WO2017054006A1 - Système et procédé pour timbre de biocapteur et d'administration de médicament - Google Patents

Système et procédé pour timbre de biocapteur et d'administration de médicament Download PDF

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Publication number
WO2017054006A1
WO2017054006A1 PCT/US2016/053845 US2016053845W WO2017054006A1 WO 2017054006 A1 WO2017054006 A1 WO 2017054006A1 US 2016053845 W US2016053845 W US 2016053845W WO 2017054006 A1 WO2017054006 A1 WO 2017054006A1
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WO
WIPO (PCT)
Prior art keywords
medication
iddb
biosensor
patient
drug delivery
Prior art date
Application number
PCT/US2016/053845
Other languages
English (en)
Inventor
Robert Steven NEWBERRY
Matthew Rodencal
Original Assignee
Sanmina Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US14/866,500 external-priority patent/US10321860B2/en
Priority claimed from US15/275,388 external-priority patent/US9642578B2/en
Priority claimed from US15/275,444 external-priority patent/US9642538B2/en
Application filed by Sanmina Corporation filed Critical Sanmina Corporation
Priority to EP16849902.8A priority Critical patent/EP3337397A4/fr
Priority claimed from US15/276,760 external-priority patent/US9636457B2/en
Publication of WO2017054006A1 publication Critical patent/WO2017054006A1/fr

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    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055—Simultaneously evaluating both cardiovascular condition and temperature
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    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
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    • A61B5/024—Detecting, measuring or recording pulse rate or heart rate
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    • A61B5/6802—Sensor mounted on worn items
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Definitions

