Location tracking based on connectivity in infusion pump systems

Abstract

Methods and systems for establishing a communication protocol between wireless devices in an infusion pump system are disclosed herein. The infusion pump system may include a plurality of components capable of wireless communication with one or more other components, including an infusion pump, a continuous blood glucose monitoring (CGM) system, and a smartphone or other multipurpose consumer electronic device (i.e., a remote control device). Communication between these devices may be coordinated to ensure reliable and consistent transmission of medical data.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 585,086, filed September 25, 2023, and U.S. Provisional Application No. 63 / 604,003, filed November 29, 2023, the entire contents of each of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates to portable infusion pumps, and more specifically to wireless communication in infusion pump systems. Background Technology

[0003] Various medical treatments exist that involve administering a therapeutic fluid at predetermined intervals in precise, known amounts. Apparatus and methods for delivering such fluids, which can be liquids or gases, are known in the art.

[0004] One category of such fluid delivery devices includes insulin infusion pumps developed for administering insulin to patients with type 1 diabetes or, in some cases, type 2 diabetes. Some insulin infusion pumps are constructed as portable or mobile infusion devices and can provide continuous subcutaneous insulin injections and / or infusion therapy as an alternative to multiple daily insulin injections via syringe or insulin pen. Such pumps are worn by the user and can use replaceable cartridges. In some embodiments, these pumps can also deliver drugs other than insulin or other medications, such as glucagon, pramlintide, etc. Examples of such pumps and the various features associated therewith include those disclosed in U.S. Patent Publications Nos. 2013 / 0324928 and 2013 / 0053816, and U.S. Patent Publications Nos. 8,287,495, 8,573,027, 8,986,253, and 9,381,297, the entire contents of which are incorporated herein by reference.

[0005] Mobile infusion pumps are typically controlled by a user interface mounted on the pump. With the proliferation of handheld electronic devices, such as mobile phones (e.g., smartphones), there is a desire to optimize the use of infusion pumps by remotely utilizing such devices, as well as dedicated wireless control devices designed to work with one or more infusion pumps and / or various types of infusion pumps. These remote control devices enable more private, convenient, and comfortable monitoring, programming, and / or operation of the pumps. Therefore, a potential use of dedicated remote devices and handheld consumer electronics (such as smartphones, tablets, etc.) is to utilize such devices as control devices for remote programming and / or operation of infusion pumps.

[0006] Besides mobile control devices such as smartphones and dedicated remote control devices, it may also be beneficial to enable the infusion pump to communicate with other devices such as continuous glucose monitors, blood glucose meters, and other health monitoring devices. However, wireless communication is susceptible to interference for many reasons, and therefore relying on wireless communication for medical treatment can also have some drawbacks. Furthermore, it can be difficult to determine the optimal location for placing the infusion pump that allows for reliable and consistent communication with medical treatment devices, such as those previously described. Guessing the location with conventional techniques to achieve reliable and consistent communication is inaccurate and can lead to the loss of medical data necessary for making informed treatment decisions. Therefore, it is desirable to configure such communication to reduce the risk of critical medical data failing to be transmitted due to communication problems. Summary of the Invention

[0007] This document discloses methods and systems for establishing communication protocols between wireless devices in an infusion pump system. The infusion pump system may include multiple components capable of wirelessly communicating with one or more other components, including the infusion pump, a continuous glucose monitoring (CGM) system, and a smartphone or other multi-purpose consumer electronics device (i.e., a remote control device). Communication among these devices can be coordinated to ensure reliable and consistent transmission of medical data.

[0008] In this implementation, a method is provided for coordinating wireless communication in an infusion pump system comprising a continuous glucose monitoring (CGM) device and an infusion pump. Initially, a communication session can be initiated between the infusion pump and the CGM device to enable the CGM device to transmit CGM data to the infusion pump. It can then be determined or verified whether the communication session has actually been initiated and whether the infusion pump is now communicatively connected to the CGM device. After determining that the communication session has been initiated, a metric indicating the quality of the communication signal between the infusion pump and the CGM device can be determined based on a first position of the infusion pump relative to the CGM device or a first position of the CGM device relative to the infusion pump. The metric indicating the quality of the communication signal between the infusion pump and the CGM device can be recorded for optional use by the infusion pump system at a later time. Indications of signal quality at one or more other locations can also be optionally displayed. The indications at one or more other locations can be based on a first position of the infusion pump relative to the CGM device or a first position of the CGM device relative to the infusion pump.

[0009] In one implementation, if the communication signal strength between the infusion pump and the CGM device falls below a predetermined threshold, a suggestion to reposition at least one of the infusion pump and the CGM device to a different location can be sent to the user. In another implementation, based on a second position of the infusion pump relative to the CGM device or a second position of the CGM device relative to the infusion pump, a metric indicating the quality of the communication signal between the infusion pump and the CGM device can be relayed in a manner similar to the first metric. This metric can be recorded for optional use by the infusion pump system at a later time. In yet another implementation, the indication of the communication signal quality at one or more other locations can be updated based on a second position of the infusion pump relative to the CGM device or a second position of the CGM device relative to the infusion pump.

[0010] In one implementation, a method for coordinating wireless communication in an infusion pump system including a continuous glucose monitoring (CGM) device and an infusion pump may include: initiating a communication session between the infusion pump and the CGM device; determining that the infusion pump is communicatively connected to the CGM device; and determining a metric indicating the quality of the communication signal between the infusion pump and the CGM device based on a first position of the infusion pump relative to the user's body and a first position of the CGM device relative to the user's body.

