WO2016134374A1 - System and method for health monitoring - Google Patents

System and method for health monitoring Download PDF

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Publication number
WO2016134374A1
WO2016134374A1 PCT/US2016/018966 US2016018966W WO2016134374A1 WO 2016134374 A1 WO2016134374 A1 WO 2016134374A1 US 2016018966 W US2016018966 W US 2016018966W WO 2016134374 A1 WO2016134374 A1 WO 2016134374A1
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WO
WIPO (PCT)
Prior art keywords
component
sensor
health monitor
communications
sensor component
Prior art date
Application number
PCT/US2016/018966
Other languages
French (fr)
Inventor
Deli Wang
Hongtao Hou
Original Assignee
Neem Scientific, Inc.
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 Neem Scientific, Inc. filed Critical Neem Scientific, Inc.
Publication of WO2016134374A1 publication Critical patent/WO2016134374A1/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
    • A61B5/0205Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A61B5/02055Simultaneously evaluating both cardiovascular condition and temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/002Monitoring the patient using a local or closed circuit, e.g. in a room or building
    • 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
    • A61B5/683Means for maintaining contact with the body
    • A61B5/6832Means for maintaining contact with the body using adhesives
    • A61B5/6833Adhesive patches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0242Operational features adapted to measure environmental factors, e.g. temperature, pollution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08Sensors provided with means for identification, e.g. barcodes or memory chips
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves 
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531Measuring skin impedance
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1118Determining activity level
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/48Other medical applications
    • A61B5/4806Sleep evaluation

Definitions

  • the invention relates to wearable health monitors.
  • Wearable health monitors such as those involving the measure of movement or certain physiological quantities, are becoming ubiquitous, particularly with the advent of Fitbit® devices, the Apple Watch®, Samsung Gear® devices, and the like. However, such tend to be limited to particular types of sensors or are general-purpose computing environments that tend to be "jack of all trades and master of none" types of devices.
  • a health monitor has a two-piece design.
  • the first piece constitutes a sensor component, and in many cases is a flexible patch, which in various implementations may be disposable or not, and which contains one or more sensors.
  • the second piece is a more permanent communications component or communication module, which again can be disposable or not, and which handles data acquisition, temporary storage, and transmission to other devices.
  • Such other devices may include, e.g., cloud-based servers, smart phones, smart watches, dedicated receivers, or the like.
  • the disposable patch or sensor component may be adhesively attached to a patient's body in a less intrusive way than typical current wearable products. The same can be afforded a very small form factor, and may also be removable at the user's convenience, e.g., when taking a shower or bath.
  • the disposable patch component may be reused or disposed.
  • the communications component generally incorporates a connection to the sensor component and a communications link, e.g., by establishing a pairing with a phone or other base station, e.g., laptop, tablet computer, or the like.
  • the pairing may be permanent or not. If the communications component is disposable, then generally the user has to pair the phone with the communications component every time a new communications component is used.
  • the patch (sensor component) and the communications component generally have two connections between them - a mechanical connection and an electrical connection. Both connections may be configured to be convenient for mounting and dismounting. In the description below, these two connections are accomplished via isolated elements. It will be understood that a unitary element may also be employed to provide both functions.
  • the mechanical connection serves to fasten the communications component to the sensor component.
  • the same may be via a Velcro® or other such mechanism, e.g., other hook and loop fastener connections, watchband type connections, buttons, snaps, or the like.
  • the electrical connection may be such that one component, the sensor component or the communications component, has an integrated cable that is coupled to a connector on the other component.
  • the cable may couple to a connector on each of the sensor component and the communications component, particularly where the cable is reusable but the sensor component and the communications component are not.
  • the electrical connection may be via a flexible electrical connector.
  • the electrical connection provides a conduit for power from the communications component to the sensor component.
  • the electrical connection may also provide a conduit for signal communications between the sensor component and the communications component.
  • the electrical connection may be through a wireless RFID.
  • an identification may be applied onto each patch, e.g., a barcode, 2D barcode, QR code, or other such component, for traceability and other such identification.
  • LED or other such indicators may be provided on the communications component to communicate status and other information.
  • the invention is directed towards a health monitor, including: a sensor component, the sensor component configured to be worn by a user and including one or more sensors; and a communications component, the communications component configured to be worn by the user, where the sensor component and the communications component are coupled using at least one physical connection and at least one electrical (wired or wireless) connection.
  • Implementations of the invention may include one or more of the following.
  • the sensor component may be configured to be attached to the user, e.g., adhesively attached.
  • the sensor component may be reusable or disposable, as may the communications component.
  • the communications component may be configured for communications with an external device, where the communications may involve pairing via an RF wireless protocol and the external device is a smartphone or smart watch.
  • the electrical connection may provide at least one source of power to the sensor and at least one signal path from the sensor to the communications component.
  • the physical connection may include, e.g., a hook and loop fastener, a button, a watchband, or a snap.
  • the sensor component may include at least one identification device, whereby the sensor component may be identified and traced.
  • the communications component may include at least one user interface element, whereby status or other information may be communicated.
