Network physical layer configuration for portable physiological parameter monitoring and therapeutic intervention systems

Abstract

Certain disclosed embodiments relate to a physiological parameter monitoring system. The system may include a sensor and sensor electronics connected to the sensor. The system may also include a transmitter operably connected to the sensor electronics. The transmitter is positioned or configured to be positioned at a first location, at least a portion of which is adjacent and / or in contact with an external surface of the host's body during a sensor session, and is further configured to wirelessly transmit sensor information using intrabody communication. The system may also include a first display device including a display and a receiver. The receiver is positioned or configured to be positioned at a second location, at least a portion of which is adjacent and / or in contact with an external surface of the body during a sensor session, and is further configured to receive sensor information from the transmitter using intrabody communication.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 148,347, filed on Feb. 11, 2021, the entire content of which is incorporated herein by reference.

[0002] This application generally relates to medical devices, such as specimen sensors, including a network physical layer configuration for a system of portable physiological parameter monitoring and therapeutic intervention.

Background Art

[0003] In recent years, various portable monitors have been developed for measuring a host's physiological parameters, and personal use in the home is increasingly widespread. Some of these monitors are fully implanted within the host's body. Some have an implanted portion and an external extension that attaches to an external electronic device that is on or near the host's body surface. Some monitors have no internal components and are entirely located on the host's skin or clothing. Portable monitors typically include a sensor that generates a signal indicative of the monitored physiological state, and sensor electronics operably connected to the sensor for powering the sensor operation and processing the sensor output signal.

[0004] In addition to monitors equipped with sensors and sensor electronics, personal use of portable devices for automated or semi - automated medical intervention in the home is also increasing. Examples of medical intervention under free movement include delivery of electrical impulses (e.g., cardiac pacemaker), or infusion of drugs or other therapeutic substances based on a schedule or in response to a physiological state (e.g., insulin pump). Portable monitors and medical intervention devices can operate in cooperation with each other, in which case the medical intervention is controlled in whole or in part by the data generated by the sensor.

[0005] These portable monitoring and intervention systems may also include display devices, often including a display for acquiring and processing data generated by sensors during or after use, and providing the host with information about the current values ​​of sensed physiological parameters or the status of the intervention process. These display devices may be handheld, portable, or fixed.

[0006] Data communication between the different components of these systems can be wired or wireless. Wireless protocols are often preferred in these applications because they are user-friendly, convenient, and do not restrict the host's movements as much. However, commonly used wireless communication techniques can have their own drawbacks in these applications. These drawbacks include large, fluctuating signal attenuation, inadequate security, and generally higher power consumption for a given data rate. Data communication physical layer designs that address these issues are needed.

[0007] It should be noted that this “Background Art” is not intended to help determine the scope of the claimed subject matter, nor is it intended to be considered as limiting the claimed subject matter to embodiments that solve any or all of the defects or problems presented above. No consideration of any technology, document, or reference in this “Background Art” section should be construed as an acknowledgment that the material described is prior art to any of the claimed subject matter herein. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent No. 8001067 [Patent Document 2] U.S. Patent Application Publication No. 2005 / 0027463 [Patent Document 3] U.S. Patent Application Publication No. 2006 / 0020187 [Patent Document 4] U.S. Patent Application Publication No. 2007 / 0027385 [Patent Document 5] U.S. Patent Application Publication No. 2008 / 0119703 [Patent Document 6] U.S. Patent Application Publication No. 2008 / 0108942 [Patent Document 7] U.S. Patent Application Publication No. 2007 / 0197890 Specification [Patent Document 8] U.S. Patent No. 8565509 [Patent Document 9] U.S. Patent No. 8579690 [Patent Document 10] U.S. Patent No. 8484046 [Patent Document 11] U.S. Patent No. 8512939 [Patent Document 12] U.S. Patent No. 8477395 [Patent Document 13] U.S. Patent No. 8424847 [Patent Document 14] U.S. Patent No. 7310544 [Patent Document 15] U.S. Patent No. 8931327 [Patent Document 16] U.S. Patent Application Publication No. 2005 / 0043598 [Patent Document 17] U.S. Patent Application Publication No. 2007 / 0032706 Specification [Patent Document 18] U.S. Patent Application Publication No. 2007 / 0016381 [Patent Document 19] U.S. Patent Application Publication No. 2008 / 0033254 [Patent Document 20] U.S. Patent Application Publication No. 2005 / 0203360 Specification [Patent Document 21] U.S. Patent Application Publication No. 2005 / 0154271 [Patent Document 22] U.S. Patent Application Publication No. 2005 / 0192557 [Patent Document 23] U.S. Patent Application Publication No. 2006 / 0222566 [Patent Document 24] U.S. Patent Application Publication No. 2007 / 0203966 [Patent Document 25] U.S. Patent Application Publication No. 2007 / 0208245 [Summary of the Invention] [Means for Solving the Problems]

[0009] Human body communication (HBC) and energy harvesting technologies are applied to portable physiological monitoring and therapeutic intervention systems.

[0010] Although various configurations of the subject technology will be apparent to those skilled in the art from the present disclosure, it is understood that the various configurations of the subject technology are shown and described by way of example. As will be recognized, without departing from the scope of the subject technology in its entirety, the subject technology is capable of other different configurations and some of its details are capable of modification in various other respects. Accordingly, the summary, drawings, and detailed description should be regarded as being essentially exemplary and not restrictive.

[0011] One aspect is a physiological parameter monitoring system comprising a sensor, a sensor electronic device operably connected or connectable to the sensor, and a transmitter configured to be operably connected to the sensor electronic device, wherein at least a part of the transmitter is positioned or configured to be positioned at a first location adjacent to and / or in contact with the outer surface of the host's body during a sensor session, and the transmitter is further configured to wirelessly transmit sensor information using human body communication; and a first display device including a display and a receiver, wherein at least a part of the receiver is positioned or configured to be positioned at a second location adjacent to and / or in contact with the outer surface of the host's body during a sensor session, and the receiver is further configured to wirelessly receive sensor information from the transmitter using human body communication.

[0012] In the above system, the sensor is configured to generate a sensor output signal, the sensor electronic device is connected or connectable to the sensor by a wired connection, the transmitter is a primary sensor information transmitter connected or connectable to the sensor electronic device by a wired connection, the sensor information to be transmitted is configured to be generated by or derived from the sensor output signal, the receiver is a primary sensor information receiver, and the primary sensor information receiver is configured to directly wirelessly receive sensor information from the primary sensor information transmitter.

[0013] In the above system, the second location is the host's wrist. In the above system, the second location is the host's hand. In the above system, the sensor includes a glucose sensor. In the above system, the sensor includes an internal part configured to be implanted percutaneously in the host. In the above system, the internal part of the sensor is configured to be implanted percutaneously in the host's upper arm, in which case the first location is the host's upper arm and the second location is the host's wrist. In the above system, the sensor is configured to be implanted percutaneously in the host's abdomen, in which case the first location is the host's abdomen and the second location is the host's wrist.

[0014] In the above system, the first display device includes a smartwatch. The above system further includes a second display device. In the above system, the second display device includes a smartphone. In the above system, the first display device includes a secondary sensor information transmitter. The above system further includes a second display device. In the above system, the second display device includes a secondary sensor information receiver. In the above system, both the secondary sensor information transmitter and the secondary sensor information receiver include a Bluetooth® module.

[0015] Another embodiment includes a sensor configured to generate a sensor output signal, sensor electronic equipment connected to or connectable to the sensor via a wired connection, and a primary sensor information transmitter connected to or connectable to the sensor electronic equipment via a wired connection, wherein at least a portion of the primary sensor information transmitter is positioned or configured to be positioned at a first location adjacent to and / or in contact with the surface of a host's body during a sensor session, and the primary sensor information transmitter is further configured to wirelessly transmit sensor information generated by or derived from the sensor output signal using human body communication, and a relay module which is a primary sensor information receiver, wherein at least a portion of the primary sensor information receiver is in contact with the surface of a host's body during a sensor session. A physiological parameter monitoring system comprising: a relay module including a primary sensor information receiver, which is positioned or configured to be positioned at a second location adjacent to and / or in contact with the skin, and the primary sensor information receiver is further configured to wirelessly receive sensor information from a primary sensor information transmitter using human body communication; and a secondary sensor information transmitter, which is wired to or connectable to the primary sensor information receiver and configured to wirelessly transmit sensor information previously received from the primary sensor information transmitter by the primary sensor information receiver; and a first display device including a display and a secondary sensor information receiver configured to wirelessly receive sensor information from the secondary sensor information transmitter using wireless reception.

[0016] In the above system, both the secondary sensor information transmitter and the secondary sensor information receiver include a Bluetooth module. In the above system, the second location is the host's wrist. In the above system, the first display device includes a smartphone.

[0017] Another embodiment is a physiological parameter monitoring system comprising: a sensor configured to generate a sensor output signal; sensor electronic equipment connected to or connectable to the sensor via a wired connection; a first primary sensor information transmitter connected to or connectable to the sensor electronic equipment via a wired connection and configured to wirelessly transmit first sensor information generated by or derived from the sensor output signal using human body communication; a second primary sensor information transmitter connected to or connectable to the sensor electronic equipment via a wired connection and configured to wirelessly transmit second sensor information generated by or derived from the sensor output signal; a first display device including a display and a first primary sensor information receiver configured to wirelessly receive first sensor information from the first primary sensor information transmitter using human body communication; and a second display device including a display and a second primary sensor information receiver configured to wirelessly receive second sensor information from the second primary sensor information transmitter.

[0018] In the above system, both the second primary sensor transmitter and the second primary sensor information receiver include a Bluetooth module.

[0019] Another embodiment is a physiological parameter monitoring device comprising: a sensor configured to generate a sensor output signal related to a host; sensor electronic equipment operably connected to or connectable to the sensor; and a transmitter operably connected to or connectable to the sensor electronic equipment, the transmitter including a first conductive contact located on a first side of the sensor electronic equipment and operably connected to the sensor electronic equipment, and a second conductive contact located on a second side of the sensor electronic equipment and operably connected to the sensor electronic equipment, wherein the sensor electronic equipment is configured to apply a signal through the first and second conductive contacts to wirelessly transmit sensor information generated by or derived from the sensor output signal using human body communication.

