WO2023141700A1 - Wearable vital signs monitoring device - Google Patents

Wearable vital signs monitoring device Download PDF

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Publication number
WO2023141700A1
WO2023141700A1 PCT/CA2023/050050 CA2023050050W WO2023141700A1 WO 2023141700 A1 WO2023141700 A1 WO 2023141700A1 CA 2023050050 W CA2023050050 W CA 2023050050W WO 2023141700 A1 WO2023141700 A1 WO 2023141700A1
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WO
WIPO (PCT)
Prior art keywords
sensor unit
mounting
sensor
patient
cartridge
Prior art date
Application number
PCT/CA2023/050050
Other languages
French (fr)
Inventor
Patrick Douglas Henry Williams
Faisal ARAFSHA
Robin CASTELINO
Donald Carmon Bradley
Original Assignee
Braebon Medical 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
Application filed by Braebon Medical Corporation filed Critical Braebon Medical Corporation
Publication of WO2023141700A1 publication Critical patent/WO2023141700A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02416Detecting, measuring or recording pulse rate or heart rate using photoplethysmograph signals, e.g. generated by infrared radiation
    • A61B5/02427Details of sensor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/021Measuring pressure in heart or blood vessels
    • A61B5/02108Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics
    • A61B5/02125Measuring pressure in heart or blood vessels from analysis of pulse wave characteristics of pulse wave propagation time
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • A61B5/0245Detecting, measuring or recording pulse rate or heart rate by using sensing means generating electric signals, i.e. ECG signals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/08Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/0816Measuring devices for examining respiratory frequency
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455Measuring 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
    • A61B5/14551Measuring 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
    • A61B5/14552Details of sensors specially adapted therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6814Head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements 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
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6823Trunk, e.g., chest, back, abdomen, hip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches

Definitions

  • the present disclosure relates generally to wearable vital signs monitoring devices.
  • Wearable vital signs monitoring devices are sometimes used to monitor physiological metrics, such as heart rate, pulse rate, blood pressure, breathing rate, and blood oxygen saturation of patients and residents in hospitals, nursing homes, and other facilities where healthcare providers are present to provide in-person care. Such devices are also commonly used to monitor and record physiological metrics of patients while away from such facilities, such as at home, for later analysis and use of the recorded data by healthcare providers for diagnosis and to provide advice and assistance to the patients.
  • physiological metrics such as heart rate, pulse rate, blood pressure, breathing rate, and blood oxygen saturation of patients and residents in hospitals, nursing homes, and other facilities where healthcare providers are present to provide in-person care.
  • Such devices are also commonly used to monitor and record physiological metrics of patients while away from such facilities, such as at home, for later analysis and use of the recorded data by healthcare providers for diagnosis and to provide advice and assistance to the patients.
  • the technique of photoplethysmography is sometimes used to generate pulse rate and blood oxygen saturation metrics.
  • the technique involves illumination of target tissue with selected wavelengths of light, and the collection of resulting transmitted or reflected light which varies in dependence on changes in blood oxygenation or blood volume of target tissue or included blood vessels.
  • transmissive PPG may involve placement of a sensor device on a thin part of a patient’s body, such as a fingertip or earlobe, and the illumination thereof with selected wavelengths of light and collection of the transmitted light, wherein the relative absorbance of the illuminated body part varies depending on the oxygenation and/or volume of blood contained in the tissue microvasculature or included blood vessels.
  • reflectance PPG may involve illumination of target tissue or blood vessels with selected wavelengths of light and collection of reflected, as opposed to transmitted, light, wherein similarly the relative reflectivity of the illuminated body part varies depending on the oxygenation and/or volume of blood contained in the tissue or blood vessels. Since the oxygenation and/or volume of blood typically vary periodically with pulse, either technique can be useful to measure the patient’s pulse rate and blood oxygenation non-invasively.
  • PWV pulse wave velocity
  • ECG electrocardiography
  • PPG PPG sensor
  • the PWV method of blood pressure measure involves a number of shortcomings, however.
  • the determination of blood pressure from PWV depends on a known and stable propagation distance of the pulse wave.
  • the propagation of the pulse wave through multiple paths, as opposed to a single path, and variability of the effective propagation distance of one or more of the multiple paths both reduce the stability and the accuracy of any determined correlation between blood pressure and PWV.
  • properties as wall thickness, radius, and incremental elastic modulus may vary from blood vessel to blood vessel, so too will PWV vary between blood vessels. Any measurement of PWV which involves detection of pulse wave arrival time in relation to multiple blood vessels can therefore at best determine only an average over such multiple blood vessels.
  • movement or disturbance of the PPG sensor placement relative to the underlying multiple blood vessels may cause a change in the relative signal contribution of the different multiple blood vessels, thereby introducing stochastic variability in the average arrival time, and thus PWV and correspondingly determined blood pressure.
  • unpredictable bodily movement may likewise introduce stochastic variability in the average arrival time, and thus PWV and the correspondingly determined blood pressure.
  • FIG. 1 shows a figurative view of a disclosed system mounted to a patient.
  • FIG’s 2 & 3 show overside and underside perspective views of a disclosed first signal collection module
  • FIG’s 4 & 5 show overside and underside perspective views of a disclose first sensor unit of the first signal collection module.
  • FIG’s 6 & 7 show overside and underside perspective views of a disclosed sensor unit mounting cartridge of the first signal collection module.
  • FIG’s 8-10 show overside perspective (FIG. 8) and side elevation views (FIG’s 9 & 10) illustrating inserting and mounting of the first sensor unit and the sensor unit mounting cartridge.
  • FIG. 11 shows a figurative block diagram of a disclosed first sensor unit.
  • FIG. 12 shows a figurative block diagram of a disclosed second sensor unit.
  • FIG. 13 shows a flowchart of a disclosed method of mounting a disclosed first signal collection module to a patient.
  • FIG. 14 shows a flowchart of a disclosed method of mounting and using a disclosed physiological metric measuring system.
  • FIG. 15 shows a flowchart of a disclosed method of using the system of FIG. 14 to measure a blood pressure of a patient.
  • brace (‘ ⁇ ‘ or ’ ⁇ ’) between reference characters designates a genus and species relationship, such that “A ⁇ B” indicates that ‘B’ is a species of a broader genus ‘A’.
  • a numerical reference character suffixed by a letter e.g. “800A”, “900B” designates a separate instance of the element designated by the numerical reference character (e.g. “800A”, “800B” are each separate instances of the element designated by “800”).
  • the physiological metrics may include, without limitation, heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head position.
  • the techniques may enable more precise placement of sensors for measurement and collection of the physiological metrics.
  • the techniques further enable maintenance of the sensor placement position more durably over time, during the collection of the physiological metrics, and may additionally enable improved maintenance of underlying physical parameters which affect the measured and collected physiological metrics.
  • the system 100 may include a first signal collection module 300.
  • the system 100 may also include a second signal collection module 400.
  • Each of the first signal collection module 300 and the second signal collection module 400 may be mountable at any preconfigured site on a patient 200.
  • the first signal collection module 300 may be mountable at a temple 205 of the patient 200.
  • the second signal collection module 400 may be mountable on a chest 210 of the patient 200 at a location over or proximal the heart (not shown) of the patient 200.
  • the first signal collection module 300 and the second signal collection module 400 are each independently mountable at any other preconfigured site on the patent 200.
  • the system 100 may further include an electrode cable 500 operable to connect the first signal collection module 300 and the second signal collection module 400.
  • the first signal collection module 300 may include a first sensor unit 310 and a sensor unit mounting cartridge 330.
  • the first sensor unit 310 and the sensor unit mounting cartridge 330 may independently be formed of any suitable materials and structures providing the desired properties, features, and capabilities disclosed here.
  • the first sensor unit 310 may have a housing 311 including a battery compartment (not shown) enclosed by a battery compartment cover 312 for containing a battery (not shown) to power the sensor unit 310.
  • the first sensor unit 310 may be configured for measurement of any desired physiological metrics. In different embodiments, the first sensor unit 310 may be configured for measurement of any one or more of heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position. Other configurations are possible and contemplated.
  • the first sensor unit 310 may further have a electrode cable port 314 for receiving an end of the electrode cable 500 to connect the first signal collection module 300 and the second signal collection module 400.
  • the housing 311 and battery compartment cover 312 may be formed from plastic, which may be thermoplastic. Other materials are possible and contemplated.
  • the mounting cartridge 330 may have a body 331 including mounting bed 332 for receiving the first sensor unit 310 for mounting the first sensor unit 310 to the mounting cartridge 330.
  • the body 331 may be formed from plastic, which may be thermoplastic. Other materials are possible and contemplated.
  • the first sensor unit 310 and the mounting cartridge 330 may be so sized, shaped, and configured, and possess such respective structures and properties, such that the first sensor unit 310 is selectively and reversibly mountable to the mounting cartridge 330.
  • the first sensor unit 310 may have at a first end 313 thereof a mounting tongue 315.
  • the mounting cartridge 330 may have at a corresponding first end 333 of the mounting bed 332 a mounting groove 334.
  • the mounting tongue 315 and the mounting groove 334 may be so respectively sized, shaped, and configured for sliding and fitting insertion and mating of the mounting tongue 315 in the mounting groove 334.
  • the first sensor unit 310 may further have at or proximal a second end 316 thereof opposite or distal the first end 313 at least one mounting slot 317.
  • the mounting cartridge 330 may have at or proximal a corresponding second end 335 thereof opposite or distal the first end 333 at least one corresponding mounting tooth 336.
  • the at least one mounting slot 317 and the at least one mounting tooth 336 may be so respectively and correspondingly sized, shaped, configured, and relatively positioned for receiving each mounting tooth 336 in a corresponding mounting slot 317 when the first sensor unit 310 is mounted in the mounting cartridge 330, as described herein, for selectively and releaseably retaining the first sensor unit 310 in the mounting cartridge 330 mounting bed 332.
  • the first sensor unit 310 may be tilted at least somewhat in relation to the mounting cartridge 330, and the first sensor unit 310 and mounting cartridge 330 may be moved relatively to insert and mate the first sensor unit 310 mounting tongue 315 into the mounting cartridge 330 mounting groove 334, as illustrated by arrow 700.
  • the first sensor unit 310 and the mounting cartridge 330 may then be moved relatively to move together the second end 316 of the first sensor unit 310 and the second end 335 of the mounting cartridge 330 to seat the underside 318 of the first sensor unit 310 in the mounting bed 332 of the mounting cartridge 330.
  • the mounting cartridge 330 may be formed of a material which is sufficiently resilient and flexible such that as the second end 316 of the first sensor unit 310 and the second end 335 of the mounting cartridge 330 are moved together, the second end 335 of the mounting cartridge 330 may be bent and deflected slightly to provide clearance to seat the first sensor unit 310 fittingly in the mounting bed 332 of the mounting cartridge 330.
  • the second end 335 of the mounting cartridge 330 may be rebounded such that the second end 316 of the first sensor unit 310 and the second end 335 of the mounting bed 332 contact or face, and the at least one mounting tooth 336 may be reversibly received in the corresponding at least one mounting slot 317.
  • the mounting tongue 315 and the mounting groove 334, on the one hand, and the at least one mounting slot 317 and at least one mounting tooth 336, on the other hand may cooperate to retain the first sensor unit 310 resiliently seated in the mounting cartridge 330 mounting bed 332.
  • Such mounted state is shown particularly in FIG’s 2, 3 & 10.
  • the first sensor unit 310 so mounted to the mounting cartridge 330 may be retained in alignment and position relative to the mounting cartridge 330, with no or minimal relative motion between the first sensor unit 310 and the mounting cartridge 330.
  • the first sensor unit 310 may include and contained within the housing 311 a processor 320 powered by a power source 321 (e.g. the battery mentioned above) and communicatively connected to the electrode cable port 314.
  • the processor 320 may be communicatively coupled to at least one memory 325 which stores computer-readable instructions executable by and for causing the processor 320 to perform the functions and actions described herein.
  • the processor 320 may be configured to use the at least one sensor 322 to collect measurements, and to use the at least one memory 325 to store the measurements.
  • the first sensor unit 310 may have more than one memory 325, and in particular may have a first memory 325 configured for storage of computer- readable instructions for execution by the processor 320, and a second different memory 325 for storage of measurements made by the processor 320 using the at leaf one sensor 322. Other arrangements are possible and contemplated.
  • the first sensor unit 310 may further include and contained within the housing 311 a communications module 323 communicatively coupled with the processor 320 and operable by the processor 320 for communication.
  • the communications module 323 may be or include a wireless transceiver.
  • the processor 320 may be configured to use the communications module 323 to communicate, wired or wirelessly, which may be via a network 900, with one or more remote devices 910, which may include, without limitation, any one or more of a server, a mobile communications device such as a smartphone or tablet, or a base station which itself may be communicatively connected to a server or mobile communications device.
