WO2019175660A1 - Procédé de détection d'un état de santé au moyen de biomarqueurs - Google Patents

Procédé de détection d'un état de santé au moyen de biomarqueurs Download PDF

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Publication number
WO2019175660A1
WO2019175660A1 PCT/IB2019/000237 IB2019000237W WO2019175660A1 WO 2019175660 A1 WO2019175660 A1 WO 2019175660A1 IB 2019000237 W IB2019000237 W IB 2019000237W WO 2019175660 A1 WO2019175660 A1 WO 2019175660A1
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WO
WIPO (PCT)
Prior art keywords
contact lens
biomarker
user
aqueous solution
level
Prior art date
Application number
PCT/IB2019/000237
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English (en)
Other versions
WO2019175660A9 (fr
Inventor
Mouad Lamrani
Stephen D. Newman
Original Assignee
Menicon Co. Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Menicon Co. Ltd. filed Critical Menicon Co. Ltd.
Publication of WO2019175660A1 publication Critical patent/WO2019175660A1/fr
Publication of WO2019175660A9 publication Critical patent/WO2019175660A9/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/30—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for calculating health indices; for individual health risk assessment
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/65—Raman scattering
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00—Features of devices classified in G01N21/00
    • G01N2201/02—Mechanical
    • G01N2201/022—Casings
    • G01N2201/0221—Portable; cableless; compact; hand-held

Definitions

  • proteins, lipids, antibodies, and other types of biological materials from the user’s tear fluid or other optical fluid can be bonded to, adsorbed by, or deposited on the user’s contact lens.
  • the bonding of proteins is a result of the protein denaturing, but in other situations the protein has not denatured before adsorbing to the contact lens.
  • Protein deposits that are visible to the naked eye are most often a result of denaturation. These proteins can build up on the surface of the contact lenses, forming protein deposits that impact the transparency of the lens and the integrity of the lens surface.
  • the protein deposits trigger an immune reaction and the body produces antibodies in response. These antibodies can cause inflammation, irritation, redness and itching in the eye.
  • the build-up of certain biological material can be indicative of a health condition of the contact lens wearer.
  • Contact lenses have been previously modified to collect biological material within tear fluid or otherwise bind biological material to the surface of the contact lens to assess a health condition of the wearer.
  • a contact lens can include a substrate that forms at least part of a body of the contact lens, and one or more cavities disposed within the substrate are configured to collect and store tear fluid over time when the contact lens is worn over an eye.
  • Etzkom also discloses a contact lens that includes a substrate that forms at least part of a body of the contact lens and one or more receptors disposed on or within the substrate, the one or more receptors being configured to bind to a known ligand.
  • a contact lens for collecting an analyte can be modified to have surface charges present in a density sufficient to impart to the contact lens an increased adsorption of the analyte of interest, a coating including a receptor which specifically binds the analyte of interest, molecular imprints for the analyte of interest, and a core material that is prepared from a composition containing a receptor which binds specifically the analyte of interest.
  • U.S. Patent Publication No. 7,429,465 issued to Achim Miiller, et al. teaches a process for analyzing an analyte in a hydrogel contact lens following its wear on the eye.
  • the method includes physically or chemically inducing a volume reduction of the hydrogel contact lens and thereby squeezing the analyte out of the polymer material making up the contact lens and feeding the analyte obtained according to step (a) into an analyzer.
  • U.S. Patent No. 6,060,256 issued to Dennis S. Everhart, et al. teaches an inexpensive and sensitive device and method for detecting and quantifying analytes present in a medium.
  • the device includes a metalized film upon which is printed a specific, predetermined pattern of analyte-specific receptors.
  • a target analyte Upon attachment of a target analyte to select areas of the plastic film upon which the receptor is printed, diffraction of transmitted and/or reflected light occurs via the physical dimensions and defined, precise placement of the analyte.
  • a diffraction image is produced which can be seen with the eye or, optionally, with a sensing device.
  • U.S. Patent Publication No. 2001/0034500 issued to Wayne Front March, et al. teaches an ophthalmic lens including a receptor moiety that can be used to determine the amount of an analyte in an ocular fluid.
  • the receptor moiety can bind either a specific analyte or a detectably labeled competitor moiety.
  • the amount of detectably labeled competitor moiety which is displaced from the receptor moiety by the analyte is measured and provides a means of determining analyte concentration in an ocular fluid, such as tears, aqueous humor, or interstitial fluid.
  • the concentration of the analyte in the ocular fluid indicates the concentration of the analyte in a fluid or tissue sample of the body, such as blood or intracellular fluid.
  • a method of ascertaining a health condition of a user can include analyzing an aqueous solution using a measuring device to determine a characteristic of at least one biomarker within the aqueous solution.
  • the aqueous solution can be positioned within a container which has been configured to house at least one contact lens.
  • the method can also include receiving data relative to the biomarker characteristic from a database.
  • the method can further include comparing the data with a plurality of biomarker characteristics stored within the database. The comparison between the data and the plurality of biomarker characteristics stored within the database can be accomplished using a computing device or processor.
  • the method can also include correlating the data with a health condition based on the comparison.
  • Analyzing the aqueous solution using the measuring device can include emitting light through the aqueous solution, and conducting a spectral analysis. Analyzing the aqueous solution using the measuring device can include generating a current or potential through the aqueous solution, and conducting a electrochemical analysis, included but not limited to photoelectrochemistry, spectroelectrochemistry, electrogenerated
  • the at least one biomarker within the aqueous solution can include a protein build-up on the contact lens.
  • the method can also include predicting the health condition of the user based on the correlation.
  • the measuring device can include a sensor incorporated into a container holding the aqueous solution.
  • the measuring device can include a sensor incorporated into a mobile device.
  • comparing the data with the plurality of biomarker characteristics stored within the database includes sending the data to a remote device, a mobile device, a networked device, or a combination thereof.
  • the at least one biomarker can be deposited into the aqueous solution by submerging the at least one contact lens within the aqueous solution.
  • a method of ascertaining a health condition of a user can include providing an aqueous solution configured to receive a contact lens from a user.
  • the method can also include emitting light through the aqueous solution using a light source and measuring at least one characteristic of the light source with a sensor.
  • the method can further include sending data related to the at least one characteristic to a database and comparing the data to the contents of the database to determine a health condition of the user.
  • the light source can emit isolated predetermined wavelengths of light through the aqueous solution.
  • the light source can emit a broad spectrum of wavelengths and the sensor can include at least one filter.
  • the measuring step can include utilizing Raman spectroscopy.
  • the database can be configured to organize and manipulate the data after the data has been received by the database.
  • the method can also include storing the data within the database.
  • the method can further include generating a recommendation for the user to be tested for the health condition.
  • a method of ascertaining a health condition of a user can include providing an aqueous solution configured to receive a contact lens from the user. The method can also include analyzing the aqueous solution using a measuring device after a first duration of time to determine a first characteristic of a first biomarker within the aqueous solution. The method can further include analyzing the aqueous solution using the measuring device after a second duration of time to determine a second characteristic of a second biomarker within the aqueous solution. The method can also include determining a change between the first and second characteristics and comparing the change with a database that correlates the first and second characteristics with a known health condition.
  • the method can further include determining a health condition of the user based, at least in part, on the comparison.
  • additional considerations are used to determine the health condition including, but in no way limited to, age, health history, family health histories, living conditions, and similar health influencing factors.
  • Analyzing the aqueous solution can include emitting light through the solution and measuring a light characteristic of the light using Raman spectroscopy.
  • the change between the first and second characteristics can be a change in concentration of the first biomarker within the aqueous solution.
  • the first duration of time and the second duration of time can be equal in duration.
  • the method can further include replacing the aqueous solution with uncontaminated aqueous solution between the first duration of time and the second duration of time.
  • a computing device can include ultra-microelectrodes array.
  • the change between the first and second characteristic can be a change in concentration, the ratios of concentration and their kinetics.
  • a computing device can include a processor, a mixed analog and digital circuit and a memory.
  • the processor can obtain information which indicates a characteristic of at least one biomarker which is derived from a contact lens used by a user.
  • the processor can also determine a health condition of the user based, at least in part, on the information.