[0011] In one implementation, a method for coordinating wireless communication in an infusion pump system including a continuous glucose monitoring (CGM) device and an infusion pump may include: receiving input from a user via a user interface to initiate a communication session between the infusion pump and the CGM device; and providing the user with guidance on the user interface regarding the location of at least one of the infusion pump and the CGM device relative to the user's body, based on measurements of the signal strength between the infusion pump and the CGM device.

[0012] The above overview is not intended to describe every illustrated embodiment or implementation of the subject matter of the invention. The following figures and detailed description illustrate various embodiments in more detail. Attached Figure Description

[0013] The subject matter of the invention can be more fully understood by considering the following detailed description of various embodiments in conjunction with the accompanying drawings, in which:

[0014] Figure 1 An embodiment of the infusion pump system according to this disclosure is described.

[0015] Figure 2 A block diagram illustrating an embodiment of the infusion pump system according to the present disclosure is depicted.

[0016] Figures 3A to 3B An embodiment of the infusion pump system according to this disclosure is described.

[0017] Figure 4An embodiment of the infusion pump system according to this disclosure is described.

[0018] Figures 5A to 5B A remote control device for an infusion pump system according to an embodiment of the present disclosure is described.

[0019] Figure 6 A schematic diagram of an infusion pump system according to an embodiment of the present disclosure is depicted.

[0020] Figure 7 A schematic diagram of an infusion pump system according to an embodiment of the present disclosure is depicted.

[0021] Figure 8 A flowchart depicts the steps of a method for managing wireless communication in an infusion pump system according to an embodiment of the present disclosure.

[0022] Figure 9 A user interface for use with an infusion pump system according to an embodiment of the present disclosure is depicted.

[0023] While various embodiments can be modified into various alterations and alternatives, details of the various embodiments have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the claimed invention to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter defined by the claims. Detailed Implementation

[0024] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are similarly labeled. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0025] Figure 1Exemplary medical devices that can be used with embodiments of this disclosure are depicted. In this embodiment, the medical device is configured as a pump 12, such as an infusion pump, which may include an output / display 44 and a pumping or delivery mechanism and reservoir for delivering medication to a patient. The type of output / display 44 may vary depending on the needs of a particular application. The output / display 44 may include an interactive and / or touch-sensitive screen 46 having an input device, such as a touchscreen including a capacitive or resistive screen. The pump 12 may also include a keyboard, microphone, or other input devices known in the art for data input, which may be separate from the display. The pump 12 may also include the ability to be operatively coupled to one or more blood glucose meters (BGM) or continuous glucose monitors (CGM) and / or one or more auxiliary devices, such as remote displays, remote control devices, laptop computers, personal computers, tablet computers, mobile communication devices such as smartphones, wearable electronic watches, smart rings, electronic health monitors or fitness trackers or personal digital assistants (PDAs), CGM displays, etc.

[0026] In one embodiment, the medical device may be a portable pump configured to deliver insulin to a patient. Further details of such a pump device can be found in U.S. Patent No. 8,287,495, the entire contents of which are incorporated herein by reference. In other embodiments, the medical device may be an infusion pump configured to deliver one or more additional medications or other drugs to a patient.

[0027] Figure 2 The diagram illustrates block diagrams of some of the features that can be used with various embodiments, including features that can be incorporated into the housing 26 of a medical device, such as pump 12. Pump 12 may include a processor 42 that controls the overall function of the device. Infusion pump 12 may also include, for example, a memory device 30, a transmitter / receiver 32, an alarm 34, a speaker 36, a clock / timer 38, an input device 40, a user interface adapted to accept input and commands from users such as caregivers or patients, a drive mechanism 48, an estimator device 52, and a microphone (not shown). Figure 2One embodiment of the user interface shown is a graphical user interface (GUI) 60, which has a touch-sensitive screen 46 with input capabilities. In some embodiments, the processor 42 can communicate via a transmitter / receiver with one or more other processors within the pump 12 and / or with one or more processors of other devices, such as a continuous glucose monitor (CGM), a display device, a smartphone, etc. The processor 42 may also include programming that allows it to receive signals and / or other data from one or more input devices, such as sensors that can sense pressure, temperature, and / or other parameters.

[0028] Figures 3A to 3B A second infusion pump is depicted that can be used in conjunction with one or more embodiments of the mobile infusion pump system of this disclosure. Pump 102 includes a pump drive unit 118 and a drug cartridge 116. Pump 102 includes a processor 42 that can communicate with one or more processors within pump 102 and / or processors of other devices such as remote devices (e.g., CGM devices), remote control devices, or consumer electronics devices (e.g., laptops, personal computers, tablets, smartphones, smartwatches, smart rings, electronic health or fitness monitors, or personal digital assistants). Processor 42 may also be programmed to receive signals and / or other data from input devices, such as pressure sensors, temperature sensors, etc. Pump 102 also includes a processor for controlling some or all of the operations of the pump. In some embodiments, pump 102 receives commands from a separate device for controlling some or all of the operations of the pump. Such a separate device may include, for example, a dedicated remote device or a consumer electronic device, such as a smartphone, having a processor that executes an application configured to enable the device to transmit operating commands to the processor 42 of the pump 102. In some embodiments, the processor 42 may also transmit information, such as information relating to device parameters, alarms, alerts, pump status, etc., to one or more separate devices. Such a separate device may include any remote display, remote device, remote control device, or consumer electronic device as described above.