  • the processor 320 may thus be configured to communicate and cooperate with such remote devices 910 to provide functionality, which may include, without limitation, transfer of collected measurements, processing of collected measurements, and display of collected measurements or processed data deriving from the collected measurements.
  • the remote devices 910 may include a smartphone or tablet configured with software, such as an app, operable using a communications device of the smartphone or tablet to receive directly or over the network 900 measurements from the first sensor unit 310, to process the measurements, and to display processed data on a display of the smartphone of tablet.
  • the smartphone or tablet may be configured to display one or more of a hear rate trace, an SpO2 trace, a blood pressure trace, or a head position. Other arrangements are possible and contemplated.
  • the first sensor unit 310 may further have at least one sensor 322 provided at the underside 318 thereof. Any suitable kind of sensor for the measurement and collection of physiological metrics is contemplated.
  • the at least one sensor 322 may be configured for measurement of one or more of heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position.
  • the at least one sensor 322 may include optical sensors, such as light sources and light sensors, electrodes, accelerometers, and magnetometers. Other alternatives are possible and contemplated.
  • the at least one sensor 322 may be communicatively coupled with the processor 320 and operable by the processor 320 to perform measurement of one or more physiological metrics.
  • the at least one sensor 322 may also be coupled with the power source 321 to be powered thereby, or it may be powered by the processor 320.
  • Each one of the at least one sensor 322 may be located at a corresponding position of the underside 318 of the first sensor unit 310 such that when the first signal collection module 300 is placed on a patient 200 for measurement of physiological metrics, the sensor 322 is positioned at or relative to a specific surface location or physiological structure, such as a blood vessel, of the patient 200.
  • the first sensor unit 310 may be mountable in the sensor unit mounting cartridge 330.
  • the mounting cartridge 330 may include structures or properties selected for cooperation with the at least one sensor 322 of the first sensor unit 310 when the first sensor unit 310 is mounted in the mounting cartridge 330, such that when the first signal collection module 300 is placed on the patient 200, such structures or properties of the mounting cartridge 330 and the corresponding at least one sensor 322 of the first sensor unit 310 cooperate for measurement of the physiological metrics.
  • the mounting cartridge 330 may have at least one opening 337 in the mounting bed 332 thereof, wherein the at least one opening 337 is so sized, shaped, and positioned that when the first sensor unit 310 is mounted in the mounting cartridge 330 as described above, the at least one sensor 322 are aligned with corresponding ones of the at least one opening 337, so as to expose the at least one sensor 322 to an underside 338 of the mounting cartridge 330, which may also be considered an underside 338 of the first signal collection module 300 (see particularly FIG. 3).
  • the at least one sensor 322 is exposed to the surface of the patient 200 for measurement of physiological metrics.
  • the at least one sensor 322 of the first sensor unit 100 may include a PPG sensor 600.
  • the PPG sensor 600 may include at least one light source 610 and at least one light-sensitive sensor 620.
  • the light source 610 may include at least one light-emitting diode (LED) 612.
  • the at least one LED 612 may include at least one of a red LED 614, an infrared LED 616, and a green LED 618.
  • the at least one light-sensitive sensor 620 may include one or more sensors correspondingly light-sensitive to any one or more of the at least one light source 610 when present.
  • the at least one light-sensitive sensor 620 may be light-sensitive to light emitted by the red LED 614, and similarly for the infrared LED 616 and/or green LED 618 when present.
  • the at least one light-sensitive sensor 620 may include at least one photodiode 622.
  • the processor 320 of the first sensor unit 310 may be operable to control the at least one light source 610 to illuminate the patient 200 including preconfigured physiological structures of the patient 200, and to control the at least one light-sensitive sensor 620 to detect and light transmitted through or reflected from those physiological structures.
  • the processor 320 may be operable to control at least one of the red LED 614, infrared LED 616, and green LED 618 to illuminate the at least one blood vessel, and to operate the photodiode 622 to detect and measure light reflected from the at least one blood vessel.
  • the mounting cartridge 330 of the first signal collection module 300 may be sized, shaped, configured, and formed of such materials, so as to be mountable at or on the temple 205 of the patient 200.
  • the mounting cartridge 300 mounting bed 332 may be formed with at least one opening 337 for exposing the at least one sensor 322 of the first sensor unit 310 to the underside 338 of the mounting cartridge 330 and thus to the patient 200 when the first signal collection module 300 is assembled and mounted on the patient 200.
  • the first sensor unit 310 and the mounting cartridge 330 may be so sized, shaped, and configured, that the PPG sensor 600 protrudes or extends a preconfigured distance below the underside 339 of the mounting cartridge 330 (shown particularly in FIG’s 9 & 10, such that when the first signal collection module 300 is mounted to the patient 200, a preconfigured pressure is maintained between the PPG sensor 600 and the patient 200 surface.
  • the mounting cartridge 330 may be mounted to the patient 200 before or after the first sensor unit 310 is mounted to the mounting cartridge 330.
  • the mounting cartridge 330 may be mounted to the patient 200 first, and then the first sensor unit 310 may be mounted to the mounting cartridge 330.
  • the at least one opening 337 in the mounting cartridge 330 may be useful when mounting the mounting cartridge 330 to the patient 200 to visually align the each of the at least one opening 337 to selected location and/or physiological structure of the patient 200.
  • the selected physiological structure may include one or more selected temporal arteries.
  • a relative overlying position at or about the template 205 of the patient 200 may be located, and then the mounting cartridge 330 may be applied and mounted at or about the patient 200 temple 205 while visually aligning the at least one opening 337 to corresponding surface locations relative to the selected temporal arteries.
  • the first sensor unit 310 may then be inserted and mounted to the mounting cartridge 330, as described above.
  • the at least one sensor 322 may be positioned at the underside 318 of the first sensor unit 310 such that when the first sensor unit 310 is mounted to the mounting cartridge 330, each of the at least one sensor 322 aligns with a corresponding one of the at least one openings 337 of the mounting cartridge 330.
  • the at least one sensor 322 includes the PPG sensor 600, including the at least one light source 610 and at least one light-sensitive sensor 620, such as the red LED 614, infrared LED 616, green LED 618, and photodiode 622
  • each of these may be aligned with a corresponding opening 337 of the mounting cartridge 330.
  • each of the openings 337 may be visually aligned with a surface location of the patient 200 relative to a selected physiological structure, such as one or more temporal arteries, in this manner each of the red LED 614, infrared LED 616, green LED 618, and photodiode 622 may be selectively and reliable aligned and positioned relative to the temporal arteries.
  • the first signal collection module 300 may be so mounted and placed at either the left or right temple 205 of the patient 200, the it may be placed in particular at the right temple 205 of the patient 200, for reasons described below.
  • the first signal collection module 300 may be provided with other means and structures for cooperation with the at least one sensor 322 of the first sensor unit 310 for cooperation therewith the measure and monitor physiological metrics of the patient 200.
  • the mounting cartridge 330 may include in the mounting bed 332 thereof at or about a location adjacent the at least one sensor 322 when the first sensor unit 310 is mounted in the mounting cartridge 330 a coupling structure 340 which is operative to couple or intermediate the at least one sensor 322 with the surface of the patient 200 in relation to the specific physiological metric desired to be collected.
  • the at least one sensor 322 operates to illuminate the patient 200 with preconfigured wavelengths of light
  • mounting of the first signal collection module 300 on the patient 200 involves the application on the patient 200 surface a gel or other composition having a preconfigured refractive index
  • the structure provided in the mounting cartridge 330 mounting bed 332 may be formed of a material having a refractive index matched to the refractive index of the gel or other composition applied to the patient 200.
  • the at least one sensor 322 may include at least one electrode 630, which may be formed of a conductive material, which may include metal, which may include gold or silver, for measuring, for example, electrical signals at a contact surface of the patient 200.
  • the coupling structure 340 may be or include a conductive film 341 or other conductive material, such as hydrogel patches, for providing conductive contact between the at least one electrode 630 and the surface of the patient 200.
  • any such structure may be provided and preconfigured to cooperate with the corresponding at least one sensor 322 so as to cooperate therewith and with any other preconfigured aspect of the system 100, patient 200, or preconfigured or expected aspect of the surrounding environment, based on and for the purpose of facilitating or improving the intended physiological metric measurement.
  • the mounting cartridge 330 may further have at an underside 338 thereof an affixing layer 339 operable to affix the mounting cartridge 330 to the patient 200.
  • the affixing layer 339 may include an adhesive layer, which may include a plastic cover peelable off the adhesive layer to expose the adhesive layer for affixing contact with the patient 200.
  • the mounting cartridge 330 may also have at least one tab 342 formed in the body 331 thereof, which may be two tabs, at or proximal the second end 335, which may be sized, shaped, and configured to be grasped by a person, such as the patient 200, which may useful for removal of the mounting cartridge 330 from the patient 200, wherein the at least one tab 342 may be configured to be grasped by the patient 200 or another person and pulled away from the patient 200 surface to peel or otherwise remove the mounting cartridge 330 from the patient 200 surface.
  • the at least one tab 342 may also be useful to unseat and remove the first sensor unit 310 from the mounting bed 332 of the mounting cartridge 330.
  • the at least one tab 342 may be graspable or pressable by the patient 200 or another person to bend and slightly deflect the second end 335 of the mounting cartridge 330 to decouple the at least one mounting tooth 336 and the corresponding at least one mounting slot 317, thereby to permit the second end 316 of the first sensor unit 310 to be raised and the first sensor unit 310 to be tilted to lift the second end 316 out of the mounting bed 332, and then to withdraw the mounting tongue 315 of the first sensor unit 310 from the mounting groove 334 of the mounting cartridge 330 - or, in other words, to perform the opposite of the procedure described above for mounting the first sensor unit 310 to the mounting cartridge 330.
  • the first sensor unit 310 and the mounting cartridge 330 may be readily and repeatedly coupled and decoupled as described.
  • a method 800 of mounting a signal collection module to a patient 200 may include providing a sensor unit (such as first sensor unit 310) and corresponding mounting cartridge (such as mounting cartridge 330) (step 810), mounting cartridge having at least one opening sized, shaped, and positioned in correspondence with at least one sensor of the sensor unit provided at an underside thereof.
  • the mounting cartridge may then be applied, mounted, or affixed to a patient so as to align the at least one opening at, over, or about a surface location corresponding to a preconfigured target physiological structure (step 820).
  • the sensor unit may then be inserted and seated in a mounting bed of the mounting cartridge, thereby positioning the at least one sensor of the sensor unit in alignment with the target physiological structure (step 830).
  • the sensor unit may then be used and operated to measure physiological metrics related to the target physiological structure (step 840).
  • a second signal collection module 400 is illustrated figuratively in FIG 12.
  • the second signal collection module 400 may have a second sensor unit 410 and an electrode cable port 415 for coupling with an opposite end of the electrode cable 500, thereby to communicatively couple the first sensor unit 310 and the second sensor unit 410.
  • the second sensor unit 410 may also have at least one sensor 430.
  • the second sensor unit 410 may be configured for the measurement of any desired preconfigured physiological metrics, either alone or in cooperation with the first sensor unit 310.
  • the physiological metrics may include one or more of heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position.
  • the second signal collection module 400 and the second sensor unit 410 may be similarly configured as the first signal collection module 300 and first second unit 310, respectively, or they may be differently configured.
  • the second unit 410 may also have a processor 420, memory 425, power source 421 , and communications module 423.
  • the second signal collection module 400 may omit one or more of these related structures.
  • the second sensor unit 410 including the at least one sensor 430, may be operable by the processor 320 and powered by the power source 321 of the first sensor unit 310 via the electrode cable 500.
  • the second signal collection module 400 may include such structures and materials for cooperation with the at least one sensor 430 of the second sensor unit 410 for mounting on the patient 200 at a preconfigured location and for selective preconfigured positioning of the at least one sensor 430 of the second sensor unit 410 relative to physiological structures of the patient 200 for measurement and collection of preconfigured physiological metrics.
  • the processor 320 of the first signal collection module 300 may be configured to control and operate the at least one sensor 322 of the first sensor unit 310 and the at least one sensor 430 of the second signal collection module 400 in cooperation for the measurement and collection of preconfigured physiological metrics selectively from physiological structures of the patient 200 at or about where the first signal collection module 300 and second signal collection module 400 are respectively mounted to the patient 200.
  • the processor 320 may operate and selectively coordinate the operation of the at least one sensor 322 of the first sensor unit 310 and the at least one sensor 430 of the second sensor unit 410 to measure and collect preconfigured physiological metrics from the respective mounting positions of the first signal collection module 300 and the second signal collection module 400 for processing and computing a resultant or derivative physiological metric based on the primary physiological metrics thus collected.
