Low energy bluetooth programmer instruction class

Abstract

A system and method of ambulatory medical devices including an inductive link, a radio frequency (RF) link, and control circuitry are disclosed. The inductive link includes a coil antenna configured to receive a near field communication signal using mutual inductance. The RF link includes an RF antenna configured to receive an RF communication signal during a communication session. The control circuitry is configured to decode an instruction received in the RF communication signal, wherein a class of the instruction requires, upon execution of the instruction, initiating the communication session using the inductive link; execute the instruction when the communication session is initiated using the inductive link, and reject the instruction when the communication session is initiated using the RF link.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 555,625, filed February 20, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This document generally relates to medical devices, and more specifically to systems, methods and apparatus for wireless communication between medical devices. Background Technology

[0004] Ambulatory medical devices (AMDs) (including implantable, subcutaneous, wearable, or one or more other medical devices) can monitor, detect, or treat a variety of conditions, among others, including heart failure (HF), fibrillation, and myocardial infarction. AMDs can be used to treat patients with electrotherapy or other therapies, or to assist physicians or caregivers in diagnosing patients through internal monitoring of their condition. Devices may include one or more electrodes communicating with one or more sensing amplifiers to monitor electrical activity in the patient's heart, and typically include one or more sensors to monitor one or more other internal patient parameters. Patient treatment can be adjusted by changing parameters related to the detection of the patient's condition and the therapy provided by the device. Patient status can be monitored by uploading diagnostic information from the device. Summary of the Invention

[0005] Systems and methods for mobile medical devices (AMDs) with near-field telemetry links and far-field telemetry links are disclosed.

[0006] In the first example (Example 1), AMD includes an inductive link comprising a coil antenna configured to receive near-field communication signals using mutual inductance; a radio frequency (RF) link comprising an RF antenna configured to receive RF communication signals during a communication session; and control circuitry configured to decode instructions received in the RF communication signals. The instructions may be a class of instructions requiring the inductive link to be used to initiate the communication session when the instructions are executed. The control circuitry executes such instructions when the communication session is initiated using the inductive link, and refuses to execute such instructions when the communication session is initiated using the RF link.

[0007] In Example 2, the subject matter according to Example 1 may optionally include control circuitry configured to decode another instruction received in another RF communication signal during another communication session, wherein the class of the other instruction does not require the communication session to be initiated using the inductive link when the instruction is executed, and the other instruction is executed when the communication session is initiated using the RF link or the inductive link.

[0008] In Example 3, the subject matter described in one or both of Examples 1 and 2 may optionally include control circuitry configured to authenticate the role of the second device transmitting the RF communication signal, to reject the instruction based on the role of the second device, and to execute the instruction when the communication session is initiated using the RF link.

[0009] In Example 4, the subject matter described according to one or any combination of Examples 1-3 may optionally include control circuitry configured to determine that the instruction received in the RF communication signal is a programming instruction for programming one or more operating parameters of the AMD, execute the programming instruction when the communication session is initiated using the inductive link, and reject the programming instruction when the communication session is initiated using the RF link.

[0010] In Example 5, the subject matter according to one or any combination of Examples 1-4 may optionally include therapeutic circuitry operatively coupled to the control circuitry and configured to provide electrotherapy, and control circuitry configured to determine that the instruction received in the RF communication signal is a programming instruction for programming values ​​of therapeutic parameters of the electrotherapy provided by the AMD, execute the programming instruction when the communication session is initiated using the inductive link, and reject the programming instruction when the communication session is initiated using the RF link.

[0011] In Example 6, the subject matter according to one or any combination of Examples 1-5 may optionally include control circuitry configured to determine that the instruction received in the RF communication signal is an upload instruction for uploading an amount of information stored in the AMD greater than a predetermined threshold amount, execute the upload instruction when the communication session is initiated using the inductive link, and reject the upload instruction when the communication session is initiated using the RF link.

[0012] In Example 7, the subject matter according to one or any combination of Examples 1-6 may optionally include control circuitry configured to determine that the instruction received in the RF communication signal is an instruction that, when executed, causes the duration of the communication session to exceed a predetermined threshold time amount, execute the instruction when the communication session is initiated using the inductive link, and reject the instruction when the communication session is initiated using the RF link.

[0013] In Example 8, the subject matter described according to one or any combination of Examples 1-7 may optionally include control circuitry configured to determine that the instruction received in the RF communication signal is an update instruction to update firmware in the AMD, execute the update instruction when the communication session is initiated using the inductive link, and reject the update instruction when the communication session is initiated using the RF link.

[0014] In Example 9, the subject matter described according to one or any combination of Examples 1-8 may optionally include control circuitry, which includes a timeout timer and is configured to begin executing the instructions when the communication session is initiated using the inductive link, detect an interruption of the RF communication signal on the RF link, and resume execution of the instructions when another near-field communication signal is received on the inductive link before the timeout timer expires.

[0015] In Example 10, the subject matter according to one or any combination of Examples 1-9 may optionally include control circuitry configured to authenticate the role of the second device transmitting the RF communication signal, and to reject the instruction when the role of the second device is authenticated, and the instruction to program parameters included in a parameter configuration file for enabling programming based on the role of the second device.

[0016] In Example 11, the subject matter according to one or any combination of Examples 1-10 may optionally include control circuitry configured to authenticate the role of the second device transmitting the RF communication signal, and to execute the instructions when the communication session is initiated using the RF link and the role of the second device is authenticated.

[0017] In Example 12, the subject matter according to one or any combination of Examples 1-11 may optionally include control circuitry configured to execute the instructions when the communication session is initiated using the RF link, and the instructions enable a predetermined profile of the AMD's operating parameters.

[0018] Example 13 includes topics such as methods of operating an AMD to communicate with external devices, or may optionally be combined with one or any combination of Examples 1-10 to include such topics, including receiving instructions via the AMD's radio frequency (RF) communication link as part of a communication session with a second device, determining the class of the received instructions requiring the communication session to be initiated using the AMD's inductive link when the instructions are executed, executing the instructions when the communication session is initiated using the inductive link, and rejecting the instructions when the communication session is initiated using the RF link.