  • the electrical connection and the physical connection may be configured to be detachable at the sensor component or at the communications component, whereby the sensor component may be rendered disposable, and where the communications component may be reused with a new or subsequent sensor component.
  • the invention is directed towards a computer-readable medium, including instructions for causing a computing environment to perform a method of health monitoring using the health monitor described above, the method including steps of: upon making an electrical connection between the sensor component and the communications component, initializing at least one sensor and receiving a signal from the sensor; and providing an indication of a status of the sensor on the user interface element.
  • Implementations of the invention may include one or more of the following.
  • the providing an indication may include activating a visual or audible user interface element, or communicating a signal to a connected device for display of a status, e.g., may include lighting an LED.
  • the invention is directed towards a health monitor, including: a sensor component, the sensor component including at least two sensors selected from the group consisting of: heart rate, skin conductance, temperature, pressure, sound and ultrasonic wave, motion, blood oxygen level, glucose, DNA, protein, vitamin, UV light intensity, air quality, carbon monoxide, toxic gas, chemicals, and location, the sensor component including an adhesive patch configured to be worn by a user, the sensor component including a first mechanical coupling configured to couple to a user and a second mechanical coupling configured to couple to a communications component; a communications component, the communications component configured to be worn by the user, the communications component further configured to receive a signal from the sensor component using a flexible circuit and to transmit an indication of the signal from the sensor to a mobile device using an RF wireless communications scheme; where the second mechanical coupling includes a hook and loop fastener system on a strap, and where the communications component is configured to be securely held against egress by the strap.
  • a sensor component including at least two sensors selected from the group consisting of: heart rate
  • Implementations of the invention may include one or more of the following.
  • the first mechanical coupling may include an adhesive, e.g., the sensor component may be configured as or within an adhesive patch.
  • Advantages of the invention may include, in certain embodiments, one or more of the following.
  • the systems and methods according to present principles may be employed to conveniently allow integration of numerous types of sensors within a single platform-type module. With the use of unified protocols and connections for power integration in signal coupling, multiple types of sensors may be employed on a single sensor component, and the multiple types of sensors effectively taken advantage of for physiological and activity monitoring of a host.
  • Other advantages will be understood from the description that follows, including the figures and claims.
  • Fig. 1 illustrates schematically an exemplary sensor system coupled by a flexible cable to a connector.
  • Fig. 2 is an outside view of a patch, e.g., sensor component, according to present principles.
  • Fig. 3 is an inside view of a patch, e.g., sensor component, according to present principles.
  • Fig. 4 is an inside view of the patch, showing an adhesive surface and a sensor portion according to present principles.
  • FIG. 5 is a top schematic illustration of a first implementation of a communication module according to present principles.
  • FIG. 6 is a top schematic illustration of a second implementation of a communication module according to present principles.
  • Fig. 7 is a bottom view of the communication module of Fig. 5.
  • Fig. 8 is a bottom view of the communication module of Fig. 6.
  • Fig. 9 shows a first step of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
  • Fig. 10 shows a second step of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
  • Fig. 1 1 shows a third step of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
  • Fig. 12 shows fourth and fifth steps of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
  • FIGs. 13(A) and 13(B) illustrate an alternative implementation of a sensor component according to present principles.
  • Figs. 14(A) - 14(C) illustrate another alternative implementation of a sensor component according to present principles.
  • Figs. 15(A) - 15(D) illustrate exemplary sizes for the sensor component of Fig. 14 (Fig. 15(A) and 15(B)), along with a related implementation (Figs. 15(C) and 15(D)).
  • Figs. 16(A) - 16(F) illustrate an application of the sensor component and communications component for the use case of real-time body temperature monitoring, along with an exemplary user interface on, e.g., a smart phone.
  • a sensor backplane 10 provides a substrate or support for one or more sensors 14.
  • the one or more sensors 14 are signally coupled via leads 16 to a connector 23 via a flexible cable bundle 18.
  • the connector 23 may be, e.g., a 6-pin connector allowing coupling to a communications component (the communications component providing both communications functionality as well as power to the sensor).
  • the connector 23 can be virtual and be a wireless RFID connection.
  • the connector 23 is a six pin male connector.
  • the sensor backplane 10 may be, e.g., 5 mm x 5 mm, and may be, e.g., 2 mm thick.
  • the sensors may be coupled to the backplane or substrate via a thermal conducting epoxy. In some cases the sensors may be incorporated directly into a band (described below) without a sensor substrate or backplane.
  • Fig. 2 illustrates an outside view of the sensor component, e.g., showing certain portions that would be visible even when the system according to present principles (here the system refers to the combination of a sensor component and a communications component) is in use on a patient or user.
  • the sensor component generally has a band or strap 25 on which the sensor backplane 10 is mounted (not shown in Fig. 2).
  • a barcode or QR code 22 may be provided to allow traceability of the particular sensor component, as well as for identification purposes. For example, the same may indicate a production lot, the same may indicate the type of sensor(s) provided, the same may identify an owner or user, or the like.
  • a Velcro® portion 21 is illustrated, which is employed later in mounting the communications component to the band 25.
