Managing telemetry communication patterns for implantable devices

Abstract

Systems, devices, methods, and computer-readable storage media are provided that facilitate managing operations of an implantable medical device ("IMD") using multiple communication modes. The IMD is configured to operate in a disabled mode in which radio frequency (RF) telemetry communication is disabled or operate in a first advertisement mode using RF telemetry communication. The IMD receives a clinician session request from a clinician device via an inductive telemetry protocol while operating in the disabled mode or the first advertisement mode and transitions from operating in the disabled mode or the first advertisement mode to operating in a second advertisement mode based on receiving the clinician session request. In accordance with the second advertisement mode, the IMD can establish a clinician telemetry session with the clinician device using RF telemetry communication and a unique security mechanism that is facilitated by an identifier of the clinician device that is included in the clinician session request.

Description

[0001] This application is a divisional application of the invention patent application entitled "Managing the Telemetry Communication Mode of an Implantable Device", with an international filing date of April 4, 2017, international application number PCT / US2017 / 025821, and Chinese national phase application number 201780026418.1. Technical Field

[0002] This disclosure generally relates to implantable devices, and more specifically, to systems, apparatus, methods, and computer-readable storage media that facilitate the management of telemetry communication modes in implantable devices. Background Technology

[0003] Implantable medical devices (IMDs) are commonly used in modern healthcare to enhance patients' ability to lead healthy and fulfilling lives. For example, IMDs such as pacemakers, implantable cardioverter-defibrillators (ICDs), neurostimulators, and drug pumps can help manage a wide range of conditions, including but not limited to arrhythmias, diabetes, and Parkinson's disease. Patients and healthcare providers can monitor IMDs and assess a patient's current and historical physiological state to identify conditions and / or predict impending events.

[0004] The complexity of IMDs is constantly evolving to provide advanced computing and telemetry capabilities. One obstacle to realizing such highly functional devices is efficient power management. Specifically, many implantable devices operate with power supplies that have a limited lifespan and / or are non-rechargeable. Thus, once the implantable device is implanted in the body and the power supply's lifespan has been reached, it may be necessary to remove the implantable device. Another challenge associated with employing telemetry communication to wirelessly transmit information between the IMD and external devices involves data security. Therefore, it is desirable to have systems, apparatuses, methods, and computer-readable storage media that adopt and / or manage different communication modes to promote data security while providing efficient power consumption. Summary of the Invention

[0005] The following provides a brief overview of one or more examples to offer a basic understanding of them. This summary is not a comprehensive overview of the examples described herein. It is not intended to identify key or essential elements of the examples, nor is it intended to depict any scope of the examples or claims. Its sole purpose is to present some concepts of the examples in a simplified form as a prelude to the more detailed description that follows. It will also be understood that the detailed description may include additional or alternative examples beyond those described in the summary section.

[0006] Examples described herein include systems, apparatus, methods, and computer-readable storage media that facilitate the management of telemetry communication modes of implantable devices. In some examples, the implantable device is or includes an IMD. In other examples, the implantable device is or includes a device configured to interact with an IMD. In these examples, both the implantable device and the IMD are implanted in the patient's body.

[0007] In one embodiment, an IMD (Intended Physical Device) is provided. The IMD includes: a housing configured to be at least partially implanted in a patient. The IMD further includes: a memory coupled to the housing, the memory storing executable components; and a circuit system coupled to the housing and configured to perform at least one of acquiring sensory physiological data associated with the patient or delivering a treatment to the patient. The IMD further includes: a processor coupled to the housing, the processor executing the executable components stored in the memory. The executable components include at least: a communication component configured to facilitate telemetry communication between the implantable device and one or more external devices using a first telemetry communication protocol and a second telemetry communication protocol to convey data associated with at least one of the sensory physiological data or the treatment; and a communication mode management component configured to control the operation of the implantable device in different communication modes. The different communication modes include: a disabled mode configured to block telemetry communication between the implantable device and the one or more external devices according to the first telemetry communication protocol and enable telemetry communication between the implantable device and the one or more external devices according to the second telemetry communication protocol. The communication modes further include: a first notification mode configured to facilitate the establishment of a first type of telemetry communication session between the implanted device and the one or more external devices using the first telemetry communication protocol; and a second notification mode configured to facilitate the establishment of a second type of telemetry communication session between the implanted device and the one or more external devices using the first telemetry communication protocol.

[0008] In one implementation, a first type of telemetry communication session includes a monitoring telemetry session, wherein the implantable device and the one or more external devices are authorized to transmit a first data packet according to first communication parameters. A second type of telemetry communication session includes a clinician telemetry session, wherein the implantable device and the one or more external devices are authorized to transmit the first data packet and a second data packet according to second communication parameters that are less restrictive than the first communication parameters. In some examples, during a first notification mode, the communication component may transmit one or more first notification data packets at a first limited rate according to the first telemetry communication protocol, and during a second notification mode, the communication component may transmit one or more second notification data packets at a second limited rate faster than the first limited rate according to the first telemetry communication protocol.

[0009] In various implementations, the communication mode management component can be configured to switch the operation of the implantable device from the disabled mode or the first notification mode to the second notification mode based on a clinician session request received by the communication component from a clinician device in one or more external devices according to the second telemetry communication protocol, wherein the clinician session request includes a request to establish a second type of telemetry communication session with the implantable device using the first telemetry communication protocol. The clinician session request further includes an identifier of the clinician device that restricts the establishment of the second type of telemetry communication session between the implantable device and the clinician device.

[0010] The different communication modes may further include a clinician mode, wherein the communication component performs a second type of telemetry communication session between the implantable device and the clinician device using the first telemetry communication protocol, and wherein the communication mode management component may be configured to: switch the operation of the implantable device from the second notification mode to the clinician mode in response to establishing a second type of telemetry communication session between the implantable device and the clinician device based on an identifier included in the clinician session request of the clinician device. The different communication modes may further include a standby mode, wherein the communication component performs the second type of telemetry communication session between the implantable device and the clinician device with reduced functionality relative to the functionality used during the clinician mode, resulting in a reduction in power consumption of the implantable device during the standby mode relative to the power consumption in the clinician mode.

[0011] The additional example relates to a method for managing the operation of an implantable device using different communication modes. The method includes: facilitating telemetry communication between the implantable medical device, including a processor, and one or more external devices using a radio frequency telemetry communication protocol and a non-radio frequency telemetry communication protocol; and controlling the operation of the implantable medical device under different communication modes. The different communication modes include: a first notification mode configured to facilitate the establishment of a first type of telemetry communication session between the implantable medical device and the one or more external devices using the radio frequency telemetry communication protocol; and a second notification mode configured to facilitate the establishment of a second type of telemetry communication session between the implantable medical device and the clinician device using the radio frequency telemetry communication protocol based on a session initiation request received by the implantable medical device from a clinician device among the one or more external devices via the non-radio frequency telemetry communication protocol.

[0012] In one or more embodiments, the control includes: the implantable medical device transmitting one or more first notification data packets at a first limited rate according to the radio frequency telemetry communication protocol during a first notification mode; and the implantable medical transmitting device transmitting one or more second notification data packets at a second limited rate faster than the first limited rate according to the radio frequency telemetry communication protocol during a second notification mode. The control may further include: the implantable medical device operating in the disabled mode, or the implantable medical device operating in the first notification mode; and the implantable medical device switching from operating in the disabled mode or operating in the first notification mode to operating in the second notification mode based on a clinician session request received by the implantable medical device from a clinician device in one or more external devices according to the non-radio frequency telemetry communication protocol, wherein the clinician session request includes a request to establish a second type of telemetry communication session with the implantable medical device using the first telemetry communication protocol.

[0013] In another embodiment, the method includes: the implantable medical device switching from operating in the second notification mode to operating in the disabled mode based on the implantable medical device and the clinician device failing to establish a telemetry communication session of the second type within a defined time period, and determining that the use of the first telemetry communication protocol by the implantable device is undesirable or insecure based on a defined context of the implantable device. For example, the implantable device may determine that the use of the first telemetry communication protocol by the implantable device is undesirable or insecure based on at least one of the following: no implantation of the implantable medical device is detected, the magnetic imaging mode of the implantable medical device is enabled, or the remote monitoring function of the implantable medical device is disabled.

[0014] In one or more additional examples, a non-transitory computer-readable medium is provided comprising computer-executable instructions that, in response to execution, cause an implantable device including at least one processor to perform various operations. These operations include: operating in a disabled mode, including preventing the implantable device from performing telemetry communication using a radio frequency telemetry protocol; or operating in a first notification mode, including transmitting a first notification data packet at a first rate according to the radio frequency telemetry protocol. The operations further include: simultaneously operating in the disabled mode or the first notification mode, receiving a clinician session initiation request from a clinician device via an inductive telemetry protocol, the clinician session initiation request including an identifier of the clinician device; and, based on receiving the clinician session initiation request, transitioning from operation in the disabled mode or the first notification mode to operation in a second notification mode, the second notification mode including transmitting a second notification data packet at a second rate according to the radio frequency telemetry protocol.

[0015] In some implementations, the operation may further include: generating clinician session authorization information based on receiving the clinician session initiation request, wherein the authorization information includes a unique session identifier and at least one unique session key; and using the authorization information to facilitate the establishment of a clinician telemetry session with the clinician device.

[0016] In other examples, a system is disclosed comprising a first external device configured to perform telemetry communication sessions with other devices, and an implantable device. The implantable device is configured to: operate in a first notification mode, which includes facilitating the establishment of a first type of telemetry communication session between the implantable device and the first or second external device using a first telemetry communication protocol; and operate in a second notification mode, which includes facilitating the establishment of a second type of telemetry communication session between the implantable device and the first external device using the first telemetry communication protocol, wherein the implantable device is configured to operate in the second notification mode based on receiving a clinician session initiation request from the first device via the second telemetry communication protocol.

[0017] In one or more embodiments, the implantable device is further configured to: generate authorization information based on receiving the clinician session initiation request, wherein the authorization information includes a unique session identifier and at least one unique session key; and use the authorization information to establish a second type of telemetry communication session with the first external device. The implantable device is further configured to: operate again in the first notification mode based on the closure of the second type of telemetry communication with the first external device, and to prevent the authorization information from being used to establish a second type of telemetry communication session with the first external device at a later time based on the closure of the second type of telemetry communication session.

[0018] Other examples and various non-limiting examples, scenarios, and implementations are described in more detail below. The following description and drawings illustrate certain illustrative examples of the specification. However, these examples indicate only a few of the various ways in which the principles of this specification can be applied. Other advantages and novel features of the described examples will become apparent from the following detailed description of the specification when considered in conjunction with the accompanying drawings. Attached Figure Description

[0019] Figure 1 A schematic diagram of an example non-limiting medical device telemetry system configured to facilitate the management of telemetry communication modes for implantable devices, based on one or more examples described herein.

[0020] Figure 2 An example non-limiting state diagram of an implantable device based on one or more examples described herein is shown.

[0021] Figure 3Example non-limiting flowcharts illustrating methods for managing the operation of implanted devices in disabled mode, first notification mode, second notification mode, and monitoring session mode, based on one or more examples described herein.

[0022] Figure 4 Example non-limiting flowcharts illustrating methods for managing the operation of implantable devices in disabled mode, first notification mode, second notification mode, clinician mode, and standby mode, based on one or more examples described herein.

[0023] Figure 5 Another example non-limiting flowchart illustrates a method for facilitating the management of the operation of an implantable device in disabled mode, first notification mode, second notification mode, clinician mode, and standby mode, based on one or more examples described herein.

[0024] Figure 6 A block diagram of an example non-restrictive implantable device based on one or more examples described herein is shown.

[0025] Figure 7 A block diagram of an example non-limiting external monitoring device is shown, illustrating one or more examples described herein.

[0026] Figure 8 A block diagram of an example non-limiting external clinician device is shown, illustrating one or more examples as described herein.

[0027] Figure 9 A schematic diagram of another example of a non-limiting medical device telemetry system configured to facilitate the management of telemetry communication modes for implantable devices, based on one or more examples described herein.

[0028] Figures 10 to 12 A flowchart illustrating an example non-limiting method for managing telemetry communication patterns of an implanted device, based on one or more examples described herein.

[0029] Figure 13 A block diagram of an example non-restricted computer operable to facilitate the management of telemetry communication modes for implanted devices, based on one or more examples described herein. Detailed Implementation

[0030] The following detailed description is illustrative only and is not intended to limit the examples and / or their application or use. Furthermore, it is not intended to be limited by any information expressed or implied in the foregoing technical fields, background art, or summary of the invention, or in the detailed description.

[0031] One or more examples will now be described with reference to the accompanying drawings, wherein the same reference numerals throughout refer to the same elements. In the following description, various specific details are set forth for illustrative purposes in order to provide a more thorough understanding of the one or more examples. However, it will be apparent in various cases that the one or more examples can be practiced without these specific details.

[0032] Additionally, the following description refers to components that are “connected” and / or “coupled” to each other. As used herein, unless otherwise expressly stated, the terms “connected” and / or “coupled” mean that one component is directly or indirectly connected to another component (mechanically, electrically, wirelessly, inductively, or otherwise). Thus, although the accompanying drawings may depict exemplary arrangements of components, additional and / or intervening components may be present in one or more examples.

[0033] This subject matter discloses systems, apparatuses, methods, and computer-readable storage media that employ and / or manage different communication modes to promote data security while providing efficient power consumption. In various examples, systems, apparatuses, methods, and computer-readable storage media are provided to promote enhanced battery saving associated with telemetry operation of implantable devices by employing different communication operation modes, each associated with different battery consumption levels. The different battery consumption levels associated with these different communication modes are attributed to the activation of different types of telemetry hardware circuitry system components (e.g., radio frequency (RF) components and sensing components) of the implantable device, and the different activation levels of the corresponding telemetry hardware circuitry system components (e.g., different duty cycles for receiver and transmitter activation). Because the activation and deactivation of different telemetry hardware circuitry system components involve physical and electrical processes and components, the battery-saving techniques of this subject matter cannot be replicated or performed by humans. Furthermore, the battery-saving techniques of this subject matter provide substantial improvements in the field of implantable device telemetry operation while facilitating different types of telemetry communication performed by implantable devices. The disclosed systems, apparatuses, methods, and computer-readable storage media further provide substantial improvements in the field of telemetry security for implantable medical devices. Specifically, the systems, apparatus, methods, and computer-readable storage media of this subject facilitate enhanced security associated with establishing and executing telemetry sessions with implantable devices using RF-based telemetry communication technologies / protocols, which enable rapid (and high-power) bidirectional telemetry communication with the implantable device for data considered highly invasive or sensitive (e.g., programming data or waveform data associated with a clinician session).

[0034] Now refer to the attached diagram, Figure 1A schematic diagram of an example non-limiting medical device telemetry system 100 configured to facilitate the management of telemetry communication operating modes of an implantable device, according to one or more examples described herein, is shown. In the illustrated embodiment, the medical device telemetry system 100 includes an implantable device 104 implanted within a body 102, an external monitoring device 116, and an external clinician device 120. In some examples, the implantable device 104 is an IMD that can also be configured to facilitate one or more diagnostic or therapeutic functions relative to a patient's body 102. In other examples, the implantable device 104 is separate from the IMD (not shown in this embodiment), which is also implanted within the body 102 and communicatively and / or electrically coupled to the IMD. Still in another example, the implantable device 104 may include a medical device that can be implanted within or used outside the body to administer medical medications or treatments to the body, such as an insulin pump.

[0035] Examples of devices, apparatuses, and systems described herein may include one or more machine-executable components embedded within one or more machines (e.g., embedded in one or more computer-readable storage media associated with one or more machines). Such components, when executed by said one or more machines (e.g., processors, computers, computing devices, virtual machines, etc.), may enable said one or more machines to perform the described operations.

[0036] One or more examples of the medical device telemetry system 100 are described in conjunction with various telemetry communication operation modes for managing the implantable device 104, said telemetry communication operation modes being associated with performing telemetry communication with one or more external devices such as external monitoring device 116 and / or external clinician device 120. These external devices may include a variety of external device types, including but not limited to: tablet computers associated with patients or physicians, smartphones associated with patients or physicians, medical devices associated with patients or physicians, electronic devices in the patient's home or physician's office, off-the-shelf devices purchased in stores, etc.

[0037] Implantable device 104 can use wireless telemetry to exchange various types of information with external devices, including external monitoring device 116 and external clinician device 120. For example, using wireless telemetry, implantable device 104 can transmit information to external monitoring device 116 and / or external clinician device 120, including but not limited to sensed physiological or biometric data from body 102, diagnostic determinations based on sensed physiological or biometric data, treatment data associated with treatment delivered to the body, and / or performance data regarding the operation and performance of implantable device 104 (e.g., power level information, information about the strength of received signals, information about the frequency of received interrogation requests, remaining battery life, etc.). In some embodiments, implantable device 104 is an IMD configured to sense physiological or biometric data from body 102. The IMD can also provide treatment to body 102 and retain treatment information about the treatment provided. In other embodiments, implantable device 104 is associated with an IMD configured to sense physiological or biometric data or provide treatment to body 102.

[0038] In another example, external monitoring device 116 and / or external clinician device 120 may employ telemetry communication to read data captured by implantable device 104. For example, external monitoring device 116 and / or external clinician device 120 may read electrogram data captured by implantable device 104 or other physiological or biometric data sensed by implantable device 104. In another example, using wireless telemetry, external monitoring device 116 may send information or signals to implantable device 104 to program, configure, or reconfigure implantable device 104.

[0039] In the various examples, the implantable device 104, the external monitoring device 116, and / or the external clinician device 120 may communicate using commercially available RF-based communication protocols and technologies. By way of example, and not limitation, the communication protocols may include, but are not limited to, those described above. Low Energy (BLE), Near Field Communication (NFC), Wi-Fi protocol, RF4CE, WirelessHART, 6LoWPAN, Z-Wave, ANT, etc. It is desirable to use commercially available telemetry communication protocols for wireless communication between implantable devices and external devices (e.g., implantable device 104 and external monitoring device 116 or external clinician device 120) to facilitate wider availability of telemetry solutions. For example, many modern mobile devices such as smartphones and tablet PCs are configured to communicate using various publicly available telemetry protocols.