  • the health condition can include at least one of a blood sugar level, an intraocular pressure, an eye condition, an eye comfort level, a comeal strain level, an allergic condition, and an infection.
  • the biomarker can include at least one of: a protein, an antibody, an electrolyte level, a sodium level, a chloride level, a potassium level, a calcium level, an iron level, a lysozyme level, a lactoferrin level, a lipocalin level, an albumin level, a cytokine level, an enzyme level, a lipid level, a proteases level, an immunoglobulin E level, an immunoglobulin G level, an immunoglobulin A level, and an immunoglobulin M level, osmolarity and matrix metallopeptidase 9.
  • the processor can also obtain information which indicates a characteristic of at least one biomarker which is derived from a contact lens used by the user.
  • the processor can also be configured to obtain information which indicates a characteristic of the biomarker which is derived from another contact lens used by the user.
  • the processor can also determine the health condition of the user based on the obtained information.
  • the processor can also obtain information which indicates a characteristic of at least one biomarker that is derived from a contact lens worn by the user for a time period.
  • the processor can also be configured to obtain information that indicates a characteristic of the biomarker which is derived from contact lens worn by the user for another time period.
  • the processor can also determine the health condition of the user based on the obtained information.
  • the processor can also obtain information that indicates a characteristic of at least one biomarker which is derived from a contact lens worn on a first eye of the user.
  • the processor can also be configured to obtain information that indicates a characteristic of the biomarker which is derived from a contact lens worn on a second eye of the user.
  • the processor can also determine the health condition of the user based on the obtained information.
  • a non-transitory computer readable recording medium can store a program that causes the computer to execute the steps of obtaining information which indicates a characteristic of at least one biomarker derived from a contact lens used by a user and determining a health condition of the user based on the information.
  • FIG. 1 illustrates an exemplary cross-sectional view of a contact lens positioned on an eye, in accordance with the present disclosure.
  • FIG. 2 illustrates an exemplary cross-sectional view of biomarkers adhered to a contact lens, in accordance with the present disclosure.
  • FIG. 3 illustrates an exemplary cross-sectional view of a contact lens in solution, in accordance with the present disclosure.
  • FIG. 4A illustrates a cross-sectional view of running a test on the solution containing biomarkers from a contact lens, according to one embodiment.
  • FIG. 4B illustrates a cross-sectional view of running a test on the solution containing biomarkers from a contact lens, according to another embodiment.
  • FIG. 5 illustrates a block diagram of an example of a health condition system, in accordance with the present disclosure.
  • FIG. 6 illustrates a block diagram of an example of a database, in accordance with the present disclosure.
  • FIG. 7 illustrates a cross-sectional view of an example of a health condition system, in accordance with the present disclosure.
  • FIG. 8 illustrates a block diagram of a method of an example of determining a health condition, in accordance with the present disclosure.
  • FIG. 9 illustrates a block diagram of a method of an example of determining a health condition, in accordance with the present disclosure.
  • FIG. 10 illustrates a block diagram of a method of an example of determining a health condition, in accordance with the present disclosure.
  • FIG. 11 illustrates a block diagram of a method of an example of determining a health condition, in accordance with the present disclosure.
  • FIG. 12 illustrates an example of a mold for making a contact lens, in accordance with the present disclosure.
  • FIG. 13 illustrates an example of a mold for making a contact lens, in accordance with the present disclosure.
  • FIG. 14 illustrates an example of a mold for making a contact lens, in accordance with the present disclosure.
  • FIG. 15 illustrates an example of a spinning structure for making a contact lens, in accordance with the present disclosure.
  • FIG. 16 illustrates a block diagram of a method of an example of determining a health condition, in accordance with the present disclosure.
  • FIG. 17 depicts a graphical representation of measured current at an electrode, in accordance with the present disclosure.
  • FIG. 18 depicts a graphical representation of measured current intensity at an electrode, in accordance with the present disclosure.
  • FIG. 19 depicts a graphical representation of the impedance measured at an electrode, in accordance with the present disclosure.
  • a healthy human eye is coated with tear fluid.
  • the tear fluid includes a base mucous layer that coats the cornea of the eye, an aqueous layer, and a lipid layer that protects the aqueous layer by forming an outer hydrophobic barrier that helps to retain the aqueous layer against the mucous layer.
  • the aqueous layer includes metabolites, proteins, electrolytes, and other constituents.
  • the make-up of the tear fluid can result, in part, from a physiological response to an illness or an allergy. In some examples, the make-up of the tear fluid can represent the physiological expression of an individual’s unique DNA.
  • biomarkers that can be analyzed to determine a health condition of a user.
  • biomarkers can be collected on a contact lens worn by the user. Any appropriate type of contact lens can be used to collect the biomarkers.
  • Any appropriate type of contact lens can be used to collect the biomarkers.
  • unaltered commercially available contact lenses from a wide variety of manufacturers for corrective vision are envisioned to be the contact lens that are used to collect the biomarkers.
  • Biomarkers, such as proteins generally start to bind to these contact lenses as soon as the contact lenses are placed over the user’s eye. Without modifying the contact lens as they are provided by the manufacturers, proteins, electrolytes, and/or other biomarkers in the tear fluid can bind to the contact lens.
  • a user removes the contact lenses after wearing them for a period of time. Often, before the user retires to bed, the user removes their contact lenses and places their contact lenses in a storage example for the night.
  • the storage example can include a storage solution that disinfects the contact lenses and also breaks down any build-up on the contact lenses.
  • the storage solution can be an aqueous solution that causes the build-up on the contact lenses to dissolve into the solution. After a period of time, the storage solution can be replaced with fresh storage solution to reduce the concentration of tear fluid constituents or other contaminants within the solution.
  • the storage solution can be analyzed to determine the type and/or
  • the solution can be analyzed with the contact lens in the solution. In other examples, the contact lens can be removed from the solution before analyzing the
  • a sensor or a sensing device can be used to collect analyte information from the solution. Any appropriate type of sensor can be used to identify the type, concentration, the ratios of concentration and their kinetics and/or any
  • the senor can be incorporated into the contact lenses’ storage container.
  • the sensor can be a single electrode or an array of electrodes operably coupled to the storage container.
  • the electrodes can be ultra microelectrode array.
  • the sensor can be an optical spectral analyzer that passes light from a light source, through a cavity within the storage container
  • the storage container can include the sensor, a processor, and a memory.
  • the sensor can be configured to obtain information which indicates a characteristic of at least one biomarker derived from a contact lens used by a user and stored in the storage container.
  • the processor can be configured to send the information to a computing device which ascertains a health condition of the user based on the information.
  • the senor can be incorporated into a hand-held device.
  • the sensor can be incorporated into the user’s mobile or networked device, such as a smart phone and/or electric tablet.
  • the user can direct a beam of light into the storage solution and measure a reflection with a sensor incorporated into the hand-held or networked device.
  • the measured values can be augmented with complementary information and metadata, such as an amount of time that the user wore the contact lens.
  • the user can interact with a user interface to input how long the user wore the contact lenses.
  • the user can be prompted to input the number of hours that the user wore the contact lenses.
  • the user can be prompted to input the number of days that she/he wore the contact lenses, whether the user removed the contact lenses during the night, the time of when the storage solution was last replaced, other factors that can affect the concentration of biomarkers in the storage solution, or
  • the user may be prompted for additional information that can be relevant to a health condition determination such as age, gender, family health history, geographic area, race, and other medical condition influences.
  • the sensor or other sensing device can record the measured values to determine a concentration or other measurable characteristic of one or more biomarkers.
  • the recorded measurements i.e., the measured values
  • the sensor can record the measurements in real time or near real time.
  • the sensor can include local and/or cloud, on premise private cloud, based logic to determine the type, concentration, and/or other characteristics of the varying kinds of biomarkers.
  • the sensor or sensing device including a sensor can use learning algorithms, predictive models, data correlation models, clustering models, any other appropriate computational techniques, and combinations thereof.
  • the sensor or sensing device including a sensor can include a database that stores the correlation between the identification/concentration of the biomarkers and a health condition of the user.
  • the measurements can be sent to a computing device that processes the information collected by the sensor.
  • at least some computations are performed by the sensor before sending data to a computing device where the computations are finished.