[0019] In Example 14, the subject matter according to Example 13 may optionally include receiving different instructions from the second device via the RF link, wherein the class of the different instructions does not require the communication session to be initiated using the inductive link when the instructions are executed; and the different instructions are executed by the AMD when the communication session is initiated using the RF link or the inductive link.

[0020] In Example 15, the role of the second device may be optionally included in the topics described in one or both of Examples 13 and 14, and when the communication session is initiated using the RF link, the instruction may be rejected and executed based on the role of the second device.

[0021] In Example 16, the subject matter described according to one or any combination of Examples 13-15 may optionally include determining that the instruction received via the RF link is a programming instruction for programming one or more operating parameters of the AMD, and requesting the inductive link to initiate the communication session to execute the programming instruction.

[0022] In Example 17, the subject matter described according to one or any combination of Examples 13-16 may optionally include determining that the instruction received via the RF link is a programming instruction for programming values ​​of therapeutic parameters of an electrotherapy provided by the AMD, and requesting the inductive link to initiate the communication session to execute the programming instruction.

[0023] In Example 18, the subject matter of one or any combination of Examples 11-15 may optionally include determining that the instruction received via the RF link is an upload instruction for uploading an amount of information stored in the AMD that is greater than a predetermined threshold amount, and requesting that the communication session be initiated using the inductive link to execute the upload instruction.

[0024] Example 19 includes a subject (such as an external medical device) or may optionally be combined with one or any combination of Examples 1-18 to include such a subject, including an inductive link comprising a coil antenna configured to use mutual inductance to transmit near-field communication signals to the AMD; an RF link comprising an RF antenna configured to transmit RF communication signals with the AMD; and control circuitry operatively coupled to the inductive link and the RF link. The control circuitry is configured to initiate a communication session with the AMD using the inductive link when a first type of instruction is sent to the AMD, to initiate the communication session with the AMD using the RF link when a second type of instruction is sent to the AMD, and to send authentication information to the AMD during the communication session to authenticate the external medical device.

[0025] In Example 20, the subject matter of claim 19 may optionally include control circuitry configured to initiate a communication session with the AMD using the near-field communication signal when sending programming instructions to program one or more operating parameters of the AMD.

[0026] These non-limiting examples can be combined in any arrangement or combination. This summary is intended to provide an overview of the subject matter of this patent application. It is not intended to provide a unique or exhaustive interpretation of this disclosure. The detailed description is included to provide further information about this patent application. Other aspects of this disclosure will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the accompanying drawings, which form a part of it, and each of the drawings should not be construed as limiting. Attached Figure Description

[0027] In accompanying drawings that are not necessarily drawn to scale, the same numbers may describe similar parts in different views. The same numbers with different letter suffixes may represent different instances of similar parts. The accompanying drawings illustrate various embodiments discussed in this document by way of example and not by way of limitation.

[0028] Figure 1 This is an example of a patient management system.

[0029] Figure 2 This is an example of a mobile medical device (AMD).

[0030] Figure 3 This is a block diagram of some examples from AMD.

[0031] Figure 4 This is a block diagram showing some examples of external devices included in a patient management system.

[0032] Figure 5This is a flowchart illustrating an example of a method for operating AMD's communication link. Detailed Implementation

[0033] Mobile medical devices (AMDs) include implantable, subcutaneous, insertable, wearable, or one or more other medical devices. An AMD may include or be configured to receive physiological information from one or more sensors located within, on, or near the patient's body. Among other things, the patient's physiological information may include respiratory information (e.g., respiratory rate, respiratory volume (tidal volume), cardiac acceleration information (e.g., cardiac vibration information, pressure waveform information, heart sound information, endocardial acceleration information, acceleration information, activity information, posture information, etc.); impedance information; electrocardiographic information; body activity information (e.g., activity, steps, etc.); posture or position information; pressure information; plethysmography information; chemical information; temperature information; or other physiological information of the patient. Among other things, the inventors have recognized devices, systems, and methods for providing customizable wireless telemetry links to transfer information between the AMD and individual devices.

[0034] Figure 1 An example patient management system 100 and a portion of the environment in which the patient management system 100 may operate are illustrated. The patient management system 100 can perform a range of activities, including remote patient monitoring and disease condition diagnosis. These activities can be performed in proximity to the patient 101, such as in the patient's home or office, via a central server such as in a hospital, clinic, or doctor's office, or via a remote workstation such as a secure wireless mobile computing device.

[0035] The patient management system 100 may include one or more medical devices, an external system 105, and a communication link 111 providing communication between the one or more mobile medical devices and the external system 105. The one or more medical devices may include mobile medical devices (AMDs), such as implantable medical devices (IMDs) 102, insertable cardiac monitors (ICMs), wearable medical devices 103, or one or more other implantable, leadless, subcutaneous, external, wearable, or medical devices configured to monitor, sense, or detect information from the patient 101, determine physiological information about the patient 101, or provide one or more therapies to treat various conditions of the patient 101, such as one or more cardiac or non-cardiac conditions (e.g., dehydration, sleep apnea, etc.).

[0036] In the example, Figure 1The IMD 102 may include one or more cardiac rhythm management devices implanted in the patient's chest, having a lead system comprising one or more transvenous, subcutaneous, or non-invasive leads or catheters to position one or more electrodes or other sensors (e.g., heart sound sensors) within, on, or around the heart, or in one or more other locations in the patient's chest, abdomen, or neck. In another example, the IMD 102 may include, for example, a monitor subcutaneously implanted in the patient's chest. The IMD 102 includes a housing containing a circuitry system and, in some examples, includes one or more sensors, such as temperature sensors.