  • Fig. 3 illustrates an inside or bottom view of the band 25, illustrating protective layers 24 that may be peeled off to reveal an adhesive portion that may subsequently be employed to adhere the sensor component to the patient.
  • the adhesive portion is shown as elements 28, which also shows the sensor portion 10.
  • This "inside” or “bottom” view generally shows the band prior to mounting on a user. Once mounted on a user, this view would generally not be visible.
  • Fig. 5 shows a communications component 20a having an oval shape.
  • the communications component 20a may be provided with a vivid color 32 for identification.
  • Fig. 6 illustrates a communications component having a rectangular, rather than an oval shape. It will be clear to one of ordinary skill in the art given this teaching that other shapes are also possible, e.g., square shapes, circular shapes, and so on.
  • the communications components 20a and 20b also include a connector 29 for coupling to the connector 23.
  • the connector 29 may be, e.g., a matching female connector.
  • Both the sensor component and the communications component may be constructed of soft biocompatible materials for comfort to the user.
  • Figs. 7 and 8 illustrate bottom surfaces 34a and 34b of communications components 20a and 20b, respectively, along with respective Velcro® surfaces 36 and 36' .
  • the communications component generally includes a battery, a data acquisition circuit, a memory, a power management circuit, and a communications circuit for communications to an external device, e.g., a smart phone or the like, as has been described elsewhere.
  • the communication component may or may not include a sensor or sensors as well.
  • the communications may be, e.g., short range RF wireless communications, e.g., via Bluetooth®, NFC, WiFi, or the like. In some cases no such communications are necessary, and a visual (or audible or tactile) display on the communications component, e.g., via LEDs or a small LCD display, may communicate measurement data from the sensor component to the user.
  • Figs. 9-12 illustrate an exemplary mounting procedure for use of systems and methods according to present principles.
  • a user opens an appropriate mobile app on their smart phone 30, and scans the 2-D barcode 22 on the band 25, i.e., on the outside of the patch.
  • the communications component 20b may then be mounted by coupling the connector 23 with the connector 29 (not shown in Fig. 10).
  • the communications component 20b may then be folded such that its Velcro® surface 36' matches up with the Velcro® surface 21 on the band 25, holding the communications component securely, during use, to the sensor component.
  • the protective layer may then be peeled off and the patch attached to the body. If necessary, in the mobile app, the smart phone may be appropriately paired with the communications component if such pairing has not already been performed.
  • Figs. 13(A) and 13(B) illustrate other patch designs.
  • a patch 45 is illustrated having an open center 46.
  • the area 44 indicates areas of adhesives, while the area 42 illustrates patch areas without adhesive.
  • a communication component/sensor component 40 may be held in place by the patch 45, but may partially protrude through the same, due to the open hole 46.
  • Fig. 14(A)-14(C) illustrate yet another patch 50, this design termed a "back sticking" type.
  • Fig. 14(A) illustrates a "front" side, which faces the user's skin.
  • Fig. 14(B) illustrates a backside, which is adjacent the communications component.
  • a window 56 is illustrated for sensor access.
  • the portion 52 and 54 indicate where an adhesive may be placed, and a portion 55 is indicated without adhesive.
  • a significant portion of the patch 50 contacts the skin, although sensor access is provided through the hole 56.
  • the adhesive portion 54 may be used for mounting the communications component and sensor component (shown as combination 51), or Velcro® or other like fastener may also be used.
  • Figs. 15(A)-15(B) show exemplary sizing for components of Fig. 14(A)-14(C). Where a circular patches desired, the alternative implementation of Figs. 15(C)-15(D) show exemplary sizing. It will be understood that such sizing is purely exemplary and that various other sizing options are available as may be dictated by the particular type of sensor and communication component.
  • Figs. 16(A)- 16(F) illustrate an implementation of systems and methods according to present principles as applied to the case of real-time body temperature monitoring.
  • Fig. 16(A) illustrates a sensor component (left) and a communications component (right), while Figs. 16(B) -16(E) illustrate various views of the two in combination.
  • Fig. 16(F) illustrates an exemplary user interface showing a result of the measurement of the sensor.
  • the communications component may include an LED display which may provide indications via colored LEDs of various status indicators. For example, appropriate color schemes may be encoded for indicating, e.g., good connection to the sensor, sensor needs replacement, data is being transmitted, communications component needs replacement or a new battery, and so on.
  • the sensors may be connected by the user to the sensor component or the sensors may be manufactured to be integral with the sensor component.
  • the communications component may be manufactured to be integral with the sensor component.
  • the band 25 may be replaced with other means of a fixing the systems according to present principles to a user, including, e.g., a wristband.
  • the type of sensors employed may vary, but the same may include, e.g., those measuring temperature, pressure, motion, pulse, blood oxygen level, glucose, UV light intensity, air quality, carbon monoxide, toxic gas, and so on.
  • Systems and methods according to present principles may be employed in various fields of use, including, e.g., child activity monitoring, fever monitoring, sleep monitoring, early death prevention, and so on.
  • Other fields include pregnancy planning, fetus activity monitoring, monitoring of activity levels of pregnant users, depression monitoring, and so on.
