WO2008097652A2

WO2008097652A2 - Body patch for none-invasive physiological data readings

Info

Publication number: WO2008097652A2
Application number: PCT/US2008/001734
Authority: WO
Inventors: Demetrios Sapounas; Emil Jovanov
Original assignee: Senior Vitals, Inc.
Priority date: 2007-02-08
Filing date: 2008-02-08
Publication date: 2008-08-14
Also published as: WO2008097652A3

Abstract

Systems, methods, controller program products and devices for facilitating the sensing, reading, transmission and presentation of physiological data within a wireless body area network are disclosed. The remote collection and monitoring of a person's (e.g., patient's) physiological data and activity levels for the purposes of determining the well-being of the person, as well as making additional health status determinations based on the historical information and trends of the collected data are provided. The systems, methods, and controller program products disclosed herein, in varying aspects, readily lend themselves to incremental component and functionality modifications, which allow for increased sensor data sources, accuracy, reliability and utility of the collected information, further solidifying the uniqueness and desirability of the systems, methods, controller program products and devices.

Description

BODY PATCH FOR NON-INVASIVE PHYSIOLOGICAL DATA READINGS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of, and is related to, the following of

Applicants' co-pending applications:

U.S. Provisional Application No. 60/900,118 titled "Device for Non-Invasive Physiological Data Readings," filed on February 8, 2007;

U.S. Provisional Application No. 60/900,987 titled "Physiological Data Processing Architecture for Situation Awareness," filed on February 13, 2007;

U.S. Provisional Application No. 60/924,083, titled "Heterogeneous Data Collection and Data Mining Platform," filed on April 30, 2007;

U.S. Provisional Application No. 60/924,125 titled "Heterogeneous Data Collection and Data Mining Platform" filed on May 1, 2007;

U.S. Provisional Application No. 61/006,094, titled "Improved Communications and Biosensor Device," filed on December 19, 2007;

U.S. Provisional Application No. 61/006,095, titled "Gateway for Discrete and Continuous Monitoring of Ambient Data with Emergency Functions," filed on December 19, 2007;

U.S. Provisional Application No. 61/006,097, titled "Gateway for Discrete and Continuous Monitoring of Physiological Data," filed on December 19, 2007;

U.S. Provisional Application No. 61/006,099, titled "Method and System for Discrete and Continuous Monitoring of Physiological and Ambient Data," filed on December 19, 2007;

U.S. Provisional Application No. 61/006,100, titled "User Interface for System for Discrete and Continuous Monitoring of Physiological and Ambient Data," filed on December 19, 2007;

U.S. Provisional Application No. 61/006,098, titled "Method and System for Data Transmission for Use with Biosensor Device or Gateway," filed on December 19, 2007 U.S. Non-provisional Application No. , titled System and Method for Physiological Data Readings, Transmission, and Presentation, filed on January 25, 2008; and

U.S. Non-provisional Application No. , titled System and Method for Physiological Data Readings, Transmission, and Presentation, filed on February 5, 2008; each of which is incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] This invention is generally related to automated systems, methods and devices for non-invasive methods of collecting and transmitting a person's physiological data. More particularly, the present invention is directed to wireless body area network systems for collecting and transmitting a person's physiological data in order to determine activity levels for the purposes of determining the well-being of a person, plus making additional health status determinations based on the historical information and trends of the collected data.

Related Art

[0003] Individual sensors with or without wireless transceivers have been created and used for collecting and transmitting physiological data. Systems of sensors have been at various stages of development, commonly referred to as Body Area Networks (BANs). If wireless communication is employed the system is called Wireless Body Area Networks (WBANs), utilizing a storage device for aggregating the data for future access and processing, or are dependent on wireless transceivers, smart phones and similar mobile devices for collecting and transmitting the data to a healthcare provider. While such systems work for their intended purposes, they are cumbersome and difficult to operate, both from the perspective of weight and size of the equipment. In addition, they require many wires for interconnecting the various components, further rendering the equipment difficult to operate and use. [0004] Given the foregoing, there is a need for an improved wireless device for the collection, storage, transmission and presentation of physiological data. There is also a need for an improved lightweight, wireless device that allows for ease of use and desirability.

BRIEF DESCRIPTION OF THE INVENTION

[0005] The present invention meets the above-identified needs by providing systems, methods, computer program products and devices for collecting, storing, processing and securely transmitting a person's physiological data (i.e., vital signs) through non-invasive means. That is, the present invention is directed to a physiological and activity data aggregation, transmission and presentation system, for the purpose of monitoring a person's vital signs by the person's family members, loved ones, care takers and healthcare providers, a call center, through non-invasive means. The invention readily lends itself to incremental component and functionality modifications, which would allow for any number of physiological data to be collected through the introduction of any number of either noninvasive or implantable sensors. This results in higher accuracy, reliability, and utility of the collected information, further solidifying the uniqueness and desirability of the present invention, for consumer and clinical applications.

[0006] An advantage of aspects of the present invention include providing miniaturized physiological sensors along with a computer system, transceiver, and proprietary software for data aggregation and transmission from multiple sensors. [0007] Another advantage of aspects of the present invention include a device that is completely wireless, collecting data through non-invasive means on a near-real-time basis and securely transmitting the data. In addition, the device, which is configured to be placed on a person's body, consists of small and lightweight components that do not interfere with normal daily activities.

[0008] Yet another advantage of the present invention is that the device may be disposable or may consist of multiple pieces, only some of which may be disposable. [0009] Further features and advantages of aspects of the present invention, as well as the structure and operation of these various aspects of the present invention, are described in detail below with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS.

[0010] The features and advantages of aspects of the present invention will become more apparent from the detailed description set forth below when taken in conjunction with the claims and drawings, in which like reference numbers indicate identical or functionally similar elements. Additionally, the left-most digit of a reference number identifies the drawing in which the reference number first appears.

[0011] FIG. 1 is an electronic block diagram illustrating an exemplary device according to an aspect of the present invention.

