films 409, the plurality of hydrogel films 409 may include at least one or more first hydrogel films and one or more second hydrogel films that are different from the one or more first hydrogel films. In some embodiments involving different first and second hydrogel films, the first hydrogel film can include first analyte indicator molecules 311 configured to reversibly bind to a first analyte and to emit a first emission light 331 in an amount indicative of the amount of first analyte indicator molecules 311 reversibly bound to the first analyte (e.g., in response to irradiation with excitation light 329), and the second hydrogel film can include second analyte indicator molecules 311 configured to reversibly bind to a second analyte and to emit a second emission light 331 in an amount indicative of the amount of second analyte indicator molecules 311 reversibly bound to the second analyte, where the second analyte can be different from the first analyte. In some embodiments that include at least a first and a second hydrogel film that are different, steps 402, 404, and 406 of process 400 may be repeated for each of the various hydrogel films. In some embodiments, the same mold 600 and hydrogel cutting tool 700 may be used to fabricate the first and second hydrogel sheets and cut them into the first and second hydrogel films, respectively.However, this is not required, and in some alternative embodiments, different molds 600 and / or different hydrogel cutting tools 700 may be used to produce the first and second hydrogel sheets and cut them into the first and second hydrogel films, respectively.

[0091]

[0126] 16 shows experimental results of a repeatability and reproducibility (R&R) test of a device 100 including a hydrogel film 409 applied to a product 101, according to some embodiments. The experimental results of the R&R test demonstrate that the process 400 for creating and applying the hydrogel film 409 to a product 101 is repeatable and reproducible. In FIG. 16, S037 is the baseline signal, mods37 is the signal channel modulation signal, modr37 is the reference channel modulation signal, Sig_wmard is the weighted mean relative difference, perROC is the rate of change of the signal channel, and Sig_T90 is the response time of a change in glucose.

[0092]

[0127] FIG. 17 shows experimental results of functionality testing of devices 100 including a hydrogel film 409 applied to an article 101 after sterilization, according to some embodiments. In some embodiments, sterilization was performed on a group of 29 devices 100 including a hydrogel film 409 applied to an article 101. Sterilization was ethylene oxide (ETO) sterilization, although various types of sterilization may be used in some alternative embodiments. A quality control process was performed after sterilization. The sensor functionality test output in FIG. 17 demonstrates maintenance of device parameters. In FIG. 17, S037 is the baseline signal, Mods37 is the signal channel modulation signal, and T90 is the response time to a change in glucose.

[0093]

[0128] 18A and 18B show experimental results of stability tests on a hydrogel film formed on an article and a hydrogel film applied to an article embodying an embodiment of the present invention, respectively. Figures 18A and 18B show that a device 100 including a hydrogel film 409 applied to an article 101 according to an embodiment of the present invention performs similarly to a hydrogel film formed on an article by conventional methods.

[0094]

[0129] While the subject matter of the present disclosure has been described and illustrated in considerable detail with reference to specific exemplary embodiments incorporating various combinations and subcombinations of features, those skilled in the art will readily appreciate other embodiments, as well as variations and modifications thereof, that are encompassed within the scope of the present disclosure. Moreover, the description of such embodiments, combinations, and subcombinations is not intended to convey that the claimed subject matter requires any features or combinations of features other than those expressly recited in the claims. Accordingly, the scope of the present disclosure is intended to include all modifications and variations encompassed within the spirit and scope of the appended claims that follow.

Claims

1. Injecting a monomer solution into a mold; polymerizing the monomer solution in the mold to produce a hydrogel sheet; cutting the hydrogel sheet to create one or more hydrogel films; applying a hydrogel film of the one or more hydrogel films to an article; The process includes:

2. 2. The process of claim 1, The process, wherein the mold includes a first plate and a second plate and one or more clips configured to hold the first plate and the second plate together, and the monomer solution is injected between the first plate and the second plate.

3. 3. The process of claim 2, The process wherein the first plate is a glass plate, the second plate is a stamping plate, and the one or more clips are plastic clips.

4. 4. The process according to any one of claims 1 to 3, The process further comprising assembling the mold.

5. 5. The process according to any one of claims 1 to 4, The process wherein injecting the monomer solution into the mold comprises injecting the monomer solution into an injection port of the mold.

6. 6. The process according to any one of claims 1 to 5, The process wherein cutting the hydrogel sheet to create the one or more hydrogel films comprises using a hydrogel cutting tool to divide the hydrogel sheet.

7. 7. The process of claim 6, 2. Using the hydrogel cutting tool to divide the hydrogel sheet, providing the hydrogel sheet between a platform of the hydrogel cutting tool and a cutout sheet, the platform including a protrusion and the cutout sheet including an opening that mates with the protrusion of the platform; inserting the protrusion of the platform into the opening of the cutout sheet; The process includes:

8. 8. The process according to any one of claims 1 to 7, The step of attaching the hydrogel sheet to the product comprises: applying an adhesive to the product; placing a first edge of the hydrogel film on the adhesive in the product; placing a second edge of the hydrogel film on the adhesive in the product; The process includes:

9. 9. The process of claim 8, A process wherein applying the hydrogel sheet to the product comprises rotating the product and pressing the hydrogel film against the product as the product rotates.

10. 8. The process according to any one of claims 1 to 7, The process wherein the step of applying the hydrogel sheet to the product comprises using a hydrogel film application tool.

11. 11. The process of claim 10, The step of using the hydrogel film application tool includes: holding the product in one or more product racks of the hydrogel film application tool; using a roller of the hydrogel film application tool to apply the hydrogel film to the product; The process includes:

12. 12. The process of claim 11, wherein retaining the product on the one or more product racks comprises using one or more magnets of the hydrogel film application tool to retain the product on the one or more product racks.

