Dynamic range for establishing wireless communication

Abstract

A medical protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations and configured to determine a patient risk level associated with a transmission; based on the patient risk level meeting a criterion, dynamically select a transmission power configuration; based on one or more of the risk level or a result of one or more previous communication sessions, dynamically select a PHY layer configuration; broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.

Description

Atty Ref. No. A0011921W001DYNAMIC RANGE FOR ESTABLISHING WIRELESS COMMUNICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 733,205, filed December 12, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] This disclosure generally relates to medical devices and, more particularly, to transmitting data indicative of patient health by such devices.BACKGROUND

[0003] A variety of devices are configured to monitor physiological signals of a patient. Such devices include implantable or wearable medical devices, as well as a variety of wearable health or fitness tracking devices. The physiological signals sensed by such devices include as examples, electrocardiogram (ECG) signals, respiration signals, perfusion signals, activity and / or posture signals, pressure signals, blood oxygen saturation signals, body composition, and blood glucose or other blood constituent signals. In general, using these signals, such devices facilitate monitoring and evaluating patient health over a number of months or years, outside of a clinic setting.

[0004] In some cases, such devices are configured to detect acute health events based on the physiological signals, such as episodes of cardiac arrhythmia, myocardial infarction, stroke, or seizure. Example arrhythmia types include cardiac arrest (e.g., asystole), ventricular tachycardia (VT), and ventricular fibrillation (VF). The devices may store ECG and other physiological signal data collected during a time period including an episode as episode data. Such acute health events are associated with significant rates of death, particularly if not treated quickly.

[0005] For example, VF and other malignant tachyarrhythmias are the most commonly identified arrhythmia in sudden cardiac arrest (SCA) patients. If this arrhythmia continues for more than a few seconds, it may result in cardiogenic shock and cessation of effective blood circulation. The survival rate from SCA decreases between 7 and 10 percent for every minute that the patient waits for defibrillation. Consequently, sudden cardiac death (SCD) may result in a matter of minutes.Atty Ref. No. A0011921W001SUMMARY

[0006] In general, this disclosure describes techniques for establishing a wireless network connection or other such communication session between two or more proximate devices in response to a medical device of the two or more proximate devices determining to initiate a transmission, e.g., to provide an emergency alert and / or to transmit data for analysis, which may occur opportunistically or on a periodic schedule. More specifically, this disclosure describes techniques for broadcasting advertisements using a wireless communication protocol and dynamically switching between PHY layer configurations and / or transmission power configurations of the wireless communication protocol, e.g., Bluetooth® Low Energy (BLE), to establish a connection and / or to facilitate efficient data transmission.

[0007] An implantable medical device (IMD), for example, may be configured to sense physiological signals, such as electrocardiogram (ECG) signals or other electrogram signals, accelerometer signals, bioimpedance signals, optical signals, e.g., photoplethysmography (PPG) signals, etc. Processing circuitry of the IMD may determine, e.g., determine based on the physiological signals, to initiate a transmission, e.g., a transmission of an emergency alert, acute health event data, or non-acute health data, such as atrial arrhythmia data and / or data used to determine a patient risk level. Communication circuitry of the IMD may broadcast advertisements to establish a wireless connection with an external device, e.g., a patient smartphone or another computing device. In some examples, the wireless communication protocol comprises Bluetooth®, e.g., BLE. Bluetooth® 5.0 comprises a plurality of physical (PHY) layer configurations associated with different communication ranges, data throughput rates, etc.

[0008] In some examples, the IMD may attempt to broadcast advertisements to establish a connection with a computing device. The IMD may select one or more of a PHY layer configuration of a plurality of PHY layer configurations and / or a transmission power configuration of a plurality of transmission power configurations based on a patient risk level associated with the transmission. In some examples, the IMD may select the transmission power configuration and / or the PHY layer configuration based on a comparison of the patient risk level to one or more criteria. In some examples, the IMD additionally or alternatively selects the PHY layer configuration based on a result of one or more previous communication sessions with the computing device. As an example, theAtty Ref. No. A0011921W001IMD may select the PHY layer configuration based on whether the PHY layer configuration was successful or not in the previous communication session.

[0009] In one example, a medical device comprises: communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; and processing circuitry configured to: determine a patient risk level associated with a transmission; based on the patient risk level meeting a criterion, dynamically select a transmission power configuration of the plurality of transmission power configurations; based on one or more of the risk level or a result of one or more previous communication sessions, dynamically select a PHY layer configuration of the plurality of PHY layer configurations; control the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, control the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration

[0010] In another example, a method comprises: determining, by processing circuitry of a medical device, a patient risk level associated with a transmission, wherein the medical device comprising communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; dynamically selecting, by the processing circuitry and based on the patient risk level meeting a criterion, a transmission power configuration of the plurality of transmission power configurations of a protocol for wireless communication; dynamically selecting, by the processing circuitry and based on one or more of the risk level or a result of one or more previous communication sessions, a PHY layer configuration of the plurality of PHY layer configurations; controlling, by the processing circuitry, the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and controlling, by the processing circuitry and in response to a determination that the connection has been established with a computing device using the selected transmissionAtty Ref. No. A0011921W001 power configuration and the selected PHY layer configuration, the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.

[0011] In another example, a non-transitory computer-readable medium stores instructions that when executed cause processing circuitry to: determine a patient risk level associated with a transmission, wherein the medical device comprising communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; based on the patient risk level meeting a criterion, dynamically select a transmission power configuration of the plurality of transmission power configurations; based on one or more of the risk level or a result of one or more previous communication sessions, dynamically select a PHY layer configuration of the plurality of PHY layer configurations; control the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, control the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.

[0012] This summary is intended to provide an overview of the subject matter described in this disclosure. It is not intended to provide an exclusive or exhaustive explanation of the apparatus and methods described in detail within the accompanying drawings and description below. Further details of one or more examples are set forth in the accompanying drawings and the description below.BRIEF DESCRIPTION OF DRAWINGS

[0013] FIG. l is a block diagram illustrating an example system configured to detect acute health events of a patient, and to respond to such detections, in accordance with one or more techniques of this disclosure.

[0014] FIGS. 2A and 2B are conceptual diagrams illustrating example implantable medical devices that operate in accordance with one or more techniques of this disclosure.Atty Ref. No. A0011921W001

[0015] FIG. 3 is a block diagram illustrating an example configuration of a medical device that operates in accordance with one or more techniques of the present disclosure.

[0016] FIG. 4 is a block diagram illustrating an example protocol stack structure of a Bluetooth® protocol, in accordance with one or more techniques of the present disclosure.

[0017] FIG. 5 is a block diagram illustrating an example configuration of a computing device that operates in accordance with one or more techniques of the present disclosure.

[0018] FIG. 6 is a flow diagram illustrating an example operation for controlling communication circuitry to transmit data using selected transmission power and physical (PHY) layer configurations, in accordance with one or more techniques of this disclosure.

[0019] FIG. 7 is a flow diagram illustrating an example operation for selecting transmission power and PHY layer configurations, in accordance with one or more techniques of this disclosure.

[0020] FIG. 8 is a flow diagram illustrating another example operation for selecting transmission power and PHY layer configurations, in accordance with one or more techniques of this disclosure.

[0021] Like reference characters refer to like elements throughout the figures and description.DETAILED DESCRIPTION

[0022] A variety of types of implantable and external devices are configured to detect acute health events and non-acute health events based on sensed ECGs and, in some cases, other physiological signals. External devices that may be used to non-invasively sense and monitor ECGs and other physiological signals include wearable devices with electrodes configured to contact the skin of the patient, such as patches, watches, rings, necklaces, hearing aids, clothing, car seats, or bed linens. Such external devices may facilitate relatively longer-term monitoring of patient health during normal daily activities.

[0023] Implantable medical devices (IMDs) also sense and monitor ECGs and other physiological signals and detect acute health events such as episodes of arrhythmia, cardiac arrest, myocardial infarction, stroke, and seizure and non-acute health events such as atrial arrhythmia. Example IMDs include pacemakers and implantable cardioverterdefibrillators, which may be coupled to intravascular or extravascular leads, as well asAtty Ref. No. A0011921W001 pacemakers with housings configured for implantation within the heart, which may be leadless. Some IMDs do not provide therapy, such as implantable patient monitors. One example of such an IMD is the Reveal LINQ II™ Insertable Cardiac Monitor (ICM), available from Medtronic, Inc., which may be inserted subcutaneously. Such IMDs may facilitate relatively longer-term monitoring of patients during normal daily activities, and may periodically or on demand transmit collected data, e.g., episode data for detected arrhythmia episodes, to a remote patient monitoring system, such as the Medtronic CareLink™ Network.

[0024] In some examples, to transmit collected data and / or alerts associated with the collected data to the remote patient monitoring system, IMDs may be configured to communicate with an external computing device, such as a patient smart phone with a remote patient monitoring system application. In some examples, HMDs are configured for wireless communication, e.g., Bluetooth®, with the external device. Bluetooth® may comprise multiple physical (PHY) layer configurations with differing ranges and data throughputs as well as multiple transmission power configurations with differing ranges. IMDs may dynamically switch between PHY layer configurations and / or transmission power configurations to facilitate the transmission of data, e.g., emergency alerts, event data, non-acute physiological and / or device data transmission, and / or regularly scheduled transmission data.

[0025] The techniques of this disclosure may provide one or more technical and clinical advantages. For example, the techniques of this disclosure may be implemented by a system including an IMD that can continuously (e.g., on a periodic basis without human intervention) sense signals while subcutaneously implanted in a patient over months or years to enable the systems herein to identify health events and enable a user to respond to such health events. By dynamically switching between PHY layer configurations and / or transmission power configurations, the techniques of this disclosure may facilitate timely system / user responses to health events or other data transmissions.

[0026] For example, a patient with an IMD may experience a potentially lethal acute health event, e.g., sudden cardiac arrest (SCA). The IMD may determine the patient risk level associated with transmission of data and / or an alert associated with the SCA event. The IMD may compare the patient risk level to one or more criteria, and based on the comparison, the IMD may determine the patient risk level is high. The IMD may select aAtty Ref. No. A0011921W001 high transmission power configuration relative to a nominal transmission power configuration. The IMD may select the PHY layer configuration based on one or more of the comparison of the patient risk level to the one or more criteria or one or more previous communication sessions with the computing device. The IMD may broadcast advertisements using the selected PHY layer configuration and transmission power configuration and establish a connection with the computing device. By selecting the PHY layer configuration and / or transmission power configuration based on the patient risk level, the techniques of this disclosure may facilitate timely system / user responses to urgent health events.

[0027] As another example, the techniques of this disclosure may additionally allow the IMD to select PHY layer and transmission power configurations that may consume less power of the IMD when the patient risk level is relatively low, e.g., when the IMD determines to transmit regularly scheduled transmissions that do not include urgent cardiac events, which may increase the IMD’s operational longevity relative to a device that always uses PHY layer and transmission power configurations that are associated with longer ranges.