[0012] FIG. 2 is a block diagram of an exemplary computer system, useful for implementing aspects of the present invention, according to an aspect of the present invention.

[0013] FIG. 3 is a flowchart depicting the operation and data flow of a device according to an exemplary aspect of the present invention.

[0014] FIG. 4 is a schematic diagram depicting the device according to an exemplary aspect of the present invention.

[0015] FIG. 5 is a drawing showing an exemplary power supply according to an exemplary aspect of the present invention.

[0016] FIG. 6 is a schematic diagram depicting the device according to an exemplary aspect of the present invention.

DETAILED DESCRIPTION

[0017] Aspects of the present invention are directed to a device, methods, and computer program product for collecting and transmitting physiological data. [0018] An aspect of the present invention includes a device for collecting and transmitting physiological data (e.g., vital signs) through a non-invasive device. Such a device, in one aspect, may include a suite of electronic components which include a number of electrodes designed to contact a monitored person's body and receive the monitored person's physiological data, sensors in communication with the electrodes, the sensors being adapted to interpret and receive the data or signals received from the electrodes, a signal conditioning unit which may be used to amplify, condition or improve the signals or data received by the sensors, a computer system which controls all operations within the device, stores the received data within a memory component of the computer system and later processes the collected data, a transceiver for transmitting the collected and processed data and a power supply for providing the device with power.

[0019] In an aspect of the present invention, the suite of electronic components of the device may be connected to a printed circuit board, for example soldered. This printed circuit board might be flexible and allows for freedom of movement.

[0020] In an aspect of the present invention, the device may additionally include a mechanical device such as an accelerometer, inclinometer or the like which may be used to determine the user's orientation or physical activity, or additional sensors capable of monitoring ambient data.

[0021] In another aspect of the present invention, the device includes an antenna for communicating with an external device, location or individual. In another aspect of the present invention, communication may be wireless and may be implemented by using any one of a number of wireless communication protocols such as ZigBee (802.15.4), Cellular (CDMA, GSM and others), Wireless (802.11 a/b/g/n), Wi-Fi (802.11 p), ANT, Bluetooth (802.15.1), or custom wireless protocols working in any available frequency or frequencies, etc.

[0022] In another aspect of the present invention, the device may include an internal clock for synchronizing the electronic components of the device.

[0023] In another aspect of the present invention, the device may be made up of disposable and non-disposable components, both components being connected by connectors or reliable contacts. The disposable component may include electrodes for sensing physiological data while the non-disposable component may include the other device electronics such as the sensors, signal processing unit, computer, transceiver, accelerometer, internal clock and antenna. In alternate aspects, the power supply for the device may be included in either of the disposable and non-disposable components.

[0024] In another aspect of the present invention, the method of the present invention performs the steps of sensing and receiving physiological data indicative of the health status of a person by electrodes and sensors, respectively, the electrodes being capable of being attached to or contacting a person's body, conditioning the data received, collecting and storing the physiological data received, processing and transmitting the physiological data.

The transmission of the physiological data is primarily done by a transceiver.

[0025] In an additional aspect, the method performs the step of synchronizing the electronic components of the device. The synchronization may be implemented by an internal clock of the device.

[0026] In an additional aspect, the method performs the step of encrypting the physiological data. The encryption is performed in order to secure the physiological data during transmission.

[0027] In an additional aspect, the method performs the step of sensing physical and/or orientation activity using a mechanical device, which may be an accelerometer, an inclinometer or the like. Additional steps performed by the method include the steps of generating data regarding the physical and orientation activity and transmitting the generated data.

[0028] In yet another aspect of the present invention, the computer program product of the present invention, uses control logic to implement the receipt of physiological data indicative of the health status of a monitored person, collection and storage of the physiological data received, processing and transmission of the physiological data. In aspects of the present invention, raw physiological data may also be transmitted. The computer program product also has control logic which is used to determine the appropriate time to transmit the physiological data. For example, data may be transmitted on a periodic basis or on a near real-time basis. [0029] In yet another aspect of the present invention, the computer program product of the present invention, uses control logic to encrypt the physiological data. The encryption is performed in order to secure the physiological data during transmission. [0030] In yet another aspect of the present invention, the computer program product of the present invention, use control logic to sense physical and orientation activity using a mechanical device, which may be an accelerometer, an inclinometer or the like. Additionally, the computer program product uses additional control logic to process data regarding the physical and orientation activity and transmitting the generated data. [0031] Aspects of the present invention will now be described in more detail herein in terms of the above exemplary context and the accompanying figures. This description is for convenience only and is not intended to limit the application of aspects of the present invention. In fact, after reading the following description, it will be apparent to those skilled in the relevant art(s) how to implement aspects of the following invention in alternative ways. [0032] The terms "person," "patient," "subject," "user," "subscriber," "client,"

"wearer," "being," and/or the plural form of these terms are sometimes used interchangeably herein to refer to those person(s) or other living being(s) from whom physiological data are being collected (or, in some cases, the safety and medical personnel and professionals entrusted with their well being), and thus would benefit from the system, method, and computer program products that aspects of the present invention provide for facilitating the receipt, collection, storage, transmission and presentation of physiological data of persons or other living beings.

[0033] Referring to FIG. 1, an electronic block diagram of body-wearable (i.e., body patch) device 100 according to an aspect of the present invention is shown. In this aspect, device 100 comprises one or more electrodes 402a, 402b...402n (shown in FIG. 4), one or more one or more sensors 102a, 102b...102n, an accelerometer or inclinometer or similar activity/body positioning mechanical device 104, a signal conditioning unit 106, an on-board computer 108 (with memory), a clock 110, a power supply 112, a transceiver 114 and antenna 116. Various aspects of the present invention may include more or fewer components than those shown in FIG. 1. [0034] Sensors 102a, 102b...l02n are used to collect physiological and activity data.