  • the sensor can send raw data to the computing device.
  • all data processing including data cleaning, data management, data mining, and any application specific issues, is performed remotely away from the sensor.
  • the determinations of the type of biomarkers, the characteristics of biomarkers, such as the concentration of the biomarkers, chemometric data such as ratio kinetics, peak, plateau, time constant, decay, and so forth can be compared to data points stored in a database.
  • the database can be local to the computing device or the computing device can have remote access to the database.
  • the data in the database can correlate the different types and concentrations of biomarkers with health conditions, such as eye health conditions, allergic conditions, other physiological conditions, or combinations thereof.
  • the data in the database can be used as input or training data to implement and supervise machine learning techniques, or other statistical learning approaches to solve prediction inference, or other data mining problems related to health conditions, such as eye health conditions, allergic conditions, disease, other physiological conditions, or
  • the database can also correlate the measured biomarkers characteristics to health conditions in subcategories based on at least one population demographic.
  • the database is in communication with multiple users and data sources. As data relating to a user’s biomarker characteristics is collected, this data and data from a plurality of other users can contribute to the information stored within the database. In some examples, data collection can automatically launch a data management system of the database. In some examples, the data management system or another process can incorporate additional data into the database, such as health conditions of each of the users. As a result, the correlations in the database can include reports from the users. The computing device can update the database based on the reports from the users. In some examples, patient data can be used as predictors in a statistical machine learning process.
  • the database’s input can identify correlations between health conditions and specific levels of different types of biomarkers that are unknown to the scientific community.
  • the computing device can, with reference to the database, send information related to the diagnosis of a disease, a disease severity assessment, a risk stratification, a therapeutic decision or request, a recommendation to the user to be tested for a specific type of health condition, or combinations thereof.
  • the database can send information related to the diagnosis of a disease, a disease severity assessment, a risk stratification, a therapeutic decision or request, or test recommendations to a user specified physician.
  • the database can include supplementary user data such as age, gender, weight, height, and the like.
  • FIG. 1 depicts an example of a contact lens 110 situated on the outside of a human eye 150.
  • the contact lens 110 spans a portion of the outside surface of the exposed portion of the eye 150.
  • the contact lens 110 is adjacent a set of eyelashes 152 of the upper eye lid.
  • the contact lens 110 can include a posterior side that is in contact with the cornea of the eye 150, and an anterior side that is opposite of the posterior side. As the eye lid travels over the eye 150, the eye lid can move across the anterior side of the contact lens 110.
  • the contact lens can include an optic zone 120 and a peripheral zone 122.
  • the optic zone 120 can include a region that focuses light to the center of the user’s retina 124.
  • the peripheral zone 122 can contact the eye near or over the sclera. While this example discloses using commercially available contact lenses configured for vision correction to be worn on the eye, other types of contact lenses can be used in accordance with the principles described in the present disclosure.
  • the contact lens may not include a curvature or other features that correct vision. Indeed, a physician can prescribe contact lenses for the sole purpose of collecting biomarkers within the patient’s tear fluid, in one embodiment.
  • the contact lens 110 can be soft contact lenses, rigid gas permeable (RGP) contact lenses, orthokeratology contact lens, another type of contact lenses, or combinations thereof.
  • the contact lens can be made of any appropriate type of material.
  • a non-exhaustive list of materials that can be used to construct the contact lens include any appropriate silicone material and/or hydrogel material.
  • Such material can be formed of polymers, such as tefilcon, tetrafilcon A, crofilcon, helfilcon A&B, mafilcon, polymacon, hioxifilcon B, lotrafilcon A, lotrafilcon B, galyfilcon A, senofilcon A, sifilcon A, comfilcon A, enfilcon A, lidofilcon B, surfilcon A, lidofilcon A, alfafilcon A, omafilcon A, vasurfilcon A, hioxifilcon A, hioxifilcon D, nelfilcon A, hilafilcon A, acofilcon A, bufilcon A, deltafilcon A, phemfilcon A, bufilcon A, perfilcon, etafilcon A, focofilcon A, ocufilcon B, ocufilcon C, ocufilcon D ocufilcon E, ocufilcon F, phemfilcon A, methafilcon
  • the contact lens material can be made of hydrogel polymers without any silicone. This can be desirable to increase the wettability of the contact lens.
  • the contact lens material can be made of silicone hydrogel material.
  • the tear fluid in the ocular cavity can come into contact with the contact lens.
  • the entire surface area of the contact lens comes into contact with the tear fluid.
  • the constituents of the tear fluid can include lipids, electrolytes, metabolites, proteins, antibodies, other types of compounds, or combinations thereof. These constituents can be biomarkers that can be indicative of a health condition of the user. The biomarkers can bind to the contact lens.
  • a non-exhaustive list of biomarkers from the tear fluid that can be of interest includes, but is not limited to, electrolytes, sodium, potassium, chloride, phenylalanine, uric acid, galactose, glucose, cysteine, homocysteine, calcium, ethanol, acetylcholine and acetylcholine analogs, ornithine, blood urea nitrogen, creatinine, metallic elements, iron, copper, magnesium, polypeptide hormones, thyroid stimulating hormone, growth hormone, insulin, luteinizing hormones, chorionogonadotrophic hormone, obesity hormones, leptin, serotonin, medications, dilantin, phenobarbital, propranolol, cocaine, heroin, ketamine, hormones, thyroid hormones, ACTH, estrogen, cortisol, progesterone, histamine, IgE, cytokines, lipids, cholesterol, apolipo protein Ai, proteins and enzymes, lactoferrin,
  • contact lenses can have surface properties to allow the biomarkers to bind to the contact lens without any modifications.
  • protein build-up and other types of build-up is considered a problem on regular contact lenses that do not have surface modifications to enhance a biomarker’s ability to bind specifically or non specifically to the contact lens.
  • the contact lens can be modified to enhance the binding ability of the biomarkers or just for specific biomarkers.
  • the binding enhancements and taging can be made to any appropriate location on the contact lens, including, but not limited to, the peripheral zone or surface of the contact lens, the optical zone, the anterior side of the contact lens, the posterior side of the contact lens, inside the contact lens other areas of the contact lens, or combinations thereof.
  • FIG. 2 depicts an example of biomarkers 114 attached to the posterior surface 130 of the contact lens. While this example depicts the biomarkers 114 attached to the posterior surface 130 of the contact lens, the biomarkers 114 can be attached to just the anterior surface 132 or to both the anterior surface 132 and posterior surface 130 of the contact lens 110. In some embodiments, the biomarkers 114 can be adsorbed, absorbed, bonded, covalently bonded, ionically bonded, adhered, cohered, or otherwise connected to a surface of the contact lens 110. In some embodiments, the biomarkers 114 are incorporated into the thickness of the contact lens 110.
  • the biomarkers 114 can stay with the contact lens 110 as depicted in FIG. 2.
  • the amount of biomarkers 114 that are attached to the contact lens 110 can be related to the amount of time that the contact lens 110 was on the eye.
  • the contact lens 110 can be worn by the user during that day and removed at night. Under these circumstances, biomarkers 114 can cover a substantial amount of the contact lens’ surface area.
  • the contact lens 110 can be worn by the user for a smaller period of time.
  • a patient can be provided with a contact lens 110 for a period of minutes in a doctor’s office to collect biomarkers 114 for analysis.
  • a patient can be instructed to keep a contact lens 110 in for a matter of hours or some other duration of time to collect the desired amount of biomarkers 114.
  • FIG. 3 depicts an example of a contact lens 110 in a storage container 140 with an internal cavity 102.
  • the cavity 102 is defined by a first wall 104 and a second wall 106 that are connected together at a bottom surface 108.
  • a contact lens 110 and a solution 112 are also disposed within the cavity 102.
  • the solution 112 can include a cleansing agent, such as a hydrogen peroxide or another type of agent to clean the contact lens and kill bacteria, fungus, other types of germs, or combinations thereof.
  • the solution 112 can be an off-the-shelf type of storage solution that hydrates and cleans the contact lens.
  • the storage solution 112 can cause the biomarkers 114 to dissolve into the solution 112 thereby cleaning the contact lens 110.
