NON-INVASIVE NANOSENSOR SYSTEM TO DETERMINE ANALYTE CONCENTRATION IN BLOOD AND/OR BODILY FLUIDS.

Abstract

The device is an ultra-low power, non-invasive in-vivo blood analyte sensor system incorporating multiple sensors including a carbon base and/or carbon base material coated with metallic nanoparticles and/or metallic nanoparticle nanoprobes, as a modified Clark electrode sensor system, that detects hydrogen peroxide concentrations, pH, and/or glucose concentrations (and other analytes) in bodily secretions (e.g. tears, saliva, sweat). The device consists of multiple chemoreceptive sensors, a microprocessor, a signal amplifier, signal filtering, error correction algorithms, analog-to-digital converter and wireless electromagnetic data transmitter to a remote device for further processing and/or data storage (e.g. on a server, on a cloud-based storage system, etc) and/or visual representation via software. The method involves applying the nanoprobe sensor array to skin tissue and the resulting electrical impulses correlate with glucose concentration within liquids such as tears, saliva, blood, etc. The collected data is then represented visually on a computer (handheld, smart-phone, desktop, laptop, etc) via software. The device is powered by ambient electromagnetic radiation, thermoelectric and/or solar power and/or rechargeable battery. The device is placed against the skin or immersed in a sample for sensor measurement. Single and continuous data collection is possible. The device can be reused repeatedly, re-sterilized and it is a high accuracy, low-cost option for multiple use glucose concentration measurements. The device can monitor blood glucose for Type I and Type II diabetics and it is suitable for a wide range of applications including gases, liquids and solids, biological, organic and inorganic chemical analysis.

Claims

1. The core technology and features of the device are as follows. A device can be used individually and/or collectively. The device can be customized extensively by a user, meaning, that features and sensors that can be activated or deactivated by the user during a setup of the device prior to use, to perform concentration analysis measurements of any of the following: gases, liquids and solids, biological material, organic, inorganic chemicals, electromagnetic radiation and ionization radiation. The device consists of a physical shell that will allow the user to attach it to any body part. The device and/or its individual sensors may be attached to other body parts as required by the user, as a method to customize the device to the needs of the user. Each device contains any combination of the following: a) multiple chemoreceptive; b) electromagnetic and/or; c) environmental sensors. Each device contains a near-infrared wavelength pulse wave photodiode emitter source, a photoelectric sensor, multiple chemoreceptive, electromagnetic and environmental sensors, a near-infrared wavelength pulse wave photodiode emitter source, a photoelectric sensor, microprocessor, a signal amplifier, signal filtering, error correction algorithms, analog-to-digital converter and wireless electromagnetic data transmitter, to transmit processed data from a local device to a remote device for further processing and/or data storage (e.g. on a server, on a cloud-based storage system, etc) and/or visual representation via software. electrical system that is sufficiently isolated from the surrounding environment, in accordance with national and international, industrial, occupational health and safety standards (physical shell that will waterproof and/or water repellant and/or suitable for light underwater work, to a depth of X meters). The device provides data that can be streamed, recorded and stored locally and/or remotely, for the end-user, for the purposes of data science, such as correlative analysis, data collections, predictive modelling, artificial intelligence, data mining and machine learning.

2. The device, as indicated in claim #1, consists of non-invasive sensors and/or invasive sensors, and both are capable of single and/or continuous data collection.

3. The device, as indicated in claim #1, consists of sensors that requires physical contact with, in any combination: a) skin; b) objects; c) samples and/or; environmental mediums (e.g. air, water, etc).

4. The device, as indicated in claim #1, contains one or more modified Clark electrode chemoreceptive sensor systems, namely carbon base and/or decorated carbon-based materials with metallic nanoparticles and/or metallic nanoparticle nanoprobes.

5a. The device, as indicated in claim #4, requires physical contact with a liquid (for example, but not limited to, tears, saliva, sweat, etc.), to measure hydrogen peroxide concentrations and/or pH and/or glucose concentrations and/or other analytes in bodily secretions (for example, but not limited to, tears, saliva, sweat, etc.).