Physiological data collected by sensors 102a, 102b...102n may include body surface temperature, ambient temperature, ambient humidity, heart rate, electrocardiogram (ECG), electromyogram (EMG), electroencephalogram (EEG), orientation, galvanic skin resistance, photoplethysmograph, location and activity. Sensors 102a, 102b...l02n are electronic devices which receive signal impulses from electrodes or other sensing surfaces (i.e., electrodes 402a, 402b...402n as shown in FIG. 4). Such electrodes or sensing surfaces may or may not touch on the surface of the skin of a monitored person. These electrodes transmit their electrical signals to sensors 102a, 102b...l02n, which in turn interpret the signals and forward the data to on-board computer 108.

[0035] Accelerometer, inclinometer or similar mechanical device 104 is used to sense the orientation and physical activity of the person wearing patch 100. Accelerometer 104 can provide data to determine the state of the person - for example whether the person is moving fast or slow, being immobile or resting. Accelerometer 104 can also be used to provide information on the person's orientation for example sitting, lying down, or a sudden change of body position that has occurred (e.g. sudden fall), etc. Accelerometer data is first sent to on-board computer 108 where the data is then analyzed using computer programs (algorithms) resident on on-board computer 108. The computer programs are configured to determine the user's condition (e.g., whether the user has fallen).

[0036] • Signal conditioning unit 106 is used to modify the signals and/or data received from sensors 102a, 102b...102n. Such modification, in one aspect of the present invention, may include amplification or filtering of the signals as needed in order for the signal or data to be processed. In this aspect of the present invention, signal amplifiers may be used for this purpose.

[0037] Clock 110 has the primary purpose of synchronizing various components found on patch 100. It is also used for synchronisation of external components, because there is communication with other devices, through transceiver 114. Device 100 and communications synchronisation is managed through on-board computer 108. Clock 110 may also be integrated as an integral part of on-board computer 108 to simplify the implementation.

[0038] Transceiver 114 and associated antenna 116 are the communication interface for patch 100 to communicate with external devices external devices within a WBAN as described in more detail in U.S. Provisional Application No. 60/897,243 titled "Method and System for Physiological Data Readings, Transmission, and Presentation," filed on January 25, 2007. Antenna 116 is used for transmitting and receiving signals while transceiver 114 defines the communication protocols and frequencies supported for communication. Any number of protocols may be used, the majority of which specify an operating frequency range. Other protocols may operate on a single frequency. Transmission protocols may include ZigBee (802.15.4), Cellular (CDMA, GSM and others), Wireless (802.11 a/b/g/n), Wi-Fi (802.11 p), ANT, Bluetooth (802.15.1) or custom wireless protocols working in any available frequency or frequencies.

[0039] Power supply 112 may consist of one or multiple batteries, which may or may not be replaceable depending on the configuration. Power supply 112 provides the necessary electrical power to the electronic components, so they can operate properly and perform their designed tasks. Because the availability of sufficient power is necessary for the proper operation of the electronic components, on-board computer 108 monitors the power levels and generates a notification message when it detects power levels below a certain threshold. This power threshold is defined by the suite of electronic components on the patch and their collective power requirements for proper operation. The notification message is transmitted to an external device, to indicate and warn that the power level on the patch is becoming insufficient for sustaining ongoing operations.

[0040] In another aspect of the present invention, device 100 may be powered by using external RF transmission and an inductive coil. Furthermore, device 100 can be powered by harvesting energy from the body's motion, differential temperature gradient, applied pressure (piezoelectric sensors), using collar cells, etc.

[0041] On-board computer 108 is the controlling unit for all electronic components within device 100. On-board computer 108 is also the processing unit for incoming and outgoing signals and data. On-board computer 108 also manages all communications, through transceiver 114, with external devices. Such other devices, in one aspect of the present invention, may be a body-wearable gateway collecting data from the patch 100 and/or other physiological data different than the data from the patch, as described in more detail in co-pending U.S. Provisional Application No. 61/006,095, titled "Gateway for Discrete and Continuous Monitoring of Ambient Data with Emergency Functions," filed on December 19, 2007 and U.S. Provisional Application No. 61/006,097, titled "Gateway for Discrete and Continuous Monitoring of Physiological Data," filed on December 19, 2007; which are incorporated by reference herein in their entirety. In effect, on-board computer 108 is a computer system similar to the block diagram in FIG. 2.

[0042] Referring now to FIG. 2, a computer system 108 depicting various computer system components for use with an exemplary implementation of a data collection, communications and analysis device, in accordance with an aspect of the present invention is shown.

[0043] Various software aspects are described in terms of this exemplary computer system. After reading this description, it will become apparent to a person skilled in the relevant art(s) how to implement the invention using other computer systems and/or architectures.

[0044] The computer system 108 includes one or more processors, such as processor

204. Processor 204 is connected to a communications infrastructure 202 (e.g., a communications bus, cross-over bar or network). Computer system 108 can include a display interface 208 that forwards graphics, text and other data from the communication infrastructure 202 (or from a frame buffer not shown) for display on display unit 210. [0045] Computer system 108 also includes a main memory 206, preferably random access memory (RAM), and may also include a secondary memory 212. The secondary memory 212 may include, for example, and/or a removable storage drive 216, representing a flash memory card, a magnetic tape drive, an optical disk drive, etc. The removable storage drive 216 reads from and/or writes to a removable storage unit 218 in a well known manner. Removable storage unit 218 represents a flash memory card, magnetic tape, optical disk, etc. which is read by and written to by removable storage drive 216. As will be appreciated, the removable storage unit 218 includes a computer usable storage medium having stored therein computer software and/or data.

[0046] In alternative aspects, secondary memory 212 may include other similar devices for allowing computer programs or other instructions to be loaded into computer system 108. Such devices may include, for example, a secondary removable storage unit and an interface. Examples of such may include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as flash memory, an erasable programmable read only memory (EPROM), or programmable read only memory (PROM)) and associated socket, and other secondary removable storage units and interfaces, which allow software and data to be transferred from the secondary removable storage unit to computer system 108.

[0047] Computer system 108 may also include a communications interface 224.