[0040] Implantable device 104, external monitoring device 116, and / or external clinician device 120 can communicate using commercially available and / or proprietary communication protocols and techniques involving non-RF-based wireless communication technologies. For example, in one or more examples, implantable device 104, external monitoring device 116, and / or external clinician device 120 are configured to communicate using electromagnetic induction-based wireless communication technologies. Inductive telemetry utilizes mutual inductance established between two closely placed coils. This type of telemetry is called inductive telemetry or near-field telemetry because the coils typically must be closely positioned to achieve inductively coupled communication. Example inductive wireless communication technologies utilize inductive coils in a first device (e.g., external clinician device 120) that, when energized by an external voltage source, generate an inductive field that can be used to transmit communication signals and / or charging signals to a second device (e.g., implantable device 104). The proximity required to use inductive telemetry protocols provides enhanced security and allows active IMDs to transmit and receive data from devices outside the patient's body. In other examples, the implantable device 104, the external monitoring device 116, and / or the external clinician device 120 may employ infrared (IR) based communication technology, ultrasound based communication technology, or microwave based communication technology.

[0041] In various exemplary examples, implantable device 104 can be configured to communicate different types of information with external monitoring device 116 and external clinician device 120. Specifically, implantable device 104 can establish a monitoring telemetry session 118 with external monitoring device 116 and a clinician telemetry session 122 with external clinician device 120. The nature, purpose, and type of information communicated between implantable device 104 and external monitoring device 116 during a monitoring session and between implantable device 104 and external clinician device 120 during a clinician session can vary. Typically, monitoring session 118 is used by implantable device 104 to communicate data captured and / or monitored by implantable device 104 during the lifetime of implantable device 104 (or since the last communication session) to an external monitoring device in the vicinity of implantable device 104 (e.g., within a few feet or in the same room). For example, the captured and monitored data may include physiological data associated with body 102 and captured by implantable device 104, treatment data associated with treatment provided to body 102 by implantable device 104, operational information associated with operation of implantable device 104, etc. Information received from implantable device 104 by external monitoring device 116 may be processed by external monitoring device 116 and / or may be relayed to server device (hereinafter referred to as...). Figure 9 (As shown and described as server device 904), and facilitates monitoring of the patient's health over time.

[0042] Conversely, clinician session 122 is typically used to facilitate more invasive and on-demand or real-time communication between implantable device 104 and external clinician device 120. Specifically, external clinician device 120 may include a device operated by the patient's caregiver or clinician. Clinician session 122 can be used during interactions between the patient and the patient's caregiver or clinician, such as during a scheduled visit, during a routine check-up, or during an emergency. Using external clinician device 120, caregivers or clinicians can establish a clinician session with implantable device 104 to program or reprogram the operating parameters of implantable device 104, command implantable device 104 to administer treatments to the body, send specific data captured by implantable device 104 to external clinician device 120 in real time, and send specific data associated with implantable device 104 that is only authorized for clinician use, etc.

[0043] In various exemplary examples, implantable device 104 can be configured to operate using different communication operating modes or states to facilitate different features and functions associated with monitoring sessions with external monitoring device 116 and clinician sessions with external clinician device 120 using commercially available RF-based telemetry communication technologies (e.g., BLE, etc.). For example, considering the different sensitivities of information transmitted between implantable device 104 and external clinician device 120 during a clinician session and between implantable device 104 and external monitoring device 116 during a monitoring session, implantable device 104 can employ different communication operating modes for the corresponding external sessions to facilitate different levels of telemetry security. These different communication operating modes can employ different telemetry communication technologies and protocols to facilitate different levels of telemetry security. Furthermore, these different communication operating modes can facilitate the activation and deactivation of different numbers of transmitters and / or receivers to facilitate different types of data communication (e.g., one-way communication, two-way communication, real-time communication, etc.) associated with the monitoring session and clinician session. Therefore, the power consumption associated with monitoring sessions and clinician sessions performed by the implantable device 104 has been optimized and / or reduced.

[0044] In addition to facilitating different safety levels and / or reducing power consumption associated with RF telemetry communication between implantable device 104 and external monitoring device 116, and between implantable device 104 and external clinician device 120, implantable device 104 can also be configured to employ different communication operation modes in examples where RF telemetry communication performed by implantable device 104 is not needed or is insecure. Implantable device 104 is further configured to operate using non-RF-based telemetry communication protocols to enable telemetry communication between implantable device 104 and external monitoring device 116, external clinician device 120, and / or another external device in these scenarios.

[0045] In one or more exemplary examples, the implantable device 104 may be configured to operate using a variety of different communication operation modes, including but not limited to: a disabled mode, a monitoring session mode, a first notification mode, a second notification mode, a standby mode, and / or a clinician session mode. In various examples, one or more of these different communication operation modes may facilitate different telemetry functions of the implantable device 104. For example, the disabled mode may be configured to ensure that the implantable device 104 does not perform RF-based telemetry communication in scenarios where RF-based communication is unnecessary, undesirable, or unsafe. However, during the disabled mode, the implantable device 104 may be configured to implement telemetry communication using non-RF-based telemetry communication technologies / protocols, such as inductively based telemetry communication technologies / protocols. The first notification mode may be configured to facilitate the establishment of a monitoring telemetry session 118 between the implantable device 104 and an external monitoring device 116 using an RF-based telemetry communication protocol (e.g., BLE). The first notification mode further restricts the establishment of a monitoring session with the implanted device 104 to one or more external monitoring devices that have been previously programmed to consider establishing a monitoring session with the implanted device 104. The monitoring session mode can be configured to support the execution of monitoring telemetry sessions established between the implanted device 104 and the external monitoring device 116 using an RF-based telemetry communication protocol.

[0046] The second notification mode can be configured to facilitate the establishment of a clinician telemetry session 122 between the implantable device 104 and an external clinician device 120 using an RF-based telemetry communication protocol. The second notification mode further restricts the establishment of a clinician session with the implantable device 104 to a single external clinician device with a current authorization to establish a clinician session with the implantable device 104. Authorization for a clinician session between the implantable device 104 and a specific external clinician device can be established when a specific external clinician device requests to establish a clinician session with the implantable device 104. This authorization is further cleared or otherwise invalidated when the clinician session is closed. The clinician session mode can be configured to support the execution of an external clinician telemetry communication session established between the implantable device 104 and the external clinician device 120 using an RF-based telemetry communication protocol. The standby mode can be configured to facilitate reduced power consumption associated with the execution of the clinician telemetry session during periods of reduced or suspended telemetry communication activity between the implantable device 104 and the external clinician device 120. In some implantations, instead of using a standby mode, the implantable device 104 is configured to remain in a clinician session mode but with modifications to its data transmission and / or reception to facilitate reduced power consumption. For example, the implantable device may remain in clinician session mode and prevent the transmission of real-time data to an external clinician device 120, while simultaneously enabling fast bidirectional communication between the implantable device 104 and the external clinician device. In addition to operating using the various telemetry communication operating modes described above, the implantable device 104 is further configured to intelligently determine, based on various limiting conditions, whether, how, and / or why the appropriate telemetry communication operating mode should be used during the lifetime of the implantable device 104.

[0047] By employing various communication operation modes to operate the implantable device 104, in one or more examples, the medical device telemetry system 100 can employ a more robust security mechanism (e.g., its implementation of programming the implantable device 104) associated with establishing a clinician session with the implantable device 104, compared to the security mechanisms associated with generating a monitoring session with the implantable device 104 using RF-based telemetry communication technologies / protocols. Additionally, the medical device telemetry system 100 can facilitate rapid, bidirectional, and secure communication of sensitive data during a clinician session. The medical device telemetry system 100 can also facilitate minimizing battery consumption during a clinician session by employing a standby mode. In examples where the implantable device is not operating in clinician session mode when external monitoring is enabled, the medical device telemetry system 100 can also occasionally facilitate minimizing battery use / consumption. Furthermore, in examples where monitoring sessions are conducted via a disabled mode and / or where telemetry communication with the implantable device 104 is unnecessary for the clinician session but still occurs via non-RF-based telemetry communication technologies, the medical device telemetry system 100 can facilitate minimizing battery consumption. The following is about... Figures 2 to 9 Additional details are provided for examples of telemetry communication operation modes and telemetry communication mode management techniques in this topic.

[0048] It should be understood that the implantable device 104 may include one or more devices, transducers, and / or circuits that can facilitate and disable telemetry communication according to one or more of the telemetry communication technologies described above. For example, the implantable device 104 may include an RF transmitter that converts electrical energy into a signal associated with the transmitted data packets. Additionally, the implantable device 104 may include one or more RF devices, transducers, and / or circuits that can facilitate the reception of information from one or more devices (e.g., external monitoring device 116, external clinician device 120, etc.). For example, the implantable device 104 may include an RF receiver that converts signals into electrical energy. The implantable device 104 may also include hardware, software, or a combination of hardware and software that can facilitate non-RF-based telemetry communication technologies and protocols. For example, the implantable device 104 may include an inductive antenna and associated circuitry that can facilitate the reception and interpretation of inductively based signals as well as the generation and transmission of inductively based signals.

[0049] In various examples, implantable device 104 may include any number of different types of implantable devices configured to communicate with external monitoring device 116, external clinician device 120, or another external device. In some examples, the specific size, shape, placement, and / or function of implantable device 104 may not be critical to the disclosure of this subject matter. In one embodiment, as mentioned, implantable device 104 is or includes an IMD. For example, some example IMDs may include, but are not limited to, pacemakers, defibrillators, cardiac resynchronization devices, cardiac monitoring devices, cardiac pressure monitoring devices, spinal cord stimulation devices, nerve stimulation devices, gastric stimulation devices, diabetes pumps, drug delivery devices, and / or any other medical device. In various examples, however, implantable device 104 may be or include any number of other types of implantable devices that are not IMDs.

[0050] For illustrative purposes, implantable device 104 is shown in medical device telemetry system 100 as an IMD implanted in a patient's chest and configured to provide medical therapies or treatments associated with cardiac disease or condition (e.g., implantable cardioverter defibrillator (ICD) and / or pacemaker). In addition to medical therapies, implantable device 104 may also be configured to provide the data packetization and communication operations described herein. Implantable device 104 includes a housing 106 that houses electrical components and one or more power sources. The electrical components may be powered via the one or more power sources. Power sources (not shown) may include, but are not limited to, batteries, capacitors, charge pumps, mechanically derived power sources (e.g., microelectromechanical systems (MEMS) devices), or sensing components. The examples described herein may provide improved power management associated with the one or more power sources.

[0051] The electrical components can vary depending on the specific features and functions of the implantable device 104. In various examples, these electrical components may include, but are not limited to, one or more processors, memories, transmitters, receivers, transceivers, sensors, sensing circuitry systems, therapeutic circuitry systems, antennas, and other components. In embodiments, the electrical components may be formed on or within a substrate disposed within the housing 106. The housing 106 may be formed of conductive materials, non-conductive materials, or combinations thereof. For example, the housing 106 may include conductive materials (such as metals or metal alloys), non-conductive materials (such as glass, plastics, ceramic lamps), or a combination of conductive and non-conductive materials. In some examples, the housing 106 may be a biocompatible housing (e.g., liquid crystal polymers, etc.).

[0052] In the illustrated embodiment, the implantable device 104 is also an IMD and further includes leads 110a, b connected to the housing 106. Leads 110a, b extend into the heart and each includes one or more electrodes. For example, as depicted in the medical device telemetry system 100, each lead 110a, b includes a corresponding tip electrode 112a, b and a loop electrode 114a, b positioned near the distal end of its corresponding lead 110a, b. In the implantation example, the tip electrode 112a, b and / or the loop electrode 114a, b are placed or positioned relative to or within selected tissue, muscle, nerve, or other location within the patient's body 102. As depicted in the medical device telemetry system 100, the tip electrode 112a, b is an extendable helical electrode to aid in securing the distal end of the lead 110a, b to a target location within the patient's body 102. In this manner, the tip electrode 112a, b is formed to define a fixation mechanism. In other examples, one or both of the tip electrodes 112a, b may be formed to define a fixation mechanism for other structures. In other cases, leads 110a, b may include a fixation mechanism separate from the tip electrodes 112a, b. The fixation mechanism can be of any suitable type, including gripping mechanisms, helical or threaded mechanisms, drug-coated attachment mechanisms (where the drug is used to reduce tissue infection and / or swelling), or other attachment mechanisms.

[0053] Leads 110a and b are connected to the proximal end of implantable device 104 via connector block 108. Connector block 108 may include one or more receivers interconnected with one or more connector terminals positioned on the proximal ends of leads 110a and b. Leads 110a and b are ultimately electrically connected to one or more electrical components within housing 106. One or more conductors (not shown) extend from connector block 108 along the length of the leads within leads 110a and b to engage annular electrodes 114a and b and tip electrodes 112a and b, respectively. In this manner, each of tip electrodes 112a and b and annular electrodes 114a and b is electrically coupled to a corresponding conductor within its associated lead body. For example, a first electrical conductor may extend from connector block 108 along the body length of lead 110a and be electrically coupled to tip electrode 112a, and a second electrical conductor may extend from connector block 108 along the body length of lead 110a and be electrically coupled to annular electrode 114a. Corresponding conductors can be electrically coupled to the circuitry of the implantable device 104, such as a treatment module or a sensing module, via connections in connector block 108. In one or more examples, the implantable device 104 can be configured to deliver treatment to the heart (or other location) via electrical conductors to one or more of electrodes 112a and 112b and 114a and 114b. In the case of pacing therapy, for example, the treatment circuitry within the implantable device 104 can generate pacing pulses and deliver them via a monopolar electrode configuration, for example, using electrodes 112a and 112b and the housing electrodes of the implantable device 104. In other cases, the treatment circuitry within the implantable device 104 can deliver pacing pulses via a bipolar electrode configuration, for example, using electrodes 112a and 112b and ring electrodes 114a and 114b. The treatment circuitry may include one or more pulse generators, capacitors, and / or other components capable of generating and / or storing energy for delivery as pacing therapy according to a pacing protocol stored in memory.

[0054] The implantable device 104 can also receive sensed electrical signals on the electrical conductors from one or more of electrodes 112a and 112b and 114a and 114b. The implantable device 104 can sense the electrical signals using a monopolar or bipolar electrode configuration. The sensing circuitry of the implantable device 104 can process the sensed electrical signals, and the implantable device 104 can analyze the processed and / or sensed electrical signals and provide pacing based on the sensed electrical signals. The sensing circuitry may include one or more sensing amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), or other analog or digital components.

[0055] The configuration, features, and functionality of the implantable device 104 are provided as examples only. In other examples, the implantable device 104 may include more or fewer leads extending from the housing 106. For example, the implantable device 104 may be coupled to three leads, such as a third lead implanted in the left ventricle of a patient's heart. In another example, the implantable device 104 may be coupled to a single lead implanted in the ventricle of a patient's heart. In other examples, the lead may be an extravascular lead with an electrode subcutaneously implanted above or below the sternum. Example extravascular ICDs with subcutaneous electrodes are described in U.S. Patent Publication No. 2014 / 0214104 (now U.S. Patent No. 9,072,914) (Greenhut et al.) and U.S. Patent Publication No. 2015 / 0133951 (Seifert et al.). An example extravascular ICD with a substernal electrode is described in U.S. Patent Publication No. 2014 / 0330327 (Thompson-Nauman et al.). In some examples, the implantable device 104 may include additional leads (e.g., atrial leads and / or left ventricular leads). Thus, the implantable device 104 can be used for single-chamber or multi-chamber rhythm management therapy. Each of the leads may include more or fewer electrodes in addition to more or fewer leads. In cases where the implantable device 104 is used for therapy rather than pacing (e.g., defibrillation or cardioversion), the leads may include elongated electrodes, which in some cases may be in the form of coils. The therapeutic circuitry of the implantable device 104 can generate a defibrillation or cardioversion shock and deliver the shock to the heart via any combination of the elongated electrodes and the housing electrodes. The treatment circuitry may include one or more high-voltage (HV) output capacitors and HV charging and discharging circuitry, the HV charging circuitry including one or more capacitors, resistors, sensors, transformers, switches, or other analog or digital components, and the discharging circuitry for delivering cardioversion or defibrillation treatment, including, for example, an H-bridge circuitry. In another embodiment, the implantable device 104 may include leads with multiple loop electrodes (e.g., as used in some implantable neurostimulators), without a tip electrode or with one of the loop electrodes serving as a "tip electrode".

[0056] In another embodiment, such as in the case of an intracardiac pacemaker or a leadless pressure sensor, the implantable device 104 may not include leads. In the case of an intracardiac pacemaker, the device may include a housing sized to fit entirely within the patient's heart. In one example, the housing may have a volume of less than 1.5 cc and more preferably less than 1.0 cubic centimeter (cc). However, in other examples, the housing may be greater than or equal to 1.5 cc. The intracardiac pacemaker includes at least two electrodes spaced apart along an outer portion of the housing for sensing cardiac electrogram signals and / or delivering pacing pulses. Example intracardiac pacemakers are described in commonly assigned U.S. Patent Publication No. 2012 / 0172690 (Anderson et al.), U.S. Patent Publication No. 2012 / 0172941 (now U.S. Patent No. 8,386,051) (Kenneth), and U.S. Patent Publication No. 2014 / 0214104 (now U.S. Patent No. 9,072,914) (Greenhut et al.). In the case of a leadless pressure sensor, the device may include a housing having a fixing member and a pressure sensing component. An example of a leadless pressure sensor is described in U.S. Patent Publication No. 2012 / 0108922 (now U.S. Patent No. 8,475,372) (Schell et al.).

[0057] External monitoring device 116 and / or external clinician device 120 may include any suitable computing device configured to communicate with implantable device 104. In some examples, external monitoring device 116 and / or external clinician device 120 may be external electronic devices. For example, external monitoring device 116 and / or external clinician device 120 may include, but are not limited to, handheld computing devices, mobile phones, smartphones, tablet PCs, portable computers, desktop computers, personal digital assistants (PDAs), and / or wearable devices. In some examples, external monitoring device 116 and / or external clinician device 120 may include a display capable of presenting information associated with implantable device 104. In another embodiment, external monitoring device 116 and / or external clinician device 120 may include applications and / or programs associated with implantable device 104. Still in yet another embodiment, one or more features and functions of external monitoring device 116 and external clinician device 120 may be provided on a single computing device. According to this embodiment, a single computing device may be configured to operate with external monitoring capabilities and external clinician capabilities depending on the context and application of the computing device.