[0028] FIG. l is a block diagram illustrating an example system 2 configured detect health events, e.g., acute and non-acute health events, of a patient 4, and to respond to such detection, in accordance with one or more techniques of this disclosure. As used herein, the terms “detect,” “detection,” and the like may refer to detection of a health event presently (at the time the data is collected) being experienced by patient 4, as well as detection based on the data that the condition of patient 4 is such that they have a suprathreshold likelihood of experiencing the event within a particular timeframe, e.g., prediction of the health event. The example techniques may be used with one or more patient sensing devices, e.g., IMD 10, which may be in wireless communication with one or more patient computing devices, e.g., patient computing devices 12A and 12B (collectively, “patient computing devices 12”). Although not illustrated in FIG. 1, IMD 10 include electrodes and other sensors, e.g., accelerometers and / or optical sensors, to sense physiological signals of patient 4 and may collect and store sensed physiological data based on the signals and detect episodes based on the data.

[0029] IMD 10 may be implanted outside of a thoracic cavity of patient 4 (e.g., subcutaneously in the pectoral location illustrated in FIG. 1). IMD 10 may be positionedAtty Ref. No. A0011921W001 near the sternum near or just below the level of the heart of patient 4, e.g., at least partially within the cardiac silhouette. In some examples, IMD 10 takes the form of the LINQ II™ ICM. Although described primarily in the context of examples in which IMD 10 takes the form of an ICM, the techniques of this disclosure may be implemented in systems including any one or more implantable or external medical devices, including monitors, pacemakers, defibrillators, wearable external defibrillators, neurostimulators, or drug pumps. Furthermore, although described primarily in the context of examples including a single implanted patient sensing device, in some examples a system includes one or more patient sensing devices, which may be implanted within patient 4 or external to (e.g., worn by) patient 4. For example, a system with two IMDs 10 may capture different values of a common patient parameter with different resolution / accuracy based on their respective locations. In some examples, instead of or in addition to two IMDs 10, system 2 may include a ventricular assist device or a wearable ambulatory external defibrillator(WAED) in addition to IMD 10.

[0030] Patient computing devices 12 are configured for wireless communication with IMD 10. Computing devices 12 retrieve event data and other sensed physiological data from IMD 10 that was collected and stored by the IMD. In some examples, computing devices 12 take the form of personal computing devices of patient 4. For example, computing device 12A may take the form of a smartphone of patient 4, and computing device 12B may take the form of a smartwatch or other smart apparel of patient 4. In some examples, computing devices 12 may be any computing device configured for wireless communication with IMD 10, such as a desktop, laptop, or tablet computer. In some examples, computing devices 12 may communicate with IMD 10 and each other according to the Bluetooth® protocols, e.g., Bluetooth® Low Energy (BLE) protocols. In some examples, only one of computing devices 12, e.g., computing device 12A, is configured for communication with IMD 10, e.g., due to execution of software (e.g., part of a health monitoring application as described herein) enabling communication and interaction with an IMD.

[0031] In some examples, computing device(s) 12, e.g., wearable computing device 12B in the example illustrated by FIG. 1, may include electrodes and other sensors to sense physiological signals of patient 4, and may collect and store physiological data and detect episodes based on such signals. Computing device 12B may be incorporated intoAtty Ref. No. A0011921W001 the apparel of patient 14, such as within clothing, shoes, eyeglasses, a watch or wristband, a hat, etc. In some examples, computing device 12B is a smartwatch or other accessory or peripheral for a smartphone computing device 12 A.

[0032] One or more of computing devices 12 may be configured to communicate with a variety of other devices or systems via a network 16. For example, one or more of computing devices 12 may be configured to communicate with one or more computing systems, e.g., computing systems 20A and 20B (collectively, “computing systems 20”) via network 16. Computing systems 20A and 20B may be respectively managed by manufacturers of IMD 10 and computing devices 12 to, for example, provide cloud storage and analysis of collected data, maintenance and software services, or other networked functionality for their respective devices and users thereof. Computing system 20A may comprise, or may be implemented by, the Medtronic CareLink™ Network, in some examples. In the example illustrated by FIG. 1, computing system 20A implements a health monitoring system (HMS) 22, although in other examples, either or both of computing systems 20 may implement HMS 22. As will be described in greater detail below, HMS 22 facilitates detection of health events of patient 4 by system 2, and the responses of system 2 to such health events, e.g., acute health events.

[0033] Computing device(s) 12 may transmit data, including data retrieved from IMD 10, to computing system(s) 20 via network 16. The data may include sensed data, e.g., values of physiological parameters measured by IMD 10 and, in some cases one or more of computing devices 12, data regarding episodes of arrhythmia or other health events detected by IMD 10 and computing device(s) 12, and other physiological signals or data recorded by IMD 10 and / or computing device(s) 12. HMS 22 may also retrieve data regarding patient 4 from one or more sources of electronic health records (EHR) 24 via network. EHR 24 may include data regarding historical (e.g., baseline) physiological parameter values, previous health events and treatments, disease states, comorbidities, demographics, height, weight, and body mass index (BMI), as examples, of patients including patient 4. HMS 22 may use data from EHR 24 to configure algorithms implemented by IMD 10 and / or computing devices 12 to detect health events for patient 4. In some examples, HMS 22 provides data from EHR 24 to computing device(s) 12 and / or IMD 10 for storage therein and use as part of their algorithms for detecting health events.Atty Ref. No. A0011921W001

[0034] Network 16 may include one or more computing devices, such as one or more non-edge switches, routers, hubs, gateways, security devices such as firewalls, intrusion detection, and / or intrusion prevention devices, servers, cellular base stations and nodes, wireless access points, bridges, cable modems, application accelerators, or other network devices. Network 16 may include one or more networks administered by service providers and may thus form part of a large-scale public network infrastructure, e.g., the Internet. Network 16 may provide computing devices and systems, such as those illustrated in FIG. 1, access to the Internet, and may provide a communication framework that allows the computing devices and systems to communicate with one another. In some examples, network 16 may include a private network that provides a communication framework that allows the computing devices and systems illustrated in FIG. 1 to communicate with each other but isolates some of the data flows from devices external to the private network for security purposes. In some examples, the communications between the computing devices and systems illustrated in FIG. 1 are encrypted.

[0035] As will be described herein, IMD 10 may be configured to detect health events and / or arrhythmias of patient 4, based on data sensed by IMD 10 and, in some cases, other data, such as data sensed by computing devices 12A and / or 12B, and data from EHR 24. To detect health events and / or arrhythmias, IMD 10 may apply rules to the data, which may be referred to as patient parameter data. In response to detection of a health event and / or an arrhythmia, IMD 10 may wirelessly transmit a message to one or both of computing devices 12A and 12B. The message may indicate that IMD 10 detected a health event and / or an arrhythmia of the patient. The message may indicate a time that IMD 10 detected the health event. The message may include physiological data collected by IMD 10, e.g., data which lead to detection of the health event, data prior to detection of the health event, and / or real-time or more recent data collected after detection of the health event. The physiological data may include values of one or more physiological parameters and / or digitized physiological signals. Examples of acute health events are SC A, a ventricular fibrillation (VF), a ventricular tachycardia (VT), myocardial infarction, a pause in heart rhythm (asystole), or Pulseless Electrical Activity (PEA), acute respiratory distress syndrome (ARDS), a stroke, a seizure, or a fall. IMD 10 may additionally detect atrial fibrillation (AF), premature atrial contractions (PACs), premature ventricular contractions (PVCs), etc. In some examples, whether the health event is defined as acute or non-acuteAtty Ref. No. A0011921W001 may depend on the patient. IMD 10 may additionally communication with computing device(s) 12 regarding device status updates and other non-health events.

[0036] In some examples, the detection of the acute health event or arrhythmia by IMD 10 may include multiple phases. For example, IMD 10 may complete an initial detection of a health event, e.g., SCA or tachyarrhythmia, and initiate wireless communication, e.g., Bluetooth®, e.g., BLE, with computing device(s) 12 in response to the initial detection. IMD 10 may, based on the patient risk level, select a transmission power configuration and / or a PHY layer configuration. IMD 10 may determine whether the risk level falls into one of a plurality of categories, e.g., high, intermediate, or low, based on a comparison of the patient risk level to one or more criteria. In some examples, to determine the patient risk level, IMD 10 compare the initial detection, e.g., transmission data associated with the detection, to a lookup table. In some examples, IMD 10 determines the patient risk level by comparing a patient risk score associated with the detection to one or more thresholds. In some examples, the patient risk level for an acute event, such as SCA, the patient risk level may be a high risk level and for non-acute events, such as AF, the patient risk level may be an intermediate risk level. For device status updates, the patient risk level may be low. In some examples, for some non-acute events, such as PACs, the patient risk level may be low risk. In some examples, in addition to or alternatively to selecting the PHY layer configuration based on the patient risk level, IMD 10 may select the PHY layer based on one or more prior communication sessions.

[0037] The initial detection may occur five to ten seconds after onset of the health event and / or arrhythmia, for example. IMD 10 may continue monitoring to determine whether the health event and / or arrhythmia is sustained, e.g., a sustained detection of SCA or tachyarrhythmia. In some examples, IMD 10 may use more patient parameters and / or different rules to determine whether event is sustained or otherwise confirm detection.

[0038] Initiating communication with computing device(s) 12 in response to an initial detection may facilitate the communication being established at the time the health event and / or arrhythmia is confirmed as sustained. To conserve power of IMD 10 and computing device(s) 12, IMD 10 may wait to send the message, e.g., including sensed data associated with the acute health event, until it is confirmed as sustained, which may be determined about thirty seconds after onset of the event, or after a longer period of time. Less urgent events may have longer confirmation phases and may be alerted with lessAtty Ref. No. A0011921W001 urgency, such being alerted as health care events rather than acute health events. However, the initiation of communication after initial detection may still benefit less urgent events. Conserving power may be significant in the case of non-rechargeable IMDs to prolong their life prior to needing surgery for replacement, as well as for rechargeable IMDs or external devices to reduce recharge frequency.

[0039] In response to the message from IMD 10, e.g., in examples in which the patient risk level is high and, in some cases, in examples in which the patient risk level is intermediate, computing device(s) 12 may output an alarm that may be visual and / or audible and configured to immediately attract the attention of patient 4 or any person in environment 28 with patient 4, e.g., a bystander 26. Additionally, or alternatively, computing device(s) 12 may transmit an alert or alarm message to devices and users outside the visible / audio range of computing device(s) 12, e.g., to Internet of Things (loT) devices, such as loT devices 30A-30D (collectively “loT devices 30”), bystander computing device 42, or HMS 22. Environment 28 may be a home, office, or place of business, or public venue, as examples. An alert or alarm message sent to HMS 22 via network 16, or other messages sent by computing device(s) 12, may include the data received from IMD 10 and, in some cases, additional data collected by computing device(s) 12 or other devices in response to the detection of the acute health event and / or arrhythmia by IMD 10. For example, the message may include a location of patient 4 determined by computing device(s) 12. In some examples, computing device(s) 12 may further configure or change the content of alert or alarm messages based on the location of patient 4, e.g., different messages may be sent depending on whether patient 4 is at home, another residence, an office or business, a public location, or in a health care facility. The health care needed by patient, and thus the messaging of system 2, may vary depending on the location of patient 4.