[0020] In the above apparatus, the sensor electronic equipment, the first conductive contact, and the second conductive contact are fixed to a common substrate. In the above apparatus, the common substrate includes an adhesive. In the above apparatus, the sensor electronic equipment is positioned between the first conductive contact and the second conductive contact. In the above apparatus, the first conductive contact includes a metal plate that is capacitively coupled to or configured to be capacitively coupled to the skin of a host. In the above apparatus, the second conductive contact includes a metal plate that is capacitively coupled to or configured to be capacitively coupled to the skin of a host. In the above apparatus, the first conductive contact is covered with a first insulating film, and the second conductive contact is covered with a second insulating film. In the above apparatus, the first insulating film is thinner than the second insulating film.

[0021] Another embodiment is a physiological parameter monitoring system comprising: a sensor configured to generate a sensor output signal; a sensor electronics module operably connected to or connectable to the sensor and including a human body communication (HBC) transmitter, the HBC transmitter configured to be positioned on or adjacent to a first part of the host's body during a sensor session, and the HBC transmitter further configured to wirelessly transmit sensor information generated by or derived from the sensor output signal using human body communication; and a display device operably connected to the HBC transmitter and configured to receive sensor information from the HBC transmitter using human body communication, the HBC receiver configured to be positioned on or adjacent to a second part of the host's body during a sensor session, the second part being distinct from the first part.

[0022] Another aspect is a method for communicating sensor information using a physiological parameter monitoring system, comprising: generating a sensor output signal in a sensor of the physiological parameter monitoring system; wirelessly transmitting sensor information generated by or derived from the sensor output signal using body communication in a transmitter of the physiological parameter monitoring system positioned on or adjacent to a first part of the host's body; wirelessly receiving the sensor information from the transmitter using body communication in a receiver of the physiological parameter monitoring system positioned on or adjacent to a second part of the host's body, wherein the second part is different from the first part; and displaying the received sensor information in a display device of the physiological parameter monitoring system.

[0023] In the above method, the display device includes a smartwatch.

[0024] Another embodiment is a physiological parameter monitoring device comprising: a sensor configured to generate a sensor output signal; sensor electronic equipment operably connected to or connectable to the sensor; and a transmitter operably connected to or connectable to the sensor electronic equipment, the transmitter comprising: a first conductive contact operably connected to the sensor electronic equipment having a first area configured to be applied to a host at a first offset distance from the host's skin; and a second conductive contact operably connected to the sensor electronic equipment having a second area configured to be applied to a host at a second offset distance from the host's skin, wherein the second area is smaller than the first area and the second offset distance is greater than the first offset distance, and the sensor electronic equipment is configured to apply a signal through the first and second conductive contacts to wirelessly transmit sensor information generated by or derived from the sensor output signal using human body communication.

[0025] In the above-described apparatus, the sensor electronic equipment is positioned substantially between the first conductive contact and the second conductive contact.

[0026] Any feature of a particular embodiment is applicable to all embodiments specified herein. Furthermore, any feature of a particular embodiment can be individually combined in part or in whole with other embodiments described herein in any way, for example, one, two, or three or more embodiments may be combined in whole or in part. Furthermore, any feature of a particular embodiment may be optional for other embodiments. Any embodiment of a method may include another embodiment of a physiological parameter monitoring system / device, and any embodiment of a physiological parameter monitoring system / device may be configured to perform the method of another embodiment.

[0027] Various embodiments are discussed in detail below, in conjunction with the drawings, with an emphasis on highlighting advantageous features. These embodiments are for illustrative purposes only, and any scale shown therein does not limit the scope of the disclosed art. These drawings include the following figures, where similar figures indicate similar parts. [Brief explanation of the drawing]

[0028] [Figure 1A] This document describes exemplary specimen sensor systems that can be improved by implementing embodiments of the present disclosure. [Figure 1B] Figure 1A shows a schematic block diagram of a sample sensor system configured to communicate sample data wirelessly. [Figure 2A] The following are electrical and / or electromagnetic paths related to an HBC sample sensor system according to several embodiments. [Figure 2B] Similarly, electrical and / or electromagnetic paths related to an HBC sample sensor system according to several embodiments are shown. [Figure 3A] A schematic block diagram of an HBC sample sensor system according to several embodiments is shown. [Figure 3B] The following are examples of components and connection layouts for a sensor electronics module according to several embodiments that implement the architecture of Figure 3A. [Figure 3C] The image shows a top view of a sensor electronics module configured to wirelessly communicate sample data through the host tissue, according to several embodiments. [Figure 3D] The first specimen sensor system, comprising a sensor electronics module and a display device configured to perform human body communication according to several embodiments, is shown. [Figure 3E] A second specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 3F]A third specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 3G] A fourth specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 3H] A fifth specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 4A] This is a table of several different configurations of an insulated transmitting electrode that can be used for human body communication according to several embodiments. [Figure 4B] This graph shows the relative intensity of the received signal in a human body communication receiver when the transmitter electrodes have the configuration summarized in the table in Figure 4A. [Figure 5A] This is a schematic block diagram of another HBC sample sensor system according to several embodiments. [Figure 5B] A sixth specimen sensor system is shown, comprising a sensor electronics module, a display device, and other components configured to perform human body communication, according to several embodiments. [Figure 5C] A seventh specimen sensor system is shown, comprising a sensor electronics module, a display device, and other components configured to perform human body communication, according to several embodiments. [Figure 5D] An eighth specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 5E] A ninth specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 6A]A tenth specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 6B] An eleventh specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 6C] A twelfth specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 6D] A thirteenth specimen sensor system is shown, comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. [Figure 6E] A 14th specimen sensor system is shown, comprising a sensor unit and a display device configured to perform human body communication, according to several embodiments. [Figure 6F] A 15th specimen sensor system is shown, comprising a sensor unit and a display device configured to perform human body communication, according to several embodiments. [Figure 7A] A 16th specimen sensor system, comprising a sensor unit, a display device configured to perform human body communication, and an injection pump, according to several embodiments, is shown. [Figure 7B] A 17th specimen sensor system, comprising a sensor unit, a display device configured to perform human body communication, and an injection pump, according to several embodiments, is shown. [Modes for carrying out the invention]

[0029] The figures, which are described in more detail in the following description and examples, are provided for illustrative purposes only and only illustrate typical or exemplary embodiments of the Disclosure. The figures are not intended to be exhaustive or to limit the Disclosure to the exact form disclosed. It should also be understood that the Disclosure may be implemented with modifications or changes, and that the Disclosure may be limited only by the claims and their equivalents.

[0030] The following description and examples illustrate some exemplary embodiments, configurations, and configurations of the disclosed technology. Those skilled in the art will recognize that there are many variations and modifications of the invention that are encompassed by the scope of the invention. Therefore, the description of certain exemplary embodiments should not be considered limiting to the scope of the invention.

[0031] The embodiments of the technology described herein are generally directed toward communication between components of portable physiological monitoring and therapeutic intervention systems. To facilitate understanding of the various embodiments described herein, specific terms used herein are defined below.

[0032] definition Wired transmission and reception: Signal propagation from a signal source to a signal reception location when the signal source and signal reception location are galvanically connected by a conductive solid metal or semiconductor signal propagation medium. Examples of wired propagation mediums include metal wires, traces on printed circuit boards, solid-state electronic components, and integrated circuits.

[0033] Wireless transmission and reception: Signal propagation from a signal source to a signal receiver when the signal source and signal receiver are not galvanically connected by a conductive solid metal or semiconductor signal propagation medium. For example, signal propagation through air or any other gas, conductive or non-conductive liquids, insulating films, biological materials, or living organisms are all examples of wireless transmission and reception.

[0034] High-frequency transmission and reception: A form of wireless communication between a transmitting antenna and a receiving antenna, in which essentially all signal energy propagates through the air gap separating the transmitting and receiving antennas. This form of communication can be far-field, where the wavelength of the signal carrier is relatively small compared to the distance between the communicating devices, or near-field, where the wavelength of the signal carrier is relatively large compared to the distance between the communicating devices. Far-field high-frequency communication is typically implemented using patch antennas or their variations, with Wi-Fi and Bluetooth® being examples. Near-field high-frequency communication is typically implemented using coil antennas, with NFC and NFMI being examples. The carrier frequency for both is typically around 1 MHz to 100 GHz.

[0035] Wired connection: A wired connection exists between a given signal source and a given signal receiver when they are configured and deployed to communicate using wired transmission and reception.

[0036] Wireless connection: A wireless connection exists between a given signal source and a given signal receiver when they are configured and deployed to communicate using wireless transmission and reception.

[0037] Sensor: A device configured to generate an output signal indicating the presence and / or quantity of physiological, environmental, chemical, or other substances or states present at, near, or otherwise related to the sensor location, and includes, but is not limited to, sample sensors, temperature sensors, pressure sensors, and motion sensors.

[0038] Sensor Information: Any information associated with one or more sensors. Sensor information includes raw data streams or simply data streams of analog or digital signals directly related to the measurement signal output from a sample sensor (or other signals received from another sensor), as well as calibrated and / or filtered raw data. Sensor information may include calibrated data, smoothed data, filtered data, transformed data, and / or any other information associated with the sensor, such as sensor ID values, calibration codes, and manufacturing information.

[0039] A sample sensor is a structure that incorporates any mechanism (e.g., enzymatic or non-enzymatic) capable of quantifying the volume or concentration of a sample. A common example is a glucose sensor used to monitor glucose levels in diabetic patients. Some glucose sensors utilize a membrane containing glucose oxidase, which catalyzes the conversion of oxygen and glucose to hydrogen peroxide and gluconic acid. This reaction can be used to measure glucose concentration by monitoring the conductivity resulting from hydrogen peroxide production using electrodes. Fluorescence detection can also be used to quantify glucose concentration using fluorescent molecules that exhibit glucose concentration-dependent fluorescence. Other samples, such as lactates and hormones, can be quantified by similar chemical and / or optical methods.

