System and method for managing Bluetooth low energy advertisements

Abstract

An implantable medical device (IMD), a computer-implemented method, and a computer program product are provided. The IMD includes sensing circuitry, a memory, a processor, and communication circuitry configured to wirelessly communicate with at least one other implantable or external device. When in a fully awake state, the communication circuitry is configured to perform tasks and actions associated with a Communication Protocol Start (CPS) instruction set, the CPS instruction set including an Advertisement Scan Related (ASR) instruction subset and a non-ASR instruction subset. When in a partially awake state, the communication circuitry is configured to perform, in accordance with the ASR instruction subset, sending advertisement notifications on one or more channels according to a wireless communication protocol and scanning one or more channels for connection requests from external devices. When no connection request is received, returning to a sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPS instruction set.

Description

Technical Field

[0001] The present disclosure relates to an implantable medical device. Background Art

[0002] An implantable medical device (IMD) is a medical device configured to be implanted within a patient's anatomy, typically employing one or more leads with electrodes that receive or deliver voltage, current, or other electromagnetic pulses from or to an organ or tissue for diagnostic or therapeutic purposes. Typically, an IMD includes a battery, electronic circuitry, a pulse generator, a transceiver, and / or a microprocessor configured to handle communications with external instruments and control patient therapy. The components of an IMD are enclosed in a metal housing.

[0003] An IMD is typically programmed by, and exchanges data with, an external instrument controlled by a physician and / or patient. Some commercially available external instruments use commercial operating systems (e.g., iOS, Android) that communicate with the IMD via a wireless, two-way communication link. For example, a mobile device with Bluetooth Low Energy (BLE) circuitry can be used to communicate with certain implantable medical devices. The two-way communication link is formed using a wireless communication protocol that includes advertising notifications received by the external instrument. The advertising notifications are broadcast by the IMD at a predetermined, constant frequency. The use of advertising notifications to facilitate the establishment of wireless communications involves significant power consumption by the implantable medical device.

[0004] Currently, during an advertising operation, a BLE-enabled IMD sends advertising notifications and searches for scan requests from external devices. When an advertising operation needs to be performed, the IMD is often in a sleep state. Therefore, before the IMD can send advertising notifications and search for scan requests, the IMD must first wake up from the sleep state. Each time the IMD wakes up from the sleep state, the IMD performs a predetermined set of startup and initialization actions or tasks. The IMD utilizes a certain amount of power to perform all of the startup and initialization actions / tasks associated with waking up. Over the lifetime of the IMD, the IMD will enter the sleep state and wake up from the sleep state a considerable number of times (for example, several times a day over a period of several years). Therefore, the actions and tasks performed during each wake-up operation simply to perform the advertising operation utilize an inordinate amount of power over the lifetime of the device.

[0005] There remains a need for improved ways to manage advertising operations of IMDs. Summary of the Invention

[0006] According to an embodiment of the present invention, an implantable medical device (IMD) is provided, comprising a sensing circuit, a memory, and a processor, wherein the sensing circuit is configured to collect biological signals, the memory is configured to store program instructions, and the processor is configured to implement the program instructions to analyze the biological signals and / or manage the storage or delivery of biological signals. The IMD also includes a communication circuit configured to wirelessly communicate with at least one other implantable or external device. The communication circuit can be configured to switch between a sleep state, a partially awake state, and a fully awake state. When in the fully awake state, the communication circuit can be configured to perform tasks and actions associated with a communication protocol start (CPS) instruction set, which includes an advertisement scan-related (ASR) instruction subset and a non-ASR instruction subset. When in the partially awake state, the communication circuit can be configured to perform functions according to the ASR instruction subset. These functions may include sending advertisement notifications on one or more channels according to a wireless communication protocol and scanning one or more channels to obtain a connection request from an external device. When no connection request is received, the communication circuit can return to a sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPS instruction set.