[0029] Pump 102 can also be combined with about Figure 2Any or all of the features described in Pump 12. In some embodiments, communication is wirelessly achieved via a Near Field Communication (NFC) radio frequency (RF) transmitter or a transmitter operating according to the “Wi-Fi” or Bluetooth® protocol, Bluetooth® Low Energy protocol, etc., by way of example only. Further details about such pumps can be found in U.S. Patent No. 10,279,106 and U.S. Patent Publications Nos. 2016 / 0339172 and 2017 / 0049957, the entire contents of each of which are incorporated herein by reference.

[0030] Reference Figures 4 to 5B For example, according to embodiments of this disclosure, one or more remote devices 170, 171 can be used to communicate with the processor 42 of pump 12 and / or pump 102 to control drug delivery and transmit data to pump 12 / 102 via wired or wireless electromagnetic signals, such as via near field communication (NFC) radio frequency (RF) modes or other RF modes such as Bluetooth®, Bluetooth® Low Energy, mobile, or Wi-Fi communication protocols. Such remote devices may include, for example, mobile communication devices 170, such as smartphones (e.g., smartphones) executing software applications for controlling pump 12 / 102. Figure 4 (as depicted in the text), dedicated remote control device 171 (such as...) Figures 5A to 5B The devices described herein include wearable electronic watches, smart rings, electronic health or fitness monitors, or personal digital assistants (PDAs), or tablets, laptops, or personal computers. Such communication between one or more remote devices 170, 171 and pump 12 / 102 (and between one or more remote devices 170, 171 and pump 12 / 102) can be one-way or two-way for purposes such as efficiently transmitting data between the devices and pumps, controlling the operation of the pumps, updating the software on the devices and / or pumps, and allowing the viewing of pump-related data on the devices and / or pumps.

[0031] Figure 6A schematic diagram of a pump system 200 according to an embodiment of the present disclosure is depicted. System 200 includes a user-wearable infusion pump, such as pump 12 or pump 102 described above. In embodiments, a user may alternatively wear pump 102A directly on the body or place pump 102B in a pocket or other location near the user's body, wherein infusion tubing 144 extends to infusion kit 148 on the user's body. System 200 also includes a continuous glucose monitoring (CGM) sensor and a corresponding transmitter 208. The CGM sensor acquires measurements related to blood glucose levels in the body, and the transmitter transmits this information to pumps 102A / 102B. Pump 208 can then use the blood glucose data to determine treatment. The system may also include one or more devices, such as smartphone 204 or other multi-purpose consumer electronics devices capable of operating software applications for communicating with and / or controlling the pump, and alternatively or additionally, the system may also include a dedicated remote device specifically designed for use with pumps 102A / 102B. In some implementations, the smartphone 204 or other remote device can also communicate with the CGM sensor / transmitter 208. Additionally, the pump 102A / 102B and / or the smartphone 204 or other remote device may optionally communicate with additional devices, such as blood glucose meters or other analyte sensing devices, activity or other health monitors, etc.

[0032] Although the multipurpose consumer electronics device 204 is depicted as a smartphone, in various embodiments, the consumer electronics device may alternatively or additionally include one or more of the following: a wearable electronic watch such as a smartwatch, a smart ring, an electronic health or fitness monitor, a personal digital assistant (PDA), or a tablet, laptop computer, or personal computer. The multipurpose consumer electronics device 204 can be any device sold to a consumer and used for a variety of functions, and as one of those functions, it may be configured or programmed to communicate with and / or control the infusion pump. In some embodiments, the system as described herein may include more than one multipurpose consumer electronics device 204 (e.g., a smartphone and a smartwatch) configured to communicate with the infusion pump.

[0033] Figure 6 The devices in the pump system 200 can communicate using any wireless communication mode known in the art. In some embodiments, the devices communicate via Bluetooth®. Figure 6In the embodiments depicted, Bluetooth® communication between pumps 102A / 102B and the CGM sensor / transmitter 208 is generally stable because the devices are positioned relatively close to each other and are typically located on the same side of the body. However, it is well known that Bluetooth® and other radio signals are interfered with by water and cannot be reliably received through water. Because the human body is primarily composed of water, Bluetooth® signals cannot be reliably transmitted and received through the body. Therefore, in, for example... Figure 6 The systems described herein (where the CGM sensor / transmitter is worn on the body and the infusion pump is worn on or close to the body) pose a risk that the body may interfere with Bluetooth® or other signals that send information from the CGM sensor / transmitter to the pump. In systems that rely on CGM data to make appropriate treatment decisions, such signal interference could lead to serious medical consequences.

[0034] Reference Figure 7 This paper depicts an implementation of a configuration of system 200 in which such signal interference may occur. In the depicted configuration, the CGM sensor / transmitter 208 is positioned on the rear of the user's body (as indicated by the dashed line) and on the side of the body opposite to the pumps 102A / 102B. Because Bluetooth® signals cannot be reliably transmitted through the body, the pumps 102A / 102B may have difficulty receiving a stable signal from the CGM, and there may be periods of time when no signal is received.

