WO2021049956A1 - Système de détection non invasif - Google Patents

Système de détection non invasif Download PDF

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Publication number
WO2021049956A1
WO2021049956A1 PCT/NZ2020/050103 NZ2020050103W WO2021049956A1 WO 2021049956 A1 WO2021049956 A1 WO 2021049956A1 NZ 2020050103 W NZ2020050103 W NZ 2020050103W WO 2021049956 A1 WO2021049956 A1 WO 2021049956A1
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WIPO (PCT)
Prior art keywords
antenna
support means
sensing system
invasive sensing
measuring
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PCT/NZ2020/050103
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English (en)
Inventor
Shane Richard Leath
Robin HOLDSWORTH
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Sensorflo Limited
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Publication of WO2021049956A1 publication Critical patent/WO2021049956A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/0507—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves  using microwaves or terahertz waves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4887—Locating particular structures in or on the body
    • A61B5/489—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/684—Indicating the position of the sensor on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002—Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802—Sensor mounted on worn items
    • A61B5/681—Wristwatch-type devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6887—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient mounted on external non-worn devices, e.g. non-medical devices
    • A61B5/6898—Portable consumer electronic devices, e.g. music players, telephones, tablet computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/7405—Details of notification to user or communication with user or patient ; user input means using sound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient ; user input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N22/00—Investigating or analysing materials by the use of microwaves or radio waves, i.e. electromagnetic waves with a wavelength of one millimetre or more
    • 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
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood

Definitions

  • This invention relates to a non-invasive sensing system.
  • the invention may be suitable for use in non-invasively detecting the presence of, and/or measuring the concentration(s) of, a substance(s) within a living being.
  • the invention may be particularly suitable for use in non-invasively detecting the presence of, and/or measuring the concentration(s) of, a substance within the blood of a human being, for example metabolites, lactate, urates, blood sugar (glucose), water, alcohol, and drugs.
  • a substance within the blood of a human being for example metabolites, lactate, urates, blood sugar (glucose), water, alcohol, and drugs.
  • a substance within the blood of a human being for example metabolites, lactate, urates, blood sugar (glucose), water, alcohol, and drugs.
  • a substance within the blood of a human being for example metabolites, lactate, urates, blood sugar (glucose), water, alcohol, and drugs.
  • the invention will be predominantly described in relation to such use.
  • Diabetes mellitus which is more commonly referred to as diabetes, is a chronic metabolic disease characterised by high blood sugar (glucose) levels over a prolonged period of time. It can also be described as a condition where a person’s blood glucose levels cannot be regulated normally by the person’s body alone. Diabetes is an incurable condition (except in very specific situations).
  • Type 1 diabetes is caused by the failure of the pancreas to produce enough insulin.
  • Type 2 diabetes is a condition which is primarily caused by a person’s cells failing to respond properly to insulin (and is primarily, but not exclusively, caused by a person having excess body weight and/or a poor diet and/or not exercising enough).
  • Gestational diabetes occurs in pregnant woman who have not previously had a history of diabetes.
  • a person undertakes a fasting blood test and records a blood glucose level below 5.5 mmol/1 they do not have diabetes. If they record a level between 5.5 mmol/1 - 6.9 mmol/1 they can be said to have impaired fasting glucose, a type of prediabetes - which increases their risk of developing Type 2 diabetes. A level above 6.9 mmol/1 usually means the person has diabetes.
  • a blood glucose level above 11.1 mmol/1 will usually mean the person has diabetes.
  • an estimated 400 million people worldwide suffer from diabetes, with approximately 90% of the cases being Type 2 diabetes. This disease is therefore a significant health burden in virtually every country, and also results in a significant number of deaths each year.
  • the main treatment methods for diabetes include dietary regulation (to optimise blood glucose levels), insulin injections, and oral medications.
  • the control or management of blood glucose levels requires that a diabetic regularly self monitor or self-measure their blood glucose levels, and (if or when considered necessary) administer an appropriate amount of insulin (or possibly consume an appropriate type of food/drink to help restore balance if need be).
  • Most people with Type 2 diabetes measure their blood glucose levels at least once per day.
  • people who use insulin to treat the disease usually test their blood glucose levels more frequently, usually between two to ten times per day. The more regular testing is primarily done to determine whether or when a dose of insulin may be required, and/or to test the effectiveness of any prior insulin doses.
  • the finger-prick test is an invasive procedure where a person pricks their finger and a droplet of the resultant blood is applied to a glucose meter - which is a medical device capable of determining the concentration of blood glucose levels from a droplet of blood.
  • the finger-prick test is not always accurate, or consistent, in that measurements can be up to 15% different to actual (or as compared to more accurate laboratory testing).
  • the invasive nature of the finger-prick test may result in damage to the finger tissue and/or result in an on-going, general feeling of discomfort in the fingers.
  • the glucose meter only measures the blood glucose levels of the person each time that the person draws blood by pricking their finger. That is, the finger-prick test does not enable the person to continuously monitor their blood glucose levels, over time. Hence, the person is unable to gain more comprehensive knowledge of their blood glucose levels or patterns over time (especially when sleeping). Moreover, any occurrences of hyperglycaemia or hypoglycaemia (and/or possible causes of same), between each discrete finger-prick test, are also not able to be noted or recorded.
  • US 2012/0130212 Pluta et al describes a system for non-invasively measuring blood metabolites of a patient by repeatedly measuring a plurality of electromagnetic impedance readings from both the epidermis layer and the dermis layer of the patient, until a difference between the readings exceeds a certain threshold.
  • An impedance value representing the difference is calculated using an equivalent circuit model and an “individual adjustment factor data” representative of a physiological characteristic of the patient.
  • a blood metabolite level of the patient is determined from the impedance value and a “blood metabolite level algorithm”.
  • a drawback or disadvantage associated with Pluta is that the “individual adjustment factor data” and the “blood metabolite level algorithm” is/are specific to a particular patient profile - or to a group of patients with a similar profile.
  • group profile may be: “Caucasian women between the ages of 45-50, weighing 120-130 pounds, with 15-18% body fat”.
  • a blood glucose level may be determined using an impedance value representing the difference between the actual readings (epidermis and dermis) and a glucose algorithm tailored to that patient’s profile.
  • Pluta also describes a preferred embodiment whereby the glucose algorithm is tailored to each and every patient.
  • the system in Pluta is somewhat impractical or laborious as it requires each patient to firstly undergo pre-testing for fat content, as well as being asked about their age and weight - before the system can be used to determine that patient’s specific blood glucose reading.
  • US 2013/0225960 Porch describes a blood glucose monitor for the non-invasive, in-vivo characterisation of a blood glucose level in a living body.
  • the monitor includes a microwave resonator (actually a resonant cavity) having a resonant response to input microwaves and designed so that the response will experience a perturbation by a living body in proximity or contact with the resonator.
  • the monitor also includes detection means for detecting changes in the resonant response from which the blood glucose level can be determined or characterised.
  • Porch One possible drawback associated with Porch is that the microwave resonator has to be built to pick out the frequency(ies) that correlate to the target and would therefore likely require a difference resonator for each chemical targeted.