[0007] On the other hand, a computer-implemented method is provided. Under the control of one or more processors of a medical device, wherein the one or more processors are configured with specific executable instructions, the method may include collecting biological signals, and implementing program instructions to analyze the biological signals and / or manage the storage and / or delivery therapy of the biological signals. The method may also include wirelessly communicating with at least one other implantable or external device, and when in a fully awake state, performing tasks and actions associated with a communication protocol start (CPS) instruction set, the CPS instruction set including an advertisement scan related (ASR) instruction subset and a non-ASR instruction subset. When in a partially awake state, the method may include performing functions in accordance with the ASR instruction subset. The functions may include sending advertisement notifications on one or more channels according to a wireless communication protocol, scanning one or more channels to obtain connection requests from external devices, and when no connection request is received, returning to a sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPS instruction set.

[0008] On the other hand, a computer program product is provided. The computer program product may include a non-signal computer-readable storage medium having computer executable code to collect biosignals. The computer program product may also include computer executable code to analyze the biosignals, and / or manage the storage of the biosignals, and / or deliver therapy. The computer program product may also include computer executable code to wirelessly communicate with at least one other implantable or external device and, when in a fully awake state, perform tasks and actions associated with a communication protocol start (CPS) instruction set, the CPS instruction set including an advertisement scan-related (ASR) instruction subset and a non-ASR instruction subset. When in a partially awake state, the computer executable code may perform functions according to the ASR instruction subset. These functions may include sending advertisement notifications on one or more channels according to a wireless communication protocol, scanning one or more channels for connection requests from external devices, and returning to a sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPS instruction set when no connection request is received. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1A Shown is a diagrammatic representation of a heart with an implantable medical device (IMD) implemented in accordance with embodiments herein.

[0010] Figure 1B A system for integrating external diagnostics with remote monitoring provided by an implantable medical device that manages wake-up communication circuitry according to embodiments herein is shown.

[0011] Figure 2 A block diagram of an IMD formed in accordance with embodiments herein is shown.

[0012] Figure 3A An example of an initialization box of a BLE peripheral application in a fully awake state is shown.

[0013] Figure 3B An example of an initialization box of a BLE advertising application in a partially awake state is shown.

[0014] Figure 4 An example of an application switching sequence between a BLE advertising application in a partially awake state and a BLE advertising application in a fully awake state according to embodiments herein is shown.

[0015] Figure 5 is a state machine diagram illustrating states of a communication circuit configured according to embodiments herein. DETAILED DESCRIPTION

[0016] The terms "cardiac activity signal," "cardiac activity signals," "CA signal," and "CA signals" (collectively, "CA signals") are used interchangeably throughout to refer to analog or digital electrical signals recorded by two or more electrodes located subcutaneously or on the skin, wherein the electrical signals are indicative of cardiac electrical activity. Cardiac activity can be normal / healthy or abnormal / arrhythmic. Non-limiting examples of CA signals include ECG signals collected by subcutaneous electrodes, and EGM signals collected by subcutaneous electrodes and / or by electrodes placed on or near the heart wall and / or heart chambers.

[0017] The terms “body-generated analyte” and “BGA” shall mean a test substance or specimen that is naturally produced by or naturally present in the human body as defined in U.S. Provisional Patent Application No. 62 / 875,870, filed on July 18, 2019, entitled “METHODS, DEVICE AND SYSTEMS FOR HOLISTIC INTEGRATED HEALTHCARE PATIENT MANAGEMENT,” the entire subject matter of which is incorporated herein by reference.

[0018] The term "BGA test equipment" shall mean any and all equipment, devices, disposable products used to collect and analyze BGAs as defined in the 62 / 875,870 provisional application. The BGA test equipment may implement one or more of the methods, devices, and systems described in the 62 / 875,870 provisional application.

[0019] The term "bio-signal" shall include CA signal, BGA data indicating BGA, etc.

[0020] The term "low power" refers to the amount of power utilized by an IMD during a series of predefined actions or tasks that occur upon entering a partially awake state.

[0021] The term "high power" refers to the amount of power utilized by an IMD during a series of predefined actions or tasks that occur when entering a fully awake state.

[0022] The terms "low power" and "high power" are used relative to each other and not to refer to specific power levels.