[0058] Figure 2An example non-limiting state diagram 200 is shown for an implantable device (e.g., implantable device 104) according to one or more examples described herein. For the sake of brevity, repetitive descriptions of similar elements used in the corresponding examples described herein have been omitted.

[0059] State diagram 200 depicts six dedicated communication operation modes of implantable device 104, including disable mode 201, monitoring session mode 202, first notification mode 203, second notification mode 204, standby mode 205, and clinician session mode 206. Each of these different communication operation modes (or one or more in some examples) can facilitate different telemetry functions of the implantable device (e.g., implantable device 104).

[0060] For example, disable mode 201 could be an operating mode of an implantable device in which RF-based telemetry communication of the implantable device is disabled or blocked by deactivating the RF transmitter / receiver or transceiver of the implantable device. However, during disable mode, telemetry communication (e.g., sensing) via non-RF telemetry communication technologies of the implantable device 104 can be enabled, thereby allowing optional communication with the implantable device (e.g., typically using proprietary telemetry communication protocols or near-field communication protocols). Disable mode 201 can be configured to ensure that the implantable device does not perform RF-based telemetry communication in limited scenarios or situations where RF-based communication of the implantable device is unnecessary, desired, and / or insecure, thereby minimizing power consumption associated with activation of one or more RF components of the implantable device and minimizing the chance of unauthorized external devices attempting to communicate with the implantable device (e.g., read data from the implantable device or program the implantable device) using commercially available RF telemetry communication protocols (e.g., BLE). For example, an implantable device can be configured to operate in a disabled mode 201 before it is implanted in a patient, thereby reducing the power consumption associated with the activation of one or more RF components of the implantable device prior to implantation. Additionally, after the implantable device is implanted in a patient, disabled mode 201 can provide reduced power consumption associated with the activation of one or more RF components of the implantable device when RF telemetry is not needed or unsafe. For example, in one or more examples, if the patient is undergoing a medical procedure (e.g., a magnetic medical imaging procedure) that might be hindered if the RF components of the implantable device are activated, the implantable device can operate in disabled mode. In another example, in one or more examples, after implantation, if an authorized external device (e.g., external clinician device 120, external monitoring device 116, or another external device) is communicating with the implantable device using a non-RF-based telemetry communication protocol, the implantable device can operate in disabled mode 201. In yet another embodiment, after implantation, if the implantable device is not performing or facilitating a clinician session (e.g., with external clinician device 120) and if the implantable device is not scheduled to perform a monitoring session (e.g., with external monitoring device 116), the implantable device may operate using disabled mode 201.

[0061] The first notification mode 203 facilitates the establishment of a monitoring telemetry session between the implanted device and an external monitoring device. During the first notification mode 203, the implanted device can activate one or more RF components (e.g., an RF transmitter, RF receiver, or RF transceiver) according to a defined RF telemetry communication protocol (e.g., BLE) adopted by the implanted device for the first notification mode. The implanted device can further transmit one or more notification data packets according to the defined RF telemetry communication protocol and receive one or more responses to the notification data packets. The implanted device can further determine whether the one or more responses are received from an authorized external monitoring device (e.g., external monitoring device 116) and request the establishment of a defined monitoring session between the authorized external monitoring device and the implanted device. The implanted device can further communicate with the authorized external monitoring device to establish or create an authorized monitoring session.

[0062] Monitoring session mode 202 can support the execution of an external monitoring telemetry session established between the implantable device and an external monitoring device (e.g., external monitoring device 116). In one or more examples, during monitoring session mode 202, the implantable device performs RF telemetry communication with the authorized external monitoring device according to the defined communication parameters of the monitoring session. For example, the implantable device can send previously acquired physiological information about the patient to the external monitoring device. In another example, the implantable device can send operational performance information monitored by the implantable device to the external monitoring device.

[0063] The second notification mode 204 can be configured to facilitate the establishment of a clinician telemetry session between the implantable device and an external clinician device (e.g., external clinician device 120). During the second notification mode, the implantable device can activate one or more RF components (e.g., an RF transmitter, RF receiver, or RF transceiver) of the implantable device according to a defined RF telemetry communication protocol (e.g., BLE) adopted by the implantable device for the second notification mode. For example, the implantable device can further transmit one or more notification packets according to the defined RF telemetry communication protocol and receive one or more responses to the notification packets. The implantable device can further determine whether the one or more responses are received from an authorized external clinician device (e.g., external clinician device 120) and request the establishment of a defined clinician session between the authorized external clinician device and the implantable device. The implantable device can further communicate with the authorized external clinician device to establish or establish an authorized clinician session.

[0064] Clinician session mode 206 can support the execution of an external clinician telemetry communication session established between the implantable device and an external clinician device. For example, in one or more examples, during clinician session mode 206, the implantable device performs RF telemetry communication with an authorized external clinician device according to defined communication parameters of the clinician session. For example, the external clinician device can send programming or command information to the implantable device for application by the implantable device. In another example, the implantable device can send information requested by the external clinician device to the external clinician device. In one or more examples, during clinician session mode 206, the authorized external clinician device can command the implantable device to operate in a waveform mode, in which the implantable device sends waveform data (e.g., live waveform data) captured by the implantable device from the external clinician device.

[0065] Standby mode 205 can facilitate reduced power consumption associated with the execution of a clinician telemetry session during periods of reduced or suspended telemetry communication activity between the implantable device and an external clinician device. In one or more examples, during standby mode 205, the implantable device maintains a clinician session telemetry connection with the authorized external clinician device (e.g., connection 122) and reduces the amount of RF component activation and usage relative to the amount of RF components activated and used by the implantable device during clinician session mode 206. For example, in some examples, the implantable device may activate its transmitter to occasionally (e.g., every few seconds) send one or more idle packets with idle information to the external clinician device, the idle information informing the clinician device that the implantable device can be used to communicate with the clinician device according to parameters and protocols defined for the established external clinician telemetry session. After sending the one or more idle packets, the implantable device may activate its receiver for a defined duration (e.g., one second) to allow receiving a request from the clinician device to exit standby mode 205 and re-enter clinician session mode 206. Between transmissions of the one or more idle packets, the implantable device can operate in sleep mode, in which its receiver and transmitter are temporarily deactivated. In some implantations, instead of standby mode 205, the implantable device is configured to remain in clinician session mode 206 but with modifications to its data transmission and / or reception to facilitate reduced power consumption. For example, the implantable device can remain in clinician session mode 206 and prevent the transmission of real-time data to an external clinician device while enabling fast bidirectional communication between the implantable device and the external clinician device.

[0066] Implantable devices can switch between these corresponding communication operating modes throughout their lifespan. Implantable devices are typically configured to operate using only one of these six communication operating modes at a time; however, in some examples, they can operate simultaneously in two or more of these modes. Using different communication operating modes during implantable device operation can extend the device's power life, provide efficient telemetry communication of different types of information between the implantable device and one or more external devices, and enhance the security of telemetry communication of different types of information between the implantable device and one or more external devices.

[0067] The arrows connecting one communication mode to another identify the path an implantable device takes to switch between corresponding communication modes. Each number box associated with a corresponding arrow defines a transition event that allows the implantable device to switch from one communication mode to another in the direction of the arrow associated with that event.

[0068] First, referring to disabled mode 201, the implantable device in disabled mode 201 can typically be received by a clinician or other suitable healthcare professional or technician (e.g., from the manufacturer of the implantable device). According to one or more examples, the implantable device can be configured to perform telemetry communication using at least a first telemetry communication technology / protocol and a second telemetry communication technology / protocol, including at least one RF-based telemetry communication technology / protocol. For example, the implantable device can be configured to operate using inductively based telemetry communication technology / protocols and BLE technology / protocols, NFC technology / protocols, Wi-Fi technology / protocols, etc. In another example, the implantable device can be configured to operate using an acoustically based telemetry communication technology protocol and BLE technology / protocol. In yet another example, the implantable device can be configured to operate using an NFC technology protocol and BLE technology / protocol. For illustrative purposes, state diagram 200 is described, in which the implantable device employs BLE as the first telemetry communication method and inductively based telemetry communication as the second telemetry communication method.

[0069] In an example where the implanted device is operating in disabled mode 201, the implanted device can be configured to deactivate telemetry communication according to a first telemetry communication technology / protocol and activate or enable telemetry communication according to a second telemetry communication technology / protocol. For example, when in disabled mode 201, the implanted device can deactivate or disable the wireless adapter, RF transmitter, RF receiver, and / or RF transceiver used by the implanted device for telemetry communication using the first telemetry communication technology / protocol. However, during disabled mode 201, the implanted device can enable or activate the reception and / or transmission of telemetry signals based on induced current (e.g., via the implanted device's induction coil / antenna and associated circuitry).

[0070] The implantable device can be configured to remain in disabled mode 201 during and / or when transition event 214 occurs, said transition event including a situation where the implantable device indicates that using RF telemetry communication by the implantable device is unnecessary, undesirable, or unsafe. For example, in one embodiment, once in disabled mode 201, the implantable device can be configured to remain in disabled mode when and / or during a telemetry communication session established and executed using a second telemetry communication technology / protocol between the implantable device and an external device (e.g., external monitoring device 116, external clinician device 120, and / or another external device), referred to in state diagram 200 as Protocol-2 (Pro-2) session. The implantable device can also be configured to remain in disabled mode 201 if it detects that it is not implanted or is partially implanted in the patient. The implantable device can determine that the mechanism via which implantation is performed may vary based on the characteristics and functionality of the implantable device. In one implementation, in examples where the implantable device includes, for example, an ICD or a pacemaker, the implantable device can determine whether it is implanted or not primarily based on lead impedance measurements (e.g., leads 110a, b of implantable device 104). According to this implementation, the implantable device can capture lead impedance measurement results (e.g., on each pacing beat). If the implantable device is not yet implanted in the patient (e.g., when initially received from the manufacturer), no leads will be connected to the heart, and therefore the lead impedance measurement results will be higher. Once the atrial and right ventricular unipolar lead impedance measurements are within defined normal ranges, the implantable device assumes that it is connected to leads and implanted in the body. This determination can trigger the implantable device to begin recording diagnostic data.

[0071] The implantable device can also be configured to activate magnetic resonance imaging (MRI) mode—such as the MRI SureScan offered in commercially available MRI conditioners from Medtronic (PLC). TMThe mode—remaining in disabled mode 201 during and / or at times—is as used herein. As used herein, an “MRI” mode refers to an operating mode of the implantable device that facilitates the performance of magnetic imaging (e.g., magnetic resonance imaging (MRI)) of a patient with the implanted device without causing physical harm to the patient or the implantable device. For example, if one or more RF components of the implantable device are activated during an MRI procedure, the magnetic and RF energy of the MRI machine may affect the RF components in the implantable device. The MRI mode is also referred to herein as a magnetic imaging mode. In embodiments where the MRI mode is enabled, the one or more RF components of the implantable device (e.g., transmitters and / or receivers) may be deactivated to prevent undesired interaction between the device’s RF components and the MRI machine. In various implementations, when the implantable device 104 is in disabled mode 201 and other modes (e.g., monitoring session mode 202, clinician session mode 206, etc.), the MRI mode may be enabled and disabled by an external device (e.g., external clinician device 120 or another external device) by providing an MRI mode enable or disable signal to the implantable device using a first telemetry communication technology / protocol or a second telemetry communication protocol / technology. In some examples, the implantable device may be configured to automatically remain in a disabled mode or enter a disabled mode from another mode based on the detection of the presence of an MRI device (e.g., a large static magnetic field). In various examples, the implantable device may be configured to enter disabled mode 201 from another communication mode when the MRI mode is activated. Furthermore, once in disabled mode 201, the implantable device may be configured to remain in disabled mode if the remote monitoring function of the implantable device is disabled. The remote monitoring function of the implantable device refers to programmable conditions of the implantable device. If the implantable device will be used to perform a monitoring telemetry session in conjunction with an external monitoring device (e.g., external monitoring device 116), the implantable device may be programmed to be 'external monitoring enabled'. If the implantable device will not be used in conjunction with an external monitoring device, the implantable device may be programmed to be 'external monitoring disabled'. This is typically a one-time programming action and may or may not change over time in various examples. In one or more examples, programming the implantable device to an external monitoring enabled mode or an external monitoring disabled mode may be performed via a wired or wireless telemetry communication protocol using an external clinician device (e.g., external clinician device 120).

[0072] The implanted device can be configured to transition from a disabled mode 201 to a first announcement mode 203 or a second announcement mode 204. During the first announcement mode 203 and the second announcement mode 204, the implanted device activates telemetry communication using a first telemetry communication technology / protocol. For example, in embodiments where the first telemetry communication technology / protocol is BLE or another RF technology, the implanted device can activate or enable its BLE wireless adapter, RF transmitter, RF receiver, and / or RF transceiver for performing telemetry. After activation, the implanted device's RF transmitter can then transmit announcement packets according to the defined announcement packet signaling parameters for the first announcement mode 203 and the second announcement mode 204. For example, according to various short-range communication protocols (e.g., BLE communication protocols) that can be used for RF telemetry communication between two devices, the implanted device can transmit announcement packets according to a defined schedule (e.g., every few seconds, every minute, every three minutes, etc.) or in response to a triggering event. As used herein, in some examples, the announcement signal or announcement packet may also include a beacon signal. Notification packets or signals may include information indicating that the implantable device is ready or available for communication with external devices. External devices (e.g., external monitoring device 116 and / or external clinician device 120) that actively employ a first telemetry communication technology / protocol (e.g., BLE) may be configured to detect or receive notification signals emitted by the implantable device. The receipt of a notification signal from the implantable device by an external device is referred to herein as a “discovery event.”

[0073] The implantable device can be configured to establish a telemetry communication session with an external device (e.g., external monitoring device 116, external clinician device 120, or another external device) in part based on receiving a notification data packet from the implantable device. For example, according to the BLE telemetry communication protocol, after the external device receives a notification data packet from the implantable device, the external device can send a connection request to the implantable device to establish a telemetry communication session with the implantable device. The implantable device can then respond to the connection request and establish a telemetry session with the external device.

[0074] In addition to establishing a telemetry session with an external device (e.g., external monitoring device 116, external clinician device 120, and / or another external device) based on an external device receiving a notification signal emitted by the implantable device, the implantable device can also be configured to establish a telemetry session with the external device based on determining that the external device is authorized to establish a telemetry session. Specifically, information communicated between the IMD and the external device using telemetry technology is often highly sensitive and private. Because commercially available telemetry protocols (e.g., BLE) are used to perform telemetry with the implantable device, knowledge about how to initiate and conduct a telemetry session with the implantable device can become publicly available. For example, in an embodiment where the implantable device uses BLE to perform telemetry, an unauthorized device can detect a notification signal emitted by the implantable device and attempt to establish a telemetry session with the implantable device. Therefore, the implantable device can be configured to employ one or more security mechanisms to determine that an external device that receives a notification data packet emitted by the implantable device (e.g., during the first notification mode 203 or the second notification mode 204) is authorized to establish a telemetry session with the implantable device.

[0075] In various examples, the implantable device may be configured to employ a first notification mode 203 to facilitate a first type of telemetry communication session with an external device (e.g., external monitoring device 116 and / or external clinician device 120) and a second notification mode 204 to facilitate a second type of telemetry communication session with an authorized device (e.g., external monitoring device 116 and / or external clinician device 120). The first type of telemetry communication session includes a monitoring session (identified as MS in state diagram 200), and the second type of telemetry communication session includes a clinician session (identified as CS in state diagram 200). The external device authorized to establish a monitoring session with the implantable device is referred to herein as the external monitoring device (e.g., external monitoring device 116), and the external device authorized to establish a clinician session with the implantable device is referred to herein as the external clinician device (e.g., external clinician device 120).

[0076] The nature, purpose, and type of information communicated between the implantable device and the external device during monitoring sessions and clinician sessions can vary. Specifically, data communication during a monitoring session can be more restrictive (e.g., read-only) than data communication during a clinician session (e.g., reading and programming). For example, according to one or more examples, the implantable device can establish and execute a monitoring session with an external monitoring device to transmit or report information monitored by the implantable device during implantation and manipulation within the patient. For example, the implantable device can be configured to capture (periodically, randomly, or otherwise) physiological information about a patient with the implantable device and transmit this physiological information to an external monitoring device (e.g., external monitoring device 116). The external monitoring device may include a device associated with the patient with the implantable device, carried by the patient, or otherwise periodically (e.g., throughout the day, at home, while the patient is sleeping, etc.) located within the wireless transmission range of the implantable device, such as a smartphone or tablet computer. The implantable device can be configured to establish a monitoring session once a day, several times a day, once an hour, once a week, or every other week in response to the detection of specific triggering physiological information, etc. Telemetry communication between the implanted device and the external monitoring device during a monitoring session primarily involves one-way communication from the implanted device to the external monitoring device. In many implementations, telemetry communication during a monitoring session rarely, if not at all, involves the implanted device receiving programming, configuration, or reconfiguration information from the external monitoring device.

[0077] Conversely, in the various examples, clinician sessions can be configured to facilitate rapid one-way or two-way communication between the implanted device and an external clinician device (e.g., external clinician device 120). For example, a clinician session can be initiated by a medical clinician or a caregiver authorized to care for a patient with an implanted device (e.g., a doctor, nurse, medical technician, mother, etc.) using an authorized external clinician device. Clinician sessions can be used in clinics, hospitals, or during private meetings between patients and medical clinicians to perform more complex, critical, or invasive data communications between the implanted device and the external clinician device compared to data communications associated with monitoring sessions. For example, in addition to reading or receiving data monitored by the implanted device, the clinician session can also be used by the external clinician device to send programming information (e.g., the frequency of physiological sensing, the dosage of therapeutic drugs supplied by the implanted device, etc.) to the implanted device for programming or reconfiguration of one or more operating parameters of the implanted device. In another example, a clinician session could be used to request an implantable device to capture certain types of data on demand and report the data to an external clinician device in real time (e.g., electrocardiogram waveform data). In yet another example, a clinician session could be used to request an implantable device to perform certain functions on demand (e.g., drug delivery, therapeutic applications, etc.).