[0035] For example Figures 6 to 7In those systems depicted that integrate a smartphone or other remote device 204, the remote device 204 can be used to resolve any connectivity issues between the pump and the CGM. If the pump 102A / 102B does not receive CGM data from the CGM sensor / transmitter 208, the remote device 204 can receive the data and then relay the data to the pump 102A / 102B. In various embodiments, the remote device 204 can determine that the pump is not receiving data by, for example, by: (1) the remote device 204 communicating periodically with the pump 102A / 102B to ensure that the pump is receiving CGM data; (2) when the pump is not receiving data, the pump 102A / 102B notifying the remote device 204; and / or (3) the CGM sensor / transmitter 208 communicating with the remote device 204 to notify the remote device that the CGM data has not been received by the pump 102A / 102B. In various embodiments, when the pump is not receiving data, the remote device 204 may communicate with the CGM sensor / transmitter 208 to request CGM data, or the CGM sensor / transmitter 208 may automatically send CGM data to the remote device 204 to relay to the pumps 102A / 102B. In some embodiments, the remote device 204 may typically receive CGM data continuously from the CGM sensor / transmitter 208, but only relays data to the pumps 102A / 102B if it is determined that the pump is not reliably receiving CGM data by one of the aforementioned methods. As described above, although the remote device 204 is depicted as a smartphone, various other devices (e.g., smartwatches, smart rings, etc.) may also be used to assist in relaying data between the pump and the CGM.

[0036] As described herein, CGM data may include blood glucose levels and trend data that the pump can use to determine treatment, but other data transmitted from the CGM sensor / transmitter to the pump may also be relayed. For example, one or more diagnostic data such as battery life, sensor performance metrics, sensor algorithm information, treatment or dosage recommendations from the sensor, calibration requests or information, low battery alerts, etc., may also be relayed.

[0037] Now refer to Figure 8This document describes a flowchart of method steps for a method 300 for coordinating wireless communication in an infusion pump system according to embodiments of the present disclosure. At 302, a communication session between the infusion pump and the CGM device can be initiated via Bluetooth® or another suitable communication protocol. At 304, it can then be determined or verified whether the communication session has actually been initiated and whether the infusion pump is now communicatively connected to the CGM device. If it is determined that the infusion pump is not communicatively connected to the CGM device, then at 306, the infusion pump and the CGM device are communicatively connected together. At 308, a relay indicates a measure of the communication signal strength between the infusion pump and the CGM device, based on either the infusion pump being in a first position relative to the CGM device relative to the user's body or the CGM device being in a first position relative to the infusion pump relative to the user's body.

[0038] At point 310, a measurement indicating the strength of the communication signal between the infusion pump and the CGM device can be recorded. Optionally, the measurement is stored in the memory unit of the infusion pump system for later use. At point 312, an indication of signal strength above a predetermined threshold at one or more other locations can optionally be displayed. As described below, in some embodiments, these indications are displayed only if the signal strength at the current location is below such a predetermined threshold. In embodiments, the indication of one or more other locations is based on the infusion pump being in a first position relative to the user's body relative to the CGM device or the CGM device being in a first position relative to the user's body relative to the infusion pump.

[0039] In one implementation, if the communication signal strength between the infusion pump and the CGM device is below a predetermined threshold (i.e., weak signal strength), a suggestion to reposition at least one of the infusion pump and the CGM device to a different location can be sent to the system user. As described below, in some implementations, this suggestion may include a graphical representation of the user's body displayed on the user interface indicating the different location. If the communication signal strength is above the predetermined threshold (i.e., strong signal strength), a notification can be sent to the user that the infusion pump and the CGM device have been properly positioned. The notification may be a message using text and / or numbers, color-coded indications, symbols, or any other form of indication that the system user can understand.

[0040] Optionally, a metric indicating the strength of the communication signal between the infusion pumps can be relayed, based on a second position of the infusion pump relative to the CGM device or a second position of the CGM device relative to the infusion pump. The metric indicating the strength of the communication signal between the infusion pump and the CGM device can be recorded in a manner similar to the first metric. In an embodiment, the indication of the communication signal strength at one or more other locations can be updated based on the second position of the infusion pump relative to the CGM device or the second position of the CGM device relative to the infusion pump.

[0041] The methods and systems disclosed herein can be used to guide a user on where to place an infusion pump based on the quality of the communication signal between the infusion pump and the CGM device (e.g., to mitigate connectivity issues associated with Bluetooth® and the human body, and / or connectivity issues due to other reasons). This can be achieved by tracking location data associated with the past and current locations of the infusion pump and / or the CGM device, which may include measurements of the communication signal strength or other signal quality at each recorded location. In addition to the CGM device, remote devices, including but not limited to smartphones, wearable smartwatches, or smart rings, may be used, for example, to relay CGM data from the CGM to the pump, and the system can be configured to provide an indication of the quality of the communication signal between the remote device, the infusion pump, and / or the CGM device to determine the optimal placement of these components relative to the user.

[0042] In implementations, the methods and systems may include a human body display depicting the past and / or current position of the infusion pump and / or CGM device relative to a user. The display may be directly mounted on the infusion pump or mounted on an external, remote device. The display may be configured to automatically update position data (i.e., for real-time changes in the user) based on the movement of the infusion pump and / or CGM device relative to the user, creating a map of data points corresponding to positions with, for example, good, moderate, and weak communication signal strengths between the components. This advantageously allows the user to determine the optimal position for placing the infusion pump and / or CGM device in the shortest possible time based on communication signal strength. Additionally, the display may be configured to show and / or recommend one or more locations on the user's body based on previous positions—locations where the CGM device and / or pump should be placed for optimal CGM measurement and / or insulin absorption—to avoid tissue scarring and insulin absorption-related problems at recently used locations.