  • the signal collection module 400 may be or include an ECG sensor 700 configured with adhesive or other affixing means for affixing the ECG sensor 700 to the patient 200 at a selected location, such as on a chest 210 of the patient 200 at or about a surface location proximal the heart (not shown) of the patient 200.
  • the at least one sensor 322 of the first sensor unit 310 of the first signal collection module 300 may further include at least one electrode 630 operable in cooperation with the ECG sensor 700 for measurement of ECG metrics of the patient 200.
  • Such use may be enabled, improved, or facilitated by placement of the first signal collection module 300, and hence the at least one electrode 630 of the first sensor unit 310, at the right temple 205 of the patient 200 as shown in FIG. 1 , wherein the at least one electrode 630 may be operable as a reference electrode.
  • the first sensor unit 310 and the second sensor unit 410 may be connected using the electrode cable 500 by mating a first end 510 of the electrode cable 500 with the electrode cable port 314 of the first sensor unit 310 and a second end 520 of the electrode cable 500 with the electrode cable port 415 of the second sensor unit 410.
  • the system 100 may be operated to collect preconfigured physiological metrics including at least one of: heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position. Other configurations are possible and contemplated.
  • a method 1000 of measuring physiological metrics of a patient 200 using the system 100 may include mounting the first signal collection module 300 at a temple of the patient 200 (step 1010), mounting the second signal collection module 400 on the chest 210 of the patient 200 at or about a surface location proximal the heart of the patient 200 (step 1020), communicatively connecting the first signal collection module 300 and the second signal collection module 400 (step 1030), which may be by the electrode cable 500, and then using the system 100 to measure the physiological metrics as described herein (step 1040).
  • some embodiments of the system 100 may be especially advantageous for the collection of PPG metrics by the first signal collection module 300.
  • the particular configuration of the mounting cartridge 330 as described, including the use of the at least one opening 337 thereof for precise placement on the patient 200 and accurate relative alignment with the target physiological structures, such as selected temporal arteries, combined with the accurate and reliable alignment of the at least one sensor 322 of the first sensor unit 310, such as the one or more of the red LED 614, infrared LED 616, and green LED 618, as well as the photodiode 622, may result in the precise and reliable relative alignment and positioning of these with the target physiological structures, thereby enabling a more predictable and reliable collection of PPG metrics from those target physiological structures.
  • placement of the first signal collection module 300 including PPG sensor 600 may avoid many of the disadvantages of other devices for PPG measurement described above by virtue of their placement and location at structures subject to not insignificant motion during the measurement process, such as, for example, on the wrist, hand, or finger, wherein such motion may cause relative motion of the sensors and target physiological structures, resulting in impaired selectivity of such physiological structures and stochastic average blurring resulting from collection from changing and extended regions of tissue and vasculature.
  • placement of the PPG sensor 600 at the patient 200 temple 205 may avoid the disadvantage of other PPG devices when placed at other body parts, such as, for example, on the wrist, hand, or finger, which impair, limit, or frustrate motion of the body part by virtue of the presence of the PPG device. Placement of the PPG sensor 600 at the patient 200 temple 205 may entirely or at least partly avoid this disadvantage.
  • the described embodiment of the system 100 may be especially advantageous for the collection of PPG metrics by the first signal collection module 300, for the reasons given above, and ECG metrics by the first signal collection module 300 and the second signal collection module 400, as described above, specifically for the purpose of measuring and monitoring the blood pressure of the patient 200.
  • blood pressure may be measured by way of measurement of pulse wave velocity (“PWV”), which may be done by the combined use of a PPG sensor and an ECG sensor.
  • PWV pulse wave velocity
  • the processor 320 may be operable to operate the ECG sensor 700 of the second signal collection module 400 in combination with the at least one electrode 630 of the first signal collection module 300 to detect a start time of electrical stimulation of the ventricles of the heart of the patient 200, and simultaneously to operate the PPG sensor 600 of the first signal collection module 300 to detect an arrival time of a systolic pulse wave at the temple 205 the patient 200, and specifically within a selected one or plurality of temporal arteries.
  • the range of motion of the target location and structure for the PPG sensor 600 i.e. the temple 205 and selected temporal arteries, is very limited relative to the heart, the change of the effective length of the systolic pulse propagation path due to this cause may be eliminated or minimized.
  • the mounting cartridge 330 and first sensor unit 310 may be collectively configured for precise and reliable placement of the PPG sensor 600 relative to the target temporal arteries, as described, it may be possible to be more selective as to which temporal arteries are measured, and thus less tissue and/or fewer arteries may contribute to the resultant signal, which may eliminate or minimize averaging resulting from such contributing structures having different effective path lengths.
  • first sensor unit 310 and the second sensor unit 410 can contribute no or minimal delay in the receipt by the processor 320 of a signal corresponding to the detection by the ECG sensor 700 of the start time of the electrical stimulation of the ventricles of the heart of the patient 200, the interval between the start time of the electrical stimulation of the ventricles of the heart, and arrival of the systolic pulse at the temple, may be more accurately and precisely determined.
  • the system 100 so configured and operated may enable a more accurate and precise measurement of pulse wave velocity (“PWV”), and thus determination of blood pressure therefore, than was possible with previous devices.
  • PWV pulse wave velocity
  • a method 1100 of using the system 100 to measure and determine a blood pressure of a patient 200 may include mounting and using the system 100 as described above, which may be in accordance with method 800 and method 1000, operating the system 100 to use the first sensor collection module 300 and the second sensor collection module 400 to detect an ECG signal of a start time of electrical stimulation of the ventricles of the heart of the patient 200 (step 1110), using the first sensor collection module 300 to detect a PPG signal of an arrival time of a systolic pulse wave at the patient 200 temple (step 1120), generating a pulse wave velocity based on the measured electrical stimulation start time and the systolic pulse wave arrival time (step 1130), and generating a blood pressure value based on the generated pulse wave velocity (step 1140).
  • Embodiments of the disclosure may overcome disadvantages and provide additional advantages over previous techniques.
  • Disclosed embodiments allows secure attachment of a wearable device, such as the disclosed signal collection modules, which provide both electrical and physical contact for optimal signal collection of ECG and optical, such as PPG, signals. It may optimize alignment of the optical PPG sensor by attaching the cartridge first then the sensor unit, as described. It may maintain electrical contact between the sensor unit and the patient’s skin for ECG signal measurement. It may maintains correct pressure for optimal PPG signal collection.
  • the sensor unit may allow the sensor unit to be easily and conveniently removed for changing a battery or cleaning, or for the patient to shower, bathe, or go swimming, while the mounting cartridge remains mounted, and thus the alignment of the sensor unit sensors with the target physiological structures is retained once the sensor unit is again mounted. It may allows freedom of motion for arms as previous wearable devices which measure physiometric metrics typically attach either to the fingers or wrists. It allows for repositioning of the signal collection module and sensor unit. In view of the foregoing, it can reduce anxiety for the patient on changing the sensor unity as the mounting cartridge may ensure correct placement of the sensor unit by the patient.
  • the mounting cartridge may be easily removed by the patient using tabs on the mounting cartridge.
  • the mounting cartridge may be made inexpensively and easily disposed of which may enable the sensor unit to be reused reducing costs and environmental impact.
  • the mounting cartridge may have a small footprint which may be almost the same size as the sensor unit, whereas previous wearable attachment mechanisms typically make use of bands or tabs which increase the size of the wearable device.
  • Embodiment 1 A signal collection module for measuring at least one physiological metric of a patient, the signal collection module comprising: a sensor unit comprising a housing and at least one sensor positioned at an underside of the housing, wherein the at least one sensor is operable to measure the at least one physiological metric; and a sensor unit mounting cartridge comprising a body forming a mounting bed sized, shaped, and configured to receive the sensor unit for fitting mounting of the sensor unit to the sensor unit mounting cartridge, the sensor unit mounting cartridge body having an underside configured for mounting to a patient at a site proximal a predetermined physiological structure of the patient corresponding to the at least one physiological metric; wherein: the sensor unit mounting cartridge body defines at least one opening between the mounting bed and the underside of the body, and the sensor unit housing and the sensor unit mounting cartridge mounting bed are so sized, shaped, and configured that when the sensor unit is mounted in the mounting bed the at least one sensor of the sensor unit is positioned in alignment with the at least one opening.
  • Embodiment 2 The signal collection module of Embodiment 1 , wherein the sensor unit housing and the sensor unit mounting cartridge mounting bed are so respectively sized, shaped, and configured such that when the sensor unit is mounted in the mounting bed of the sensor unit mounting cartridge a range of motion of the sensor unit relative to the sensor unit mounting cartridge is no greater than a preconfigured amount.
  • the signal collection module of Embodiment 1 or 2 wherein: the sensor unit housing has a mounting tongue at or proximal a first end of the sensor unit housing; the sensor unit mounting cartridge has a mounting groove at or proximal a first end of the sensor unit mounting cartridge mounting bed; and the mounting tongue and the mounting groove are respectively sized, shaped, and configured for receiving the mounting tongue in the mounting groove for fitting mating of the mounting tongue and the mounting groove to retain the sensor unit body in the sensor unit mounting cartridge mounting bed and to retain the sensor unit in alignment and position relative to the sensor unit mounting cartridge.
  • Embodiment 4 The signal collection module of Embodiment 3, wherein: the sensor unit housing has at least one mounting slot at or proximal a second end of the sensor unit housing opposite the first end of the sensor unit housing; the sensor unit mounting cartridge has at least one mounting tooth at or proximal a second end of the sensor unit mounting cartridge mounting bed; and the at least one mounting tooth and the at least one mounting slot are respectively sized, shaped, and configured for receiving the at least one mounting tooth respectively and correspondingly in the at least one mounting slot for fitting mating of the at least one mounting tooth and the at least one mounting slot to retain the sensor unit body in the sensor unit mounting cartridge mounting bed and to retain the sensor unit in alignment and position relative to the sensor unit mounting cartridge.
  • Embodiment 5 The signal collection module of Embodiment 4, wherein the sensor unit mounting cartridge has an affixing layer at the underside of the body to affix the sensor unit mounting cartridge to the patient.
  • Embodiment 6 The signal collection module of Embodiment 5 further comprising at least one tab formed in the body of the sensor unit mounting cartridge at or proximal the second end of the sensor unit mounting cartridge, wherein the at least one tab is sized, shaped, and configured to be graspable by the patient or another person to lift the sensor unit mounting cartridge body to remove the the sensor unit mounting cartridge from the patient.
  • Embodiment 7 The signal collection module of any one of Embodiments 1 to 6, wherein: the sensor unit further comprises: a processor communicatively coupled to operate the at least one sensor; at least one memory communicatively connected to the processor; a power source connected to power the processor; and a communications module communicatively coupled to the processor; wherein the at least one memory stores computer-readable instructions executable by the processor: to operate the at least one sensor to measure the at least one physiological metric; to store the at least one physiological metric in the at least one memory; and to operate the communications module to communicate the at least one physiological metric to a remote device.
  • the sensor unit further comprises: a processor communicatively coupled to operate the at least one sensor; at least one memory communicatively connected to the processor; a power source connected to power the processor; and a communications module communicatively coupled to the processor; wherein the at least one memory stores computer-readable instructions executable by the processor: to operate the at least one sensor to measure the at least one physiological metric; to store the at
  • Embodiment 8 The signal collection module of any one of Embodiments 1 to 7, wherein the at least one sensor comprises at least one of an optical sensor, an electrode, an accelerometer, and a magnetometer.
  • Embodiment 9 The signal collection module of any one of Embodiments 1 to 8, wherein the at least one sensor comprises at least one photoplethysmography (“PPG”) sensor comprising at least one light-emitting diode (“LED”) and at least one light-sensitive sensor.
  • PPG photoplethysmography
  • LED light-emitting diode
  • Embodiment 10 The signal collection module of Embodiment 9, wherein the at least one sensor further comprises an electrode operable as an electrocardiography (“ECG”) reference electrode.
  • ECG electrocardiography
  • Embodiment 11 A system for measuring at least one physiological metric of a patient, the system comprising: a first signal collection module comprising: a first sensor unit comprising: a housing; a first at least one sensor positioned at an underside of the housing; and a first electrode cable port; a sensor unit mounting cartridge comprising a body forming a mounting bed sized, shaped, and configured to receive the first sensor unit for fitting mounting of the first sensor unit to the sensor unit mounting cartridge, the sensor unit mounting cartridge body having an underside configured for mounting to a patient at a first site proximal a first predetermined physiological structure of the patient corresponding to the at least one physiological metric; wherein: the sensor unit mounting cartridge body defines at least one opening between the mounting bed and the underside of the body, and the first sensor unit housing and the sensor unit mounting cartridge mounting bed are so sized, shaped, and configured that when the first sensor unit is mounted in the mounting bed the first at least one sensor of the first sensor unit is positioned in alignment with the at least one opening;
  • Embodiment 12 The system of Embodiment 11 , wherein: the first sensor unit further comprises: a processor communicatively coupled to operate the first at least one sensor and the second at least one sensor via the first electrode cable port and the electrode cable; at least one memory communicatively connected to the processor; a power source connected to power the processor; and a communications module communicatively coupled to the processor; wherein the at least one memory stores computer-readable instructions executable by the processor: to operate the first at least one sensor and the second at least one sensor to measure the at least one physiological metric; to store the at least one physiological metric in the at least one memory; and to operate the communications module to communicate the at least one physiological metric to a remote device.