  • This application relates to a systems and methods of non-invasive, autonomous health monitoring and drug delivery system, and in particular a health monitoring and drug delivery patch that assists in tracking a patient's vitals and delivering a medication to the patient using needles.
  • a patient's vitals such as temperature, blood oxygen levels, blood pressure, etc.
  • instruments for obtaining vitals of a patient include blood pressure cuffs, thermometers, S0 2 measurement devices, glucose level meters, etc.
  • blood pressure cuffs such as blood pressure
  • thermometers such as thermometers
  • S0 2 measurement devices such as glucose level sensors
  • glucose level meters such as glucose sensors
  • multiple instruments must be brought to a patient's room by a caretaker, and the measurements collected using the multiple instruments. This monitoring process can be time consuming, inconvenient and is not always continuous. It may also disrupt sleep of the patient. The measurements of the vitals must then be manually recorded into the patient's electronic medical record.
  • one or more medications may need to be administered to a patient.
  • Medications may be administered, e.g. intravenously or orally.
  • the dosage of the medications is predetermined prior to administration orally or prior to applying the medication to an intravenous system. There currently is no continuous or real-time measurement of efficacy or absorption rates of the dosage of medication.
  • a patient monitoring system that includes an accurate, continuous and non-invasive biosensor that may measure patient vitals, and deliver medication in response to the patient's vitals.
  • an integrated drug delivery and biosensor (IDDB) system is implemented on a patch configured for attaching to a patient.
  • the IDDB system includes a drug delivery system coupled to the patch, wherein the drug delivery system is configured to administer a dosage of medication at an administration rate to the patient.
  • the IDDB system also includes a biosensor system coupled to the patch, wherein the biosensor system is configured to monitor biosensor data of the patient, wherein the biosensor data includes one or more of: respiratory rate, heart rate or blood pressure; monitor absorption rate of the medication into one or more of: surrounding tissue or arterial blood flow; and monitor concentration of a substance in one or more of: surrounding tissue or arterial blood flow.
  • the drug delivery system is further configured to alter at least one of the dosage of the medication or the administration rate of the medication in response to the biosensor data.
  • FIG. 11 illustrates a schematic block diagram of an exemplary embodiment of the biosensor illustrating the PPG circuit in more detail.
  • FIG. 12 illustrates a schematic block diagram of another exemplary embodiment of the biosensor illustrating the PPG circuit in more detail.
  • FIG. 13 illustrates a logical flow diagram of an embodiment of a method of the biosensor.
  • FIG. 14 illustrates a logical flow diagram of an exemplary method to determine blood concentration levels of a plurality of substances using the spectral response for a plurality of wavelengths.
  • FIG. 15 illustrates a schematic block diagram of an embodiment of a method for determining concentration levels or indicators of substances in pulsating blood flow in more detail.
  • FIG. 17 illustrates a schematic block diagram of an embodiment of an exemplary EMR network in which the IDDB system described herein may operate.
  • FIG. 18 illustrates a schematic block diagram of an embodiment of a network illustrating interoperability of a plurality of IDDB systems.
  • the IDDB system 100 further includes a battery 116 and a wireless transceiver 118 configured to communicate instructions and biosensor data to and from the IDDB system 100.
  • the IDDB system 100 may also include a joint test action group (JTAG) header 120 for programming and testing of the IDDB system 100 at manufacture.
  • JTAG joint test action group
  • the transceiver may also include a near field transceiver that may operate using RFID, short range radio frequency, Bluetooth, infrared link, or other short range wireless communication protocol.
  • the near field transceiver may transmit the patient identification (ID) 208 and biosensor data over a short range to local devices.
  • the wireless transceiver may include a thin foil for an antenna that is specially cut and includes a carbon pad contact to a main PCB of the IDDB system 100. This type of antenna is inexpensive to manufacture and may be printed on the inside of an enclosure for the IDDB system 100 situated away from the skin of the patient to minimize absorption.
  • the transceiver 220 may also include a wired transceiver interface, e.g., a USB port or other type of wired connection, for communication with one or more other devices over a LAN, MAN and/or WAN.
  • the IDDB system 100 further includes a biosensor 200 and drug delivery system 210.
  • the biosensor 200 includes one or more types of sensors, such as a PPG circuit 110, a temperature sensor 112 or an activity monitoring circuit 114.
  • the temperature sensor 112 is configured to detect a temperature of a patient.
  • the temperature sensor 112 may include an array of sensors (e.g., 16x16 pixels) positioned on a side of the biosensor 200 such that the array of sensors are adjacent to the skin of the patient. The array of sensors then detects an indication of the temperature of the patient from the skin.
  • the activity monitoring circuit 114 is configured to monitor the activity level of the patient.
  • the activity monitoring circuit 114 may include a multiple axes accelerometer that measures a position of the patient and motion of the patient. In one aspect, the activity monitoring circuit 114 determines periods of activity and rest. For example, the activity monitoring circuit 114 monitors and records periods of rest that meet a predetermined threshold of low motion or activity level, such as sitting, lying, sleeping, etc. The activity monitoring circuit 114 may also monitor and record periods of activity that meet a predetermined threshold of motion or activity level, such as walking, running, lifting, squatting, etc.
  • the biosensor 200 is then configured to measure and store the patient vitals with an indicator of the activity level of the patient. For example, blood oxygen levels may vary greatly in patients with COPD during rest and activity. The vitals of the patient are tracked during periods of activity and rest and the level of activity at time of measuring the vitals is recorded. The biosensor 200 is thus configured to associate measurements of patient vitals with the activity level of the patient.
  • the IDDB system 100 includes a rest mode.
  • the activity monitoring circuit 114 may signal a rest mode when a patient is asleep or meets a predetermined threshold of low activity level for a predetermined time period. In the rest mode, the IDDB system 100 signals one or more modules to halt non-essential processing functions. When the activity monitoring circuit 114 detects a higher activity level exceeding another predetermined threshold for a predetermined time period, the the IDDB system 100 signals one or more modules to exit rest mode and resume normal functions. This activity monitoring feature helps to save power and extend battery life of the IDDB system 100.
  • the activity monitoring circuit is configured to include a fitness tracker application.
  • the activity monitoring circuit 114 may monitor a number of steps of the patient, amount and length of periods of sleep, amount and length of periods of rest, amount and length of periods of activity, etc.
  • the biosensor 200 also includes a PPG circuit 110.
  • the PPG circuit 110 may be configured to detect oxygen saturation (Sa0 2 or Sp0 2 ) levels in blood flow, as well as heart rate and blood pressure.
  • the PPG circuit 110 is configured to detect concentration levels or indicators of one or more substances in the blood flow of the patient as described in more detail herein.
  • the IDDB system 100 also includes the integrated drug delivery system 210.
  • the drug delivery system 210 is configured to deliver a dosage of medication at a rate of administration and at a scheduled time.
  • the drug delivery system 210 includes an integrated drug receptacle 102 though an external source of medication may also be employed.
  • the drug delivery system 210 includes a fuel cell 104, one or more needles 106 and tubing 108 connecting the drug receptacle 102 to the needles 106.
  • the fuel cell 104 releases a predetermined amount of fuel, such as hydrogen, to pressurize the tubing 108 and force a dosage of medication from the drug receptacle 102 through the needles 106 into the skin.
  • other integrated medication delivery systems 212 may be used to control the dosage of medication, rate of administration of the medication and schedule of administration.
  • the IDDB system 100 may also include a display 230.
  • the IDDB system 100 may be configured to display a graphical user interface (GUI) that includes biosensor data and drug delivery information.
  • GUI graphical user interface
  • one or more of the needles 106 include coatings to react with targeted biomarkers.
  • a first needle 106 may include a coating with an enzyme that reacts in the presence of glucose while a second needle 106 includes a coating that reacts in the presence of another targeted biomarker.