[0040] Sensor electronics: Analog and / or digital circuits having or configured to have wired connections to one or more sensors, providing power for sensor operation, and / or receiving, processing, and / or storing output signals from one or more sensors, and / or transmitting them to another device. In the case of a sample sensor, the sensor electronics may include a potentiostat, other sensor current acquisition circuits such as switches, buffers, and filters, an A / D converter, and memory for storing digital data indicating the magnitude of the sensor current.

[0041] Primary sensor information transmitter: A communication device having or configured to have a wired connection to a sensor electronic device, which is configured and deployed to transmit, using wireless transmission, sensor information generated by or derived from signals output from one or more sensors having or configured to have a wired connection to a sensor electronic device.

[0042] Sensor electronics module: A combination of sensor electronics, one or more primary sensor information transmitters, and one or more wired connections between them. The components of a sensor electronics module are, but not necessarily, generally enclosed, coupled, or otherwise mechanically associated in a housing or other mounting structure that is characterized for attachment to the host's body or clothing.

[0043] Primary sensor information receiver: A communication device configured and deployed to receive sensor information from a primary sensor information transmitter using wireless reception.

[0044] Secondary sensor information transmitter: A communication device configured and deployed to transmit sensor information previously transmitted by a primary sensor information transmitter using wireless transmission. The secondary sensor information transmitter may also be a primary sensor information transmitter for sensor information generated by or derived from signals output from one or more sensors, which may be wired (and vice versa).

[0045] Secondary sensor information receiver: A communication device configured and deployed to receive sensor information from a secondary sensor information transmitter using wireless reception. A secondary sensor information receiver can also be a primary sensor information receiver (and vice versa) if it is configured and deployed to communicate with both a secondary sensor information transmitter and a primary sensor information transmitter.

[0046] Relay module: A combination of one or more primary sensor information receivers, one or more secondary sensor information transmitters, and one or more wired connections between them. Similar to sensor electronics modules, relay modules are typically, but not always, enclosed in, coupled to, or otherwise mechanically associated with a housing or other mounting structure that is designed to be attached to the host's body or clothing.

[0047] Transmitter: A device configured and deployed to transmit a wireless signal suitable for energy harvesting by another device. The signal may also function as a data transmission mechanism in addition to a power transmission mechanism, so that primary and secondary sensor information transmitters can also be transmitters.

[0048] Power receiver: A device configured and deployed to direct at least a portion of the energy of the received electric and / or magnetic field to an energy storage device such as a capacitor and / or rechargeable battery. The power receiver may utilize all or part of a primary sensor information receiver or a secondary sensor information receiver to perform its energy capture function.

[0049] Display device: A combination of a display and one or more primary sensor information receivers and / or one or more secondary sensor information receivers, having a wired connection between them, configured to display sensor information received by the primary sensor information receivers and / or secondary sensor information receivers. The display device may be, for example, a multi-functional smartphone or smartwatch, or a dedicated device specially manufactured for use with a monitoring system.

[0050] To be operationally connected: One or more components of a device or system are linked to another component of that device or system in a manner that enables the transmission of signals between the components. The term operationally connected includes the ability to transmit or exchange signals, whether with mechanical contact (e.g., wired connection) or without mechanical contact (e.g., wireless connection).

[0051] Determining: This includes calculating, manipulating, processing, deriving, investigating, taking in, looking up (e.g., looking up a table, database, or another data structure), verifying, estimating, detecting, etc. Determining may also include receiving (e.g., receiving information), accessing (e.g., accessing data in memory), etc. Determining may also include resolving, selecting, choosing, calculating, deriving, establishing, etc. Determining also includes classifying whether a parameter or condition exists or does not exist, and / or meeting predetermined criteria, including meeting a threshold, passing a threshold, exceeding a threshold, etc.

[0052] In effect: not necessarily exactly as specified, but nearly as specified, and at least the practical effect or purpose of the specification is maintained.

[0053] Percutaneous: Located beneath the epidermis of the subject, including locations in the dermis, subcutaneous tissue, and / or underlying muscle tissue, but excluding locations within veins or arteries.

[0054] Transcutaneous sensor: A sensor configured to take measurements when it is in a transcutaneous location, and the method of installing the sensor in a transcutaneous location is not limited.

[0055] Non-invasive: Does not penetrate the epidermis.

[0056] Non-invasive sensor: A sensor that can perform measurements without penetrating the epidermis. The term non-invasive sensor includes sensors that are designed for use in natural cavities such as the mouth.

[0057] Smartphone: A portable electronic device that wirelessly supports communication services, including voice and / or text, and internet access.

[0058] Bluetooth (BLE) module - One or more electronic circuits in a physical package configured to communicate wirelessly with other electronic circuits using high-frequency transceivers, in a manner that satisfies the interoperability requirements related to communication in any version of the Bluetooth Core Specification (or related specifications such as IEEE 802.15.1) adopted by the Bluetooth Special Interest Group or any successor standards development organization when in operation.

[0059] Near-field communication (NFC) modules and near-field magnetic induction (NFMI) modules: Electronic circuits in one or more physical packages configured to communicate wirelessly with other electronic circuits using inductive coupling via near-field high-frequency transceivers. NFC operates at 13.56 MHz. NFMI operates at 10.5 MHz.

[0060] Human Body Communication (HBC): Signal communication from a transmitting location on or near the surface of a host's body to a receiving location, also on or near the surface of the host's body, where the propagation of signal energy from the transmitting location to the receiving location is substantially carried out by electric current, field flux, and / or magnetic field flux penetrating and / or through the host's body tissue. HBC is a form of wireless transmission and reception. HBC is one of three standardized physical layer configurations for use in so-called body area networks, as described in IEEE 802.15.6. The HBC physical layer in this IEEE standard uses a 21 MHz carrier wave. The HBC signal may be galvanic, capacitive, inductive, or hybrid.

[0061] Galvanic HBC: A type of HBC that primarily relies on adjusting charge transfer within the host tissue to enable the operation of an HBC transmitter and receiver through forward and return current paths formed within the host tissue.

[0062] Capacitive HBC: An HBC that primarily relies on adjusting the electric field flux within the host's body tissue to enable the coupling of an HBC transmitter and an HBC receiver.

[0063] Inductive HBC: An HBC that primarily relies on regulating the magnetic field flux within the host's body tissues to enable the coupling of an HBC transmitter and an HBC receiver.

[0064] Hybrid HBC: An HBC that uses a combination of galvanic HBC, capacitive HBC, and inductive HBC to enable the operation of HBC transmitters and HBC receivers.

[0065] Mobile applications: Mobile applications are software programs that can run on smartphone operating systems such as iOS and Android. While mobile applications are generally designed to run on smartphones held in one hand, they can also run on non-mobile devices running the appropriate operating system.

[0066] Server: Processing hardware configured to be connected to a computer network in which network resources are stored or accessible, and which has software to respond to client access requests for the use or retrieval of the stored network resources. Multiple independent instances of the server software program can run simultaneously on the same processing hardware. In some cases, each of such instances constitutes a server.

[0067] Internet: A globally interconnected system of computers and computer networks that can utilize the TCP / IP network communication protocol, evolving from ARPANET and NSFNET in the late 1980s and early 1990s.

[0068] Website - A collection of network resources that include at least several web pages that share a common network resource identifier portion, for example, a set of web pages that share a common domain name but have different URLs with different path names.

[0069] A web server is a server that includes the functionality to respond to requests issued to the network by a browser, including requests to receive network resources such as web pages. Currently, browsers and web servers format these requests and responses to them according to the HyperText Transfer Protocol (HTTP) published by the IETF and W3C. In some embodiments, the web server may also be a content server.

[0070] World Wide Web - A collection of web pages that are stored and accessible from computers running a browser connected to the Internet, including references to one another through internal linking syntax.

[0071] overview The systems and devices described herein utilize sensors of physiological parameters that are implanted and / or fixed to the human body and are configured to communicate sensor information using human body communication (HBC). For example, as described in relation to some figures, one or more systems use the host's body tissue as the primary medium for signal propagation between transmitters and receivers within the system.

[0072] Many communication protocols conventionally used in portable monitoring systems are unsuitable for HBC (Head-Based Control). For example, far-field protocols such as Bluetooth, Zigbee, and ANT typically use modulated carriers of 2 gigahertz (GHz) or higher. The human body readily absorbs electromagnetic radiation at these frequencies. Propagation from transmitter to receiver using these protocols does not occur through the body, but only away from or around the body, making these protocols unsuitable for use with body tissue as a signal transmission medium. Furthermore, communication at such relatively high frequencies requires considerable power, resulting in significant battery drain, which, combined with the associated requirements for high-profile antennas, necessitates a relatively large size for the host device.

[0073] NFC technology, commonly used in smart credit cards and inventory RFID tags, has been proposed and is commercially used for sensor information communication. NFC uses two coils as a transmitting antenna and a receiving antenna, respectively. The coupling mechanism for data transfer is magnetic induction from the transmitting coil to the receiving coil, typically using a 13.56 megahertz (MHz) carrier wave. During data communication, the receiving antenna is typically separated from the transmitting antenna by an air gap of 10 cm or less, and the signal propagates through this gap. Therefore, this technology is not used in applications where the human body is the signal propagation medium.

[0074] NFMI, under the trade name MiGlo®, is implemented in HBC systems for wireless communication between hearing aids and audio earphones across the human head. Similar to NFC, NFMI also couples coil antennas via magnetic induction, but at a frequency of approximately 10.5 MHz. The NFMI protocol is not used in physiological monitoring systems.

[0075] The following describes embodiments of physiological monitoring devices and systems using various forms of HBCs. Novel physical configurations for transmitters and receivers in physiological monitoring systems are provided. Depending on the specific implementation, the system embodiments may operate at frequencies, for example, less than about 120 MHz, about 8 MHz to about 32 MHz in some embodiments, about 5 MHz to about 25 MHz in some embodiments, and about 10 MHz or 20 MHz to 21 MHz in some embodiments. These frequencies are merely examples, and other frequencies are possible. These ranges have desirable low path loss through the host's body tissues and allow for low energy consumption during such communication. As a result, such HBC configurations can achieve lower battery output current, flexible accessories that conform to the user's skin, and reliable sensor information communication between components. These features allow for the construction of physiological monitoring systems and components with smaller batteries or no batteries at all, as well as reduced height and / or form factor of user accessories.