  • a processor communicatively coupled to operate the first at least one sensor and the second at least one sensor via the first electrode cable port and the electrode cable
  • at least one memory communicatively connected to the processor
  • a power source connected to power the processor
  • a communications module communicatively coupled to the processor
  • Embodiment 13 The system of Embodiment 12, wherein the first at least one sensor comprises a photoplethysmography (“PPG”) sensor and a first electrocardiography (“ECG”) sensor, and the second at least one sensor comprises a second electrocardiography (“ECG”) sensor.
  • PPG photoplethysmography
  • ECG electrocardiography
  • ECG electrocardiography
  • Embodiment 14 The system of Embodiment 13, wherein: the first site is a temple of the patient; the second site is on a chest of the patient proximal a heart of the patient; the computer-readable instructions are executable by the processor: to operate the first ECG sensor and the second ECG sensor to detect a start time of electrical stimulation of ventricles of the heart of the patient; and to operate the PPG sensor to detect an arrival time of a systolic pulse wave at the temple the patient.
  • Embodiment 15 The system of Embodiment 14, wherein the computer- readable instructions are further executable by the processor to generate a pulse wave velocity (“PWV”) based on the start time and the arrival time.
  • PWV pulse wave velocity
  • Embodiment 16 The system of Embodiment 15, wherein the computer- readable instructions are further executable by the processor to generate a blood pressure value based on the PWV.
  • Embodiment 17 A method for measuring at least one physiological metric of a patient, comprising: a) providing the system of Embodiment 11 ; A mounting the sensor unit mounting cartridge at the first site; c) mounting the first sensor unit in the mounting bed of the sensor unit mounting cartridge; d) mounting the second signal collection module at the second site; e) mating the electrode cable at respective opposite ends with the first electrode cable port and the second electrode cable port to communicatively couple the first signal collection module and the second signal collection module; and f) operating the first at least one sensor and the second at least one sensor to measure the at least one physiological metric of the patient.
  • Embodiment 18 The method of Embodiment 17, wherein the first at least one sensor comprises a photoplethysmography (“PPG”) sensor and a first electrocardiography (“ECG”) sensor, and the second at least one sensor comprises a second electrocardiography (“ECG”) sensor.
  • PPG photoplethysmography
  • ECG electrocardiography
  • ECG electrocardiography
  • Embodiment 19 The method of Embodiment 18, wherein: the first site is a temple of the patient; the second site is on a chest of the patient proximal a heart of the patient; and the method comprises: operating the first ECG sensor and the second ECG sensor to detect a start time of electrical stimulation of ventricles of the heart of the patient; and operating the PPG sensor to detect an arrival time of a systolic pulse wave at the temple the patient.
  • Embodiment 20 The method of Embodiment 19, further comprising generating a pulse wave velocity (“PWV”) based on the start time and the arrival time.
  • PWV pulse wave velocity
  • Embodiment 21 The method of Embodiment 20, further comprising generating a blood pressure value based on the PWV.
  • An apparatus for performing the operations herein can implement the present disclosure.
  • This apparatus may be specially constructed for the required purposes, or it may comprise a general-purpose computer, selectively activated or reconfigured by computer-readable instructions stored in the computer.
  • Such a computer-readable instructions may be stored in a non-transient computer readable storage medium, such as, but not limited to, any type of disk including floppy disks, hard disks, optical discs, compact disc read-only memories (CD-ROMs), and magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), FLASH memories, magnetic or optical cards, etc., or any type of media suitable for storing electronic instructions either local to the computer or remote to the computer.
  • ROMs read-only memories
  • RAMs random access memories
  • EPROMs electrically programmable read-only memories
  • EEPROMs electrically erasable programmable read
  • any algorithms and displays presented herein are not inherently related to any particular computer or other apparatus.
  • Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the required method.
  • any of the methods according to the present disclosure can be implemented in hard-wired circuitry, by programming a general-purpose processor, or by any combination of hardware and software.
  • One of ordinary skill in the art will immediately appreciate that the invention can be practiced with computer system configurations other than those described, including hand-held devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, digital signal processing (DSP) devices, set top boxes, network PCs, minicomputers, mainframe computers, and the like.
  • DSP digital signal processing
  • Embodiments of the disclosure can also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network.
  • Disclosed methods may be implemented using computer software. If written in a programming language conforming to a recognized standard, sequences of instructions designed to implement the methods can be compiled for execution on a variety of hardware platforms and for interface to a variety of operating systems.
  • the present disclosure is not made with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the present disclosure.
  • a machine-readable or computer-readable medium is understood to include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer).
  • a machine-readable medium includes read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; electrical, optical, acoustical or other form of propagated signals which upon reception causes movement in matter (e.g. electrons, atoms, etc.) (e.g., carrier waves, infrared signals, digital signals, etc.); etc.
  • a range should be considered to have specifically disclosed all the possible sub-ranges, fractions, and individual numerical values within that range.
  • description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1 , 2, 3, 4, 5, and 6, and decimals and fractions, for example, 1.2, 3.8, 1%, and 4%. This applies regardless of the breadth of the range.

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Abstract

A vital signs measuring device has a signal collection module mountable in a sensor unit mounting cartridge, wherein the module is operable to collect physiological metrics from a patient, and has at least one sensor provided at an underside thereof. The sensor unit housing has first mounting structures for mounting the sensor unit to the mounting cartridge. The mounting cartridge has a body forming a mounting bed and includes second mounting structures. The sensor unit housing and the mounting bed, and the first and second mounting structures, are sized, shaped, and configured for reversible fitting and resilient mounting and seating of the sensor unit in the mounting bed of the sensor unit mounting cartridge. The mounting cartridge body has at least one opening in the mounting bed sized, shaped, and positioned relative to the at least one sensor to expose the sensor to an underside of the mounting cartridge.

Description

WEARABLE VITAL SIGNS MONITORING DEVICE
FIELD [0001] The present disclosure relates generally to wearable vital signs monitoring devices.
BACKGROUND
[0002] Wearable vital signs monitoring devices are sometimes used to monitor physiological metrics, such as heart rate, pulse rate, blood pressure, breathing rate, and blood oxygen saturation of patients and residents in hospitals, nursing homes, and other facilities where healthcare providers are present to provide in-person care. Such devices are also commonly used to monitor and record physiological metrics of patients while away from such facilities, such as at home, for later analysis and use of the recorded data by healthcare providers for diagnosis and to provide advice and assistance to the patients.
[0003] In particular, the technique of photoplethysmography (“PPG”) is sometimes used to generate pulse rate and blood oxygen saturation metrics. The technique involves illumination of target tissue with selected wavelengths of light, and the collection of resulting transmitted or reflected light which varies in dependence on changes in blood oxygenation or blood volume of target tissue or included blood vessels. For example, transmissive PPG may involve placement of a sensor device on a thin part of a patient’s body, such as a fingertip or earlobe, and the illumination thereof with selected wavelengths of light and collection of the transmitted light, wherein the relative absorbance of the illuminated body part varies depending on the oxygenation and/or volume of blood contained in the tissue microvasculature or included blood vessels. Similarly, reflectance PPG may involve illumination of target tissue or blood vessels with selected wavelengths of light and collection of reflected, as opposed to transmitted, light, wherein similarly the relative reflectivity of the illuminated body part varies depending on the oxygenation and/or volume of blood contained in the tissue or blood vessels. Since the oxygenation and/or volume of blood typically vary periodically with pulse, either technique can be useful to measure the patient’s pulse rate and blood oxygenation non-invasively.
[0004] In addition, blood pressure is sometimes measured and monitored non- invasively by way of measurement of pulse wave velocity (“PWV”), that is the velocity at which a blood pressure pulse propagates through the circulatory system, such as through one or a collection of blood vessels. Measured PWV can be correlated to blood vessel compliance and volume, and thus varies with blood pressure. PWV measurements are sometimes performed by the combined use of an electrocardiography (“ECG”) sensor and a PPG sensor, wherein the ECG sensor is used to detect a start time of electrical stimulation of the ventricles of the heart, and the PPG sensor is used to detect an arrival time of a systolic pulse wave at a selected part of the patient’s body. The PWV may then be determined based on the interval between this start time and arrival time.
[0005] The PWV method of blood pressure measure involves a number of shortcomings, however. The determination of blood pressure from PWV depends on a known and stable propagation distance of the pulse wave. Thus, the propagation of the pulse wave through multiple paths, as opposed to a single path, and variability of the effective propagation distance of one or more of the multiple paths, both reduce the stability and the accuracy of any determined correlation between blood pressure and PWV. For example, since such properties as wall thickness, radius, and incremental elastic modulus may vary from blood vessel to blood vessel, so too will PWV vary between blood vessels. Any measurement of PWV which involves detection of pulse wave arrival time in relation to multiple blood vessels can therefore at best determine only an average over such multiple blood vessels. Moreover, movement or disturbance of the PPG sensor placement relative to the underlying multiple blood vessels may cause a change in the relative signal contribution of the different multiple blood vessels, thereby introducing stochastic variability in the average arrival time, and thus PWV and correspondingly determined blood pressure. Yet further, when the PPG sensor is located at a body location such that movement of the body can change or otherwise affect the effective pulse wave propagation path lengths, then unpredictable bodily movement may likewise introduce stochastic variability in the average arrival time, and thus PWV and the correspondingly determined blood pressure.
[0006] Therefore, there remains a pressing need for improved non-invasive techniques for measurement and monitoring of physiological metrics, such as heart rate, blood pressure, and blood oxygen saturation, which overcome the above-described disadvantages and which additionally provide further advantages.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] Embodiments will now be described, by way of example only, with reference to the attached Figures.
[0008] FIG. 1 shows a figurative view of a disclosed system mounted to a patient. [0009] FIG’s 2 & 3 show overside and underside perspective views of a disclosed first signal collection module
[0010] FIG’s 4 & 5 show overside and underside perspective views of a disclose first sensor unit of the first signal collection module.
[0011] FIG’s 6 & 7 show overside and underside perspective views of a disclosed sensor unit mounting cartridge of the first signal collection module.
[0012] FIG’s 8-10 show overside perspective (FIG. 8) and side elevation views (FIG’s 9 & 10) illustrating inserting and mounting of the first sensor unit and the sensor unit mounting cartridge.
[0013] FIG. 11 shows a figurative block diagram of a disclosed first sensor unit.
[0014] FIG. 12 shows a figurative block diagram of a disclosed second sensor unit.
[0015] FIG. 13 shows a flowchart of a disclosed method of mounting a disclosed first signal collection module to a patient.
[0016] FIG. 14 shows a flowchart of a disclosed method of mounting and using a disclosed physiological metric measuring system.
[0017] FIG. 15 shows a flowchart of a disclosed method of using the system of FIG. 14 to measure a blood pressure of a patient.
[0018] Throughout the drawings, sometimes only one or fewer than all of the instances of an element visible in the view are designated by a lead line and reference character, for the sake only of simplicity and to avoid obfuscation. It will be understood, however, that in such cases, in accordance with the corresponding description, that all other instances are likewise designated and encompassed by the corresponding description.
[0019] In the drawings and this description, the use of a brace (‘{‘ or ’}’) between reference characters designates a genus and species relationship, such that “A { B” indicates that ‘B’ is a species of a broader genus ‘A’. A numerical reference character suffixed by a letter (e.g. “800A”, “900B”) designates a separate instance of the element designated by the numerical reference character (e.g. “800A”, “800B” are each separate instances of the element designated by “800”).
DESCRIPTION
[0020] Techniques, including, but not limited, to devices, systems, and methods, for measuring and monitoring physiological metrics are disclosed herein. The physiological metrics may include, without limitation, heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head position. The techniques may enable more precise placement of sensors for measurement and collection of the physiological metrics. The techniques further enable maintenance of the sensor placement position more durably over time, during the collection of the physiological metrics, and may additionally enable improved maintenance of underlying physical parameters which affect the measured and collected physiological metrics.