  • the needles 106 are electrically stimulated using an AC and/or DC current. The coatings of the needles 106 may then change impedance or provide another different electrical or chemical signature based on the presence and concentration of the targeted biomarker.
  • a dosage of lcc of medication may be injected into the skin using a bed of 50 ⁇ bore micro-needles 106.
  • the IDDB system 100 is configured to control the dosage and dosing rate of the medication by controlling the release of the fuel H 2 gas 402
  • the fuel cell 194 releases the fuel 402 under the control of the processing circuit 202 in order to exert a pressure configured to administer a predetermined dosage at a predetermined dosage rate.
  • the tubing 108 and/or the rubber stopper 404 may be manufactured from durable Silicone, EPDM, Neoprene and/or natural Pure Gum rubber.
  • the medication 406 may be stored in the drug receptacle 102 and/or tubing 108.
  • the receptacle 102 includes an interface 408 with the needles 106, e.g. with a one way valve, for flow of medication into the bores of the needles 106.
  • the rubber stamper 404 is situated between Port A 130a and Port B 130b (shown in FIG. 1) within the tubing.
  • the fuel cell 104 releases H 2 gas 402 through Port A 130a into the tubing 108.
  • the H 2 gas 402 pushes the stamper 404 in the tubing 108 and pressurizes the medication 406 in the tubing 108 and drug receptacle 102. This pressure forces the medication 406 through the bores 300 of the needles 106.
  • valve or pump mechanisms may alternatively be implemented for dispensing medication through the needles 106 in the IDDB system 100.
  • an air pump or electrically controlled syringe mechanism or atomizing spray pump may be implemented alternatively or in addition to the mechanisms described herein.
  • Additional medication 406 may be added to the drug receptacle 102, e.g. through Port B 130b or through an additional opening into the drug receptacle 102.
  • an IV catheter may be coupled to the drug delivery system 210, e.g. through Port B 130b, to administer medication 406 through the one or more needles 106.
  • the fuel cell 104 may be implemented to release 3 ⁇ 4 fuel 402 and force the medication 406 from the catheter of the IV system into the one or more needles 106.
  • FIG. 5 illustrates a logical flow diagram of an embodiment of a method 500 for a needle sensing system.
  • the individual needles 106 include a coating with a reactant that reacts in the presence of a targeted biomarker, such as glucose, NACL or other substance.
  • the needles 106 may be formed or manufactured from one or more materials doped with a reactant that reacts with one or more targeted biomarkers.
  • at least one needle may include a coating with an enzyme that reacts in the presence of glucose.
  • one or more other needles 106 may include different coatings that react with different targeted biomarkers.
  • the IDDB system 100 is configured to electrically stimulate the needles 106 using an AC and/or DC current at 502 and measure any feedback at 504.
  • the reactant in the coatings of the needles 106 may change impedance or provide another different electrical or chemical response based on the presence and concentration of the targeted biomarker.
  • the IDDB system 100 analyzes the feedback and determines the presence and concentration of the targeted biomarker from the reaction at 506.
  • the IDDB system 100 includes an ECG system wherein a plurality of the individual needles 106 include electrodes to detect Electrocardiography (ECG) measurements.
  • ECG Electrocardiography
  • the electrodes in the needles 106 detect the electrical charges at multiple locations through the patient's skin that arise from the heart's pattern of depolarizing during each heartbeat.
  • An array or bed of needles 106 may be placed at different location on a single patch to better determine the magnitude and direction of the heart's electrical depolarization through the cardiac cycle.
  • multiple patches may be used in different locations to determine the ECG.
  • the differences in voltage measured by the electrodes in the needles 106 at the various locations are correlated to generate the electrocardiogram.
  • the ECG can be used to measure the heart rate and rhythm of heartbeats of the patient.
  • FIG. 6 illustrates an exemplary embodiment of the IDDB system 100 having a processing circuit 202 with interchangeable connector leads 600.
  • the IDDB system 100 includes a wireless patch 602 having a wireless transceiver 118 coupled to a printed circuit board (PCB) 622.
  • the PCB 622 includes at least one processing circuit 202 coupled to a plurality of connector leads 600.
  • the connector leads 600 have a common interface for interchangeability of modules.
  • the connector leads 600 may interface with one or more types of devices desired for use with the wireless patch 620. Though only two interfaces 600 are illustrated in FIG. 6, additional connector leads 600 may be implemented.
  • one of the plurality of connector leads 600 is coupled to the drug delivery system 210. In another aspect, one of the plurality of connector leads 600 is coupled to the ECG system 606.
  • the ECG system 606 includes an ECG processing circuit 616, an interface (such as a 3.5mm jack) 612, and the plurality of needle electrodes 614.
  • the ECG processing circuit 616 e.g., determines the differences in voltage measured by the needle electrodes 614 at the various locations of the patient and may also correlate the measurements to generate the electrocardiogram.
  • the electrocardiogram is then wirelessly transmitted to a monitoring device by the wireless transmitter 118. In another embodiment, the monitoring device may determine the electrocardiogram based on information from the ECG processing circuit 616.
  • one of the plurality of connector leads 600 is coupled to the needle sensing system 608.
  • the needle sensing system 608 includes a processing circuit and interfaces with one or more of the needles 106 that include coatings to react with one or more targeted biomarkers.
  • the processing circuit for the needle sensing system 608 controls the stimulation of the needles 106 using an AC and/or DC current and determines a presence or concentration of the targeted biomarker based on the feedback.
  • one of the plurality of connector leads 600 is coupled to a user interface 610.
  • the user interface 610 may wirelessly communicate with a user device.
  • the user interface may transmit data and information from the IDDB system 100, such as the historical and real-time biosensor data of the patient, dosage history, etc.
  • the wireless patch 620 may thus be coupled to a combination of one or more of: the biosensor 200, the drug delivery system 210, the ECG system 606, the needle sensing system 608, the user interface 610, or other device/module.
  • FIG. 7A illustrates a perspective view of an exemplary embodiment of a form factor of the IDDB system 100.
  • the IDDB system 100 is implemented on a wearable patch 700.
  • the wearable patch 700 may include an adhesive backing 702 to attach to the skin of a patient, such as on a hand, arm, wrist, forehead, chest, abdominal area, or other area of the skin or body or living tissue.
  • the wearable patch 700 may be attached to the skin using adhesive tape.
  • the wearable patch 700 should be secured such that an aperture 706 for the biosensor and the needles 106 are positioned against the skin.
  • FIG. 7B illustrates a perspective view of an exemplary embodiment of another form factor of the IDDB system 100.
  • the IDDB system 100 is implemented on an arm band 710.
  • the arm band 710 may be configured with an adjustable band for placement on an arm, the wrist, on one or more fingers, around a leg, etc.
  • the arm band 700 should be secured such that an aperture 706 for the biosensor and the needles 106 are positioned against the skin.
  • FIG. 8A illustrates a perspective view of an exemplary embodiment of another form factor of the IDDB system 100.
  • the IDDB system 100 is configured in an earpiece 800.
  • the earpiece 800 includes an earbud 802.
  • the biosensor 200 is configured to transmit light into the ear canal from one or more optical fibers in the ear bud 1802 and detect light from the ear canal using the one or more optical fibers.
  • FIG. 8B illustrates a perspective view of an exemplary embodiment of another form factor of the IDDB system 100.
  • the IDDB system 100 is configured to attach to a finger or fingertip using finger attachment 806.
  • the finger attachment 806 includes the PPG circuit 110 and the drug delivery system 210.
  • the finger attachment 806 is configured to securely hold a finger that is inserted into the finger attachment 806.
  • the finger attachment 806 may be implemented within the same encasement as the other components of the IDDB system 100 or be communicatively coupled either through a wired or wireless interface to the other components of the IDDB system 100.
  • a display 804 is implemented for the IDDB system 100 with a graphical user interface (GUI) that displays biosensor data and dosage information.
  • GUI graphical user interface
  • the IDDB system 100 may be configured to be attached to an ear lobe or to a fingertip. Various other form factors may be implemented as well. In addition, one or more IDDB system 100s in one or more form factors may be used in combination to determine biosensor data and/or administer medications at one or more areas of the body.