[0078] As noted above, the first notification mode 203 can facilitate the establishment of a monitoring session between the implantable device and an external monitoring device (e.g., external monitoring device 116), and the second notification mode 204 can facilitate the establishment of a clinician session between the implantable device and an external clinician device (e.g., external clinician device 120). Considering the different information sensitivities conveyed between the implantable device and the external clinician device during a clinician session and between the implantable device and the external monitoring device during a monitoring session, the second notification mode 204 can be configured to employ higher security measures than those employed by the first notification mode 203. Based on the different security measures associated with the second notification mode 204 and the first notification mode 203, in various examples, the implantable device can establish a monitoring session with the authorized external monitoring device (e.g., external monitoring device 116) only according to the first notification mode 203 and a clinician session with the authorized external clinician device (e.g., external clinician device 120) according to the second notification mode 204.

[0079] Furthermore, the first notification mode 203 and the second notification mode 204 can be customized to employ different communication parameters and security measures to account for these differences in the types of telemetry communication sessions supported respectively. For example, the number, frequency, and / or timing of notification packets to be transmitted by the implanted device when operating under the first notification mode 203 and the second notification mode 204 can be customized to facilitate monitoring sessions and clinician sessions respectively. The information included in the various notification packets can also vary based on the application of the implanted device associated with the first notification mode 203 and the second notification mode 204. For example, in one embodiment, the notification packets in the second notification mode 204 are transmitted at a higher frequency than the notification packets in the first notification mode 203. For example, during the second notification mode, the implanted device can be configured to transmit notification packets at a rate of approximately one notification packet per second. Therefore, external devices (e.g., external clinician device 120) can quickly discover the implanted device and establish and / or re-establish (e.g., in response to unintentional loss) a telemetry session with the implanted device. Rapidly establishing and re-establishing telemetry sessions with the implantable device can improve the likelihood of efficient and consistent data transfer between the implantable device and external devices, a feature that is often more critical in clinician sessions than in monitoring sessions. On the other hand, during the first notification mode, the implantable device can transmit notification packets at a lower rate, such as one notification packet every three minutes. In some implementations, during the first notification mode, the implantable device can be configured to transmit notification packets only during specific time periods of the day. Therefore, the current consumption associated with transmitter and receiver activation related to transmitting notification signals and waiting for responses can be reduced and / or minimized.

[0080] In another embodiment, the implantable device can be configured to transmit notification packets associated with a “notification session.” According to this embodiment, a “notification session” involves the implantable device transmitting notification packets at a rate of N notification packets per M milliseconds (ms). For example, the notification rate in this embodiment may include 3 notification packets per 80 ms. With this embodiment, the implantable device can transmit notification packets at the same rate (e.g., 3 packets / 80 ms) during both a first notification mode and a second notification mode, but with different durations for the corresponding notification sessions. For example, the duration of a notification session during the first notification mode 203 may be much shorter (e.g., 480 ms) than the duration of a notification session used by the implantable device during the second notification mode 204 (e.g., 5 minutes). Additionally, during the first notification mode 203, the implantable device can be configured to perform notification sessions at a low frequency (e.g., once every three minutes) according to a defined protocol (e.g., at a rate of 3 packets / 80 ms over a duration of 480 ms). Conversely, in the various examples, the implantable device is configured to perform a notification session associated with operation in the second notification mode 204 only and immediately in response to entering the second notification mode (e.g., based on receiving a clinician session initiation request). The implantable device may be further configured to perform the notification session according to a defined protocol (e.g., at a rate of 3 packets / 80 ms) throughout the entire duration of operation of the implantable device in the second notification mode 204.

[0081] Referring back to state diagram 200, transition event 218 identifies several example transition events that can cause an implantable device to transition from disabled mode 201 to first announced mode 203. In one or more examples, the implantable device can be configured to transition from disabled mode 201 to first announced mode 203 in response to implantation detection, MRI mode timeout, or the end of a Protocol-2 telemetry session, and the satisfaction of subcondition 1. Subcondition 1 refers to a limiting context for the implantable device that makes it necessary, desirable, or safe for the implantable device to use a first type of telemetry communication protocol (e.g., an RF-based telemetry communication protocol). In one or more examples, for the implantable device to transition from disabled mode 201 to first announced mode 203, subcondition 1 may include three conditions that must be met in addition to the occurrence of one of the transition events identified by transition event 218. These three conditions include MRI mode being disabled, implantation being detected, and external monitoring being enabled. If subcondition 1 is not met, the implantable device may remain in disabled mode 201. For example, when in disabled mode 201 and the implantable device detects an implantation, the implantable device may remain in disabled mode if MRI is enabled or external monitoring is disabled. In another example, when in disabled mode 201 and the implantable device detects an MRI mode timeout, the implantable device may remain in disabled mode if the MRI mode is still enabled or external monitoring is disabled. In yet another example, when in disabled mode 201 and the implantable device determines that a Protocol-2 telemetry session has been established between the implantable device and an external device (e.g., external monitoring device 116, external clinician device 120, or another external device), the implantable device may remain in disabled mode if the MRI mode is enabled, no implantation is detected, or external monitoring is disabled.

[0082] Transition event 210 identifies an example transition event that causes the implantable device to transition from disabled mode 201 to a second notification mode; a clinician session initiation request. A clinician session initiation request is a request received by the implantable device from an external device (e.g., external clinician device 120) for initiating a clinician session with the implantable device using a first telemetry communication protocol (e.g., BLE). In one embodiment, a clinician session initiation request is also a transition event that causes the implantable device to transition from first notification mode 203 to second notification mode 204, as indicated by transition event 224. Therefore, in the embodiment depicted in state diagram 200, the only way the implantable device can enter second notification mode 204 is in response to receiving a clinician session initiation request. Furthermore, in the illustrated embodiment, the only way the implantable device can establish a clinician session and operate in clinician session mode 206 is via a transition from second notification mode 204.

[0083] Clinician session initiation requests can facilitate enhanced security mechanisms to ensure or increase the likelihood that only authorized devices can establish clinician sessions with the implantable device using a first telemetry communication protocol / technology (e.g., BLE). In one or more examples, the implantable device is configured not to receive clinician session initiation requests from external devices via the first telemetry communication protocol. Instead, the implantable device uses a second (or third) telemetry communication protocol to receive clinician session initiation requests. The second telemetry communication protocol can be considered more secure than the first telemetry communication protocol. For example, in embodiments where the second telemetry communication protocol includes an inductively based telemetry communication protocol, only external devices configured to use an inductively based telemetry communication protocol can send clinician session initiation requests to the implantable device. The proximity required to use an inductive telemetry protocol provides an enhanced level of security. In another example, the second telemetry communication protocol includes a proprietary (e.g., not commercially available) telemetry communication protocol. Therefore, when operating in disabled mode 201 and first notification mode 203, the implantable device can be configured to perform telemetry communication via a second telemetry communication technology / protocol, thereby enabling it to receive clinician session initiation requests.

[0084] The implantable device can be configured to interpret a clinician session initiation request received from an external clinician device (e.g., external clinician device 120) via a second telemetry communication protocol / technology as a request to establish a clinician session with the implantable device using a first telemetry communication technology / protocol. In one embodiment, the clinician session initiation request may include identification information required by the external clinician device to establish a clinician session with the implantable device. In one or more examples, the identification information includes at least an identifier for the external clinician device. For example, the identifier for the external clinician device may include the radio frequency module (RFM) address of the external clinician device, the media access control (MAC) address of the external clinician device, or any other value.

[0085] In response to receiving a clinician session initiation request, the implantable device can generate unique time-sensitive authorization information. In one embodiment, this information is required to establish the requested clinician session between the implantable device and an external clinician device. This time-sensitive authorization information can be used to establish the currently requested clinician session. For example, after closing a clinician session established using the authorization information between the implantable device and the external clinician device, the implantable device clears the authorization information from memory (e.g., deletes or otherwise invalidates it). Additionally, if the implantable device and the external clinician device fail to establish a clinician session using the authorization information within a defined time window (e.g., a notification period), the implantable device clears the authorization information from memory (e.g., deletes or otherwise invalidates it). Therefore, in order for the same external clinician device to establish a new clinician session with the implantable device, in some examples, the external clinician device will have to send a new clinician session initiation request to the implantable device, and the implantable device will have to generate new authorization information.

[0086] In an exemplary embodiment, the time-sensitive authorization information includes a dynamically generated unique session identifier, including a random number (e.g., a Universally Unique Identifier (UUID)). The time-sensitive authorization information may also include one or more dynamically generated unique session keys (e.g., an Advanced Encryption Standard (AES) key). For example, the implantable device may generate unique application-layer encryption keys (e.g., a 128-bit application-layer encryption key) and unique link-layer encryption keys (e.g., a 128-bit link-layer encryption key). The one or more unique session keys can be used by the implantable device and an external clinician device to encrypt and decrypt information transmitted between devices during a clinician session. The implantable device may be configured to generate unique time-sensitive authorization information (e.g., a unique session identifier and the one or more session keys) in response to receiving a clinician session initiation request. Therefore, the authorization information is not previously known or available to any device, including the implantable device and the external clinician device. The implantable device may be further configured to send the dynamically generated time-sensitive authorization information to the clinician device using a second telemetry communication technology / protocol via a formatted information signal sent to the clinician device. For example, in embodiments where the second telemetry communication technology / protocol includes an induction-based protocol, the implantable device can be configured to send authorization information to a clinician device using induction-based telemetry communication signals. After the implantable device sends the authorization information to the requesting external clinician device using the second telemetry communication technology / protocol, the implantable device can begin operating in the second notification mode 204. In one or more embodiments, when operating in the second notification mode, the implantable device can generate and transmit one or more notification packets indicating the availability of establishing a telemetry session using the first telemetry communication protocol. Each of the one or more notification packets includes a unique session identifier (e.g., UUID) generated by the implantable device in response to receiving a clinician session request and provided to the external clinician device using the second telemetry communication technology / protocol.

[0087] Once the implantable device is operating in the second notification mode 204, it can transition to clinician session mode 206 or return to the first notification mode 203 or disabled mode 201. As identified by transition event 234, the implantable device can be configured to transition from the second notification mode 204 to clinician session mode 206 based on establishing a clinician session with an authorized external clinician device. The implantable device can establish and conduct a clinician session using a first telemetry communication technology / protocol (e.g., BLE). In one or more examples, if the implantable device establishes a clinician session with an authorized external clinician device, it can disable telemetry communication performed by the implantable device using the second telemetry communication technology / protocol. For example, the implantable device can disable induction-based telemetry communication performed by the implantable device.

[0088] An implantable device can establish a clinician session with an authorized external clinician device based on receiving a clinician session connection request from an authorized external clinician device when operating in the second notification mode 204. In some embodiments, the device with which the implantable device is authorized to establish a clinician session is a specific external clinician device that causes the implantable device to enter the second notification mode 204 via a clinician session initiation request transmitted to the implantable device using a second telemetry communication technology / protocol (e.g., induction-based telemetry). Specifically, after the implantable device begins transmitting one or more notification packets including a unique session identifier in the second notification mode 204, the implantable device can be configured to ignore any incoming packets from the device other than those from the specific external clinician device. For example, the implantable device can receive incoming connection requests (e.g., for a clinician session or for another type of telemetry communication session) from various devices employing a first telemetry communication protocol that have received notification packets transmitted by the implantable device. However, when in the second notification mode 204, the implantable device can examine the received external clinician connection request to determine whether the received external clinician connection request was provided by a specific external clinician device that initiated the clinician session request. In an exemplary embodiment, the specific clinician session device can be configured to include an identifier of the specific external clinician device (e.g., external clinician device RFM address, external clinician device MAC address, etc.) in the clinician session connection request sent to the implantable device using a first telemetry communication technology / protocol (e.g., BLE), the identifier being provided to the implantable device by the external clinician device using the clinician session initiation request. According to this embodiment, the implantable device can determine whether the received clinician session connection request was provided by the specific external clinician device based on the identification of the identifier of the specific external clinician device in the clinician session connection request. Based on the determination that the received clinician session connection request was provided by the specific external clinician device, the implantable device can establish a clinician session with the specific external clinician device.

[0089] In one or more examples, the implantable device may limit a period of time after which it enters a second notification mode 204 to establish a clinician session. This period is referred to herein as a “notification period.” For example, the implantable device may not receive a clinician session connection request during the notification period, causing the notification period to expire. In another example, the implantable device may fail to receive an external clinician connection request from a specific (authorized) external clinician device during the notification period, causing the notification period to expire. In yet another example, the implantable device may receive a clinician session connection request from a specific external clinician device, but is unable to respond to the clinician session connection request or otherwise establish a clinician session with the specific external clinician device due to channel interference, low received signal strength (e.g., based on the implantable device being separated from the specific external clinician device by wireless transmission range), or other factors. In some implementations, the notification period associated with the second notification mode 204 is set to five minutes. However, it should be understood that the notification period may include any appropriate length of time that facilitates clinician sessions with authorized external clinician devices while limiting the current consumption associated with making notifications at a relatively high rate in vain.

[0090] As identified by transition event 228, the implantable device can be configured to transition from the second notification mode 204 to the first notification mode based on the expiration of the notification period and the satisfaction of sub-condition 1 (e.g., MRI mode is disabled, implantation is detected, and external monitoring is enabled). If the notification period expires and sub-condition 1 is not satisfied, the implantable device can be configured to transition from the second notification mode 204 to a disabled mode (not shown in state diagram 200). Transition event 222 further indicates another transition event that can cause the implantable device to transition from the second notification mode 204 to the disabled mode 201—the initiation of a Protocol-2 telemetry session. As indicated by transition event 212, if a Protocol-2 telemetry session between the implantable device and an external device is initiated while the implantable device is operating in the first notification mode 203, or if the implantable device detects that the indication RF telemetry communication of the implantable device is an unnecessary, undesirable, or unsafe limiting situation for the use of the implantable device (e.g., no implantation of the implantable device in the body, MRI mode activation, or remote monitoring function of the implantable device is disabled), the implantable device may also be configured to transition from the first notification mode 203 to the disabled mode 201.

[0091] Other transition events (not shown) that can trigger the implantable device to transition from slow notification mode 203 to disabled mode may include events associated with the battery consumption of the implantable device. For example, the implantable device may be configured to monitor the power level of the implantable device and transition from first notification mode 203 to disabled mode 201 if the power level of the implantable device drops below a threshold level. In another example, when operating in first notification mode, the implantable device may be configured to monitor the amount of unauthorized or unsuccessful requests to establish telemetry sessions with the implantable device within a defined time period (e.g., a calendar day). Based on the amount of unauthorized or unsuccessful requests exceeding a threshold amount, the implantable device may further transition from first notification mode 203 to disabled mode. In yet another example, when operating in first notification mode 203, the implantable device may be configured to monitor the telemetry usage of the implantable device (e.g., in terms of duration or bytes) within a defined time period (e.g., a calendar day) and transition to disabled mode 201 if the telemetry usage exceeds an allocated amount within the defined time period.

[0092] Referring to Clinician Session Mode 206, when operating in Clinician Session Mode 206, the implantable device can be configured to perform or conduct a clinician session based on one or more parameters defined for the clinician session. For example, the parameters may define the types of data that the devices are authorized to communicate with each other and how the data should be formatted. The parameters may also define how the devices transmit different types of data to each other (e.g., using one-way or two-way communication, the duration between communication signals, the number of data packets transmitted, the activation and deactivation periods of the receiver and transmitter, etc.) and when the devices transmit different types of data to each other. The parameters may also define when and how data transmitted via the clinician session is encrypted and decrypted. In various examples, one or more parameters of the clinician session are defined and stored in the memory of the respective devices. For example, the implantable device may be pre-programmed with information defining general communication parameters and protocols to be used during the clinician session. In another embodiment, one or more communication parameters and protocols for the clinician session can be established and agreed upon between the implantable device and an external clinician device when the clinician session is established.

[0093] The type of data communication performed between the implantable device and the external clinician device during a clinician session will vary depending on the characteristics and functionality of the implantable device and the purpose of the clinician session. The implantable device and the external clinician device are configured to encrypt and decrypt data communicated during the clinician session using one or more session keys generated by the implantable device in response to receiving a clinician session request from the external clinician device (e.g., transition events 210 and 224). In various examples, the clinician session can facilitate dynamic bidirectional (e.g., one-way and two-way) communication between the implantable device and the external clinician device. Therefore, in various examples, when in clinician session mode 206, the implantable device maintains receiver activation to facilitate efficient bidirectional communication. For example, as indicated by transition event 244, during clinician session mode 206, the implantable device can receive one or more downlink data packets (e.g., data packets including commands or programming information, etc.) from the external clinician device and process uplink data packets for transmission to the external clinician device (e.g., data packets including waveform information). In some implementations, during a clinician session, the external clinician device can request and receive physiological data monitored by the implanted device in real-time or non-real-time. For example, transition event 240 indicates that the implanted device can enable or disable a live waveform mode during clinician session mode 206. Specifically, in embodiments where the implanted device is an ICD, the ICD can be configured to capture electrical signals of the heart via one or more leads (e.g., leads 110a, b), referred to herein as waveform data. Live waveform mode refers to an operating mode of the implanted device in which the implanted device can transmit waveform data in real-time (e.g., as it is captured) to the external clinician device while the patient is interacting with a clinician operating the external clinician device. Enabling and disabling live waveform mode can be in response to a qualifying event (e.g., establishing a clinician session) and / or in response to a command received from the external clinician device. In another example, during external clinician session, the external clinician device can program or reconfigure one or more operating parameters of the implanted device by transmitting a command-line script to the implanted device.