[0043] For example, the display may show the current location of the infusion pump on the user and provide color-coded indications of where to place the CGM device, or the display may show the current location of the CGM device on the user and provide color-coded indications of where to place the infusion pump to optimize communication between components. The color-coded indications may, for example, show green areas on the body corresponding to locations with strong communication signal quality between the infusion pump and the CGM device, yellow areas corresponding to locations with medium communication signal quality, and red areas corresponding to locations with weak communication signal quality. It should be understood that different color schemes or other forms of indication may be used to replace or supplement the green-yellow-red color scheme described by example, such as for yes / no arrangements, where locations with sufficient signal quality are depicted in one manner (e.g., green) and locations with insufficient signal quality are depicted in another manner (e.g., red).

[0044] Figure 9 One embodiment of a user interface 46 is depicted, which may be located on an infusion pump and / or remote device to allow a user to select areas of the body to indicate the location where a new infusion kit, pump, and / or CGM transmitter has been inserted. In the depicted embodiment, the user interface 46 displays both a front view and a rear view of the body, highlighting the most frequently used infusion sites. In some embodiments, the user may only be able to select the highlighted areas, while in other embodiments, the highlighted areas may be provided solely as guidance for the user, or no areas may be highlighted. In some embodiments, the user can select, for example... Figure 9 The general area depicted can be zoomed in by selecting a given area to more accurately indicate the position where the infusion kit has been inserted. As mentioned above, due to the relative position of the devices in the system, various areas can be highlighted with different colors based on signal quality.

[0045] In implementations, the methods and systems disclosed herein can be configured to provide recommendations for relaying communication sessions between an infusion pump and a CGM device using a remote device such as a smartphone or wearable smartwatch. Relaying communication sessions via a remote device can advantageously extend the range of strong communication signal strength, thus providing, for example, more green areas on a display indicating strong communication signal strength between the insulin pump, CGM device, and / or remote device. Therefore, in addition to the positions of the infusion pump and CGM device, the system may also include determining the position of a relay or repeater device. For example, a user may have a smartwatch on one side of their body and a smartphone on the other. A predetermined set of data points corresponding to strong, medium, and weak communication signal qualities between, for example, a repeater, infusion pump, CGM device, and / or any other remote device can be updated in real-time or semi-real-time based on changes in the positions of these components. In implementations, a user may first place the infusion pump and CGM device on their body and then place the remote device at a position determined based on the optimal communication signal quality between the infusion pump, CGM device, and remote device, based on the communication quality strength between these components. This can also improve power efficiency, as a remote device, such as a smartwatch or smartphone, is a better transmitter of communication signals in terms of power consumption compared to an infusion pump or CGM device.

[0046] In some implementations, communication signal quality can be determined based on signal strength between devices. For example, communication signal strength can be measured as a Received Signal Strength Indicator (RSSI), which is a measurement of the power present in a received radio signal. For example, Bluetooth® RSSI is a measurement representing the relative quality level of a Bluetooth® signal received on a device such as an infusion pump, CGM unit, or remote device. In other implementations, Bluetooth® direction finding can be used in conjunction with communication signal strength measurements, such as RSSI, or in addition to communication signal strength measurements, such as RSSI. Bluetooth® direction finding uses a comparison between the angle of arrival (AoA) and the angle of departure (AoD) between antennas to determine the location of a received or transmitted signal. Applied to the methods and systems disclosed herein, Bluetooth® direction finding can be used to determine the location of a signal relative to an infusion pump, CGM unit, and / or remote device, eliminating the need for manual input of the locations of these components by the user.

[0047] In implementations, communication signal quality can be determined by accumulating data points (e.g., body position) that result in communication loss or weak signal strength between components. For example, the position of the infusion pump, CGM device, and / or remote device can be tracked by the system, and the relative position of the device can be recorded when a communication interruption occurs (e.g., loss of CGM data points). When the user places the device on the body as discussed, the indication of signal quality displayed to the user can be based on the number of lost CGM data points or other measurements related to the communication interruption at the relative position of the device. In implementations, other CGM data aspects indicative of signal quality can be tracked using the methods and systems disclosed herein, including the amount of time the user is within a “range” (e.g., above a hypoglycemic threshold and below a hyperglycemic threshold) when the infusion pump, CGM device, and / or remote device are in various relative positions.

[0048] The methods and systems disclosed herein may include position trackers linking at least two of an infusion pump, a CGM device, and a remote device. Position data can be shared among these components to ensure that the position of one component is not reused by another component in the next iteration of the user's treatment. For example, it is desirable to avoid placing the infusion pump in the same location as the CGM was previously placed to avoid, for example, tissue scarring and problems associated with insulin absorption and CGM data measurement. These aspects may be associated with determining the quality of the communication signal to simultaneously optimize several parameters. Therefore, in some embodiments, the system may combine tracking based on communication signal quality and insulin absorption at various locations to provide recommendations based on a better location for both communication and insulin delivery parameters.

[0049] In some implementations, the system can begin with a predetermined set of data points corresponding to locations on the body with known strong, medium, and / or weak communication signal quality (e.g., a map of location data points). For example, placing the infusion pump and CGM device on the same side of the body, such as the right side, can be classified as a coupled location data point with strong communication signal quality because Bluetooth® or other radio signals transmitted between the components will not be interrupted by having to traverse the body. The set of predetermined data points can be continuously updated to specifically correspond to the user. In this way, the map of location data points can be expanded or reduced based on subsequently received data indicating locations with strong, medium, or weak communication signal quality.