  • the contact lens 110 can remain in the storage solution 112 until the contact lens 110 is subsequently retrieved by the user. In some examples, the contact lens 110 is immersed into the solution for a short period of time, such as a couple of minutes. In other examples, the contact lens 110 can remain in the solution for multiple hours, such as overnight. With the biomarkers 114 removed from the contact lens 110, the biomarkers 114 can be diluted into the solution 112 where the biomarker types, their respective concentrations, or other biomarker characteristics can be measured or analyzed.
  • the biomarkers 114 can be removed from the contact lens 110 without adversely affecting the contact lens 110.
  • the contact lens 110 can be re- worn by the user.
  • the contact lens 110 is removed from the solution 112 so that the contact lens 110 is not affected by the testing mechanism performed on the solution.
  • the contact lens 110 remains in the solution 112 while the solution 112 is analyzed, but the analysis does not adversely affect the contact lens 110 so that the contact lens 110 can be re- worn by the user.
  • the biomarkers 114 can be analyzed in the storage container 140.
  • the solution 112 can be transferred to another type of device with a sensor for taking the measurements.
  • a hand-held device can incorporate a sensor that can perform the analysis on the solution.
  • a storage container 140 for a contact lens 110 includes a cavity 102 that is defined by at least one wall 104 that is connected by a floor 126.
  • a single circular wall defines at least a portion of the cavity 102.
  • multiple independent walls are joined together to define the cavity 102.
  • a light source 142 can be incorporated into a first side of the cavity 102.
  • the light source 142 can be oriented to direct a beam of light 144 through the solution 112 to a light receiver 146.
  • a portion of the light can be absorbed by the solution, depending on its contents.
  • a solution 112 with a different type of biomarker 114 can have a different or unique light transmittance through the solution 112. Further, a solution 112 with a different concentration of the same biomarker 114 can also exhibit a different or unique light transmittance.
  • the light source 142 can isolate a range of wavelengths to be transmitted independently through the solution 112.
  • the transmittance for each wavelength can be measured.
  • Certain biomarkers in the solution 112 may not affect the optical transmittance at a first wavelength, but can affect the optical transmittance at a second wavelength.
  • a more refined measurement of the solution’s composition can be measured.
  • the measured transmittances at each wavelength can be compared to the data of other solutions wherein the types and
  • the measured transmittance levels can be correlated to the types and concentration of the biomarkers 114 in the solution 112.
  • spectroscopic methods can be used to analyze and identify the types and concentration of the biomarkers in the solution.
  • measuring a frequency rather than a wavelength can be performed by the light receiver 146 (e.g., spectral analyzer).
  • a non-exhaustive list of other types of spectroscopic mechanisms for analyzing the solution can include atomic absorption spectroscopy, attenuated total reflectance
  • spectroscopy electron paramagnetic spectroscopy, electron spectroscopy, Fourier transform spectroscopy, gamma-ray spectroscopy, infrared spectroscopy, laser spectroscopy, mass spectrometry multiplex or frequency-modulated spectroscopy, Raman spectroscopy, and x- ray spectroscopy.
  • FIG. 4A While the example embodiment of FIG. 4A includes the light source 142 and the light receiver 146 on different sides of the cavity walls, the light source 142 and the light receiver 146 can be on the same side of the cavity 102. In such an example, light emitted from the light source 142 can be reflected within container and the reflection can be recorded or otherwise measured by the light receiver 146 (e.g., a spectral analyzer).
  • the light receiver 146 e.g., a spectral analyzer
  • the senor can be part of a hand-held device 702, as depicted in FIG. 7.
  • the hand-held device includes a sensor, such as an infrared spectrometer, that can measure a concentration of a biomarker within the solution.
  • the hand-held device can include a portion that has an infrared source that sends infrared light into the solution when the user orients the hand-held device to appropriately direct the infrared light and instructs the hand-held device to send the light.
  • the amount of the infrared light that is absorbed into the solution can be based, at least in part, on the concentration of the biomarker in the solution.
  • the returning amount of the infrared light to the hand-held device can be measured with an infrared receiver incorporated into the hand-held device.
  • the solution 112 can be poured into another device for analysis.
  • the solution 112 can be poured into an immunodiffusion machine, a centrifuge, another type of device, or combinations thereof for measuring at least one property (e.g., a biomarker characteristic) of the solution 112.
  • FIG. 4B Another approach of analyzing the solution is depicted in FIG. 4B.
  • at least one electrode can be incorporated into the storage solution container 140 to analyze the contents of the storage solution 112 by chronoamperometry.
  • an electrical potential can be applied to an electrode 148 over a predetermined time period to elicit a resultant current intensity.
  • the current intensity can vary relative to the properties of the solution 112.
  • the current intensity measured at the electrode 148 can vary relative to the concentration of glucose within the solution 112, in one embodiment.
  • the current intensity of the electrode 148 can be recorded and compared with a database to determine a health condition of the contact lens user.
  • the electrode 148 can be incorporated into the floor 126 of the container 140.
  • a stepped potential or voltage can be applied to the electrode 148, wherein the voltage applied to the electrode 148 increases by predetermined steps over a period of time.
  • the potential or voltage applied to the electrode 148 can be a constant potential over a period of time.
  • a plurality of electrodes including an array of electrodes can be incorporated into the floor 126 or any other surface of the container 140.
  • the electrode 148 can be operably coupled to a power supply (not shown) configured to supply electrical power to the electrode 148.
  • the electrode 148 can be operably coupled to a processing unit (not shown) configured to measure operational parameters of the electrode
  • FIG. 5 depicts a diagram of a health condition system 500.
  • the system 500 includes a base station 505 having a processor 515, an input/output (I/O) controller 520, and memory 525.
  • the processor 515 and the memory 525 are
  • the base station 505 can be a computing device.
  • the I/O controller 520 can be in communication with a sensing device 530, for example, through an antenna.
  • a sensor of the sensing device 530 can be incorporated into the contact lens storage example, into a hand-held device, an independent machine configured to analyze the solution, another type of sensor, or combinations thereof.
  • the sensing device can include its own processor, memory, and/or I/O controller 520.
  • the components of the system and the sensing device 530 can communicate wirelessly, through hard wired connections, or combinations thereof.
  • the memory 525 of the system can include a biomarker characteristic obtainer 545, a database 550, a biomarker and database comparer 555, a health condition determiner 560, and a recommendation generator 565.
  • the system 500 can further include a base station 505 in communication with the memory 525, the base station 505 can be in communication with the processor 515 and/or the sensing device 530, for example via an antenna within the I/O controller 520 or a transponder.
  • the sensing device 530 is at least one electrode and/or optical spectral analyzer.
  • the processor 515 can include an intelligent hardware device, (e.g., a general- purpose processor, a digital signal processor (DSP), a central processing unit (CPU), a microcontroller, an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), a programmable logic device, a discrete gate or transistor logic component, a discrete hardware component, or any combination thereof).
  • the processor 515 can be configured to operate a memory array using a memory controller.
  • a memory controller can be integrated into the processor 515.
  • the processor 515 can be configured to execute computer-readable instructions stored in a memory to perform various functions (e.g., functions or tasks supporting the evaluation of the prescribed optical devices).
  • the I/O controller 520 can include or interact with a modem, a keyboard, a mouse, a touchscreen, or a similar device. In some examples, the I/O controller 520 can be implemented as part of the processor. In some examples, a user can interact with the system via the I/O controller 520 or via hardware components controlled by the I/O controller 520. The I/O controller 520 can be in communication with any input and any output of the system 500.
  • the memory 525 can include random access memory (RAM) and read only memory (ROM).
  • the memory 525 can store computer-readable, computer-executable software including instructions that, when executed, cause the processor 515 to perform various functions described herein.
  • the memory 525 can include, among other elements, a basic input/output system (BIOS) which can control basic hardware and/or software operation such as the interaction with peripheral components or devices.
  • BIOS basic input/output system
  • the memory 525 storing the software e.g., a program
  • the recording medium can be a "non-transitory tangible medium" such as, for example, a tape, a disk, a card, a semiconductor memory, a programmable logic circuit, or the like.
  • the program can be supplied to the computer via any transmission medium (such as a communication network or a broadcast wave) that can transmit the program.