[0094] The implantable device can be configured to transition from clinician session mode 206 to a first notification mode 203, a second notification mode 204, a disabled mode 201, or a standby mode 205. As identified by transition event 232, the implantable device can be configured to transition from clinician session mode 206 to the first notification mode 203 in response to clinician session closure and the fulfillment of sub-condition 1 (i.e., MRI mode is disabled, implantation is detected, and external monitoring is enabled). If the clinician session is closed and sub-condition 1 is not met, the implantable device can transition from clinician session mode 206 to a disabled mode (not shown in state diagram 200). In some examples, if the external session is closed and the implantable device enters the first notification mode, the implantable device uses a second telemetry communication technology / protocol to perform telemetry communication. Additionally, if the clinician session is closed, the implantable device can clear the authorization information established by the implantable device for the clinician session in response to receiving a clinician session initiation request (e.g., transition events 210 and 224). Specifically, the implantable device can clear or remove authorization from its memory or otherwise render authorization information unavailable. For example, the implantable device can clear the unique session identifier, the one or more unique session keys, and the identifier of the specific external clinician device. Therefore, the authorization information cannot be used to establish a new clinician session between the implantable device and the specific external clinician device. In order to establish a new clinician session between the implantable device and the specific external clinician device, in this embodiment, the external clinician device must send a new clinician session initiation request to the implantable device, and the implantable device must generate new authorization information.

[0095] As identified by transition event 230, in response to the loss of a clinician session and the satisfaction of subcondition 2, the implantable device can transition from clinician session mode 206 to a second notification mode 204. Subcondition 2 includes disabling MRI mode. If the clinician session is lost and subcondition 2 (e.g., enabling MRI mode) is not satisfied, the implantable device can transition from clinician session mode 206 to a disabled mode (not shown in state diagram 200). The loss of a clinician session refers to the loss of the integrity of the telemetry connection between the implantable device and the clinician session device associated with the clinician session. For example, the loss of a clinician session may include the inability to receive or transmit data packets through the implantable device and / or the external clinician device associated with the clinician session, or the inability to receive or transmit data packets through the implantable device and / or the external clinician device at a limited throughput level. The loss of a clinician session can be caused by a variety of factors, such as, but not limited to, channel interference, the implantable device being separated from a specific external clinician device beyond its wireless transmission range, or other factors. In some examples, if an external session is lost and the implantable device enters a second notification mode 204, the implantable device can use a second telemetry communication technology / protocol (e.g., induction) to achieve telemetry communication. Additionally, the notification period can be reset (e.g., reset to five minutes). The implantable device and the specific external clinician device can then have a notification period duration to reconnect and re-establish the clinician session using authorization information. In one or more examples, if the implantable device is in waveform mode during a clinician session when the clinician session is lost and subsequently re-establishes the clinician session with the external clinician device, the implantable device can be configured to automatically enable or activate waveform mode upon re-establishment of the clinician session.

[0096] Standby mode 205 is an energy-saving mode in which the implantable device uses less power compared to the power used for operation in clinician session mode 206, while maintaining a clinician session with an external clinician device. Standby mode 205 can facilitate reduced power consumption associated with the implantable device performing an external clinician telemetry session, for example, during reduced or suspended telemetry communication activity between the implantable device and the external clinician device. For example, the implantable device may enter standby mode 204 in response to a request to enter standby mode received from the external clinician device (e.g., when the clinician is not checking live waveform data, not programming the implantable device, or when the patient is using the restroom). The implantable device may also enter standby mode 205 in response to a limited period of detected telemetry communication inactivity (e.g., 2 minutes, 5 minutes, 15 minutes, etc.). In one or more examples, the implantable device may be configured to interpret any of these transition events as initiating a standby signal. The implantable device can be configured to begin operation in standby mode 205 upon receiving a start standby signal, as indicated by transition event 236. In one or more examples, if the implantable device is in waveform mode when operating in clinician session mode 206, the implantable device can disable waveform mode upon entering standby mode 205.

[0097] During standby mode 205, the implantable device can maintain and perform a clinician session with reduced functionality compared to the functionality employed during clinician session mode 206. For example, when operating in clinician session mode 206, the implantable device can actively transmit one or more data packets containing actionable data, such as waveform data or other types of data requested by the clinician device from the implantable device, or receive one or more data packets including actionable data (e.g., programming information). When in standby mode 205, no such active data communication occurs between the implantable device and an external clinician device. For example, when in standby mode 205, the implantable device can maintain an established clinician session with an external clinician device, but may not communicate data with the external clinician device or may communicate a limited amount of idle data to maintain the clinician session. In some examples, when in standby mode 205, the implantable device can transmit one or more data packets including idle or inactive information. As used herein, the term "actionable data" refers to information that can be acted upon. For example, actionable data may include commands (e.g., programming commands, commands to exit or enter standby mode, confirmation signals, etc.) or informative information associated with the operation of the implantable device. Actionable data can vary. Conversely, idle data refers to data that serves only as a heartbeat or indication that the implantable device and the clinician device are maintaining a connection. The implantable device may transmit one or more idle data packets at a low duty cycle (e.g., once every 10 seconds, once every 30 seconds, once every minute, etc.) and deactivate its transmitter and / or receiver when transmitting each idle packet. In other examples, during standby mode 205, the implantable device may deactivate its RF transmitter and activate its RF receiver at a low duty cycle (e.g., once every ten seconds) to receive a wake-up signal that transitions the implantable device back to clinician session mode 206.

[0098] In some implants, instead of using standby mode 205, the implantable device is configured to remain in clinician session mode 206 but with modifications to its data transmission and / or reception aspects to facilitate reduced power consumption. For example, the implantable device may remain in clinician session mode 206 and prevent the transmission of real-time waveform data to an external clinician device while enabling fast bidirectional communication between the implantable device and the external clinician device. In another example, the implantable device may remain in clinician session mode 206 and provide real-time unidirectional data transmission (e.g., waveform data) to an external clinician device, but deactivate the RF receiver of the implantable device for extended periods when data communication from the external clinician device is not expected to reduce battery consumption.

[0099] Once in standby mode 205, the implantable device can transition back to clinician session mode 206, first notification mode 203, second notification mode 204, or disabled mode 201. In one or more examples, the implantable device can transition from standby mode 205 back to clinician session mode 206, as indicated by transition event 238, in response to receiving a stop standby signal (e.g., a wake-up signal) transmitted by an external clinician device or in response to receiving downlink information. In one or more examples, to enter standby mode, the external clinician device can transmit a signal via a communication link instructing the implantable device to turn off a waveform and enter a low-power state or standby mode 205. In some examples, circuitry, components, and / or devices that enable the implantable device to transition to standby mode may be provided in the external clinician device. In other examples, circuitry, components, and / or devices that enable the implantable device to transition to standby mode may be provided in the implantable device. All such embodiments are contemplated.

[0100] In one or more examples, if the implantable device is in waveform mode during clinician session mode 206 before entering standby mode 205, the implantable device can be configured to enable or activate waveform mode when transitioning from standby mode 205 back to clinician session mode 206.

[0101] In one or more additional examples, an external clinician device is configured to manage the entry and exit of the implantable device into standby mode 205. For example, when operating in clinician session mode 206, the external clinician device may send a command to the implantable device to enter standby mode. The implantable device may be further configured to enter standby mode only in response to receiving this command from the external clinician device during a clinician session established with the external clinician device. Similarly, when operating in standby mode 205, the external clinician device may send a command to the implantable device to exit standby mode. The implantable device may be further configured to exit standby mode only in response to receiving this exit standby mode command.

[0102] The implantable device can be configured to transition from standby mode 205 to first notification mode 203 in response to the closure of a clinician session and the fulfillment of sub-condition 1 (i.e., MRI mode is disabled, implantation is detected, and external monitoring is enabled), as identified by transition event 226. If the clinician session is closed and sub-condition 1 is not met, the implantable device can transition to a disabled mode (not shown in state diagram 200). As described above with reference to transition event 232, in some examples, if the external session is closed and the implantable device enters the first notification mode, the implantable device uses a second telemetry communication technology / protocol to perform telemetry communication by the implantable device. Additionally, if the clinician session is closed, the implantable device can also be configured to clear the authorization information established by the implantable device for the clinician session in response to receiving a clinician session initiation request (e.g., transition events 210 and 224).

[0103] As identified by transition event 242, in response to the loss of a clinician session and the satisfaction of sub-condition 2 (i.e., disabling MRI mode), the implantable device can be configured to transition from standby mode 205 to a second notification mode 204. If the clinician session is lost and sub-condition 2 (e.g., MRI mode is enabled) is not satisfied, the implantable device can transition from standby mode 205 to a disabled mode (not shown in state diagram 200). As described above with reference to transition event 230, in some examples, if an external session is lost and the implantable device enters the second notification mode 204, the implantable device can use a second telemetry communication technology / protocol (e.g., induction) to enable telemetry communication performed by the implantable device. Additionally, the notification period can be reset (e.g., reset to five minutes). The implantable device and the specific external clinician device can then have the duration of the notification period to reconnect and re-establish the clinician session using authorization information.

[0104] Returning to the first notification mode 203. In response to establishing a monitoring session with an authorized external monitoring device, the implantable device can transition from the first notification mode 203 to a monitoring session mode 202, as identified by transition box 220. During monitoring session mode 202, the implantable device and the authorized external monitoring device conduct or perform a monitoring session. For example, the implantable device may transmit monitored information to the external monitoring device, including but not limited to physiological information about the patient captured by the implantable device or monitored operating parameters associated with the performance of the implantable device. In various examples, the types of information that the implantable device may communicate with the external monitoring device during a monitoring session can be defined and programmed into the implantable device. In one or more examples, the implantable device may also be programmed with information identifying one or more external monitoring devices with which the implantable device is authorized to establish a monitoring session. For example, before or after implantation (e.g., during a clinician session or Protocol-2 telemetry session), the implantable device may receive and store the information identifying the one or more external monitoring devices with which the implantable device is authorized to establish a monitoring session. For example, the one or more devices may include a home monitoring device provided to a patient associated with receiving an implanted device, or a smartphone or tablet device previously owned and / or operated by the patient and later programmed to facilitate remote monitoring associated with the patient's implanted device. In one or more implants, these authorized external devices may receive authorization information (e.g., secret keys, unique identifiers, etc.) from a trusted server device or system associated with managing and ensuring the telemetry security of each patient's implanted device to establish a trusted relationship with the implanted device. In various examples, the one or more external monitoring devices authorized to establish a monitoring session may be paired with the implanted device.

[0105] During the first notification mode 203, the implanted device may transmit one or more notification packets according to a defined RF telemetry communication protocol (e.g., BLE). As noted above, in various examples, the transmission rate is lower or slower than the transmission rate used by the implanted device to transmit one or more notification packets during the second notification mode 204. For example, the transmission rate during the first notification mode 203 may be approximately one notification packet every three minutes, compared to one notification packet per second in the second notification mode 204. The one or more notification packets transmitted by the implanted device during the first notification mode may include information indicating that the implanted device is ready and available for a monitoring session. In one or more examples, the implanted device may be configured to receive a response to a transmitted notification packet received by an external device. For example, the response may include a request to establish a telemetry session with the implanted device. The implanted device may then be configured to determine whether the response is provided by an external monitoring device with which the implanted device is authorized to establish a monitoring session. In response to determining that the device is not authorized, the implanted device may remain in the first notification mode. However, if the implantable device can determine that the external device is an authorized external monitoring device, the implantable device can establish a monitoring session with the authorized external monitoring device and switch to monitoring session mode 202.

[0106] The implantable device can be configured to transition from monitoring session mode 202 to first notification mode 203 in response to a transition event identified by transition event 216. In one embodiment, the implantable device can be configured to transition from monitoring session mode 202 to first notification mode 203 based on monitoring session closure and the satisfaction of sub-condition 1 (i.e., MRI mode is disabled, implantation is detected, and external monitoring is enabled). If the monitoring session is closed and sub-condition 1 is not satisfied, the implantable device can be configured to transition from monitoring session mode 202 to disabled mode 201. The implantable device can also be configured to transition from monitoring session mode 202 to first notification mode 203 in response to loss of monitoring session. The implantable device can also be configured to transition to disabled mode 201, as identified by transition event 221, based on receiving a request to establish a Protocol-2 telemetry session with an external device while operating in monitoring session mode 203.

[0107] Refer again Figure 1 and Figure 2System 100 provides several technical solutions to the technical shortcomings associated with existing implantable device telemetry systems. Specifically, implantable devices, including IMDs (e.g., implantable device 104), are becoming increasingly complex and smaller in size. One obstacle to achieving such small and highly functional devices is efficient power management. Many implantable devices, such as implantable device 104, operate with power supplies that have a limited lifespan and / or are non-rechargeable. Thus, after the implantable device is implanted in the body and the power supply has reached its lifespan, it may be necessary to remove or replace the implantable device. Telemetry communication performed between the implantable device and external devices can significantly impact the lifespan of the implantable device's power supply.

[0108] System 100 facilitates enhanced battery saving associated with telemetry operation of the implantable device 104 by employing different communication operation modes, each associated with different battery consumption levels. These different communication operation modes include, but are not limited to: a disabled mode 201, a monitoring session mode 202, a first notification mode 203, a second notification mode 204, a standby mode 205, and a clinician session mode 206. The different battery consumption levels associated with these different communication modes are attributed to the activation of different types of telemetry hardware circuitry system components of the implantable device (e.g., RF components and sensing components) and the different activation levels of each telemetry hardware circuitry system component (e.g., different duty cycles for receiver and transmitter activation). Because the activation and deactivation of the different telemetry hardware circuitry system components involve physical and electrical processes and components, the battery-saving techniques of this subject cannot be replicated or performed by a human.

[0109] Furthermore, the battery-saving technology of this topic provides substantial improvements in the field of telemetry operation of implantable devices. According to system 100, the activation of different types of telemetry communication hardware components and the different activation levels of each telemetry communication hardware component are selected and optimized to balance the type of telemetry communication required by implantable device 104 at any given time during the lifetime of implantable device 104 with the communication responsiveness required by implantable device 104 associated with the type of telemetry communication session being performed (e.g., Protocol-2 telemetry session, monitoring session, clinician session, etc.). For example, when RF telemetry communication is not needed or is insecure, implantable device 104 can operate using disabled mode 201, thereby minimizing the power consumption associated with activating the one or more RF components of the implantable device. Additionally, when implantable device 104 does not actively receive downlinks or provide uplinks during a clinician session, implantable device 104 can operate using standby mode 205, thereby minimizing the power consumption associated with activating the one or more RF components. The implantable device 104 may also employ a first and second notification mode associated with different RF transmitter and receiver activation levels, which have been optimized based on the communication responsiveness required by the implantable device in relation to the establishment and re-establishment of monitoring sessions and clinician sessions. For example, in one or more embodiments, during the first notification mode 203, the implantable device 104 may activate its RF transmitter once every N minutes (e.g., three minutes) to transmit a notification data packet and then activate its receiver over M seconds (e.g., five seconds) to enable the reception of a response. On the other hand, during the second notification mode 204, the implantable device 104 may activate its RF transmitter once every X seconds (e.g., sixty seconds) to transmit a notification data packet and maintain receiver activation between notification data packets to enable the reception of a response. In one or more embodiments, X may be at least 100% greater than N, and in some examples, at least 200% greater than N, and in some examples, 300% greater than N.

[0110] In various examples, the implantable device 104 can also be configured to detect transition events and cause the implantable device to transition into and out of different communication operating modes, each of which relates to a physical process or reaction performed by the implantable device 104 that cannot be performed by a human. Specifically, the communication modes corresponding to insertion and removal involve the activation and / or deactivation of one or more telemetry communication hardware components of the implantable device 104. Furthermore, the ability to detect various transition events and conditions is rooted in the physical structure of the hardware circuitry system involving the implantable device 104. For example, in some embodiments, the implantable device 104 can be configured to detect implantation based on electrical signals received from connected leads (e.g., leads 110a, b). In another example, the implantable device 104 can be configured to detect when a transition to a second notification mode is achieved based on sensing signals received via a sensing antenna activating the implantable device 104. In another example, the implantable device 104 may be configured to determine when to switch to monitoring session mode 202 or clinician session mode 206 based on receiving a limited response signal via the RF receiver or transceiver of the implantable device within a limited notification period.

[0111] System 100 can also provide substantial improvements in the field of telemetry security for implantable medical devices. Specifically, System 100 facilitates enhanced security associated with establishing and executing telemetry sessions with implantable device 104 using RF-based telemetry communication technologies / protocols (e.g., BLE), which enable rapid (and high-power) bidirectional telemetry communication with implantable device 104 over data considered highly invasive or sensitive (e.g., programming data or waveform data associated with clinician sessions). Modern IMDs (e.g., implantable device 104) are entrusted with important tasks such as measuring and collecting data on vital signs and facilitating the provision of the collected data to physicians and nurses using telemetry communication. For example, in many applications, important information is periodically and automatically communicated between implantable devices and external devices such as external devices accessible to patients with implanted devices and / or healthcare personnel.

[0112] The technical security mechanism employed by the implantable device 104 associated with system 100 may utilize an authorized external clinician device (e.g., external clinician device 120) to generate and send a clinician session initiation request (e.g., transition event 210 or transition event 224) using a non-RF-based telemetry communication protocol / technology (e.g., sensing) to cause the implantable device 104 to switch to a dedicated communication mode (e.g., a second notification mode 204), via which the implantable device 104 can establish a clinician session. Based on the received clinician session request (e.g., via activation of the non-RF-based telemetry hardware components of the implantable device 104), the implantable device can interpret the clinician session request and generate unique authorization information that can be used to establish and execute the currently requested clinician session. Specifically, in one embodiment, the unique authorization information restricts the establishment of the currently requested clinician session with the implantable device 104 to only authorized external clinician devices that provide non-RF-based session initiation signals. The unique authorization information may further restrict the use of the authorization information to only for establishing the currently requested session. Therefore, in one embodiment, if a clinician session fails to be established (e.g., due to the expiration of the notification period, transition event 224) or is closed, the authorization information becomes invalid and cannot be used to conduct a new clinician session with the implantable device 104.

[0113] Now refer to Figure 3 The diagram shown is an example non-limiting flowchart of a method 300 for managing the operation of an implantable device (e.g., implantable device 104) in disabled mode, first notification mode, second notification mode, and monitoring session mode, according to one or more examples described herein. For brevity, repetitive descriptions of similar elements used in the corresponding examples described herein have been omitted.

