WEARABLE, NONINVASIVE GLUCOSE SENSING METHODS AND SYSTEMS

• US 20160192867A1
• Filed: 11/27/2015
• Published: 07/07/2016
• Est. Priority Date: 03/09/2012
• Status: Active Grant

• Current Assignee: Rinat O. Esenaliev
• Original Assignee: Rinat O. Esenaliev
• Inventors: Esenaliev, Rinat O.
• Granted Patent: US 10,188,325 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0095 by applying light and detecting acoustic waves, i.e. photoacoustic measurements
• CPC Class Codes: A61B 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/6801 specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/681 Wristwatch-type devices
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61B 5/7445 Display arrangements, e.g. multiple display units
• CPC Class Codes: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002
• CPC Class Codes: A61B 8/10 Eye inspection
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces
• CPC Class Codes: A61B 8/5223 for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

New wearable systems for noninvasive glucose sensing include an ultrasound generator, an ultrasound detector and a feedback unit. Methods for noninvasive glucose sensing using a wearable device include measuring a thickness (geometrical and/or optical) of a target tissue or a time of flight of ultrasound or optical pulses in the target tissue and determining a glucose value from the thickness of the target tissue or the time of flight in the target tissue in accordance with a target tissue thickness (geometrical and/or optical) or time of flight versus glucose calibration curve.

Claims

1. A system for noninvasive glucose sensing comprising:

a wearable glucose monitor including an ultrasound source and a ultrasound detector and a feedback unit.

2. The system of claim 1, wherein the ultrasound source generating ultrasound in the frequency range from about 20 kHz to about 10 Gigahertz with one, two, or multiple frequencies or broad-band ultrasound generated by a piezoelectric element, or by short electromagnetic pulses irradiating a strongly absorbing medium.

3. The system of claim 1, further comprising an electromagnetic source generating electromagnetic pulses or waves are optical radiation (near infrared, infrared, far infrared, visible, or UV light in the wavelength range from about 200 nanometers to about 100 microns), terahertz waves, microwaves, radiowaves, low-frequency waves, static electric or magnetic field or combination of different waves with one, two, or multiple wavelengths (frequencies).

4. The system of claim 1, wherein measurement of time of flight of said ultrasound or optical pulses or measurement of tissue dimension is combined with measurement of attenuation, phase, and frequency spectrum of the ultrasound or optical pulses reflected from or transmitted through the tissues to improve accuracy and specificity of glucose monitoring.

5. The system of claim 1, wherein the target tissue includes but not limited to:

skin tissues (dermis, epidermis, subcutaneous fat), eye tissues (lens, anterior chamber, vitreous cavity, eye ball, sclera), mucosal tissues, nailbed, lunula, connective tissue, muscle tissue, blood vessels, cartilage tissue, tendon tissue.

6. The system of claim 1, wherein the ultrasound or electromagnetic pulses or waves are detected using reflection, focused reflection, refraction, scattering, polarization, transmission, confocal, interferometric, low-coherence, low-coherence interferometry techniques.

7. The system of claim 4, wherein the electromagnetic pulses are ultrashort in the range from about 1 femtosecond to about 1 microsecond to provide accurate time of flight or dimension measurement.

8. The system of claim 1, wherein the measurement of dimensions or time of flight in tissue using ultrasound, optical, or optoacoustic technique where dimensions of time of flight are measured in at least one tissue or tissue layer in skin (dermis, epidermis, subcutaneous connective tissue, subcutaneous fat, subcutaneous muscle), eye (lens, anterior chamber, vitreous cavity, eye ball, sclera), mucosal tissues, nailbed, lunula, connective tissue, muscle tissue, blood vessels, cartilage tissue, and/or tendon tissue.

9. The system of claim 8, wherein the wearable, noninvasive glucose monitoring is attached to a) a wrist area, b) at least one eye tissue or tissue layer, c) at least one tissue or tissue layer in an arm, forearm, wrist, shoulder, hand, palm, finger, abdomen, chest, neck, head, ear, back, leg, and/or foot.

10. The system of claim 9, wherein the system comprises:

a) a wrist watch or incorporated in a wrist watch and provides current glucose concentration and/or a graph of glucose concentration vs. time by probing skin and/or subcutaneous tissues such as dermis, epidermis, subcutaneous connective tissue, subcutaneous fat tissue, subcutaneous muscle tissue;

b) a contact lens and the system is incorporated in a contact lens provides glucose monitoring by probing the cornea, eye lens, iris, sclera, retina, eye ball and show the current glucose concentration and/or a graph of glucose concentration vs. time, or c) wearable, noninvasive glucose monitoring method is applied to at least one tissue or tissue layer in an arm, forearm, wrist, shoulder, hand, palm, finger, abdomen, chest, neck, head, ear, back, leg, and/or foot.