Communications interface 224 allows software and data to be transferred between computer system 108 and external devices. Examples of communications interface 224 may include a modem, a serial interface, such as Universal Serial Bus (USB) or RS232, a network interface (such as an Ethernet card), a communications port, etc. Software and data transferred via communications interface 224 are in the form of signals 226 which may be electronic, electromagnetic, optical or other signals capable of being received by communications interface 224. These signals 226 are provided to communications interface 224 via a communications path (e.g., channel) 228. This channel 228 carries signals 226 and may be implemented using wire or cable, fiber optics, a telephone line, a cellular link, an radio frequency (RF) link and other communications channels.

[0048] In this document, the terms "computer program medium" and "computer usable medium" are used to generally refer to media such as removable storage drive 216, a hard disk installed in hard disk drive 214, and signals 226. These computer program products provide software to computer system 108. The invention is directed to such computer program products. [0049] Computer programs (also referred to as computer control logic) are stored in main memory 206 and/or secondary memory 212. Computer programs may also be received via communications interface 224. Such computer programs, when executed, enable the computer system 108 to perform the features of the present invention, as discussed herein. In particular, the computer programs, when executed, enable the processor 204 to perform the features of the present invention. Accordingly, such computer programs represent controllers of the computer system 108.

[0050] In an aspect where the invention is implemented using software, the software may be stored in a computer program product and loaded into computer system 108 using removable storage drive 216, hard drive 214 or communications interface 224. The control logic (software), when executed by the processor 204, causes the processor 204 to perform the functions of the invention as described herein.

[0051] Aspects of the present invention may also be implemented using, for example, a microcontroller. A microcontroller may include a microprocessor on a single integrated circuit configured to operate as a single-chip embedded system. The microcontroller may include a CPU, RAM as working memory, program memory (e.g. flash memory, ROM, or PROM), direct memory access (DMA), timers, I/O ports, other serial communications interfaces, EEPROM or flash memory for permanent data storages, peripheral devices (such as timers, event counters, etc.), a clock generator, analog-to-digital converters, digital-to- analog converters, comparators, and in-circuit programming and debugging support. [0052] In another aspect, the invention is implemented primarily in hardware using, for example, hardware components such as application specific integrated circuits (ASICs). Implementation of the hardware state machine so as to perform the functions described herein will be apparent to persons skilled in the relevant art(s).

[0053] In yet another aspect, the present invention is implemented using a combination of both hardware and software.

[0054] Referring now to FIG. 3, a flowchart depicting exemplary operation and data flow 300 of device 100 according to an aspect of the present invention is shown. In this aspect, physiological and/or ambient data previously received by one of a combination of sensors 102a, 102b...l02n, contained within device 100 is then collected and stored in step 302 into the internal storage of on-board computer 108 to be processed for on-patch analysis. In step 304, the data is processed by on-board computer 108 for on-device analysis. Next, in step 304, processor 108 determines whether it is time to initiate a scheduled transmission of the data to a pre-defined external device, individual, or location. If it is not yet time for the transmission, device 100 waits in step 308 until it is time to transmit. If in step 306 on-board computer 108 determines that it is time to transmit, the transmission preparation process begins. In preparing the data for transmission, all the data from the internal storage of onboard computer 108 (including data from external devices, accelerometer 104 and signal conditioning unit 106) and readings from sensors 102a, 102b...l02n, are aggregated in step 310.

[0055] In step 312, the data is then encrypted and packaged for transmission in step

314. The data is encrypted to ensure its security during transmission. In packaging the data, identifying information such as source, destination, transmission type and other pertinent information are included in step 314 in preparation for transmission. The data is then packaged into a message, according to the transmission protocol being employed. Any number of protocols may be used, the majority of which specify an operating frequency range and signal modulation. Other protocols may operate on a single frequency. In alternate aspects, transmission protocols may include ZigBee (802.15.4), Cellular (CDMA, TDMA, GSM and others), Wireless (802.11 a/b/g/n), Wi-Fi (802.11 p), ANT, Bluetooth (802.15.1) or custom wireless protocols working in any available frequency or frequencies. In step 316, on-board computer 108 activates transceiver 114.

[0056] After transceiver 114 has been activated and a network connection is established in step 316, a burst transmission of data from device 100 to an external device occurs in step 318. Such external device may be a body-wearable gateway collecting other physiological data different than, and in addition to, patch 100 as described in more detail in co-pending U.S. Provisional Application No. 61/006,095, titled "Gateway for Discrete and Continuous Monitoring of Ambient Data with Emergency Functions," filed on December 19, 2007 and U.S. Provisional Application No. 61/006,097, titled "Gateway for Discrete and Continuous Monitoring of Physiological Data," filed on December 19, 2007; which are incorporated by reference herein in their entirety. Transceiver 114 is then deactivated until the next transmission event (e.g., until data flow 300 is repeated). At the external device, the transmitted data undergoes further analysis, processing and preparation for reporting. [0057] Referring now to FIG. 4, a schematic diagram of device 100 according to an aspect of the present invention is shown. The electronic components of device or patch 100 (as shown in FIG. 2) are packaged in a water tight container to prevent short circuits from moisture and are connected to a printed circuit board (PCB) 404, for example in one embodiment, by soldering, which may be constructed of flexible material, so not to restrict freedom of movement. PCB 404 is attached to a bandage-type (fabric, which may be synthetic) material 406 (thus the reference to device 100 as a "patch") with only electrodes 402a, 402b...402n protruding through the bandage-type material in order to make contact with the monitored person's skin or body. One side of the patch 100 contains adhesive 408 which secures the patch onto the monitored person's skin or body.

[0058] Electrodes 402a, 402b...402n make contact with the skin and adhesive 408 holds them in place, ensuring a constant and secure contact which is necessary to provide accurate and continuous collection of physiological data.

[0059] Power supply 112 is located on the PCB 404 and may or may not be replaceable. In the case of a non-replaceable power supply, the whole patch becomes disposable, because no data can be collected and transmitted when there is insufficient power. In the case of a replaceable power supply, the battery compartment is sealed with a traditional water resistant twist-lock cap, which when opened allows the batteries to be replaced. FIG. 5 shows a representative twist-lock battery cap and battery 112, but 112 may also be a thin film battery.