[0021] A system 100 for measuring and monitoring physiological metrics of a patient 200 is shown in FIG. 1. The system 100 may include a first signal collection module 300. The system 100 may also include a second signal collection module 400. Each of the first signal collection module 300 and the second signal collection module 400 may be mountable at any preconfigured site on a patient 200. For example, the first signal collection module 300 may be mountable at a temple 205 of the patient 200. The second signal collection module 400 may be mountable on a chest 210 of the patient 200 at a location over or proximal the heart (not shown) of the patient 200. In other embodiments the first signal collection module 300 and the second signal collection module 400 are each independently mountable at any other preconfigured site on the patent 200. The system 100 may further include an electrode cable 500 operable to connect the first signal collection module 300 and the second signal collection module 400.
[0022] An embodiment of the first signal collection module 300 is shown in FIG’s 2 to 3. The first signal collection module 300 may include a first sensor unit 310 and a sensor unit mounting cartridge 330. The first sensor unit 310 and the sensor unit mounting cartridge 330 may independently be formed of any suitable materials and structures providing the desired properties, features, and capabilities disclosed here.
[0023] An embodiment of the first sensor unit 310 is shown in FIG’s 4 to 5. The first sensor unit 310 may have a housing 311 including a battery compartment (not shown) enclosed by a battery compartment cover 312 for containing a battery (not shown) to power the sensor unit 310. The first sensor unit 310 may be configured for measurement of any desired physiological metrics. In different embodiments, the first sensor unit 310 may be configured for measurement of any one or more of heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position. Other configurations are possible and contemplated. The first sensor unit 310 may further have a electrode cable port 314 for receiving an end of the electrode cable 500 to connect the first signal collection module 300 and the second signal collection module 400. Without limitation, the housing 311 and battery compartment cover 312 may be formed from plastic, which may be thermoplastic. Other materials are possible and contemplated.
[0024] An embodiment of the mounting cartridge 330 is shown in FIG’s 6 to 7. The mounting cartridge 330 may have a body 331 including mounting bed 332 for receiving the first sensor unit 310 for mounting the first sensor unit 310 to the mounting cartridge 330. Without limitation, the body 331 may be formed from plastic, which may be thermoplastic. Other materials are possible and contemplated.
[0025] The first sensor unit 310 and the mounting cartridge 330 may be so sized, shaped, and configured, and possess such respective structures and properties, such that the first sensor unit 310 is selectively and reversibly mountable to the mounting cartridge 330. For example, the first sensor unit 310 may have at a first end 313 thereof a mounting tongue 315. The mounting cartridge 330 may have at a corresponding first end 333 of the mounting bed 332 a mounting groove 334. The mounting tongue 315 and the mounting groove 334 may be so respectively sized, shaped, and configured for sliding and fitting insertion and mating of the mounting tongue 315 in the mounting groove 334. The first sensor unit 310 may further have at or proximal a second end 316 thereof opposite or distal the first end 313 at least one mounting slot 317. The mounting cartridge 330 may have at or proximal a corresponding second end 335 thereof opposite or distal the first end 333 at least one corresponding mounting tooth 336. The at least one mounting slot 317 and the at least one mounting tooth 336 may be so respectively and correspondingly sized, shaped, configured, and relatively positioned for receiving each mounting tooth 336 in a corresponding mounting slot 317 when the first sensor unit 310 is mounted in the mounting cartridge 330, as described herein, for selectively and releaseably retaining the first sensor unit 310 in the mounting cartridge 330 mounting bed 332.
[0026] In particular, and as shown in FIG’s 8 and 9, while in tilted orientation relative to the mounting cartridge 330, with an underside 318 of the first sensor unit 310 facing the mounting bed 332 of the mounting cartridge 330, and the first end 313 and second end 316 of the first sensor unit 310, on the one hand, and the first end 333 and the second end 335 of the mounting cartridge 330, on the other hand, in respective relative alignment, the first sensor unit 310 may be tilted at least somewhat in relation to the mounting cartridge 330, and the first sensor unit 310 and mounting cartridge 330 may be moved relatively to insert and mate the first sensor unit 310 mounting tongue 315 into the mounting cartridge 330 mounting groove 334, as illustrated by arrow 700. While retaining the mounting tongue 315 in the mounting groove 334, the first sensor unit 310 and the mounting cartridge 330 may then be moved relatively to move together the second end 316 of the first sensor unit 310 and the second end 335 of the mounting cartridge 330 to seat the underside 318 of the first sensor unit 310 in the mounting bed 332 of the mounting cartridge 330. In this connection, the mounting cartridge 330, or at least a portion at or about the second end 335 thereof, may be formed of a material which is sufficiently resilient and flexible such that as the second end 316 of the first sensor unit 310 and the second end 335 of the mounting cartridge 330 are moved together, the second end 335 of the mounting cartridge 330 may be bent and deflected slightly to provide clearance to seat the first sensor unit 310 fittingly in the mounting bed 332 of the mounting cartridge 330. Having done so, the second end 335 of the mounting cartridge 330 may be rebounded such that the second end 316 of the first sensor unit 310 and the second end 335 of the mounting bed 332 contact or face, and the at least one mounting tooth 336 may be reversibly received in the corresponding at least one mounting slot 317. In such arrangement, the mounting tongue 315 and the mounting groove 334, on the one hand, and the at least one mounting slot 317 and at least one mounting tooth 336, on the other hand, may cooperate to retain the first sensor unit 310 resiliently seated in the mounting cartridge 330 mounting bed 332. Such mounted state is shown particularly in FIG’s 2, 3 & 10. In particular, the first sensor unit 310 so mounted to the mounting cartridge 330 may be retained in alignment and position relative to the mounting cartridge 330, with no or minimal relative motion between the first sensor unit 310 and the mounting cartridge 330.
[0027] As shown in FIG. 11 , the first sensor unit 310 may include and contained within the housing 311 a processor 320 powered by a power source 321 (e.g. the battery mentioned above) and communicatively connected to the electrode cable port 314. The processor 320 may be communicatively coupled to at least one memory 325 which stores computer-readable instructions executable by and for causing the processor 320 to perform the functions and actions described herein. The processor 320 may be configured to use the at least one sensor 322 to collect measurements, and to use the at least one memory 325 to store the measurements. The first sensor unit 310 may have more than one memory 325, and in particular may have a first memory 325 configured for storage of computer- readable instructions for execution by the processor 320, and a second different memory 325 for storage of measurements made by the processor 320 using the at leaf one sensor 322. Other arrangements are possible and contemplated. The first sensor unit 310 may further include and contained within the housing 311 a communications module 323 communicatively coupled with the processor 320 and operable by the processor 320 for communication. For example, the communications module 323 may be or include a wireless transceiver. The processor 320 may be configured to use the communications module 323 to communicate, wired or wirelessly, which may be via a network 900, with one or more remote devices 910, which may include, without limitation, any one or more of a server, a mobile communications device such as a smartphone or tablet, or a base station which itself may be communicatively connected to a server or mobile communications device. The processor 320 may thus be configured to communicate and cooperate with such remote devices 910 to provide functionality, which may include, without limitation, transfer of collected measurements, processing of collected measurements, and display of collected measurements or processed data deriving from the collected measurements. For example, the remote devices 910 may include a smartphone or tablet configured with software, such as an app, operable using a communications device of the smartphone or tablet to receive directly or over the network 900 measurements from the first sensor unit 310, to process the measurements, and to display processed data on a display of the smartphone of tablet. For example, the smartphone or tablet may be configured to display one or more of a hear rate trace, an SpO2 trace, a blood pressure trace, or a head position. Other arrangements are possible and contemplated.
[0028] The first sensor unit 310 may further have at least one sensor 322 provided at the underside 318 thereof. Any suitable kind of sensor for the measurement and collection of physiological metrics is contemplated. In different embodiments, the at least one sensor 322 may be configured for measurement of one or more of heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position. For example, the at least one sensor 322 may include optical sensors, such as light sources and light sensors, electrodes, accelerometers, and magnetometers. Other alternatives are possible and contemplated. The at least one sensor 322 may be communicatively coupled with the processor 320 and operable by the processor 320 to perform measurement of one or more physiological metrics. The at least one sensor 322 may also be coupled with the power source 321 to be powered thereby, or it may be powered by the processor 320. Each one of the at least one sensor 322 may be located at a corresponding position of the underside 318 of the first sensor unit 310 such that when the first signal collection module 300 is placed on a patient 200 for measurement of physiological metrics, the sensor 322 is positioned at or relative to a specific surface location or physiological structure, such as a blood vessel, of the patient 200. [0029] As described above, the first sensor unit 310 may be mountable in the sensor unit mounting cartridge 330. As shown in FIG’s 6 to 7, the mounting cartridge 330 may include structures or properties selected for cooperation with the at least one sensor 322 of the first sensor unit 310 when the first sensor unit 310 is mounted in the mounting cartridge 330, such that when the first signal collection module 300 is placed on the patient 200, such structures or properties of the mounting cartridge 330 and the corresponding at least one sensor 322 of the first sensor unit 310 cooperate for measurement of the physiological metrics. For example, the mounting cartridge 330 may have at least one opening 337 in the mounting bed 332 thereof, wherein the at least one opening 337 is so sized, shaped, and positioned that when the first sensor unit 310 is mounted in the mounting cartridge 330 as described above, the at least one sensor 322 are aligned with corresponding ones of the at least one opening 337, so as to expose the at least one sensor 322 to an underside 338 of the mounting cartridge 330, which may also be considered an underside 338 of the first signal collection module 300 (see particularly FIG. 3). In this way, when the first signal collection module 300 as mounted on a surface of the patient 200, the at least one sensor 322 is exposed to the surface of the patient 200 for measurement of physiological metrics.
[0030] For example, in some embodiments of the system 100, the at least one sensor 322 of the first sensor unit 100 may include a PPG sensor 600. The PPG sensor 600 may include at least one light source 610 and at least one light-sensitive sensor 620. The light source 610 may include at least one light-emitting diode (LED) 612. The at least one LED 612 may include at least one of a red LED 614, an infrared LED 616, and a green LED 618. The at least one light-sensitive sensor 620 may include one or more sensors correspondingly light-sensitive to any one or more of the at least one light source 610 when present. For example, when the at least one light source 610 includes a red LED 614, then the at least one light-sensitive sensor 620 may be light-sensitive to light emitted by the red LED 614, and similarly for the infrared LED 616 and/or green LED 618 when present. For example, the at least one light-sensitive sensor 620 may include at least one photodiode 622. The processor 320 of the first sensor unit 310 may be operable to control the at least one light source 610 to illuminate the patient 200 including preconfigured physiological structures of the patient 200, and to control the at least one light-sensitive sensor 620 to detect and light transmitted through or reflected from those physiological structures. For example, when the physiological structures include at least one blood vessel, the processor 320 may be operable to control at least one of the red LED 614, infrared LED 616, and green LED 618 to illuminate the at least one blood vessel, and to operate the photodiode 622 to detect and measure light reflected from the at least one blood vessel.
[0031] In such non-limiting embodiments, the mounting cartridge 330 of the first signal collection module 300 may be sized, shaped, configured, and formed of such materials, so as to be mountable at or on the temple 205 of the patient 200. As described above, the mounting cartridge 300 mounting bed 332 may be formed with at least one opening 337 for exposing the at least one sensor 322 of the first sensor unit 310 to the underside 338 of the mounting cartridge 330 and thus to the patient 200 when the first signal collection module 300 is assembled and mounted on the patient 200. In particular, the first sensor unit 310 and the mounting cartridge 330 may be so sized, shaped, and configured, that the PPG sensor 600 protrudes or extends a preconfigured distance below the underside 339 of the mounting cartridge 330 (shown particularly in FIG’s 9 & 10, such that when the first signal collection module 300 is mounted to the patient 200, a preconfigured pressure is maintained between the PPG sensor 600 and the patient 200 surface.
[0032] In general, the mounting cartridge 330 may be mounted to the patient 200 before or after the first sensor unit 310 is mounted to the mounting cartridge 330. In particular, the mounting cartridge 330 may be mounted to the patient 200 first, and then the first sensor unit 310 may be mounted to the mounting cartridge 330. In such case, the at least one opening 337 in the mounting cartridge 330 may be useful when mounting the mounting cartridge 330 to the patient 200 to visually align the each of the at least one opening 337 to selected location and/or physiological structure of the patient 200. For example, the selected physiological structure may include one or more selected temporal arteries. A relative overlying position at or about the template 205 of the patient 200 may be located, and then the mounting cartridge 330 may be applied and mounted at or about the patient 200 temple 205 while visually aligning the at least one opening 337 to corresponding surface locations relative to the selected temporal arteries. With the mounting cartridge 330 so mounted, the first sensor unit 310 may then be inserted and mounted to the mounting cartridge 330, as described above. As described, the at least one sensor 322 may be positioned at the underside 318 of the first sensor unit 310 such that when the first sensor unit 310 is mounted to the mounting cartridge 330, each of the at least one sensor 322 aligns with a corresponding one of the at least one openings 337 of the mounting cartridge 330. For example, when the at least one sensor 322 includes the PPG sensor 600, including the at least one light source 610 and at least one light-sensitive sensor 620, such as the red LED 614, infrared LED 616, green LED 618, and photodiode 622, each of these may be aligned with a corresponding opening 337 of the mounting cartridge 330. And since, as described above, each of the openings 337 may be visually aligned with a surface location of the patient 200 relative to a selected physiological structure, such as one or more temporal arteries, in this manner each of the red LED 614, infrared LED 616, green LED 618, and photodiode 622 may be selectively and reliable aligned and positioned relative to the temporal arteries. While the first signal collection module 300 may be so mounted and placed at either the left or right temple 205 of the patient 200, the it may be placed in particular at the right temple 205 of the patient 200, for reasons described below.