5b. The device, as indicated in claim #4, contains one or more near-infrared wavelength electromagnetic radiation pulse wave photodiode emitter source(s) and a photoelectric sensor(s).

5c. The device, as indicated in claim #4, uses near-infrared wavelength electromagnetic radiation transmission through an object (e.g. skin) and reflectivity data from the surface or inner contents of an object (e.g. skin) to determine the analyte concentrations in the fluid(s) underneath the surface of the object (e.g. skin).

6. The device, as indicated in claim #1, consists of a sensor system for detecting concentrations of analytes and/or particulate in any combination of the following: a) blood; b) bodily fluids (e.g. saliva, tears, sweat, etc); c) air; d) water; e) soil; f) gases; g) liquids, h) solids and/or i) pH.

7. The device, as indicated in claim #1, consists of multiple physical sensor types in any combination, including, but not limited to: a) accelerometer; b) gyroscope; c) magnetometer; d) vibration; e) temperature; f) humidity; g) heart rate activity measuring sensor; h) electroencephalography electrodes; i) one or more near-infrared wavelength electromagnetic radiation pulse wave photodiode emitter source(s) and a photoelectric sensor(s) and/or; j) near-infrared wavelength electromagnetic radiation transmission through an object (e.g. skin) and reflectivity data from the surface or inner contents of an object (e.g. skin) to determine the analyte concentrations in the fluid(s) underneath the surface of the object (e.g. skin).

8. The device, as indicated in claim #1, consists of a camera, capable of still photographs and/or video recording and/or video streaming and/or two-way communication.

9. The device, as indicated in claim #1, consists of a microphone, capable of audio recording and/or audio streaming and/or two-way communication.

10. The device, as indicated in claim #1, consists of at least two methods of wireless communication in any combination: a) short range communication (within 7 feet radius of a device transceiver); b) medium range communication (within 50 feet radius of a device transceiver); c) long-range communication (full geographic expanse of a computer network, user defined, from the device transceiver).

11a. The device, as indicated in claim #10a, consists of a wireless communication transceiver in the radio frequency electromagnetic spectrum, for example, but not limited to, Bluetooth, approximately 700 MHz range, for short-distance communication between an individual sensor modality mounted to a user and the local device and in order to specifically identify a single device. The communication range is limited to less than 7 feet from the device transceiver.

11b. The device, as indicated in claim #10a, consists of an encryption method, identification number and temporal identification encoding, to connect the Bluetooth signal physically attached to one user, to only communicate with the local device of the user, to minimize cross-talk between other users wearing similar devices and in order to specifically identify a single device, via a method different from that used in 10b and 10c above.

12a. The device, as indicated in claim #10b, consists of a wireless microwave communication transceiver, for example, but not limited to, ZigBee or Wifi, approximately 2.4 GHz range, for medium distance communication with a network access point. The communication range is limited to 50 feet radius from the device transceiver.

12b. The device, as indicated in claim #10b, consists of an encryption method, modulation and temporal identification encoding, to connect the wireless communication device physically attached to one user, to only communicate with the nearest network wireless node, to minimize cross-talk between other users wearing similar devices and in order to specifically identify a single device, via a method different from that used in 10a and 10c above.

13. The device, as indicated in claim #10c, consists of an encryption method and identification number, to convey data from the wireless access node in a fixed location and/or ad-hoc computer network to communication directly with a remote computer and/or remote device (including, but not limited to, a handheld computer, smart-phone, desktop, tablet, netbook, laptop, etc), where the collected data is represented visually via software, in order to minimize cross-talk between other users wearing similar devices and in order to specifically identify a single device, via a method different from that used in 10a and 10b above. The remote device and/or remote computer shall be capable of accurately locating the individuals using RF based localization techniques.

14. The device, as indicated in claim #1, uses near-infrared wavelength electromagnetic radiation transmission through an object (e.g. skin) and reflectivity data from the surface or inner contents of an object (e.g. skin) to determine the analyte concentrations in the fluid(s) underneath the surface of the object (e.g. skin).

15. The device, as indicated in claim #1, contains error correcting coding and/or neural networks and/or machine learning and/or software algorithms and/or electronic filtering methods to generate processed data with high accuracy and high precision.