  • Further fields include elder well-being, UV level alerts, sleep monitoring, applications in remote clinical monitoring or nursing, sports (e.g., dancing, diving, golf, and so on), field worker well-being monitoring, particularly for dangerous occupations such as mine workers, firefighters, police, and so on.
  • Yet other potential applications include those related to smart farming, pet well-being or activity monitoring, home security, oilfield or other driller structure integrity monitoring, big tree well-being and failing or falling tree alerts and alarms, phone or other device unlock mechanisms, reminder functionality, and so on.
  • the major embodiments described here relate to human host monitoring, systems and methods according to present principles may be advantageously employed in monitoring of pets, other animals, livestock, vehicles, machines, plants, trees, and the like.
  • the communications component may incorporate a sensor, and the "sensor component" is passive, e.g., has no sensor loaded, and primarily acts to attach the system including communications component to the user.
  • the sensor does not require direct communications with the body of the host.
  • the sensor senses toxic gas, carbon monoxide, air quality, or the like.
  • the system and method may be fully implemented in any number of computing devices.
  • instructions are laid out on computer readable media, generally non- transitory, and these instructions are sufficient to allow a processor in the computing device to implement the method of the invention.
  • the computer readable medium may be a hard drive or solid state storage having instructions that, when run, are loaded into random access memory.
  • Inputs to the application e.g., from the plurality of users or from any one user, may be by any number of appropriate computer input devices.
  • users may employ a keyboard, mouse, touchscreen, joystick, trackpad, other pointing device, or any other such computer input device to input data relevant to the calculations.
  • Data may also be input by way of an inserted memory chip, hard drive, flash drives, flash memory, optical media, magnetic media, or any other type of file - storing medium.
  • the outputs may be delivered to a user by way of a video graphics card or integrated graphics chipset coupled to a display that maybe seen by a user. Alternatively, a printer may be employed to output hard copies of the results. Given this teaching, any number of other tangible outputs will also be understood to be contemplated by the invention. For example, outputs may be stored on a memory chip, hard drive, flash drives, flash memory, optical media, magnetic media, or any other type of output.
  • the invention may be implemented on any number of different types of computing devices, e.g., personal computers, laptop computers, notebook computers, net book computers, handheld computers, personal digital assistants, mobile phones, smart phones, tablet computers, and also on devices specifically designed for these purpose.
  • a user of a smart phone or Bluetooth® or Wi-Fi - connected device downloads a copy of the application to their device from a server using a wireless Internet connection.
  • An appropriate authentication procedure and secure transaction process may provide for payment to be made to the seller.
  • the application may download over the mobile connection, or over the WiFi or Bluetooth® or other wireless network connection.
  • the application may then be run by the user.
  • Such a networked system may provide a suitable computing environment for an implementation in which a plurality of users provide separate inputs to the system and method.
  • the plural inputs may allow plural users to input relevant data at the same time, or may allow plural inputs (sensors) to provide plural physiological measurements at the same time.

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Abstract

Systems and methods are disclosed that provide a health monitor with a two- piece design. The first piece constitutes a sensor component, and in many cases is a flexible patch, which in various implementations may be disposable or not, and which contains one or more sensors. The second piece is a more permanent communications component or communication module, which again can be disposable or not, and which handles data transmission to other devices. Such other devices may include, e.g., cloud-based servers, smart phones, smart watches, dedicated receivers, or the like.

Description

TITLE
SYSTEM AND METHOD FOR HEALTH MONITORING
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefit of priority of U.S. Provisional Patent Application 62/118,541, filed February 20, 2015, entitled "HEALTH MONITOR", which is incorporated by reference herein in its entirety.
FIELD
[0002] The invention relates to wearable health monitors.
BACKGROUND
[0003] Wearable health monitors, such as those involving the measure of movement or certain physiological quantities, are becoming ubiquitous, particularly with the advent of Fitbit® devices, the Apple Watch®, Samsung Gear® devices, and the like. However, such tend to be limited to particular types of sensors or are general-purpose computing environments that tend to be "jack of all trades and master of none" types of devices.
[0004] There is a need in the art for more general platforms for providing wearable sensors that are specific, that provide a small form factor, and yet incorporate high accuracy.
[0005] This Background is provided to introduce a brief context for the Summary and Detailed Description that follow. This Background is not intended to be an aid in determining the scope of the claimed subject matter nor be viewed as limiting the claimed subject matter to implementations that solve any or all of the disadvantages or problems presented above. SUMMARY
[0006] Systems and methods according to present principles meet the needs of the above in several ways. In one implementation, a health monitor has a two-piece design. The first piece constitutes a sensor component, and in many cases is a flexible patch, which in various implementations may be disposable or not, and which contains one or more sensors. The second piece is a more permanent communications component or communication module, which again can be disposable or not, and which handles data acquisition, temporary storage, and transmission to other devices. Such other devices may include, e.g., cloud-based servers, smart phones, smart watches, dedicated receivers, or the like.