  • FIG. 9 illustrates a logical flow diagram of an embodiment of a method 900 of the IDDB system 100.
  • the optimal dosage of a medication is the dosage that gives the desired effect with minimum side effects.
  • the IDDB system 100 may provide feedback of biosensor data, such as absorption rate of the medication and patient vital information, related to the efficacy of the medication to determine more optimal dosages.
  • the IDDB system 100 administers a predetermined dosage of medication to the patient's skin at a predetermined rate at 902.
  • the IDDB system 100 non-invasively and continuously monitors the absorption rate of the medication by the skin and surrounding tissue at 904.
  • one or more optical fibers situated in one or more of the needles 106 detect reflected light from the skin and surrounding tissue.
  • the PPG circuit 110 detects a spectral response of the reflected light. The spectral response is analyzed to determine a concentration level of the medication on and/or in the epidermis layer of the skin and surrounding tissue. Over time, the cells of the skin absorb the medication, e.g.
  • the medication is absorbed into cells of the surrounding tissues at lower levels of the dermis and hypodermis, which include blood vessels.
  • the medication is absorbed into cells of the skin and the surrounding tissue and into the blood vessels.
  • the spectral response of the reflected light is continuously analyzed, e.g. multiple times per second, to monitor the concentration of the medication as it decreases due to the absorption. The absorption rate over time of the medication may thus be determined.
  • the IDDB system 100 may also non-invasively and continuously monitor concentration of relevant substances in surrounding tissues and arterial blood flow at 906.
  • the PPG circuit 110 using PPG or spectroscopy techniques described herein, detects a spectral response of reflected light at one or more wavelengths. Based on the spectral response, concentration of a substance in the surrounding tissues or arterial blood flow may be determined. The concentration of the medication in the arterial blood flow may be determined or the concentration of a related, relevant substance in the arterial blood flow may be determined.
  • administration of an antibiotic may affect a number of white blood cells in the arterial blood flow. So the concentration of the antibiotic and/or white blood cells may be monitored in the arterial blood flow by the PPG circuit 110.
  • administration of insulin affects glucose levels in the arterial blood flow. So the absorption rate of insulin into the skin and surrounding tissues is monitored as well as insulin levels or blood glucose levels in the arterial blood flow by the PPG circuit 110.
  • the IDDB system 100 may also monitor patient vitals, such as respiratory rate, temperature, heart rate, blood pressure, blood oxygen SP0 2 levels, ECG, etc.
  • patient vitals such as respiratory rate, temperature, heart rate, blood pressure, blood oxygen SP0 2 levels, ECG, etc.
  • the IDDB system 100 may also monitor other biosensor data, such as activity level, of the patient at 908.
  • the IDDB system 100 may determine to alter administration of the medication at 910. For example, the IDDB system 100 may determine to alter one or more of a dosage of the medication, administration rate of the medication, frequency of dosages of the medication, etc. The IDDB system 100 may determine to halt the administration of a dosage or further dosages based on the biosensor data, e.g. when an allergic reaction is detected. The IDDB system 100 then transmits instructions to the drug delivery system 210 to halt further administration of the medication or otherwise alter administration of the medication.
  • the biosensor data is provided to a caretaker, such as a physician or pharmacy through a user interface. The caretaker may then instruct the IDDB system 100 to alter administration of medication based on the biosensor data through the user interface.
  • the IDDB system 100 may also monitor patient vitals, such as respiratory rate, temperature, heart rate, blood pressure, blood oxygen SP02 levels, ECG, etc.
  • patient vitals such as respiratory rate, temperature, heart rate, blood pressure, blood oxygen SP02 levels, ECG, etc.
  • the IDDB system 100 may also monitor other biosensor data, such as activity level, of the patient at 1004.
  • the IDDB system 100 may monitor heart rate, respiratory rate, blood pressure, etc. to determine an allergic reaction in a patient.
  • the IDDB system 100 may determine insulin levels after caloric intake in arterial blood flow have fallen to a predetermined threshold. The IDDB system 100 may then determine to administer insulin to the patient through the drug delivery system 210. Based on the insulin level, the IDDB system 100 may determine a dosage amount, rate of dosage and frequency of dosages.
  • the IDDB system 100 may detect patient vitals indicating a dangerous allergic reaction and determine to administer a dosage of epinephrine. For example, the IDDB system 100 may detect one or more of blood pressure, respiratory rate or heart rate that exceed a predetermined threshold indicating an allergic reaction. The IDDB system 100 would then administer epinephrine or other allergy medication in response to the feedback. The IDDB system 100 may thus replace epi-pens in patients with life threatening allergic reactions. Epi-pens may not be available or may be difficult for a person having an allergic reaction to administer. The IDDB system 100 would automate this administration of life saving medication.
  • the driver circuit 1118 is configured to control the one or more LEDs 1122a-n to generate light at one or more frequencies for predetermined periods of time.
  • the driver circuit 1118 may control the LEDs 122a-n to operate concurrently or progressively.
  • the driver circuit 1118 is configured to control a power level, emission period and frequency of emission of the LEDs 1122a-n.
  • the biosensor 200 is thus configured to emit one or more frequencies of light in one or more spectrums that is directed at the surface or epidermal layer of the skin tissue of a patient.
  • the PPG circuit 110 further includes one or more photodetector circuits 1130a-n.
  • a first photodetector circuit 1130a may be configured to detect visible light and the second photodetector circuit 1130b may be configured to detect IR light.
  • the first photodetector circuit 1130a and the second photodetector circuit 1130b may also include a first filter 1160 and a second filter 1162 configured to filter ambient light and/or scattered light. For example, in some embodiments, only light received at an approximately perpendicular angle to the skin surface of the patient is desired to pass through the filters.
  • the first photodetector circuit 1130 and the second photodetector circuit 1132 are coupled to a first A/D circuit 1138 and a second A/D circuit 1140.
  • the A/D circuits 1138 and 1140 may also include an amplifier and other components needed to generate the spectral response.
  • the plurality of photodetectors 1130 is coupled in parallel to a single amplifier and A/D circuit 1138. The light detected by each of the photodetectors 1130 is thus added and amplified to generate a single spectral response.
  • a single photodetector circuit 1130 may be implemented operable to detect light over multiple spectrums or frequency ranges.
  • the photodetector circuit 1130 may include a Digital UV Index / IR / Visible Light Sensor such as Part No. Sil l45 from Silicon LabsTM.
  • FIG. 12 illustrates a schematic block diagram of another exemplary embodiment of the biosensor 200 illustrating the PPG circuit 110 in more detail.
  • the biosensor 200 is configured for emitting and detecting light through fibers situated in one or more needles 106.
  • the PPG circuit 110 is optically coupled to a plurality of optical fibers 1152a-c.
  • the plurality of optical fibers 1152 includes a first optical fiber 1152a optically coupled to the light source 1120, a second optical fiber 1152b optically coupled to a first photodetector circuit 1130 and a third optical fiber 1152c optically coupled to the second photodetector circuit 1132.
  • Other configurations and numbers of the plurality of optical fibers 1152 may also be implemented.
  • the plurality of optical fibers 1152 is situated within the needles 106 to transmit and detect light through the bores 300 of the needles 106.
  • a light collimator 1116 such as a prism, may be used to align a direction of the light emitted from the light source 1120, e.g. such as light emitted in the visible frequency range.
  • One or more filters 1160 may optionally be implemented to receive the reflected light 1142 from the plurality of optical fibers 1152b, 1152c. However, the filters 1160 may not be needed as the plurality of optical fibers 1152b, 1152c may be sufficient to filter ambient light and/or scattered light.
  • One or more of the embodiments of the biosensor 200 described herein are configured to detect a concentration level or indicator of one or more substances within blood flow, such as analyte levels, nitric oxide levels, insulin resistance or insulin response after caloric intake and predict diabetic risk or diabetic precursors.
  • the biosensor 200 may detect insulin response, vascular health, cardiovascular sensor, cytochrome P450 proteins (e.g. one or more liver enzymes or reactions), digestion phase 1 and 2 or caloric intake.