  • Hancock describes an apparatus for the (minimally) non-invasive measurement of constituents contained within a biological tissue structure (one example being blood glucose levels).
  • Hancock includes a microwave energy source, a first antenna coupled to the microwave energy source for transmitting microwaves into the tissue structure, and a second antenna arranged for receiving the transmitted microwaves after they have passed through the tissue structure.
  • Hancock also includes a signal processor for determining the resonant frequency of the received microwaves and a data processor arranged to provide an output of the concentration of constituents within the tissue structure according to the determined resonant frequency.
  • Hancock has a similar disadvantage to Pluta in that certain pre-testing of the individual must be made. Namely, before measurement for an individual can be made, it is necessary to know the thickness of the tissue structure. That is, since there will be a variation in the thickness of the biological tissue structure between individuals (and differences in the composition of the tissue structure, eg, thickness of skin, muscle and fat layers), the resonant frequency of the tissue structure for any given constituent concentration will vary from individual to individual.
  • a further disadvantage associated with Hancock is that the microwaves have to pass through a significant thickness of tissue (eg, through an entire human arm or wrist) before they are received by the second antenna. Moreover, the microwaves have to pass through several layers of different types of tissue (eg, skin, muscle and fat). Since each tissue layer causes its own unique interactions with the microwaves (eg, in relation to attenuation and phase) the apparatus has to de-convolve these effects. This would be impossible without knowing the thickness of each tissue layer (and hence, without knowing the distance the microwaves have to travel through each tissue layer).
  • EP 1620002 Esenaliev describes a non-invasive system for determining blood glucose levels in a patient which includes an optical probe with a tip designed to be placed over a vein on the underside of the patient’s tongue.
  • the tip of the probe includes an excitation port through which an input signal generated by a signal generator subsystem impinges on a surface of the tissue over the vein, and a response port through which a response signal is received by and forwarded to a detector and analyser - which then converts the response signal into a concentration of a blood component and/or a value of a blood parameter.
  • Esenaliev preferably requires a static magnetic or electrical field.
  • US 2014/0213870 Hsu et al describes a non-invasive blood glucose monitoring sensor for measuring a numerical value of the blood glucose in a human body by way of placing the non-invasive blood glucose sensor near the human body.
  • the sensor includes a substrate, a first metal layer formed on one surface of the substrate and which includes an internal microstrip antenna, and a second metal layer formed on an opposite surface of the substrate.
  • the sensor further includes a blood glucose sensing unit electrically connected to the first metal layer and the second metal layer and capable of providing an RF signal, wherein the blood glucose sensing unit would output the RF signal to the first metal layer. Therefore, it is claimed, a resonance is produced by the first metal layer with the RF signal and blood glucose in the human body.
  • the numerical value of the blood glucose is allegedly calculated and displayed by the blood glucose sensing unit. Opposite to the substrate, an overlapping area and a non-overlapping area are provided between the first metal layer and the second metal layer for allegedly improving the bandwidth of the microstrip antenna and the sensing sensitivity of the blood glucose sensing unit.
  • the armband includes a detection device for detecting a blood picture parameter of blood in a blood vessel of the arm and a setting device for setting a predetermined contact pressure of the armband on the arm.
  • the detection device comprises a transmitter configured to transmit a wave signal into the person’s arm, and a receiver configured to receive the signal after it has passed through a blood vessel.
  • the setting device is configured in such a way that it can set the predetermined or prescribed contact pressure, at least during the detection of the blood picture parameter by the detection device.
  • Fischer has a similar disadvantage as Hancock in that the transmitted wave signal has to pass through a significant thickness of tissue (eg, through an entire human arm) before the wave signal is received by the receiver. Fischer also requires pressure to be applied to the arm, via the arm band, and this may be an uncomfortable experience for some people.
  • results, as described, appear to be fairly unreliable. Furthermore, they are measuring only one component (water) that has the biggest effect, and the measurements take place in the flesh of the fish. By inference they are also saying that they can’t measure a second (and only slightly subtler) component.
  • the system is handheld and manually operated.
  • Leath describes an effective non-invasive sensing system for measuring the concentration of a substance within an object (for example, and preferably, glucose concentrations within blood).
  • the system includes a support means adapted to be placed near to, or against, a surface of the object (for example, a skin surface of a human being - and preferably in the region of the inside surface of the wrist of the human being).
  • the system further includes a first transmitting antenna mounted upon or within the support means for transmitting electromagnetic radiation signals into the object/skin, and a second receiving antenna mounted upon or within the support means, and adjacent to the first transmitting antenna, for receiving at least a portion of the electromagnetic radiation signals that are reflected back to the same surface of the object/skin covered by the support means, due to the transmitted electromagnetic radiation signals having interacted with the substance (glucose) within the object (blood) being measured.
  • a first transmitting antenna mounted upon or within the support means for transmitting electromagnetic radiation signals into the object/skin
  • a second receiving antenna mounted upon or within the support means, and adjacent to the first transmitting antenna, for receiving at least a portion of the electromagnetic radiation signals that are reflected back to the same surface of the object/skin covered by the support means, due to the transmitted electromagnetic radiation signals having interacted with the substance (glucose) within the object (blood) being measured.
  • a non-invasive blood glucose monitoring sensor such as that described in Leath, but which device further included suitable means which allowed for the optimal and/or consistent positioning of the device above an artery /vein, when taking a reading(s), and/or which allowed for the most optimal and/or accurate reading of many readings taken at substantially the same time, to be determined and/or calculated.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, said system including: a. a support means adapted to be placed near to, or against, a surface of the being, b. a measuring means incorporated within the support means for non- invasively measuring the concentration of the substance within the being, c. a positioning means incorporated within the support means, which provides for the optimal positioning of the support means in relation to the being, to enable the measuring means to consistently take an optimal reading or measurement.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein said system further includes a measurement determining means, incorporated within the support means and in communication with the positioning means, which allows for the most optimal reading/measurement, of many measurements/readings taken at substantially the same time, to be the measurement/reading which is ultimately determined to be the best and/or correct reading by the system.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein, in use, the support means is adapted to be moved with respect to the surface of the being, or vice versa.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein, in use, the support means is adapted to be moved in a substantially circular motion(s) with respect to the surface of the being, or vice versa.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein, in use, the support means is adapted to be moved backwards and forwards across, or just above, the surface of the being.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein, in use, the support means is adapted to be moved backwards and forwards across the surface of the being, and in any direction.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein the system further includes an indication means to indicate when the support means is in the optimal position, whereby the optimal measurement/reading may be taken and/or determined.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein the support means includes a. a first transmitting antenna mounted upon or within the support means for transmitting electromagnetic radiation signals into the object, b. a second receiving antenna mounted upon or within the support means, and adjacent to the first transmitting antenna, for receiving at least a portion of the electromagnetic radiation signals that are reflected back to the same surface of the being covered by the support means, due to the transmitted electromagnetic radiation signals having interacted with the substance within the being being measured.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein the system and/or the support means is substantially the same as that described in WO 2017/111623.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein the substance is glucose and the living being is a human being.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein the optimal positioning of the support means occurs when the first antenna and/or the second antenna is directly above an artery/vein of the human being.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein the optimal positioning of the support means occurs when the first antenna and/or the second antenna is directly above the centre -point of an artery/vein of the human being.