[0007] The disposable patch or sensor component may be adhesively attached to a patient's body in a less intrusive way than typical current wearable products. The same can be afforded a very small form factor, and may also be removable at the user's convenience, e.g., when taking a shower or bath. The disposable patch component may be reused or disposed.
[0008] The communications component generally incorporates a connection to the sensor component and a communications link, e.g., by establishing a pairing with a phone or other base station, e.g., laptop, tablet computer, or the like. The pairing may be permanent or not. If the communications component is disposable, then generally the user has to pair the phone with the communications component every time a new communications component is used.
[0009] The patch (sensor component) and the communications component generally have two connections between them - a mechanical connection and an electrical connection. Both connections may be configured to be convenient for mounting and dismounting. In the description below, these two connections are accomplished via isolated elements. It will be understood that a unitary element may also be employed to provide both functions.
[0010] The mechanical connection serves to fasten the communications component to the sensor component. The same may be via a Velcro® or other such mechanism, e.g., other hook and loop fastener connections, watchband type connections, buttons, snaps, or the like.
[0011] The electrical connection may be such that one component, the sensor component or the communications component, has an integrated cable that is coupled to a connector on the other component. Alternatively, the cable may couple to a connector on each of the sensor component and the communications component, particularly where the cable is reusable but the sensor component and the communications component are not. The electrical connection may be via a flexible electrical connector. The electrical connection provides a conduit for power from the communications component to the sensor component. The electrical connection may also provide a conduit for signal communications between the sensor component and the communications component. The electrical connection may be through a wireless RFID.
[0012] In additional implementations, an identification may be applied onto each patch, e.g., a barcode, 2D barcode, QR code, or other such component, for traceability and other such identification. Likewise, LED or other such indicators may be provided on the communications component to communicate status and other information.
[0013] In one aspect, the invention is directed towards a health monitor, including: a sensor component, the sensor component configured to be worn by a user and including one or more sensors; and a communications component, the communications component configured to be worn by the user, where the sensor component and the communications component are coupled using at least one physical connection and at least one electrical (wired or wireless) connection.
[0014] Implementations of the invention may include one or more of the following. The sensor component may be configured to be attached to the user, e.g., adhesively attached. The sensor component may be reusable or disposable, as may the communications component.
[0015] The communications component may be configured for communications with an external device, where the communications may involve pairing via an RF wireless protocol and the external device is a smartphone or smart watch. The electrical connection may provide at least one source of power to the sensor and at least one signal path from the sensor to the communications component. The physical connection may include, e.g., a hook and loop fastener, a button, a watchband, or a snap. The sensor component may include at least one identification device, whereby the sensor component may be identified and traced. The communications component may include at least one user interface element, whereby status or other information may be communicated. The electrical connection and the physical connection may be configured to be detachable at the sensor component or at the communications component, whereby the sensor component may be rendered disposable, and where the communications component may be reused with a new or subsequent sensor component.
[0016] In another aspect, the invention is directed towards a computer-readable medium, including instructions for causing a computing environment to perform a method of health monitoring using the health monitor described above, the method including steps of: upon making an electrical connection between the sensor component and the communications component, initializing at least one sensor and receiving a signal from the sensor; and providing an indication of a status of the sensor on the user interface element.
[0017] Implementations of the invention may include one or more of the following.
[0018] The providing an indication may include activating a visual or audible user interface element, or communicating a signal to a connected device for display of a status, e.g., may include lighting an LED.
[0019] In yet a further aspect, the invention is directed towards a health monitor, including: a sensor component, the sensor component including at least two sensors selected from the group consisting of: heart rate, skin conductance, temperature, pressure, sound and ultrasonic wave, motion, blood oxygen level, glucose, DNA, protein, vitamin, UV light intensity, air quality, carbon monoxide, toxic gas, chemicals, and location, the sensor component including an adhesive patch configured to be worn by a user, the sensor component including a first mechanical coupling configured to couple to a user and a second mechanical coupling configured to couple to a communications component; a communications component, the communications component configured to be worn by the user, the communications component further configured to receive a signal from the sensor component using a flexible circuit and to transmit an indication of the signal from the sensor to a mobile device using an RF wireless communications scheme; where the second mechanical coupling includes a hook and loop fastener system on a strap, and where the communications component is configured to be securely held against egress by the strap.
[0020] Implementations of the invention may include one or more of the following. The first mechanical coupling may include an adhesive, e.g., the sensor component may be configured as or within an adhesive patch.
[0021] Advantages of the invention may include, in certain embodiments, one or more of the following. The systems and methods according to present principles may be employed to conveniently allow integration of numerous types of sensors within a single platform-type module. With the use of unified protocols and connections for power integration in signal coupling, multiple types of sensors may be employed on a single sensor component, and the multiple types of sensors effectively taken advantage of for physiological and activity monitoring of a host. Other advantages will be understood from the description that follows, including the figures and claims.