[0037] Cardiac rhythm management devices (such as insertable cardiac monitors, pacemakers, defibrillators, or cardiac resynchronizers) include implantable or subcutaneous devices with a sealed housing configured to be implanted in a patient's chest. A cardiac rhythm management device may include one or more leads for positioning one or more electrodes or other sensors at or near various locations within or near the heart, such as one or more atria or ventricles of the heart. Thus, a cardiac rhythm management device may include an aspect located subcutaneously but distal to the patient's skin, and an aspect located near one or more organs of the patient, such as leads or electrodes. Separately from or in addition to the one or more electrodes or other sensors in the leads, a cardiac rhythm management device may include one or more electrodes or other sensors (e.g., pressure sensors, accelerometers, gyroscopes, microphones, etc.) powered by a power source within the cardiac rhythm management device. The one or more electrodes or other sensors in the leads, the cardiac rhythm management device, or a combination thereof may be configured to detect physiological information from the patient or to provide the patient with one or more therapies or stimuli.

[0038] Implantable devices may include, additionally or separately, leadless cardiac pacemakers (LCPs), small (e.g., smaller than conventional implantable rhythm management devices, approximately 1 cc in some examples), or standalone devices comprising one or more sensors, circuitry, or electrodes configured to monitor physiological information from the heart (e.g., heart rate), detect cardiac-associated physiological conditions (e.g., tachycardia), or deliver one or more therapies or stimuli to the heart without the complications associated with conventional leaded or implantable rhythm management devices (e.g., required incisions and pockets, complications associated with lead placement, breakage, or migration, etc.). In some examples, leadless pacemakers may have more limited power and processing capabilities than conventional rhythm management devices; however, multiple leadless pacemakers may be implanted within or around the heart to detect physiological information from one or more chambers of the heart, or to deliver one or more therapies or stimuli to them. Multiple leadless pacemakers may communicate with each other or with one or more other implantable or external devices.

[0039] IMD 102 may include assessment circuitry configured to detect or determine specific physiological information of patient 101, or to determine one or more conditions, or to provide information or alerts to users such as patient 101 (e.g., a patient), clinicians, or one or more other caregivers or processes. The implantable medical device 102 may alternatively or additionally be configured as a therapeutic device, configured to treat one or more medical conditions of patient 101. Therapies may be delivered to patient 101 via a lead system and associated electrodes or using one or more other delivery mechanisms. Therapies may include delivering one or more medications to patient 101, such as using the implantable medical device 102 or one or more other mobile medical devices. In some examples, the therapy may include a cardiac reflex (CRT) for correcting asynchrony in patients with heart failure and improving their cardiac function. In other examples, the implantable medical device 102 may include a drug delivery system, such as a drug infusion pump, to deliver medication to the patient for managing arrhythmias or complications arising from arrhythmias, hypertension, hypotension, or one or more other physiological conditions. In other examples, the implantable medical device 102 may include one or more electrodes configured to stimulate the patient’s nervous system or to provide stimulation to the muscles of the patient’s airway, etc.

[0040] Wearable medical device 103 may include one or more wearable or external medical sensors or devices (e.g., automated external defibrillator (AED), Holter monitor, patch-based device, smartwatch, smart accessory, wrist or finger-worn medical device, such as finger-based photoplethysmography sensor, etc.).

[0041] External system 105 may include dedicated hardware / software systems, such as a medical device programmer, a remote server-based patient management system, or alternatively, a system defined primarily by software running on a standard personal computer. External system 105 may manage patient 101 via implantable medical device 102 or one or more other mobile medical devices connected to external system 105 via communication link 111. In other examples, IMD 102 may be connected to wearable medical device 103 via communication link 111, or wearable medical device 103 may be connected to external system 105. This may include, for example, programming IMD 102 to perform, acquire physiological data, perform at least one self-diagnostic test (such as for device operating status), analyze physiological data, or optionally deliver or adjust therapy for patient 101. Furthermore, external system 105 may send or receive information to or from IMD 102 or wearable medical device 103 via communication link 111. Examples of information may include: real-time or stored physiological data from patient 101; diagnostic data, such as detection of patient hydration status, hospitalization, and response to therapies delivered to patient 101; or device operating status (e.g., battery status, lead impedance, etc.) of implantable medical device 102 or wearable medical device 103. Communication link 111 may be an inductive telemetry link, a capacitive telemetry link, or a radio frequency (RF) telemetry link, or wireless telemetry based on standards such as Bluetooth Strong, Bluetooth Low Energy (BLE), or IEEE 602.11 Wireless Fidelity Wi-Fi interface. Other configurations and combinations of patient data source interfaces are also possible. For example, a medical device may include more than one type of communication link.

[0042] External system 105 may include an external device 106 located near one or more mobile medical devices, and a remote device 108 located relatively far from the one or more mobile medical devices, communicating with external device 106 via communication network 107. Examples of external device 106 include a medical device programmer that can monitor or program the AMD to make changes that may affect the patient; or simply monitor the device (such as a patient monitor) that only monitors the patient information collected by the AMD but cannot make changes to the device that may affect the patient. Remote device 108 may be configured to evaluate the collected patient or patient information and provide alarm notifications and other possible functions. In examples, remote device 108 may include a centralized server acting as a central hub for collecting data and analyzing from multiple different sources.

[0043] Information from multiple sources can be combined to determine and update individual patient statuses, or to adjust one or more alerts or determinations for one or more other patients. The server can be configured as a single, multiple, or distributed computing and processing system. Remote device 108 can receive data from multiple patients. This data can be collected by one or more mobile medical devices and other data acquisition sensors or devices associated with patient 101. The server may include storage devices to store data in a patient database. The server may include alarm analyzer circuitry to evaluate the collected data to determine if specific alarm conditions are met. The fulfillment of alarm conditions can trigger the generation of alarm notifications, for example, provided by one or more human-perceptible user interfaces. In some examples, alarm conditions may alternatively or additionally be evaluated by one or more mobile medical devices, such as implantable medical devices. By way of example, alarm notifications may include web page updates, telephone or pager calls, emails, SMS, text or "instant" messages, as well as messages to patients and direct notifications to emergency services and clinicians simultaneously. Other alarm notifications are also possible. The server may include alarm priority sorting circuitry configured to prioritize alarm notifications. For example, similarity metrics between physiological data associated with detected medical events and physiological data associated with historical alerts can be used to prioritize alerts for detected medical events.