[0023] Figure 1AAn implantable medical device (IMD) 101 is shown, intended for subcutaneous implantation at a site near the heart. IMD 101 includes a pair of spaced-apart sensing electrodes 114, 126 positioned relative to housing 102. Sensing electrodes 114, 126 provide for detection of far-field electrogram signals. Many configurations of electrode arrangements are possible. For example, electrode 114 may be located at the distal end of IMD 101, while electrode 126 is located at the proximal end of IMD 101. Additionally or alternatively, electrode 126 may be located on opposite sides, opposite ends, or elsewhere on IMD 101. Distal electrode 114 may be formed as part of housing 102, for example, by coating all but a portion of the housing with a non-conductive material, such that the uncoated portion forms electrode 114. In this case, electrode 126 may be electrically isolated from the housing 102 electrodes by being placed on a component separate from housing 102, such as header 120. Alternatively, header 120 may be formed as an integral part of housing 102. The head 120 includes an antenna 128 and electrodes 126. The antenna 128 is configured to wirelessly communicate with the external instrument 201 according to one or more predetermined wireless protocols (eg, Bluetooth, Bluetooth Low Energy, Wi-Fi, etc.).

[0024] The housing 102 includes various other components, such as sensing electronics for receiving signals from the electrodes, a microprocessor for analyzing far-field CA signals (including evaluating the presence of R-waves in heart beats that occur when the IMD is in different positions relative to gravity), circulating memory for temporary storage of CA data, device memory for long-term storage of CA data, sensors for detecting patient activity (including an accelerometer for detecting acceleration characteristics indicative of heart sounds), and a battery for powering the components.

[0025] In at least some embodiments, the IMD 101 is configured to be placed subcutaneously using a minimally invasive approach. Subcutaneous electrodes are provided on the housing 102 to simplify the implantation procedure and eliminate the need for a transvenous lead system. Sensing electrodes can be located on opposing sides of the device to provide robust event detection through consistent contact at the sensor-tissue interface. The IMD 101 can be configured to be activated by the patient or automatically activated in conjunction with recording subcutaneous ECG signals. The IMD 101 senses far-field, subcutaneous cardiac arrest (CA) signals, processes the CA signals to detect arrhythmias, and, if an arrhythmia is detected, automatically records the CA signals in a memory for subsequent transmission to an external instrument 201.

[0026] As explained herein, the IMD 101 includes electrodes that collect cardiac activity (CA) signals associated with multiple heart beats and associated with different IMD positions (e.g., different positions and / or different orientations). The IMD 101 also includes one or more sensors to collect acceleration characteristics indicative of heart sounds occurring at different points in the cardiac cycle.

[0027] Figure 1B A system for integrating external diagnostics with remote monitoring provided by an implantable medical device that manages wake-up communication circuitry according to an embodiment of the present invention is shown. The system can be implemented using various architectures, which are collectively referred to as a healthcare system 132. As an example, the healthcare system 132 can be implemented in the manner described herein. The healthcare system 132 is configured to receive data from various external and implantable sources, including but not limited to an active IMD 101 capable of delivering therapy to a patient, a passive IMD or sensor 134, a BGA test device 136, a wearable sensor 138, and a point-of-care (POC) device 140 (e.g., at home or in a healthcare facility). The POC device 140 can represent a type of BGA test device 136. Data from one or more of the external and / or implantable sources is collected and sent to one or more secure databases within the healthcare system 132.

[0028] For example, the external BGA test device 136 can collect laboratory test results for a specific test and then send the laboratory test results to the healthcare system 132. The BGA test device 136 can be implemented in various physical locations, such as one or more "core" laboratories, a doctor's office, an ER (emergency room), an OR (operating room), and / or a healthcare facility point-of-care (POC) (e.g., during a hospital stay or a routine healthcare visit). The BGA test device 136 can be implemented as a home-based POC device 140 that periodically collects test results or continuously monitors one or more body-generated analytes (e.g., blood glucose). The home-based POC device can include a mobile device, such as an iPhone, an Android phone, or other mobile device with Bluetooth wireless networking (such as Wi-Fi or cellular data capabilities). The home-based POC device 140 can send the raw BGA data to a healthcare network (e.g., a local external device and / or a remote server). Additionally or alternatively, the home-based POC device 140 can perform corresponding tests on the BGA data for characteristics of interest (COIs) (e.g., malnutrition status COI, electrolyte COI, cardiac marker COI, hematology COI, blood gas COI, coagulation COI, endocrinology COI). When the test is performed at home or elsewhere, the POC device 140 sends the COI (and optionally the BGA data) to the healthcare system 120. The POC device 140 can implement periodic or continuous glucose level testing, such as through sensors and the FREESTYLE® product offered by Abbott Laboratories under the trademark Alternatively, the BGA test device 136 may be implemented as a fully implantable "lab on a chip," such as an implantable biosensor array configured to collect laboratory test results.