[0076] Embodiment Many specific embodiments of physiological monitoring systems described herein relate to systems for monitoring blood glucose levels in a host having diabetes. For this purpose, a variety of non-invasive, transcutaneous, and / or implantable electrochemical sensors have been developed and are commercially available for the continuous detection and / or quantification of blood glucose levels. These devices generally include (1) a transcutaneous glucose sensor, (2) a sensor electronics module connected to or connectable to the transcutaneous sensor attached to the host's skin, and (3) a display device. The sensor electronics module may transmit raw, minimally processed, or fully processed and calibrated sensor information for further processing (if necessary) and display to the host. The sensor electronics module and the display device may be operablely connected by a wireless communication protocol, Bluetooth being the most common. While this form of physiological monitoring system provides examples for the following considerations, the described devices and methods of operation are applicable to the characteristics of any host being monitored.

[0077] Figure 1A shows an exemplary sample sensor system which may be improved by implementing embodiments of the present disclosure. Figure 1B shows a schematic block diagram of the sample sensor system configured to wirelessly communicate the sample data of Figure 1A. Referring here to Figures 1A and 1B, in some embodiments the sample sensing system may include a sample sensor 10 configured to continuously or periodically generate a signal indicating the concentration of a host sample. In some embodiments the sample sensor 10 includes a sustained glucose sensor, e.g., a subcutaneous, transdermal, or intravascular device.

[0078] A glucose sensor, as used herein, may be any device capable of measuring glucose concentration. To provide a data stream indicating glucose concentration in a host, the glucose sensor may use any known method, including invasive, minimally invasive, and non-invasive detection techniques (e.g., fluorescence monitoring). This data stream is typically a raw data signal, which is converted into a calibrated and / or filtered data stream used to provide a useful glucose value to a user, such as a patient or caregiver (e.g., a parent, relative, guardian, teacher, doctor, nurse, or any other individual interested in the host's health).

[0079] In certain embodiments, the sample sensor 10 is an implantable sample sensor, as described with reference to U.S. Patent No. 8,001,067 and U.S. Patent Application Publication No. US-2005-0027463(A1). In some embodiments, the sample sensor 10 is a transdermal sample sensor having an internal and an external portion, as described with reference to U.S. Patent Application Publication No. US-2006-0020187(A1). In some embodiments, the sample sensor 10 is configured to be implanted intravascularly or extravascularly in a host, as described, for example, in U.S. Patent Application Publication US-2007-0027385(A1), concurrently pending U.S. Patent Application Publication US-2008-0119703(A1) filed on 4 October 2006, U.S. Patent Application Publication US-2008-0108942(A1) filed on 26 March 2007, and U.S. Patent Application Publication US-2007-0197890(A1) filed on 14 February 2007. In some embodiments, the sample sensor includes, for example, a transdermal sensor as described in U.S. Patent No. 8,565,509 by Say et al. In some embodiments, the sample sensor 10 includes a subcutaneous sensor, for example, as described with reference to U.S. Patent No. 8,579,690 by Bonnecaze et al. or U.S. Patent No. 8,484,046 by Say et al. In some embodiments, the sample sensor includes a refillable subcutaneous sensor, for example, as described with reference to U.S. Patent No. 8,512,939 by Colvin et al. The sample sensor 10 may include an intravascular sensor, for example, as described with reference to U.S. Patent No. 8,477,395 by Schulman et al. The sample sensor 10 may include an intravascular sensor, for example, as described with reference to U.S. Patent No. 8,424,847 by Mastrototaro et al. All U.S. patents and publications mentioned in this paragraph are incorporated herein by reference in their entirety.

[0080] The system may further include a sensor electronics module 8, which includes a sensor electronics module 12 operably connected to a telemetry module 220 by a wired connection 212. The sensor electronics module 8 is operably connected to at least one specimen sensor 10 during a sensor session. In certain embodiments, the sensor electronics module 12 includes electronics associated with measuring and processing specimen sensor data, which may include predictive algorithms associated with processing and calibration of sensor data. The sensor electronics module 12 may be connected to the transdermal specimen sensor 10 by a wired connection 202. The sensor electronics module 12 may be integrated with the transdermal specimen sensor 10, permanently attached to the transdermal specimen sensor 10, or detachably attached to or attachable to the transdermal specimen sensor 10. Components of the sensor electronics module may be enclosed in a housing or holder 230 configured to be attached to the host's skin or clothing during a sensor session, or otherwise attached.

[0081] The sensor electronic device 12 may include hardware, firmware, and / or software that enables the measurement of a sample level. For example, the sensor electronic device 12 may include a potentiostat (not shown), a battery 216 for providing power to the components of the sensor electronic device, other components useful for signal processing (e.g., a processor, and optionally an analog front end (AFE) including at least an analog-to-digital (A / D) conversion circuit), and a data storage device (e.g., memory).

[0082] The telemetry module 220 (e.g., a high-frequency transmitter or transceiver) is operablely connectable to the sensor electronic device 12 via a wired connection 212, thereby enabling the sensor electronic device module 12 to transmit data to one or more display devices 120, 140 using the high-frequency transmission circuit 220, such as 4G LTE, Wi-Fi, NFC, and / or BLE.

[0083] The sensor electronic device 12 can be fixed to a rigid or flexible printed circuit board (PCB) or the like, and can take various forms. For example, the sensor electronic device 12 can take at least partially the form of an integrated circuit (IC), such as an application-specific integrated circuit (ASIC), a microcontroller, and / or other types of processor 204. In some embodiments, the sensor electronic device 12 is configured to have a signal processing algorithm (programming), for example, to filter, calibrate, convert, and / or execute other algorithms on the sensor data. Examples of systems and methods for processing sensor sample data are described in detail herein and in U.S. Patents Nos. 7,310,544 and 8,931,327, and U.S. Patent Publications Nos. 2005 / 0043598, 2007 / 0032706, 2007 / 0016381, 2008 / 0033254, 2005 / 0203360, 2005 / 0154271, 2005 / 0192557, 2006 / 0222566, 2007 / 0203966, and 2007 / 0208245, all of which are incorporated herein by reference in their entirety for all purposes. Some or all of the components of the telemetry module 220 can be fixed to the same PCB as the sensor electronics 12, and the wired connection 212 is formed by circuit components and conductive traces on or within the PCB that connect the components to each other.

[0084] The sensor electronics module 8 may further include an adhesive pad, which is installed before, during, or after insertion of the sensor 10, to ensure adhesion and, optionally, to ensure an hermetically or watertight seal around the wound exit site (or sensor insertion site) (not shown). A suitable adhesive pad can be selected and designed to stretch, elongate, conform to, and / or aerate the area (e.g., the host's skin). The water resistance, waterproofing, and / or hermetically sealing properties associated with the embodiments of the mounting unit / sensor electronics module described herein can be achieved by configuration and arrangement.

[0085] The sample sensor system may also include one or more display devices 120 and 140 relating to a particular aspect of the present disclosure. The display devices 120 and 140 may include a telemetry module including a high-frequency receiver 242, displays 122 and 142, a processor or controller 244, and a battery 246. Wired connections 248 and 249 connect the processor 244, the displays 122 and 142, and the primary receiver 242, all of which may be contained within a common housing 250. The sensor electronics module 8 can communicate wirelessly with one or more display devices 120 and 140.

[0086] One or more of the display devices 120, 140 can be further configured to transmit data to one or more other devices, for example, one or more of the other display devices 120, 140, which may be raw or otherwise processed sample data or other sensor information.

[0087] The display devices 120, 140 are configured to display (and / or warn) sensor information at least partially derived from data transmitted by the sensor electronics module 8 (for example, in a series of data packages transmitted to a suitable display device). Thus, each of the display devices 120, 140 configured in this manner may also include a corresponding display, such as a touchscreen display 122, 142, for displaying sensor information, sample data, and / or other data or alarms to the user, and / or for receiving input from the user. For example, a graphical user interface may be presented to the user for such purposes. In some embodiments, the display device may include other types of user interfaces, such as a voice user interface, instead of or in addition to a touchscreen display, for communicating sensor information to the user of the display device and / or receiving user input.

[0088] The systems in Figures 1A and 1B use high-frequency transmitters and receivers 110, 112, such as Bluetooth, to transfer sensor information from the sensor electronics module 8 to one or more display devices 120, 140. These circuits may require considerable power to operate and therefore a relatively large battery 216 may be necessary.

[0089] Figure 2A shows the electrical and / or electromagnetic paths associated with an HBC sample sensor system according to some embodiments. Figure 2B also shows the electrical and / or electromagnetic paths associated with an HBC sample sensor system according to some embodiments. In some embodiments described herein, different wireless communication methods may be used for some parts of communication between components that may require far less power than the embodiments in Figures 1A and 1B, as conceptually shown in Figures 2A and 2B. In these embodiments, the sample sensor system includes a transmitter 312 having a first insulated transmitting electrode 313 positioned in close proximity to the host tissue and a second insulated transmitting electrode 314 offset from the host tissue by a predetermined distance compared to the first insulated contact 313. The sample sensor system further includes a receiver 305 having a first insulated receiving electrode 306 positioned to press against the host tissue and a second insulated receiving electrode 307 offset from the host tissue by a predetermined distance compared to the first receiving electrode 306.

[0090] As shown in Figures 2A and 2B, the specimen sensor system utilizes human body communication (HBC) technology because the host tissue forms the primary transmission medium for wireless signals between the transmitter 312 and the receiver 305. The specific path through which the wireless signals travel depends on a particular configuration of the capacitances of the electrodes of the transmitter 312 and the receiver 305, the host tissue, and other aspects of the local external environment. As shown in Figure 2A, the capacitive coupling configuration establishes a transmission path for wireless signals, which includes a path 330 through the tissue between the first insulating electrode 313 of the transmitter 312 and the first insulating electrode 306 of the receiver 305, and a second path 340 that is more strongly coupled to the local external environment for the host, such as the ground 320, between the transmitting electrode 314 of the transmitter 312 and the receiving electrode 307 of the receiver 305. In Figure 3A, the linear arrows extending from the transmitting electrode 314 to the receiving electrode 307 represent illustrative electric field lines generated by the electrostatic potential associated with capacitive coupling, passing through the local external environment between the transmitter 312 and the receiver 305 and the common external ground between them. Accordingly, the first insulated contacts 313 and 306 of the transmitter 312 (e.g., the primary transmitter) and the receiver 305, respectively, function as signal electrodes, while the second insulated contacts 314 and 307 of the primary transmitter 312 and the receiver 305, respectively, function as ground electrodes.