[0044] Remote device 108 may additionally include one or more locally configured clients or remote clients securely connected to the server via communication network 107. Examples of clients may include personal desktop computers, laptops, mobile devices, or other computing devices. System users, such as clinicians or other qualified medical professionals, can use the clients to securely access stored patient data in a database on the server, and select and prioritize patients and alerts for healthcare provisioning. In addition to generating alert notifications, remote device 108, including the server and interconnected clients, can also implement follow-up protocols by sending follow-up requests to one or more mobile medical devices, or by sending messages or other communications as compliance notifications to patient 101 (e.g., the patient), clinicians, or authorized third parties.

[0045] The communication network 107 can provide wired or wireless interconnection. In this example, the communication network 107 can be based on the Transmission Control Protocol / Internet Protocol (TCP / IP) network communication standard, although other types or combinations of networking implementations are also possible. Similarly, other network topologies and arrangements are also possible.

[0046] One or both of the external device 106 or remote device 108 may output detected medical events to a system user, such as a patient or clinician, or to a process including, for example, an instance of a computer program executable in a microprocessor or other processor. In examples, this process may include automatically generating recommendations for antiarrhythmic therapy, or recommendations for further diagnostic tests or treatments. In examples, external device 106 or remote device 108 may include a corresponding display unit for displaying physiological or functional signals, or alarms, alerts, emergency calls, or other forms of warning to signal the detection of an arrhythmia. In some examples, external system 105 may include an external data processor configured to analyze physiological or functional signals received by one or more mobile medical devices and confirm or reject the detection of an arrhythmia. Computationally intensive algorithms, such as machine learning algorithms, may be implemented in the external data processor to retrospectively process data to detect arrhythmias.

[0047] One or more portions of the mobile medical device or external system 105 may be implemented using hardware, software, firmware, or a combination thereof. One or more portions of the mobile medical device or external system 105 may be implemented using dedicated circuitry, which may be constructed or configured to perform one or more functions, or may be implemented using general-purpose circuitry, which may be programmed or otherwise configured to perform one or more functions. Such general-purpose circuitry may include a microprocessor or a portion thereof, a microcontroller or a portion thereof, or programmable logic circuitry, memory circuitry, network interfaces, and various components for interconnecting these components. For example, a “comparator” may, among other things, include an electronic circuit comparator that may be constructed to perform a specific function of comparing two signals, or the comparator may be implemented as part of a general-purpose circuitry that may be driven by code instructing a portion of the general-purpose circuitry to perform a comparison between two signals. A “sensor” may include electronic circuitry configured to receive information and provide an electronic output representing such received information.

[0048] The system includes a therapeutic device 112, which can be configured to send or receive information from one or more of a mobile medical device or an external system 105 using a communication link 111. In this example, one or more mobile medical devices, an external device 106, or a remote device 108 can be configured to control one or more parameters of the therapeutic device 112. The external system 105 can allow programming of one or more mobile medical devices and can receive information acquired by the one or more mobile medical devices regarding one or more signals, such as those received via the communication link 111. The external system 105 may include a local external implantable medical device programmer. The external system 105 may include a remote patient management system, which can, for example, monitor patient status or adjust one or more therapies from a remote location.

[0049] Figure 2 An example of a mobile medical device as IMD 102 is shown. IMD 102 is electrically coupled to heart 110, such as via one or more leads, which are coupled to IMD 102 through one or more lead ports (such as first lead port 241, second lead port 242, or third lead port 243) in connector 202 of IMD 102. In the example, IMD 102 may include an antenna, such as in connector 202, which is configured to communicate with one or more electronic circuits in an external system and a hermetically sealed housing (CAN) 201. IMD 102 illustrates an example medical device (or medical device system) as described herein.

[0050] IMD 102 may be an implantable cardiac monitor (ICM), pacemaker, defibrillator, cardiac resynchronizer, or other subcutaneous IMD or cardiac rhythm management (CRM) device configured to be implanted in the chest of a subject, having one or more leads for positioning one or more electrodes or other sensors at or near various locations in or near the heart 110, such as in one or more of the atria or ventricles. Separate from or in addition to the one or more electrodes or other sensors in the leads, IMD 102 may also include one or more electrodes or other sensors (e.g., pressure sensors, accelerometers, gyroscopes, microphones, etc.) powered by a power source within IMD 102. The leads, IMD 102, or combinations thereof, or the one or more electrodes or other sensors, may be configured to detect physiological information from the patient or to deliver one or more therapies or stimuli to the patient.

[0051] IMD 102 may include one or more electronic circuits configured to sense one or more physiological signals, such as an electrogram or signal representing the mechanical function of the heart 110. In some examples, CAN 201 may be used as an electrode, such as for sensing or pulse delivery. For example, electrodes from one or more leads may be used with CAN 201, such as for unipolar sensing of an electrogram or for delivering one or more pacing pulses. Defibrillation electrodes (e.g., first defibrillation coil electrode 228, second defibrillation coil electrode 229, etc.) may be used with CAN 201 to deliver one or more cardioversion / defibrillation pulses.

[0052] In the example, IMD 102 can sense impedance, such as the impedance between electrodes on one or more leads or between CAN 201. IMD 102 can be configured to inject current between a pair of electrodes, sense the combined voltage between the same or different electrode pairs, and determine impedance, such as using Ohm's law. Impedance can be sensed in a bipolar configuration, where the same pair of electrodes can be used for both current injection and voltage sensing; in a tripolar configuration, where the electrode pair used for current injection and the electrode pair used for voltage sensing can share a common electrode; or in a quadrupole configuration, where the electrode used for current injection can be different from the electrode used for voltage sensing, and so on. In the example, IMD 102 can be configured to inject current between the electrodes on one or more of the first, second, third, or fourth leads 220, 225, 230, 235 and CAN 201, and sense the combined voltage between the same or different electrodes and CAN 201.