  • any transmission medium such as a communication network or a broadcast wave
  • aspects of the present disclosure can also be achieved in the form of a computer data signal in which the various programs are embodied via electronic transmission and which is embedded in a carrier wave.
  • the biomarker characteristic obtainer 545 can include programmed instructions that cause the processor 515 to obtain a biomarker characteristic from the solution. In other words, the processor 515 can execute the programmed instructions to function as the biomarker characteristic obtainer 545.
  • the biomarker characteristic can include a biomarker identification, a biomarker concentration, another type of characteristic, or combinations thereof.
  • the biomarker characteristic obtainer 545 passively receives a signal containing information about the biomarker characteristic. In other examples, the biomarker characteristic obtainer 545 actively requests information about the biomarker characteristic.
  • the database 550 can include a data structure that holds information relating to the biomarker characteristics.
  • the database 550 can include information relating to the biomarker characteristics that have been recorded or measured in labs, for example by chemometric methods, obtained from at least one user, or combinations thereof.
  • the database can be initially populated with information from patients and/or users who have known health conditions and the biomarkers types and concentration levels in the tear fluid have been studied in labs or in other settings. Since some users with the same health condition can exhibit slightly different biomarker characteristics, the information from a plurality of users can be compiled. In some examples, thousands to millions of sample biomarker characteristics can be collected.
  • the biomarker and database comparer 555 can represent or otherwise include programmed instructions that cause the processor 515 to compare the obtained biomarker characteristic against the information stored in the database 550. In other words, the processor 515 can execute the programmed instructions to function as the biomarker and database comparer 555. In some examples, the programmed instructions can include data mining algorithms to compare biomarker characteristics.
  • the health condition determiner 560 can represent or otherwise include programmed instructions that cause the processor 515 to correlate a user’s biomarker characteristics to similar biomarker characteristics stored within the database 550 to determine or predict a health condition of the user. In other words, the processor 515 can execute the programmed instructions to function as the health condition determiner 560.
  • characteristics of users with a specific health conditions can be analyzed which can reveal that certain biomarkers that had not previously been linked to that health condition have a statistically significant normal concentration level, a statistically significant low
  • concentration level a statistically significant high concentration level, another statistically significant concentration level, a statistically insignificant type of concentration level, or combinations thereof that had not previously been observed.
  • the recommendation generator 565 can represent or otherwise include programmed instructions that cause the processor 515 to generate a recommendation to the user.
  • the processor 515 can execute the programmed instructions to function as the recommendation generator 565.
  • the recommendation can include a confirmation test to confirm whether or not the user has that determined health condition.
  • the confirmation test can be conducted by an external computing device commonly operated by the user (e.g., a mobile device).
  • the results of the confirmation test can be sent to the database and/or computing device. The results can be used to assist the database and its associated analytics to improve the health condition determinations.
  • Another recommendation can prompt a user to receive treatment for the determined health condition. Another recommendation can prompt the user to visit a specific type of doctor. Another recommendation can include avoiding certain types of foods. Yet, another recommendation can include a health regime, a particular type of diet, another recommendation to perform a type of action, or combinations thereof.
  • FIG. 6 depicts an example of a database 600 that associates a characteristic of the tear chemistry (e.g., constituents and their associated concentrations within a user’s tear fluid), potential indications, and potential causes of the tear chemistry.
  • the database 600 includes a first column 602 that represents the tear chemistry, a second column 604 that represents the potential indications, and a third column 606 that represents the potential causes of the tear chemistry.
  • the database 600 can include a first row 608 that includes the correlation for a tear chemistry with a normal lactoferrin level and a normal IgE level, a second row 610 that includes the correlation for a tear chemistry with a normal lactoferrin level and a high IgE level, a third row 612 that includes the correlation for a tear chemistry with a low lactoferrin level and a normal IgE level, a fourth row 614 that includes the correlation for a tear chemistry with a low lactoferrin level, a fifth row 616 that includes the correlation for a tear chemistry with a high lactoferrin level, and a sixth row 618 that includes the correlation for a tear chemistry with a high IgE level.
  • any appropriate type of correlation can be included in the database.
  • the characteristics correlated with a single biomarker can be included as depicted in rows 614, 616, 618.
  • the characteristics correlated with a specific set of biomarkers can be included.
  • the health conditions correlated with two or more characteristics of different types of biomarkers can be included as depicted in rows 608, 610, 612.
  • Any appropriate number of biomarker characteristics can be included. For example, anywhere from one, three, to hundreds of characteristics can be collectively correlated to a specific type of health condition. Further, while the example of FIG.
  • the database can include any appropriate type of biomarker correlation. In the embodiment depicted in FIG. 6, whether a biomarker level is "Normal”, “Low”, or “High” can be determined by comparing the measured value of the biomarker with a predetermined threshold.
  • FIG. 7 depicts an example of a system 700 of ascertaining or otherwise determining a health condition of a user.
  • a storage solution i.e., aqueous solution
  • a hand-held device 702 with a sensor can be used to take a measurement of at least one characteristic of the biomarkers in the solution.
  • the hand-held device 702 can send the biomarker characteristic to a mobile device 704 (i.e., a computing device) that is in communication with a server and database network or a cloud based data center 706 that stores the database (FIG. 6, 600).
  • the mobile device 704 can relay the measured biomarker characteristics to the database in the data center 706, which can send a correlation between the biomarker characteristics and a health condition back to the mobile device 704.
  • the mobile device 704 can present the results from the hand-held device 702 and/or the correlations from the database in a user-interface of the mobile device 704.
  • the mobile device 704 can include a program that retrieves the correlations from the database and performs additional tasks.
  • the mobile device 704 can retrieve information about the health condition from another source other than the database in response to receiving the health condition from the database.
  • the mobile device 704 can also retrieve a health professional’s contact information, consult a user’s calendar to set up an appointment with the health professional, schedule an appointment with the health professional, perform another task, or combinations thereof.
  • FIG. 8 illustrates an example of a method 800 of determining a health condition.
  • the method 800 includes analyzing 802 a characteristic of at least one biomarker contained on a contact lens to determine the health condition of the user and comparing 804 the characteristic with a database that correlates the characteristic with a health condition.
  • a characteristic of at least one biomarker is analyzed. This process can be performed by the sensing device 530 or by the processor 515 (e.g ., the biomarker characteristic obtainer 545) after the processor 515 obtains or otherwise receives the measured values detected by a sensor within the sensing device 530.
  • the biomarkers can be obtained from a contact lens. In some examples, the biomarkers can remain on the contact lens when the biomarkers are being analyzed or otherwise measured. In other examples, the biomarkers can be removed from the contact lens before the analysis.
  • the biomarker characteristic can include a type of biomarker, a concentration of biomarker, a location of the biomarker on the contact lens, another type of characteristic, or combinations thereof.
  • the biomarker characteristic can involve a single biomarker. In other examples, the biomarker characteristic can include the collective condition of multiple biomarkers.
  • the biomarker characteristic can be compared to a database that correlates the biomarker characteristic with a health condition (e.g., the database 550 in FIG.
  • the database can include the type and concentration of a single biomarker that is correlated with a specific health condition. This process can be performed by the processor 515 (e.g., the biomarker and database comparer 555). In another example, the database can correlate that a first type of biomarker having a specific concentration and a second type of biomarker having different specific concentration can be associated with a specific type of health condition.
  • FIG. 9 illustrates an example of a method 900 of determining a health condition.
  • the method 900 includes obtaining 902 biomarkers from a contact lens previously worn by a user, analyzing 904 at least one biomarker to determine the health condition of the user, obtaining 906 a concentration level based on the analysis of the biomarker, and comparing 908 the concentration level with a database that correlates concentration levels with health conditions.
  • the process blocks 904 and 906 can be performed by the same entity (e.g., a processor) as that of block 802 in FIG. 8.
  • the process block 908 can be performed by the same entity (e.g., a processor) as that for block 804 in FIG. 8.
  • the biomarkers can be obtained from the contact lens in any appropriate way.
  • the biomarkers can dissociate from the contact lens in a multi-purpose contact lens storage solution.
  • the biomarkers are obtained from the contact lens by wiping a material across the contact lens’ surface.