16. The device, as indicated in claim #1, is a device with ultra-low power requirements for operation, for energy efficiency, powered by ambient thermoelectric and/or electromagnetic radiation and/or piezoelectric generator and/or rechargeable batteries and/or rechargeable supercapacitors.

Description

SUMMARY OF THE DISCLOSURE

[0038] In accordance with certain embodiments of the present disclosure, optical sensor arrangements suited for use in physiological and/or chemical and/or environmental monitoring devices that are used for medical, healthcare, rehabilitation, blood analyte monitoring, chemical analysis, physical training, exercise, and/or general health monitoring are disclosed. In some embodiments, the monitoring devices may be a wrist watch, bracelet, arm band, nose bridge device, wearable glasses, wearable adhesives, gloves, hats, helmets, headbands, t-shirts, undershirts, socks, underwear, and belts, comprising one or more optical sensor arrangements.

[0039] In accordance with certain embodiments of the present disclosure, each optical sensor arrangement may comprise one or more light sources and/or photo detectors. In such embodiments, the light sources may comprise two or more spaced apart light emitting diodes or laser. Each photo detector may be, for example, a photodiode. In some embodiments, each photodiode may be positioned near a corresponding light emitting diodes or laser, or between a corresponding pair of light emitting diodes or lasers.

SUMMARY OF EMBODIMENTS

[0040] In various embodiments, the device, in its many possible user-defined configurations, is capable of use in any of the following environments, but not limited to the following, individually or in any combination: a) mining, construction, law enforcement, police, military application; b) drug analysis, biochemical analysis; c) microbial analysis; d) food, agriculture, livestock analysis; e) soil, air, water analysis; f) hospitals, physiotherapy, geriatric remote monitoring, patient monitoring, rehabilitation; gait correction; g) man-down alarm safety system; h) vehicle tracking, driver behaviour analysis, tire movement, tire corrective control, driverless vehicle technologies and/or; i) fitness, health, athletic monitoring, leisure activities, daily personal use.

[0041] In various embodiments, the device shall target one, and/or more, analytes within a specific sample.

[0042] In various embodiments, the device shall target one, and/or more, environmental conditions within a specific sample and/or the surrounding environment.

[0043] In various embodiments, the device shall target one, and/or more, biological features within a specific sample and/or the surrounding environment.

[0044] In various embodiments, the device shall target one, and/or more, chemicals within a specific sample and/or the surrounding environment.

[0045] In various embodiments, the device shall target one, and/or more, physiological features within a specific sample and/or the surrounding environment.

[0046] In various embodiments, the device shall incorporate one, and/or more, sensors such as accelerometer, gyroscope, magnetometer, pH, heart-rate monitor, humidity sensor, piezoelectric sensor, GPS sensor system, light sensor, audio sensor, vibration sensor, chemical sensors (such as, but not limited to, coal dust, carbon dioxide, carbon monoxide, nitric oxide, nitrous oxide, nitrate, hydrogen sulfide, oxygen, nitrogen, boron, sulfur, carbon, alcohols, aldehyes, ketones, organic compounds, explosives, weapons, controlled substances, etc.), radiological agents (beta, gammma, alpha radiation), electromagnetic radiation sensors (such as, but not limited to, biological materials sensors (such as, but not limited to, microbes, DNA, RNA, protein, carbohydrate, lipid, enzyme, virus, bacteria, prions, etc.).

[0047] In various embodiments, the device shall target one, and/or more, electromagnetic features within a specific sample and/or the surrounding environment, including, but not limited to, photographs, video and/or audio.

[0048] In various embodiments, the device shall target one, and/or more, radiological features within a specific sample and/or the surrounding environment, including, but not limited to, alpha, beta, gamma, X-ray, subatomic particles and/or cosmic ray particle detection.

[0049] In various embodiments, the device shall receive power wirelessly from the surrounding environment, by means of, but not limited to, electromagnetic radiation, radiological particles, heat and/or vibration.

[0050] In various embodiments, the device shall be a wearable device, such as, but not limited to, one that can be attached permanently and/or temporarily, to any part of the body, internally or externally.