[0029] Embodiments may be implemented in conjunction with one or more implantable medical devices (IMDs). Non-limiting examples of IMDs include one or more of a neurostimulator device, an implantable leadless monitoring and / or therapy device, and / or an alternative implantable medical device. The IMD may represent or include a BGA test device as described in the 62 / 875,870 provisional application. The IMD may represent a cardiac monitoring device, a pacemaker, a cardioverter, a cardiac rhythm management device, a defibrillator, a neurostimulator, a leadless monitoring device, a leadless pacemaker, or the like. For example, an IMD may include one or more structural and / or functional aspects of the device(s) described in U.S. Patent 9,333,351, “Neurostimulation Method And System To Treat Apnea,” and U.S. Patent 9,044,610, “System And Methods For Providing A Distributed Virtual Stimulation Cathode For Use With An Implantable Neurostimulation System,” which are incorporated herein by reference. Additionally or alternatively, the IMD may be a leadless implantable medical device (LIMD) that includes one or more structural and / or functional aspects of the device(s) described in U.S. Patent 9,216,285, “Leadless Implantable Medical Device Having Removable And Fixed Components,” and U.S. Patent 8,831,747, “Leadless Neurostimulation Device And Method Including The Same,” which are incorporated herein by reference. Additionally or alternatively, the IMD may include one or more structural and / or functional aspects of the device(s) described in U.S. Patent 8,391,980, “Method And System For Identifying A Potential Lead Failure In An Implantable Medical Device,” and U.S. Patent 9,232,485, “System And Method For Selectively Communicating With An Implantable Medical Device,” which are incorporated herein by reference.Additionally or alternatively, the IMD may be a subcutaneous IMD that includes one or more structural and / or functional aspects of the devices described in U.S. application serial number 15 / 973,195, filed May 7, 2018, entitled “Subcutaneous Implantation Medical Device With Multiple Parasternal-Anterior Electrodes,” U.S. application serial number 15 / 973,219, filed May 7, 2018, entitled “Implantable Medical Systems And Methods Including Pulse Generators And Leads,” and U.S. application serial number 15 / 973,249, filed May 7, 2018, entitled “Single Site Implantation Methods For Medical Devices Having Multiple Leads,” each of which is hereby incorporated by reference in its entirety. Furthermore, one or more combinations of IMDs from the aforementioned incorporated patents and applications may be utilized in accordance with embodiments herein. Additionally or alternatively, the IMD may be a leadless cardiac monitor (ICM) that includes one or more structural and / or functional aspects of the device(s) described in U.S. patent application entitled “METHOD AND SYSTEM TO DISCRIMINATE RHYTHMPATTERNS IN CARDIAC ACTIVITY,” filed on March 29, 2016, with registration number A15E1059, U.S. patent application Ser. No. 15 / 084,373, which is expressly incorporated herein by reference.

[0030] All references, including publications, patent applications, and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0031] Figure 2 A block diagram of the internal components of IMD 101 is shown. The components described herein may include or represent hardware and software instructions (e.g., software stored on a tangible and non-transitory computer-readable storage medium such as a computer hard drive, ROM, RAM, etc.) that perform the operations described herein. The hardware may include electronic circuitry that includes and / or is connected to one or more logic-based devices such as a microprocessor, processor, controller, etc. Additionally or alternatively, the components may be hard-wired logic circuitry.