[0050] In one implementation, instead of indicating the optimal communication signal strength location on a display, the user can use a remote device, such as a smartphone or other device with a camera, to take a photograph of their body and then have the smart device determine or suggest where the infusion pump and CGM device should be placed. This eliminates the need for a separate display and instead relies on the remote device to provide an optimal placement location specifically tailored to the user. The determination or suggestion may include several locations sorted by communication signal quality and indicated by colors as described herein. In other implementations, the application on the smart device may include a pictogram or other illustrative diagram of the user's body showing locations of strong, medium, and weak communication signal strengths indicated by colors. Additionally, the pictogram or other illustrative diagram may include past locations of the infusion pump and CGM device, or the location of one of the infusion pump and CGM device already placed on the body, and suggestions on where to place the other component.

[0051] In other implementations, users can utilize augmented reality (AR) to determine the optimal location for placing the infusion pump and CGM device. For example, a user can point a camera, included in a remote device such as a smartphone, at a mirror, highlighting the optimal placement location and / or locations with strong, medium, and weak communication signal quality on the user's body. In other examples, AR headsets or AR glasses can be used to help users determine where to place the infusion pump and CGM device.

[0052] In another implementation, a smartphone or other device can use a light-detecting and ranging device (LiDAR) to create a three-dimensional map of the user's body to determine the optimal placement of components. The three-dimensional map may include a grid feature placed on the user's body to help distinguish areas of strong, medium, and weak communication signal strength.

[0053] Considering the various complexities unique to specific users, photos of the user's body, pictographs, AR, or other illustrative graphics can be used to create more personalized experiences.

[0054] It should be noted that although the embodiments described herein primarily describe the coordination of communication from the CGM, the communication methods disclosed herein can be applied to other devices in the infusion pump system. For example, this disclosure can relate to other devices, such as another analyte sensing device, activity or other health monitors, heart rate monitors, etc.

[0055] In one implementation, a method for coordinating wireless communication in an infusion pump system including a continuous glucose monitoring (CGM) device and an infusion pump may include: initiating a communication session between the infusion pump and the CGM device; determining that the infusion pump is communicatively connected to the CGM device; and determining a metric indicating the quality of the communication signal between the infusion pump and the CGM device based on a first position of the infusion pump relative to the user's body and a first position of the CGM device relative to the user's body.

[0056] In an implementation, the method may further include recording a metric in memory that indicates the quality of the communication signal.

[0057] In an implementation, the method may further include displaying on a user interface an indication of the quality of the communication signal at one or more other locations on the user's body and / or at one or more other locations on the user's body for the infusion pump and / or the CGM device.

[0058] In an implementation, the indication of the communication signal quality at one or more other locations of the infusion pump relative to the user's body and / or at one or more other locations of the CGM device relative to the user's body includes an indication of the communication signal quality at one or more other locations of the infusion pump relative to a first location of the CGM device.

[0059] In an implementation, the indication of the quality of the communication signal at one or more other locations of the infusion pump relative to the user's body and / or the CGM device relative to one or more other locations of the user's body includes the indication of the quality of the communication signal at one or more other locations of the CGM device relative to the first location of the infusion pump.

[0060] In an implementation, an indication of the quality of the communication signal at one or more other locations on the user's body and / or at one or more other locations on the user's body of the CGM device includes displaying a graphical representation of the user's body identifying the locations on the user interface.

[0061] In one implementation, if a metric indicating the quality of the communication signal between the infusion pump and the CGM device is below a predetermined threshold based on a first position of the infusion pump relative to the user's body and a first position of the CGM device relative to the user's body, an indication of the quality of the communication signal at one or more other positions of the infusion pump relative to the user's body and / or one or more other positions of the CGM device relative to the user's body is displayed.

[0062] In an implementation, the method may further include comparing a metric indicating the quality of the communication signal between the infusion pump and the CGM device with a predetermined threshold based on a first position of the infusion pump relative to the user's body and a first position of the CGM device relative to the user's body.

[0063] In an implementation, the method may further include: providing a suggestion to move at least one of the infusion pump and the CGM device to a second position when a metric indicating the quality of the communication signal is below a predetermined threshold.

[0064] In one implementation, providing a suggestion to move at least one of the infusion pump and the CGM device to a second position includes displaying a graphical representation of the user's body indicating the second position on the user interface.

[0065] In an implementation, the method may further include: displaying an indication on a user interface that the measurement indicating the quality of the communication signal is acceptable when the metric indicating the quality of the communication signal is higher than a predetermined threshold.

[0066] In one implementation, a method for coordinating wireless communication in an infusion pump system including a continuous glucose monitoring (CGM) device and an infusion pump may include: receiving input from a user via a user interface to initiate a communication session between the infusion pump and the CGM device; and providing the user with guidance on the user interface regarding the location of at least one of the infusion pump and the CGM device relative to the user's body, based on measurements of the signal strength between the infusion pump and the CGM device.

[0067] In one implementation, providing guidance on where to position at least one of the infusion pump and the CGM device relative to the user's body includes displaying a graphical representation of the user's body on the user interface.

[0068] In an implementation, providing guidance on where to locate at least one of the infusion pump and the CGM device includes displaying a metric on a graphical representation of the user’s body indicating the quality of the communication signal between the infusion pump and the CGM device at one or more previous locations of the infusion pump and the CGM device.

[0069] In an implementation, providing guidance on where to locate at least one of the infusion pump and the CGM device includes displaying, on a graphical representation of the user's body, measures of the quality of the communication signals between the infusion pump and the CGM device at the current position of the infusion pump relative to the user's body and the current position of the CGM device relative to the user's body.