[0060] Referring now to FIG. 6, a schematic diagram depicting device 100 according to another exemplary aspect of the present invention is shown. Specifically, in FIG. 6, a different configuration of the patch assembly allowing for more flexibility and longevity is shown. The patch or device 100 could be constructed of two separate components, one that can be non-disposable and one that is disposable. Non-disposable piece 602 contains all the electronics, excluding electrodes 402a, 402b ... 402n. The construction is the same as with the single piece patch, except there are connectors 606a, 606b ... 606n used to connect non- disposable piece 602 to disposable piece 604. Disposable piece 604 contains electrodes 402a, 402b...402n. This configuration provides two alternatives for power supply 112. In one aspect of the present invention, power supply 112 could be placed in non-disposable piece 602, mounted on PCB 404, along with the other electronic components. In this configuration, power supply 112 may be either replaceable or not. Another aspect of the present invention places power supply 112 in disposable piece 604, along with electrodes 402a, 402b...402n. In this configuration power supply 112 does not need to be replaceable, because it is found within the disposable portion of device 100.

[0061] Aspects of the present invention include an integrated system for obtaining a person's physiological data (vital signs) and other relevant data regarding the person or person's surrounding atmosphere, through non-invasive methods, via a biosensor device and securely transmitting the information and transforming it into an easily understood display.

[0062] Aspects of the present invention are directed to a physiological and activity data aggregation, transmission and presentation system, for the purpose of monitoring a person's vital signs by the person, the person's family members, care takers and healthcare providers, through non-invasive means. This aspect includes at least one biosensor, a gateway device, short and long range transceivers, proprietary software for data aggregation and transmission from multiple sensors, a data centre environment with multiple computers and custom software for data storage, retrieval, manipulation, analysis, display and transmission to an end-user viewing device via the Internet. This system is completely wireless and presents the data to the end users on both a periodic and optionally, on a realtime basis based on a triggering event or on request. The system components placed on a person's body are small and lightweight so that they do not interfere with normal daily activities. Finally, the gateway device offers alert features including simple two-way voice communication.

[0063] The system obtains physiological and other relevant data from at least one sensor, processes the data, encrypts the data, and then transmits the data to the gateway device. That gateway aggregates the physiological data from all the sensor sources, processes the data, and forwards the data to a data collection centre. Additional processing and analysis of the data may occur at the data collection centre.

[0064] In an aspect, the sensor may include an adhesive patch attached to the body of a person, integrating several miniaturized physiological sensors. This patch may include a microprocessor, a short-range wireless transceiver and a power supply miniaturized onto a single board. The sensors obtain vital sign physiological data, which are processed, encrypted and aggregated by the microprocessor for transmission by the transceiver to the gateway, at set intervals. The gateway then transmits the data to the data collection center.

[0065] In one embodiment, the patch may include a feature to measure galvanic skin resistance (GSR).

[0066] In another embodiment, the patch has a feature for determining if the patch is loose or has been removed. In one exemplary embodiment, the amount of resistance between at least two electrodes may be measured. In one embodiment, the at least two electrodes may be the electrodes in an ECG sensor. A person's skin is expected to have a resistance within a certain range. Therefore, removal of the patch may be determined when the resistance between the at least two electrodes rises above that range. In another embodiment, a determination may be made that a patch has become loose by recognizing that large variations in a signal, coming from at least one sensor, have occurred. [0067] In certain embodiments, the identification of a loose or removed patch may trigger an alarm that alerts the monitored person that the patch has become loose or removed. This alarm may be a sound, light, vibration, etc. In addition, a message may be sent to the subscriber and/or the call or data center to notify that a patch has become loose or removed from the monitored person.

[0068] In one embodiment, at least one biosensor, for example on the patch, may process the data to determine whether an "event" has occurred. An event may include at least one of the monitored physiological or other characteristics falling outside a predetermined range, or a trend of parameter change specified by the user (e.g. evident trend of heart rate decrease or abnormal fall, predefined changes in heart rhythm, etc.).. The predetermined range may be set at will through a web interface. The predetermined range information will be sent to the gateway and patch, stored, and used in analyzing sensor data for events.

[0069] When the biosensor determines that an event has occurred, the patch or the gateway transmits data in an event mode for a predetermined period of time. Event mode transmission involves a transmission of physiological or other data in a different form than the previously processed, packaged, and periodically transmitted data. For example, in one embodiment, once an event has been identified, the at least one sensor may transmit unprocessed data on a near real time basis in addition to the results of processing. This at least one sensor may be the sensor that recorded the event data that falls outside the predetermined range.

[0070] For example, at least one biosensor may measure the pulse rate of the monitored person. A family member, care giver, or physician may have set a predetermined acceptable range for the heart rate of the monitored person. If the biosensor determines that the heart rate has fallen below the acceptable range, the biosensor will begin to transmit data to the gateway on a different basis. For example, the biosensor may transmit the ECG signal or the sequence of RR intervals on a near real time basis for a predetermined period of time. Although in this example the biosensor transmits real time heart rate data, the gateway may transmit any type of additional data in this event mode, such as body position and activity signals, as well as previous history of the selected parameter.

[0071] Other possible triggers may include the detection of a fall, cardiac changes,

ECG morphology changes (e.g. QT segment, ST segment deviation, J-point value, etc.), wandering outside a pre-determined distance from a defined base location, etc.

[0072] In one embodiment, based on the event mode transmission, a number of actions may occur. An emergency call may be placed to the gateway to attempt to contact the monitored person. This call may provide more information on the status of that person or provide assistance to the person. A call may be directed to emergency services to direct an emergency response to the location of the monitored person. A call may be directed to a selected contact such as a family member, a care giver, or a physician. An alarm may be sounded at the gateway device. An emergency message may be sent via e-mail, pre-recorded voice mail, text message, or any other desired method, to a family member, care giver, or physician.