[0114] First, method 300 is described with reference to 302, wherein the implantable device can operate in a disabled mode. At 304, the implantable device detects that it has been implanted in the body. Based on the detection of implantation, the implantable device can then determine at 310 whether a Protocol-2 telemetry session has been established between the implantable device and an external device, whether MRI is enabled, or whether external monitoring is disabled. In response to the decision at 310 that a Protocol-2 telemetry session has been established between the implantable device and the external device, MRI is enabled, or external monitoring is disabled, method 300 returns to operating the implantable device in disabled mode at 302. However, in response to the decision at 310 that no Protocol-2 telemetry session has been established between the implantable device and the external device, MRI is disabled, and external monitoring is disabled, the implantable device can operate in a first notification mode at 318. At 306, the implantable device detects that the MRI mode of the implantable device has timed out. Based on the detected MRI mode timeout, the implantable device can then determine at 312 whether a Protocol-2 telemetry session has been established between the implantable device and the external device, whether the implant detection is false, or whether external monitoring is disabled. In response to the decision at 312 that a Protocol-2 telemetry session has been established between the implantable device and the external device, the implant detection is false, or external monitoring is disabled, method 300 can return to operating in disabled mode at 302. However, in response to the decision at 312 that no Protocol-2 telemetry session has been established between the implantable device and the external device, the implant detection is true, and external monitoring is disabled, the implantable device can operate in first notification mode at 318. At 308, the implantable device can detect that the established Protocol-2 telemetry session has ended. Based on the detection of the closure of the Protocol-2 telemetry session, the implantable device can then determine at 314 whether the implant detection is false, whether MRI is enabled, or whether external monitoring is disabled. In response to a decision at 314 that the implant detection is false, MRI is enabled, or external monitoring is disabled, method 300 may return to operating the implanted device in disabled mode at 302. However, in response to a decision at 314 that the implant detection is true, MRI is disabled, and external monitoring is disabled, the implanted device may operate in first notification mode at 318.

[0115] When operating in the first notification mode at 318, in some embodiments, at 316, the implantable device can establish a monitoring session with an external monitoring device (e.g., external monitoring device 116). The implantable device then begins operation in monitoring session mode at 322. In another embodiment, when operating in the first notification mode at 318, the implantable device can receive a clinician session initiation request from a clinician device at 324. Based on receiving the clinician session initiation request, the implantable device can switch to operating in the second notification mode at 326. In yet another embodiment, when operating in disabled mode at 302, the implantable device can receive a clinician session initiation request at 320, and based on receiving the clinician session initiation request, the implantable device can switch to operating in the second notification mode at 326.

[0116] Figure 4 A non-limiting flowchart illustrating an example of a method 400 for facilitating the management of operation of an implantable device (e.g., implantable device 104) in disabled mode, first notification mode, second notification mode, clinician mode, and standby mode, according to one or more examples described herein. For brevity, repetitive descriptions of similar elements used in the corresponding examples described herein have been omitted.

[0117] First, referring to method 400, which is described with reference to 402, the implantable device may operate in a second notification mode based on receiving a clinician session initiation request from a clinician device. At 406, the implantable device may determine whether it has established a clinician session with the clinician device within a defined notification period (e.g., five minutes). If yes, the implantable device may then switch to operating in clinician session mode at 416. If no, the implantable device may then determine at 408 whether implantation was not detected, whether MRI was enabled, or whether external monitoring was disabled. In response to determining that implantation was not detected, MRI was enabled, or external monitoring was disabled, the implantable device may switch to operating in disabled mode at 404. However, in response to determining that implantation was detected, MRI was disabled, and external monitoring was enabled, the implantable device may switch to operating in the first notification mode at 412.

[0118] Referring to 416, in one embodiment, when operating in clinician session mode, at 414, the clinician session established between the implantable device and the clinician device is closed. With this embodiment, the implantable device can then determine at 408 whether implantation was not detected, whether MRI was enabled, or whether external monitoring was disabled. In response to determining that implantation was not detected, MRI was enabled, or external monitoring was disabled, the implantable device can switch to operating in disabled mode at 404. However, in response to determining that implantation was detected, MRI was disabled, and external monitoring was enabled, the implantable device can switch to operating in first notification mode at 412.

[0119] Referring to 416, in another embodiment, when operating in clinician session mode, at 418, the established clinician session between the implanted device and the external clinician device may be lost. The implanted device can then determine at 410 whether MRI is enabled. If MRI is enabled, the implanted device begins operation in disabled mode at 404. However, if MRI is disabled, the implanted device returns to operation in second notification mode at 402. In yet another embodiment, when operating in clinician session mode at 416, the implanted device can receive a request to enter standby mode or an inactivity indication. For example, the external clinician device can send a request to the implanted device to enter standby mode to allow the patient with the implanted device to use the restroom. In another example, the external clinician device can disable the waveform mode of the implanted device and not transmit or receive data packets from the implanted device during a defined inactivity period (e.g., fifteen minutes). Therefore, the implanted device can enter standby mode at 422.

[0120] Figure 5 Another example non-limiting flowchart illustrating a method 500 for facilitating the management of operation of an implantable device (e.g., implantable device 104) in disabled mode, first notification mode, second notification mode, clinician mode, and standby mode, according to one or more examples described herein. For brevity, repetitive descriptions of similar elements used in the corresponding examples described herein have been omitted.

[0121] First, method 500 is described with reference to 502, wherein the implantable device can operate in a clinician session mode. At 506, the implantable device may receive a request to enter a standby mode or an inactivity indication (e.g., from clinician device 120). In response to the request, the implantable device may then enter a standby mode at 520. After the implantable device begins operating in standby mode, in one embodiment, at 512, the implantable device may receive a request to exit standby mode. In response to the request to exit standby mode, the implantable device may then re-enter the clinician session mode at 502. In another embodiment, after the implantable device has operated in standby mode, at 518, the clinician session established between the implantable device and the clinician device is closed. With this embodiment, the implantable device may determine at 510 whether an implantation was not detected, whether MRI is enabled, or whether external monitoring is disabled. In response to determining that the implantation detection is false, MRI is enabled, or external monitoring is disabled, the implantable device may switch to operating in a disabled mode at 504. However, in response to the detection of implantation, MRI being disabled, and external monitoring being enabled, the implantable device can switch to operation in the first notification mode at 516. Referring to 522, in another embodiment, when operating in standby mode, at 522, the clinician session established between the implantable device and the external clinician device may be lost. The implantable device can then determine at 514 whether MRI is enabled. If MRI is enabled, the implantable device can begin operation in the disabled mode at 504. However, if MRI is disabled, the implantable device can return to operation in the second notification mode at 508.

[0122] Figure 6 A block diagram of an example non-limiting implantable device (e.g., implantable device 104) according to one or more examples described herein is shown. Implantable device 104 includes a communication component 602, a communication mode management component 608, and an authorization component 610. Implantable device 104 also includes an implantable device circuitry 616 and a power supply 618. Aspects of the systems, apparatus, or processes explained in this disclosure may constitute machine-executable components embodied within (e.g.,) a machine(s), for example, embodied in one or more computer-readable media (or media) associated with one or more machines. Such components, when executed by said one or more machines (e.g., computers(s), computing devices(s), virtual machines(s), etc.), may cause said machines(s) to perform the described operations.

[0123] The implantable device 104 may include memory 620 configured to store computer-executable components and instructions. The implantable device 104 may also include a processor 612 for facilitating operation of instructions (e.g., computer-executable components and instructions) by the implantable device 104. The implantable device 104 may include a bus 614 coupling various components of the implantable device 104, including but not limited to a communication component 602, a communication mode management component 608, an authorization component 610, a processor 612, an implantable device circuitry 616, a power supply 618, and memory 620. For brevity, repetitive descriptions of similar elements used in other examples described herein have been omitted.

[0124] Reference Figure 1 , Figure 2 and Figure 6 The communication component 602 can be configured to facilitate telemetry communication between the implantable device 104 and one or more external devices (e.g., external monitoring device 116 and external clinician device 120) using at least a first RF-based telemetry communication technology / protocol and a second telemetry communication technology / protocol. In one or more examples, the communication component 602 includes a first telemetry communication component 604 configured to facilitate telemetry communication between the implantable device 104 and the one or more external devices according to the first RF-based telemetry communication technology / protocol. In an exemplary embodiment, the first telemetry communication technology / protocol includes BLE. For example, the first telemetry communication component 604 can control the operation of an RF transceiver (or RF transmitter-receiver) and a repeater to establish an RF-based external monitoring telemetry session with the external monitoring device 116 and control the transmission and reception of one or more data packets associated with the monitoring session by the implantable device 104. In another example, the first telemetry communication component 604 may control the operation of an RF transceiver (or RF transmitter-receiver) and repeater to establish an RF-based external clinician telemetry session with external clinician device 120 and control the transmission and reception of one or more data packets associated with the clinician session by the implantable device 104. In some examples, as an alternative to including a transceiver or in addition to including a transceiver, the implantable device 104 may include transmitters and receivers that do not share a common circuit system.

[0125] Communication component 602 may further include a second telemetry communication component 606 configured to facilitate telemetry communication by implantable device 104 according to a second telemetry communication protocol / technology. In one or more embodiments, the second telemetry communication technology / protocol includes non-RF-based telemetry communication technologies / protocols, such as induction-based telemetry communication technologies / protocols. For example, second telemetry communication component 606 may include an inductive antenna or coil and repeater configured to generate and receive electromagnetic induction signals associated with a Protocol-2 telemetry session between the implantable device and one or more external devices. In another example, the inductive antenna or coil and repeater may receive an inductive signal including a clinician session initiation request from an external clinician device. The inductive antenna or coil may also generate and transmit an electromagnetic induction signal including a response to the clinician session initiation request to the external clinician device. The response may include authorization information for the clinician session (e.g., a UUID and one or more unique session keys).

[0126] Communication component 602 can facilitate telemetry communication between implantable device 104 and external devices (e.g., external monitoring device 116 and external clinician device 120) using various networks (not shown) and / or wireless communication protocols. For example, in one or more examples, communication component 602 can communicate with external monitoring device 116 using NFC or other types of communication protocols on a PAN or LAN (e.g., a Wi-Fi network), which can provide communication over greater distances than the NFC protocol or can achieve one or more aspects described herein (e.g., enhanced security).

[0127] In some examples, communication component 602 can control the transmission and reception of one or more data packets via a communication channel associated with a communication protocol that utilizes lower power consumption than conventional communication protocols used for wireless data transmission. For example, in a non-limiting example, the first telemetry communication component 604 uses the BLE protocol to control the transmission and reception of data packets. Other communication protocols that communication component 602 can use to communicate with external monitoring device 116 and / or external clinician device 120 may include, but are not limited to: others. Communication protocols, protocols based on Session Initiation Protocol (SIP), Protocols, RF4CE protocol, WirelessHART protocol, 6LoWPAN (IPv6 on low-power wireless personal area networks) protocol, Z-Wave protocol, ANT protocol, ultra-wideband (UWB) standard protocol, RF communication protocol and / or other proprietary and non-proprietary communication protocols.

[0128] In one or more examples, communication component 602 may be configured to establish a secure or trusted telemetry session with external monitoring device 116 or external clinician device 120 before facilitating sensitive data exchange between implantable device 104 and external monitoring device 116 or external clinician device 120. In one embodiment, to establish such a secure or trusted connection, after the first telemetry session, communication component 604 may receive a request from external monitoring device 116 or external clinician device 120 to establish a telemetry session with implantable device 104, wherein implantable device 104 may determine whether external monitoring device 116 or external clinician device is authorized to communicate with implantable device 104. In response to determining that the corresponding device is authorized, the first telemetry communication component 604 may proceed to establish a secure telemetry session with the corresponding device using a first telemetry communication technology / protocol (e.g., BLE).

[0129] Authorization component 610 can facilitate the determination of whether an external device requesting to establish a telemetry session with the implanted device is authorized to do so. For example, in one or more examples, after the implanted device 104 can receive a monitoring session request from an external device, authorization component 610 can determine whether the external device is an authorized external monitoring device based on authorization device information 622 stored in memory 620, which includes unique identification information of one or more authorized external monitoring devices with which the implanted device 104 is authorized to establish a monitoring session. For example, when operating in first notification mode 203, associated with sending a request to establish a monitoring telemetry session with the implanted device 104 after receiving a notification data packet transmitted by the implanted device 104, the external monitoring device 116 can provide the implanted device 104 with information indicating communication parameters for the telemetry session. In some examples, the information may also include external monitoring device 116 authentication information (e.g., device identifier, encryption key, MAC, or other suitable authentication information) that uniquely identifies the external monitoring device 116. This authentication information can be provided to the implantable device 104 in advance and stored in the implantable device's memory 620 as authorized device information 622. The implantable device 104 can process the received authorization information to determine whether the external monitoring device 116 is authorized to communicate with the implantable device 104.

[0130] In various additional examples, the authorization component 610 may be configured to generate session authorization information for a clinician session in response to receiving a clinician session initiation request from the implantable device 104 via the second telemetry communication component 606. For example, in response to receiving a sensing signal including a clinician session initiation request from an external clinician device 120, the authorization component 610 may generate a unique (e.g., randomly generated) session identifier (e.g., UUID) and one or more unique session keys. The authorization component 610 may temporarily store the session authorization information together with a unique identifier of the external clinician device (e.g., RFM address, MAC address, etc.) received from the external clinician device using the clinician session initiation request in the memory 620 of the implantable device 104. The second telemetry communication component 606 may further use the sensing signal to generate a response including the authorization information and send it to the external clinician device 120. Based on a connection request received by the first telemetry communication component 604 from the external clinician device 120, including the identifier of the external clinician device, the authorization component 610 can further authorize the establishment of a clinician session between the implantable device 104 and the external clinician device 120. After the clinician session is established, the first telemetry communication component 604 can use one or more session keys to encrypt and decrypt information transmitted between the implantable device 104 and the external clinician device 120.

[0131] The implantable device 104 includes a communication mode management component 608 for facilitating the transition of the implantable device between a plurality of communication operation modes, including but not limited to a disabled mode 201, a monitoring session mode 202, a first notification mode 203, a second notification mode 204, a standby mode 205, and a clinician session mode 206. For example, the communication mode management component 608 may be configured to identify the occurrence of transition events (e.g., transition events 210, 212, 214, 216, 218, 220, 221, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, and 244), determine whether the transition event requires the implantable device 104 to transition from a first communication mode to a second communication mode, and implement the transition accordingly. The communication mode management component 608 may employ information identifying transition events and conditions (e.g., sub-condition 1 and sub-condition 2) associated with transition events that respectively keep the implanted device in a specific communication mode or switch it to another communication mode.

[0132] The implantable device circuitry 616 may include hardware, software, or a combination of hardware and software to facilitate the operation of various components of the implantable device 104. For example, the implantable device circuitry may include, but is not limited to: a pulse generator, capacitors, leads (e.g., leads 110a, b), electrodes (e.g., tip electrodes 112a, b and ring electrodes 114a, b), sensors, accelerometers, pumping mechanisms, storage, communication component 602 hardware (e.g., antennas, transmitters, receivers, transceiver repeaters, etc.), therapeutic output modules, etc. The implantable device circuitry 616 can facilitate various operations of the implantable device, including but not limited to medical-related operations (e.g., sensing electrical signals from the heart, dispensing medication, etc.), and can facilitate telemetry communication mode operation of the implantable device (e.g., RF telemetry and non-RF telemetry such as sensing). The implantable device 104 further includes a power supply 618 for driving the operation of the implantable device 104 and providing power to the various electrical components of the implantable device 104. In one or more examples, the power source includes, but is not limited to, a battery, capacitor, charge pump, mechanically derived power source (e.g., microelectromechanical system (MEM) device), or sensing component. The sensing component may also be used by the second telemetry communication component 606 to facilitate the transmission and reception of sensing-based telemetry signals.

[0133] Figure 7 A block diagram of an example non-limiting external monitoring device (e.g., external monitoring device 116) according to one or more examples described herein is shown. The external monitoring device includes a communication component 702, a monitoring component 704, and an authorization component 706. External monitoring device 116 may also include a transmitter / receiver 710. One or more of the components of external monitoring device 116 constitute multiple machine-executable components implemented within the machine(s)—for example, implemented in one or more computer-readable media associated with the machine(s). Such multiple components, when executed by said one or more machines (e.g., multiple computers, multiple computing devices, multiple virtual machines, etc.), enable said machines(s) to perform the described operations.

[0134] External monitoring device 116 may include memory 712 for storing computer-executable components and instructions, and processor 714 for facilitating operation of the computer-executable components and instructions by external monitoring device 116. External monitoring device 116 also includes a bus 708 coupling various components of external monitoring device 116, including communication component 702, monitoring component 704, authorization component 706, transmitter / receiver 710, memory 712, and processor 714. For brevity, repetitive descriptions of similar elements used in other examples described herein are omitted.

[0135] Reference Figure 1 , Figure 2 and Figure 7 Communication component 602 can be configured to facilitate telemetry communication between external monitoring device 116 and implantable device 104. Communication component 602 can also facilitate communication between external monitoring device 116 and other devices (e.g., external clinician device 120, server device, or another suitable device). In some examples, communication component 702 can perform one or more functions that are the same as or similar to those of communication component 602. For example, communication component 702 can control the operation of transmitter / receiver 710 to establish a monitoring telemetry session with the implantable device and control the transmission and reception of data packets by external monitoring device 116.

[0136] Communication component 702 can facilitate telemetry communication between external monitoring device 116 and implantable device 104 using various networks (not shown) and / or wireless communication protocols. For example, in one or more examples, communication component 702 can communicate with implantable device 104 or another device (e.g., external clinician device 120) using NFC or other types of communication protocols on a PAN or LAN (e.g., a Wi-Fi network). These other types of communication protocols can provide communication over greater distances than the NFC protocol or can offer various advantages (e.g., enhanced security).

[0137] In some examples, communication component 702 can control the transmission and reception of data packets via a communication channel associated with a communication protocol that utilizes lower power consumption than conventional communication protocols used for wireless data transmission. For example, in a non-limiting example, communication component 702 uses the BLE protocol to control the transmission and reception of data packets. Other communication protocols that communication component 702 can use to communicate with implanted device 104 may include, but are not limited to: others. Communication protocols, protocols based on Session Initiation Protocol (SIP), Protocols, RF4CE protocol, WirelessHART protocol, 6LoWPAN (IPv6 on low-power wireless personal area networks) protocol, Z-Wave protocol, ANT protocol, ultra-wideband (UWB) standard protocol, radio frequency (RF) communication protocols and / or other proprietary and non-proprietary communication protocols.