[0040] Other devices in the environment 28 of patient 4 may also be configured to output alarms or take other actions to attract the attention of patient 4 and, possibly, a bystander 26, or to otherwise facilitate the delivery of care to patient 4. For example, environment 28 may include one or more loT devices 30 illustrated in the example of FIG. 1. loT devices 30 may include, as examples, so called “smart” speakers, cameras, televisions, lights, locks, thermostats, appliances, actuators, controllers, or any other smart home (or building) devices. In the example of FIG. 1, loT device 30C is a smart speakerAtty Ref. No. A0011921W001 and / or controller, which may include a display. loT devices 30 may provide audible and / or visual alarms when configured with output devices to do so. As other examples, loT devices 30 may cause smart lights throughout environment 28 to flash or blink and unlock doors. In some examples, loT devices 30 that include cameras or other sensors may activate those sensors to collect data regarding patient 4, e.g., for evaluation of the condition of patient 4.

[0041] Computing device(s) 12 may be configured to wirelessly communicate with loT devices 30 to cause loT devices 30 to take the actions described herein. In some examples, HMS 22 communicates with loT devices 30 via network 16 to cause loT devices 30 to take the actions described herein, e.g., in response to receiving the alert message from computing device(s) 12 as described above. In some examples, IMD 10 is configured to communicate wirelessly with one or more of loT devices 30, e.g., in response to detection of an acute health event and / or arrhythmia when communication with computing devices 12 is unavailable. In such examples, loT device(s) 30 may be configured to provide some or all of the functionality ascribed to computing devices 12 herein.

[0042] In some examples, devices, e.g., loT devices 30, of environment 28 may be connected to one another according to a protocol, such as a protocol corresponding to the Matter® connectivity standard loT devices. In some examples, the Matter® connectivity standard may facilitate inter-device communication between loT devices 30 as well as other devices within environment 28. In some examples, environment 28 may additionally or alternatively be equipped with Apple HomeKit®, Amazon Alexa®, Google Assistant®, Samsung SmartThings®, or the like.

[0043] Environment 28 includes computing facilities, e.g., a local network 32, by which computing devices 12, loT devices 30, and other devices within environment 28 may communicate via network 16, e.g., with HMS 22. For example, environment 28 may be configured with wireless technology, such as IEEE 802.11 wireless networks, IEEE 802.15 ZigBee networks, an ultra-wideband protocol, near-field communication, or the like. Environment 28 may include one or more wireless access points, e.g., wireless access points 34A and 34B (collectively, “wireless access points 34”) that provide support for wireless communications throughout environment 28. Additionally, or alternatively, e.g., when local network is unavailable, computing devices 12, loT devices 30, and otherAtty Ref. No. A0011921W001 devices within environment 28 may be configured to communicate with network 16, e.g., with HMS 22, via a cellular base station 36 and a cellular network.

[0044] Computing device(s) 12, and in some examples loT device(s) 30, may include input devices and interfaces to allow a user to override the alarm in the event the detection of the acute health event and / or arrhythmia, e.g., the SCA, by IMD 10 was false. In some examples, one or more of computing device(s) 12 and loT device(s) 30 may implement an event assistant. The event assistant may provide a conversational interface for patient 4 and / or bystander 26 to exchange information with the computing device or loT device. The event assistant may query the user regarding the condition of patient 4 in response to receiving the alert message from IMD 10. Responses from the user may be used to confirm or override detection of the acute health event by IMD 10, or to provide additional information about the acute health event or the condition of patient 4 more generally that may improve the efficacy of the treatment of patient 4. For example, information received by the event assistant may be used to provide an indication of severity or type (differential diagnosis) for the acute health event and / or arrhythmia. The event assistant may use natural language processing and context data to interpret utterances by the user. In some examples, in addition to receiving responses to queries posed by the assistant, the event assistant may be configured to respond to queries posed by the user. For example, patient 4 may indicate that they feel dizzy and ask the event assistant, “how am I doing?”.

[0045] In some examples, computing device(s) 12 and / or HMS 22 may implement one or more algorithms to evaluate the sensed physiological data received from IMD 10, and in some cases additional physiological or other patient parameter data sensed or otherwise collected by the computing device(s) or loT devices 30, to confirm or override the detection of the acute health event and / or arrhythmia by IMD 10. In some examples, computing device(s) 12 and / or computing system(s) 20 may have greater processing capacity than IMD 10, enabling more complex analysis of the data. In some examples, the computing device(s) 12 and / or HMS 22 may apply the data to a machine learning model or other artificial intelligence developed algorithm, e.g., to determine whether the data is sufficiently indicative of the acute health event and / or arrhythmia.

[0046] In examples in which computing device(s) 12 are configured perform a health event confirmation analysis, computing device(s) 12 may transmit alert messages to HMS 22 and / or loT devices 30 in response to confirming the acute health event. In someAtty Ref. No. A0011921W001 examples, computing device(s) 12 may be configured to transmit the alert messages prior to completing the confirmation analysis and transmit cancellation messages in response to the analysis overriding the detection of the health event by IMD 10. HMS 22 may be configured to perform a number of operations in response to receiving an alert message from computing device(s) 12 and / or loT device(s) 30. HMS 22 may be configured to cancel such operations in response to receiving a cancellation message from computing device(s) 12 and / or loT device(s) 30.

[0047] For example, HMS 22 may be configured to transmit alert messages to one or computing devices 38 associated with one or more care providers 40 via network 16. Care providers may include emergency medical systems (EMS) and hospitals, and may include particular departments within a hospital, such as an emergency department, catheterization lab, or a stroke response department. In some examples, HMS 22 may transmit alert messages to EMS and hospitals when the patient risk level is high and may refrain from transmitting alert messages when the patient risk level is intermediate or low. Computing devices 38 may include smartphones, desktop, laptop, or tablet computers, or workstations associated with such systems or entities, or employees of such systems or entities.

[0048] The alert messages may include any of the data collected by IMD 10, computing device(s) 12, and loT device(s) 30, including sensed physiological data, time of the health event and / or arrhythmia, e.g., the acute health event associated with the high patient risk level, location of patient 4, and results of the analysis by IMD 10, computing device(s) 12, loT device(s) 30, and / or HMS 22. The information transmitted from HMS 22 to care providers 40 may improve the timeliness and effectiveness of treatment of the acute health event of patient 4 by care providers 40. In some examples, instead of or in addition to HMS 22 providing an alert message to one or more computing devices 38 associated with an EMS care provider 40, computing device(s) 12 and / or loT devices 30 may be configured to automatically contact EMS, e.g., autodial 911, in response to receiving an alert message from IMD 10. Again, such operations may be cancelled by patient 4, bystander 26, or another user via a user interface of computing device(s) 12 or loT device(s) 30, or automatically cancelled by computing device(s) 12 based on a confirmatory analysis performed by the computing device(s) overriding the detection of the acute health event by IMD 10.Atty Ref. No. A0011921W001

[0049] Similarly, HMS 22 may be configured to transmit an alert message to computing device 42 of bystander 26, which may improve the timeliness and effectiveness of treatment of the acute health event of patient 4 by bystander 26. Computing device 42 may be similar to computing devices 12 and computing devices 38, e.g., a smartphone. In some examples, HMS 22 may determine that bystander 26 is proximate to patient 4 based on a location of patient 4, e.g., received from computing device(s) 12, and a location of computing device 42, e.g., reported to HMS 22 by an application implemented on computing device 42. In some examples, HMS 22 may transmit the alert message to any computing devices 42 in an alert area determined based on the location of patient 4, e.g., by transmitting the alert message to all computing devices in communication with base station 36, using any of the networking methods described herein.

[0050] In some examples, the alert message to bystander 26 may be configured to assist a layperson in treating patient. For example, the alert message to bystander 26 may include a location (and in some cases a description) of patient 4, the general nature of the acute health event, directions for providing care to patient 4, such as directions for providing cardio-pulmonary resuscitation (CPR), a location of nearby medical equipment for treatment of patient 4, such as an automated external defibrillator (AED) 44 or life vest, and instructions for use of the equipment. In some examples, computing device(s) 12, loT device(s) 30, and / or computing device 42 may implement an event assistant configured to use natural language processing and context data to provide a conversational interface for bystander 42. The assistant may provide bystander 26 with directions for providing care to patient 4 and respond to queries from bystander 26 about how to provide care to patient 4.

[0051] In some examples, HMS 22 may mediate bi-directional audio (and in some cases video) communication between care providers 40 and patient 4 or bystander 26. Such communication may allow care providers 40 to evaluate the condition of patient 4, e.g., through communication with patient 4 or bystander 26, or through use of a camera or other sensors of the computing device or loT device, in advance of the time they will begin caring for the patient, which may improve the efficacy of care delivered to the patient. Such communication may also allow the care providers to instruct bystander 42 regarding first responder treatment of patient 4.Atty Ref. No. A0011921W001

[0052] In some examples, HMS 22 may control dispatch of a drone 46 to environment 28, or a location near environment 28 or patient 4. Drone 46 may be a robot and / or unmanned aerial vehicle (UAV). Drone 46 may be equipped with a number of sensors and / or actuators to perform a number of operations. For example, drone 46 may include a camera or other sensors to navigate to its intended location, identify patient 4 and, in some cases, bystander 26, and to evaluate a condition of patient. In some examples, drone 46 may include user interface devices to communicate with patient 4 and / or bystander 26. In some examples, drone 46 may provide directions to bystander 26, to the location of patient 4 and regarding how to provide first responder care, such as CPR, to patient 4. In some examples, drone 46 may carry medical equipment, e.g., AED 44, and / or medication to the location of patient 4.

[0053] In some examples, e.g., responsive to failing to establish a connection with computing device(s) 12, IMD 10 may attempt to establish a connection with other devices in environment 28. In some examples, IMD 10 may be configured to sequentially attempt to establish a connection with several devices in environment 28, e.g., according to a device hierarchy or priority list, which may be maintained by IMD 10, and in some cases configurable by a user via computing devices 12, 38 and / or HMS 22. As an example, IMD 10 may initially attempt to establish a connection with computing device(s) 12, and responsive to failing to establish the connection, IMD 10 may attempt to establish a connection with one or more of loT devices 30, followed by bystander computing device 42. The hierarchy of devices described herein serves merely as an example; other hierarchies of the devices in environment 28 are also possible. Additionally, the hierarchy may comprise any device configured for wireless communication.

[0054] In addition to detecting acute health events and / or arrhythmias, IMD 10 may be configured to send regularly scheduled transmissions of data, e.g., to HMS 22 via a wireless connection with a computing device 12. In some examples, IMD 10 may be configured to dynamically switch between PHY layer and / or transmission power configurations to establish a connection for data transmission. Additionally, or alternatively, IMD 10 may be configured to dynamically switch between PHY layer and / or transmission power configurations to adjust, e.g., increase, data throughput to improve efficiency of data transmissions.Atty Ref. No. A0011921W001

[0055] In some examples, if IMD 10 does not successfully establish a connection using the dynamically switched PHY layer and / or transmission power configurations, IMD 10 may determine to switch to a non-RF based communication scheme, such as alerting patient 4 and / or a caregiver of patient 4 of the transmission and / or a need for patient 4 to move closer to a device to establish a connection. As an example, processing circuitry 350 may control IMD 10 to alert patient 4 via on-device haptics, e.g., vibration, and / or on-device audible alerts, e.g., audible alerts generated by a speaker or a piezoelectric and / or on-device light emission, e.g., a blinking light emitting diode (LED) visible through the skin of patient 4.