  • a non-invasive sensing system for measuring the concentration of a substance within a living being, substantially as described above, wherein the surface is the underside of the wrist of the human being.
  • the system further includes an analyser which is in electrical communication with the first transmitting antenna and the second receiving antenna, the analyser being adapted to break down the reflected signal received by the second receiving antenna into spectra or a spectral file.
  • the system further includes a data processor adapted to receive the spectra or spectral file from the analyser, and turn the reading into a measurement of the concentration of the substance within the being.
  • the longitudinal axis of the first transmitting antenna is substantially orthogonal to the longitudinal axis of the second receiving antenna.
  • the polarity (or axis of polarity) of the first transmitting antenna is substantially orthogonal to the polarity (or axis of polarity) of the second receiving antenna.
  • the central longitudinal axis of the second receiving antenna passes substantially through the midpoint of the first transmitting antenna, or vice versa.
  • the centre of the axis of polarity of the second receiving antenna may pass substantially through the midpoint of the first transmitting antenna, or vice versa.
  • the support means includes a first conductive track(s) for electrically connecting the analyser to the first transmitting antenna, and a second conductive track(s) for electrically connecting the analyser to the second receiving antenna, wherein the first conductive track(s) is substantially orthogonal to the second conductive track(s).
  • the analyser is a vector network analyser (VNA), and the VNA uses S parameters to break down the received signal from the second receiving antenna into spectra or a spectral file.
  • VNA vector network analyser
  • the first transmitting antenna and second receiving antenna are in direct contact with the surface of the being.
  • the substance being measured is a blood component within the blood of a body of a living being.
  • the transmitted electromagnetic radiation signals are transmitted continuously.
  • the transmitted electromagnetic radiation signals are transmitted in pulses or chirps.
  • the support means includes a printed circuit board.
  • the system is able, or adapted, to operate automatically at predetermined times.
  • the system is able, or adapted, to operate automatically and continuously.
  • the system is able, or adapted, to be operated manually by a user of the system.
  • the system is able to measure the concentrations of a plurality of substances at any one time.
  • system may also be used to merely detect the presence of a substance within a living being, rather than measure the concentration of the substance within the being.
  • a non-invasive sensing system for detecting the presence of a substance within a living being, said system including: a. a support means, substantially as described herein, adapted to be placed near to, or against, a surface of the being, b. a detection means incorporated within the support means, for detecting the presence of the substance within the being, wherein, in use, the support means is adapted to be moved with respect to the surface of the object, substantially as described herein.
  • a method for detecting the presence of, and/or measuring the concentration of, a substance within a living being including the step of utilising the non-invasive sensing system, substantially as described herein.
  • the invention will be predominantly described in relation to measuring the concentration of a substance within a being, rather than merely detecting the substance. However, it will be appreciated that if the system can measure the concentration of a substance within a being, then it is of course also detecting that substance within the being. Hence, the invention, as described hereinafter applies to both embodiments of, or uses for, the invention.
  • the invention in one embodiment, includes a positioning means which provides for the optimal positioning of the support means in relation to the being, to enable the measuring means to consistently take an optimal reading or measurement.
  • system may further include a measurement determining means which allows for the most optimal reading/measurement, of many measurements/readings taken at substantially the same time, to be the measurement/reading which is ultimately determined to be the best and/or correct reading by the system.
  • the support means may be adapted to be moved with respect to the surface of the being, or vice versa.
  • the support means may be adapted to be moved in a substantially circular motion(s) with respect to the surface of the being, or vice versa.
  • the support means may be adapted to be moved or swiped backwards and/or forwards across or just above the surface of the being.
  • the support means may be adapted to be moved or swiped backwards and/or forwards across the surface of the being, and in any direction.
  • the support means may be moved or swiped directly across the surface and/or then swiped back again, and along substantially the same path.
  • the support means may be moved or swiped diagonally (and/or at any other angle or orientation) across, or with respect to, the surface and/or then swiped back again, and along substantially the same path.
  • direction and/or orientation of the swiping of the support means across the surface may be the same or different to the direction and/or orientation of the subsequent swiping of the support means back to its start position.
  • the system may include an indication means to indicate when the support means is in the optimal position, whereby the optimal measurement/reading may be taken and/or determined. Further details of the above embodiments will be provided later in the ‘Description of Preferred Embodiments’ section.
  • the analyser may include a signal generator adapted to facilitate the generation of the electromagnetic radiation signals transmitted by the first transmitting antenna (hereinafter: “first antenna”).
  • the reflected electromagnetic radiation signals received (directly or indirectly) by the analyser from the second receiving antenna may be analysed by the analyser (or broken down into spectra or a spectral file) utilising techniques such as S Parameters (Sn, S12, S21, and/or S22) and/or Transmission Line Parameters (Power Loss, Phase angle, RGLC) and/or dielectric parameters ( ⁇ r, ⁇ r’, ⁇ r”).
  • the analyser may be a VNA.
  • Suitable analysers include a voltage standing wave ratio meter (V SWR) or a vector volt meter.
  • the data processor may comprise or include one or more software program(s) and/or algorithm(s) and/or formulae for transforming the spectra or spectral file received from the analyser into a measurement of the concentration of the substance being measured. Any suitable support means may be utilised, according to the intended use of the sensing system.
  • the support means may be in the form of, or include, a housing and/or a substrate, upon (or within) which the first antenna and second antenna (and any other electronics or components) may be mounted. Examples of suitable support means (and/or housings/substrates) will be described throughout this specification.
  • the system further includes an electronics control module (ECM) for controlling the overall operation of the system and/or the analyser and/or the data processor.
  • ECM electronics control module
  • the ECM may be a stand alone unit or it may comprise part of another component of the system, for example the analyser or data processor.
  • the data analyser may be included as part of the ECM.
  • the electromagnetic radiation signals may include signals that are in the microwave spectrum.
  • the electromagnetic radiation signals may include signals that are in the radio wave spectrum. It is also envisaged that other types of electromagnetic signals may be utilised.
  • the electromagnetic radiation signals may include signals from two or more spectra. In one embodiment, the electromagnetic signals may be transmitted continuously.
  • the electromagnetic signals may be transmitted in pulses or chirps.
  • the power of the transmitted electromagnetic radiation signals may be below 500mW, and preferably below 50mW.
  • Any suitable type or shape of antennae may be utilised. Examples of suitable antennae may include SMD antennae, wire antennae, travelling wave antennae, reflector antennae, microstrip antennae, log-periodic antennae, and aperture antennae.
  • the system may include at least one first transmitting antenna and/or at least one second receiving antenna.
  • a plurality of first antennae may be grouped substantially together as one first antenna unit.
  • a plurality of second antennae may also be all grouped substantially together as one second antenna unit. Having a plurality of transmitting and receiving antennae within the overall first antenna unit and the second antenna unit may help to ensure that there is always at least one transmitting antenna and at least one receiving antenna above the substance being measured within the being, for example above an artery/vein of a human being if a blood component is the substance being measured.