[0033] The first signal collection module 300, and in particular the mounting cartridge 330, may be provided with other means and structures for cooperation with the at least one sensor 322 of the first sensor unit 310 for cooperation therewith the measure and monitor physiological metrics of the patient 200. For example, in relation to one or more of the at least one sensor 322, the mounting cartridge 330 may include in the mounting bed 332 thereof at or about a location adjacent the at least one sensor 322 when the first sensor unit 310 is mounted in the mounting cartridge 330 a coupling structure 340 which is operative to couple or intermediate the at least one sensor 322 with the surface of the patient 200 in relation to the specific physiological metric desired to be collected. For example, and without limitation, where the at least one sensor 322 operates to illuminate the patient 200 with preconfigured wavelengths of light, and mounting of the first signal collection module 300 on the patient 200 involves the application on the patient 200 surface a gel or other composition having a preconfigured refractive index, and the structure provided in the mounting cartridge 330 mounting bed 332 may be formed of a material having a refractive index matched to the refractive index of the gel or other composition applied to the patient 200. Alternatively or additionally, the at least one sensor 322 may include at least one electrode 630, which may be formed of a conductive material, which may include metal, which may include gold or silver, for measuring, for example, electrical signals at a contact surface of the patient 200. In such case, the coupling structure 340 may be or include a conductive film 341 or other conductive material, such as hydrogel patches, for providing conductive contact between the at least one electrode 630 and the surface of the patient 200. In general, any such structure may be provided and preconfigured to cooperate with the corresponding at least one sensor 322 so as to cooperate therewith and with any other preconfigured aspect of the system 100, patient 200, or preconfigured or expected aspect of the surrounding environment, based on and for the purpose of facilitating or improving the intended physiological metric measurement. [0034] The mounting cartridge 330 may further have at an underside 338 thereof an affixing layer 339 operable to affix the mounting cartridge 330 to the patient 200. For example, but without limitation, the affixing layer 339 may include an adhesive layer, which may include a plastic cover peelable off the adhesive layer to expose the adhesive layer for affixing contact with the patient 200. The mounting cartridge 330 may also have at least one tab 342 formed in the body 331 thereof, which may be two tabs, at or proximal the second end 335, which may be sized, shaped, and configured to be grasped by a person, such as the patient 200, which may useful for removal of the mounting cartridge 330 from the patient 200, wherein the at least one tab 342 may be configured to be grasped by the patient 200 or another person and pulled away from the patient 200 surface to peel or otherwise remove the mounting cartridge 330 from the patient 200 surface. The at least one tab 342 may also be useful to unseat and remove the first sensor unit 310 from the mounting bed 332 of the mounting cartridge 330. In particular, the at least one tab 342 may be graspable or pressable by the patient 200 or another person to bend and slightly deflect the second end 335 of the mounting cartridge 330 to decouple the at least one mounting tooth 336 and the corresponding at least one mounting slot 317, thereby to permit the second end 316 of the first sensor unit 310 to be raised and the first sensor unit 310 to be tilted to lift the second end 316 out of the mounting bed 332, and then to withdraw the mounting tongue 315 of the first sensor unit 310 from the mounting groove 334 of the mounting cartridge 330 - or, in other words, to perform the opposite of the procedure described above for mounting the first sensor unit 310 to the mounting cartridge 330. In this way, the first sensor unit 310 and the mounting cartridge 330 may be readily and repeatedly coupled and decoupled as described.
[0035] Thus, with reference to FIG. 13, a method 800 of mounting a signal collection module to a patient 200 may include providing a sensor unit (such as first sensor unit 310) and corresponding mounting cartridge (such as mounting cartridge 330) (step 810), mounting cartridge having at least one opening sized, shaped, and positioned in correspondence with at least one sensor of the sensor unit provided at an underside thereof. The mounting cartridge may then be applied, mounted, or affixed to a patient so as to align the at least one opening at, over, or about a surface location corresponding to a preconfigured target physiological structure (step 820). The sensor unit may then be inserted and seated in a mounting bed of the mounting cartridge, thereby positioning the at least one sensor of the sensor unit in alignment with the target physiological structure (step 830). The sensor unit may then be used and operated to measure physiological metrics related to the target physiological structure (step 840).
[0036] One embodiment of a second signal collection module 400 is illustrated figuratively in FIG 12. As with the first signal collection module 300, the second signal collection module 400 may have a second sensor unit 410 and an electrode cable port 415 for coupling with an opposite end of the electrode cable 500, thereby to communicatively couple the first sensor unit 310 and the second sensor unit 410. The second sensor unit 410 may also have at least one sensor 430. The second sensor unit 410 may be configured for the measurement of any desired preconfigured physiological metrics, either alone or in cooperation with the first sensor unit 310. In different embodiments, the physiological metrics may include one or more of heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position. Other configurations are possible and contemplated. The second signal collection module 400 and the second sensor unit 410, may be similarly configured as the first signal collection module 300 and first second unit 310, respectively, or they may be differently configured. For example, the second unit 410 may also have a processor 420, memory 425, power source 421 , and communications module 423. Alternatively, the second signal collection module 400 may omit one or more of these related structures. In such case, the second sensor unit 410, including the at least one sensor 430, may be operable by the processor 320 and powered by the power source 321 of the first sensor unit 310 via the electrode cable 500. Similar to the first signal collection module 300, the second signal collection module 400 may include such structures and materials for cooperation with the at least one sensor 430 of the second sensor unit 410 for mounting on the patient 200 at a preconfigured location and for selective preconfigured positioning of the at least one sensor 430 of the second sensor unit 410 relative to physiological structures of the patient 200 for measurement and collection of preconfigured physiological metrics.
[0037] In particular, in some embodiments, the processor 320 of the first signal collection module 300 may be configured to control and operate the at least one sensor 322 of the first sensor unit 310 and the at least one sensor 430 of the second signal collection module 400 in cooperation for the measurement and collection of preconfigured physiological metrics selectively from physiological structures of the patient 200 at or about where the first signal collection module 300 and second signal collection module 400 are respectively mounted to the patient 200. In particular, the processor 320 may operate and selectively coordinate the operation of the at least one sensor 322 of the first sensor unit 310 and the at least one sensor 430 of the second sensor unit 410 to measure and collect preconfigured physiological metrics from the respective mounting positions of the first signal collection module 300 and the second signal collection module 400 for processing and computing a resultant or derivative physiological metric based on the primary physiological metrics thus collected.
[0038] Thus, in some embodiments of the system 100, the signal collection module 400 may be or include an ECG sensor 700 configured with adhesive or other affixing means for affixing the ECG sensor 700 to the patient 200 at a selected location, such as on a chest 210 of the patient 200 at or about a surface location proximal the heart (not shown) of the patient 200. The at least one sensor 322 of the first sensor unit 310 of the first signal collection module 300 may further include at least one electrode 630 operable in cooperation with the ECG sensor 700 for measurement of ECG metrics of the patient 200. Such use may be enabled, improved, or facilitated by placement of the first signal collection module 300, and hence the at least one electrode 630 of the first sensor unit 310, at the right temple 205 of the patient 200 as shown in FIG. 1 , wherein the at least one electrode 630 may be operable as a reference electrode.
[0039] Before or after the first signal collection module 300 and the second signal collection module 400 are placed as described above, the first sensor unit 310 and the second sensor unit 410 may be connected using the electrode cable 500 by mating a first end 510 of the electrode cable 500 with the electrode cable port 314 of the first sensor unit 310 and a second end 520 of the electrode cable 500 with the electrode cable port 415 of the second sensor unit 410.
[0040] With the first signal collection module 300 and the second signal collection module 400 so applied and mounted to the patient 200 as the specific selected locations, and the first sensor unit 310 and the second sensor unit 410 communicatively connected by the electrode cable 500, the system 100 may be operated to collect preconfigured physiological metrics including at least one of: heart rate, peripheral oxygen saturation (SpO2), pulse rate, blood pressure, respiratory rate, temperature, motion intensity, and head or other body part position. Other configurations are possible and contemplated.
[0041] Thus, with reference to FIG. 14, a method 1000 of measuring physiological metrics of a patient 200 using the system 100 may include mounting the first signal collection module 300 at a temple of the patient 200 (step 1010), mounting the second signal collection module 400 on the chest 210 of the patient 200 at or about a surface location proximal the heart of the patient 200 (step 1020), communicatively connecting the first signal collection module 300 and the second signal collection module 400 (step 1030), which may be by the electrode cable 500, and then using the system 100 to measure the physiological metrics as described herein (step 1040).
[0042] In particular, some embodiments of the system 100 may be especially advantageous for the collection of PPG metrics by the first signal collection module 300. The particular configuration of the mounting cartridge 330 as described, including the use of the at least one opening 337 thereof for precise placement on the patient 200 and accurate relative alignment with the target physiological structures, such as selected temporal arteries, combined with the accurate and reliable alignment of the at least one sensor 322 of the first sensor unit 310, such as the one or more of the red LED 614, infrared LED 616, and green LED 618, as well as the photodiode 622, may result in the precise and reliable relative alignment and positioning of these with the target physiological structures, thereby enabling a more predictable and reliable collection of PPG metrics from those target physiological structures. In particular, placement of the first signal collection module 300 including PPG sensor 600 may avoid many of the disadvantages of other devices for PPG measurement described above by virtue of their placement and location at structures subject to not insignificant motion during the measurement process, such as, for example, on the wrist, hand, or finger, wherein such motion may cause relative motion of the sensors and target physiological structures, resulting in impaired selectivity of such physiological structures and stochastic average blurring resulting from collection from changing and extended regions of tissue and vasculature. Moreover, placement of the PPG sensor 600 at the patient 200 temple 205 may avoid the disadvantage of other PPG devices when placed at other body parts, such as, for example, on the wrist, hand, or finger, which impair, limit, or frustrate motion of the body part by virtue of the presence of the PPG device. Placement of the PPG sensor 600 at the patient 200 temple 205 may entirely or at least partly avoid this disadvantage.
[0043] Moreover, the described embodiment of the system 100 may be especially advantageous for the collection of PPG metrics by the first signal collection module 300, for the reasons given above, and ECG metrics by the first signal collection module 300 and the second signal collection module 400, as described above, specifically for the purpose of measuring and monitoring the blood pressure of the patient 200. As described above, blood pressure may be measured by way of measurement of pulse wave velocity (“PWV”), which may be done by the combined use of a PPG sensor and an ECG sensor. Thus, the processor 320 may be operable to operate the ECG sensor 700 of the second signal collection module 400 in combination with the at least one electrode 630 of the first signal collection module 300 to detect a start time of electrical stimulation of the ventricles of the heart of the patient 200, and simultaneously to operate the PPG sensor 600 of the first signal collection module 300 to detect an arrival time of a systolic pulse wave at the temple 205 the patient 200, and specifically within a selected one or plurality of temporal arteries. Given that the range of motion of the target location and structure for the PPG sensor 600, i.e. the temple 205 and selected temporal arteries, is very limited relative to the heart, the change of the effective length of the systolic pulse propagation path due to this cause may be eliminated or minimized. Moreover, since the mounting cartridge 330 and first sensor unit 310 may be collectively configured for precise and reliable placement of the PPG sensor 600 relative to the target temporal arteries, as described, it may be possible to be more selective as to which temporal arteries are measured, and thus less tissue and/or fewer arteries may contribute to the resultant signal, which may eliminate or minimize averaging resulting from such contributing structures having different effective path lengths. Moreover, when the communicative connection between first sensor unit 310 and the second sensor unit 410, such as by the electrode cable 500, can contribute no or minimal delay in the receipt by the processor 320 of a signal corresponding to the detection by the ECG sensor 700 of the start time of the electrical stimulation of the ventricles of the heart of the patient 200, the interval between the start time of the electrical stimulation of the ventricles of the heart, and arrival of the systolic pulse at the temple, may be more accurately and precisely determined. For all of the foregoing reasons, the system 100 so configured and operated may enable a more accurate and precise measurement of pulse wave velocity (“PWV”), and thus determination of blood pressure therefore, than was possible with previous devices.