  • the biomarkers can be removed from the contact lens by scratching the biomarkers off of the lens’s surface.
  • obtaining the biomarkers from the contact lens results in a contact lens that can be re-wom by the user.
  • obtaining the biomarkers from the contact lens results in modifying the contact lens such that it cannot be re-wom by the user.
  • the biomarker characteristic obtainer 545 obtains from, for example, the sensing device 530, information indicating characteristics of the biomarkers obtained as above.
  • FIG. 10 illustrates an example of a method 1000 of determining a health condition.
  • the method 1000 includes comparing 1002 a characteristic of biomarkers from a contact lens previously worn by a user to an aggregated database that correlates characteristics of biomarkers with health conditions.
  • the process block 1002 can be performed by the same entity as that for the block 804 in FIG. 8.
  • the aggregated database can include the concentration levels associated with health conditions from multiple sources.
  • doctors, patients, other types of professionals, other types of sources, or combinations thereof can contribute information that can be populated into the database.
  • thousand and even millions of health conditions, with their associated biomarker characteristics, can be aggregated into the database.
  • the user can have an option to confirm whether the health condition was accurate. For example, a user can place his or her contact lens in the storage example and receive a notification that he or she has or may have a health condition. As a result, the user can visit with a doctor, who performs a test to confirm whether the user has that health condition. In the event that the user has the health condition indicated by the database, the user can send a confirmation message to the database. The confirmation message can increase a confidence level of the correlation between the characteristic of the biomarker and the health condition.
  • the user can send confirmation message to the database indicating that the user does not have the health condition.
  • This confirmation message can cause a decrease in a confidence level of the correlation between the characteristic of the biomarker and the health condition.
  • the database can reassess the correlation drawn and determine whether the correlation drawn is based on proper assumptions.
  • the message indicating that the user does not have the indicated health condition can include that the user has a different health condition that was not identified by the database previously.
  • the database can correlate the different health condition with the user’s determined biomarker characteristics.
  • FIG. 11 illustrates an example of a method 1100 of determining a health condition based, at least in part, on biomarker analysis.
  • the method 1100 includes dissolving 1102 a build-up on a contact lens into a solution, analyzing 1104 the constituents of the protein build-up in the solution, and sending 1106 at least one parameter derived from the analysis to a computing device.
  • the process illustrated in 1104 and 1106 can be performed by, for example, the sensing device 530.
  • the build-up can be dissolved by placing the contact lens into a contact lens storage solution.
  • a contact lens storage solution Any appropriate type of contact lens solution can be used.
  • the contact lens solution can be a hydrogen peroxide solution, a multiple purpose storage solution, another type of solution, or combinations thereof.
  • the contact lens solution includes hyaluronan, sulfobetaine, poloxamine, boric acid, sodium borate, ascorbic acid, edetate disodium, sodium chloride, hydroxyalkyl phosphate, poloxamer, sodium phosphate buffer, polyoxyethylene polyoxypropylene block copolymer with ethylene diamine, and polyaminopropyl biguanide, or combinations thereof.
  • the contact lens can include a disinfectant, a surfactant, an anti fungal agent, an anti-bacterial agent, another type of agent, or combinations thereof.
  • the removal of the biomarkers from the contact lens into the solution can occur over any appropriate time period.
  • the biomarkers are in the solution for at least one minute, at least five minutes, at least 20 minutes, at least 45 minutes, at least an hour, at least two hours, at least 5 hours, at least 7 hours, at least one day, at least two days, another appropriate time period, or combinations thereof.
  • the contact lens is free of surface cavities that are constructed to be binding sites for biomarkers or to draw in tear fluid into the contact lens. In some examples, the contact lens is free of surface treatments that target the binding of specific biomarkers to the contact lens.
  • the storage solution can includes binding agents configured to facilitate the bonding between a surface of the contact lens and a biomarker from the tear fluid. In other examples, no binding agents are introduced to the contact lens solution.
  • the contact lens can include a surface where the biomarkers are as likely to bind to any surface of the contact lens as any other surface of the contact lens.
  • the biomarkers can attach to the optical zone of the contact lens, a peripheral zone of the contact lens, an edge of the contact lens, a posterior side of the contact lens, an anterior side of the contact lens, another area of the contact lens, or combinations thereof.
  • the dissolved contents can then be analyzed at 1104, for example according to the process 802 or 904 described herein with reference to FIGS. 8 and 9, respectively.
  • At 1106 at least one parameter derived from the analysis is sent to a computing device, for example as described with reference to FIG. 7.
  • the contact lens can be made through any appropriate mechanism.
  • the contact lenses are molded (i.e. cast molded) into their shape.
  • the contact lenses are machined to their precise shape.
  • the contact lens are spin cast.
  • Spin cast contact lenses can have an advantage of making a continuous surface on the posterior side of the contact lens that matches a profile constructed to assist the user with his or her vision.
  • the front side of the contact lens during a spin casting procedure can include a profile that matches a contact lens mold.
  • the contact lens mold can include a continuous, curved surface without interruptions.
  • the spin cast contact lens provide for a continuous surface that is substantially free of interruptions, such as micro-cavities.
  • having a continuous, interruption free surface on both the anterior side and the posterior side can prevent the collection of tear fluid in the contact lens. Avoiding the collection of tear fluid can prevent the contact lens from having an additional amount of weight. Further, when the contact lens is introduced into the solution, a substantial amount of tear fluid may not mix with the contact lens solution, which can skew the volume of fluid in being analyzed and affect the concentration analyses. In some examples where tear fluid is not collected, just the biomarkers can be carried with the contact lens into the solution. Thus, the analysis does not have to be adjusted to accommodate an increase in fluid. But, in some examples, the amount of fluid being analyzed may not require a precise amount of fluid.
  • the example lens example can include a fill line and the
  • the concentrations of the biomarkers that bind to the contact lens can be more reflective of the actual concentration of that biomarker in the tear fluid.
  • An enhanced ability to collect a particular biomarker or a wide variety of biomarkers can cause a disproportionate amount of that biomarker to bind to the contact lens, which can skew the concentration levels made when analyzing the solution and potentially lead to an inaccurate characterization of the biomarker’s actual concentration.
  • FIGS. 12-15 illustrate various components that can be used in certain examples for making a contact lens 110 in accordance with the principles described in the present disclosure.
  • a liquid lens material 1052 can be applied to a profile 1054 of the mold 1042.
  • the mold 1042 with the liquid lens material 1052 can be loaded into a spinning structure 68 that is configured to spin the mold 1042 so that the liquid lens material 1052 centrifugally spreads across the profile 1054 into the desired shape of the contact lens.
  • a curing agent e.g., temperature, actinic radiation, or another type of curing agent
  • the liquid lens material 1052 hardens into the contact lens 110.
  • FIG. 12 is a cross-sectional view of one embodiment of a mold for a contact lens according to the principles of the present disclosure.
  • the mold 1042 has a base 1056 with multiple cut outs 1058, 1060, 1062 that are spaced and shaped to interlock with an internal surface of a spinning structure during a later stage of
  • the profile 1054 of the mold 1042 is shaped to form the anterior surface of the contact lens 110. In some examples, the profile 1054 of the mold 1042 can be continuous without substantial interruptions.
  • FIG. 13 is a cross-sectional view of one embodiment of a mold 1042 with a liquid lens material 1052 according to the principles of the present disclosure.
  • the liquid lens material 1052 is deposited into the profile 1054 of the mold.
  • the liquid lens material 1052 can be made from any material suitable for use in contact lenses.
  • the liquid lens material 1052 can be made of any silicone material and/or hydrogel material.
  • Such material can be formed of polymers, such as tefilcon, tetrafilcon A, crofilcon, helfilcon A&B, mafilcon, polymacon, hioxifilcon B, lotrafilcon A, lotrafilcon B, galyfilcon A, senofilcon A, sifilcon A, comfilcon A, enfilcon A, lidofilcon B, surfilcon A, lidofilcon A, alfafilcon A, omafilcon A, vasurfilcon A, hioxifilcon A, hioxifilcon D, nelfilcon A, hilafilcon A, acofilcon A, bufilcon A, deltafilcon A, phemfilcon A, bufilcon A, perfilcon, etafilcon A, focofilcon A, o
  • the liquid lens material is made of hydrogel polymers without any silicone. This can be desirable to increase the wettability of the contact lens.