[0056] In some examples, IMD 10 may additionally or alternatively determine to switch to a longer range telemetry scheme and send a small transmission, such as a single bit indicator, including non-sensitive and non-secure information indicating that a telemetry session is requested and that patient 4 should take measures to enable the transmission to be offloaded to a device, e.g., patient computing devices 12 or another device of system 2. The longer range telemetry scheme may comprise a low power wide area network (LPWAN), such as LoRa or LoRaWAN, Zigbee, mesh networks, RFID technology, Bluetooth, SMS text message, 4G, 5G, or any other wireless communication protocols that could connect to one of loT devices 30 or integrated with a wearable device, such as patient computing device 12B.

[0057] FIG. 2A is a perspective drawing illustrating an IMD 10A, which may be an example configuration of IMD 10 of FIG. 1 as an ICM. In the example shown in FIG. 2 A, IMD 10A may be embodied as a monitoring device having housing 212, proximal electrode 216A and distal electrode 216B. Housing 212 may further comprise first major surface 214, second major surface 218, proximal end 220, and distal end 222. Housing 212 encloses electronic circuitry located inside the IMD 10A and protects the circuitry contained therein from body fluids. Housing 212 may be hermetically sealed and configured for subcutaneous implantation. Electrical feedthroughs provide electrical connection of electrodes 216A and 216B.

[0058] In the example shown in FIG. 2A, IMD 10A is defined by a length / ., a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width IF, which in turn is larger than the depth D. In one example, the geometry of the IMD 10A - in particular a width W greater than theAtty Ref. No. A0011921W001 depth D - is selected to allow IMD 10A to be inserted under the skin of the patient using a minimally invasive procedure and to remain in the desired orientation during insertion. For example, the device shown in FIG. 2A includes radial asymmetries (notably, the rectangular shape) along the longitudinal axis that maintains the device in the proper orientation following insertion. For example, the spacing between proximal electrode 216A and distal electrode 216B may range from 5 millimeters (mm) to 55 mm, 30 mm to 55 mm, 35 mm to 55 mm, and from 40 mm to 55 mm and may be any range or individual spacing from 5 mm to 60 mm. In addition, IMD 10A may have a length L that ranges from 30 mm to about 70 mm. In other examples, the length L may range from 5 mm to 60 mm, 40 mm to 60 mm, 45 mm to 60 mm and may be any length or range of lengths between about 30 mm and about 70 mm. In addition, the width W of major surface 214 may range from 3 mm to 15, mm, from 3 mm to 10 mm, or from 5 mm to 15 mm, and may be any single or range of widths between 3 mm and 15 mm. The thickness of depth D of IMD 10A may range from 2 mm to 15 mm, from 2 mm to 9 mm, from 2 mm to 5 mm, from 5 mm to 15 mm, and may be any single or range of depths between 2 mm and 15 mm. In addition, IMD 10A according to an example of the present disclosure has a geometry and size designed for ease of implant and patient comfort. Examples of IMD 10A described in this disclosure may have a volume of three cubic centimeters (cm) or less, 1.5 cubic cm or less or any volume between three and 1.5 cubic centimeters.

[0059] In the example shown in FIG. 2A, once inserted within the patient, the first major surface 214 faces outward, toward the skin of the patient while the second major surface 218 is located opposite the first major surface 214. In addition, in the example shown in FIG. 2 A, proximal end 220 and distal end 222 are rounded to reduce discomfort and irritation to surrounding tissue once inserted under the skin of the patient. IMD 10A, including instrument and method for inserting IMD 10A is described, for example, in U.S. Patent No. 11,311,312, incorporated herein by reference in its entirety.

[0060] Proximal electrode 216A is at or proximate to proximal end 220, and distal electrode 216B is at or proximate to distal end 222. Proximal electrode 216A and distal electrode 216B are used to sense ECG signals thoracically outside the ribcage, which may be sub-muscularly or subcutaneously. ECG signals may be stored in a memory of IMD 10 A, and data may be transmitted via integrated antenna 230 A to another device, which may be another implantable device or an external device, such as external device 212. InAtty Ref. No. A0011921W001 some example, electrodes 216A and 216B may additionally or alternatively be used for sensing any bio-potential signal of interest, which may be, for example, an electroencephalogram (EEG), electromyogram (EMG), or a nerve signal, or for measuring impedance, from any implanted location.

[0061] In the example shown in FIG. 2A, proximal electrode 216A is at or in close proximity to the proximal end 220 and distal electrode 216B is at or in close proximity to distal end 222. In this example, distal electrode 216B is not limited to a flattened, outward facing surface, but may extend from first major surface 214 around rounded edges 224 and / or end surface 226 and onto the second major surface 218 so that the electrode 216B has a three-dimensional curved configuration. In some examples, electrode 216B is an uninsulated portion of a metallic, e.g., titanium, part of housing 212.

[0062] In the example shown in FIG. 2A, proximal electrode 216A is located on first major surface 214 and is substantially flat, and outward facing. However, in other examples proximal electrode 216A may utilize the three-dimensional curved configuration of distal electrode 216B, providing a three dimensional proximal electrode (not shown in this example). Similarly, in other examples distal electrode 216B may utilize a substantially flat, outward facing electrode located on first major surface 214 similar to that shown with respect to proximal electrode 216A.

[0063] The various electrode configurations allow for configurations in which proximal electrode 216A and distal electrode 216B are located on both first major surface 214 and second major surface 218. In other configurations, such as that shown in FIG. 2 A, only one of proximal electrode 216A and distal electrode 216B is located on both major surfaces 214 and 218, and in still other configurations both proximal electrode 216A and distal electrode 216B are located on one of the first major surface 214 or the second major surface 218 (e.g., proximal electrode 216A located on first major surface 214 while distal electrode 216B is located on second major surface 218). In another example, IMD 10A may include electrodes on both major surface 214 and 218 at or near the proximal and distal ends of the device, such that a total of four electrodes are included on IMD 10A.Electrodes 216A and 216B may be formed of a plurality of different types of biocompatible conductive material, e.g., stainless steel, titanium, platinum, iridium, or alloys thereof, and may utilize one or more coatings such as titanium nitride or fractal titanium nitride.Atty Ref. No. A0011921W001

[0064] In the example shown in FIG. 2A, proximal end 220 includes a header assembly 228 that includes one or more of proximal electrode 216A, integrated antenna 230A, anti-migration projections 232, and / or suture hole 234. Integrated antenna 230A is located on the same major surface (i.e., first major surface 214) as proximal electrode 216A and is also included as part of header assembly 228. Integrated antenna 230A allows IMD 10A to transmit and / or receive data. In other examples, integrated antenna 230A may be formed on the opposite major surface as proximal electrode 216A or may be incorporated within the housing 212 of IMD 10A. In the example shown in FIG. 2A, antimigration projections 232 are located adjacent to integrated antenna 230A and protrude away from first major surface 214 to prevent longitudinal movement of the device. In the example shown in FIG. 2A, anti -migration projections 232 include a plurality (e.g., nine) small bumps or protrusions extending away from first major surface 214. As discussed above, in other examples anti -migration projections 232 may be located on the opposite major surface as proximal electrode 216A and / or integrated antenna 230A. In addition, in the example shown in FIG. 2A, header assembly 228 includes suture hole 234, which provides another means of securing IMD 10A to the patient to prevent movement following insertion. In the example shown, suture hole 234 is located adjacent to proximal electrode 216A. In one example, header assembly 228 is a molded header assembly made from a polymeric or plastic material, which may be integrated or separable from the main portion of IMD 10 A.

[0065] FIG. 2B is a perspective drawing illustrating another IMD 10B, which may be another example configuration of IMD 10 from FIG. 1 as an ICM. IMD 10B of FIG. 2B may be configured substantially similarly to IMD 10A of FIG. 2A, with differences between them discussed herein.

[0066] IMD 10B may include a leadless, subcutaneously-implantable monitoring device, e.g., an ICM. IMD 10B includes housing having a base 240 and an insulative cover 242. Proximal electrode 216C and distal electrode 216D may be formed or placed on an outer surface of cover 242. Various circuitries and components of IMD 10B may be formed or placed on an inner surface of cover 242, or within base 240. In some examples, a battery or other power source of IMD 10B may be included within base 240. In the illustrated example, antenna 230B is formed or placed on the outer surface of cover 242 but may be formed or placed on the inner surface in some examples. In some examples,Atty Ref. No. A0011921W001 insulative cover 242 may be positioned over an open base 240 such that base 240 and cover 242 enclose the circuitries and other components and protect them from fluids such as body fluids. The housing including base 270 and insulative cover 272 may be hermetically sealed and configured for subcutaneous implantation.

[0067] Circuitries and components may be formed on the inner side of insulative cover 242, such as by using flip-chip technology. Insulative cover 242 may be flipped onto a base 240. When flipped and placed onto base 240, the components of IMD 10B formed on the inner side of insulative cover 242 may be positioned in a gap 244 defined by base 240. Electrodes 216C and 216D and antenna 230B may be electrically connected to circuitry formed on the inner side of insulative cover 242 through one or more vias (not shown) formed through insulative cover 242. Insulative cover 242 may be formed of sapphire (i.e., corundum), glass, parylene, and / or any other suitable insulating material. Base 240 may be formed from titanium or any other suitable material (e.g., a biocompatible material). Electrodes 216C and 216D may be formed from any of stainless steel, titanium, platinum, iridium, or alloys thereof. In addition, electrodes 216C and 216D may be coated with a material such as titanium nitride or fractal titanium nitride, although other suitable materials and coatings for such electrodes may be used.

[0068] In the example shown in FIG. 2B, the housing of IMD 10B defines a length / ., a width W and thickness or depth D and is in the form of an elongated rectangular prism wherein the length L is much larger than the width W, which in turn is larger than the depth D, similar to IMD 10A of FIG. 2A. For example, the spacing between proximal electrode 216C and distal electrode 216D may range from 5 mm to 50 mm, from 30 mm to 50 mm, from 35 mm to 45 mm, and may be any single spacing or range of spacings from 5 mm to 50 mm, such as approximately 40 mm. In addition, IMD 10B may have a length L that ranges from 5 mm to about 70 mm. In other examples, the length L may range from 30 mm to 70 mm, 40 mm to 60 mm, 45 mm to 55 mm, and may be any single length or range of lengths from 5 mm to 50 mm, such as approximately 45 mm. In addition, the width may range from 3 mm to 15 mm, 5 mm to 15 mm, 5 mm to 10 mm, and may be any single width or range of widths from 3 mm to 15 mm, such as approximately 8 mm. The thickness or depth D of IMD 10B may range from 2 mm to 15 mm, from 5 mm to 15 mm, or from 3 mm to 5 mm, and may be any single depth or range of depths between 2 mm and 15 mm, such as approximately 4 mm. IMD 10B may have a volume of threeAtty Ref. No. A0011921W001 cubic centimeters (cm) or less, or 1.5 cubic cm or less, such as approximately 1.4 cubic cm.