[0044] Thus, with reference to FIG. 15, a method 1100 of using the system 100 to measure and determine a blood pressure of a patient 200 may include mounting and using the system 100 as described above, which may be in accordance with method 800 and method 1000, operating the system 100 to use the first sensor collection module 300 and the second sensor collection module 400 to detect an ECG signal of a start time of electrical stimulation of the ventricles of the heart of the patient 200 (step 1110), using the first sensor collection module 300 to detect a PPG signal of an arrival time of a systolic pulse wave at the patient 200 temple (step 1120), generating a pulse wave velocity based on the measured electrical stimulation start time and the systolic pulse wave arrival time (step 1130), and generating a blood pressure value based on the generated pulse wave velocity (step 1140).
[0045] Embodiments of the disclosure may overcome disadvantages and provide additional advantages over previous techniques. Disclosed embodiments allows secure attachment of a wearable device, such as the disclosed signal collection modules, which provide both electrical and physical contact for optimal signal collection of ECG and optical, such as PPG, signals. It may optimize alignment of the optical PPG sensor by attaching the cartridge first then the sensor unit, as described. It may maintain electrical contact between the sensor unit and the patient’s skin for ECG signal measurement. It may maintains correct pressure for optimal PPG signal collection. It may allows the sensor unit to be easily and conveniently removed for changing a battery or cleaning, or for the patient to shower, bathe, or go swimming, while the mounting cartridge remains mounted, and thus the alignment of the sensor unit sensors with the target physiological structures is retained once the sensor unit is again mounted. It may allows freedom of motion for arms as previous wearable devices which measure physiometric metrics typically attach either to the fingers or wrists. It allows for repositioning of the signal collection module and sensor unit. In view of the foregoing, it can reduce anxiety for the patient on changing the sensor unity as the mounting cartridge may ensure correct placement of the sensor unit by the patient. The mounting cartridge may be easily removed by the patient using tabs on the mounting cartridge. The mounting cartridge may be made inexpensively and easily disposed of which may enable the sensor unit to be reused reducing costs and environmental impact. The mounting cartridge may have a small footprint which may be almost the same size as the sensor unit, whereas previous wearable attachment mechanisms typically make use of bands or tabs which increase the size of the wearable device.
[0046] The following are non-limiting embodiments according to the present disclosure.
[0047] Embodiment 1. A signal collection module for measuring at least one physiological metric of a patient, the signal collection module comprising: a sensor unit comprising a housing and at least one sensor positioned at an underside of the housing, wherein the at least one sensor is operable to measure the at least one physiological metric; and a sensor unit mounting cartridge comprising a body forming a mounting bed sized, shaped, and configured to receive the sensor unit for fitting mounting of the sensor unit to the sensor unit mounting cartridge, the sensor unit mounting cartridge body having an underside configured for mounting to a patient at a site proximal a predetermined physiological structure of the patient corresponding to the at least one physiological metric; wherein: the sensor unit mounting cartridge body defines at least one opening between the mounting bed and the underside of the body, and the sensor unit housing and the sensor unit mounting cartridge mounting bed are so sized, shaped, and configured that when the sensor unit is mounted in the mounting bed the at least one sensor of the sensor unit is positioned in alignment with the at least one opening.
[0048] Embodiment 2. The signal collection module of Embodiment 1 , wherein the sensor unit housing and the sensor unit mounting cartridge mounting bed are so respectively sized, shaped, and configured such that when the sensor unit is mounted in the mounting bed of the sensor unit mounting cartridge a range of motion of the sensor unit relative to the sensor unit mounting cartridge is no greater than a preconfigured amount. [0049] Embodiment 3. The signal collection module of Embodiment 1 or 2, wherein: the sensor unit housing has a mounting tongue at or proximal a first end of the sensor unit housing; the sensor unit mounting cartridge has a mounting groove at or proximal a first end of the sensor unit mounting cartridge mounting bed; and the mounting tongue and the mounting groove are respectively sized, shaped, and configured for receiving the mounting tongue in the mounting groove for fitting mating of the mounting tongue and the mounting groove to retain the sensor unit body in the sensor unit mounting cartridge mounting bed and to retain the sensor unit in alignment and position relative to the sensor unit mounting cartridge.
[0050] Embodiment 4. The signal collection module of Embodiment 3, wherein: the sensor unit housing has at least one mounting slot at or proximal a second end of the sensor unit housing opposite the first end of the sensor unit housing; the sensor unit mounting cartridge has at least one mounting tooth at or proximal a second end of the sensor unit mounting cartridge mounting bed; and the at least one mounting tooth and the at least one mounting slot are respectively sized, shaped, and configured for receiving the at least one mounting tooth respectively and correspondingly in the at least one mounting slot for fitting mating of the at least one mounting tooth and the at least one mounting slot to retain the sensor unit body in the sensor unit mounting cartridge mounting bed and to retain the sensor unit in alignment and position relative to the sensor unit mounting cartridge. [0051] Embodiment 5. The signal collection module of Embodiment 4, wherein the sensor unit mounting cartridge has an affixing layer at the underside of the body to affix the sensor unit mounting cartridge to the patient.
[0052] Embodiment 6. The signal collection module of Embodiment 5 further comprising at least one tab formed in the body of the sensor unit mounting cartridge at or proximal the second end of the sensor unit mounting cartridge, wherein the at least one tab is sized, shaped, and configured to be graspable by the patient or another person to lift the sensor unit mounting cartridge body to remove the the sensor unit mounting cartridge from the patient.
[0053] Embodiment 7. The signal collection module of any one of Embodiments 1 to 6, wherein: the sensor unit further comprises: a processor communicatively coupled to operate the at least one sensor; at least one memory communicatively connected to the processor; a power source connected to power the processor; and a communications module communicatively coupled to the processor; wherein the at least one memory stores computer-readable instructions executable by the processor: to operate the at least one sensor to measure the at least one physiological metric; to store the at least one physiological metric in the at least one memory; and to operate the communications module to communicate the at least one physiological metric to a remote device.
[0054] Embodiment 8. The signal collection module of any one of Embodiments 1 to 7, wherein the at least one sensor comprises at least one of an optical sensor, an electrode, an accelerometer, and a magnetometer.
[0055] Embodiment 9. The signal collection module of any one of Embodiments 1 to 8, wherein the at least one sensor comprises at least one photoplethysmography (“PPG”) sensor comprising at least one light-emitting diode (“LED”) and at least one light-sensitive sensor.
[0056] Embodiment 10. The signal collection module of Embodiment 9, wherein the at least one sensor further comprises an electrode operable as an electrocardiography (“ECG”) reference electrode.
[0057] Embodiment 11 . A system for measuring at least one physiological metric of a patient, the system comprising: a first signal collection module comprising: a first sensor unit comprising: a housing; a first at least one sensor positioned at an underside of the housing; and a first electrode cable port; a sensor unit mounting cartridge comprising a body forming a mounting bed sized, shaped, and configured to receive the first sensor unit for fitting mounting of the first sensor unit to the sensor unit mounting cartridge, the sensor unit mounting cartridge body having an underside configured for mounting to a patient at a first site proximal a first predetermined physiological structure of the patient corresponding to the at least one physiological metric; wherein: the sensor unit mounting cartridge body defines at least one opening between the mounting bed and the underside of the body, and the first sensor unit housing and the sensor unit mounting cartridge mounting bed are so sized, shaped, and configured that when the first sensor unit is mounted in the mounting bed the first at least one sensor of the first sensor unit is positioned in alignment with the at least one opening; a second signal collection module configured for mounting to the patient at a second site proximal a second predetermined physiological structure of the patient corresponding to the at least one physiological metric, the second signal collection module comprising: a second sensor unit comprising: a second at least one sensor; and a second electrode cable port; and an electrode cable configured for mating at respective opposite ends with the first electrode cable port and the second electrode cable port to communicatively couple the first signal collection module and the second signal collection module; wherein the first at least one sensor and the second at least one sensor are together operable to measure the at least one physiological metric of the patient.
[0058] Embodiment 12. The system of Embodiment 11 , wherein: the first sensor unit further comprises: a processor communicatively coupled to operate the first at least one sensor and the second at least one sensor via the first electrode cable port and the electrode cable; at least one memory communicatively connected to the processor; a power source connected to power the processor; and a communications module communicatively coupled to the processor; wherein the at least one memory stores computer-readable instructions executable by the processor: to operate the first at least one sensor and the second at least one sensor to measure the at least one physiological metric; to store the at least one physiological metric in the at least one memory; and to operate the communications module to communicate the at least one physiological metric to a remote device.
[0059] Embodiment 13. The system of Embodiment 12, wherein the first at least one sensor comprises a photoplethysmography (“PPG”) sensor and a first electrocardiography (“ECG”) sensor, and the second at least one sensor comprises a second electrocardiography (“ECG”) sensor.
[0060] Embodiment 14. The system of Embodiment 13, wherein: the first site is a temple of the patient; the second site is on a chest of the patient proximal a heart of the patient; the computer-readable instructions are executable by the processor: to operate the first ECG sensor and the second ECG sensor to detect a start time of electrical stimulation of ventricles of the heart of the patient; and to operate the PPG sensor to detect an arrival time of a systolic pulse wave at the temple the patient.
[0061] Embodiment 15. The system of Embodiment 14, wherein the computer- readable instructions are further executable by the processor to generate a pulse wave velocity (“PWV”) based on the start time and the arrival time.
[0062] Embodiment 16. The system of Embodiment 15, wherein the computer- readable instructions are further executable by the processor to generate a blood pressure value based on the PWV.
[0063] Embodiment 17. A method for measuring at least one physiological metric of a patient, comprising: a) providing the system of Embodiment 11 ; A mounting the sensor unit mounting cartridge at the first site; c) mounting the first sensor unit in the mounting bed of the sensor unit mounting cartridge; d) mounting the second signal collection module at the second site; e) mating the electrode cable at respective opposite ends with the first electrode cable port and the second electrode cable port to communicatively couple the first signal collection module and the second signal collection module; and f) operating the first at least one sensor and the second at least one sensor to measure the at least one physiological metric of the patient.
[0064] Embodiment 18. The method of Embodiment 17, wherein the first at least one sensor comprises a photoplethysmography (“PPG”) sensor and a first electrocardiography (“ECG”) sensor, and the second at least one sensor comprises a second electrocardiography (“ECG”) sensor.
[0065] Embodiment 19. The method of Embodiment 18, wherein: the first site is a temple of the patient; the second site is on a chest of the patient proximal a heart of the patient; and the method comprises: operating the first ECG sensor and the second ECG sensor to detect a start time of electrical stimulation of ventricles of the heart of the patient; and operating the PPG sensor to detect an arrival time of a systolic pulse wave at the temple the patient.
[0066] Embodiment 20. The method of Embodiment 19, further comprising generating a pulse wave velocity (“PWV”) based on the start time and the arrival time.
[0067] Embodiment 21. The method of Embodiment 20, further comprising generating a blood pressure value based on the PWV.
[0068] So that the present disclosure may be more readily understood, certain terms are defined. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which embodiments of the invention pertain. While many methods and materials similar, modified, or equivalent to those described herein can be used in the practice of the embodiments of the present disclosure invention without undue experimentation, the preferred materials and methods are described herein. In some instances, well-known structures and devices are shown in block diagram form, rather than in detail, in order to avoid obscuring the present disclosure. These embodiments are described in sufficient detail to enable those of ordinary skill in the art to practice the invention, and it is to be understood that other embodiments may be utilized and that logical, mechanical, electrical, and other changes may be made without departing from the scope of the present disclosure.
[0069] Some portions of the description may be presented in terms of algorithms and symbolic representations of operations on, for example, data bits within a computer memory. These algorithmic descriptions and representations are the means used by those of ordinary skill in the data processing arts to most effectively convey the substance of their work to others of ordinary skill in the art. An algorithm is here, and generally, conceived to be a self-consistent sequence of acts leading to a desired result. The acts are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It has proven convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like.
[0070] It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Unless specifically stated otherwise as apparent from the discussion, it is appreciated that throughout the description, discussions utilizing terms such as “processing” or “computing” or “calculating” or “determining” or “displaying” or the like, can refer to the action and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system's registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission, or display devices.
[0071] An apparatus for performing the operations herein can implement the present disclosure. This apparatus may be specially constructed for the required purposes, or it may comprise a general-purpose computer, selectively activated or reconfigured by computer-readable instructions stored in the computer. Such a computer-readable instructions may be stored in a non-transient computer readable storage medium, such as, but not limited to, any type of disk including floppy disks, hard disks, optical discs, compact disc read-only memories (CD-ROMs), and magnetic-optical disks, read-only memories (ROMs), random access memories (RAMs), electrically programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), FLASH memories, magnetic or optical cards, etc., or any type of media suitable for storing electronic instructions either local to the computer or remote to the computer.