[0070] In an implementation, the method may further include updating in real time a metric indicating the quality of the communication signal between the infusion pump and the CGM device on a graphical representation of the user's body as the infusion pump or CGM device moves from its respective current location.

[0071] In one implementation, providing guidance to the user on the user interface regarding the location of at least one of the infusion pump and the CGM device relative to the user's body based on measurements of the signal strength between the infusion pump and the CGM device includes providing suggestions on the position of one or more of the infusion pump and the CGM device relative to the user's body.

[0072] In implementation, providing a suggestion for the position of one or more of the infusion pump and CGM device relative to the user's body based on the measurement of the signal strength between the infusion pump and the CGM device includes providing a suggestion for the position of the CGM device based on the current position of the infusion pump.

[0073] In implementation, providing a suggestion for the position of one or more of the infusion pump and CGM device relative to the user's body includes providing a suggestion for the position of the infusion pump based on the current position of the CGM.

[0074] In implementation, recommendations for the location of the infusion pump are provided, further based on the predicted effect of insulin absorption at that location.

[0075] In one implementation, based on measurements of the signal strength between the infusion pump and the CGM device, providing the user with guidance on the user interface regarding the location of at least one of the infusion pump and the CGM device relative to the user's body includes color-coded indications of different signal strength areas using different colors.

[0076] Various embodiments of the systems, apparatus, and methods have been described herein. These embodiments are given by way of example only and are not intended to limit the scope of the claimed invention. Furthermore, it should be understood that the various features of the described embodiments can be combined in various ways to produce many additional embodiments. Moreover, while various materials, sizes, shapes, configurations, and positions, etc., for use with the disclosed embodiments have been described, other materials, sizes, shapes, configurations, and positions, etc., besides those disclosed, may be utilized without departing from the scope of the claimed invention.

[0077] Those skilled in the art will recognize that the subject matter of this invention may include fewer features than those illustrated in any of the individual embodiments described above. The embodiments described herein are not intended to be an exhaustive representation of all possible combinations of features of the subject matter of this invention. Therefore, embodiments are not mutually exclusive combinations of features; rather, as will be understood by those skilled in the art, various embodiments may include combinations of different individual features selected from different individual embodiments. Furthermore, unless otherwise stated, elements described with respect to one embodiment may be implemented in other embodiments, even if not described in such embodiments.

[0078] Although a dependent claim may refer in the claims to a specific combination of one or more other claims, other embodiments may also include combinations of a dependent claim with the subject matter of each of the other dependent claims, or combinations of one or more features with other dependent claims or independent claims. Such combinations are set forth herein unless stated otherwise.

[0079] Any combination of references to the foregoing documents is limited to such that no subject matter contrary to the express disclosure herein is incorporated. Any combination of references to the foregoing documents is also limited to such that any claims included in the documents are not incorporated herein by reference. Any combination of references to the foregoing documents is further limited to such that any limitations provided in the documents are not incorporated herein by reference unless expressly included herein.

[0080] The jointly owned U.S. patents No. 6,999,854, No. 8,133,197, No. 8,287,495, No. 8,408,421, No. 8,448,824, No. 8,573,027, No. 8,650,937, No. 8,986,523, No. 9,173,998, No. 9,180,242, No. 9,180,243, No. 9,238,100, No. 9,242,043, No. 9,335,910, No. 9,381,271, No. 9,421,329, No. 9,486,171, No. 9,486,571, No. 9,492,608, No. 9,503,526, No. 9,555,186, No. 9,565,718, No. 9,603,995, No. 9,669,160, No. 9,715,327, No. 9,737,656, No. 9,750,871, No. 9,867,937, No. 9,867,953, No. 9,940,441, No. 9,993,595, No. 10,016,561, No. 10,201,656, No. 10,279,105, No. 10,279,106, No. 10,279,107, No. 10,357,603, No. 10,357,606, No. 10,492,141, No. 10,541,987, No. 10,569,016, No. 10,736,037, No. 10,888,655, No. 10,994,077, No. 11,116,901, No. 11,224,693, No. 11,291,763, No. 11,305,057, No. 11,458,246, No. 11,464,908, No. 11,654,236 and No. No. 2009 / 0287180, No. 2012 / 0123230, No. 2013 / 0053816, No. 2014 / 0276423, No. 2014 / 0276569, No. 2014 / 0276570, No. 2018 / 0071454, No. 2019 / 0307952, No. 2020 / 0206420, No. 2020 / 0329433, No. 2020 / 0368430, No. 2020 / 0372995, No. 2021 / 0001044, No.2021 / 0113766, No. 2022 / 0062553, No. 2022 / 0139522, No. 2022 / 0223250, No. 2022 / 0233772, No. 2022 / 0233773, No. 2022 / 0238201, No. 2022 / 0265927, No. 2023 / 0034408, No. 2022 / 0344017, No. 2022 / 0370708, No. 2022 / 0037465, No. 2023 / 0040677, No. 2023 / 0047034, No. 2023 / 0113545,No. Patent applications Nos. 2023 / 0113755, 2023 / 0166037, 2023 / 0173170, 2023 / 0201452, 2023 / 0277765, 2023 / 0338653, 2023 / 0381406, 2024 / 0226423, 2024 / 0226424 and 2024 / 0277924, and jointly owned U.S. patent applications Nos. 17 / 368,968, 17 / 896,492, 18 / 011,060, 18 / 071,835, 18 / 207,094, and 18 / 207,094. The entire contents of No. 18 / 398,543, No. 18 / 441,735, No. 18 / 474,839, No. 18 / 475,916, No. 18 / 478,552, and No. 18 / 678,130 are also incorporated into the text via reference.