[0091] In some embodiments, the receiver 305 may, as an alternative, replace the first and second receiving electrodes 306, 307 with an isolated high-Q magnetic antenna or pickup coil configured to generate a suitable potential across its terminals under the influence of an electrostatic potential signal generated by the transmitter 312 and propagated through the host tissue. In these embodiments, using an isolated high-Q magnetic pickup coil instead of the first and second receiving electrodes 306, 307 can increase the signal-to-noise ratio of the signal received by the receiver 305, mitigating potential problems associated with low signal levels. These embodiments can enable proper sensing and / or pickup of the HBC signal, depending on the physical dimensions of the host and / or the isolated high-Q magnetic pickup coil, even when the receiver 305 is located further up on the same arm as the transmitter 312 or on the opposite arm, or even when the receiver 305 is located further away from the transmitter 312 on the host's abdomen.

[0092] The achievable communication range and data rate between transmitter 312 and receiver 305 can vary and depend on the operating frequency, data symbol rate, modulation type, host physiological factors, limitations on the transmitter power of transmitter 312, and environmental capacitance factors of the local external environment. Accordingly, such capacitive coupling may be suitable for higher data rates but may have high sensitivity to capacitively coupled devices or objects in the immediate environment. Generally, exemplary frequency ranges for such communication may be about 120 MHz or less, about 8 MHz to about 32 MHz in some embodiments, about 5 MHz to about 25 MHz in some embodiments, and about 20 MHz to about 21 MHz in some embodiments.

[0093] Figure 3A shows a schematic block diagram of an HBC sample sensor system according to several embodiments. Figure 3B shows examples of components and connection layouts for a sensor electronics module according to several embodiments that implement the architecture of Figure 3A. Figure 3C shows a top view of a sensor electronics module configured to wirelessly communicate sample data through host tissue according to several embodiments. Figures 3D to 3H show first to fifth sample sensor systems, each comprising a sensor electronics module and a display device, respectively, configured to perform human body communication, according to several embodiments. Hereinafter, specific embodiments of the sample sensing system configured for HBC communication will be described in more detail with reference to Figures 3A to 3H. Figure 3A shows an example of a sensor electronics module 8' configured to wirelessly communicate sensor information through tissue to display devices 120', 140' using HBC communication, according to several embodiments.

[0094] As shown in Figure 3A, the sensor electronics module 8' is operably coupled to the sample sensor 10 using a wired connection 202 similar to that shown in Figure 1B. However, in Figure 3A, the communication channels 110', 112' for wireless communication between the sensor electronics module 8' and the display devices 120', 140' are HBC communication channels that may be configured according to the principles described above with reference to Figures 2A and 2B. Similar to the system in Figure 1B, in some embodiments, the battery (1) 216' may be disposable after one sensor session along with the remainder of the sensor electronics module 8' and may not be intended to be recharged for further use with a new sensor 10. In some embodiments, the battery (2) 246' may be rechargeable so that the display devices 120', 140' can be reused for many sensor sessions. In some embodiments, the battery (1) 216' may be rechargeable (e.g., periodically connected to a charging device for wired or wireless charging) so that the sensor electronics module 8' can be reused with one or more new replaceable sensors 10.

[0095] Figure 3B shows one possible embodiment of the component layout of the sensor electronics module 8' in Figure 3A. In Figure 3B, the sensor electronics module 8' is shown as operably coupled to the sensor 10, which may be disposed through an opening 406 of the PCB 480 and provides an electrical signal proportional to the detection level of a sample (e.g., glucose) in the host. The contacts and electrical traces 202 are configured to provide a wired connection for the analog signal from the sensor 10 to a processor, microcontroller, ASIC, etc. 204', which is partially similar to the processor 204 previously described in relation to Figure 1B, and which may include electronics necessary to convert the analog signal from the sensor 10 into a signal suitable for transmission to display devices 120', 140' via first and second transmitting electrodes 313, 314 through the host tissue via HBC. The signal may be provided to the first and second transmitting electrodes 313, 314 via corresponding electrical traces 450 disposed on or within the flexible PCB 480.

[0096] The sensor electronics module 8' may further include a battery 216'. The battery 216' may be any preferred type of battery (e.g., a coin cell battery), but in some embodiments, the battery 216' may include a smaller, lower-profile battery printed on the PCB 480. In other embodiments, the battery 216' may have a substantially flat upper and / or lower surface and may be mounted on the upper surface of the PCB 480, covering at least a large portion of the opening 406 and the electronics disposed on the PCB 480, thereby also functioning as a physical cover therefor.

[0097] Each of the first and second battery traces 488 may also be located on the PCB 480 and configured to directly or indirectly supply power from the battery 216' to any electrical components of the sensor electronics module 8' that require battery power.

[0098] The first transmitting electrode 313 is shown as being disposed in and / or on the surface of the PCB 480 on the first side of the sensor electronic device 204', and the second transmitting electrode 314 is shown as being disposed in and / or on the surface of the PCB 480 on the second side of the sensor electronic device 204'. In some embodiments, this second side may be disposed in the opposite direction with respect to the sensor electronic device 204' compared to the first side. In some embodiments, the bottom surface of the PCB 480 may include an adhesive layer disposed over at least the portion on which the first and second transmitting electrodes 313, 314 are disposed in and or on the surface. Such an adhesive layer may be configured to allow the sensor electronic device module 8' to be attached to the host's skin or clothing.

[0099] In some embodiments, the first portion of the PCB 480 on which the first transmitting electrode 313 is disposed in the middle or on the surface may be manufactured to have a first predetermined thickness configured to provide a first desired offset or insulation gap between the first transmitting electrode 313 and the host tissue, thereby providing a first amount of capacitive coupling between the first transmitting electrode 313 and the host tissue. The second portion of the PCB 480 on which the second transmitting electrode 314 is disposed in the middle or on the surface may have a second predetermined thickness configured to provide a second desired offset or insulation gap between the second transmitting electrode and the host tissue, thereby providing a second amount of capacitive coupling between the second transmitting electrode 314 and the host tissue. In other embodiments, a second predetermined thickness above or below the second transmitting electrode 314 is greater than a first predetermined thickness above or below the first transmitting electrode 313, providing a desired gap between the second transmitting electrode 314 and the host tissue that is larger than the gap between the first transmitting electrode 313 and the host tissue, as shown in Figures 2A and 2B.

[0100] By placing all the circuitry on a single layer of adhesive-backed PCB480, the cost and thickness of the sensor electronics module 8' are reduced compared to some other designs, especially when commercially available thin, flexible batteries 216' (e.g., printed batteries roughly the size of a small gauze pad, in contrast to larger coin cell batteries) are utilized. The areas of PCB480 in contact with the adhesive form a dielectric or insulating coupling mechanism for propagating signals to a properly configured receiver, for example, via the 21MHz IEEE 802.15.6 HBC protocol or similar.

[0101] In the operation of this embodiment, the sensor 10 generates an analog electrical signal indicating the level of a sample (e.g., glucose) detected in the host. This analog electrical signal is provided from the sensor 10 to the sensor electronics, which uses a capacitive coupling-based HBC protocol to convert the analog signal into a digital signal suitable for communication through the host tissue. This digital signal is used to modulate a carrier signal and is then applied across the first and second transmitting electrodes 313, 314, which are disposed on the host skin and / or tissue as described above. Once the first and second receiving electrodes 306, 307 of the receiver 305 (display devices 120', 140', etc.) (see, for example, Figures 2A and 2B) are also appropriately disposed on the host skin and / or tissue at a different location from the sensor electronics module 8', the provision of the modulated carrier signal across the first and second electrodes 313, 314 triggers HBC and signal propagation via the direct path 330 and the return path 340 (see, for example, Figure 2A).

[0102] HBC transmissions through the host's organization operate at substantially lower frequencies compared to other wireless protocols such as BLE and Wi-Fi, and propagate easily with substantially no attenuation while passing through the host's organization. Furthermore, since there is little to no need for signal processing, calibration, and / or storage in the sensor electronics, and these can instead be done in one or more receivers (e.g., receiver 305), the manufacturing of the sensor electronics module 8' can be less expensive in that fewer hardware components are required, and those required components can be selected at a lower cost due to the reduced processing and / or storage requirements. In addition, the reduced processing and improved efficiency of wireless transmission using HBC also result in a reduced power and / or current draw from the battery 216', which allows the battery 216' to be smaller and cheaper, and / or allows for more convenient manufacturing methods than those that can be used for the battery 216 in Figure 1B, such as printing and / or bonding the battery on a substrate as described earlier. All of these factors result in a sensor electronics module that can operate more efficiently and have a lower profile than is normally possible.

[0103] Figure 3C is a top view of some hardware features of an advantageous physical implementation of a sensor electronics module 8' according to several embodiments. In this embodiment, the sensor electronics module 8' may include a PCB 480 that is flexible or has flexible portions containing, for example, polyimide or any other suitable flexible insulating material. Transmitting electrodes 313, 314 may be disposed in and / or on the corresponding flexible portions of the PCB 480 on both sides of the electrical traces and / or electronics, as previously described in relation to the sensor electronics module 8' of Figures 3A and 3B. Electronics located between electrodes 313, 314 may be disposed on the flexible or rigid portions of the PCB 480. This embodiment of the sensor electronics module 8' may resemble an inconspicuous flexible adhesive bandage that can be applied and removed and disposed of after use in a similar manner.

[0104] In the embodiment shown in Figure 3C, the sample sensor 10 may be substantially or completely non-invasive and may be operably coupled to the sensor electronics module before the sensor electronics module is installed on the host and the sensor session is initiated. Such a sensor design makes the application of the sensor electronics module very user-friendly in terms of installation, without requiring a transcutaneous sensor inserter, which is the current common practice. This may be as easy as applying a bandage. Alternatively, the sensor 10 may first be inserted in a conventional manner, attached to a base having conductive contacts on its surface, and the sensor electronics module 8' is installed on top of it so that the sensor 10 is operably connected to the sensor electronics module 8'.