  • first antenna shall be understood to also include reference to at least one first transmitting antenna, and/or a first antenna unit, substantially as described above.
  • second antenna as used herein shall be understood to also include reference to at least one second receiving antenna, and/or a second antenna unit, substantially as described above.
  • the first antenna and the second antenna may be located directly adjacent to each other on the support means.
  • the reflected electromagnetic radiation signals (received by the second antenna) are received in substantially the same place and on the same side of the surface of the being, as where the transmitted radiation signals were originally transmitted into the being by the first antenna.
  • the distance between the first antenna and second antenna may, for example, be between 0.01mm to 10cm, but preferably between 0.5mm to 10mm In one embodiment, the first antenna and the second antenna may lie in substantially the same plane with respect to each other.
  • the first antenna and the second antenna may lie in, or on, different planes.
  • the first antenna and the second antenna may be substantially parallel with respect to each other.
  • first antenna and the second antenna may be angled with respect to each other.
  • the first antenna and the second antenna may be angled with respect to each other in substantially the same plane or in different planes (namely, different three dimensional planes or configurations).
  • the first and/or second antennae may be substantially rectangular in shape.
  • the longitudinal axis of the first antenna may be substantially orthogonal to the longitudinal axis of the second antenna.
  • the central longitudinal axis of the second antenna may preferably pass substantially through the midpoint (meaning the centre or central region) of the first transmitting antenna, or vice versa.
  • the arrangement may be such that the polarity (or axis of polarity) of the first transmitting antenna may be substantially orthogonal to the polarity (or axis of polarity) of the second receiving antenna.
  • the centre of the axis (or central axis) of polarity of the second receiving antenna may pass substantially through the midpoint (meaning the centre or central region) of the first transmitting antenna, or vice versa.
  • first antenna and the second antenna may be embedded within, and enclosed by, the support means.
  • first antenna and the second antenna may lie on the surface of, and/or protrude from, the support means whereby, in use, the first antenna and the second antenna may be in direct contact with the surface of the being.
  • one side of the support means may be in direct contact with the surface of the being, with the first antenna and the second antenna lying on, or protruding from, the opposite side of the support means.
  • the support means and/or the first and second antenna may be adapted to be held just above the surface of the being.
  • the electromagnetic radiation signals that are transmitted into the being, and the electromagnetic signals that are received back from within the being may describe or follow a transflectance-type arrangement or pattern.
  • the term “reflected” is to be understood and appreciated as including reflected and transflected electromagnetic radiation signals. It may be appreciated that the reflected electromagnetic radiation signals that are received by the second antenna have not passed entirely through the being, but instead they have merely passed slightly in and out of the being, with the points of entry (where they are transmitted) and the points of exit (where they are received) being substantially in the same place, and on the same side, of the (surface of) the being. It is to be understood and appreciated however that only a portion of the electromagnetic radiation signals transmitted into the being by the first antenna will be reflected back towards the second receiving antenna. That is, a portion of the electromagnetic radiation signals transmitted into the being by the first antenna will simply pass through, and/or be absorbed by, the being.
  • the support means may include a printed circuit board (PCB).
  • the support means may include, or be in the form of, an adhesive patch which may be (temporarily) attached or adhered to the being.
  • the substance being measured may be a blood component within the blood of a body of a living being.
  • the system may be used to measure the concentration of glucose or lactate within the blood of a human being.
  • the support means may be adapted, or be able, to be worn by a human being.
  • the support means may be in the form of a strap which may be worn around the waist, arm, leg, neck, ankle or wrist of the human being.
  • the system, and/or the support means may be in the form of, or incorporated within, a smartphone.
  • system and/or the support means may be in the form of, or incorporated within, a watch (or medical device) adapted to be continuously worn by a human being.
  • system and/or support means may simply be placed near to, or directly adjacent to, the surface of the being, in order to take a reading.
  • the system and/or support means may be placed against the surface of the being, in order to take a reading.
  • the system may be able, or adapted, to operate automatically at predetermined times. For example, the system may be configured to automatically take a measurement every hour, 24 hours a day.
  • system may be able, or adapted, to operate automatically and (more-or-less) continuously.
  • system may be configured to automatically take a measurement every second or every minute, 24 hours a day.
  • system may be able, or adapted, to be operated manually by a user of the system, and at whatever time(s) they decide or see fit to utilise the system.
  • a user may (for example) manually operate the system by pushing an “on” button associated with the system.
  • the system and/or support means is not attached to the being (or worn by a human being) then a user may manually operate the system by bringing the support means adjacent to (or placing it upon) the surface of the being (and optionally pushing an “on” button if the system is not otherwise configured to automatically take a measurement).
  • the system may be able to measure the concentrations of a plurality of substances at any one time.
  • the system may be able to communicate with an alarm means.
  • an audible alarm may be associated with the system, or an audible alarm may be associated with an electronic device such a smartphone to which the system has sent an appropriate signal - in the latter example, a text or email could additionally or alternatively be generated and sent.
  • a component of the system may send a signal to activate the alarm when a predetermined condition is met (or not met).
  • the alarm may be activated if a person’s blood glucose or lactate levels were dangerously low or high.
  • the system may further include power means for powering the operation of the system as a whole, for example for powering the analyser and/or the data processor and/or the ECM and/or the first antenna and second antennae and/or alarm (if housed within the system).
  • power means for powering the operation of the system as a whole for example for powering the analyser and/or the data processor and/or the ECM and/or the first antenna and second antennae and/or alarm (if housed within the system).
  • the power means may be a small battery incorporated within the system, or a component of the system.
  • the battery may be disposable or rechargeable.
  • the system may also include suitable power means to enable it to be powered by mains power, for example by an electrical plug or USB port/cable.
  • the system may include a communication means, for the transmission of any or all measurements or other data, or any workings on the measurements or other data, to another location, such as a computing system or other electronic device.
  • the communication means may also be able to receive data, of any kind.
  • the communications means may be a wireless communication means, for example, a wireless transceiver housed within the ECM or analyser or data processor.
  • Wi-Fi IEEE 802.11
  • LE Bluetooth® Bluetooth®
  • other radio frequencies INFRARED
  • IR Infra-Red
  • GSM Global System for Mobile communications
  • CDMA Code Division Multiple Access
  • GPRS 3G
  • 4G Third Generation
  • W-CDMA Wideband Code Division Multiple Access
  • EDGE EDGE
  • DCDMA200 DCDMA200
  • any suitable wired connections or ports may also be used, including, without limitation, USB ports or any other relevant or appropriate technology known in the art.
  • the computing device or other electronic system or device may include, without limitation, a mobile phone, a smartphone, an iPhone, an iPad, a tablet, a palmtop computer, a band or other wearable technology device, a small portable device, a laptop, a desktop computer, a cloud computing system, a remote network computer system (a public network, e.g. a website, or alternatively a private network) or to a web service.
  • the system may be configured to activate the communication means to transfer (and/or receive) measurements or any other data to/from a computing system or other electronic device (external to the system) as or when required or desired.