[0032] IMD 101 is provided for illustrative purposes only, and it will be appreciated that circuits may be duplicated, eliminated, or disabled in any desired combination to provide a device capable of treating the appropriate cardiac chamber(s) with cardioversion, defibrillation, and / or pacing stimulation, as well as providing apnea detection and therapy. Additionally or alternatively, IMD 101 may be used to generate neural stimulation for application to a desired area of ​​the body, such as spinal cord stimulation, the brain, etc. Figure 2 The housing 102 of the IMD 101, schematically shown in FIG, is often referred to as a "can," "box," or "box electrode," and can be programmably selected to serve as the return electrode for all "monopolar" modes. The housing 102 can also be used as a return electrode, alone or in combination with one or more of the coil electrodes, for shock purposes. The housing 102 also includes a connector (not shown) having multiple terminals. In other embodiments, such as when the IMD represents a transvenous device, these terminals can be configured to couple to different types of electrodes and leads. All or some of these terminals can be used in various combinations. The IMD 101 includes a controller circuit 160 that controls the operation of the IMD 101. The controller circuit 160 may include one or more processors configured to execute program instructions stored in memory to perform at least one of the following: analyze biosignals, manage storage of biosignals, or deliver therapy. The controller circuit 160 (also referred to herein as a processor module or unit) may include one or more processors, or equivalent control circuitry, specifically designed to control the monitoring, analysis, storage, and transmission of CA signals, device markers, arrhythmias, and the like.

[0033] The controller circuit 160 is configured to communicate with various RAM or ROM memories, logic and timing circuits, state machine circuits, and I / O circuits. Typically, the controller circuit 160 includes the ability to process or monitor input signals (data) while being controlled by program code stored in the memory. The details of the design and operation of the controller circuit 160 are not critical to the present disclosure. Instead, any suitable controller circuit 160 may be used to perform the functions described herein. Among other things, the controller circuit 160 receives, processes, and manages the storage of digitized cardiac data sets from various sensors and electrodes. For example, although the current IMD 101 may not collect and analyze cardiac data sets, such as IEGM data, in addition or alternatively, the IMD 101 can collect, analyze, and wirelessly transmit pressure data, heart sound data, and the like.

[0034] Controller circuit 160 also includes a timing control circuit 179 for waking IMD 101 from a sleep state. Timing control circuit 179 may include a clock for synchronizing the timing of advertising / connection events and for entering a sleep state between advertising / connection events. This clock determines when IMD 101 should next wake up after processing an advertising / connection event and before entering a sleep state. Timing control circuit 179 then sets an event to ensure timely wakeup for the next advertising / connection event. Additionally, controller circuit 160 may include a startup module 210. This processor startup module may include program instructions stored in ROM that, when executed, control modules within IMD 101, such as memory 194 and RF circuit 110. Alternatively, startup module 210 may reside on a separate circuit within IMD 101 outside of the controller circuitry. Controller circuit 160 includes an operating system module 215. Operating system module 215 supports applications running within IMD 101. Alternatively, operating system module 215 may reside on a separate circuit from controller circuit 120. Alternatively, protocol stack 220 may reside on another circuit other than the controller circuit within IMD 101. A protocol stack may include a controller and a host, each containing various communication layers.

[0035] Sensing circuits 182 and 184 can also be selectively coupled to one or more leads via switches 174 for collecting sensed physiological data (e.g., cardiac activity, neural activity, respiratory activity, etc.). Sensing circuits 182 and 184 can include dedicated sense amplifiers, multi-channel amplifiers, or shared amplifiers. The outputs of sensing circuits 182 and 184 are connected to controller circuit 160, which in turn receives the sensed data and can trigger or inhibit pulse generators 170 and 172, respectively, on demand in response to the absence and presence of activity of interest.

[0036] The sensed signals are also applied to the input of an analog-to-digital (A / D) data acquisition system 190. The data acquisition system 190 is configured to acquire IEGM signals, neural signals, and the like. The data acquisition system 190 converts the raw analog data into digital signals and stores the digital signals in a memory 194 for later processing and / or RF transmission to the EI 201. The data acquisition system 190 is coupled to one or more leads via a switch 174 to sample signals across any combination of desired electrodes. The data acquisition system 190 can also be coupled to one or more of the acoustic sensors via the switch 174. The data acquisition system 190 acquires, performs A / D conversions, generates, and stores digital pressure data and / or acoustic data.

[0037] RF circuitry 110 includes communication circuitry such as an antenna 151, a transceiver 153, a memory 155, a processor 157, and a collection of one or more transmit and receive amplifiers (collectively shown as amplifiers 159). For example, processor 157 may be similar to microcontroller 160. Alternatively, transceiver 151 may be provided as a single component, or as a separate transmitter and a separate receiver. One or more transmit amplifiers 159 are configured to be selectively connected between the output of the transmitter of transceiver 153 and antenna 151. One or more receive amplifiers 159 are configured to be selectively connected between antenna 151 and the input of the receiver of transceiver 153.