[0053] Figure 2 Example lead configurations include first, second, and third leads 220, 225, and 230 in conventional lead placements in the coronary veins 216 (e.g., the coronary sinus) above the right atrium (RA) 206, right ventricle (RV) 207, and left atrium (LA) 208 and left ventricle (LV) 209, respectively; and a fourth lead 235 located near the His bundle 211 in RV 207 between the AV knot 210 and the right and left bundle branches 212, 213 and Purkinje fibers 214, 215. Each lead can be configured to position one or more electrodes or other sensors at various locations in or near the heart 110 to detect physiological information or provide one or more therapies or stimulations.

[0054] The first lead 220 in RA 206 includes a first tip electrode 221 located at or near the distal end of the first lead 220 and a first ring electrode 222 located near the first tip electrode 221. The second lead 225 (dashed line) in RV 207 includes a second tip electrode 226 located at or near the distal end of the second lead 225 and a second ring electrode 227 located near the second tip electrode 226. The third lead 230 in the coronary vein 216 above LV 209 includes a third tip electrode 231 located at or near the distal end of the third lead 230, a third ring electrode 232 located near the third tip electrode 231, and two additional electrodes 233 and 234. The fourth lead 235 located near the His bundle 211 in RV 207 includes a fourth tip electrode 236 located at or near the distal end of the fourth lead 235 and a fourth ring electrode 237 located near the fourth tip electrode 236. Tip electrodes and loop electrodes may include pacing / sensing electrodes configured to sense electrical activity or provide pacing stimulation.

[0055] In addition to the tip electrode and the loop electrode, one or more leads may also include one or more defibrillation coil electrodes configured to sense electrical activity or provide cardioversion or defibrillation shock energy. For example, the second lead 225 includes a first defibrillation coil electrode 228 located near the distal end of the second lead 225 in RV 207 and a second defibrillation coil electrode 229 located at a distance from the distal end of the second lead 225, such as for placement in or near the superior vena cava (SVC) 217.

[0056] Different CRM devices include varying numbers of leads and lead placements. For example, some CRM devices are single-lead devices with one lead (e.g., RV only, RA only, etc.). Other CRM devices are multi-lead devices with two or more leads (e.g., RA and RV; RV and LV; RA, RV, and LV, etc.). CRM devices suitable for His bundle pacing typically use lead ports designated for LV or RV leads to deliver stimulation to the His bundle 211.

[0057] The IMD 102 is battery powered and can use a communication link (e.g.) Figure 1 Communication link 111 in the middle) and external devices (e.g. Figure 1The communication link provides data transmission from the IMD 102 to the external device. This may include, for example, transmitting real-time physiological data acquired by the IMD 102, retrieving physiological data acquired and stored in the IMD 102, retrieving therapy history data stored in the IMD 102, or retrieving data indicating the operational status of the IMD 102 (e.g., battery status and lead impedance). The communication link also provides data transmission from the external device to the IMD 102. This may include, for example, programming the IMD 102 to acquire physiological data, programming the IMD 102 to perform at least one self-diagnostic test (such as for device operational status), or programming the IMD to deliver one or more therapies. The communication link may include near-field communication links and far-field communication links.

[0058] Figure 3 This is a block diagram of an example section from an AMD device (such as any AMD device described herein). The communication link includes an inductive (near-field) link and an RF (far-field) link. The inductive link includes a coil antenna 340 and a near-field transceiver 342. The inductive link is configured to communicate with a second device (e.g., Figure 1 The external device 106 uses the mutual inductance of its coil antenna to receive and transmit near-field communication signals. The RF link includes an RF antenna 344 and an RF transceiver 350. Figure 2 In IMD 102, coil antenna 340 may be included in connector 202 or around the periphery of CAN 201. RF antenna 344 may be included in connector 202 of IMD 102.

[0059] and Figure 3 AMD communication external devices (e.g., Figure 1 The external device 106 may include one or both of an inductive link and an RF link. For the inductive link, energy can be transferred from the external device's coil antenna to the AMD's coil antenna 340 via mutual inductance linking the two coil antennas. Data is transmitted by sending data bits on the inductive link. For the RF link, the external device may use either Bluetooth Low Energy (BLE) or Wi-Fi to transmit data to the AMD.

[0060] AMD includes control circuitry 346. Control circuitry 346 can be implemented using an application-specific integrated circuit (ASIC) configured to perform one or more functions, or general-purpose circuitry programmed to perform functions. General-purpose circuitry may include, among other things, a microprocessor or a portion thereof, a microcontroller or a portion thereof, and programmable logic circuitry or a portion thereof. Control circuitry 346 controls the mode of the sensing link and the RF link (e.g., between transmitting and receiving). Control circuitry 346 also decodes instructions received via the sensing link and instructions received via the RF link.

[0061] Figure 4 It is an external system (e.g.) Figure 1 This is a block diagram of an example of an external device 406 included in an external system 105. External device 406 includes a storage device 418 and processing circuitry 416. In some examples, external device 406 includes a user interface 420. Processing circuitry 416 can be implemented using an ASIC configured to perform one or more functions or general-purpose circuitry programmed to perform those functions. Storage device 418 can be a memory integrated with processing circuitry 416 or a separate memory device. External device 406 includes an inductive link and an RF link for communicating information with another device. The inductive link includes a near-field transceiver 442 operatively coupled to an inductive coil antenna 440 and can use near-field inductive wireless signals to communicate with... Figure 3 The inductive link enables wireless information communication. The RF link includes an RF antenna 444 and an RF transceiver 450. Although disclosed herein as having both an inductive link and an RF link, in some examples, different types of external devices (such as monitoring-only devices, patient monitors, etc.) may include only an RF link (without an inductive link or its components). In contrast, a medical device programmer may include both an inductive link and an RF link, as described herein with respect to external device 406.