  • the transmissions may be made in real time, manually, continuously or automatically at predetermined set times.
  • the system may be configured to receive information or data, of any kind, from another location and/or computer system or electronic devices external to the system, using the communication means.
  • information or data of any kind
  • software updates for the antennae, ECM, analyser or data processor may be transmitted in this way.
  • the system may be paired with a smartphone loaded with a specific and dedicated software application which allows the smart phone to receive, access, process, display, transmit and/or present the measurements or the data collected by the system.
  • the analyser may transmit (via the communication means) the spectra or spectral file to the smartphone app, and the smartphone app may therefore act as the data processor in order to turn the received data into an appropriate measurement (of the concentration of the substance being measured within the object).
  • the smartphone app may be configured to simply receive (via the communication means) the reflected electromagnetic radiation signals from the second antenna before transmitting them to a remote analyser and/or data processor.
  • the system, or any component thereof, may include a memory or data storage means for the storage of measurements or any other data.
  • the memory or data storage means may be housed within a computing system or other electronic device which is in communication with the system.
  • the system may further include a user interface.
  • the user interface may comprise part of a computing system or other electronic device which is in communication with the system.
  • the system may be utilised for detecting and/or measuring the concentration(s) of any type of substance(s) in any type of being.
  • the system may be particularly suitable for measuring the concentration of metabolites, or any other substances, in the blood of a human being.
  • the system may be used for measuring the concentrations of substances in the blood of a human being, such as lactate, urates, blood sugar (glucose), water, alcohol, drugs, and so on.
  • Fig 1 is a view of one possible embodiment of the present invention.
  • Fig 2 is a view of the embodiment of Fig 1, showing transmitted and reflected electromagnetic radiation signals, when the embodiment rests against a skin surface
  • Fig 3 is a view showing the field lines of the antennae of the invention, as illustrated in Figs 1 and 2, when the embodiment is adjacent to a skin surface
  • Fig 4 a schematic view of one possible embodiment of the present invention
  • Fig 5 is a view of the embodiment of the invention illustrated in Fig 1, in use,
  • Fig 6 is a view of an embodiment of the invention included within a mobile phone
  • Fig 7 is a view of an embodiment of the invention in the form of a wearable watch or wrist strap
  • Fig 8 is a view showing different possible arrangements of antennae of the invention.
  • Fig 9 is the spectral profile or graph resulting from the testing of Volunteer 1
  • Fig 10 is an Excel Table showing the conversion of the spectral profile data into recognisable values for the blood glucose levels of Volunteer 1 (as compared to the equivalent prick test results).
  • a non-invasive sensing system for measuring the concentration of blood glucose 23 (shown as dots in Figs 2 and 3) within the blood 14 of a human being, the system being generally indicated by arrow 1.
  • the system 1 includes a support means, generally indicated by arrow 34 (Fig 4) in the form of a PCB 22, which is adapted to be placed near to (Fig 3), or against (Fig 2), a skin surface 4 of the human being - preferably in the region of the inside surface of the wrist 8 (Fig 5) of the human being.
  • the PCB 2 is comprised of a non -hydroscopic dielectric material, and may ideally be between 0.1 mm to 5mm thick, with a preferred thickness of 0.7mm.
  • the PCB 2 may instead be comprised of a hydroscopic dielectric material.
  • the system 1 includes a measuring means in the form of (or including) a first transmitting antenna 2, mounted on the PCB 22 for transmitting electromagnetic radiation signals 3 into (and through) the skin surface 4 of the human being.
  • the measuring means also includes a second receiving antenna 5, mounted on the PCB 22, and directly adjacent to the first antenna 2, for receiving the electromagnetic radiation signals 6 that are reflected back to, or towards, the same region or area of skin surface 4 covered by the PCB, due to the transmitted electromagnetic radiation signals 3 having interacted with the glucose molecules 23 within an artery/vein 13 of the human being.
  • a second receiving antenna 5 mounted on the PCB 22, and directly adjacent to the first antenna 2, for receiving the electromagnetic radiation signals 6 that are reflected back to, or towards, the same region or area of skin surface 4 covered by the PCB, due to the transmitted electromagnetic radiation signals 3 having interacted with the glucose molecules 23 within an artery/vein 13 of the human being.
  • the first antenna 2 and second antenna 5 are commercially available SMD antennas.
  • the system 1 further includes an analyser in the form of a two-port VNA 15 which is in electrical communication with the first antenna 2 and the second antenna 5 via the co axial cables 24a, b, ports 25a, b and conductive tracks 26a, b.
  • an analyser in the form of a two-port VNA 15 which is in electrical communication with the first antenna 2 and the second antenna 5 via the co axial cables 24a, b, ports 25a, b and conductive tracks 26a, b.
  • the VNA is adapted to break down the reflected or returning signals 6 received by the second antenna 5 into spectra or a spectral file (using S parameters).
  • a VNA with more than two ports may also be used.
  • the system further includes a data processor 21 which is adapted to receive the spectra or spectral file from the VNA 15, and turn the reading into a measurement of the concentration of the blood glucose 23 within the blood 14 of an artery/vein 13 of the human being that is undergoing the testing.
  • the first antenna 2 and receiving antenna 5 are directly adjacent to each other and in substantially the same plane.
  • the longitudinal axis 27 of the first antenna 2 is substantially orthogonal to the longitudinal axis 28 of the second antenna 5.
  • the polarity of the first antenna is substantially orthogonal to the polarity of the second antenna.
  • This arrangement is preferred because it minimises the coupling or interference between the first antenna 2 and the second antenna 5.
  • having the second (receiving) antenna 5 substantially at right angles to the first (transmitting) antenna 2 means that the second antenna 5 is better disposed to pick up or receive the reflected signals 6, due the change(s) in phase and/or rotation and/or attenuation that the transmitted waves 3 have undergone due to having been reflected (at points 39 - Fig 2).
  • the (central) longitudinal axis 28 of the second antenna 5 passes substantially through the midpoint 29 of the first antenna 2. This is the preferred arrangement of the first antenna 2 with respect to the second antenna 5.
  • the ports 24a, b of the VNA may be interchanged whereby the second antenna 5 becomes the transmitting antenna and the second antenna 2 becomes the receiving antenna.
  • the (central) longitudinal axis 28 of the second antenna 5 nonetheless still passes substantially through the midpoint 29 of the longitudinal axis 27 of the first antenna 2 (now the receiving antenna).
  • the distance “a” is approx 5mm
  • the distance “b” is approx 6mm
  • the distance “c” is approx 2mm.
  • the first conductive track 26a for electrically connecting the VNA 15 to the first antenna 2 is substantially orthogonal to the second conductive track 26b for electrically connecting the VNA 15 to the second antenna 5. This arrangement is preferred because it minimises the coupling or interference between the first and second conductive tracks 26a and 26b.
  • first antenna 2 and the second antenna 5 protrude slightly from the surface of the PCB 22.
  • the PCB 22, together with the first antenna 2 and second antenna 5 are held just above the skin surface 4.