[0038] As explained herein, without the addition of transmit or receive amplifiers 159, the transmitter and receiver of transceiver 153 exhibit certain power and sensitivity limitations based on the components and design of a particular implementation. One or more transmit amplifiers 159 can be provided to be selectively connected between the output of the transmitter in the antenna to increase transmit power, such as by up to 10 dBm. As another example, when operating alone without the addition of a separate receive amplifier 159, the receiver of transceiver 153 can exhibit a receive sensitivity as low as -85 dBm. One or more receive amplifiers 159 can be provided to be selectively connected between the antenna 151 and the input of the receiver of transceiver 153 to increase receive sensitivity, such as by as low as -100 dBm.

[0039] As explained herein, RF circuitry 110 is initialized. The transmitter of transceiver 153 transmits advertising notifications arranged in a composite format, followed by a sleep state according to the advertising interval. The receiver of transceiver 153 performs a scanning operation during a receive window to scan for connection requests. During a single receive window, the scanning operation can be performed during the same time period as the transmission of advertising notification 207 via the corresponding advertising channel. Optionally, the receive window and scanning operation can continue after the transmission of the advertising notification is completed. Thus, the scanning operation and receive window can be temporarily aligned with the composite of advertising notifications and / or extend beyond the composite of advertising notifications 207 into the sleep state of the advertising interval.

[0040] The RF circuitry 110 is configured to process and / or manage a bidirectional communication link between the IMD 101 and an external instrument (EI) 201. The RF circuitry 110 may include communication circuitry configured to transition between a sleep state, a partially awake state, and a fully awake state. For example, when in the fully awake state, the communication circuitry may be configured to perform tasks and actions associated with a communication protocol start (CPS) instruction set 195, which may include an advertisement scan related (ASR) instruction subset 205 and a non-ASR instruction subset 206. When in the partially awake state, the communication circuitry is configured to execute the ASR instruction subset 205. The ASR instruction subset 205 may include sending an advertisement notification 207 on one or more channels in accordance with a wireless communication protocol and scanning one or more channels for a connection request from an external device. Alternatively, the advertisement notification 207 may be stored in the RF circuitry 110. Conversely, when no connection request is received, the communication circuitry may return to the sleep state without performing actions or tasks associated with the non-ASR instruction subset 206 of the CPS instruction set 195. Figure 2 In the example of FIG, CPS instruction set 195 can be stored in memory 194 and / or 155, which is accessed by controller circuit 160 and / or processor 157, respectively. CPS instruction set 195 can provide wireless protocol syntax for controller circuit 160 and / or processor 157 to assemble data packets, advertising notifications, connection requests, connection responses, establish communication link 104, and / or partition data received from EI 201. Additionally or alternatively, CPS instruction set 195 can be stored in ROM, RAM, firmware, or other memory of RF circuit 110. As a further example, CPS instruction set 195 can be "stored" by the configuration of hardware circuits within RF circuit 110.

[0041] In an embodiment, the communication circuitry of the RF circuitry 110 may utilize a first amount of power when executing the CPS instruction set 195 with the BLE peripheral application in a fully awake state. Additionally, when executing the ASR instruction subset 205 with the BLE peripheral application in a partially awake state, the CPS instruction set 195 may utilize a second amount of power that is less than the first amount of power. The CPS instruction set 195 may include more tasks and actions that require longer time periods and more power to implement than the tasks and actions of the ASR instruction subset 205. For example, the second amount of power for implementing the ASR instruction subset may be between 40% and 80% of the first amount of power for implementing the entire CPS instruction set. As another example, the second amount of power for implementing the ASR instruction subset may be between 50% and 65% of the first amount of power for implementing the entire CPS instruction set.

[0042] The RF circuit 110 includes a receiver that scans for connection requests from the EI 201. The RF circuit 110 is controlled by the controller circuit 160 and can support one or more wireless communication protocols when communicating with the EI 201, such as Bluetooth low energy, Bluetooth, Medical Implant Communication Service (MICS), etc. The RF circuit 110 can include a transmitter, a receiver, and / or a transceiver. Optionally, the RF circuit 110 can be electrically coupled to an antenna (not shown).