[0138] In some examples, communication component 702 can control the transmission and reception of data packets via a communication channel associated with a communication protocol that utilizes lower power consumption than conventional communication protocols used for wireless data transmission. In a non-limiting example, communication component 702 uses the BLE protocol to control the transmission and reception of data packets. Other communication protocols that communication component 702 can use to communicate with external monitoring device 116 and / or external clinician device 120 may include, but are not limited to: others. Communication protocols, protocols based on Session Initiation Protocol (SIP), Protocols, RF4CE protocol, WirelessHART protocol, 6LoWPAN (IPv6 on low-power wireless personal area networks) protocol, Z-Wave protocol, ANT protocol, ultra-wideband (UWB) standard protocol, radio frequency (RF) communication protocols and / or other proprietary and non-proprietary communication protocols.

[0139] In various examples, communication component 702 can be configured to facilitate telemetry communication between external clinician device 120 and implantable device 104 associated with a monitoring session. For example, after a monitoring session is established between the implantable device and external monitoring device 116, communication component 702 can receive information monitored by the implantable device and transmitted to external monitoring device 116 (e.g., physiological information captured by the implantable device 104 from the patient, operational information monitored by the implantable device 104, etc.).

[0140] In one or more examples, communication component 702 may be configured to establish a secure or trusted telemetry session with implantable device 104 before facilitating sensitive data exchange with implantable device 104. Authorization component 706 may facilitate the establishment of a secure and trusted connection with implantable device. For example, to establish a monitoring session with implantable device, authorization component 706 may include authorization information in a monitoring session request sent by an external monitoring device to implantable device 104. In some examples, authorization information includes external monitoring device 116 information that uniquely identifies the external monitoring device 116 (e.g., device identifier, encryption key, MAC, or other suitable authentication information). This authentication information may be provided to implantable device 104 in advance and stored in the memory 620 of implantable device as authorization device information 622. Implantable device 104 may process the received authorization information to determine whether external monitoring device 116 is authorized to communicate with implantable device 104. In some embodiments, external monitoring device 116 is paired with implantable device 104.

[0141] Monitoring component 704 can be configured to facilitate the establishment and execution of a monitoring session with implanted device 104. For example, while the implanted device is operating in a first notification mode, monitoring component 704 can determine when to respond to notification packets received from implanted device 104. For example, implanted device 104 can be configured to respond according to a defined schedule (e.g., once a day, twice a day, hourly, etc.) or in response to a triggered event. Monitoring component 704 can further request communication component 702 to send a monitoring session request accordingly. Monitoring component 704 can request specific information from or receive defined information from implanted device during the monitoring session. Monitoring component 704 can further determine whether the monitoring session is complete and close the monitoring session.

[0142] Figure 8 A block diagram illustrating an example non-limiting external clinician device (e.g., external clinician device 120) according to one or more examples described herein is shown. External clinician device 120 may include any suitable computing device operable by a clinician and configured to communicate with implantable device 104 using a first (e.g., RF) telemetry communication protocol / technology and a second (e.g., inductive) telemetry communication protocol / technology. For example, external clinician device 120 may include a smartphone, tablet computer, dedicated handheld device, wearable device, or other suitable device. In some examples, external clinician device 120 may include output and / or input devices such as a display, speaker, microphone, keypad, touchscreen, etc. In other examples, external clinician device 120 may be configured to communicate with another external device to receive input and / or present output.

[0143] External clinician device 120 includes a communication component 802, an authorization component 808, and a clinician component 816. Aspects of the systems, apparatus, or processes explained in this disclosure may constitute machine-executable components embodied within (multiple) machines, for example, embodied in one or more computer-readable media (or media) associated with one or more machines. Such components, when executed by said one or more machines (e.g., computers, computing devices, virtual machines, etc.), may cause said machines to perform the described operations.

[0144] External clinician device 120 may include memory 812 configured to store computer-executable components and instructions. External clinician device 120 may also include processor 810 for facilitating operation of instructions (e.g., computer-executable components and instructions) by external clinician device 120. External clinician device 120 may include bus 814 coupling various components of external clinician device 120, including but not limited to communication component 802, authorization component 808, clinician component 816, processor 810, and memory 812. For brevity, repetitive descriptions of similar elements used in other examples described herein are omitted.

[0145] Reference Figure 1 , Figure 2 and Figure 8 Communication component 802 can be configured to facilitate telemetry communication between external clinician device 120 and implantable device 104. Communication component 802 can also facilitate communication between external clinician device 120 and one or more other external devices (e.g., external monitoring device 116, server device, or another device). Communication component 802 can provide one or more features and / or functions that are the same as or similar to those of communication component 602. For example, communication component 802 can include a first telemetry communication component 804 that provides the same or similar features and functions as the first telemetry communication component 604. Communication component 802 can also include a second telemetry communication component 806 that provides the same or similar features and functions as the second telemetry communication component 606.

[0146] In one or more examples, communication component 802 may be configured to establish a secure or trusted telemetry session with implantable device 104 prior to facilitating the exchange of sensitive data between implantable device 104 and external clinician device 120. Authorization component 808 may facilitate the establishment of a trusted clinician session between external clinician device 120 and implantable device. For example, authorization component 808 may request second telemetry communication component 806 to generate an external clinician-initiated request using inductive signals and send it to implantable device 104, including a unique identifier of the external clinician device (e.g., an RFM address) in the clinician session initiation request. Second telemetry communication component 806 may further receive a response signal to the clinician session initiation request from implantable device 104 via inductive signals, and authorization component 808 may extract authorization information included in the response signal. In one or more embodiments, the authorization information includes a unique session identifier and one or more session keys. Authorization component 808 may further store the authorization information in memory 812. Authorization component 808 may further identify notification packets emitted by implantable device based on the inclusion and identification of session identifiers in notification packets. Then, the authorization component 808 may request the first telemetry communication component 804 to send a connection request to the implantable device, including a unique identifier for the external clinician device in the connection request. The implantable device 104 may then establish an authorized clinician session with the external clinician device 120. After establishing the clinician session, the first telemetry communication component 804 may use one or more session keys to encrypt and decrypt information transmitted between the implantable device 104 and the external clinician device 120.

[0147] External clinician device 120 includes a clinician component 816 for facilitating the establishment and conduct of clinician sessions with implantable device 104. For example, clinician component 816 may facilitate requesting specific information from and sending that information to implantable device 104. Clinician component 816 may include a programming component 818, a waveform component 820, and a standby component 822. Programming component 818 may facilitate the generation of programming commands and their transmission to implantable device 104. Waveform component 820 may facilitate the activation and deactivation of waveform modes of implantable device 104 and the reception of live waveform data from implantable device 104. Standby component 822 may facilitate requests to implantable device 104 to enter and exit standby modes. For example, in one or more examples, external clinician device 120 is configured to manage the entry and exit of implantable device standby mode 205. For example, when operating in clinician session mode 206, external clinician device 120 may send a command to implantable device to enter standby mode. The implantable device can be further configured to enter standby mode only in response to receiving this command from the external clinician device during a clinician session established with the external clinician device. Similarly, when operating in standby mode 205, the external clinician device 120 can send a command to the implantable device to exit standby mode. The implantable device can be further configured to exit standby mode only in response to receiving this exit standby mode command.

[0148] Figure 9 A schematic diagram of another example of a non-limiting medical device telemetry system 900 configured to facilitate the management of telemetry communication operation modes for an implantable device, according to one or more examples described herein. System 900 includes features identical or similar to those of medical device telemetry system 100. Unlike medical device telemetry system 100, system 900 does not include an external monitoring device 116 and an external clinician device 120. Instead, one or more features and functions of external monitoring device 116 and external clinician device 120 are provided on a single external device. For example, external device 902 may include a monitoring component 704 and a clinician component 816. In various examples, external device 902 may operate with the capabilities of an external monitoring device (e.g., external monitoring device 116) by using monitoring component 704, or with the capabilities of an external clinician device (e.g., clinician component 816) by using clinician component 816.

[0149] System 900 also includes server device 904. In various examples, external device 902 may communicate with server device using one or more of the wired or wireless communication technologies and protocols described herein. In one or more examples, external device 902 may be configured to send to server device 904 information received by external device 902 from implantable device 104 (e.g., monitored physiological information, operational information associated with implantable device, real-time waveform data received from implantable device, etc.). Server device 904 may also send to external device 902 information associated with performing telemetry communication with implantable device 104. For example, server device 904 may send to external device 902 authorization information required to establish an authorized monitoring session with implantable device 104. In another example, server device 904 may send to external device 902 programming information provided by external device 902 to implantable device 104 via clinician component 816. For brevity, repetitive descriptions of similar elements used in the corresponding examples are omitted.

[0150] Figures 10 to 12 A flowchart illustrating an example non-limiting method for facilitating the management of the operation of an implantable device (e.g., implantable device 104) in different communication operating modes, according to one or more examples described herein. For the purpose of simplification, although the method is shown and described as a series of actions, the disclosed subject matter is not limited to the order of the actions, as some actions may occur in a different order and / or simultaneously with other actions shown and described herein. For example, those skilled in the art will understand and recognize that the method may alternatively be represented as a series of interrelated states or events, as in a state diagram. Furthermore, not all shown actions may require the implementation of the method described according to the disclosed subject matter. Additionally, it will be understood that the methods disclosed herein can be stored on an article of manufacture facilitating the transmission and delivery of such methods to a computer or other computing device.

[0151] The method of this subject promotes enhanced battery saving associated with telemetry operation of an implantable device (e.g., implantable device 104) by employing different communication operation modes, each associated with different battery consumption levels. The different battery consumption levels associated with these different communication modes are attributed to the activation of different types of telemetry hardware circuitry system components of the implantable device (e.g., RF components and sensing components) and the different activation levels of each telemetry hardware circuitry system component (e.g., different duty cycles for receiver and transmitter activation). Because the activation and deactivation of different telemetry hardware circuitry system components involves physical and electrical processes and components, the battery-saving technique of this subject cannot be replicated or performed by humans. Furthermore, the battery-saving technique of this subject provides substantial improvements in the field of implantable device telemetry operation while facilitating different types of telemetry communication performed by the implantable device. System 100 further provides substantial improvements in the field of telemetry security for implantable medical devices. Specifically, the following methods facilitate enhanced security associated with establishing and performing telemetry sessions with an implantable device (e.g., implantable device 104) using RF-based telemetry communication technologies / protocols (e.g., BLE), which enable rapid (and high-power) bidirectional telemetry communication with the implantable device 104 of data considered highly invasive or sensitive (e.g., programming data or waveform data associated with a clinician session).

[0152] Now refer to Figure 10 The diagram illustrates a flowchart of an example method 1000 configured to facilitate the management of telemetry communication operating modes for an implantable device according to one embodiment. In some examples of method 1000, the implantable device (e.g., implantable device 104) employs a communication component (e.g., communication component 602), an authorization component (e.g., authorization component 610), and a communication mode management component (e.g., communication mode management component 608) to manage the operation of the implantable device using multiple different communication operating modes. For brevity, repetitive descriptions of similar elements used in other examples described herein are omitted.

[0153] At 1002, the implantable medical device (e.g., implantable device 104) can facilitate the management of telemetry communications between the implantable device and one or more external devices using a first telemetry communication protocol (e.g., BLE) and a second telemetry communication protocol (e.g., sensing). At 1004, the implantable medical device can control its operation in different communication operation modes, including a disabled mode (e.g., disabled mode 201), a first notification mode (e.g., first notification mode 203), and a second notification mode (e.g., second notification mode 204). For example, during the disabled mode, the implantable device (e.g., via communication mode management component 608) can block telemetry communications between the implantable device and the one or more external devices according to the first telemetry communication protocol and enable telemetry communications between the implantable device and the one or more external devices according to the second telemetry communication protocol. During a first notification mode, the implantable device may facilitate the establishment of a first type of telemetry communication session (e.g., a monitoring session) between the implantable device and the one or more external devices (e.g., external monitoring device 116 or external device 902) using a first telemetry communication protocol. During a second notification mode, the implantable device may facilitate the establishment of a second type of telemetry communication session (e.g., a clinician session) between the implantable device and the one or more external devices (e.g., external clinician device 120 or external device 902) using the first telemetry communication protocol. In one embodiment, during the first notification mode, the implantable device may transmit (e.g., via the first telemetry communication component 604) one or more first notification data packets at a first limited rate (e.g., once every three minutes) according to the first telemetry communication protocol, and during the second notification mode, the implantable device may transmit (e.g., via the first telemetry communication component 604) one or more second notification data packets at a second limited rate (e.g., once per second) according to the first telemetry communication protocol. In some examples, the second limited rate may be faster than the first limited rate.

[0154] Turn now Figure 11 The diagram illustrates a flowchart of an example method 1100 configured to facilitate the management of telemetry communication operating modes for an implantable device according to one embodiment. In some examples of method 1100, the implantable device (e.g., implantable device 104) employs a communication component (e.g., communication component 602), an authorization component (e.g., authorization component 610), and / or a communication mode management component (e.g., communication mode management component 608) to manage the operation of the implantable device using multiple different communication operating modes. For brevity, repetitive descriptions of similar elements used in other examples described herein are omitted.

[0155] At 1102, the implantable device including the processor can operate in a disabled mode (e.g., disabled mode 201) or a first notification mode (e.g., first notification mode 203). When operating in disabled mode, the implantable device can block telemetry communication performed by the implantable device using a first telemetry communication protocol. When operating in the first notification mode, the implantable device can transmit a first notification data packet at a first rate (e.g., once every three minutes) according to the first telemetry communication protocol. At 1104, when operating in disabled mode or the first notification mode, the implantable device can receive a clinician session request from a clinician device according to a second telemetry communication protocol (e.g., via a sensing signal). At 1106, the implantable device can switch from operating in disabled mode or the first notification mode to operating in the second notification mode based on receiving a clinician session request. When operating in the second notification mode, the implantable device can transmit a second notification data packet at a second rate according to the first telemetry communication protocol. In one or more embodiments, the second rate is faster than the first rate.

[0156] Now refer to Figure 12 The diagram illustrates a flowchart of another example method 1200 configured to facilitate the management of telemetry communication operation modes for an implantable device, based on one or more examples. In some examples of method 1200, the implantable device (e.g., implantable device 104) employs a communication component (e.g., communication component 602), an authorization component (e.g., authorization component 610), and a communication mode management component (e.g., communication mode management component 608) to manage the operation of the implantable device using multiple different communication operation modes. For the sake of brevity, repetitive descriptions of similar elements used in other examples described herein are omitted.

[0157] At 1202, the implantable device including the processor (e.g., implantable device 104) can operate in a disabled mode (e.g., disabled mode 201) or a first notification mode (e.g., first notification mode 203). When operating in disabled mode, the implantable device can block telemetry communication performed by the implantable device using a first telemetry communication protocol. When operating in the first notification mode, the implantable device can transmit a first notification data packet at a first rate (e.g., once every three minutes) according to the first telemetry communication protocol. At 1204, when operating in disabled mode or the first notification mode, the implantable device can receive a clinician session request from a clinician device according to a second telemetry communication protocol (e.g., via a sensing signal). The clinician session request may include an identifier of the clinician device.

[0158] At point 1206, the implantable device can switch from operating in a disabled mode or a first notification mode to operating in a second notification mode based on receiving a clinician session request. When operating in the second notification mode, the implantable device can transmit a second notification data packet at a second rate according to a first telemetry communication protocol. In one or more embodiments, the second rate is faster than the first rate.

[0159] At 1208, the implantable device can establish a clinician session with the clinician device based on transmitting a second notification data packet and an identifier. For example, in response to receiving a clinician session request, the implantable device can generate (e.g., via authorization component 610) session authorization information including a unique session identifier and one or more unique session keys. The implantable device can send the session authorization information to the clinician device using a second telemetry communication protocol. The implantable device can then begin transmitting a second notification data packet including the unique session identifier. The clinician device can receive the second notification data packet and identify the unique session identifier in the second notification data packet. Based on the identification of the unique session identifier, the clinician device can send a connection request to the implantable device including the clinician device's identifier. The implantable device can be configured to accept only connection requests received from a clinician device that provides a clinician session request using the second telemetry communication protocol and includes the clinician device's identifier. The implantable device can determine that the connection request is provided by the clinician device based on the identification of the clinician device's identifier.

[0160] Figure 13 A block diagram illustrating an example non-limiting computer operable to facilitate the management of telemetry communication modes for implantable devices, according to one or more examples described herein. For example, in some examples, the computer may be or be included within implantable device 104, external monitoring device 116, external clinician device 120, external device 902, and / or server 904. For brevity, repetitive descriptions of similar elements used in other examples described herein have been omitted.

[0161] To provide additional context for one or more examples described in this article, Figure 13 The following discussion is intended to provide a brief general description of a suitable computing environment 1300 in which one or more of the examples described herein may be implemented.

[0162] Generally, program modules include routines, programs, components, data structures, etc., that perform specific tasks or implement specific abstract data types. Furthermore, those skilled in the art will recognize that the methods of this invention can be practiced with other computer system configurations, including single-processor or multi-processor computer systems, microcomputers, mainframe computers, and personal computers, handheld computing devices, microprocessor-based or programmable consumer electronics, etc., each of which is operatively coupled to one or more associated devices.

[0163] Computing devices typically include a variety of media, which may include computer-readable storage media and / or communication media, these two terms being used differently from each other herein. A computer-readable storage medium can be any available storage medium accessible by a computer and includes both volatile and non-volatile media, removable and non-removable media. For example, but not limited to, a computer-readable storage medium can be implemented in conjunction with any method or technology to store information such as computer-readable instructions, programming modules, structured data, or unstructured data. Tangible and / or non-transitory computer-readable storage media may include, but are not limited to, random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technologies, optical disc read-only memory (CD-ROM), digital versatile optical disc (DVD) or other optical disc storage devices, magnetic tape cassettes, magnetic tape, disk storage devices, other magnetic storage devices, and / or other media that can be used to store desired information. A computer-readable storage medium can be accessed by one or more local or external computing devices, for example, via access requests, queries, or other data retrieval protocols, to perform various operations regarding the information stored by the medium.