  • the near field lines 30 are those generated by the electromagnetic signals transmitted by the first antenna 2, and the near field lines 31 are those received by the second antenna 5, after the electromagnetic signals associated with the field lines 30 have been reflected off the blood glucose molecules 23 and/or the bottom 32 of the artery 13.
  • the PCB 22 is placed against the skin surface 4, wherein the first antenna 2 and second antenna 5 are in direct contact with the skin surface 4. This is the preferred arrangement when using the sensing system 1 for this purpose.
  • the reflected signals 6 are received by the second antenna 5 in substantially the same place, and on the same side of the skin surface 4 (of the wrist 8), as where the transmitted radiation signals 3 were originally transmitted into the skin 4 by the first antenna 2.
  • the first transmitting antenna 2 transmits rapidly pulsed electromagnetic radiation signals 3 in the form of a broadband (wide frequency) low power signal.
  • the first antenna 2 transmits electromagnetic radiation signals 3 in the form of continuous waves, with frequencies of between 4Mhz to 4Ghz, and a power signal of less than 2mW.
  • Both the first antenna 2 and the second antenna 5 are approximately 0.18cm 2 , and hence this results in a power density of approximately 1 lmW/cm 2 .
  • the transmitted signals 3 generally penetrate up to approximately 10mm within the skin 4, and/or underlying tissue of the human being, before being absorbed by the skin 4 (or underlying tissue).
  • a portion 33 of the transmitted signals 3 simply pass right through the artery 13, where they are absorbed by the underlying tissue (that is the signal portions 33 are not reflected back to the second antenna 5). In most (but not all) cases the points 39 where the transmitted signals 3 are reflected back as the reflected signals 6 will generally be between 1 to 5mm below the skin surface 4.
  • the transmitted signals 3 are reflected back as the reflected signals 6 they are rotated in phase prior to being received by the second antenna 5. Furthermore, the reflected signals 6 also undergo a phase change and a change in attenuation due to having interacted with the glucose molecules 23. It is these changes in dielectric effects that are measured by the VNA 15 in order to produce the spectral file, which is ultimately turned into a blood glucose reading by the data processor 21.
  • Coupling is increased lOOx between the first antenna 2 and the second antenna 5, when the antennae 2, 5 are in contact with the skin 4 (Fig 2) - as compared to when the first antenna 2 and the second antenna 5 (and/or the PCB 22) are held just above the skin 4 (Fig 3).
  • This gives rise to absorption or resonant lines or curves in the scans of Sn and S22 by the VNA 15.
  • S12 and S21 convey the coupling levels.
  • the scans of Sn, S21, S12 and S22 are recorded and/or analysed by the VNA and reduced to spectra or a spectral file, and subsequently transmitted to the data processor 21 where they are turned into a recognisable blood glucose concentration (in mml/1) by the data processor 21.
  • the field needs only to be stable for the period of time that the measurements are being taken, thus high speed pulsed fields and/or “Time of Flight” chirps of only a few wavelengths duration may be considered stable if very high speed signal capturing circuits are used.
  • Devices exist that can generate a pulse/chirp (short electromagnetic pulse) at very specific frequencies.
  • Devices also exist that are able to very rapidly generate through a series of chirps at different frequencies, establish a stable field, capture the signal and measure the field’s parameters.
  • the data output of such devices may be referred to as a spectrum. A spectrum of a few hundred discrete data points (frequency steps) can be captured within several milliseconds.
  • the electromagnetic field can be characterised using several techniques, including but not limited to: “S Parameters (Sn, S12, S21, and S22), Transmission Line Parameters (Power Loss, Phase angle, RGLC) and dielectric parameters ( ⁇ r , ⁇ r ⁇ ⁇ r ”) ⁇ These data may be further analysed to discern properties of the antennae, the waves themselves and the materials that the waves have interacted with.
  • Electromagnetic radiation signals interact with materials in several ways.
  • the electromagnetic radiation signals may be reflected (e.g. a mirror and radar), diffracted, refracted (e.g. light prism), speed altered (resulting in phase changes along the wave path), partially or completely absorbed or polarised.
  • the degree of these impacts generally changes with frequency and are specific to the material being interacted with.
  • Each of these interactions impact the electromagnetic radiation signals differently and may therefore be inferred from the wave characteristics.
  • These interactions may be described as dielectric parameters and modelled mathematically using the field parameters.
  • the received signal may be attenuated but not necessarily.
  • a reflected wave is 180 degrees out of phase but has not been attenuated.
  • a prism will refract (light) into different wavelengths (or in microwave terms into different frequencies) but again there is no loss or attenuation.
  • Dielectric Parameters are mathematical terms that describe the effect of the material (eg, blood) on the wave. In homogeneous and stable materials (like plastics and water) these values are very consistent. The terms will typically tell the model the phase change and attenuation per unit of distance that the wave travels in the material (media). These terms may include (a) Phase and attenuation at different frequencies, (b) Real and Imaginary vectors (c) E r , E E r" . From these other parameters can be determined such as (d) RGFC (which are used in an equation involving frequency to get the values for (a) and (b)), also (e) a and b which describe attenuation and phase losses per unit length in a material at any frequency. Transfer functions may be used to convert between some models and their related parameters. For example the S parameters can be converted in E r parameters using mathematics involving complex numbers.
  • Field parameters are descriptive of the geometric shape of the field.
  • the field parameter may determine what the mathematical model used (and the complexity and degree of difficulty to solve).
  • an electromagnetic radiation signal passes through biological fluids (for example blood, urine, saliva, fruit juice etc) the signals may interact with the fluid in several ways:
  • Salt ions and polar molecules are driven by the electrical and magnetic fields and migrate to the regions with the opposite charge.
  • the ions absorb some of the wave’s energy as they accelerate towards the pole or decelerate if they are moving in the opposite direction to the force.
  • the regions of charge are constantly changing poles rapidly, causing the ions to constantly accelerate, decelerate and change directions and absorb energy in proportion to the moment of inertia that has to be overcome. This effect is most prominent at low frequencies and when the ions and molecules are larger and/or highly charged.
  • Water and polar molecules may also be driven to align with the fields by rotating about their centre of mass and absorb energy as they build up (lose) inertia during acceleration (deceleration). This effect is most prominent in the microwave region.
  • Bio compounds may also have bonds and structures that resonate, flex or otherwise distort at specific frequencies or angles of incidence.
  • the VNA 15 includes a signal processing unit 9 (SPU).
  • SPU signal processing unit 9
  • One function of the SPU 9 is to facilitate the transmission of the electromagnetic radiation signals 3 by the first antenna 2. This is facilitated by the SPU 9 being in electrical communication with a signal generator 10, which in turn is in electrical communication with the first antenna 2.
  • Another function of the SPU 9 is to receive (or facilitate the receipt of) the reflected radiation signals 6.
  • a signal receiver 11 which is in electrical communication with both the second antenna 5 and the SPU 9.
  • the transflected or reflected electromagnetic radiation signals 6 which are received initially by the second antenna 5, are subsequently transmitted to the signal receiver 11 , which in turns transmits them to the SPU 9.
  • the received signal 6 is analysed in the SPU 9 by initially digitising the received signal 6, and then breaking the digitised signal 6 down into spectra or a spectral file.