  • the biosensor 200 may even be configured to detect proteins or other elements or compounds associated with cancer.
  • the biosensor 200 may also detect various electrolytes and many common blood analytic levels, such as bilirubin amount and sodium and potassium.
  • the biosensor 200 performs PPG techniques using the PPG circuit 110 to detect the concentration levels of substances in blood flow.
  • the biosensor 200 analyzes reflected visible or IR light to obtain a spectrum response such as, the resonance absorption peaks of the reflected visible, UV or IR light.
  • the spectrum response includes spectral lines that illustrate an intensity or power or energy at a wavelength or range of wavelengths in a spectral region of the detected light.
  • Iini is the intensity of the initial light at ⁇ Ii n2 is the intensity of the initial light at ⁇ 2 oi g i is the absorption coefficient of the substance in arterial blood at ⁇ a g2 is the absorption coefficient of the substance in arterial blood at ⁇ 2 a w i is the absorption coefficient of arterial blood at ⁇ a w2 is the absorption coefficient of arterial blood at ⁇ 2 C gW is the concentration of the substance and arterial blood C w is the concentration of arterial blood [0091] Then letting R equal:
  • the concentration of the substance Cg may then be equal to:
  • the biosensor 200 may thus determine the concentration of various substances in arterial blood using spectroscopy at two different wavelengths using Beer-Lambert principles.
  • the biosensor 200 may transmit light at the first predetermined wavelength and in a range of approximately lnm to 50nm around the first predetermined wavelength.
  • the biosensor 200 may transmit light at the second predetermined wavelength and in a range of approximately lnm to 50nm around the second predetermined wavelength.
  • the range of wavelengths is determined based on the spectral response since a spectral response may extend over a range of frequencies, not a single frequency (i.e., it has a nonzero linewidth).
  • the light that is reflected or transmitted light by the target substance may by spread over a range of wavelengths rather than just the single predetermined wavelength.
  • the center of the spectral response may be shifted from its nominal central wavelength or the predetermined wavelength.
  • the range of lnm to 50nm is based on the bandwidth of the spectral response line and should include wavelengths with increased light intensity detected for the targeted substance around the predetermined wavelength.
  • the first spectral response of the light over the first range of wavelengths including the first predetermined wavelength and the second spectral response of the light over the second range of wavelengths including the second predetermined wavelengths is then generated.
  • the biosensor 200 analyzes the first and second spectral responses to detect an indicator or concentration level of one or more substances in the arterial blood flow at 406.
  • the biosensor 200 is configured to filter the reflected/transmitted light II of the pulsating arterial blood from the transmitted/reflected light 1 ⁇ 2. This filtering isolates the light due to reflection/transmission of substances in the pulsating arterial blood from the light due to reflection/transmission from venous (or capillary) blood, other tissues, etc. The biosensor 200 may then measure the concentration levels of one or more substances from the reflected/transmitted light II in the pulsating arterial blood. Though the above has been described with respect to arterial blood flow, the same principles described herein may be applied to venous blood flow.
  • FIG. 13 illustrates a logical flow diagram of an embodiment of a method 1300 of the biosensor 200.
  • the biosensor 200 emits and detects light at a plurality of predetermined frequencies or wavelengths, such as approximately 940nm, 660nm, 390 nm, 592nm, and 468nm.
  • the light is pulsed for a predetermined period of time (such as lOOusec or 200Hz) sequentially at each predetermined wavelength.
  • light may be pulsed in a wavelength range of lnm to 50nm around each of the predetermined wavelengths. Then, the spectral responses are obtained for the plurality of wavelengths at 1302.
  • the spectral response may be measured over a predetermined period (such as 300usec.). This measurement process is repeated sequentially pulsing the light and obtaining spectral measurements over a desired measurement period, e.g. from 1-2 seconds to 1-2 minutes or 2-3 hours or continuously over days or weeks. Because the human pulse is typically on the order of magnitude of one 1 HZ, typically the time differences between the systolic and diastolic points are on the order of magnitude of milliseconds or tens of milliseconds or hundreds of milliseconds. Thus, spectral response measurements may be obtained at a frequency of around 10-100 Hz over the desired measurement period.
  • a low pass filter (such as a 5Hz low pass filter) is applied to the spectral response signal at 1304.
  • the relative contributions of the AC and DC components are obtained IA C+DC and IA C -
  • a peak detection algorithm is applied to determine the systolic and diastolic points at 1306. Beer Lambert equations are applied as described below at 1308. For example, the values are then calculated for one or more of the wavelengths ⁇ at 1310, wherein the LA, values for a wavelength equals:
  • L x Log 10 (- ⁇ ) wherein IA C+DC is the intensity of the detected light with AC and DC components and I D c is the intensity of the detected light with the AC filtered by the low pass filter.
  • the value LA isolates the spectral response due to pulsating arterial blood flow, e.g. the AC component of the spectral response.
  • a broadband tungsten light source for spectroscopy may be used.
  • the spectral response of the reflected light is then measured across the wavelengths in the broad spectrum, e.g. from 350nm to 2500nm, concurrently.
  • a charge coupled device (CCD) spectrometer 1030 may be configured to measure the spectral response of the reflected light.
  • the spectral response of the reflected light is analyzed at the plurality of wavelengths, e.g. at lnm to 1.5nm to 2nm, incremental wavelengths across the wavelengths from 350nm to 2500nm.
  • the spectral response of the reflected light is analyzed for a set of predetermined wavelengths.
  • the plurality of LEDs 1122a-n emit light at a plurality of wavelengths.
  • the spectral response of the reflected light is analyzed for a set of predetermined wavelengths.
  • FIG. 14 illustrates a logical flow diagram of an exemplary method 1400 to determine blood concentration levels of a plurality of substances using the spectral response for a plurality of wavelengths.
  • the biosensor 100 transmits light directed at living tissue.
  • the light may be across a broad spectrum or at a plurality of discrete frequencies or at a single frequency at 1402.
  • the light may be emitted using a broad spectrum light source or multiple LEDs transmitting at discrete wavelengths or a tunable laser transmitting at one or more frequencies.
  • the spectral response of light (e.g. either transmitted through the living tissue or reflected by the living tissue) is detected at 1404.
  • a ratio R value may also be determined using L values derived from a first spectral response obtained for a first wavelength (and in one aspect including a range of +/- 20 to 50 nm) and a spectral response obtained for a second wavelength (and in one aspect including a ranges of +/- 20 to 50 nm).
  • the concentration levels of a plurality of substances may then be determined at 1408.
  • the intensity of light may be due to absorption by a plurality of substances in the arterial blood flow.
  • the intensity of light at a plurality of wavelengths may be due to absorption by a single substance in the arterial blood flow.
  • a single substance may absorb or reflect a plurality of different wavelengths of light.
  • the concentration level C of the substance may be determined from the spectral response for each of the wavelengths (and in one aspect including a range of lnm to 50 nm around each of the wavelengths). Using the spectral response at multiple frequencies provides a more robust determination of the concentration level of the substance.
  • An example for calculating the concentration of one or more substances over multiple wavelengths may be performed using a linear function, such as is illustrated herein below. wherein,
  • Ii_n intensity of light at wavelengths ⁇ _ ⁇
  • a peak detection algorithm or other means is used to determine the diastolic point and the systolic point of the spectral response at 1508.
  • the systolic and diastolic measurements are compared in order to compute the L values using Beer-Lambert equations at 1510.
  • a logarithmic function may be applied to the ratio of IAC+DC and IDC to obtain an L value for the first wavelength I 1 and for the second wavelength I 2.
  • the ratio R of the first wavelength L l and for the second wavelength L 2 may then be calculated at 1512.
  • the linear function described herein are applied at 1516, and the one or more concentration levels of the substances or analytes are determined at 1518.
  • the operation of the IDDB system 100 may need to be adjusted in response to its positioning due to such varying characteristics of underlying tissue. For example, absorption coefficients may be different for various substances depending on the underlying tissue. As such, different wavelengths or wavelength ranges may be more effective in detecting various substances depending on the underlying tissue.