11. The system of claim 10, wherein the wearable, noninvasive glucose monitoring system wirelessly communicate with a cell phone which displays a current glucose concentration and/or a graph of glucose concentration vs. time and/or with medical personnel in a health care facility or not in a health care facility and the medical personnel can contact the patient and/or provide medical care, if necessary.

13. The method of claim 8, wherein the ultrasound is in the frequency range from about 20 kHz to about 10 Gigahertz with one, two, or multiple frequencies or broad-band ultrasound generated by a piezoelectric element, or by short electromagnetic pulses irradiating a strongly absorbing medium.

14. The method of claim 8, wherein the electromagnetic pulses or waves are optical radiation (near infrared, infrared, far infrared, visible, or UV light in the wavelength range from about 200 nanometers to about 100 microns), terahertz waves, microwaves, radiowaves, low-frequency waves, static electric or magnetic field or combination of different waves with one, two, or multiple wavelengths (frequencies).

15. The method of claim 8, wherein measurement of time of flight of said ultrasound or optical pulses or measurement of tissue dimension is combined with measurement of attenuation, phase, and frequency spectrum of the ultrasound or optical pulses reflected from or transmitted through the tissues to improve accuracy and specificity of glucose monitoring.

16. The method of claim 8, wherein the target tissue includes but not limited to:

skin tissues (dermis, epidermis, subcutaneous fat), eye tissues (lens, anterior chamber, vitreous cavity, eye ball, sclera), mucosal tissues, nailbed, lunula, connective tissue, muscle tissue, blood vessels, cartilage tissue, tendon tissue.

17. The method of claim 8, wherein the ultrasound or electromagnetic pulses or waves are detected using reflection, focused reflection, refraction, scattering, polarization, transmission, confocal, interferometric, low-coherence, low-coherence interferometry techniques.

18. The method of claim 13, wherein the electromagnetic pulses are ultrashort in the range from about 1 femtosecond to about 1 microsecond to provide accurate time of flight or dimension measurement.

19. The system of claim 1, wherein the measurement of dimensions or time of flight in tissue using ultrasound, optical, or optoacoustic technique where dimensions of time of flight are measured in at least one tissue or tissue layer in skin (dermis, epidermis, subcutaneous connective tissue, subcutaneous fat, subcutaneous muscle), eye (lens, anterior chamber, vitreous cavity, eye ball, sclera), mucosal tissues, nailbed, lunula, connective tissue, muscle tissue, blood vessels, cartilage tissue, and/or tendon tissue.

20. The system of claim 19, wherein the wearable, noninvasive glucose monitoring is attached to a) a wrist area, b) at least one eye tissue or tissue layer, c) at least one tissue or tissue layer in an arm, forearm, wrist, shoulder, hand, palm, finger, abdomen, chest, neck, head, ear, back, leg, and/or foot.

21. The system of claim 20, wherein the system comprises:

a) a wrist watch or incorporated in a wrist watch and provides current glucose concentration and/or a graph of glucose concentration vs. time by probing skin and/or subcutaneous tissues such as dermis, epidermis, subcutaneous connective tissue, subcutaneous fat tissue, subcutaneous muscle tissue;

b) a contact lens and the system is incorporated in a contact lens provides glucose monitoring by probing the cornea, eye lens, iris, sclera, retina, eye ball and show the current glucose concentration and/or a graph of glucose concentration vs. time, or c) wearable, noninvasive glucose monitoring method is applied to at least one tissue or tissue layer in an arm, forearm, wrist, shoulder, hand, palm, finger, abdomen, chest, neck, head, ear, back, leg, and/or foot.

22. The system of claim 21, wherein the wearable, noninvasive glucose monitoring system wirelessly communicate with a cell phone which displays a current glucose concentration and/or a graph of glucose concentration vs. time and/or with medical personnel in a health care facility or not in a health care facility and the medical personnel can contact the patient and/or provide medical care, if necessary.

12. A method for noninvasive glucose sensing including the steps of:

providing a noninvasive glucose sensing system comprising a wearable glucose monitor including an ultrasound source and a ultrasound detector and a feedback unit;

measuring time of flight of ultrasound or electromagnetic pulses (or waves) in a target tissue or measuring at least one dimension of a target tissue using ultrasound or electromagnetic pulses (or waves); and

determining a glucose value from the time of flight in the target tissue in accordance with a time of flight versus glucose calibration curve or determining a glucose value from the dimension of the target tissue in accordance with the dimension versus glucose calibration curve.