[0062] External device 406 can be used to program pacing therapy parameters and other information in the AMD and upload information stored in the AMD. For the inductive link, the coil antennas of external device 406 and the AMD are placed close to each other, such that energy generated in the coil antenna 440 of external device 406 creates energy in the coil antenna 440 of the AMD. The presence of energy at a predetermined time corresponds to a "1" bit, and the absence of energy at a predetermined time corresponds to a "0" bit. Thus, the inductive link is a serial communication link. Processing circuitry 415 may include a near-field protocol driver that defines the content and order of data bytes sent to the AMD and the content and order of data bytes received from the AMD. For the RF link, the external device can use the BLE protocol as described above to transmit data to the AMD. Processing circuitry 415 may include a far-field protocol driver that provides data to and receives data from the AMD according to the BLE protocol or Wi-Fi protocol.

[0063] A communication session between external device 406 and the AMD can be initiated using either an inductive link or an RF link. A communication session is typically initiated by external device 406 sending an interrogation message and AMD sending a response message. In some examples, communication is initiated using an inductive link and then switched to an RF link. External device 406 can send interrogation messages using the inductive link until a response message is received from the AMD on the inductive link. External device 406 can then optionally enable the far-field RF link for further communication with the AMD. This is particularly useful during the AMD implantation process, where the AMD is first identified using near-field telemetry and then communicated using far-field telemetry after identification. This allows near-field telemetry to wake the AMD, but far-field telemetry allows communication while the AMD is in a sterile area without requiring the coil antenna of the telemetry "stick" to enter the sterile field.

[0064] Initiating communication with the inductive link and then switching to the RF link also provides a level of security for communication with the AMD, since the external device 406 must be near the patient to initiate communication with the AMD. Unnecessary RF communication with the AMD can be prevented because unwanted devices may not include an inductive link or be too far away to initiate a communication session.

[0065] Different types of information can communicate between the AMD and external devices. Some information may be diagnostic information read from the IMD's memory. In the example, this type of information could be transmitted by a monitoring-only device or a medical device programmer with an RF link, an inductive link, or both. Some information may be instructions sent to the AMD that can affect the patient (e.g., patient treatment parameters). In the example, this type of information could be transmitted by a medical device programmer, rather than a monitoring-only device without an inductive link. Communication that may have a potential impact on the patient should have a higher level of security than communication that will not have a potential impact on the patient.

[0066] Figure 5 Is operating AMD (e.g.) Figure 3 AMD) to work with a second device (e.g. Figure 4A flowchart illustrating an example of a method 500 for communication with an external device 406 is provided. In method 500, different instructions received by the AMD have different classes. For example, instructions can be designated as Class A instructions and Class B instructions. Class A instructions can be instructions that may potentially affect the patient by altering the operation of the AMD or that substantially affect the AMD in a meaningful way. In the example, Class A instructions can be considered high-risk changes, including, among other things, programming changes that modify the AMD's firmware, operating parameters, or therapeutic parameters, or instructions that cause substantial changes to the operation of the AMD (these changes may affect the AMD's available lifetime (e.g., a lifetime impact greater than a threshold amount, etc.)). Class B instructions can be instructions that do not alter the operation of the AMD (e.g., instructions that only read data from the AMD) or instructions that do not affect the AMD's available lifetime beyond a threshold amount. For the patient's health, it may be desirable to send Class A instructions with a higher level of security than Class B instructions. The requirement to send Class A instructions during a communication session initiated via an inductive link provides a higher level of security for sending Class A instructions.

[0067] In the example, requiring the use of an inductive link to initiate the programming of Class A instructions ensures that programming is performed using a medical device programmer in a clinical setting. In some examples, this clinical setting may require clinician involvement and proximity to medical device resources when making changes that could affect patient safety or condition. Furthermore, the medical device programmer can monitor the patient's condition before and after programming changes, enabling it to trigger or suggest additional programming changes based on differences in the patient's condition before and after the changes.

[0068] In the example, changes before and after programming could include, among other things, assessing cardiac function (such as heart rate, rhythm, or cardiac performance), evaluating patient condition, analyzing AMD performance metrics, or the impact on the projected battery life of AMD. Requiring the use of medical device programmers to perform high-risk changes and conduct pre- and post-change assessments may require supervision to minimize potential risks to patient safety and AMD operation, thereby improving AMD treatment outcomes.

[0069] At block 505, as part of the communication session, AMD receives instructions from the second device via AMD's RF link. At block 510, AMD determines the class of the instructions and whether that class requires the instructions to be sent during a communication session initiated via an inductive link.

[0070] At block 515, if the instruction class requires the use of an inductive link to start a communication session, and the communication session is indeed started using an inductive link, then AMD executes the instruction. At block 520, if the instruction class requires the use of an inductive link to start a communication session, and the communication session is started using an RF link instead of an inductive link, then AMD refuses to execute the instruction.

[0071] If an instruction is rejected, AMD may send a message to the second device indicating that the instruction was rejected. In some examples, AMD may send a message to the second device that the communication session should be restarted using the inductive link. In some examples, AMD may not send a response to the second device when the instruction is rejected. When AMD determines that the instruction belongs to a class that does not require instruction transmission during a communication session initiated using an inductive link (e.g., a Class B instruction), AMD executes the instruction when initiating the communication session using either the inductive link or the RF link.

[0072] Security can be implemented for communication with AMD using external devices. These external devices can perform authentication on the user or remote device before allowing communication with AMD. The requirement for inductive links for certain instructions increases the level of authentication by AMD itself. This can be extended to other forms of authentication performed by AMD. For example, AMD firmware could require authentication of the programming device before executing Class A instructions.