  • the IDDB system 100 is configured to obtain position information at 1602.
  • the position information may be input from a user interface.
  • the IDDB system 100 may determine its positioning, e.g. using the activity monitoring circuit 114 and/or PPG circuit 110.
  • the PPG circuit 110 may be configured to detect characteristics of underlying tissue.
  • the IDDB system 100 then correlates the detected characteristics of the underlying tissue with known or predetermined characteristics of underlying tissue (e.g. measured from an abdominal area, wrist, forearm, leg, etc.) to determine its positioning. Information of amount and types of movement from the activity monitor may be used as well.
  • the drug delivery system 210 may also adjust operation in response to positioning of the IDDB system 100 at 1608. For example, the drug delivery system 210 may automatically adjust administration rate of a medicine depending on positioning due to known or predetermined absorption rates of different tissues.
  • FIG. 17 illustrates a schematic block diagram of an embodiment of an exemplary EMR network 1700 in which the IDDB system 100 described herein may operate.
  • the exemplary EMR network 1700 includes one or more networks that are communicatively coupled, e.g., such as a wide area network (WAN) 1702, a wired local area network (LAN) 1704, a wireless local area network (WLAN) 1706, and/or a wireless wide area network (WAN) 1708.
  • the LAN 1704 and the WLANs 1708 may operate inside a home 1718 or in an enterprise environment, such as a physician's office 1716, pharmacy 1710 or hospital 1712 or other facility.
  • the wireless WAN 1708 may include, for example, a 3G or 4G cellular network, a GSM network, a WIMAX network, an EDGE network, a GERAN network, etc. or a satellite network or a combination thereof.
  • the WAN 1702 includes the Internet, service provider network, other type of WAN, or a combination of one or more thereof.
  • the IDDB system 100 may communicate to user devices 1720 that may include a smart phone, laptop, desktop, smart tablet, smart watch, or any other electronic device that includes a display for illustrating the patient's vitals.
  • the user device 1720 may communicate the patient's vitals from the IDDB systems 100 to a monitoring station 1722 or the EMR application server 1730.
  • the IDDB system 100 may communicate directly with the EMR application server 1730 over the EMR network 1700.
  • an IDDB system 100 may be programmed with a patient identification 208 that is associated with a patient's EMR 206. The IDDB system 100 is then attached to the patient.
  • the IDDB system 100 may then immediately begin to measure a patient's vitals, such as heart rate, pulse, blood oxygen levels, blood glucose or insulin levels, etc. and administer medications.
  • the IDDB system 100 may be used to track progress throughout the patient care chain and provide medical alerts to notify when vitals are critical or reach a certain predetermined threshold.
  • the IDDB system 100 transmits biosensor data and medication dosages, absorption rates, etc. to the EMR network for inclusion in the patient's EMR 206 as well as to a monitoring station 1722, another hospital or physician's office, etc.
  • the IDDB system 100 may be disposable and unique to each patient.
  • One or more IDDB system 100s are communicatively coupled to an EMR application server 1730 through one or more of the exemplary networks in the EMR network 1700.
  • the EMR application server 1730 includes a network interface circuit 1732 and a server processing circuit 1734.
  • the network interface circuit (NIC) 1732 includes an interface for wireless and/or wired network communications with one or more of the exemplary networks in the EMR network 1700.
  • the network interface circuit 1732 may also include authentication capability that provides authentication prior to allowing access to some or all of the resources of the EMR application server 1730.
  • the network interface circuit 1732 may also include firewall, gateway and proxy server functions.
  • the EMR application server 1730 also includes a server processing circuit 1734 and a memory device 1736.
  • the memory device 1736 is a non-transitory, processor readable medium that stores instructions which when executed by the server processing circuit 1734, causes the server processing circuit 1734 to perform one or more functions described herein.
  • the memory device 1736 stores a patient EMR 206 that includes biosensor data transmitted to the EMR application server 1730 from the plurality of IDDB systems 100 and/or user devices 1720.
  • the EMR application server 1730 includes an EMR server application 1738.
  • the EMR server application 1738 is operable to communicate with the IDDB systems 100, user devices 1720 or monitoring stations 1722.
  • the EMR server application 1738 may be a web- based application supported by the EMR application server 1730.
  • the EMR application server 1730 may be a web server and support the EMR server application 1738 via a website.
  • the EMR server application 1738 is a stand-alone application that is downloaded to the user devices 1720 by the EMR application server 1730 and is operable on the user devices 1720 without access to the EMR application server 1730 or only needs to accesses the EMR application server 1730 for additional information, such as biosensor data.
  • the EMR application server 1730 may also be operable to communicate with a pharmacy 1710 or other third party health care provider over the EMR network 1700 to provide biosensor data and receive instructions on dosages of medication.
  • the EMR server application 1738 may transmit heart rate information or pulse rate information or medication absorption rates or blood concentration levels of one or more relevant substances to a physician's office 1716.
  • the EMR server application 1738 may also transmit alerts to a doctor's office, pharmacy or hospital or other caregiver or business over the communication network 1220.
  • the EMR server application 1738 may also receive instructions from a doctor's office, pharmacy or hospital or other caregiver regarding a prescription or administration of a dosage of medication.
  • the EMR server application 1738 may then transmit the instructions to the IDDB system 100.
  • the instructions may include a dosage amount, rate of administration or frequency of dosages of a medication.
  • the IDDB system 100 may then administer the medication automatically as per the transmitted instructions.
  • FIG. 18 illustrates a schematic block diagram of an embodiment of a network illustrating interoperability of a plurality of IDDB systems 100.
  • An IDDB system 100 interfacing with a patient may communicate with one or more other IDDB systems 100 interfacing with the patient directly or indirectly through a WLAN or other type of network as illustrated in the EMR Network 1700 of FIG. 17.
  • IDDB system 100a may include a needle sensing system 608 or PPG circuit 110 configured to detect a glucose and/or insulin indicators/concentration levels.
  • IDDB system 100a is positioned on a wrist.
  • IDDB system 100b may include a drug delivery system 210 configured to administer insulin to the patient and is positioned on an abdominal area of the patient.
  • IDDB system 100a continuously monitors glucose and/or insulin concentration levels/indicators and then communicates either directly or indirectly the detected concentration levels/indicators to IDDB system 100b. IDDB system 100b then administers a dosage of insulin at an administration rate and/or frequency rate in response to the detected concentration levels/indicators.
  • the first IDDB system 100a may include a PPG circuit 110 configured to detect alcohol levels in arterial blood flow.
  • the user device may include a locking system installed in an ignition system of a vehicle.
  • the first IDDB system 100a detects the blood alcohol concentration (BAC) of the patient.
  • the first IDDB system 100a determines whether the blood alcohol concentration (BAC) is above or below a preset legal limit. If it is below this limit, the IDDB system 100 communicates an instruction to the user device 1720 to unlock the ignition to allow starting of the vehicle. If it is above the limit, the IDDB system 100 instructs the user device 1720 to lock the ignition to prevent starting of the vehicle.
  • the IDDB system 100 may be more accurate and convenient than current breathe analyzers.
  • the term "operable to” or “configurable to” indicates that an element includes one or more of circuits, instructions, modules, data, input(s), output(s), etc., to perform one or more of the described or necessary corresponding functions and may further include inferred coupling to one or more other items to perform the described or necessary corresponding functions.
  • the term(s) "coupled”, “coupled to”, “connected to” and/or “connecting” or “interconnecting” includes direct connection or link between nodes/devices and/or indirect connection between nodes/devices via an intervening item (e.g., an item includes, but is not limited to, a component, an element, a circuit, a module, a node, device, network element, etc.).
  • inferred connections i.e., where one element is connected to another element by inference