[0069] In the example shown in FIG. 2B, once inserted subcutaneously within the patient, outer surface of cover 242 faces outward, toward the skin of the patient. In addition, as shown in FIG. 2B, proximal end 246 and distal end 248 are rounded to reduce discomfort and irritation to surrounding tissue once inserted under the skin of the patient. In addition, edges of IMD 10B may be rounded.

[0070] FIG. 3 is a block diagram illustrating an example configuration of IMD 10 of FIG. 1. As shown in FIG. 3, IMD 10 includes processing circuitry 350, memory 352, sensing circuitry 354 coupled to electrodes 356A and 356B (hereinafter, “electrodes 356”) and one or more sensor(s) 358, and communication circuitry 360.

[0071] Processing circuitry 350 may include fixed function circuitry and / or programmable processing circuitry. Processing circuitry 350 may include any one or more of a microprocessor, a controller, a graphics processing unit (GPU), a tensor processing unit (TPU), a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or analog logic circuitry. In some examples, processing circuitry 350 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more GPUs, one or more TPUs, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processing circuitry 350 herein may be embodied as software, firmware, hardware, or any combination thereof. In some examples, memory 353 includes computer-readable instructions that, when executed by processing circuitry 350, cause IMD 10 and processing circuitry 350 to perform various functions attributed herein to IMD 10 and processing circuitry 350. Memory 352 may include any volatile, non-volatile, magnetic, optical, or electrical media, such as a random-access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media.

[0072] Sensing circuitry 354 may monitor signals from electrodes 356 in order to, for example, monitor electrical activity of a heart of patient 4 and produce ECG data for patient 4. In some examples, processing circuitry 350 may identify features of the sensed ECG, such as heart rate, heart rate variability, T-wave alternans, intra-beat intervals (e.g.,Atty Ref. No. A0011921W001QT intervals), and / or ECG morphologic features, to detect a health event, e.g., an episode of cardiac arrhythmia of patient 4. Processing circuitry 350 may store the digitized ECG and features of the ECG used to detect the health event in memory 352 as episode data for the health event.

[0073] In some examples, sensing circuitry 354 measures impedance, e.g., of tissue proximate to IMD 10, via electrodes 356. The measured impedance may vary based on respiration, cardiac pulse or flow, and a degree of perfusion or edema. Processing circuitry 350 may determine physiological data relating to respiration, cardiac pulse or flow, perfusion, and / or edema based on the measured impedance.

[0074] In some examples, IMD 10 includes one or more sensors 358, such as one or more accelerometers, gyroscopes, microphones, optical sensors, temperature sensors, pressure sensors, and / or chemical sensors. In some examples, sensing circuitry 352 may include one or more filters and amplifiers for filtering and amplifying signals received from one or more of electrodes 356 and / or sensors 358. In some examples, sensing circuitry 354 and / or processing circuitry 350 may include a rectifier, filter and / or amplifier, a sense amplifier, comparator, and / or analog-to-digital converter. Processing circuitry 350 may determine physiological data, e.g., values of physiological parameters of patient 4, based on signals from sensors 358, which may be stored in memory 352. Patient parameters determined from signals from sensors 358 may include oxygen saturation, glucose level, stress hormone level, heart sounds, body motion, body posture, or blood pressure.

[0075] Memory 352 may store applications 370 executable by processing circuitry 350, and data 380. Applications 370 may include an event surveillance application 372. Processing circuitry 350 may execute event surveillance application 372 to detect a health event of patient 4 based on combination of one or more of the types of physiological data described herein, which may be stored as event data 386. In some examples, event data 386 may additionally include patient parameter data sensed by other devices, e.g., computing device(s) 12 or loT device(s) 30, and received via communication circuitry 360.

[0076] As examples, event surveillance application 372 may detect acute, high risk health events such as SCA, VF, VT, supra-ventricular tachycardia (e.g., conducted AF), ventricular asystole, or myocardial infarction, as well as intermediate health risk events,Atty Ref. No. A0011921W001 such as non-life-threatening arrhythmias, based on an ECG and / or other physiological data of patient 4. In some examples, processing circuitry 350 may determine whether a patient risk level associated with an event is high risk or intermediate risk by comparing event data to a lookup table including data corresponding to a plurality of types of events. In some examples, event surveillance application 372 may detect stroke based on such cardiac activity data. In some examples, sensing circuitry 354 may detect brain activity data, e.g., an electroencephalogram (EEG) via electrodes 356, and event surveillance application 372 may detect stroke or a seizure based on the brain activity alone, or in combination with cardiac activity data or other physiological data. In some examples, event surveillance application 372 detects whether the patient has fallen based on data from an accelerometer alone, or in combination with other physiological data. When event surveillance application 372 detects a health event, event surveillance application 372 may store the event data 386 that led to the detection.

[0077] In some examples, in response to detection of a health event, processing circuitry 350 transmits, via communication circuitry 360, event data 386 and a corresponding alert for the event to computing device(s) 12 (FIG. 1). This transmission may be included in an alert indicating a health event, e.g., an acute health event associated with a high patient risk level, as described herein. Transmission of the alert may occur on an ad hoc basis and as quickly as possible. Communication circuitry 360 may include any suitable hardware, firmware, software, or any combination thereof for wirelessly communicating with another device, such as computing devices 12 and / or loT devices 30. Memory 352 may store thresholds 382. To facilitate the transmission of messages and / or data, thresholds 382 may comprise thresholds for selecting a PHY layer configuration of a plurality of PHY layer configurations and / or a transmission power configuration of a plurality of transmission power configurations. In some examples, thresholds 382 may additionally comprise thresholds for determining whether to dynamically switch between PHY layer configurations and / or transmission power configurations. As examples, thresholds 382 may comprise timing / duration thresholds, e.g., 15-30 seconds for transmissions associated with high risk and emergency alerts, 15-30 second intervals intermittently over 15 minutes for transmissions associated with intermediate risk, or for 15-30 second intervals intermittently over 1-3 days for regularly scheduled transmissionsAtty Ref. No. A0011921W001 that are low risk, for comparison with elapsed times corresponding to broadcasting advertisements to attempt to establish a wireless connection.

[0078] In addition to detecting health events, e.g., acute and non-acute health events, and transmitting alerts and / or data corresponding to the health events, IMD 10 may additionally transmit regularly scheduled transmissions, such as device status information and / or patient data that does not include health events and / or arrhythmias. IMD 10 may dynamically select transmission power configurations and / or PHY layer configurations to facilitate regularly scheduled transmissions.

[0079] In some examples, memory 352 is configured to store one or more communication protocols 312. Each protocol of communication protocols 312 may define a set of rules that govern one or more aspects of data exchange between IMD 10 and other devices (e.g., external device 12). In some examples, communication protocols 312 are stored as lists of computer-readable instructions and communication protocols may be executed by any combination of hardware (e.g., processing circuitry 30) and software. In some examples, communication protocols 312 includes a Bluetooth® protocol such as a Bluetooth Low Energy (BLE) protocol, a Session Initiation Protocol (SIP) based protocol, a Zigbee® protocol, a RF4CE protocol, a WirelessHART protocol, a 6L0WPAN (IPv6 over Low power Wireless Personal Area Networks) protocol, a Z-Wave protocol, an ANT protocol, an ultra-wideband (UWB) standard protocol, a radio frequency (RF) communication protocol, and / or other proprietary and non-proprietary communication protocols. In some examples, communication protocols 312 exclusively includes the Bluetooth® protocol, e.g., the BLE protocol. Alternatively, in other examples, communication protocols 312 may include any combination of Bluetooth® protocols, protocols developed by the manufacturer of IMD 10, and protocols licensed from a third- party developer. For example, communication protocols 312 may include any combination of one or more Bluetooth® protocols and one or more other communication protocols, such as a communication protocol utilized for communications using magnetic induction.

[0080] In some examples, memory 352 is configured to store operational parameters 314. Operational parameters 314 may govern aspects of the operation of IMD 10. For example, operational parameters 314 may include combinations of electrodes 356 and sensors 358 for sensing physiological signals of patient 4. Additionally, or alternatively, operational parameters 314 may include a sampling rate for sampling analog signalsAtty Ref. No. A0011921W001 sensed by electrodes 356 and sensors 358. Additionally, or alternatively, operational parameters 314 may include thresholds for detecting events, such as acute health events, based on one or more physiological signals and / or parameters. Operational parameters 314 may be updated based on instructions received from an external device (e.g., external device 12) via communication circuitry 360. In some examples, processing circuitry 350 of IMD 10 updates operational parameters 314 only if instructions to update operational parameters 314 are received over a secure link.

[0081] IMD 10 may establish one or more communication links with another device, such as computing device 12. For example, IMD 10 may receive data from computing device 12 via communication circuitry 360, and IMD 10 may send data to computing device 12 via communication circuitry 360. IMD 10 may send and receive data according to one or more of communication protocols 312. Communication protocols 312 may include one or more protocols and may enable IMD 10 to communicate according to a Bluetooth® protocol, such as a BLE protocol, a magnetic induction communication protocol, and the like.

[0082] Processing circuitry 350 of IMD 10 is configured to periodically broadcast, via communication circuitry 360, advertisements (e.g., in the form of Bluetooth® advertising packets) that indicates IMD 10 is able to be paired with other external devices. External devices (e.g., computing devices 12) may be able to detect such advertisements and to establish one or more wireless communication links with IMD 10 based on the information contained within the advertisements. Processing circuitry 350 may be configured to broadcast advertisements in accordance with one or more communication protocols 312, such as in accordance with a BLE communication protocol.

[0083] FIG. 4 illustrates an example of a full protocol stack structure 460 of a Bluetooth®, e.g., BLE, protocol. In some examples, the full protocol stack structure 460 is an example of communication protocols 312 (FIG. 3). Communication circuitry 360 may be configured to implement the BLE protocol of FIG. 4, including dynamically switching between PHY layer configurations and / or transmission power configurations. Application layer 462 comprises various applications that utilize wireless communication. Host layer 464 manages aspects of the protocol stack and sets the framework for wireless communication. Controller layer 466 implements PHY layer 468 and link layer 470. Communication circuitry 360 may be configured to support communications using aAtty Ref. No. A0011921W001 selected PHY layer configuration, e.g., a 1 Megabit PHY layer configuration, a 2 Megabit PHY layer configuration, or a Coded PHY layer configuration, e.g., an S=2 Coded PHY layer configuration or an S=8 Coded PHY layer configuration. Communication circuitry 360 may be configured to support communications using a selected transmission power configuration of a plurality of transmission power configurations ranging from -50 dBm to 10 dBm. In some examples, processing circuitry 350 may be configured to dynamically switch between PHY layer and / or transmission power configurations of full protocol stack structure 460 based on a patient risk level associated with a transmission.

[0084] FIG. 5 is a block diagram illustrating an example configuration of a computing device 12 of patient 4, which may correspond to either (or both operating in coordination) of computing devices 12A and 12B illustrated in FIG. 1. In some examples, computing device 12 takes the form of a smartphone, a laptop, a tablet computer, a personal digital assistant (PDA), a smartwatch or other wearable computing device. In some examples, loT devices 30, computing devices 38 and 42, AED 44, and / or drone 46 may be configured similarly to the configuration of computing device 12 illustrated in FIG. 5.