  • examples of other possible ways to break the signal 6 down into spectra, or a spectral file include power loss and phase and time of flight.
  • the spectra, or spectral file is subsequently passed to the data processor 21 and converted into dielectric properties (such as phase angle, power loss; alpha and beta values; ⁇ r, ⁇ r ' and ⁇ r " ) and analysed spectrally using chemometric methods, such as and for example, N-PLS, PCA, Neural network Analysis, radio signal processing methods (preferably), Time of Flight Fourier transform) to resolve the component of interest.
  • dielectric properties such as phase angle, power loss; alpha and beta values; ⁇ r, ⁇ r ' and ⁇ r "
  • chemometric methods such as and for example, N-PLS, PCA, Neural network Analysis, radio signal processing methods (preferably), Time of Flight Fourier transform) to resolve the component of interest.
  • the data processor 21 also includes appropriate algorithms, which, when applied to the component of interest (of the spectra or spectral file) ultimately allow the person’s blood glucose levels to be determined. A specific example of the type of calculations involved will be described later.
  • VNA circuits could be built into the back of the antennae 2,5 if we were looking at miniaturising the system 1.
  • the electromagnetic radiation signals 3 which are transmitted into the wrist 8, and the electromagnetic signals 6 that are received from the wrist 8, may describe or follow a transflectance-type arrangement or pattern, within the electromagnetic field that has been created.
  • the data processor 21 includes (or is in communication with) a wireless communication means in the form of a wireless transceiver 16 for the transmission (and/or receipt) of any or all measurements or other data, or any workings on the measurements or other data, to a remote location or computing device.
  • the wireless transceiver 16 is adapted to send its transmissions to the smartphone 17 of the person being tested.
  • the smartphone 17 includes a downloaded app unique to the system 1 for receiving and/or manipulating and/or displaying the measurements, or other received data, or any workings on the measurements or other data.
  • the smartphone 17 includes an alarm 18, in this case an audible alarm associated with the smartphone 17 - to which the data processor 21 or ECM 12 is programmed to send an appropriate signal (via the transceiver 16) if a predetermined condition is met (for example, the person’s blood glucose levels were dangerously low or high and/or that a shot of insulin was required).
  • a predetermined condition for example, the person’s blood glucose levels were dangerously low or high and/or that a shot of insulin was required.
  • the data processor 21 or ECM 12 may also be adapted to wirelessly transmit (via the transceiver 16) the measurements, and/or any other data or alarm warnings, to the person’s health care professional 19 or to a cloud computing system 20.
  • a PIC chip, cellular chip and/or alarm could be put on the same circuit board in the VNA.
  • the data processor 21 or ECM 12 may be configured to cause the wireless transceiver 16 to transmit and/or receive measurements or other data to/from the person’s smartphone 17 or cloud computing system as or when required or desired.
  • the transmissions may be made in real time, manually or at predetermined set times.
  • the system 1 or ECM 12 may be configured to receive data or information from the person’s smartphone 17 (or cloud computing system 20). For example, software updates for the ECM 12 or data processor 21 or VNA 15 may be transmitted in this way.
  • the smart phone 17 may also be configured to transfer the measurements or other data obtained from the system 1 to a web services platform (not shown).
  • the system may include a memory (not shown) for the storage of the measurements or other data, or any workings on the measurements or other data.
  • the memory may be stored in the ECM 12, data processor 15 and/or smartphones 17.
  • a volatile type computer memory including RAM, DRAM, SRAM, may be used.
  • the system may continually transmit the measurements or other data to the smartphone 17 or medical professional 19 or cloud computing system 20.
  • non-volatile memory formats may be used, including ROM, EEPROM, flash memory, ferroelectric RAM (F-RAM), optical and magnetic computer memory storage devices.
  • ROM read only memory
  • EEPROM electrically erasable programmable read-only memory
  • flash memory electrically erasable programmable read-only memory
  • F-RAM ferroelectric RAM
  • the system 1 may further include a user interface, preferably as part of the smartphone app.
  • the user interface may also be used to access measurements or other data recorded or received/transmitted by the system 1, and also change any settings of the system 1 (for example, date/time, visual/audio alert settings).
  • the user interface may also be used to access any measurements or other data received (or transmitted) by the system 1 or to control the upload of the measurements or other data.
  • the system 1 may be able or adapted to operate automatically and/or continuously.
  • the system 1 may be configured to automatically take a measurement every hour, 24 hours a day.
  • system 1 may be able, or adapted, to operate automatically and (more-or-less) continuously.
  • system 1 may be configured to automatically take a measurement every second or every minute, 24 hours a day.
  • the system 1 may be able or adapted to be operated manually.
  • a person may place the PCB 22 on the inside of their wrist 8 and manually take a reading, for example by engaging an “on” button associated with the system 1 (or smartphone app).
  • the support means 34, VNA 15, data processor 21 and transceiver 16 may be housed within its own housing (not shown) which, for example, may be carried by a person.
  • the person’s smartphone 17 (and associated app) may be adapted, or able to operate, or be in communication with, the componentry.
  • the componentry and the app combine to operate the system 1 or facilitate the operation of the system 1.
  • Fig 5 illustrates how the embodiment illustrated in Fig 1 may be used in practice.
  • a person who wishes to take a blood glucose reading places the PCB 22 against an inside surface of their wrist 8, as shown. It is envisaged however that the PCB 22 could be placed against any skin surface, for example the neck, the leg, foot or chest. However, the wrist is a preferred place given that it has at least one artery 13 close to the skin surface 4.
  • the PCB 22 is connected to the VNA 15, which in turn is connected to a data processor in the form of a laptop 37.
  • the PCB 22 should be placed upon the wrist 8, wherein the longitudinal axis of the first antenna 2 or the longitudinal axis of the second antenna 5 line up substantially with the longitudinal axis 38 of at least one artery 13, as this allows for greater accuracy in the blood glucose readings (as compared to the PCB 22 being placed on the wrist 8, wherein the longitudinal axes 27, 28 of the antennae 2, 5 are both at an angle with respect to the longitudinal axis 38 of at least one artery 13).
  • the desired requirement is to try and position the PCB 22 over the artery 13 in a consistent position and/or whereby a reading is taken when the PCB 22 and/or antennae 2,5 are directly or squarely over an/or above the artery 13.
  • such a positioning method may be independent of the measurement spectra.
  • the antennae 2,5 can be used to assist, and/or act as, the positioning method, but the antennae 2,5 must be used at the time a measurement/scan is taken
  • a preloaded spectra profile is a spectra previously taken and stored as a reference.
  • the artery 13 is located, the PCB sensor 22 is placed directly/correctly/optimally over the artery, and the spectra taken. This can be done/taken when the system 1 was first setup for that person, or subsequently.
  • the system may be provided with an indication means which activates when the PCB 22 means is in the optimum position.
  • suitable indications means includes audio and/or visual alerts such as a beep or the flashing of an LED light.
  • the person may be preferable for the person to be alerted when the PCB 22 has just gone past the optimal position (by identifying the position of the maximum signal strength, which is the optimal position) and then move the PCB 22 ever-so-slightly backwards. A bit like how you used to tune in a radio by manually turning the tuning knob.