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  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un système de biocapteur et d'administration de médicament intégré (IDDB) qui est mis en œuvre sur un brassard ou sur un timbre. Le système d'administration de médicament comprend des aiguilles conçues pour percer la peau et pour diriger l'injection d'une dose prédéterminée de médicament à travers les aiguilles dans l'épiderme de la peau d'un patient. Le biocapteur intégré surveille l'absorption du médicament dans l'épiderme de la peau du patient et peut également surveiller la concentration du médicament ou d'autres substances pertinentes dans la circulation sanguine artérielle du patient. Le biocapteur intégré peut également surveiller des signes vitaux du patient en réponse au médicament. Le biocapteur intégré peut ensuite modifier une dose ou une fréquence d'administration de doses ou même arrêter une dose de médicament en réponse aux signes vitaux du patient ou à l'absorption du médicament.
PCT/US2016/053845 2015-09-25 2016-09-26 Système et procédé pour timbre de biocapteur et d'administration de médicament WO2017054006A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP16849902.8A EP3337397A4 (fr) 2015-09-25 2016-09-26 Système et procédé pour timbre de biocapteur et d'administration de médicament

Applications Claiming Priority (18)

Application Number Priority Date Filing Date Title
US14/866,500 US10321860B2 (en) 2015-07-19 2015-09-25 System and method for glucose monitoring
US14/866,500 2015-09-25
US201662276934P 2016-01-10 2016-01-10
US62/276,934 2016-01-10
US201662307375P 2016-03-11 2016-03-11
US62/307,375 2016-03-11
US201662312614P 2016-03-24 2016-03-24
US62/312,614 2016-03-24
US201662373283P 2016-08-10 2016-08-10
US62/373,283 2016-08-10
US201662383313P 2016-09-02 2016-09-02
US62/383,313 2016-09-02
US15/275,388 US9642578B2 (en) 2015-07-19 2016-09-24 System and method for health monitoring using a non-invasive, multi-band biosensor
US15/275,388 2016-09-24
US15/275,444 US9642538B2 (en) 2015-07-19 2016-09-25 System and method for a biosensor monitoring and tracking band
US15/275,444 2016-09-25
US15/276,760 US9636457B2 (en) 2015-07-19 2016-09-26 System and method for a drug delivery and biosensor patch
US15/276,760 2016-09-26