[0105] Figure 3D shows a first specimen sensor system comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. Figure 3D shows an embodiment of the concept described herein in the context of a specimen concentration monitoring system. The system comprises a sensor (not shown), a sensor electronics module 8' operably connected to the sensor including a primary sensor information transmitter configured to perform HBC communication, and a display device 140' including a primary sensor information receiver configured to perform HBC communication. A smartwatch 150 is an exemplary display device for several embodiments, for this reason, as it includes a display 152 and may also include receiving electrodes 306, 307 that function as electrodes for receiving HBC signals, either on the back of the watch body or inside the band (as shown in Figure 3D). In some embodiments, instead of electrodes 306, 307, the display device 150 may include an isolated high-Q magnetic antenna or pickup coil for receiving HBC signals from host tissue. A smartwatch can be an advantageous display device having a primary sensor information receiver configured to perform HBC communication, because it is a device with internal data processing capabilities designed for long-term contact with the host's tissue. However, as described in the embodiments below, the display device 150 can take on a wide variety of different forms.

[0106] Accordingly, several exemplary embodiments of a sample sensor system configured to communicate sample data through the host tissue using HBC are described below, at least with reference to Figures 3E to 3H.

[0107] Figure 3E shows a second specimen sensor system comprising a sensor electronics module and a display device configured to perform human body communication, according to one of several embodiments. In Figure 3E, the receiver is formed as a “smart ring” 160, 160’ instead of a smartwatch. The ring may include a simpler display mechanism, such as an alphanumeric display 162 or an LED light 162’, to present sensor information, such as specimen concentration, to the host.

[0108] Figure 3F shows a third specimen sensor system comprising a sensor electronic device module and a display device configured to perform human body communication, according to several embodiments. In Figure 3F, the display device is formed as a medical warning bracelet or necklace 170 having HBC contacts 306, 307 on one side and an LED display indicator 172 on the other side.

[0109] Figure 3G shows a fourth specimen sensor system comprising a sensor electronic module and a display device configured to perform human body communication, according to several embodiments. In the embodiment shown in Figure 3G, the display device 180 may be configured to operate in a manner similar to a single-point glucose monitor when picked up by a host, but without requiring a finger-prick blood sample. In the system of Figure 3G, the display device 180 has HBC receiving electrodes 306, 307 on its outer surface. The sensor electronic module 8' may be configured to transmit its most recently acquired sensor information periodically (e.g., every 5 seconds, every 10 seconds, every 15 seconds, every 20 seconds, or every 30 seconds, etc.) using its transmitting electrodes. The above numbers are merely illustrative period times, and other times are possible. When a user picks up the display device 180, the receiving electrodes 306, 307 on the outer surface of the display device 180 come into contact with the host's skin. Next, the display device 180 listens for transmissions from the sensor electronics module 8', which are assumed to occur within 10 seconds of picking up the display device 180. After receiving the transmitted sensor information, the display device 180 displays the received sensor information or information derived therefrom (e.g., the current EGV data point) on the display 182.

[0110] The display device 180 in Figure 3G can be implemented in various ways. A particular example illustrated is a dedicated device with a form factor similar to a conventional single-point glucose monitor, which receives a blood sample on a test strip and outputs the glucose value read from the test strip. In another embodiment, a USB dongle may have an HBC electrode on its outer surface. The USB dongle can be plugged into an I / O port on a smartphone, tablet, PC, or other display / computing device. The USB dongle can receive sample data communication via HBC through contact of the host's finger with the receiving electrode and deliver it to the computing device. Appropriate software, such as a downloadable smartphone application, may receive data from the dongle for display on the dongle.

[0111] Such embodiments may enable on-demand acquisition of estimated sample values ​​without user-specific pairing between the sensor electronics module 8'' and the display device 180. At least one reason why user-specific pairing is not required is that capacitively coupled or galvanically coupled HBC transmitters and receivers can only communicate with each other through the host's tissue via HBC, thus requiring direct contact between the transmitting and receiving electrodes and skin / tissue (through contacts or pickup coils in the case of capacitively coupled devices, or through conductive contacts in the case of galvanically coupled devices), which in itself provides a degree of privacy and security.

[0112] As shown in Figure 3G and as previously described, the sensor electronics module 8'' is configured to communicate with the display device 180 through the host tissue using HBC. In some embodiments of the system in Figure 3G, the sensor electronics module 8'' may be configured to periodically or continuously modulate and transmit data packets through the host tissue using any preferred frequency (e.g., 20 MHz). In some embodiments related to Figure 3G, the sensor electronics module 8'' is configured to use an internal processor to calibrate, process, and estimate glucose values, to use internal memory to store one or more of the sensor data and estimated sample concentration data, and to transmit the data or information derived therefrom continuously or periodically through the host tissue via HBC. Thus, in some embodiments, the display device may receive a series of sample data points, optionally with associated timestamps, which may enable the display of a graph output of sample concentration data similar to that of a CGM device. In some embodiments, it would be understood that the sensor electronics module 8'' measures raw sensor data or minimally processed sensor data (e.g., AD conversion, filtering) and transmits it to the display device 180. In such embodiments, the display device 180 further processes the data received from the sensor electronics module 8'' to provide an estimated glucose value or some other meaningful value suitable for the user to understand.

[0113] In some embodiments, the display device 180 does not store estimated glucose values ​​or other sample data communicated through the tissue 50 by the sensor electronics module 8'', but may be configured to display a single, most recently generated estimated glucose value when the host is holding it (e.g., in the host's hand). For example, the sensor electronics module 8'' may be configured to continuously or periodically transmit data packets containing estimated sample concentration values ​​through the host's tissue. As previously described in relation to at least Figures 2A, 2B, and 3A, when the host picks up and holds the display device 180, the HBC circuit between the sensor electronics module 8'' and the display device 180 is completed through the tissue, and the display device 180 receives data packets containing estimated sample concentration values, which are then presented to the host on the display 182.

[0114] In some embodiments, the display device 180 is configured to display a countdown or other animation on its display while waiting to decode the next estimated glucose value transmission from the sensor electronics module 8'', for example, to mimic the integration process of a one-handed blood glucose meter. In some embodiments, the display device 180 may be configured to wake from a low-power sleep mode based on the sensing that a host has touched and / or picked up the display device 180, for example, by utilizing established capacitive sensing technology.

[0115] Some embodiments of the system shown in Figure 3G allow for the sharing of system components, for example, within a home or clinic, because all sensor electronics modules 8'' may be configured to communicate with all display devices 180 without a pairing procedure, and in these embodiments at least, estimated glucose values ​​do not need to be stored in the display devices 180.

[0116] As previously mentioned, in some embodiments, replacing BLE communication with HBC communication allows both the sensor electronics modules 8', 8'' and the display devices 150, 160, 170, 180 to omit or turn off the BLE high-frequency module, thereby reducing peak and continuous power demands compared to BLE-based transmitters. When the BLE high-frequency module is omitted, a smaller minimum height of the accessory is also possible by omitting the BLE antenna, which requires minimal separation from the host body to maintain communication performance. All of this results in a discreet, ultra-low-profile, and ultra-low-cost sensor electronics module that further benefits from lower power consumption and increased battery life.

[0117] Figure 3H shows a fifth specimen sensor system comprising a sensor electronics module and a display device configured to perform human body communication, according to several embodiments. Other exemplary embodiments of the specimen sensor system are described in relation to Figure 3H. In some embodiments that conform to both capacitively coupled and galvanically coupled HBC embodiments described herein, the sensor electronics module 8''' includes a first primary transmitter circuit for transmitting data through the host's tissue via HBC to a first display device 150, such as a smartwatch, as previously described, and may also include a second primary transmitter circuit (not shown) configured to communicate with another display device 125 using a second communication protocol (e.g., BLE, Wi-Fi, 4G LTE) that does not utilize the host's tissue as the primary transmission medium. The second, higher-power primary transmitter circuit may only be used if the first display device 150 has not received an HBC signal from the sensor electronics module 8''' through the tissue, as determined, for example, by the absence of an HBC ACK message returning from the display device 150 to the sensor electronics module 8'''.

[0118] In some such embodiments, the sensor electronics module 8''' is configured to maintain the second primary transmitter circuit in a reduced output or low-power sleep state as long as an energized HBC link between the sensor electronics module 8''' and the first display device 150 is maintained. However, in such embodiments, the sensor electronics module 8''' may be configured to determine that the display device 150 is not receiving an HBC signal from the sensor electronics module 8''' through the tissue. Based on such determination, the sensor electronics module 8''' may be configured to turn on the second wireless communication module, increase its output, or exit low-power sleep mode to communicate one or more sample data signals (e.g., analog, raw digital, partially or entirely processed sample data, estimated glucose values, or warnings) to another display device 125 using a second communication protocol (e.g., BLE, Wi-Fi, 4G LTE). In this way, many of the advantages of using HBC over other more power-intensive and / or higher frequency wireless communication protocols can be realized, while at the same time providing an alternative route for communicating sample data when such HBC protocols are not functioning, or are unavailable or unsuitable.

[0119] Similar technology may be used in specific situations involving swimming or bathing. Swimming and / or being submerged in water can present unique challenges for users of specimen sensor systems. During swimming, the host's sensor electronics module 8'' is inevitably submerged for at least some time. Specimen monitoring systems using transmitters and receivers that utilize communication protocols such as BLE and Wi-Fi cannot communicate underwater because the 2.4 GHz high frequency does not propagate well in water. As a result, in order to periodically check the patient's receivers 140, 120 (Figures 1A and 1B), parents of pediatric patients must remove the child from the swimming pool, and adult patients must get out of the pool. Although this is not as inconvenient as the use of repetitive finger punctures, such requirements can still place a considerable burden on users of such specimen sensor systems.

[0120] In contrast, HBCs that pass through host tissue at, for example, about 20 MHz to 21 MHz, or preferably about 10 MHz, can reach the host's body tissue in water to locations on the body that can be easily seen by the host or its caregiver.