[0051] In various embodiments, the device shall be a portable device, such as, but not limited to, one that can be attached permanently and/or temporarily, to any part of the body, internally or externally.

[0052] In various embodiments, the device shall be a fixed location device, such as, but not limited to, one that can be attached permanently and/or temporarily, to any part of the body, internally or externally, and/or any fixed object (e.g. table, chair, desk, wall, ceiling, floor, etc).

[0053] In various embodiments, the device shall encased in a material designed to isolate the electrical system of the device from the surrounding the environment. The encasement can consist of, but it is not limited to, plastic, graphene, boron-nitride, metal, wood, polymers, glass, nanomaterials, gels, meshes, etc.

[0054] In various embodiments, the device shall consist of a sensor (and/or nanoprobe sensors and/or an nanoprobe sensor array) and microcontroller system, the processed digital data. The data shall be forwarded to an output device such as, but not limited to, a wireless communication system and/or a visual display system integrated into the device.

[0055] In various embodiments, a device shall possess accompanying software to be installed on an external hardware device, such as, but not limited to, a personal computer, smart-phone, PDA, tablet, notebook, netbook, laptop, or other programmable wearable device, for the purposes of visualization and interpretation of sensor data.

[0056] In various embodiments, a device will possess a signal conversion system and/or signal filtering system and/or software to analyze sensor data and/or software to improve signal-to-noise ratio and/or software to remove artifacts from raw sensor data and/or sensor fusion processing methods, for the processing of digital and/or analog signals into a form to optimize efficiency within the microcontroller and central processing system.

[0057] In various embodiments, a device will possess a microcontroller system for the processing of digital and/or analog signals.

[0058] In various embodiments, a device will possess a wireless communications system, such as, but not limited to, electromagnetic communication protocols (e.g. 802.11a) and/or audio communication protocols and/or chemical communication protocols.

[0059] In various embodiments, a device may possess the ability to reference points within a sample and/or cross-reference a sample with a known material for comparison and data analysis.

[0060] In various embodiments, a device may possess a nanoprobe, or nanoprobes, which extend beyond the physical housing of the device and/or may be retractable within the device and/or may be removable from the device.

[0061] In various embodiments, a device may possess suitable contact with a sample (e.g. nanoprobe sensor making contact with human skin) and in said circumstances, the device may possess an ability to calibrate electronically and/or adjust physical distance from and/or within a sample.

[0062] In various embodiments, a device may be used for sensing, measuring, and display of physiological, chemical and environmental data gathered from a sample, including, but not limited to humans, animals, plants, microbes, situated in any indoor environment, outdoor environment, in any soil, liquid, solid, gel, gas or chemical medium, or as part of a larger multipurpose device for analytical purposes, not limited to biological sample analysis, oilfield liquid analysis, inorganic molecular analysis, organic molecular analysis, aerosol analysis, gas analysis, microbial analysis.

[0063] In various embodiments, a device may contain multiple nanoprobe sensors, consisting of a material demonstrating a high sensitivity to a specific analyte, with each nanoprobe sensor targeting a different analyte.

[0064] In various embodiments, a device may contain multiple nanoprobe sensors, consisting of a material demonstrating a high sensitivity to a specific analyte, with each nanoprobe sensor targeting the same analyte.

[0065] In various embodiments, the device may consist of a processor-based computing system representative of the type of computing system in which chemical and/or biological and/or environmental and/or biometric data is collected and analyzed.

[0066] In various embodiments, the device may include one or more hardware and/or software components configured to execute software programs, such as software for storing, processing, and analyzing data.

[0067] In various embodiments, the device circuit board may be in wired, wireless, or electrical contact with one another to facilitate the exchange of signals/information between them.

[0068] In various embodiments, the modules of the present receivers are present on integrated circuits.

[0069] In various embodiments, variations of the device may be defined as water resistant or waterproof upon meeting said criteria.

[0070] In various embodiments, the device may hermetically sealed.

[0071] In various embodiments, the device may incorporate multiple channels of measurement.

[0072] In various embodiments, the device may incorporate multiple data filtering methods and/or error correction methods.

[0073] In various embodiments, the device shall provide information about the following, in any combination, but is not limited to, body mass index, calories, SpO2 and other biometric information.