Publications (1)

Publication Number Publication Date
WO2017054006A1 true WO2017054006A1 (fr) 2017-03-30

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EP (1) EP3337397A4 (fr)
WO (1) WO2017054006A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019118053A1 (fr) * 2017-12-15 2019-06-20 Stc. Unm Auto-injecteur pouvant être porté
CN112827061A (zh) * 2021-02-26 2021-05-25 中山大学 药物释放控制装置及其控制方法和计算机可读存储介质
US20210275077A1 (en) * 2020-03-05 2021-09-09 Wolfgang Richter Device for measuring or stimulating vital signs of a user
CN117976125A (zh) * 2024-04-02 2024-05-03 山东拓庄医疗科技有限公司 一种基于数据分析的医疗设备管理系统及方法

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269310A (en) * 1990-09-06 1993-12-14 Spacelabs Medical, Inc. Method of measuring blood pressure with a plethysmograph
US5515847A (en) 1993-01-28 1996-05-14 Optiscan, Inc. Self-emission noninvasive infrared spectrophotometer
US20080241199A1 (en) * 2007-03-30 2008-10-02 Silverman David G "Micro-Patch" for Assessment of the Local Microvasculature and Microcirculatory Vasoreactivity
US20090062730A1 (en) 2007-09-01 2009-03-05 San Hoon Woo Control of body fluid condition using diuretics, based on biological parameters
US20090156988A1 (en) * 2007-12-18 2009-06-18 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Circulatory monitoring systems and methods
US20090187167A1 (en) * 2007-12-17 2009-07-23 New World Pharmaceuticals, Llc Integrated intra-dermal delivery, diagnostic and communication system
US20110106050A1 (en) 2008-04-29 2011-05-05 Ofer Yodfat Method for Selecting Bolus Doses and Bolus Delivery Patterns in a Drug Delivery Device
US20110166553A1 (en) * 2003-09-11 2011-07-07 Holmes Elizabeth A Medical device for analyte monitoring and drug delivery

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5269310A (en) * 1990-09-06 1993-12-14 Spacelabs Medical, Inc. Method of measuring blood pressure with a plethysmograph
US5515847A (en) 1993-01-28 1996-05-14 Optiscan, Inc. Self-emission noninvasive infrared spectrophotometer
US20110166553A1 (en) * 2003-09-11 2011-07-07 Holmes Elizabeth A Medical device for analyte monitoring and drug delivery
US20080241199A1 (en) * 2007-03-30 2008-10-02 Silverman David G "Micro-Patch" for Assessment of the Local Microvasculature and Microcirculatory Vasoreactivity
US20090062730A1 (en) 2007-09-01 2009-03-05 San Hoon Woo Control of body fluid condition using diuretics, based on biological parameters
US20090187167A1 (en) * 2007-12-17 2009-07-23 New World Pharmaceuticals, Llc Integrated intra-dermal delivery, diagnostic and communication system
US20090156988A1 (en) * 2007-12-18 2009-06-18 Searete Llc, A Limited Liability Corporation Of The State Of Delaware Circulatory monitoring systems and methods
US20110106050A1 (en) 2008-04-29 2011-05-05 Ofer Yodfat Method for Selecting Bolus Doses and Bolus Delivery Patterns in a Drug Delivery Device

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3337397A4

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019118053A1 (fr) * 2017-12-15 2019-06-20 Stc. Unm Auto-injecteur pouvant être porté
US20210275077A1 (en) * 2020-03-05 2021-09-09 Wolfgang Richter Device for measuring or stimulating vital signs of a user
CN112827061A (zh) * 2021-02-26 2021-05-25 中山大学 药物释放控制装置及其控制方法和计算机可读存储介质
CN117976125A (zh) * 2024-04-02 2024-05-03 山东拓庄医疗科技有限公司 一种基于数据分析的医疗设备管理系统及方法
CN117976125B (zh) * 2024-04-02 2024-06-04 山东拓庄医疗科技有限公司 一种基于数据分析的医疗设备管理系统及方法

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Publication number Publication date
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EP3337397A4 (fr) 2019-09-04

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