[0085] As shown in the example of FIG. 5, computing device 12 may be logically divided into user space 502, kernel space 504, and hardware 506. Hardware 506 may include one or more hardware components that provide an operating environment for components executing in user space 502 and kernel space 504. User space 502 and kernel space 504 may represent different sections or segmentations of memory, where kernel space 504 provides higher privileges to processes and threads than user space 502. For instance, kernel space 504 may include operating system 520, which operates with higher privileges than components executing in user space 502.

[0086] As shown in FIG. 5, hardware 506 includes processing circuitry 530, memory 532, one or more input devices 534, one or more output devices 536, one or more sensors 538, and communication circuitry 540. Although shown in FIG. 5 as a stand-alone device for purposes of example, computing device 12 may be any component or system that includes processing circuitry or other suitable computing environment for executing software instructions and, for example, need not necessarily include one or more elements shown in FIG. 5.

[0087] Processing circuitry 530 is configured to implement functionality and / or process instructions for execution within computing device 12. For example, processingAtty Ref. No. A0011921W001 circuitry 530 may be configured to receive and process instructions stored in memory 532 that provide functionality of components included in kernel space 504 and user space 502 to perform one or more operations in accordance with techniques of this disclosure. Examples of processing circuitry 530 may include, any one or more microprocessors, controllers, GPUs, TPUs, DSPs, ASICs, FPGAs, or equivalent discrete or integrated logic circuitry.

[0088] Memory 532 may be configured to store information within computing device 512, for processing during operation of computing device 512. Memory 532, in some examples, is described as a computer-readable storage medium. In some examples, memory 532 includes a temporary memory or a volatile memory. Examples of volatile memories include random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), and other forms of volatile memories known in the art. Memory 532, in some examples, also includes one or more memories configured for long-term storage of information, e.g. including non-volatile storage elements. Examples of such non-volatile storage elements include magnetic hard discs, optical discs, floppy discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable (EEPROM) memories. In some examples, memory 532 includes cloud-associated storage.

[0089] One or more input devices 534 of computing device 12 may receive input, e.g., from patient 4 or another user. Examples of input are tactile, audio, kinetic, and optical input. Input devices 534 may include, as examples, a mouse, keyboard, voice responsive system, camera, buttons, control pad, microphone, presence-sensitive or touch-sensitive component (e.g., screen), or any other device for detecting input from a user or a machine.

[0090] One or more output devices 536 of computing device 12 may generate output, e.g., to patient 4 or another user. Examples of output are tactile, haptic, audio, and visual output. Output devices 534 of computing device 12 may include a presence-sensitive screen, sound card, video graphics adapter card, speaker, cathode ray tube (CRT) monitor, liquid crystal display (LCD), light emitting diodes (LEDs), or any type of device for generating tactile, audio, and / or visual output.

[0091] One or more sensors 538 of computing device 12 may sense physiological parameters or signals of patient 4. Sensor(s) 538 may include electrodes, accelerometers (e.g., 3-axis accelerometers), an optical sensor, impedance sensors, temperature sensors,Atty Ref. No. A0011921W001 pressure sensors, heart sound sensors (e.g., microphones), and other sensors, and sensing circuitry (e.g., including an ADC), similar to those described above with respect to IMD 10.

[0092] Communication circuitry 540 of computing device 12 may communicate with other devices by transmitting and receiving data. Communication circuitry 540 may include a network interface card, such as an Ethernet card, an optical transceiver, a radio frequency transceiver, or any other type of device that can send and receive information. For example, communication circuitry 140 may include a radio transceiver configured for communication according to standards or protocols, such as 3G, 4G, 5G, WiFi (e.g., 802.11 or 802.15 ZigBee), or Bluetooth®, e.g., BLE.

[0093] As shown in FIG. 5, health monitoring application 550 executes in user space 502 of computing device 12. Health monitoring application 550 may be logically divided into presentation layer 552, application layer 554, and data layer 556. Presentation layer 552 may include a user interface (UI) component 560, which generates and renders user interfaces of health monitoring application 550.

[0094] Application layer 554 may include, but is not limited to, an event engine 570, rules engine 572, rules configuration component 574, event assistant 576, and location service 578. Computing device 12 may implement event engine 570 responsive to receipt of an alert transmission from IMD 10 indicating that IMD 10 detected a health event, e.g., an acute health event. Event engine 570 may control performance of any of the operations in response to detection of a health event ascribed herein to computing device 12, such as activating an alarm, transmitting alert messages to HMS 22, controlling loT devices 30, and analyzing data to confirm or override the detection of the acute health event by IMD 10.

[0095] Rules engine 572 analyzes sensed data 590, and in some examples, patient input 592 and / or EHR data 594, to determine whether there is a sufficient likelihood that patient 4 is experiencing the health event, e.g., the acute health event, detected by IMD 10. Sensed data 590 may include data received from IMD 10 as part of the alert transmission, additional data transmitted from IMD 10, e.g., in “real-time,” and physiological and other data related to the condition of patient 4 collected by, for example, computing device(s) 12 and / or loT devices 30. As examples, sensed data 590 from computing device(s) 12 may include one or more of: activity levels, walking / running distance, resting energy, activeAtty Ref. No. A0011921W001 energy, exercise minutes, quantifications of standing, body mass, body mass index, heart rate, low, high, and / or irregular heart rate events, heart rate variability, walking heart rate, heart beat series, digitized ECG, blood oxygen saturation, blood pressure (systolic and / or diastolic), respiratory rate, maximum volume of oxygen, blood glucose, peripheral perfusion, and sleep patterns.

[0096] Patient input 592 may include responses to queries posed by health monitoring application 550 regarding the condition of patient 4, such as input by patient 4 or another user, such as bystander 26. The queries and responses may occur responsive to the detection of the event by IMD 10, or may have occurred prior to the detection, e.g., as part of long-term monitoring of the health of patient 4. User recorded health data may include one or more of exercise and activity data, sleep data, symptom data, medical history data, quality of life data, nutrition data, medication taking or compliance data, allergy data, demographic data, weight, and height. EHR data 594 may include any of the information regarding the historical condition or treatments of patient 4 described above. EHR data 594 may relate to history of SC A, tachyarrhythmia, myocardial infarction, stroke, seizure, one or more disease states, such as status of HF, COPD, renal dysfunction, or hypertension, aspects of disease state, such as ECG characteristics, cardiac ischemia, oxygen saturation, lung fluid, activity, or metabolite level, genetic conditions, congenital anomalies, history of procedures, such as ablation or cardioversion, and healthcare utilization. EHR data 594 may also include cardiac indicators, such as ejection fraction and left-ventricular wall thickness. EHR data 594 may also include demographic and other information of patient 4, such as age, gender, race, height, weight, and BMI.

[0097] Rules engine 572 may apply rules 596 to the data. Rules 596 may include one or more models, algorithms, decision trees, and / or thresholds. In some cases, rules 596 may be developed based on machine learning, e.g., may include one or more machine learning models. In some examples, rules 596 and the operation of rules engine 572 may provide a more complex analysis the patient parameter data, e.g., the data received from IMD 10, than is provided by event surveillance 372. In examples in which rules 596 include one or more machine learning models, rules engine 572 may apply feature vectors derived from the data to the model(s).

[0098] Rules configuration component 574 may be configured to modify rules 596 based on feedback indicating whether the detections and confirmations of acute healthAtty Ref. No. A0011921W001 events by IMD 10 and computing device 12 were accurate. The feedback may be received from patient 4, or from care providers 40 and / or EHR 24 via HMS 22. In some examples, rules configuration component 574 may utilize the data sets from true and false detections and confirmations for supervised machine learning to further train models included as part of rules 596.

[0099] Rules configuration component 574, or another component executed by processing circuitry of system 2, may select a configuration of rules 596 based on etiological data for patient, e.g., any combination of one or more of the examples of sensed data 590, patient input 592, and EHR data 594 discussed above. In some examples, different sets of rules 596 tailored to different cohorts of patients may be available for selection for patient 4 based on such etiological data.

[0100] As discussed above, event assistant 576 may provide a conversational interface for patient 4 and / or bystander 26 to exchange information with computing device 12. Event assistant 576 may query the user regarding the condition of patient 4 in response to receiving the alert message from IMD 10. Responses from the user may be included as patient input 592. Event assistant 576 may use natural language processing and context data to interpret utterances by the user. In some examples, in addition to receiving responses to queries posed by the assistant, event assistant 576 may be configured to respond to queries posed by the user. In some examples, event assistant 576 may provide directions to and respond to queries regarding treatment of patient 4 from patient 4 or bystander 26.

[0100] Location service 578 may determine the location of computing device 12 and, thereby, the presumed location of patient 4. Location service 578 may use global position system (GPS) data, multilateration, and / or any other known techniques for locating computing devices.

[0101] FIG. 6 is a flow diagram illustrating an example operation for controlling communication circuitry to transmit data using selected transmission power and physical (PHY) layer configurations, in accordance with one or more techniques of this disclosure. Although the example of FIG. 6 will be described as being performed by processing circuitry 350 of IMD 10, the techniques are not so limited. The example operations of FIG. 6 may be additionally or alternatively be performed by, for example, one or more other devices of system 2 of FIG. 1.Atty Ref. No. A0011921W001

[0102] Processing circuitry 350 determines a patient risk level associated with a transmission (602). In some examples, the transmission may comprise an acute health event, e.g., SCA, a non-acute health event, such as an AF episode, or a regularly scheduled transmission, such as a device status or non-episodic physiological data. Processing circuitry 350 may determine a patient risk level associated with the transmission based on the transmission type and / or the event type. In some examples, processing circuitry 350 determines the patient risk level associated with the transmission by comparing the transmission data to a lookup table. As an example, the lookup table may include a plurality of transmission types, including transmissions corresponding to acute health events, e.g., SCA, VF, and VT, non-acute health events, e.g., AF and PACs, and regularly scheduled transmissions, e.g., device status updates. In some examples, each of the transmission types may correspond to a category, e.g., a high risk category, an intermediate risk category, or a low risk category. In some examples, if the transmission does not correspond to any of the plurality of transmission types in the lookup table, processing circuitry 250 may select a default patient risk level. In some examples, the lookup table may be patient specific. For example, the transmission types corresponding to each of the categories may be different for different patients. As another example, the lookup table for some patients may include greater or fewer risk level categories, such as 2 risk categories, 4 risk categories, 10 risk categories, etc.

[0103] Processing circuitry 350 may determine a risk level for a patient, e.g., patient 4, associated with a transmission including SCA is high and / or may classify the risk level as high risk. Processing circuitry 350 may determine a patient risk level associated with a transmission including the AF episode is intermediate and / or may classify the patient risk level as intermediate risk. In some examples, processing circuitry 350 may additionally determine the patient risk level associated with the transmission based on a duration of an episode and / or a number of episodes the patient 4 has experienced within a threshold period. As an example, a transmission including a relatively short AF episode may have a lower patient risk level than a transmission including a relatively long AF episode. Processing circuitry 350 may determine a patient risk level associated with a regularly scheduled transmission, e.g., a regularly scheduled transmission with no indications of a change in patient state of patient 4, is low and / or may classify the risk level as high risk.Atty Ref. No. A0011921W001

[0104] In some examples, processing circuitry 350 determines the patient risk level based on a risk score. As an example, processing circuitry 350 may determine a risk score based on the transmission data and / or additional patient data, such as EHR data 594. Processing circuitry may compare the risk score to one or more thresholds, e.g., a high threshold, an intermediate threshold, and a low threshold, to determine whether the risk is high, low, or intermediate. In some examples, the one or more thresholds may be patient specific. As an example, for a patient that is relatively healthy, a risk level for a transmission associated with AF may be lower than for a patient that is relatively unhealthy. Therefore, the relatively healthy patient, the high threshold and / or intermediate threshold value may be set higher than for the relatively unhealthy patient.