[0073] Instructions requiring the use of an inductive link (e.g., Class A instructions) can be instructions that modify the operation of the AMD upon execution. An example of a Class A instruction is a programming instruction that programs one or more operating parameters of the AMD. The AMD may include a therapy circuit 358 that provides electrotherapy to a patient, and the programming instructions can change the values ​​of one or more therapy parameters of the therapy provided by the AMD to the patient. For example, the AMD may be an IMD (e.g., pacing therapy) that provides pacing therapy to a patient. Figure 2 In one example, the AMD may deliver high-energy defibrillation therapy to a patient, and in another example, the AMD may request instructions to program the defibrillation parameters during a communication session initiated via an inductive link. The therapy parameters may vary the energy or timing of the electrical therapy delivered to the patient, or they may be related to the detection of the patient's condition used to deliver the therapy (e.g., detecting arrhythmias). In yet another example, a Class A instruction may be an instruction for the AMD to perform diagnostic tests. These test instructions may cause the AMD to change operating parameters and monitor the results of these changes by monitoring the output of one or more sensors of the IMD.

[0074] In another example, a Class A instruction could be an update instruction for updating firmware in AMD. Back to... Figure 3AMD may include non-modifiable instructions 356 within AMD. These instructions may be part of an instruction-secure core executable by AMD. AMD also includes firmware instructions 354 stored in AMD's memory 352, which may be decoupled from or integrated with AMD's control circuitry 346. The control circuitry 346 executes the firmware instructions to perform the functions described for AMD. Updating AMD's firmware instructions 354 may be expected. AMD may execute instructions during a communication session initiated via an inductive link to load new or updated firmware into memory 352.

[0075] Other examples of Class A instructions may be those that do not directly affect the patient by altering the operation of the AMD but may impact the AMD's battery life. Communication with a separate device utilizes the AMD's battery power. Instructions involving longer communication sessions may be limited to communications initiated via an inductive link to prevent unnecessary RF communication sessions from negatively impacting the AMD's battery life. For example, a Class A instruction could be an upload instruction that uploads information stored in the AMD to a second device. When executing an instruction to upload AMD information exceeding a predetermined threshold amount, the AMD may require the upload instruction to be included in an inductive link-initiated communication session. This prevents long instructions from being executed without an inductive link. In variations, a Class A instruction can be any instruction that, when executed by the AMD, causes the communication session to last for an amount exceeding a predetermined threshold amount.

[0076] Some examples of Class B instructions that do not require initiation of communication with the sensing link include read-only instructions, such as instructions that only read AMD's programming parameters, or instructions that upload the results of diagnostic tests performed by AMD.

[0077] In some examples, AMD may also require authentication of the second device before executing Class A instructions. For instance, AMD may require the second device to prove its role as a medical device programmer capable of executing Class A instructions. To authenticate the second device, it may send a predetermined authentication key to AMD during a communication session. AMD uses the authentication key to verify the role of the second device and executes Class A instructions when the key verifies the role of the second device and a communication session is initiated via an inductive link. In some examples, one or more authentication keys are written into AMD's memory for instructions that AMD may use to authenticate other devices; these instructions may be Class A instructions, and the one or more keys are programmed during a communication session initiated via an inductive link.

[0078] Communication sessions between AMD and external devices may be interrupted, for example, due to noise, patient movement, etc. If the communication session includes Class A commands, it may be necessary to restart the communication session using an inductive link to maintain a higher level of security. In some examples, if AMD receives an inductive signal within a predetermined amount of time, the communication session can be maintained without a restart. For example, Figure 3 The AMD's control circuitry 346 may include a timeout timer 348. During a communication session, the second device may periodically send one or more special characters via the RF link to maintain alignment of data transmitted on the RF link, or to maintain communication while the AMD executes Class A instructions. If the AMD does not receive a special character within a specified amount of time after the last special character, the AMD may detect an interruption in RF communication. The AMD may interrupt instruction execution in response to the detection of an interruption in RF communication. The AMD may need to receive a near-field signal on the sensing link before resuming one or both of the communication session and instruction execution. If the timeout timer expires before the near-field signal is received, the AMD may request the start of a new communication session.

[0079] As described earlier in this article, if the instruction is sent during a communication session initiated with an inductive link, AMD executes the instruction of a specific class, and if the communication session is initiated with an RF link, it refuses to execute the instruction of that class.

[0080] Based on some examples, this requirement for an inductive link can be denied by a second device. Certain devices may be allowed to execute one or more Class A instructions using the RF link without initiating communication with the inductive link. For example, it might be desirable to use a remote server to update firmware for multiple AMD devices. Certain devices may be assigned roles with remote operation or developer privileges. These role privileges can allow the denied inductive link requirement. In another example, after a doctor is authenticated, they may be allowed to remotely execute Class A instructions. Authentication can be performed by a remote server, an external device located near the patient, or AMD.

[0081] To accept Class A commands from a second device without first receiving a near-field signal from the inductive link, AMD can authenticate the role and permissions of the second device. When AMD authenticates that the second device has the appropriate role (e.g., using an authentication key sent by the second device), AMD can reject the command based on the second device's role and execute the command when a communication session is initiated using the RF link. In some examples, AMD can authenticate the medical device programmer when the programmer sends the appropriate authentication key for its role. This is another method for authenticating the clinical presence of a programming device without using an inductive link.

[0082] Different programming profiles can be assigned to different roles. Profiles can be predefined, and each profile can include a specific subset of parameters for programmability. The roles of users or devices define the profiles that can be used for remote programming. These profiles can address scenarios that arise when using specific programming. For example, an "Ensure Pacing" profile allows users or devices with the appropriate roles or permissions to set the maximum pacing output. In some examples, profiles include predefined parameters that are set when an external device selects a profile. For example, an "Electrocautery" profile or an "MRI Mode" profile automatically sets specific operating parameters to support surgical or diagnostic needs. A "Disable Therapy" profile can be used in emergency or end-of-life care situations. An "AF Attack" profile can enable atrial fibrillation diagnosis to support the diagnosis of new-onset AF events in AF patients.