[0121] Accordingly, in some embodiments, the sensor electronics module 8'' and the display device 150 may be substantially waterproof. The display device 150 may include at least one light source (e.g., a light-emitting diode, LED) and may be configured to emit or flash the LED in one of a plurality of colors indicating the estimated sample concentration value received from the sensor electronics module through the host tissue 50 via the HBC. For example, the display device 150 may be configured to emit or flash the LED in red light when the received estimated sample concentration value is outside the safety range, in yellow light when the received estimated sample concentration value is within a predetermined range near the edge or outer boundary of such a safety range, and in green light when the received estimated sample concentration value is well within such a safety range. It will be understood that the display device 150 may be configured to emit the LED in any pattern and / or color of light indicating different levels of the estimated sample concentration value. In this way, the host, the host itself, or the host's caregiver can look at the LEDs on the display device 150 while submerged in water or from a distance outside the water to determine at a glance whether the host's estimated sample concentration is well within the safe range, approaching the edge of the safe range, or outside the safe range. In some embodiments, the display device is further, or alternatively, configured to cause the display LEDs to emit light of a specific pattern and / or color to indicate whether and since the HBC communication session between the sensor electronics module 8''' and the display device 150 is no longer active, thereby providing the host or the host's caregiver with similar notification of such a condition. Although the display device 150 is shown as a potentially waterproof wristband and / or smartwatch, the disclosure is not limited in this respect, and the display device 150 may be any suitable wearable device or may be incorporated into clothing, for example, a swim cap.

[0122] Figure 4A is a table of several different configurations of isolated transmitting electrodes that can be used for human body communication according to several embodiments. Figure 4B is a graph showing the relative intensity of the received signal in a human body communication receiver when the transmitting electrodes have the configurations summarized in the table in Figure 4A. Surprisingly, it was found that the received signal intensity improved when the transmitting electrode 313, which has greater capacitive coupling to the tissue, has a larger surface area than the transmitting electrode 314, which has less capacitive coupling to the tissue. This is shown in Figures 4A and 4B. Figure 4A shows 18 different configurations of the transmitting electrode and driver circuit, which vary depending on the applicable carrier frequency, the respective electrode areas of the transmitting electrodes 313 and 314, and the distance between electrodes 313 and 314. Figure 4B shows the signal intensity results obtained using the various configurations in the table in Figure 4A.

[0123] Comparing the results of configuration 3 (black circle) with configuration 15 (red circle), it can be seen that, given all other parameters being equal, a larger electrode 313 and a smaller electrode 314 result in better performance than in the other cases. Therefore, it is advantageous to allocate a larger area to electrode 313 for a given total electrode area between both electrodes.

[0124] Figure 5A is a schematic block diagram of another HBC sample sensor system according to one embodiment. Figures 5B to 5D show the sixth to ninth sample sensor systems, each comprising a sensor electronics module, a display device, and other components configured to perform human body communication, according to one embodiment. In some embodiments, a relay module 9 can be utilized as a primary sensor information receiver, as shown in Figures 5A to 5D. The primary sensor information receiver may include one or more wireless communication modules and / or transceivers configured to communicate using a second communication protocol different from HBC, such as BLE, Wi-Fi, 4G LTE, or any other similar preferred wireless communication protocol, which does not utilize the host's tissue as the primary transmission medium, so as to function as a secondary sensor information transmitter. In these embodiments, the primary sensor information receiver 9 can receive sensor information from the sensor electronics module 8' via a first HBC channel and / or communication session, and can also periodically relay the sensor information to the peripheral devices 120, 140 by providing a communication bridge on a second channel between the relay module 9 and other peripheral devices 120, 140 using a second communication protocol (e.g., BLE, Wi-Fi, 4G LTE). In some such embodiments, some or all of the calibration and / or processing of the sensor information transmitted from the sensor electronics module 8' to the relay module 9 can be performed by the relay module 9 before relaying the sensor information in its original and / or processed form to the display device 120. In other embodiments, the display device 120 may instead perform some or all of the calibration and / or processing of the sensor information transmitted to the relay module 9, while the relay module 9 is configured to simply relay the original sensor information received from the primary transmitter 312 via the HBC on a first communication channel to the display devices 120, 140 via a second communication protocol (e.g., BLE, Wi-Fi, 4G LTE, or any other cellular communication protocol).

[0125] In the embodiments shown in Figures 5A to 5E, at least one relay module 9 functions as both a primary sensor information receiver and a secondary sensor information transmitter, according to the respective definitions defined herein. Accordingly, the display devices 120 shown in Figures 5B, 5C, 5D, and 5E are configured to function as secondary sensor information receivers for sample data, according to the definitions defined herein.

[0126] In Figure 5B, a wristband is used as the relay module 9. In Figure 5C, a smartwatch is used as both the relay module 9 and the display device 140'.

[0127] In Figure 5D, the relay device 9 and the display device 127 are separate but connectable devices, and the wristband constituting the relay device 9 includes receiving electrodes. The display device 127 can be attached to the wristband. The wristband can use an HBC to receive sensor information from the sensor electronics module 8' and transmit that sensor information to the display component via a different wireless communication protocol such as BLE. The wristband may include a charging coil for wirelessly charging the wristband at the same time that the display component is charged in the conventional manner for smartwatches. An opening 130 may be provided in the mounting hardware for the display component so that a contact 134 (not shown) attached to the bottom of the display device for the purpose of other biosignal monitoring provided by some smartwatches can come into contact with the user's skin through the center of the wristband containing the charging coil. Figure 5E is similar to Figure 5D, except that the wrist-mounted display device functions as a relay device 9 to another display device 125.

[0128] Figure 6A shows a tenth specimen sensor system comprising a sensor electronic module and a display device configured to perform human body communication according to several embodiments. Figures 6B to 6F show eleventh to fifteenth specimen sensor systems, each comprising a sensor electronic module and a display device configured to perform human body communication according to several embodiments. Further exemplary embodiments of specimen sensor systems configured to communicate through host tissue using HBC and to recover power transmitted wirelessly through host tissue are described below with reference to Figures 6A to 6C.

[0129] In some embodiments, instead of utilizing an onboard battery, one or more of the primary sensor information transmitters and primary sensor information receivers of a sample sensor system may instead include a capacitor for energy storage. The energy stored in the capacitor can be recovered from signals transmitted wirelessly through the host tissue by another device in the sample sensor system. In this case, such energy harvesting components of the sample sensor system may be powered by the charged capacitor. The absence of an onboard chemical storage battery cell makes such a sample sensor system less expensive, lower profile, and more environmentally friendly. Human tissue substantially blocks energy radiated in the GHz range, but is a good conductor of energy radiated in the MHz range. Therefore, RF energy radiated at the same or the same frequency as the HBC protocol, except for power transmission, between the primary sensor information transmitter and primary sensor information receiver through the host tissue easily propagates through the host tissue over a distance of 1 to 2 meters between the primary transmitter and primary receiver, and is not noticeably radiated from the host body.

[0130] In some embodiments, such as the embodiment shown in Figure 6A, the sample sensor system includes a wristband 290 containing a battery that serves as a power source for HBC signal energy recoverable by the sensor electronics module 17. In this embodiment, the disposable sensor electronics module 17 does not require a battery, which is indicated by the X above battery 1 (designated 216' in Figure 5A) in Figure 6A. Instead, a battery in the wristband, battery 2 (designated 246'' in Figure 5A, which may or may not be rechargeable), indirectly powers the sensor electronics module 17. The sensor electronics module 17 may include a primary BLE transmitter for transmitting sensor information to a display device 125. In Figure 6B, the wristband is configured as a watch band 293 that serves as a power source. The smartwatch body 129 may, in this example, serve as a display device that receives sensor information from the sensor electronics module 17 via BLE communication. In Figure 6(C), the wristband 287 serves as both a power source and a relay module. In Figure 6D, the watch band 295 functions as both a power source and a relay module. In Figure 6E, the wristband 271 receives power from the smartphone 125 and therefore does not require a battery. In this embodiment, the wristband 271 functions as a power transmitter, power receiver, and relay module. In Figure 6F, the watch band 297 receives power from the watch body 309 and therefore also does not require a battery. Although the HBC transmitter is shown as being incorporated into a wearable wristband in Figures 6A–6F, this disclosure intends for such a transmitter to be incorporated into any suitable device, including but not limited to a key fob or pendant.

[0131] Figure 7A shows a 16th specimen sensor system comprising a sensor unit and display device configured to perform human body communication, and further an infusion pump, according to some embodiment. Figure 7B shows a 17th specimen sensor system comprising a sensor unit and display device configured to perform human body communication, and further an infusion pump, according to some embodiment. Figures 7A and 7B illustrate embodiments of applying the above-described principles to a system that includes not only sensing capabilities but also therapeutic capabilities. A common example is a glucose sensor and insulin infusion pump used simultaneously. In the system of Figure 7A, the wristband 403 powers both the sensor electronics module 19 and the infusion pump 402 using HBC. The wristband 403 may function as a relay module to the display device 125 for sensor information received from the sensor electronics module 19 via HBC. The wristband 403 may also receive infusion pump status information from the infusion pump 402. The wristband 403 may further include processing capabilities for processing sensor information received from the sensor electronics module 19 and using that information to intelligently control the operation of the infusion pump 402.

[0132] The embodiment in Figure 7B can function similarly to the embodiment in Figure 7A, but in the embodiment in Figure 7B, the wristband is implemented with a relay module and power supply, plus a display device.

[0133] General Interpretation Guidelines Regarding This Disclosure Various aspects of this novel system, apparatus, and method will be described more thoroughly below with reference to the accompanying drawings. However, the disclosure in this teaching may be embodied in many different forms and should not be construed as being limited to any particular structure or function presented throughout this disclosure. Rather, these aspects are provided so that this disclosure is thorough and complete and fully conveys the scope of this disclosure to those skilled in the art. Based on the teachings of this specification, those skilled in the art should understand that the scope of this disclosure is intended to encompass all aspects of the novel system, apparatus, and method disclosed herein, whether implemented independently or in combination with any other aspects of this disclosure. For example, a system or apparatus may be implemented, or a method may be performed, using any one or more of the aspects presented herein. Furthermore, the scope of this disclosure is intended to encompass systems, apparatus, or methods implemented using other structures, functions, or structures and functions, in addition to or in addition to the various aspects of this disclosure presented herein. It should be understood that any embodiment disclosed herein may be presented in one or more elements of a particular claim. While some advantages and merits of preferred embodiments are described, the scope of this disclosure is not intended to be limited to any particular advantage, use, or purpose. The detailed description and drawings are not intended to limit the scope of this disclosure as defined by the accompanying claims and equivalents, but are merely illustrative of the disclosure.