[0081] For the purposes of interpreting the claims, it is clearly intended that the provisions of 35 USC § 112(f) should not be invoked unless the specific terms “means for…” or “steps for…” are recited in the claims.

Claims

1. A method for coordinating wireless communication in an infusion pump system including a continuous glucose monitoring (CGM) device and an infusion pump, comprising: Initiate a communication session between the infusion pump and the CGM device; It is determined that the infusion pump is communicatively connected to the CGM device; A metric indicating the quality of the communication signal between the infusion pump and the CGM device is determined based on a first position of the infusion pump relative to the user's body and a first position of the CGM device relative to the user's body.

2. The method of claim 1 further includes recording a metric indicating the quality of the communication signal in a memory.

3. The method of claim 1, further comprising displaying on a user interface an indication of the communication signal quality at one or more other locations of the infusion pump relative to the user's body and / or at one or more other locations of the CGM device relative to the user's body.

4. The method of claim 3, wherein, Indications showing the quality of the communication signal at one or more other locations of the infusion pump relative to the user's body and / or at one or more other locations of the CGM device relative to the user's body include indications showing the quality of the communication signal at one or more other locations of the infusion pump relative to the first location of the CGM device.

5. The method of claim 3, wherein, Indications showing the quality of communication signals at one or more other locations of the infusion pump relative to the user's body and / or at one or more other locations of the CGM device relative to the user's body include indications showing the quality of communication signals at one or more other locations of the CGM device relative to the first location of the infusion pump.

6. The method of claim 3, wherein, Indications showing the quality of the communication signal at one or more other locations of the infusion pump relative to the user's body and / or the CGM device relative to one or more other locations of the user's body include displaying a graphical representation of the user's body identifying each location on the user interface.

7. The method of claim 3, wherein, If, based on the first position of the infusion pump relative to the user's body and the first position of the CGM device relative to the user's body, the measurement of the communication signal quality between the infusion pump and the CGM device is below a predetermined threshold, an indication of the communication signal quality at one or more other positions of the infusion pump relative to the user's body and / or at one or more other positions of the CGM device relative to the user's body is displayed.

8. The method of claim 1, further comprising: Based on the first position of the infusion pump relative to the user's body and the first position of the CGM device relative to the user's body, a metric indicating the quality of the communication signal between the infusion pump and the CGM device is compared with a predetermined threshold.

9. The method of claim 8, further comprising: If a metric indicating the quality of the communication signal is below the predetermined threshold, a recommendation is made to move at least one of the infusion pump and the CGM device to a second position.

10. The method of claim 7, further comprising: If the metric indicating the quality of the communication signal is higher than the predetermined threshold, it is acceptable to display the metric indicating the quality of the communication signal on the user interface.

11. A method for coordinating wireless communication in an infusion pump system including a continuous glucose monitoring (CGM) device and an infusion pump, comprising: The user interface is used to receive input from the user and initiate a communication session between the infusion pump and the CGM device. as well as Based on the measurement of the signal strength between the infusion pump and the CGM device, the user is provided with guidance on the user interface regarding the positioning of at least one of the infusion pump and the CGM device relative to the user's body.

12. The method of claim 11, wherein, Providing guidance on where to position at least one of the infusion pump and the CGM device relative to the user's body includes displaying a graphical representation of the user's body on the user interface.

13. The method of claim 12, wherein, Providing guidance on where to locate at least one of the infusion pump and the CGM device includes displaying on the graphical representation of the user's body a metric indicating the quality of the communication signal between the infusion pump and the CGM device at one or more previous locations.

14. The method of claim 12, wherein, Providing guidance on where to locate at least one of the infusion pump and the CGM device includes displaying, on the graphical representation of the user's body, a measure of the quality of the communication signal between the infusion pump and the CGM device at the current position of the infusion pump relative to the user's body and the current position of the CGM device relative to the user's body.

15. The method of claim 14, further comprising: As the infusion pump or the CGM device moves from its respective current location, a metric indicating the quality of the communication signal between the infusion pump and the CGM device is updated in real time on the graphical representation of the user's body.

16. The method of claim 11, wherein providing guidance to the user on the user interface regarding the location of at least one of the infusion pump and the CGM device relative to the user's body based on a measurement of the signal strength between the infusion pump and the CGM device comprises providing suggestions for the position of one or more of the infusion pump and the CGM device relative to the user's body.

17. The method according to claim 16, wherein, Providing a suggestion for the position of one or more of the infusion pump and the CGM device relative to the user's body based on the measurement of the signal strength between the infusion pump and the CGM device includes providing a suggestion for the position of the CGM device based on the current position of the infusion pump.

18. The method according to claim 16, wherein, Providing a positional recommendation for one or more of the infusion pump and the CGM device relative to the user's body includes providing a positional recommendation for the infusion pump based on the current position of the CGM.

19. The method according to claim 18, wherein, Suggestions for the location of the infusion pump are provided, further based on the predicted effect of insulin absorption at this location.

20. The method according to claim 11, wherein, Based on the measurement of the signal strength between the infusion pump and the CGM device, the user interface is provided with guidance on where to position at least one of the infusion pump and the CGM device relative to the user's body, including color-coded indications of different signal strength areas in different colors.

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