[0022] This Summary is provided to introduce a selection of concepts in a simplified form. The concepts are further described in the Detailed Description section. Elements or steps other than those described in this Summary are possible, and no element or step is necessarily required. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended for use as an aid in determining the scope of the claimed subject matter. The claimed subject matter is not limited to implementations that solve any or all disadvantages noted in any part of this disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Fig. 1 illustrates schematically an exemplary sensor system coupled by a flexible cable to a connector. [0024] Fig. 2 is an outside view of a patch, e.g., sensor component, according to present principles.
[0025] Fig. 3 is an inside view of a patch, e.g., sensor component, according to present principles.
[0026] Fig. 4 is an inside view of the patch, showing an adhesive surface and a sensor portion according to present principles.
[0027] Fig. 5 is a top schematic illustration of a first implementation of a communication module according to present principles.
[0028] Fig. 6 is a top schematic illustration of a second implementation of a communication module according to present principles.
[0029] Fig. 7 is a bottom view of the communication module of Fig. 5.
[0030] Fig. 8 is a bottom view of the communication module of Fig. 6.
[0031] Fig. 9 shows a first step of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
[0032] Fig. 10 shows a second step of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
[0033] Fig. 1 1 shows a third step of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
[0034] Fig. 12 shows fourth and fifth steps of a mounting procedure involving a smart phone and a sensor component/communications component according to present principles.
[0035] Figs. 13(A) and 13(B) illustrate an alternative implementation of a sensor component according to present principles.
[0036] Figs. 14(A) - 14(C) illustrate another alternative implementation of a sensor component according to present principles. [0037] Figs. 15(A) - 15(D) illustrate exemplary sizes for the sensor component of Fig. 14 (Fig. 15(A) and 15(B)), along with a related implementation (Figs. 15(C) and 15(D)).
[0038] Figs. 16(A) - 16(F) illustrate an application of the sensor component and communications component for the use case of real-time body temperature monitoring, along with an exemplary user interface on, e.g., a smart phone.
[0039] Like reference numerals refer to like elements throughout. Elements are not to scale unless otherwise noted.
[0040]
DETAILED DESCRIPTION
[0041] Referring to Fig. 1, a portion of a sensor component is shown, in which a sensor backplane 10 provides a substrate or support for one or more sensors 14. The one or more sensors 14 are signally coupled via leads 16 to a connector 23 via a flexible cable bundle 18. The connector 23 may be, e.g., a 6-pin connector allowing coupling to a communications component (the communications component providing both communications functionality as well as power to the sensor). In some implementations, the connector 23 can be virtual and be a wireless RFID connection. In one implementation, the connector 23 is a six pin male connector. The sensor backplane 10 may be, e.g., 5 mm x 5 mm, and may be, e.g., 2 mm thick. The sensors may be coupled to the backplane or substrate via a thermal conducting epoxy. In some cases the sensors may be incorporated directly into a band (described below) without a sensor substrate or backplane.
[0042] Fig. 2 illustrates an outside view of the sensor component, e.g., showing certain portions that would be visible even when the system according to present principles (here the system refers to the combination of a sensor component and a communications component) is in use on a patient or user. The sensor component generally has a band or strap 25 on which the sensor backplane 10 is mounted (not shown in Fig. 2). A barcode or QR code 22 may be provided to allow traceability of the particular sensor component, as well as for identification purposes. For example, the same may indicate a production lot, the same may indicate the type of sensor(s) provided, the same may identify an owner or user, or the like. A Velcro® portion 21 is illustrated, which is employed later in mounting the communications component to the band 25.
[0043] Fig. 3 illustrates an inside or bottom view of the band 25, illustrating protective layers 24 that may be peeled off to reveal an adhesive portion that may subsequently be employed to adhere the sensor component to the patient. Referring in addition to Fig. 4, the adhesive portion is shown as elements 28, which also shows the sensor portion 10. This "inside" or "bottom" view generally shows the band prior to mounting on a user. Once mounted on a user, this view would generally not be visible.
[0044] Fig. 5 shows a communications component 20a having an oval shape. The communications component 20a may be provided with a vivid color 32 for identification. Fig. 6 illustrates a communications component having a rectangular, rather than an oval shape. It will be clear to one of ordinary skill in the art given this teaching that other shapes are also possible, e.g., square shapes, circular shapes, and so on. The communications components 20a and 20b also include a connector 29 for coupling to the connector 23. The connector 29 may be, e.g., a matching female connector. Both the sensor component and the communications component may be constructed of soft biocompatible materials for comfort to the user.Figs. 7 and 8 illustrate bottom surfaces 34a and 34b of communications components 20a and 20b, respectively, along with respective Velcro® surfaces 36 and 36' .
[0045] The communications component generally includes a battery, a data acquisition circuit, a memory, a power management circuit, and a communications circuit for communications to an external device, e.g., a smart phone or the like, as has been described elsewhere. The communication component may or may not include a sensor or sensors as well. The communications may be, e.g., short range RF wireless communications, e.g., via Bluetooth®, NFC, WiFi, or the like. In some cases no such communications are necessary, and a visual (or audible or tactile) display on the communications component, e.g., via LEDs or a small LCD display, may communicate measurement data from the sensor component to the user.