[0134] With regard to the use of plural and singular forms of terms in this specification, those skilled in the art can interpret them as appropriate to the context and / or use, switching between plural and singular forms. For clarity, various singular / plural substitutions may be explicitly stated in this specification.

[0135] When describing the absolute values ​​of the features or characteristics of an object or action described herein, the terms “substantial,” “effectively,” “essentially,” “almost,” and / or other terms or phrases relating to degree may be used without a specific enumeration of numerical ranges. When applied to the features or characteristics of an object or action described herein, these terms refer to a range of features or characteristics that is not inconsistent with providing the desired function associated with that feature or characteristic.

[0136] When a single numerical value is given for a feature or characteristic, it is intended to be interpreted as encompassing at least the deviation of that value within one significant figure of the given numerical value.

[0137] Where numerical values ​​or ranges of numerical values ​​are provided to define a feature or characteristic of an object or action described herein, a specific method for measuring that feature or characteristic may also be defined herein, regardless of whether the value or range is modified in terms of degree. Where no specific method for measuring a feature or characteristic is defined herein, and there is a generally accepted alternative method of measurement for that feature or characteristic, the method of measurement shall be interpreted as the method most likely to be adopted by a person skilled in the art, given the description and context of that feature or characteristic. Furthermore, where there are two or more methods of measurement that are equally likely to be adopted by a person skilled in the art to measure that feature or characteristic, the value or range of values ​​shall be interpreted as being satisfied, regardless of which method of measurement is selected.

[0138] In this specification, terms used in particular in the appended claims (e.g., the body of the appended claims) will be understood by those skilled in the art to be "open" terms unless otherwise specifically indicated (for example, the term "including" should be interpreted as "including but not limited to," the term "having" should be interpreted as "having at least," and the term "includes" should be interpreted as "including but not limited to," etc.).

[0139] It will be further understood by those skilled in the art that if a particular number is intended in the description of a claim being introduced, such intention will be explicitly stated in the claim, and if such statement is not present, then no such intention exists. For example, for the sake of understanding, the claims attached below may include the use of introductory phrases “at least one” and “one or more” to introduce the description of a claim. However, the use of such phrases should not be interpreted as suggesting that introducing the description of a claim by the indefinite article “one (a)” or “one (an)” implies that any particular claim containing the description thus introduced is limited to embodiments containing only one such description, even if the introductory phrase “one or more” or “at least one” and the indefinite article, e.g., “one (a)” or “one (an)” are included in the same claim (e.g., “one (a)” and / or “one (an)” should generally be interpreted as meaning “at least one” or “one or more”). The same applies to the use of definite articles used to introduce the description of a claim. In addition, a person skilled in the art will recognize that if a particular number is explicitly stated in the description of a claim being introduced, such a description should generally be interpreted as meaning at least the number stated (for example, the minimal description "two descriptions" without other modifying phrases usually means at least two descriptions, or two or more descriptions).

[0140] Where a conventional expression (convention) similar to “at least one of A, B, and C” is used, such configurations would include systems having only A, only B, only C, both A and B excluding C, both A and C excluding B, both B and C excluding A, both B and C excluding A, and all of A, B, and C. A person skilled in the art will further understand that any disjunctive word and / or phrase presenting two or more alternative terms should be understood, in effect, whether in the specification, claims, or drawings, as intended to include the possibility of including one of those terms, either one or both of those terms. For example, the phrase “A or B” would be understood to include A excluding B, B excluding A, and both A and B.

[0141] Various modifications to the embodiments described herein will be readily apparent to those skilled in the art, and the general principles defined herein are applicable to other embodiments without departing from the spirit or scope of this disclosure. Therefore, this disclosure is not intended to be limited to the embodiments shown herein, but rather to be given the broadest scope consistent with the claims, principles, and novel features disclosed herein. The word “exemplary” is used herein exclusively to mean “serving as an example, case, or illustration.” Any embodiment described herein as “exemplary” should not necessarily be construed as being preferable or advantageous to other embodiments.

[0142] Certain features described in this specification in the context of separate embodiments may be combined and implemented as a single embodiment. Conversely, various features described in the context of a single embodiment may be implemented separately in multiple embodiments or in any preferred subcombination. Furthermore, features may be described as acting in a particular combination, and may even be initially claimed as such, but in some cases one or more features may be removed from the claimed combination, and the claimed combination may be directed towards a subcombination or a variation of a subcombination.

[0143] The methods disclosed herein include one or more steps or actions for achieving the described methods. These method steps and / or actions are interchangeable with one another without departing from the claims. In other words, unless a particular order of steps or actions is specifically designated, the order and / or use of any particular steps and / or actions can be modified without departing from the claims. [Explanation of symbols]

[0144] 8,8',8'',8''' Sensor Electronics Module 9 Relay Modules 10 Sample Sensors 12 Sensor Electronic Devices 13 Sensor Electronics Module 17 Sensor Electronics Module 19 Sensor Electronics Module 110 Wireless Communication Channels 110' Human body communication (HBC) 112 Wireless Communication Channels 112' HBC 120,120' Display device 122 (touchscreen) display 125 Display Devices 127 Display Devices 129 Smartwatch body 130 opening 134 Contact 140,140' Display device 142-inch (touchscreen) display 150 Smartwatches 152 displays 160,160' Smart Ring 162 alphanumeric display 162' LED Light 170 Medical Warning Bracelet or Necklace 172 LED Display Indicators 180 display devices 182 displays 202 Wired connection 204,204' processor 212 Wired connection 216,216' Battery 1 220 Telemetry Module 230,230' Housing or holder 232 High-Frequency Transmitter 240 cabinets 242 High-frequency receiver 244,244',244'' processor 246,246',246'' Battery 2 248 Wired connection 249,249',249'' Wired connection 250,250' enclosure 262 Battery 3 271 Wristbands 287 Wristbands 290 Wristbands 293 Watch Bands 295 Watch Bands 297 Watch Bands 305 Receiver 306 First insulating receiving electrode 307 Second insulating receiving electrode 309 Watch body 312 Transmitter 313 First insulated transmitting electrode 314 Second insulated transmitting electrode 320 Ground 330 Direct Route 340 Return route 402 Injection pump 403 Wristband 405 Smartwatch 406 Aperture 450 Electrical trace 480 Printed Circuit Boards (PCBs) 488 Battery Trace

Claims

1. A physiological parameter monitoring system, A sensor configured to generate an output signal from the sensor, A sensor electronic device that is connected to or can be connected to the aforementioned sensor via a wired connection, A first primary sensor information transmitter is connected to or can be connected to the aforementioned sensor electronic device by a wired connection and is configured to wirelessly transmit first sensor information generated by or derived from the sensor output signal using human body communication. A second primary sensor information transmitter is connected to or can be connected to the aforementioned sensor electronic device by a wired connection and is configured to wirelessly transmit second sensor information generated by or derived from the sensor output signal. A first display device including a display and a first primary sensor information receiver configured to wirelessly receive the first sensor information from the first primary sensor information transmitter using human body communication, A second display device including a display and a second primary sensor information receiver configured to wirelessly receive the second sensor information from the second primary sensor information transmitter, Equipped with, The aforementioned sensor electronic device is When a human body communication link is maintained between the first primary sensor information transmitter and the first display device, the second primary sensor information transmitter is kept powered off or in a low-power sleep state. Based on the determination that the first display device has not received a human body communication signal from the first primary sensor information transmitter, the second primary sensor information transmitter is powered on or exited from the low-power sleep state to wirelessly transmit the second sensor information to the second display device. A system that is configured in such a way.

2. The system according to claim 1, wherein the second sensor information is transmitted wirelessly using a communication protocol that does not use the host's organization as a transmission medium.

3. The system according to claim 2, wherein the communication protocol is one of BLE, Wi-Fi, and 4G LTE.

4. The system according to any one of claims 1 to 3, wherein the second primary sensor information transmitter and the second primary sensor information receiver each include a Bluetooth® module.

5. The system according to any one of claims 1 to 4, wherein the sensor electronic device is configured to determine that the first display device has not received the human body communication signal by determining that there is no human body communication ACK message from the first display device.

6. The system according to any one of claims 1 to 5, wherein the second sensor information includes analog, raw, digital, partially processed, or fully processed sample data, estimated glucose values, or warnings.

7. The system according to any one of claims 1 to 6, wherein the first display device is configured to relay the first sensor information received by human body communication to the second display device using a second communication protocol.

8. The system according to claim 7, wherein the first display device is configured to periodically relay the first sensor information to the second display device.

9. The system according to claim 7 or 8, wherein the second communication protocol is one of BLE, Wi-Fi, and 4G LTE.

10. The system according to any one of claims 1 to 9, wherein the sensor is a sustained glucose sensor.

11. The system according to any one of claims 1 to 10, wherein the sensor includes an internal part configured to be implanted percutaneously in a host.

12. The first primary sensor information transmitter is A first conductive contact is positioned on the first side of the sensor electronic device and is operably connected to the sensor electronic device, A second conductive contact is positioned on the second side of the sensor electronic device and is operably connected to the sensor electronic device, Includes, The system according to any one of claims 1 to 11, wherein the sensor electronic device is configured to apply a signal through the first conductive contact and the second conductive contact to wirelessly transmit the first sensor information generated by or derived from the sensor output signal using human body communication.

13. The first conductive contact includes a metal plate configured to be capacitively coupled to the skin of a host, The second conductive contact includes a second metal plate configured to be capacitively coupled to the skin of the host, The first conductive contact is covered with a first insulating film. The second conductive contact is covered with a second insulating film. The system according to claim 12, wherein the first insulating film is thinner than the second insulating film.

14. The system according to any one of claims 1 to 13, wherein the first display device is a smartwatch.

15. The system according to any one of claims 1 to 14, wherein the second display device is a smartphone.

Images