[0083] The examples of AMD described in this article provide a higher level of security when communicating with AMD using RF communication. Some classes of instructions provide convenience to patients and physicians only via RF, while others can be executed only when AMD performs a certain level of authentication, such as if, for example, an inductive communication link is used.

[0084] Various embodiments are illustrated in the accompanying drawings above. One or more features from one or more of these embodiments can be combined to form other embodiments. The method examples described herein may be at least partially implemented by a machine or computer. Some examples may include a computer-readable or machine-readable medium encoded with instructions operable to configure an electronic device or system to perform the methods described in the examples above. Implementations of this method may include code, such as microcode, assembly language code, high-level language code, or the like. Such code may include computer-readable instructions for performing various methods. The code may form part of a computer program product. Furthermore, the code may be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.

[0085] The term "transmission medium" includes any intangible medium capable of storing, encoding, or carrying machine-executable instructions, and includes digital or analog communication signals or other intangible media to facilitate communication of such software. A transmission medium is a machine-readable medium.

[0086] The detailed description above is intended to be illustrative and not restrictive. Therefore, the scope of this disclosure should be determined by reference to the appended claims and the full scope of their equivalents.

Claims

1. A mobile medical device (AMD), the device comprising: An inductive link, which includes a coil antenna configured to use mutual inductance to receive near-field communication signals; A radio frequency (RF) link, which includes an RF antenna configured to receive RF communication signals during a communication session; The control circuit is configured as follows: The received instruction in the RF communication signal is decoded, wherein the class of the instruction requires that the communication session be initiated using the inductive link when the instruction is executed; When the communication session is initiated using the inductive link, the instruction is executed; and When the communication session is initiated using the RF link, the instruction is rejected.

2. The AMD according to claim 1, wherein, The control circuit is configured as follows: Decoding another instruction received in another RF communication signal during another communication session, wherein the class of the other instruction does not require the communication session to be initiated using the inductive link when the instruction is executed; and When the communication session is initiated using the RF link or the inductive link, the other instructions are executed.

3. The AMD according to claim 1 or 2, wherein, The control circuit is configured as follows: The role of the second device that authenticates the transmission of the RF communication signal; and The instruction is rejected based on the role of the second device, and the instruction is executed when the communication session is initiated using the RF link.

4. The AMD according to any one of claims 1-3, wherein, The control circuit is configured as follows: The instruction received in the RF communication signal is determined to be a programming instruction that programs one or more operating parameters of the AMD; When the communication session is initiated using the inductive link, the programming instructions are executed; as well as When the communication session is initiated using the RF link, the programming instructions are rejected.

5. The AMD according to any one of claims 1-4, comprising: A therapeutic circuit, which is operatively coupled to the control circuit and configured to provide electrotherapy; as well as The control circuit is configured as follows: It is determined that the instruction received in the RF communication signal is a programming instruction for programming the values ​​of the therapeutic parameters of the electrotherapy provided by the AMD; When the communication session is initiated using the inductive link, the programming instructions are executed; as well as When the communication session is initiated using the RF link, the programming instructions are rejected.

6. The AMD according to any one of claims 1-5, wherein, The control circuit is configured as follows: It is determined that the instruction received in the RF communication signal is an upload instruction for uploading information stored in the AMD that exceeds a predetermined threshold amount; When the communication session is initiated using the inductive link, the upload command is executed; and When the communication session is initiated using the RF link, the upload command is rejected.

7. The AMD according to any one of claims 1-6, wherein, The control circuit is configured as follows: The instruction received in the RF communication signal is determined to be an instruction that, when executed, causes the duration of the communication session to exceed a predetermined threshold amount of time. The instruction is executed when the communication session is initiated using the inductive link; as well as When the communication session is initiated using the RF link, the instruction is rejected.

8. The AMD according to any one of claims 1-7, wherein, The control circuit is configured as follows: It was determined that the instruction received in the RF communication signal was an update instruction to update the firmware in the AMD. When the communication session is initiated using the inductive link, the update instruction is executed; as well as When the communication session is initiated using the RF link, the update instruction is rejected.

9. The AMD according to any one of claims 1-8, wherein, The control circuit includes a timeout timer and is configured to: When the communication session is initiated using the inductive link, the instructions begin to be executed; Detecting interruptions in RF communication signals on the RF link; and When another near-field communication signal is received on the sensing link before the timeout timer expires, the execution of the instruction resumes.

10. The AMD according to any one of claims 1-9, wherein, The control circuit is configured as follows: The role of the second device that authenticates the transmission of the RF communication signal; and When the role of the second device is authenticated, the instruction is rejected, and the instruction programs the parameters included in the parameter configuration file for enabling programming according to the role of the second device.

11. The AMD according to any one of claims 1-10, wherein, The control circuit is configured as follows: The role of the second device that authenticates the transmission of the RF communication signal; and The instruction is executed when the communication session is initiated using the RF link and the role of the second device is authenticated.

12. The AMD according to any one of claims 1-11, wherein, The control circuit is configured to execute the instruction when the communication session is initiated using the RF link, and the instruction enables a predetermined configuration file of the AMD's operating parameters.

13. A method of operating a mobile medical device (AMD) to communicate with an external device, the method comprising: As part of a communication session with the second device, instructions are received via the AMD's radio frequency (RF) communication link; The AMD determines that the class of the received instruction requires the inductive link of the AMD to be used to initiate the communication session when the instruction is executed; The instruction is executed when the communication session is initiated using the inductive link; as well as When the communication session is initiated using the RF link, the instruction is rejected.

14. The method of claim 13, comprising: Different instructions are received from the second device via the RF link, wherein the class of the different instructions does not require the use of the inductive link to initiate the communication session when executing the instructions; and When the communication session is initiated using the RF link or the inductive link, the different instructions are executed by the AMD.

15. The method according to claim 13 or 14, comprising: Authenticate the role of the second device; as well as When the communication session is initiated using the RF link, the instruction is rejected and executed according to the role of the second device.

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