  • the optimal reading may be determined without the need for the person to stop swiping/moving the PCB 22 across the skin surface. That is, the optimal reading may automatically be determined by the system 1 when the optimal position has been reached, and an appropriate alert may be made to indicate to the user that an optimal reading/measurement has been reached (and that no further swiping is required).
  • the PCB 22 may be provided with dimples to ensure that the swiping motion starts in a consistent place (e.g. the dimples may be adapted to rest against the tendons in the lower arm) and/or so that the antennae 2,5 align correctly along the artery 13.
  • the swiping motion may simply be based on the movement provided by the natural elasticity of the skin surface as the PCB 22 is pressed into and/or against the skin surface.
  • the first antenna 2 and the second antenna 5 are housed within or upon a mobile phone 35.
  • the mobile phone 35 may also incorporate a miniaturised VNA and/or data processor (not shown). That is, the mobile phone 35 may incorporate a miniaturised version of the system 1 as a whole - which may subsequently transmit the resultant blood glucose reading to an app associated with the smartphone 35 (as described previously with respect to Fig 4).
  • the first antenna 2 and the second antenna 5 are housed within or upon a wearable wrist or watch strap 36.
  • the first and second antennae 2, 5 may instead be housed within the body 40 of the watch itself, and preferably on the underside 41 of the watch body 40, whereby the first and second antennae 2,5 are in direct contact with the skin 4 of the person in the region of the wrist 8 (topside or underside). It may be appreciated that if worn by a human being (next to the skin 4) the system 1 may be able to continuously detect for the presence of, or measure the concentration of, or otherwise monitor, blood glucose 23 within the blood 14 - this has advantages as compared to discreet finger prick tests which only take measurements each time the person manually pricks their finger and places the resultant blood on/in a glucose meter. Moreover, being able to continuously wear the watch 40 or strap 36 means that a person is able to continuously monitor their blood glucose levels whilst working, exercising, socialising or sleeping.
  • the wearable wrist or watch strap 36 may also incorporate a miniaturised VNA and/or data processor (not shown) whereby the strap 36 may be seen to incorporate a miniaturised version of the system 1, as a whole.
  • the strap 36 or watch 40 may include a wireless transceiver (not shown) whereby the resultant blood glucose reading may be wirelessly transmitted to another electronic device, as described previously.
  • Figs 8a, 8b, 8c, and 8d four different possible configurations, and number, of first and second antennae 2, 5 that may be housed by, or within, the support means 34, such as the PCB 22.
  • Fig 8a there is one transmitting antenna 2 and one receiving antenna 5, arranged substantially parallel, and side to side.
  • Fig 8b there is one transmitting antenna 2 and one receiving antenna 5, arranged substantially parallel, and end to end.
  • Fig 8c there is one transmitting antenna 2, positioned substantially orthogonally to two substantially parallel receiving antennae 5, positioned on each side of the first transmitting antenna 2.
  • Fig 8d there are three transmitting antennae 2 positioned substantially orthogonally to two substantially parallel receiving antennae 5, positioned as shown.
  • Volunteer 1 On the day before the testing day, Volunteer 1 had their “personal profile” traced (using acetate film on the computer screen) and then practised moving their arm to consistently obtain a trace matching their “personal profile”. 2. On the testing day, Volunteer 1 was monitored for a period of up to two (2) hours. They were required to stay at the trial facilities for the period of their monitoring.
  • Volunteer 1 On the morning of the testing day, Volunteer 1 was required to have their blood glucose level between 5-7 mmolf 1 prior to starting the monitoring. This required Volunteer 1 foregoing food leading up to the trial period.
  • Volunteer 1 Prior to eating Volunteer 1 was required to do two prick tests (within a few minutes of each other). The results of the prick test were recorded (as the baseline) b. Volunteer 1 was given a moderate amount of GI food (a sandwich) c. Immediately, and then every five minutes after, Volunteer 1:
  • Fig 9 A spectral profile in the form of a graph showing the results of the testing of Volunteer 1 is marked as Fig 9.
  • Fig 10 is an Excel Table showing the conversion of the spectral profile data into recognisable values for the blood glucose levels of Volunteer 1 (as compared to the equivalent prick test results). The formula used for the conversion is also provided.
  • test results on Volunteer 1 using the system 1 are mostly very close to the equivalent prick test results (keeping in mind that prick test results can be up to 15% different to actual - as compared to more accurate laboratory testing methods).

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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

La présente invention concerne un système de détection non invasif pour mesurer la concentration d'une substance chez un être vivant. Le système comprend un moyen de support conçu pour être placé à proximité, ou contre, une surface de l'être vivant, un moyen de mesure contenu à l'intérieur du moyen de support pour mesurer de manière non invasive la concentration de la substance chez l'être vivant, et un moyen de positionnement contenu à l'intérieur du moyen de support, qui sert à positionner le moyen de support de façon optimale par rapport à l'être vivant, pour permettre au moyen de mesure d'effectuer systématiquement une lecture ou une mesure optimale. Le système est de préférence utilisé pour mesurer la concentration d'un composant sanguin chez un être humain, par exemple, la glycémie.
PCT/NZ2020/050103 2019-09-11 2020-09-11 Système de détection non invasif WO2021049956A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110245622A1 (en) * 2010-03-31 2011-10-06 Nellcor Puritan Bennett Llc System and method for determining sensor placement
US20140176944A1 (en) * 2012-12-22 2014-06-26 Covidien Lp Methods and systems for determining a probe-off condition in a medical device
WO2017115361A1 (fr) * 2015-12-31 2017-07-06 Wear2B Ltd Dispositif, système et procédé pour contrôle non invasif de mesures physiologiques
US20190104939A1 (en) * 2017-10-05 2019-04-11 American University Of Beirut Novel non-invasive biological, chemical markers and tracers monitoring device in blood including glucose monitoring using adaptive rf circuits and antenna design
US20190290161A1 (en) * 2018-03-22 2019-09-26 Arnold Chase Blood glucose tracking system
US20200187816A1 (en) * 2018-12-18 2020-06-18 Movano Inc. Systems for radio wave based health monitoring that include an alignment feature

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110245622A1 (en) * 2010-03-31 2011-10-06 Nellcor Puritan Bennett Llc System and method for determining sensor placement
US20140176944A1 (en) * 2012-12-22 2014-06-26 Covidien Lp Methods and systems for determining a probe-off condition in a medical device
WO2017115361A1 (fr) * 2015-12-31 2017-07-06 Wear2B Ltd Dispositif, système et procédé pour contrôle non invasif de mesures physiologiques
US20190104939A1 (en) * 2017-10-05 2019-04-11 American University Of Beirut Novel non-invasive biological, chemical markers and tracers monitoring device in blood including glucose monitoring using adaptive rf circuits and antenna design
US20190290161A1 (en) * 2018-03-22 2019-09-26 Arnold Chase Blood glucose tracking system
US20200187816A1 (en) * 2018-12-18 2020-06-18 Movano Inc. Systems for radio wave based health monitoring that include an alignment feature

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