[0073] By determining an event, and by sending data in a special event mode transmission, the biosensor may provide for automatic alerts or emergency responses in potentially life threatening situations.

[0074] After the event mode transmission, the biosensor may return to normal acquisition and transmission of data to the gateway until another event mode is determined. [0075] Although the gateway and system may function together with a plurality of additional sensors, the gateway does not require an additional sensor in order to function accurately. For example, the gateway may receive short range transmissions of data from a plurality of sensors placed on the body of the monitored person. The gateway may be capable of accumulating, processing, and packaging this information, together with any information gathered at the gateway device, and transmitting the packaged data.

[0076] However, in accordance with one aspect, the gateway device and system are also capable of functioning properly without data transmissions from additional sensors. In an exemplary embodiment, a subscriber to the system, whether the monitored person, the person's family member, care giver, or physician, may select a "gateway only" option, where the monitored person does not wear any additional sensors. In another aspect, although the subscriber to the service may have selected an option with at least one additional sensor, the sensor may function improperly or cease to function for any number of reasons. When this occurs, the gateway is configured to continue to report the malfunction and continue to properly collect and transmit data without the sensor.

[0077] The system is also capable of collecting and analyzing data from various types of biosensors. For example, the system is capable of functioning with biosensors from a plurality of manufacturers. The biosensors may include a common interface to the gateway or to the data collection center. This interface may ensure that data transmitted to the data collection center is transmitted in a particular format. Each of the manufacturers may offer more than one type of biosensor, with each model offering a different combination of features. The system is capable of identifying the manufacturer and model of a biosensor from the data transmitted to the remote collection center. This feature provides the ability to make an analysis of the performance of different models and manufacturers of biosensors.

[0078] In order to protect the privacy of the monitored person, data transmissions are encrypted before being transmitted. In one aspect, data is encrypted at the gateway device before being transmitted to the data collection center. In another aspect, data is encrypted at the sensor or patch before it is transmitted to the gateway. In a further aspect, data is encrypted both at the sensor and the patch before transmission to the gateway and at the gateway before transmission to the data collection center.

[0079] In another aspect, the biosensor or patch, or both, include a buffering feature that stores collected data when it is determined that transmissions are not reaching the gateway correctly. In one example, the biosensor or patch may receive an acknowledgement of transmission from the gateway when a transmission is received. If the acknowledgement is not received, the biosensor or patch begins to store data transmissions in buffer memory. When an acknowledgement is received, the data transmissions in the buffer memory are transmitted. The biosensor or patch stores data transmissions in the buffer memory until the memory is full. Once the memory is full, the buffer stores the most recent data collected.

[0080] In another aspect, the gateway includes a buffering feature that stores collected data when it is determined that transmissions are not reaching the data collection center correctly. In one example, the gateway may receive an acknowledgement of transmission from the data collection center when a transmission is received. If the acknowledgement is not received, the gateway begins to store data transmissions in buffer memory. When an acknowledgement is received, any intervening data transmissions stored in the buffer memory are transmitted and then deleted along with the acknowledged. The gateway stores data transmissions in the buffer memory until the memory is full. Once the memory is full, the buffer stores the most recent data collected.

[0081] In one aspect, both the biosensor and the gateway include a buffering feature.

In another aspect, a warning is generated at the biosensor, the patch, or the gateway, to alert the monitored person that there is an error with data transmission.

[0082] In another aspect, a message may be generated to the subscriber and/or the call centre if transmission is interrupted between the sensor and the gateway or between the gateway and the data collection center for a predetermined period of time. The predetermined period of time may be a default, and may be an option that can be set by the subscriber. In one embodiment, a default period of time may be between 3 and 5 minutes.

[0083] While various aspects of the present invention have been described above, it should be understood that they have been presented by way of example, and not limitation. It will be apparent to persons skilled in the relevant art(s) that various changes in form and detail can be made therein without departing from the spirit and scope of aspects of the present invention. Thus, aspects of the present invention should not be limited by any of the above described exemplary aspects, but should be defined only in accordance with the following claims and their equivalents.

[0084] In addition, it should be understood that the figures in the attachments, which highlight the structure, methodology, functionality and advantages of aspects of the present invention, are presented for example purposes only. Aspects of the present invention are sufficiently flexible and configurable, such that it may be implemented in ways other than that shown in the accompanying figures.

[0085] Further, the purpose of the foregoing Abstract is to enable the U.S. Patent and

Trademark Office and the public generally, and especially the scientists, engineers and practitioners in the relevant art(s) who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of this technical disclosure. The Abstract is not intended to be limiting as to the scope of aspects of the present invention in any way.

Claims

CLAIMSWhat is claimed is:

1. A device for the collection and transmission of physiological data, comprising a suite of electronic components, said suite of electronic components comprising: a. a plurality of electrodes, wherein said plurality of electrodes are configured to make contact with and receive physiological data from a user's body; b. a plurality of sensors in operative communication with said plurality of electrodes, wherein said plurality of sensors receive and interpret physiological data from said plurality of electrodes; c. a signal conditioning unit in operative communication with said plurality of sensors, wherein said signal conditioning unit modifies data received by said plurality of sensors; d. an on-board controller in operative communication with said plurality of sensors, wherein said on-board computer controls all operations of the device; e. a transceiver in operative communication with said on-board computer; and f. a power supply unit for providing power to the suite of electronic components, wherein said suite of electronic components are mounted onto a printed circuit board and wherein said printed circuit board is attached to a fabric with conductive gel and adhesive for holding said device onto the user's body.

2. The device of Claim 1, further comprising a mechanical device for sensing and determining the orientation and physical activity of the user.

3. The device of Claim 1, further comprising an antenna for wirelessly communicating with one selected from a group consisting of an external device, an individual and a location.

4. The device of Claim 3, wherein said communication with said external device, individual or location is via one of the following wireless communications protocols: Cellular, ZigBee, Wireless local area network (802.1 la/b/g/n), ANT, Bluetooth, Ultra wide Band, and custom wireless communication protocol.