13. 13. The process according to claim 11 or 12, The process wherein using the roller to apply the hydrogel film to the product includes rotating the roller 180 degrees in one of a clockwise and counterclockwise direction, and then rotating the roller 180 degrees in the other of the clockwise and counterclockwise directions.

14. 14. The process according to any one of claims 1 to 13, The process further comprising the step of determining whether the hydrogel film passes inspection before applying the hydrogel film to the product.

15. 15. The process of claim 14, The process wherein determining whether the hydrogel film passes the test comprises determining whether the hydrogel film contains a threshold amount of analyte indicator molecules.

16. 14. The process according to any one of claims 1 to 13, The process further comprising determining whether the hydrogel film applied to the product passes inspection.

17. 17. The process of claim 16, determining that the hydrogel film applied to the product fails the inspection; peeling all or a portion of the hydrogel film from the product; applying another hydrogel film to the product; The process further comprises:

18. 14. The process according to any one of claims 1 to 13, The process further comprising the step of drying the product with the hydrogel film applied thereto.

19. 14. The process according to any one of claims 1 to 13, The process further comprising the step of applying a protective material to the hydrogel film attached to the product.

20. 20. The process of claim 19, The process wherein the protective material is configured to reduce degradation of analyte indicator molecules of the hydrogel film.

21. 21. The process of claim 19 or 20, The process wherein the protective material is configured to catalyze the decomposition of reactive oxygen species (ROS).

22. 22. The process according to any one of claims 19 to 21, The process further comprising applying a second protective material to the hydrogel film attached to the product.

23. 23. The process of any one of claims 1 to 22, The process, wherein the product is a sensor.

24. 24. The process of any one of claims 1 to 23, the hydrogel film of the one or more hydrogel films is a first hydrogel film; the first hydrogel film includes a first analyte indicator molecule configured to reversibly bind to a first analyte and to emit a first emitted light in an amount indicative of the amount of the first analyte indicator molecule reversibly bound to the first analyte; The process further comprises applying a second hydrogel film to the product; the second hydrogel film includes a second analyte indicator molecule configured to reversibly bind to a second analyte and to emit a second emitted light in an amount indicative of the amount of the second analyte indicator molecule reversibly bound to the second analyte; The process wherein the second analyte is different from the first analyte.

25. 25. The process of claim 24, the monomer solution is a first monomer solution, the mold is a first mold, the hydrogel sheet is a first hydrogel sheet, the one or more hydrogel films are one or more first hydrogel films, and the process comprises: injecting a second monomer solution into a second mold, the second monomer solution including the second analyte indicator molecule; polymerizing the second monomer solution in the second mold to produce a second hydrogel sheet; cutting the second hydrogel sheet to create one or more second hydrogel films, wherein the second hydrogel film applied to the product is one of the one or more second hydrogel films; The process further comprises:

26. 1. A process of using a hydrogel film application tool to apply a hydrogel film to a product, comprising: holding the product in one or more product racks of the hydrogel film application tool; using a roller of the hydrogel film application tool to apply the hydrogel film to the product; The process includes:

27. 27. The process of claim 26, wherein retaining the product on the one or more product racks comprises using one or more magnets of the hydrogel film application tool to retain the product on the one or more product racks.

28. 28. The process of claim 26 or 27, The process wherein using the roller to apply the hydrogel film to the product includes rotating the roller 180 degrees in one of a clockwise and counterclockwise direction, and then rotating the roller 180 degrees in the other of the clockwise and counterclockwise directions.

29. one or more product racks configured to hold products; a roller configured to apply a hydrogel film to the product; Includes a hydrogel film application tool.

30. 30. The tool of claim 29, The tool further comprising one or more magnets configured to hold the product to the one or more product racks.

31. 1. An adhesive application tool for applying adhesive to a product, comprising: one or more first rollers; one or more second rollers; one or more holders including one or more slots configured to deposit the product in the one or more slots onto the one or more first rollers and the one or more second rollers; a motor configured to (i) rotate the one or more first rollers to apply adhesive to the product, and / or (ii) rotate the one or more second rollers to remove excess adhesive from the product; Adhesive application tools.

32. 1. A hydrogel film application tool for applying a hydrogel film to a product, comprising: Housing and a structure movably disposed on the housing, the structure including one or more magnets configured to hold the product and configured to place the product on the hydrogel film; and Includes a hydrogel film application tool.

33. 33. The hydrogel film application tool according to claim 32, The hydrogel film application tool further includes a base including a recess configured to hold the product.

34. 34. The hydrogel film application tool according to claim 33, A hydrogel film application tool, wherein the base is configured such that the product within the recess of the base extends from the base.

35. 35. A hydrogel film application tool according to any one of claims 32 to 34, The hydrogel film application tool further includes a holder.

36. 33. The hydrogel film application tool according to claim 32, The hydrogel film application tool further includes a film wrapping tool.

37. 37. The hydrogel film application tool according to claim 36, A hydrogel film application tool, wherein the film wrapping tool includes a film wrapping ramp, a slider, and / or a moving tool.

38. 1. A method for applying a hydrogel film to a product, comprising: placing the hydrogel film onto a film wrapping ramp of a hydrogel film application tool; placing the product on the hydrogel film on the film wrapping ramp; rolling the product onto the hydrogel film at the film wrapping ramp; A method comprising:

39. 39. The method of claim 38, The method further comprises applying an adhesive to the product.

40. 40. The method of claim 38 or 39, The method further includes the step of removing the product from the film wrapping ramp.

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