  • the liquid lens material is made of silicone hydrogel material.
  • the contact lens 110 can be shaped and sized based on a variety of factors, including the shape and size of the user’s eye and various optical properties to be achieved by a central portion of the contact lens.
  • the total thickness of the contact lens 110 can be approximately 0.1 mm to approximately 0.14 mm.
  • the thickness of the contact lens 110 can gradually vary at different locations on the contact lens 110.
  • the contact lens 110 can be thicker near the outer edge of the contact lens 110 than in the central portion of the contact lens 110.
  • FIGS. 14 and 15 are cross-sectional views of a mold 1042 with a liquid lens material 1052 centrifugally spreading across a profile 1054 of the mold 1042 according to the principles of the present disclosure.
  • the mold 1042 is spun around a central axis 1066 within a spinning structure (1068, FIG. 15).
  • the spinning structure 1068 is rotated at a speed and in such a way that forms the desired posterior surface 1070 of the contact lens 110.
  • the spinning structure 1068 includes a central loading region that can receive the molds 1042 that contain the liquid lens material 1052.
  • the central loading region can be formed by a glass tube, a metal tube, or another type of structure that can retain the molds 1042 in a stacked orientation.
  • the spinning structure 1068 can have an opaque material, a semi-transparent material, or a transparent material that include a sufficient amount of openings to allow the actinic radiation into the central loading region.
  • the spinning structure 1068 includes multiple guide posts 1074 that retain the molds 1042 in a stacked orientation.
  • the spinning structure 1068 also includes a region 1076 that can be used to attach to a spinning driver, such as a motor.
  • the spinning structure 1068 can be programmed to rotate in a precise manner to form the desired posterior surface 1070 of the contact lens 110, which is the surface of the contact lens that is intended to contact the eye.
  • the program that causes the spinning structure 1068 to rotate can be modified to create a desired profile for different users based on each user’s individual prescription.
  • the curing agent is applied to the liquid lens material 1052 while the spinning structure 1068 rotates the molds 1042. As a result, the contact lens 110 is formed while the spinning structure rotates.
  • the contact lenses are fully cured within the spinning structure.
  • the contact lens 110 can be fully cured over the course of multiple curing stages.
  • the contact lens can be cured in the spinning structure 1068 to a point where the liquid lens material retains its shape but is not fully cured.
  • the mold with the contact lens can be removed from the spinning structure to finish curing in an environment that is cost effective.
  • the spin casting method of forming the curve of the posterior side of the contact lens can result in a continuous surface that is substantially free or entirely free of cavities or micro-cavities.
  • a user’s mouth guard can be placed in a solution for cleaning when it is removed from the user’s mouth after a night’s sleep.
  • Proteins, antibodies, lipids, enzymes, electrolytes, and so forth can bind to the mouth guard.
  • These biomarkers can dissociate with the mouth guard into the solution and can be analyzed.
  • the measured biomarker levels can be compared to the correlations contained in a database to determine a dental condition of a user or another type of condition of a user.
  • the device can be a tooth brush, cotton swabs, floss, a q-tip, a head phone, needles, a digestible device, band aids, another type of bandage, removable orthopedic hardware, other types of hardware, chewing gum, other types of device, or combinations thereof.
  • FIG. 16 depicts an example of a method 1600 for determining a health condition of a user.
  • the method 1600 includes analyzing 1602 a first characteristic of at least one biomarker from a first contact lens previously worn by a user during a first time period, comparing 1604 the first characteristic with a second characteristic of the at least one biomarker from the user, determining 1606 a change between the first characteristic and the second characteristic, and comparing 1608 the change with a database that correlates the change with the health condition.
  • the process 1602 can be performed by the same entity (e.g a processor) as that for 802 in FIG. 8.
  • the process 1604 through 1608 can be performed by the processor 515 (specifically, the biomarker and database comparer 555, for example).
  • the first characteristic is compared to a second characteristic.
  • the first and second characteristics can be obtained from the same contact lens that is worn at different times. For example, the user can wear the contact lens on a first day and remove the contact lens at the end of the first day when the user has the biomarkers removed from contact lens. An analysis on the biomarkers can be done to obtain the first concentration, such as a first concentration of a first biomarker. On the second day, the user can place the contact lens back into his or her eye and removed the contact lens at the end of the day. The biomarker removal and analysis can also be performed.
  • the second characteristic can be a different concentration of the first biomarker.
  • the change can be an increased concentration, a decreased concentration, another type of concentration, or combinations thereof.
  • analysis on the biomarkers can occur once per day for the span of multiple days.
  • concentration of biomarkers can be averaged to overcome anomalies associated with a single analysis (e.g., the concentration level of a certain biomarker is found to be uncommonly high or low on one of the days but is at an ordinary concentration level the other days).
  • the database can include specific correlations.
  • not all of the biomarkers can be removed from the contact lens during the first night of cleaning, therefore, the second night when the contact lens is placed in the solution for cleaning more biomarkers can be obtained.
  • those biomarkers that remain on the contact lens after the first cleaning can block other biomarkers from attaching to the contact lens such that it is common to obtain fewer biomarkers on the second night.
  • the second set of biomarkers can be obtained from a fresh contact lens. In those situations, lingering biomarkers from the previous cleaning time may not be an issue.
  • the second set of biomarkers e.g., a second set of biomarker characteristics
  • the change between the first and second concentrations can be compared to the database where the change is correlated with a health condition.
  • the computing device can, with reference to the database, send, and the user (i.e. the mobile device, hand-held device, sensor, etc.) can receive an indication of the correlated health condition.
  • the first characteristic is obtained at a different time than when the second characteristic is obtained.
  • the first and second characteristics can be obtained in about the same time period.
  • a first contact lens can be worn in a first eye and a second contact lens can be worn in a second eye, and the characteristics of the biomarkers can be analyzed. In those situations where the characteristics are different, there can be a condition present in one of the eyes that is not in the other eye.
  • the user can have an account associated with the hand-held device, the mobile device, the database, or associated with another computing device that stores at least some of the characteristics of the user’s biomarkers when they are sent to the database. These stored recordings can compile a health history of the user. The health history can be reviewed by the doctor to assist with helping to detect other health conditions, assist in making a treatment plan, assist in making a prevention plan, assist in helping diagnosis health conditions of relatives, determine other types of information, or combinations thereof.
  • the particular embodiment utilizes an electrode disposed within a contact lens container housing an aqueous solution.
  • the electrode is configured to generate a current at a surface of the electrode.
  • Biomarkers within the aqueous solution can cause the current generated at the surface of the electrode to vary depending on the type, concentration, or other characteristics of the biomarker(s) within the solution.
  • an impedance can be measured within the aqueous solution. The measured impedance can also vary depending on the type, concentration, or other characteristics of the biomarker(s) within the solution.
  • Deionized water can be used to dilute the aqueous solution to a desired biomarker concentration.
  • FIG. 17 a graphical representation of measured current at an electrode positioned within an aqueous solution over a period of time is illustrated. More specifically, chronoamperometric measurements were taken using the electrode to overlay three sample readings. The three sample readings depicted in FIG. 17 relate to three repeated measurements (i.e., Reading 1, Reading 2, and Reading 3) using three sets of contact lenses which were each deposited into an aqueous solution after being worn for a 12 hour period. The contact lenses were configured to bind immunoglobulin E (“IgE”) onto a surface of the contact lens from the wearer’s tear fluid. As illustrated by the FIG. 17, each of the readings reached a similar steady-state current of approximately -2mA at the electrode after 50,000 seconds.
  • IgE immunoglobulin E
  • FIG. 18 a graphical representation of measured current intensity at an electrode within an aqueous solution over a period of time is illustrated. More specifically, chronoamperometric measurements were taken using a plurality of electrodes, each submerged in a different aqueous solution sample. Each aqueous solution sample contained a different concentration of glucose which ranged between 0.02 mM and 0.6 mM.
  • tear fluid containing glucose can adhere to a surface of the contact lens.
  • This tear fluid can dissolve within an aqueous solution and disseminate throughout the aqueous solution when the contact lens is placed within the solution.