5. The device of Claim 1, wherein said on-board computer comprises: a. a processor or microcontroller; b. at least one memory component, said at least one memory component being in operative communication with the processor or integrated with the processor on the same chip; and c. a communications interface, the communications interface being in operative communication with the processor.

6. The device of Claim 1, further comprising an internal clock for synchronizing the suite of electronic components.

7. A device for the collection and transmission of physiological data comprising: a. a disposable component, wherein said disposable component comprises a plurality of electrodes, said plurality of electrodes being configured to maintain contact with a user's body, said plurality of electrodes being further configured to sense physiological data from said user's body; a disposable component may contain a battery or other power source for the suite of electronic components; b. a non-disposable component, said non-disposable component comprising a suite of electronic components, said suite of electronic components comprising: i. a plurality of sensors in operative communication with said plurality of electrodes, wherein said plurality of sensors receive physiological data from said plurality of electrodes; ii. a signal conditioning unit in operative communication with said plurality of sensors, wherein said signal conditioning unit modifies data received by said plurality of sensors; iii. an on-board computer in operative communication with said plurality of sensors, wherein said on-board computer controls all operations of the device, iv. a transceiver in operative communication with said on-board computer; and c. a plurality of connectors for connecting said disposable and non- disposable components.

8. The device of Claim 7, wherein said non-disposable component further comprises an accelerometer in operative communication with said on-board computer, wherein said accelerometer is configured to determine the orientation and physical activity of said user.

9. The device of Claim 87, wherein said non-disposable component further comprises an antenna for transmitting signals from the device, said antenna being in operative communication with said transceiver.

10. The device of Claim 7, wherein said non-disposable component further comprises an internal clock for synchronizing the suite of electronic components.

11. The device of Claim 7, wherein said non-disposable component further comprises a power supply unit.

12. The device of Claim 7, wherein said disposable component further comprises a power supply unit.

13. A method for the collection and transmission of physiological data by a system comprising: a. sensing, by a plurality of electrodes, physiological data of a user; b. receiving, by a plurality of sensors in operative communication with said plurality of electrodes, said physiological data from said plurality of electrodes; c. conditioning, by a signal conditioning unit, of said physiological data, wherein said signal conditioning unit is in operative communication with said plurality of sensors; d. collecting said physiological data by an on-board computer, wherein said on-board computer is in operative communication with said signal conditioning unit; e. storing, within memory of said on-board computer, the collected physiological data; f. processing, by said on-board computer, of said physiological data; and g. transmitting said physiological data by a transceiver in operative communication with said on-board computer.

14. The method of Claim 13, wherein the step of transmitting said physiological data includes transmitted said physiological data to a gateway device and a remote data collection center, and further comprising the step of: internally synchronizing components of said system and externally synchronizing said system with the operations center and the gateway.

15. The method of Claim 13, wherein step (f) comprises the step of encrypting the physiological data.

16. The method of Claim 13, further comprising the step of sensing, by a mechanical device, the orientation and physical activity of the user.

17. The method of Claim 16, further comprising the step of generating data regarding the orientation and physical activity of the user.

18. The method of Claim 16, further comprising: a. processing said orientation and physical activity data by said on-board computer; and b. transmitting said orientation and physical activity data.

19. A computer program product comprising a computer usable medium having control logic stored therein for causing a computer to receive, collect, store and transmit physiological data, said control logic comprising: a. first computer readable program code means for causing the computer to receive, from a plurality of sensors in operative communication with said computer, physiological data; b. second computer readable program code means for causing the computer to store, within memory of said computer, the received physiological data; c. third computer readable program code means for causing the computer to process said physiological data; and d. fourth computer readable program code means for causing a computer to determine when to transmit said physiological data.

20. The computer program product of Claim 19, further comprising fifth computer readable program code means for causing the computer to encrypt the physiological data.

21. The computer program product of Claim 19, further comprising fifth computer readable program code means for causing the computer to receive orientation and physical activity data of an individual from a mechanical device.

22. The computer program product of Claim 21, further comprising: a. sixth computer readable program code means for causing the computer to process said orientation and physical activity data; and b. seventh computer readable program code means for causing the computer to transmit said orientation and physical activity data.

23. A method for the collection and transmission of physiological data by a system comprising: a. receiving, at a device configured to be worn by a user, a predetermined range for at least one physiological measurement from a remote operations center; b. storing the predetermined range at the device; c. sensing, by a plurality of electrodes, physiological data of a user; d. receiving at the device, by a plurality of sensors in operative communication with said plurality of electrodes, said physiological data from said plurality of electrodes; e. determining at the device whether the sensed physiological data falls inside of or outside of the stored predetermined range for the physiological data; and f. transmitting said physiological data by a transceiver in operative communication with said on-board computer, wherein transmitting said physiological data includes, wherein if the physiological data is inside the predetermined range, the physiological data is transmitted on a periodic basis, and wherein if the physiological data is outside the predetermined range, the physiological data is transmitted on a near real-time basis.

24. The method according to claim 23, wherein the near real-time physiological data is transmitted before being processed.

25. The method according to claim 24, wherein processed data is transmitted in addition to the unprocessed data.

26. The method according to claim 23, wherein, if the physiological data is outside the predetermined range, the method further includes automatically sending an alert to at least one selected from a group consisting of a call center, a subscriber, and the remote operations center.

27. A method for the collection and transmission of physiological data by a system comprising: a. sensing, by a plurality of electrodes located on a patch, physiological data of a user; b. receiving, by a plurality of sensors located on a patch in operative communication with said plurality of electrodes, said physiological data from said plurality of electrodes; c. collecting said physiological data by an on-board controller located on a patch, wherein said on-board computer is in operative communication with said signal conditioning unit; d. processing, by said on-board computer, of said physiological data; e. determining if the patch is correctly attached by analyzing the resistance between at least two electrodes; and f. transmitting said physiological data by a transceiver in operative communication with said on-board computer.