[0105] Based on a comparison of the patient risk level to one or more criteria, processing circuitry 350 may select a transmission power configuration of a plurality of transmission power configurations (606). The plurality of transmission power configurations may include, for example, transmission powers within a range of -50 dBm through 10 dBm, such as -20 dBm, -10 dBm, and 5 dBm. In some examples, processing circuitry 350 may compare the risk level to one or more of a high risk criterion, an intermediate risk criterion, or a low risk criterion. In some examples, if the patient risk level is high, processing circuitry 350 may determine the patient risk level meets the high transmission power criterion. If the patient risk level is intermediate, processing circuitry 350 may determine the patient risk level meets the intermediate transmission power criterion, and if the patient risk level is low, processing circuitry 350 may determine the patient risk level meets the low transmission power criterion. In some examples, processing circuitry 350 selects a relatively high transmission power within the range of transmission powers, e.g., 5 dBm, when the patient risk level meets the high risk criterion. Processing circuitry 350 may select a relatively low transmission power within the range of transmission powers, e.g., -10 dBm, when the patient risk level meets the low risk criterion, and processing circuitry 350 may select an intermediate transmission power within the range of transmission powers, e.g., -20 dBm, when the patient risk level meets the intermediate risk criterion.

[0106] Based on one or more of the patient risk level or one or more previous communication sessions, processing circuitry 350 selects a PHY layer configuration of a plurality of PHY layer configurations (608). In some examples, the plurality of PHY layerAtty Ref. No. A0011921W001 configurations include a nominal range PHY layer configuration, e.g., a 1 Megabyte PHY or a 2 Megabyte PHY, and a long range PHY layer configuration, e.g., an S=2 Coded PHY or an S=8 coded PHY. In some examples, the plurality of PHY layer configurations may include a nominal range PHY layer configuration, e.g., the 1 Megabyte PHY, an intermediate range PHY layer configuration, e.g., the 2 Megabyte PHY, and a long range PHY layer configuration, e.g., a Coded PHY. In examples in which the plurality of PHY layer configurations includes the long range PHY layer configuration and the nominal range PHY layer configuration, processing circuitry 350 selects the long range PHY for patient risk levels meeting the high risk criterion. Processing circuitry 350 may select the long range PHY for patient risk levels meeting the intermediate risk level criterion, or processing circuitry 350 may select the nominal range PHY. In some examples, processing circuitry 350 may initially select the nominal range PHY and may switch to the long range PHY if communication circuitry 360 doesn’t establish a connection within a threshold period of time or within a threshold number of attempts using the nominal range PHY.

[0107] In some examples, processing circuitry 350 may additionally or alternatively select the PHY layer configuration based on previous communication sessions. As an example, if one or more previous communication sessions using the nominal range PHY layer configuration were successful, processing circuitry 350 may select the nominal range PHY layer configuration. As another example, if communication circuitry 360 has never successfully established a connection using the long range PHY layer configuration, processing circuitry 350 may select the nominal range PHY layer configuration.

[0108] In some examples, processing circuitry 350 cycles through each PHY layer configuration of the plurality of PHY layer configurations. In some examples, processing circuitry initially selects a first PHY layer configuration, e.g., the nominal range PHY layer configuration, and switches to a second PHY layer configuration, e.g., the long range PHY layer configuration, after a threshold period of time, e.g., 5 seconds, or after a threshold number of attempts to connect using the first PHY layer configuration.

[0109] Processing circuitry 350 controls communication circuitry 360 to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection with a computing device, e.g., computing device 12 (608). If communication circuitry 360 successfully establishes a connection with computing device 12 (“YES” of 610), e.g., if communication circuitry 360 successfullyAtty Ref. No. A0011921W001 establishes a connection within a threshold period of time or within a threshold number of attempts, processing circuitry 350 controls communication circuitry 360 to transmit data, e.g., an emergency alert, a message, physiological data, and / or device status data, to computing device 12 using the selected transmission power configuration and the selected PHY layer configuration (612). If communication circuitry 360 does not successfully establish the connection with computing device 12 (“NO” of 610), processing circuitry 350 determines to dynamically switch one or more of the transmission power configuration or the PHY layer configuration (614). Processing circuitry 350 controls communication circuitry 360 to broadcast advertisements using the one or more of the dynamically switched transmission power configuration or the dynamically switched PHY layer configuration to establish the connection (616).

[0110] In some examples, if communication circuitry 360 does not establish a connection, e.g., if communication circuitry 360 does not establish a connection within a threshold period of time, processing circuitry 350 may determine to switch to a non-RF based communication scheme, such as alerting patient 4 and / or a caregiver of patient 4 of the transmission and / or a need for patient 4 to move closer to a device to establish a connection. As an example, processing circuitry 350 may control IMD 10 to alert patient 4 via on-device haptics, e.g., vibration, and / or on-device audible alerts, e.g., audible alerts generated by a speaker or a piezoelectric and / or on-device light emission, e.g., a blinking light emitting diode (LED) visible through the skin of patient 4. Any of the alert types may be configured to use specific patterns to provide different messages. For example, the LED may blink using different patterns for low risk, intermediate risk, and high risk transmissions. In some examples, the blink patterns may be proprietary. In other examples, the blink patterns may be non-proprietary, such as LiFi. In some examples, the blink pattern may be generated by IMD 10 and observed via an external optical sensing system, such as CCTV, home monitoring cameras, or a custom wearable device. The external optical sensing system may then match the observed blinking pattern to one of a plurality of blink patterns, e.g., via a lookup table, to determine the type of transmission and / or health event associated with the transmission. The external optical sensing system may then generate local audible alerts, relay the alert to system owners, or otherwise raise local awareness of the transmission and / or a need for a connection to a device of environment 28. As another example, the on-device haptics may vibrate using different patterns toAtty Ref. No. A0011921W001 indicate whether patient 4 should go to a clinic, request EMS care, or to move toward a device, e.g., a patient smartphone, to facilitate a BLE communication session and transmission of the transmission data.[oni] In some examples, if communication circuitry 360 does not establish a connection, processing circuitry 350 may determine to switch to a longer range telemetry scheme and send a small transmission, such as a single bit indicator, including nonsensitive and non-secure information indicating that a telemetry session is requested and that patient 4 should take measures to enable the transmission to be offloaded to a device, e.g., patient computing devices 12 or another device of system 2. The longer range telemetry scheme may comprise a low power wide area network (LPWAN), such as LoRa or LoRaWAN, Zigbee, mesh networks, RFID technology, Bluetooth, SMS text message, 4G, 5G, or any other wireless communication protocols that could connect to one of loT devices 30 or integrated with a wearable device, such as patient computing device 12B.

[0112] FIG. 7 is a flow diagram illustrating an example operation for selecting transmission power and PHY layer configurations, in accordance with one or more techniques of this disclosure. Although the example of FIG. 7 will be described as being performed by processing circuitry 350 of HMD 10, the techniques are not so limited. The example operations of FIG. 7 may be additionally or alternatively be performed by, for example, one or more other devices of system 2 of FIG. 1. The example of FIG. 7 may be a specific example of the example operation of FIG. 6.

[0113] Processing circuitry 350 determines a patient risk level associated with a transmission (702). Processing circuitry 350 may determine the patient risk level by comparing one or more of the transmission data or other patient data, e.g., EHR data 594, to a lookup table. The lookup table may include a plurality of types of transmissions, such as transmissions corresponding to cardiac arrhythmias, e.g., SCA, VF, VT, and AF, as well as transmissions corresponding to device diagnostics and status updates. In some examples, processing circuitry 350 may determine the patient risk level by comparing a score associated with the transmission data to one or more thresholds, e.g., one or more of a high threshold, an intermediate threshold, or a low threshold.

[0114] Based on the patient risk level, processing circuitry 350 may select a transmission power of transmission power configurations 706. If processing circuitry 350 determines the patient risk level is low (“LOW” of 704), processing circuitry 350 selectsAtty Ref. No. A0011921W001 nominal transmission power 712, e.g., -20 dBm. If processing circuitry 350 determines the patient risk level is intermediate (“INTERMEDIATE” of 704), processing circuitry 350 selects intermediation transmission power 710, e.g., -10 dBm. If processing circuitry 350 determines the patient risk level is high (“HIGH” of 704), processing circuitry 350 selects maximum transmission power 708, e.g., 5 dBm. Additionally, or alternatively, processing circuitry 350 selects a PHY layer configuration of a plurality of PHY layer configurations 714. If one or more previous communication sessions were successful using the nominal range PHY layer configuration (“YES” of 716), processing circuitry 350 selects the nominal range PHY layer configuration, e.g., the 1 Megabyte or the 2 Megabyte PHY layer configuration (718). If the one or more previous communication sessions were not successful using the nominal range PHY layer configuration (“NO” of 716), processing circuitry 350 selects the long range PHY layer configuration, e.g., the S=2 Coded PHY layer configuration or the S=8 Coded PHY layer configuration (720). Processing circuitry 350 controls communication circuitry 360 to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection with a computing device, e.g., computing device 12 (722).

[0115] In some examples, processing circuitry 350 may alternatively determine whether the one or more previous communication sessions were successful using the long range PHY layer configuration instead of determining whether the one or more previous communication sessions were successful using the nominal range PHY layer configuration. Processing circuitry 350 may select the long range PHY layer configuration if the one or more previous communication sessions were successful using the long range PHY layer configuration and may select the nominal range PHY layer configuration if the one or more previous communication sessions were unsuccessful using the long range PHY layer configuration.

[0116] FIG. 8 is a flow diagram illustrating another example operation for selecting transmission power and PHY layer configurations, in accordance with one or more techniques of this disclosure. Although the example of FIG. 8 will be described as being performed by processing circuitry 350 of HMD 10, the techniques are not so limited. The example operations of FIG. 8 may be additionally or alternatively be performed by, for example, one or more other devices of system 2 of FIG. 1. The example operation of FIG. 8 may be a specific example of the example operation of FIG. 6.Atty Ref. No. A0011921W001

[0117] Processing circuitry 350 determines a patient risk level associated with a transmission (802). Based on the patient risk level, processing circuitry 350 may select a transmission power of transmission power configurations 806. If processing circuitry 350 determines the patient risk level is low (“LOW” of 804), processing circuitry 350 selects nominal transmission power 812, e.g., -20 dBm. If processing circuitry 350 determines the patient risk level is intermediate (“INTERMEDIATE” of 804), processing circuitry 350 selects intermediation transmission power 810, e.g., -10 dBm. If processing circuitry 350 determines the patient risk level is high (“HIGH” of 804), processing circuitry 350 selects maximum transmission power 808, e.g., 5 dBm. Additionally, or alternatively, processing circuitry 350 selects a PHY layer configuration of a plurality of PHY layer configurations 814.