  • the concentration of glucose within a respective aqueous solution can influence the current intensity measured at an electrode over a period time.
  • an intensity measurement at a given period of time can be used to correlate a concentration of glucose within an aqueous solution.
  • FIG. 19 a graphical representation of the impedance measured at an electrode is illustrated. More specifically, a Nyquist plot is shown which depicts a change in measured impedance within an aqueous solution as an applied signal at an electrode transitions from a high frequency to a low frequency. Moreover, two aqueous solution samples were utilized. The first sample (i.e., ab IgG) contained no immunoglobulin G (“IgG”) in the solution and the second sample (i.e., IgG 0.56 ng/ml) contained a
  • the concentration of IgG within an aqueous solution can be determined by measuring impedance within the solution.
  • a method of ascertaining a health condition of a user includes analyzing an aqueous solution to determine a characteristic of at least one biomarker within the aqueous solution, the aqueous solution being positioned within a container configured to house at least one contact lens; receiving data relative to the characteristic from a database; comparing, using a processor, the data with a plurality of biomarker characteristics stored within the database, the data being compared with the plurality of biomarker characteristics; and correlating the data with a health condition based on the comparison.
  • the method can further include, wherein analyzing the aqueous solution further comprises using a measuring device to emit light through the aqueous solution and conduct a spectral analysis.
  • the method can further include, wherein analyzing the aqueous solution further comprises using a measuring device to generate a current or a potential through the aqueous solution and conducting an electrochemical analysis.
  • the method can further include, wherein the at least one biomarker comprises a protein build-up on a surface of the at least one contact lens.
  • the method can further include predicting the health condition of the user based on the correlation.
  • the method can further include, wherein the measuring device comprises a sensor incorporated into a container holding the aqueous solution.
  • the method can further include, wherein the measuring device comprises a sensor incorporated into a mobile device.
  • the method can further include, wherein comparing the data with the plurality of biomarker characteristics stored within the database comprises sending the data to one of a remote device, a mobile device, or a networked device.
  • the method can further include, wherein the at least one biomarker is deposited into the aqueous solution by submerging the contact lens into the aqueous solution.
  • Another method of ascertaining a health condition of a user can include providing an aqueous solution configured to receive a contact lens from the user; emitting a light through the aqueous solution using a light source; measuring at least one characteristic of the light source with a sensor; sending data related to the at least one characteristic to a database; and comparing the data to contents of the database to determine a health condition of the user.
  • the method can further include, wherein the light source emits isolated predetermined wavelengths of light through the aqueous solution.
  • the method can further include, wherein the light source emits a plurality of wavelengths; and the sensor includes at least one filter.
  • the method can further include, wherein the measuring utilizes Raman spectroscopy.
  • the method can further include, wherein the database is configured to organize and manipulate the data after the data has been received by the database. [147] The method can further include, further comprising storing the data within the database.
  • the method can further include, further comprising generating a recommendation for the user to be tested for the health condition.
  • Another method of ascertaining a health condition of a user can include providing an aqueous solution configured to receive a contact lens from the user; analyzing the aqueous solution using a measuring device after a first duration of time to determine a first characteristic of a first biomarker within the aqueous solution; analyzing the aqueous solution using the measuring device after a second duration of time to determine a second characteristic of a second biomarker within the aqueous solution; determining a change between the first and second characteristics; correlating the change between the first and second characteristics with a known health condition; and determining a health condition of the user based on the comparison.
  • the method can further include, wherein analyzing the aqueous solution comprises: emitting light through the solution; and measuring a light characteristic of the light using Raman spectroscopy.
  • the method can further include, wherein the change between the first and second characteristics comprises a change in concentration of the first biomarker within the aqueous solution.
  • the method can further include, wherein the first duration of time and the second duration of time are equal in duration.
  • the method can further include replacing the aqueous solution with uncontaminated aqueous solution between the first duration of time and the second duration of time.
  • a computing device including a processor and a memory can be configured to: obtain information that indicates a characteristic of at least one biomarker derived from a contact lens used by a user; and determine a health condition of the user based on the information.
  • the computing device can further include, wherein the health condition comprises at least one of a blood sugar level, an intraocular pressure, an eye condition, an eye comfort level, a comeal strain level, an allergic condition, and an infection.
  • the health condition comprises at least one of a blood sugar level, an intraocular pressure, an eye condition, an eye comfort level, a comeal strain level, an allergic condition, and an infection.
  • the computing device can further include, wherein the biomarker comprises at least one of: a protein, an antibody, an electrolyte level, a sodium level, a chloride level, a potassium level, a calcium level, an iron level, a lysozyme level, a lactoferrin level, a lipocalin level, an albumin level, a cytokine level, an enzyme level, a lipid level, a proteases level, an immunoglobulin E level, an immunoglobulin G level, an immunoglobulin A level, and an immunoglobulin M level.
  • the biomarker comprises at least one of: a protein, an antibody, an electrolyte level, a sodium level, a chloride level, a potassium level, a calcium level, an iron level, a lysozyme level, a lactoferrin level, a lipocalin level, an albumin level, a cytokine level, an enzyme level, a lipid level, a proteases
  • the computing device can further include, wherein the processor is configured to obtain a first contact lens information set that indicates a characteristic of at least one biomarker that is derived from a first contact lens used by the user, and a second contact lens information set that indicates a characteristic of the at least one biomarker that is derived from another contact lens used by the user; and determine a health condition of the user based on both of the first contact lens information set and the second contact lens information set.
  • the computing device can further include, wherein the processor is configured to obtain a first time period information set that indicates a characteristic of at least one biomarker that is derived from a contact lens worn by the user for a first time period, and a second time period information set that indicates a characteristic of the at least one biomarker that is derived from the contact lens worn by the user for a second time period; and determine a health condition of the user based on both of the first time period information set and the second time period information set.
  • the computing device can further include, wherein the processor is configured to obtain a first eye information set that indicates a characteristic of at least one biomarker that is derived from a first contact lens worn on a first eye of the user, and a second eye information set that indicates a characteristic of the at least one biomarker that is derived from a second contact lens worn on a second eye of the user; and determine the health condition of the user based on both of the first eye information set and the second eye information set.
  • a non-transitory computer readable recording medium can store therein a program for causing the computer to obtain information that indicates a

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Abstract

L'invention concerne une évaluation d'un état de santé d'un utilisateur pouvant consister à analyser une solution aqueuse en ce qui concerne au moins une caractéristique d'un biomarqueur contenu dans la solution aqueuse. La solution aqueuse peut être contenue dans un récipient et peut être conçue pour nettoyer des lentilles de contact. Ladite caractéristique du biomarqueur peut être envoyée à une base de données qui compare la caractéristique à une pluralité de caractéristiques de biomarqueur mémorisées dans la base de données. La comparaison peut servir à corréler des états de santé associés à la pluralité de caractéristiques de biomarqueur et à évaluer un état de santé possible de l'utilisateur.
PCT/IB2019/000237 2018-03-14 2019-03-13 Procédé de détection d'un état de santé au moyen de biomarqueurs WO2019175660A1 (fr)

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EP1650567A1 (fr) * 2003-07-31 2006-04-26 Menicon Co., Ltd. Procede pour detecter une impurete proteique sur une lentille de contact
EP2280052A1 (fr) * 2008-04-04 2011-02-02 Consejo Superior De Investigaciones Científicas Composés fluorescents pour diagnostic d'infections, procédé d'obtention et leurs applications
US20140085083A1 (en) * 2010-04-12 2014-03-27 Anton Sabeta Computer-implemented method for contact lens care compliance
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US10991185B1 (en) 2020-07-20 2021-04-27 Abbott Laboratories Digital pass verification systems and methods
US10991190B1 (en) 2020-07-20 2021-04-27 Abbott Laboratories Digital pass verification systems and methods
US11514738B2 (en) 2020-07-20 2022-11-29 Abbott Laboratories Digital pass verification systems and methods
US11514737B2 (en) 2020-07-20 2022-11-29 Abbott Laboratories Digital pass verification systems and methods
US11574514B2 (en) 2020-07-20 2023-02-07 Abbott Laboratories Digital pass verification systems and methods

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