28. The method according to claim 27, further comprising generating an alarm if it is determined that the patch is not correctly attached.

29. The method according to claim 28, further comprising transmitting an automatic alert message to at least one selected from a group consisting of a subscriber, a call center, and a remote operation center, if it is determined that the patch is not correctly attached.

30. A device for the collection and transmission of physiological data, comprising a suite of electronic components, said suite of electronic components comprising: a. a plurality of electrodes, wherein said plurality of electrodes are configured to make contact with and receive physiological data from a user's body; b. a plurality of sensors in operative communication with said plurality of electrodes, wherein said plurality of sensors receive and interpret physiological data from said plurality of electrodes; c. an on-board controller in operative communication with said plurality of sensors, wherein said on-board controller controls all operations of the device; d. a transceiver in operative communication with said on-board controller, wherein the on-board computer is configured to determine whether a transmission acknowledgement has been received from a remote data center confirming the error-free transmission of data from the device; and e. buffer memory configured to store data transmissions until the confirmation transmission is received, wherein said suite of electronic components are mounted onto a printed circuit board and wherein said printed circuit board is attached to a synthetic fabric with adhesive for holding said device onto the user's body.

31. The device according to claim 30, wherein the buffer memory is configured to store transmission data until the buffer memory is full, and wherein when the buffer memory is full, the buffer memory is configured to store the most recent data transmissions.

32. The device according to claim 30, wherein the device is configured to transmit a message to at least one selected from a group consisting of a subscriber, a call center, and the remote data center, if a transmission acknowledgment is not received within a predetermined period of time.

33. The device according to claim 30, wherein the on-board controller is configured to generate an alarm at the device, if a transmission acknowledgement is not received within a predetermined period of time.

34. A method for the collection and transmission of physiological data by a system comprising: a. sensing, by a plurality of electrodes, physiological data of a user; b. receiving, by a plurality of sensors in operative communication with said plurality of electrodes, said physiological data from said plurality of electrodes; c. collecting said physiological data by an on-board computer, wherein said on-board computer is in operative communication with said signal conditioning unit; d. processing, by said on-board computer, of said physiological data; e. transmitting said physiological data by a transceiver in operative communication with said on-board computer; f. receiving a transmission acknowledgment from a remote operations center, acknowledging receipt of the transmission; g. synchronizing with a gateway and the remote operations center, and h. storing the physiological data in buffer memory until the transmission acknowledgment is received.

35. The method according to claim 34, further comprising storing the most recent physiological data once the buffer memory is full.

36. The method according to claim 34, further comprising transmitting a message to at least one selected from a group consisting of a subscriber, a call center, and the remote data center, if a transmission acknowledgment is not received within a predetermined period of time.

37. The method according to claim 34, further comprising generating an alarm at the device, if a transmission acknowledgement is not received within a predetermined period of time.

38. A system for the collection and transmission of physiological data, comprising: a suite of electronic components, said suite of electronic components comprising: a remote data center; and a patch configured to be worn on the body of a monitored person, the patch including: a plurality of electrodes, wherein said plurality of electrodes are configured to make contact with and receive physiological data from a user's body; a plurality of sensors in operative communication with said plurality of electrodes, wherein said plurality of sensors receive and interpret physiological data from said plurality of electrodes; an on-board computer in operative communication with said plurality of sensors, wherein said on-board computer controls all operations of the device; and a transceiver in operative communication with said on-board computer, configured to transmit physiological data from the patch to the remote data center; wherein the remote data center is capable of receiving and storing transmissions from a plurality of patches and other sensors, identifying at least one of the manufacturer and model of each patch from the transmission of physiological data from each patch or sensor; analyzing the performance of each patch; and generating a report with the analysis of the plurality of patches.

39. A method for the collection and transmission of physiological data by a system comprising: collecting physiological data at a plurality of patches configured to be worn on the body of a user, including sensing, by a plurality of electrodes, physiological data of a user; receiving, by a plurality of sensors in operative communication with said plurality of electrodes, said physiological data from said plurality of electrodes; collecting said physiological data by an on-board controller, wherein said on-board controller is in operative communication with said signal conditioning unit; processing, by said on-board computer, of said physiological data; transmitting said physiological data by a transceiver in operative; and communication with said on-board computer to a remote operation center; receiving transmissions of said physiological at the remote operation center; identifying at least one of the manufacturer and model for each transmission from the plurality of patches or other sensors; analyzing the performance of each patch; and generating a report regarding the performance of the plurality of patches or other sensors.

40. The method according to claim 39, wherein the analysis includes analyzing the performance of a plurality of patches having at least one selected from a group consisting of the same manufacturer and the same model.

41. A device for the collection and transmission of physiological data, comprising a suite of electronic components, said suite of electronic components comprising: a. a plurality of electrodes, wherein said plurality of electrodes are configured to make contact with and receive physiological data from a user's body; b. a plurality of sensors in operative communication with said plurality of electrodes, wherein said plurality of sensors receive and interpret physiological data from said plurality of electrodes; c. a signal conditioning unit in operative communication with said plurality of sensors, wherein said signal conditioning unit modifies data received by said plurality of sensors; d. an on-board controller in operative communication with said plurality of sensors, wherein said on-board controller controls all operations of the device; e. a transceiver in operative communication with said on-board controller, wherein the device is configured to transmit the physiological data on a periodic basis if the physiological data is inside a predetermined range and to transmit the physiological data on a near real-time basis if the physiological data is outside the predetermined range, and f. a power supply unit for providing power to the suite of electronic components, wherein said suite of electronic components are mounted onto a printed circuit board and wherein said printed circuit board is attached to a fabric with adhesive for holding said device onto the user's body.

42. The device according to claim 41, wherein the device is configured to transmit processed data in addition to unprocessed data in a near real-time basis, if the physiological data is outside the predetermined range.

43. The device according to claim 41, wherein, if the physiological data is outside the predetermined range, the device is further configured to automatically transmit an alert to at least one selected from a group consisting of a call center, a subscriber, and a remote operations center.