[0118] Processing circuitry 350 may select the long range PHY layer configuration, e.g., the S=2 or S=8 Coded PHY layer configuration, based on the selection of the maximum transmission power configuration and / or based on the determination that the patient risk level is high (816). Processing circuitry 350 may select the nominal range PHY layer configuration, e.g., the 1 Megabyte or 2 Megabyte PHY layer configuration, based on the selection of the nominal transmission power and / or based on the determination that the patient risk level is low (820). If the patient risk level is intermediate and / or the transmission power level is elevated, processing circuitry 350 may determine whether one or more previous communication sessions were successful using the nominal range PHY layer configuration. If the one or more previous communication sessions were successful using the nominal range PHY layer configuration (“YES” of 818), processing circuitry 350 may select the nominal range PHY layer configuration (824). If the one or more previous communication sessions were not successful using the nominal range PHY layer configuration (“NO” of 818), processing circuitry 350 may select the long range PHY layer configuration (822). Processing circuitry 350 controls communication circuitry 360 to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection with a computing device, e.g., computing device 12.

[0119] In some examples, processing circuitry 350 may alternatively determine whether the one or more previous communication sessions were successful using the long range PHY layer configuration instead of determining whether the one or more previousAtty Ref. No. A0011921W001 communication sessions were successful using the nominal range PHY layer configuration. Processing circuitry 350 may select the long range PHY layer configuration if the one or more previous communication sessions were successful using the long range PHY layer configuration and may select the nominal range PHY layer configuration if the one or more previous communication sessions were unsuccessful using the long range PHY layer configuration.

[0120] Example 1. A medical device comprising: communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; and processing circuitry configured to: determine a patient risk level associated with a transmission; based on the patient risk level meeting a criterion, dynamically select a transmission power configuration of the plurality of transmission power configurations; based on one or more of the risk level or a result of one or more previous communication sessions, dynamically select a PHY layer configuration of the plurality of PHY layer configurations; control the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, control the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.

[0121] Example 2. The medical device of example 1, wherein the patient risk level associated with the transmission from a plurality of patient risk levels, wherein the plurality of patient risk levels comprises: a low risk level; an intermediate risk level; and a high risk level.

[0122] Example 3. The medical device of example 2, wherein the high risk level corresponds to a potentially lethal acute health event.

[0123] Example 4. The medical device of example 3, wherein the potentially lethal acute health event comprises one or more of: a sudden cardiac arrest event; a ventricular tachycardia event; or a premature ventricular contraction event.

[0124] Example 5. The medical device of any of examples 1^1, wherein to determine the patient risk level associated with the transmission, the processing circuitry isAtty Ref. No. A0011921W001 configured to: compare the transmission to template transmissions in a look up table; and based on the comparison, determine the patient risk level.

[0125] Example 6. The medical device of any of examples 1-5, wherein the plurality of PHY layer configurations comprises two or more of a 1 Megabit PHY layer configuration; a 2 Megabit PHY layer configuration; or a coded PHY layer configuration.

[0126] Example 7. The medical device of any of examples 1-6, wherein to select the PHY layer configuration based on the one or more previous communication sessions, the processing circuitry is configured to: determine one or more of: which PHY layer configuration of the plurality of PHY layer configurations was used in one or more previous successful attempts to establish a connection; or which PHY layer configuration of the plurality of PHY layer configurations was used in one or more previous failed attempts to establish a connection.

[0127] Example 8. The medical device of any of examples 1-7, wherein the data comprises one or more of: patient data; or an emergency alert.

[0128] Example 9. The medical device of any of examples 1-8, wherein the patient data comprises one or more of: cardiac electrogram (EGM) signal data; optical signal data; accelerometer signal data; or bioimpedance signal data.

[0129] Example 10. The medical device of any of examples 1-9, wherein in response to a determination that the connection has not been established using the selected transmission power configuration and the selected PHY layer configuration, the processing circuitry is configured to: dynamically switch one or more of the transmission power configuration or the PHY layer configuration; and control the communication circuitry to transmit data to the computing device using the one or more of the switched transmission power configuration or the switched PHY layer configuration.

[0130] Example 11. A method comprising: determining, by processing circuitry of a medical device, a patient risk level associated with a transmission, wherein the medical device comprising communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; dynamically selecting, by the processing circuitry and based on the patient risk level meeting a criterion, a transmission power configuration of the plurality of transmission power configurations of a protocol for wireless communication; dynamically selecting, by theAtty Ref. No. A0011921W001 processing circuitry and based on one or more of the risk level or a result of one or more previous communication sessions, a PHY layer configuration of the plurality of PHY layer configurations; controlling, by the processing circuitry, the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and controlling, by the processing circuitry and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.

[0131] Example 12. The method of example 11, wherein the patient risk level associated with the transmission from a plurality of patient risk levels, wherein the plurality of patient risk levels comprises: a low risk level; an intermediate risk level; and a high risk level.

[0132] Example 13. The method of example 12, wherein the high risk level corresponds to a potentially lethal acute health event.

[0133] Example 14. The method of example 13, wherein the potentially lethal acute health event comprises one or more of: a sudden cardiac arrest event; a ventricular tachycardia event; or a premature ventricular contraction event.

[0134] Example 15. The method of any of examples 11-14, wherein determining the patient risk level associated with the transmission comprises: comparing, by the processing circuitry, the transmission to template transmissions in a look up table; and determining, by the processing circuitry and based on the comparison, the patient risk level.

[0135] Example 16. The method of any of examples 11-15, wherein the plurality of PHY layer configurations comprises two or more of: a 1 Megabit PHY layer configuration; a 2 Megabit PHY layer configuration; or a coded PHY layer configuration.

[0136] Example 17. The method of any of examples 11-16, wherein selecting the PHY layer configuration based on the one or more previous communication sessions comprises: determining, by the processing circuitry, one or more of: which PHY layer configuration of the plurality of PHY layer configurations was used in one or more previous successful attempts to establish a connection; or which PHY layer configurationAtty Ref. No. A0011921W001 of the plurality of PHY layer configurations was used in one or more previous failed attempts to establish a connection.

[0137] Example 18. The method of any of examples 11-17, wherein the data comprises one or more of: patient data; or an emergency alert.

[0138] Example 19. The method of any of examples 11-18, wherein the patient data comprises one or more of: cardiac electrogram (EGM) signal data; optical signal data; accelerometer signal data; or bioimpedance signal data.

[0139] Example 20. The method of any of examples 11-19, wherein in response to determining, by the processing circuitry, that the connection has not been established using the selected transmission power configuration and the selected PHY layer configuration, the method further comprises: dynamically switching, by the processing circuitry, one or more of the transmission power configuration or the PHY layer configuration; and controlling, by the processing circuitry, the communication circuitry to transmit data to the computing device using the one or more of the switched transmission power configuration or the switched PHY layer configuration.

[0140] Example 21. A non-transitory computer-readable medium storing instructions that when executed cause processing circuitry to: determine a patient risk level associated with a transmission, wherein the medical device comprising communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; based on the patient risk level meeting a criterion, dynamically select a transmission power configuration of the plurality of transmission power configurations; based on one or more of the risk level or a result of one or more previous communication sessions, dynamically select a PHY layer configuration of the plurality of PHY layer configurations; control the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, control the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.Atty Ref. No. A0011921W001

[0141] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

Atty Ref. No. A0011921W001WHAT IS CLAIMED IS:

1. A medical device comprising: communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; and processing circuitry configured to: determine a patient risk level associated with a transmission; based on the patient risk level meeting a criterion, dynamically select a transmission power configuration of the plurality of transmission power configurations; based on one or more of the risk level or a result of one or more previous communication sessions, dynamically select a PHY layer configuration of the plurality of PHY layer configurations; control the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, control the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.

2. The medical device of claim 1, wherein the patient risk level associated with the transmission from a plurality of patient risk levels, wherein the plurality of patient risk levels comprises: a low risk level; an intermediate risk level; and a high risk level.

3. The medical device of claim 2, wherein the high risk level corresponds to a potentially lethal acute health event.Atty Ref. No. A0011921W0014. The medical device of claim 3, wherein the potentially lethal acute health event comprises one or more of: a sudden cardiac arrest event; a ventricular tachycardia event; or a premature ventricular contraction event.

5. The medical device of any of claims 1-4, wherein to determine the patient risk level associated with the transmission, the processing circuitry is configured to: compare the transmission to template transmissions in a look up table; and based on the comparison, determine the patient risk level.

6. The medical device of any of claims 1-4, wherein to determine the patient risk level associated with the transmission, the processing circuitry is configured to: determine a risk score based on the transmission data; and compare the risk score to one or more thresholds.

7. The medical device of claim 6, wherein the one or more thresholds comprise one or more patient specific thresholds.

8. The medical device of any of claims 1-7, wherein the plurality of PHY layer configurations comprises two or more of: a 1 Megabit PHY layer configuration; a 2 Megabit PHY layer configuration; or a coded PHY layer configuration.

9. The medical device of any of claims 1-8, wherein the plurality of transmission power configurations comprises a plurality of transmission power configurations ranging from -50 dBm to 10 dBm.

10. The medical device of any of claims 1-9, wherein to select the PHY layer configuration based on the one or more previous communication sessions, the processing circuitry is configured to:Atty Ref. No. A0011921W001 determine one or more of: which PHY layer configuration of the plurality of PHY layer configurations was used in one or more previous successful attempts to establish a connection; or which PHY layer configuration of the plurality of PHY layer configurations was used in one or more previous failed attempts to establish a connection.

11. The medical device of any of claims 1-10, wherein the data comprises one or more of: patient data; or an emergency alert.

12. The medical device of any of claims 1-11, wherein the patient data comprises one or more of: cardiac electrogram (EGM) signal data; optical signal data; accelerometer signal data; or bioimpedance signal data.

13. The medical device of any of claims 1-12, wherein in response to a determination that the connection has not been established using the selected transmission power configuration and the selected PHY layer configuration, the processing circuitry is configured to: dynamically switch one or more of the transmission power configuration or the PHY layer configuration; and control the communication circuitry to transmit data to the computing device using the one or more of the switched transmission power configuration or the switched PHY layer configuration.Atty Ref. No. A0011921W00114. A non-transitory computer-readable medium storing instructions that when executed cause processing circuitry to: determine a patient risk level associated with a transmission, wherein the medical device comprising communication circuitry configured for wireless communication according to a protocol that comprises a plurality of transmission power configurations and a plurality of physical (PHY) layer configurations; based on the patient risk level meeting a criterion, dynamically select a transmission power configuration of the plurality of transmission power configurations; based on one or more of the risk level or a result of one or more previous communication sessions, dynamically select a PHY layer configuration of the plurality of PHY layer configurations; control the communication circuitry to broadcast advertisements using the selected transmission power configuration and the selected PHY layer configuration to establish a connection according to the protocol; and in response to a determination that the connection has been established with a computing device using the selected transmission power configuration and the selected PHY layer configuration, control the communication circuitry to transmit data to the computing device using the selected transmission power configuration and the selected PHY layer configuration.

Images