[0046] Figs. 9-12 illustrate an exemplary mounting procedure for use of systems and methods according to present principles. In a first step, a user opens an appropriate mobile app on their smart phone 30, and scans the 2-D barcode 22 on the band 25, i.e., on the outside of the patch. The communications component 20b may then be mounted by coupling the connector 23 with the connector 29 (not shown in Fig. 10). The communications component 20b may then be folded such that its Velcro® surface 36' matches up with the Velcro® surface 21 on the band 25, holding the communications component securely, during use, to the sensor component. The protective layer may then be peeled off and the patch attached to the body. If necessary, in the mobile app, the smart phone may be appropriately paired with the communications component if such pairing has not already been performed.
[0047] Figs. 13(A) and 13(B) illustrate other patch designs. For example, and referring to Fig. 13(A), which shows the side with an adhesive, a patch 45 is illustrated having an open center 46. The area 44 indicates areas of adhesives, while the area 42 illustrates patch areas without adhesive. Referring to Fig. 13(B), a communication component/sensor component 40 may be held in place by the patch 45, but may partially protrude through the same, due to the open hole 46.
[0048] Fig. 14(A)-14(C) illustrate yet another patch 50, this design termed a "back sticking" type. Fig. 14(A) illustrates a "front" side, which faces the user's skin. Fig. 14(B) illustrates a backside, which is adjacent the communications component. A window 56 is illustrated for sensor access. The portion 52 and 54 indicate where an adhesive may be placed, and a portion 55 is indicated without adhesive. As may be seen in Fig. 14(C), a significant portion of the patch 50 contacts the skin, although sensor access is provided through the hole 56. The adhesive portion 54 may be used for mounting the communications component and sensor component (shown as combination 51), or Velcro® or other like fastener may also be used.
[0049] Figs. 15(A)-15(B) show exemplary sizing for components of Fig. 14(A)-14(C). Where a circular patches desired, the alternative implementation of Figs. 15(C)-15(D) show exemplary sizing. It will be understood that such sizing is purely exemplary and that various other sizing options are available as may be dictated by the particular type of sensor and communication component.
[0050] Figs. 16(A)- 16(F) illustrate an implementation of systems and methods according to present principles as applied to the case of real-time body temperature monitoring. Fig. 16(A) illustrates a sensor component (left) and a communications component (right), while Figs. 16(B) -16(E) illustrate various views of the two in combination. Fig. 16(F) illustrates an exemplary user interface showing a result of the measurement of the sensor.
[0051] What has been described is a combination sensor component/communications component that provides convenient physiological or other monitoring of the patient or user employing wearable sensors. Variations will be understood. For example, different types of sensors may be color-coded in different ways, and the same is true of the communications components. For example, different colors of communications components may be employed for different numbers of sensors. The communications component may include an LED display which may provide indications via colored LEDs of various status indicators. For example, appropriate color schemes may be encoded for indicating, e.g., good connection to the sensor, sensor needs replacement, data is being transmitted, communications component needs replacement or a new battery, and so on. The same may serve a decorative component for applications for children, and may blink or provide other pleasing effects.Depending upon implementation, the sensors may be connected by the user to the sensor component or the sensors may be manufactured to be integral with the sensor component. In some cases, the communications component may be manufactured to be integral with the sensor component. The band 25 may be replaced with other means of a fixing the systems according to present principles to a user, including, e.g., a wristband.
[0052] The type of sensors employed may vary, but the same may include, e.g., those measuring temperature, pressure, motion, pulse, blood oxygen level, glucose, UV light intensity, air quality, carbon monoxide, toxic gas, and so on.
[0053] Systems and methods according to present principles may be employed in various fields of use, including, e.g., child activity monitoring, fever monitoring, sleep monitoring, early death prevention, and so on. Other fields include pregnancy planning, fetus activity monitoring, monitoring of activity levels of pregnant users, depression monitoring, and so on. Further fields include elder well-being, UV level alerts, sleep monitoring, applications in remote clinical monitoring or nursing, sports (e.g., dancing, diving, golf, and so on), field worker well-being monitoring, particularly for dangerous occupations such as mine workers, firefighters, police, and so on. [0054] Yet other potential applications include those related to smart farming, pet well- being or activity monitoring, home security, oilfield or other driller structure integrity monitoring, big tree well-being and failing or falling tree alerts and alarms, phone or other device unlock mechanisms, reminder functionality, and so on. As will be understood, while the major embodiments described here relate to human host monitoring, systems and methods according to present principles may be advantageously employed in monitoring of pets, other animals, livestock, vehicles, machines, plants, trees, and the like.
[0055] In some implementations the communications component may incorporate a sensor, and the "sensor component" is passive, e.g., has no sensor loaded, and primarily acts to attach the system including communications component to the user. A particular use case may be where the sensor does not require direct communications with the body of the host. For example, such may be the case where the sensor senses toxic gas, carbon monoxide, air quality, or the like.