[0072] Any algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the required method. For example, any of the methods according to the present disclosure can be implemented in hard-wired circuitry, by programming a general-purpose processor, or by any combination of hardware and software. One of ordinary skill in the art will immediately appreciate that the invention can be practiced with computer system configurations other than those described, including hand-held devices, multiprocessor systems, microprocessor-based or programmable consumer electronics, digital signal processing (DSP) devices, set top boxes, network PCs, minicomputers, mainframe computers, and the like. Embodiments of the disclosure can also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network.
[0073] Disclosed methods may be implemented using computer software. If written in a programming language conforming to a recognized standard, sequences of instructions designed to implement the methods can be compiled for execution on a variety of hardware platforms and for interface to a variety of operating systems. In addition, the present disclosure is not made with reference to any particular programming language. It will be appreciated that a variety of programming languages may be used to implement the teachings of the present disclosure. Furthermore, it is common in the art to speak of software, in one form or another (e.g., program, procedure, application, driver,...), as taking an action or causing a result. Such expressions are merely a shorthand way of saying that execution of the software by a computer causes the processor of the computer to perform an action or produce a result. [0074] It is to be understood that various terms and techniques are used by those knowledgeable in the art to describe communications, protocols, applications, implementations, mechanisms, etc. One such technique is the description of an implementation of a technique in terms of an algorithm or mathematical expression. That is, while the technique may be, for example, implemented as executing code on a computer, the expression of that technique may be more aptly and succinctly conveyed and communicated as a formula, algorithm, or mathematical expression. Thus, one of ordinary skill in the art would recognize a block denoting A+B=C as an additive function whose implementation in hardware and/or software would take two inputs (A and B) and produce a summation output (C). Thus, the use of formula, algorithm, or mathematical expression as descriptions is to be understood as having a physical embodiment in at least hardware and/or software (such as a computer system in which the techniques of the disclosure may be practiced as well as implemented as an embodiment).
[0075] A machine-readable or computer-readable medium is understood to include any mechanism for storing or transmitting information in a form readable by a machine (e.g., a computer). For example, a machine-readable medium includes read only memory (ROM); random access memory (RAM); magnetic disk storage media; optical storage media; flash memory devices; electrical, optical, acoustical or other form of propagated signals which upon reception causes movement in matter (e.g. electrons, atoms, etc.) (e.g., carrier waves, infrared signals, digital signals, etc.); etc.
[0076] All terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting in any manner or scope. For example, as used in this specification and the appended claims, the singular forms "a," "an" and "the" can include plural referents unless the content clearly indicates otherwise. Numeric ranges recited within the specification are inclusive of the numbers defining the range and include each integer within the defined range. Throughout this disclosure, various aspects of this invention are presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges, fractions, and individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as individual numbers within that range, for example, 1 , 2, 3, 4, 5, and 6, and decimals and fractions, for example, 1.2, 3.8, 1%, and 4%. This applies regardless of the breadth of the range.
[0077] The terms “about” or “approximately” as used herein refer to variation in the numerical quantity that can occur, for example, through typical measuring techniques and equipment, with respect to any quantifiable variable, including, but not limited to, mass, volume, time, distance, voltage, and current. Further, given solid and liquid handling procedures used in the real world, there is certain inadvertent error and variation that is likely through differences in the manufacture, source, or purity of the ingredients used to make the compositions or carry out the methods and the like. The terms “about” and “approximately” also encompass these variations. Whether or not modified by either of the terms “about” or “approximately”, the claims include equivalents to the quantities.
[0078] In the preceding description, for purposes of explanation, numerous details are set forth in order to provide a thorough understanding of the embodiments. However, it will be apparent to one skilled in the art that these specific details are not required. In particular, it will be appreciated that the various additional features shown in the drawings are generally optional unless specifically identified herein as required. The above-described embodiments are intended to be examples only. Alterations, modifications and variations can be effected to the particular embodiments by those of skill in the art. The scope of the claims should not be limited by the particular embodiments set forth herein, but should be construed in a manner consistent with the specification as a whole.

Claims

WHAT IS CLAIMED IS:
1. A signal collection module for measuring at least one physiological metric of a patient, the signal collection module comprising: a sensor unit comprising a housing and at least one sensor positioned at an underside of the housing, wherein the at least one sensor is operable to measure the at least one physiological metric; and a sensor unit mounting cartridge comprising a body forming a mounting bed sized, shaped, and configured to receive the sensor unit for fitting mounting of the sensor unit to the sensor unit mounting cartridge, the sensor unit mounting cartridge body having an underside configured for mounting to a patient at a site proximal a predetermined physiological structure of the patient corresponding to the at least one physiological metric; wherein the sensor unit mounting cartridge body defines at least one opening between the mounting bed and the underside of the body, and the sensor unit housing and the sensor unit mounting cartridge mounting bed are so sized, shaped, and configured that when the sensor unit is mounted in the mounting bed the at least one sensor of the sensor unit is positioned in alignment with the at least one opening.
2. The signal collection module of claim 1 , wherein the sensor unit housing and the sensor unit mounting cartridge mounting bed are so respectively sized, shaped, and configured such that when the sensor unit is mounted in the mounting bed of the sensor unit mounting cartridge a range of motion of the sensor unit relative to the sensor unit mounting cartridge is no greater than a preconfigured amount.
3. The signal collection module of claim 1 or 2, wherein: the sensor unit housing has a mounting tongue at or proximal a first end of the sensor unit housing; the sensor unit mounting cartridge has a mounting groove at or proximal a first end of the sensor unit mounting cartridge mounting bed; and the mounting tongue and the mounting groove are respectively sized, shaped, and configured for receiving the mounting tongue in the mounting groove for fitting mating of the mounting tongue and the mounting groove to retain the sensor unit body in the sensor unit mounting cartridge mounting bed and to retain the sensor unit in alignment and position relative to the sensor unit mounting cartridge.
4. The signal collection module of claim 3, wherein: the sensor unit housing has at least one mounting slot at or proximal a second end of the sensor unit housing opposite the first end of the sensor unit housing; the sensor unit mounting cartridge has at least one mounting tooth at or proximal a second end of the sensor unit mounting cartridge mounting bed; and the at least one mounting tooth and the at least one mounting slot are respectively sized, shaped, and configured for receiving the at least one mounting tooth respectively and correspondingly in the at least one mounting slot for fitting mating of the at least one mounting tooth and the at least one mounting slot to retain the sensor unit body in the sensor unit mounting cartridge mounting bed and to retain the sensor unit in alignment and position relative to the sensor unit mounting cartridge.
5. The signal collection module of claim 4, wherein the sensor unit mounting cartridge has an affixing layer at the underside of the body to affix the sensor unit mounting cartridge to the patient.
6. The signal collection module of claim 5 further comprising at least one tab formed in the body of the sensor unit mounting cartridge at or proximal the second end of the sensor unit mounting cartridge, wherein the at least one tab is sized, shaped, and configured to be graspable by the patient or another person to lift the sensor unit mounting cartridge body to remove the sensor unit mounting cartridge from the patient.
7. The signal collection module of any one of claims 1 to 6, wherein: the sensor unit further comprises: a processor communicatively coupled to operate the at least one sensor; at least one memory communicatively connected to the processor; a power source connected to power the processor; and a communications module communicatively coupled to the processor; wherein the at least one memory stores computer-readable instructions executable by the processor: to operate the at least one sensor to measure the at least one physiological metric; to store the at least one physiological metric in the at least one memory; and to operate the communications module to communicate the at least one physiological metric to a remote device.
8. The signal collection module of any one of claims 1 to 7, wherein the at least one sensor comprises at least one of an optical sensor, an electrode, an accelerometer, and a magnetometer.
9. The signal collection module of any one of claims 1 to 8, wherein the at least one sensor comprises at least one photoplethysmography (“PPG”) sensor comprising at least one light-emitting diode (“LED”) and at least one light-sensitive sensor.
10. The signal collection module of claim 9, wherein the at least one sensor further comprises an electrode operable as an electrocardiography (“ECG”) reference electrode.
11. A system for measuring at least one physiological metric of a patient, the system comprising: a first signal collection module comprising: a first sensor unit comprising: a housing; a first at least one sensor positioned at an underside of the housing; and a first electrode cable port; a sensor unit mounting cartridge comprising a body forming a mounting bed sized, shaped, and configured to receive the first sensor unit for fitting mounting of the first sensor unit to the sensor unit mounting cartridge, the sensor unit mounting cartridge body having an underside configured for mounting to a patient at a first site proximal a first predetermined physiological structure of the patient corresponding to the at least one physiological metric; wherein the sensor unit mounting cartridge body defines at least one opening between the mounting bed and the underside of the body, and the first sensor unit housing and the sensor unit mounting cartridge mounting bed are so sized, shaped, and configured that when the first sensor unit is mounted in the mounting bed the first at least one sensor of the first sensor unit is positioned in alignment with the at least one opening; a second signal collection module configured for mounting to the patient at a second site proximal a second predetermined physiological structure of the patient corresponding to the at least one physiological metric, the second signal collection module comprising a second sensor unit comprising: a second at least one sensor; and a second electrode cable port; and an electrode cable configured for mating at respective opposite ends with the first electrode cable port and the second electrode cable port to communicatively couple the first signal collection module and the second signal collection module; wherein the first at least one sensor and the second at least one sensor are together operable to measure the at least one physiological metric of the patient.
12. The system of claim 11 , wherein: the first sensor unit further comprises: a processor communicatively coupled to operate the first at least one sensor and the second at least one sensor via the first electrode cable port and the electrode cable; at least one memory communicatively connected to the processor; a power source connected to power the processor; and a communications module communicatively coupled to the processor; wherein the at least one memory stores computer-readable instructions executable by the processor: to operate the first at least one sensor and the second at least one sensor to measure the at least one physiological metric; to store the at least one physiological metric in the at least one memory; and to operate the communications module to communicate the at least one physiological metric to a remote device.
13. The system of claim 12, wherein the first at least one sensor comprises a photoplethysmography (“PPG”) sensor and a first electrocardiography (“ECG”) sensor, and the second at least one sensor comprises a second electrocardiography (“ECG”) sensor.
14. The system of claim 13, wherein: the first site is a temple of the patient; the second site is on a chest of the patient proximal a heart of the patient; the computer-readable instructions are executable by the processor: to operate the first ECG sensor and the second ECG sensor to detect a start time of electrical stimulation of ventricles of the heart of the patient; and to operate the PPG sensor to detect an arrival time of a systolic pulse wave at the temple the patient.
15. The system of claim 14, wherein the computer-readable instructions are further executable by the processor to generate a pulse wave velocity (“PWV”) based on the start time and the arrival time.
16. The system of claim 15, wherein the computer-readable instructions are further executable by the processor to generate a blood pressure value based on the PWV.
17. A method for measuring at least one physiological metric of a patient, comprising: a) providing the system of claim 11 ; b) mounting the sensor unit mounting cartridge at the first site; c) mounting the first sensor unit in the mounting bed of the sensor unit mounting cartridge; d) mounting the second signal collection module at the second site; e) mating the electrode cable at respective opposite ends with the first electrode cable port and the second electrode cable port to communicatively couple the first signal collection module and the second signal collection module; and f) operating the first at least one sensor and the second at least one sensor to measure the at least one physiological metric of the patient.
18. The method of claim 17, wherein the first at least one sensor comprises a photoplethysmography (“PPG”) sensor and a first electrocardiography (“ECG”) sensor, and the second at least one sensor comprises a second electrocardiography (“ECG”) sensor.
19. The method of claim 18, wherein: the first site is a temple of the patient; the second site is on a chest of the patient proximal a heart of the patient; and the method comprises: operating the first ECG sensor and the second ECG sensor to detect a start time of electrical stimulation of ventricles of the heart of the patient; and operating the PPG sensor to detect an arrival time of a systolic pulse wave at the temple the patient.
20. The method of claim 19, further comprising generating a pulse wave velocity (“PWV”) based on the start time and the arrival time.
21. The method of claim 20, further comprising generating a blood pressure value based on the PWV.
PCT/CA2023/050050 2022-01-27 2023-01-18 Wearable vital signs monitoring device WO2023141700A1 (en)

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Citations (1)

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Publication number Priority date Publication date Assignee Title
US20120296174A1 (en) * 2011-02-18 2012-11-22 Mccombie Devin Modular wrist-worn processor for patient monitoring

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120296174A1 (en) * 2011-02-18 2012-11-22 Mccombie Devin Modular wrist-worn processor for patient monitoring

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