[0164] In this regard, the term “tangible” here, when applied to storage devices, memory, computer-readable media or computer-readable storage media, should be understood to exclude all standard storage devices, memory, computer-readable media or computer-readable storage media that, as modifiers themselves, only propagate tangible signals and do not relinquish coverage of all standard storage devices, memory, computer-readable media or computer-readable storage media that, in addition to propagating tangible signals themselves.

[0165] In this regard, the term "non-transient" as applied here to storage devices, memory, computer-readable media or computer-readable storage media should be understood as excluding all standard storage devices, memory, computer-readable media or computer-readable storage media that, as modifiers themselves, only propagate non-transient signals and do not relinquish coverage of all standard storage devices, memory, computer-readable media or computer-readable storage media that not only propagate non-transient signals.

[0166] Communication media typically embody computer-readable instructions, data structures, programming modules, or other structured or unstructured data in data signals (such as modulated data signals, e.g., channel waves or other transmission mechanisms), and include any information delivery or transmission medium. The term "modulated data signal" or signal refers to a signal that has one or more characteristics of a data signal characteristic set and is modified in such a way as to encode information in one or more signals. For example, but not in a limiting sense, communication media include wired media (such as wired networks or line-of-sight connections) and wireless media (such as voice media, RF media, infrared media, and other wireless media).

[0167] Refer again Figure 13 Example environment 1300, which can be used to implement one or more of the examples described herein, includes computer 1302. Computer 1302 includes processing unit 1304, system memory 1306, and system bus 1308. System bus 1308 couples system components (including, but not limited to, system memory 1306) to processing unit 1304. Processing unit 1304 can be any of a variety of commercially available processors. Dual-core microprocessors and other multi-core processor architectures can also be used as processing unit 1304.

[0168] System bus 1308 can be any of several types of bus architectures, which can be further interconnected to memory buses (with or without memory controllers), peripheral buses, and local buses using any of a variety of commercially available bus architectures. System memory 1306 includes RAM 1310 and ROM 1312. The basic input / output system (BIOS) can be stored in non-volatile memory, such as ROM, erasable programmable read-only memory (EPROM), or EEPROM, and the BIOS contains basic routines that help transfer information between components within computer 1302, such as during startup. RAM 1310 may also include high-speed RAM, such as static RAM for caching data.

[0169] Computer 1302 further includes an internal hard disk drive (HDD) 1314 (e.g., Enhanced Integrated Drive Electronics (EIDE), Serial Advanced Technology Accessory (SATA)). HDD 1314 can be connected to system bus 1308 via hard disk drive interface 1316. The drive and its associated computer-readable storage medium provide non-volatile storage of data, data structures, computer-executable instructions, etc. For computer 1302, the drive and storage medium are configured to store any data in an appropriate digital format.

[0170] Multiple programming modules can be stored in the drive and RAM 1310, including an operating system 1336, one or more application programs 1338, other programming modules 1340, and programming data 1342. All or part of the operating system, applications, modules, and / or data can also be cached in RAM 1310. The systems and methods described herein can be implemented using a variety of commercially available operating systems or combinations of operating systems.

[0171] Mobile devices can input commands and information into computer 1302 via one or more wireless input devices (e.g., wireless keyboard 1328 and pointing devices such as wireless mouse 1330). Other input devices (not shown) may include smartphones, tablets, laptops, probes, wearable devices, etc. These and other input devices are often connected to processing unit 1304 via input device interface 1318, which is coupled to system bus 1308, but may also be connected via other interfaces such as parallel ports, IEEE serial ports, game ports, and / or Universal Serial Bus (USB) ports.

[0172] Computer 1302 can operate in a networked environment via logical connections to one or more external computers (such as (multiple) external computers 1332) using wired and / or wireless communications. The (multiple) external computers 1332 can be workstations, server computers, routers, personal computers, portable computers, microprocessor-based entertainment devices, peer-to-peer devices, or other public network nodes, and generally include many or all of the elements described with respect to computer 1302, although only memory / storage device 1334 is shown for the sake of brevity. The depicted logical connections include wired / wireless connections to a local area network (LAN) 1326 and / or a larger network (e.g., a WAN 1324) as well as smaller PANs involving several (e.g., at least two) devices. LAN and WAN networked environments are common places in homes, offices (e.g., medical facility offices, hospital offices), and companies, and facilitate enterprise-wide computer networks (such as intranets) where all networks can be connected to global communications networks (e.g., the Internet).

[0173] When used in a LAN networking environment, computer 1302 can connect to the local area network (LAN) via a wired and / or wireless communication network interface or adapter 1320. Adapter 1320 can facilitate wired or wireless communication to LAN 1326, and may also include a wireless access point (AP) connected to LAN 1326 for communication with adapter 1320.

[0174] When used in a WAN networking environment, computer 1302 may include modem 1322 or a communication server that can be connected to WAN 1324, or other means for establishing communication via WAN 1324 (e.g., via the Internet). Modem 1322, which may be internal or external and wired or wireless, may be connected to system bus 1308 via input device interface 1318. In a networking environment, programming modules depicted with respect to computer 1302 or a portion thereof may be stored in external memory / storage devices. It will be understood that the network connections shown are examples and other means for establishing communication links between computers may be used.

[0175] Computer 1302 can be operated via any number of protocols (including but not limited to NFC, Wi-Fi and / or A wireless protocol (or wireless protocol) communicates with any wireless device or entity operationally deployed in wireless communication. Therefore, communication can be about the defined structure of a conventional network or simply self-organizing communication between at least two devices.

[0176] NFC allows point-to-point connections between NFC-enabled devices in an IMD NFC field, either at home or anywhere else. NFC technology can be facilitated using NFC-enabled smartphones, tablets, or other devices that can be brought within a 3-4 cm range of the embedded NFC component. NFC typically offers a maximum data rate of 424 kilobits per second (Kbps), although data rates can vary from 6.67 Kbps to 828 Kbps. NFC typically operates at a frequency of 13.56 MHz. NFC communication is typically within a range of no more than 0.2 meters (m) and setup time can be less than 0.1 seconds. Low-power (e.g., 13 mA) readings of data can be performed by NFC devices.

[0177] Wi-Fi allows wireless internet access from your sofa at home, your bed in a hotel room, or a work room. Similar to the wireless technology used in telephones, Wi-Fi enables devices such as computers to send and receive data indoors and outdoors. Wi-Fi networks use radio technology known as IEEE 802.11 (a, b, g, n, etc.) to provide secure, reliable, and fast wireless connectivity. Wi-Fi networks can be used to connect computers to each other, connect to the internet, and connect to wired networks (which can use IEEE 802.3 or Ethernet). Wi-Fi networks operate in the unlicensed 2.4 and 5 GHz radio bands at data rates of, for example, 11 Mbps (802.11a) or 54 Mbps (802.11b), or have products that include both bands (dual-band), thus providing real-world performance similar to basic 10BaseT wired Ethernet networks used in many offices.

[0178] The examples of devices described herein can employ artificial intelligence (AI) to facilitate the automatic matching of one or more features described herein. These examples (e.g., combining automatic identification of cellular sites that provide maximum / benefit after being added to an existing communication network) can employ various AI-based schemes to execute one or more of their examples. Furthermore, a classifier can be employed to determine the ranking or priority of each cellular site in the acquired network. A classifier is a function that maps an input attribute vector x = (x1, x2, x3, x4, ..., xn) to a confidence level of the category to which the input belongs, i.e., f(x) = confidence level (category). This classification can employ probabilistic and / or statistically based analysis (e.g., considering analytical tools and cost factors) to predict or infer actions that the mobile device expects to perform automatically. Support Vector Machines (SVMs) are an example of classifiers that can be employed. SVMs operate by finding a hypersurface in the possible input space that attempts to separate triggering criteria from non-triggering events. Intuitively, this allows for correct classification of test data that is close to, but not entirely equivalent to, the training data. Other guided and unguided model classification approaches include, for example, Naive Bayes (…). Various classification models, including Bayesian networks, decision trees, neural networks, and fuzzy logic models, can be employed, and probabilistic classification models providing different independent patterns can also be used. The classification used here also includes statistical regression, which is used to develop priority models.

[0179] As will be readily understood, one or more of the examples described can employ explicitly trained (e.g., via general training data) and implicitly trained (e.g., via observing mobile device behavior, operator preferences, historical information, or received external information) classifiers. For example, an SVM can be configured in the classifier builder and feature selection module via a learning or training phase. Thus, the classifier(s) can be used to automatically learn and perform multiple functions, including but not limited to determining, based on defined criteria, which acquired cellular sites will acquire the largest number of subscribers and / or which acquired cellular sites will add the smallest number to the existing communication network coverage, etc.

[0180] As used herein, the term "processor" can refer to virtually any computing processing unit or device, including but not limited to: a single-core processor; a single-core processor with software multithreading capabilities; a multi-core processor; a multi-core processor with software multithreading capabilities; a multi-core processor with hardware multithreading technology; a parallel platform; and a parallel platform with distributed shared memory. Furthermore, a processor can be an integrated circuit, an application-specific integrated circuit (ASIC), a digital signal processor (DSP), a field-programmable gate array (FPGA), a programmable logic controller (PLC), a complex programmable logic device (CPLD), discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. Processors can utilize nanoscale architectures, such as, but not limited to, molecular and quantum dot-based transistors, switch boxes, and gates, to optimize space utilization or enhance the performance of mobile device equipment. Processors can also be implemented as a combination of computing processing units.

[0181] The memory disclosed herein may include volatile memory or non-volatile memory, or both. For example, but not limited to, non-volatile memory may include ROM, programmable ROM (PROM), electrically programmable ROM (EPROM), electrically erasable PROM (EEPROM), or flash memory. Volatile memory may include RAM, which acts as external cache memory. For example, but not limited to, RAM is available in many forms, such as SRAM, dynamic RAM (DRAM), synchronous DRAM (SDRAM), dual data rate SDRAM (DDR SDRAM), enhanced SDRAM (ESDRAM), synchronous linked DRAM (SLDRAM), and direct-attached Rambus RAM (DRRAM). The memory in the examples (e.g., data storage devices, databases) is intended to include, but is not limited to, these and any other suitable type of memory.

[0182] As used herein, terms such as “data storage device,” “database,” and virtually any other information storage component relating to the operation and function of a component refer to a “memory component” or an entity embodied in a “memory” or component that includes memory. It will be understood that the memory component or computer-readable storage medium described herein can be volatile memory or non-volatile memory, or may include both volatile and non-volatile memory.

[0183] Additionally, the terms “example” and “exemplary” are used herein to refer to instances or demonstrations. Any embodiment or design described herein as an “example” or “exemplary” is not necessarily to be construed as preferred or superior to other examples or designs. Rather, the use of the terms “example” and “exemplary” is intended to present concepts in a concrete manner. As used in this specification, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or.” That is, unless otherwise specified or obvious from the context, “X adopts A or B” is intended to mean any of the natural inclusive arrangements. That is, “X adopts A or B” is satisfied in any of the foregoing cases if X adopts A; X adopts B; or X adopts both A and B. Furthermore, the articles “a” and “an” used in this application should generally be understood to mean “one or more” unless otherwise specified or obvious from the context for the singular form. The terms “first,” “second,” “third,” etc., used in the claims and specification are for brevity purposes only and do not necessarily indicate or imply any temporal order unless otherwise clearly apparent from the context.

[0184] The content described above includes only examples of one or more examples. It is certainly impossible to describe every conceivable combination of components or methods for the purpose of describing these examples, but those skilled in the art will recognize that many other combinations and arrangements of the examples herein are possible. Therefore, the examples disclosed and / or claimed herein are intended to include all such changes, modifications, and variations falling within the spirit and scope of the detailed specification and appended claims. Furthermore, with respect to the use of the term "include" in the detailed specification and claims, this term is intended to be open-ended in a manner similar to the term "comprising," as "comprising," when used, is interpreted as a transitional word in a claim.

Claims

1. A device for telemetry communication, the device comprising: A communication component configured to facilitate telemetry communication between the device and the second device using a first telemetry communication protocol in order to transmit data; as well as A communication mode management component, configured to control the operation of the device in multiple communication modes, including: A first notification mode, configured to facilitate the establishment of a first type of telemetry communication session between the device and the second device using the first telemetry communication protocol; and A second notification mode, configured to facilitate the establishment of a second type of telemetry communication session between the device and the second device using the first telemetry communication protocol, and The device switches from the first notification mode to the second notification mode in response to receiving a request for the second type of telemetry communication session.

2. The device as described in claim 1, characterized in that, The first type of telemetry communication session is more restrictive than the second type of communication session.

3. The device as described in claim 2, characterized in that, The first type of telemetry communication session only allows reading stored data, while the second type of communication session allows reading stored data as well as programming the operating parameters of the device.

4. The device as described in claim 2, characterized in that, The first type of telemetry communication session only allows reading previously stored data, while the second type of communication session allows reading previously stored data as well as obtaining real-time data.

5. The device of claim 2, further comprising a circuit system configured to perform at least one of acquiring sensory physiological data associated with a patient or delivering treatment to the patient, wherein, The first type of telemetry communication session allows reading sensory physiological data associated with the patient, and the second type of communication session allows requesting the device to provide the treatment.

6. The device as described in claim 1, characterized in that, During the first notification mode, the communication component is further configured to transmit a plurality of first notification data packets at a first limited rate according to the first telemetry communication protocol, and wherein, during the second notification mode, the communication component is further configured to transmit a plurality of second notification data packets at a second limited rate according to the first telemetry communication protocol, wherein the second limited rate is faster than the first limited rate.

7. The device as described in claim 1, characterized in that, During the first notification mode, the communication component is further configured to transmit a plurality of first notification data packets within a first duration according to the first telemetry communication protocol, and wherein, during the second notification mode, the communication component is further configured to transmit a plurality of second notification data packets within a second duration according to the first telemetry communication protocol, wherein the second duration is longer than the first duration.

8. The device as described in claim 1, characterized in that, The communication component includes a first communication component, and the device further includes a second communication component configured to facilitate telemetry communication between the device and a second device using a second telemetry communication protocol. The communication mode management component is further configured to: switch the operation of the device from the first notification mode to the second notification mode based on a request to establish a second type of telemetry communication session received by the communication component via the second telemetry communication protocol.

9. The device as described in claim 8, characterized in that, The first telemetry communication protocol includes the Bluetooth Low Energy communication protocol, and the second telemetry communication protocol includes an induction-based wireless communication protocol.

10. The device as claimed in claim 8, characterized in that, The plurality of communication modes further include a disabled mode, which is configured to: block telemetry communication between the device and the second device according to the first telemetry communication protocol and enable telemetry communication between the device and the second device according to the second telemetry communication protocol, wherein the communication mode management component is configured to: switch the operation of the device from the disabled mode to the second notification mode in response to receiving a request for a telemetry communication session of the second type via the second telemetry communication protocol.

11. The device as claimed in claim 1, characterized in that, The communication mode management component is configured to: switch the operation of the device from the second notification mode to the first notification mode based on the fact that the device and the second device associated with the request have failed to establish a telemetry communication session of the second type within a limited time period.

12. The device as claimed in claim 1, characterized in that, The device further includes a housing configured for implantation in a patient, wherein the communication components and the communication mode management components are contained within the housing. The plurality of communication modes further includes a disabled mode, which is configured to prevent telemetry communication between the device and the second device according to the first telemetry communication protocol, and the communication mode management component is configured to switch from the disabled mode to the first announcement mode in response to a transition event that causes a transition from the disabled mode to the first announcement mode.

13. A method for telemetry communication, the method comprising: The communication components of the first device are operated in a first notification mode, which is configured to facilitate the establishment of a first type of telemetry communication session between the first device and the second device using a first telemetry communication protocol. Receive a request for a second type of telemetry communication session between the first device and the second device, wherein the first type of telemetry communication session is more restrictive than the second type of telemetry communication session; In response to receiving the request, the communication component of the first device is switched from the first announcement mode to a second announcement mode, the second announcement mode being configured to facilitate the establishment of a second type of telemetry communication session between the first device and the second device using the first telemetry communication protocol.

14. The method of claim 13, further comprising: In the first type of telemetry communication session, the second device is allowed to read only the stored data; as well as In the second type of communication session, the second device is allowed to read stored data and program the operating parameters of the first device.

15. The method of claim 13, further comprising: In the first type of telemetry communication session, the second device is allowed to read only the previously stored data; as well as In the second type of communication session, the second device is allowed to read previously stored data and obtain data stored in real time.

16. The method as described in claim 13, characterized in that, When operating in the first notification mode, multiple first notification data packets are transmitted at a first limited rate according to the first telemetry communication protocol, and Furthermore, when operating in the second notification mode, a plurality of second notification data packets are transmitted at a second limited rate according to the first telemetry communication protocol, wherein the second limited rate is faster than the first limited rate.

17. The method as described in claim 13, characterized in that, When operating in the first notification mode, one or more notification data packets are transmitted within a first duration according to the first telemetry communication protocol, and Furthermore, when operating in the second notification mode, one or more second notification data packets are transmitted within a second duration according to the first telemetry communication protocol, wherein the second duration is longer than the first duration.

18. The method as described in claim 13, characterized in that, Receiving a request for the second type of telemetry communication session includes receiving the request via a second communication component configured to facilitate telemetry communication between the first device and the second device using a second telemetry communication protocol.

19. The method of claim 13, further comprising: It is determined that the first device and the second device failed to establish the second type of telemetry communication session within a limited time period; as well as In response to the determination, the communication component is switched from the second notification mode to the first notification mode.

20. The method of claim 13, further comprising: The first device is operated in a disabled mode, which is configured to block telemetry communication between the first device and the second device according to the first telemetry communication protocol and enable telemetry communication between the first device and the second device according to the second telemetry communication protocol. When operating in the disabled mode, a request for a telemetry communication session of the second type is received via the second telemetry communication protocol; as well as In response to receiving the request, the operation of the communication component of the first device is switched from the disabled mode to the second notification mode.

21. The method of claim 13, The first device is operated in a disabled mode, which is configured to block telemetry communication between the first device and the second device according to the first telemetry communication protocol and enable telemetry communication between the first device and the second device according to the second telemetry communication protocol. When operating in the disabled mode, the implantation of the first device is detected; as well as In response to a transition event that causes a change from the disabled mode to the first notification mode, the operation of the communication component of the first device is changed from the disabled mode to the first notification mode.

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