[0056] The system and method may be fully implemented in any number of computing devices. Typically, instructions are laid out on computer readable media, generally non- transitory, and these instructions are sufficient to allow a processor in the computing device to implement the method of the invention. The computer readable medium may be a hard drive or solid state storage having instructions that, when run, are loaded into random access memory. Inputs to the application, e.g., from the plurality of users or from any one user, may be by any number of appropriate computer input devices. For example, users may employ a keyboard, mouse, touchscreen, joystick, trackpad, other pointing device, or any other such computer input device to input data relevant to the calculations. Data may also be input by way of an inserted memory chip, hard drive, flash drives, flash memory, optical media, magnetic media, or any other type of file - storing medium. The outputs may be delivered to a user by way of a video graphics card or integrated graphics chipset coupled to a display that maybe seen by a user. Alternatively, a printer may be employed to output hard copies of the results. Given this teaching, any number of other tangible outputs will also be understood to be contemplated by the invention. For example, outputs may be stored on a memory chip, hard drive, flash drives, flash memory, optical media, magnetic media, or any other type of output. It should also be noted that the invention may be implemented on any number of different types of computing devices, e.g., personal computers, laptop computers, notebook computers, net book computers, handheld computers, personal digital assistants, mobile phones, smart phones, tablet computers, and also on devices specifically designed for these purpose. In one implementation, a user of a smart phone or Bluetooth® or Wi-Fi - connected device downloads a copy of the application to their device from a server using a wireless Internet connection. An appropriate authentication procedure and secure transaction process may provide for payment to be made to the seller. The application may download over the mobile connection, or over the WiFi or Bluetooth® or other wireless network connection. The application may then be run by the user. Such a networked system may provide a suitable computing environment for an implementation in which a plurality of users provide separate inputs to the system and method.
[0057] In the above system where health monitoring is contemplated, the plural inputs may allow plural users to input relevant data at the same time, or may allow plural inputs (sensors) to provide plural physiological measurements at the same time.

Claims

1. A health monitor, comprising: a. a sensor component, the sensor component configured to be worn by a user and including one or more sensors; and b. a communications component, the communications component
configured to be worn by the user, c. wherein the sensor component and the communications component are coupled using at least one physical connection and at least one electrical connection.
2. The health monitor of claim 1, wherein the sensor component is configured to be attached to the user.
3. The health monitor of claim 2, wherein the sensor component is adhesively attached to the user.
4. The health monitor of claim 1, wherein the sensor component is reusable.
5. The health monitor of claim 1, wherein the sensor component is disposable.
6. The health monitor of claim 1, wherein the communications component is reusable.
7. The health monitor of claim 1, wherein the communications component is disposable.
8. The health monitor of claim 1, wherein the communications component includes a sensor or multiple sensors.
9. The health monitor of claim 1, wherein the communications component is configured for communications with an external device.
10. The health monitor of claim 8, wherein the communications involves pairing via an RF wireless protocol and the external device is a smartphone or smart watch.
11. The health monitor of claim 1, wherein the electrical connection provides at least one source of power to the sensor and at least one signal path from the sensor to the communications component.
12. The health monitor of claim 11, wherein the electrical connection is wireless.
13. The health monitor of claim 1, wherein the physical connection includes a hook and loop fastener, a button, a watchband, or a snap.
14. The health monitor of claim 1, wherein the sensor component includes at least one identification device, whereby the sensor component may be identified and traced.
15. The health monitor of claim 1, wherein the communications component
includes at least one user interface element, whereby status or other information may be communicated.
16. The health monitor of claim 1, wherein the electrical connection and the
physical connection are configured to be detachable at the sensor component or at the communications component, whereby the sensor component may be rendered disposable, and wherein the communications component may be reused with a new or subsequent sensor component.
17. A computer-readable medium, comprising instructions for causing a computing environment to perform a method of health monitoring using the health monitor of claim 1, the method comprising steps of: a. upon making an electrical connection between the sensor component and the communications component, initializing at least one sensor and receiving a signal from the sensor; and b. providing an indication of a status of the sensor on the user interface element.
18. The medium of claim 17, wherein the providing an indication includes
activating an visual or audible user interface element, or communicating a signal to a connected device for display of a status.
19. The medium of claim 18, wherein the providing an indication includes lighting an LED.
20. A health monitor, comprising: a. a sensor component, the sensor component including at least two
sensors selected from the group consisting of: heart rate, skin conductance, temperature, pressure, motion, blood oxygen level, glucose, UV light intensity, air quality, carbon monoxide, toxic gas, and location, the sensor component including an adhesive patch configured to be worn by a user, the sensor component including a first mechanical coupling configured to couple to a user and a second mechanical coupling configured to couple to a communications component; b. a communications component, the communications component
configured to be worn by the user, the communications component further configured to receive a signal from the sensor component using a flexible circuit and to transmit an indication of the signal from the sensor to a mobile device using an RF wireless communications scheme; c. wherein the second mechanical coupling includes a hook and loop fastener system on a strap, and wherein the communications component is configured to be securely held against egress by the strap.
21. The health monitor of claim20, wherein the first mechanical coupling includes an adhesive.
22. The health monitor of claim 21, wherein the sensor component is configured as an adhesive patch.
PCT/US2016/018966 2015-02-20 2016-02-22 System and method for health monitoring WO2016134374A1 (en)

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