[0043] Controller circuit 160 is coupled to memory 194 via a suitable data / address bus 196, wherein programmable operating parameters used by controller circuit 160 are stored and modified as needed to customize the operation of IMD 101 to suit the needs of a particular patient. Memory 194 also stores data sets (raw data, aggregated data, histograms, etc.) such as IEGM data, heart sound data, pressure data, SvO2 data, etc., over a desired time period (e.g., 1 hour, 24 hours, 1 month). Memory 194 may store instructions to direct controller circuit 160 to analyze cardiac signals and heart sounds, identify characteristics of interest, and derive values ​​for predetermined statistical parameters.

[0044] In addition, the memory 194 stores a CPS instruction set 195. The CPS instruction set 195 can be loaded into the memory 194 at the time of manufacture, activation, installation, or throughout operation. The CPS instruction set 195 includes an ASR instruction subset 205 and a non-ASR instruction subset 206. The ASR instruction subset 205 can include at least two of the following: i) expiration of a wake-up timer, ii) processor startup, iii) initialization of a transmit circuit, iv) transmission of an advertising packet, v) scanning one or more channels for connection requests from external devices, or vi) validation or rejection of an incoming connection request. The non-ASR instruction subset 206 can include at least two of the following: i) initialization of a random access memory (RAM) segment / block, ii) initialization of external instrument components, iii) initialization of operating system services, or iv) initialization of the CPS instruction set 195. In one embodiment, the ASR instruction subset 205 does not include at least two of the following: i) initialization of a random access memory (RAM) segment / block, ii) initialization of external instrument components, iii) initialization of operating system services, or iv) initialization of the CPS instruction set 195. In another embodiment, the ASR instruction subset 205 does not include any of the following: i) initialization of a random access memory (RAM) segment / block, ii) initialization of external instrument components, iii) initialization of operating system services, or iv) initialization of the CPS instruction set 195.

[0045] According to embodiments herein, the advertising schedule included in the CPS instruction set 195 balances fast advertising with low power and low sensitivity with slow advertising with high power and high sensitivity to provide fast patient-initiated communication and longer-range automatic connection for remote monitoring. As explained herein, once a connection is established between the external device and the IMD, the RF circuitry 110 can set the transmit power and receive sensitivity to the desired communication session level (e.g., high) for the duration of the communication session. Regardless of whether the connection is established using short-range or long-range advertising, the transmit power and receive sensitivity are set to the desired communication session level to provide the desired communication distance during the active communication session. For example, if a patient wants to initiate a remote monitoring session, the patient will bring the external device (smartphone) close to their body to start the communication session based on the short-range advertising. Then, once the connection is established, the RF circuitry 110 adjusts the transmit power and receive sensitivity to the communication session level (e.g., maximum power setting), allowing the patient to leave the external device (smartphone) on the table and go to bed on the other side of the room without experiencing any interruption in the communication session.

[0046] Additionally or alternatively, one or more individual advertisement schedules included in the CPS instruction set 195 can be stored in the memory 194 for use in connection with each corresponding EI 201. For example, when the IMD 101 initially begins communicating with a particular EI 201, the EI 201 can download the corresponding advertisement schedule included in the CPS instruction set 195, along with instructions for utilizing the advertisement schedule included in the CPS instruction set 195, until otherwise instructed. Subsequently, the IMD 101 can communicate with another EI 201, which downloads a corresponding new advertisement schedule included in the CPS instruction set 195, along with instructions for utilizing the new advertisement schedule included in the CPS instruction set 195, until otherwise instructed. As a further example, the IMD 101 can update the advertisement schedule included in the CPS instruction set 195 throughout operation, such as based on a success rate in establishing a communication link, based on a delay in establishing a communication link, and so forth.

[0047] The operating parameters of the IMD 101 can be non-invasively programmed into the memory 194 via the RF circuitry 110 in bidirectional wireless communication with the EI 201. The RF circuitry 110 is controlled by the controller circuitry 160 and receives data for transmission via control line 111. The RF circuitry 110 allows intracardiac electrograms, pressure data, acoustic data, SvO2 data, and status information related to the operation of the IMD 101 (as contained in the controller circuitry 160 or memory 194) to be transmitted to the EI 201 via the established bidirectional communication link 104. The RF circuitry 110 also allows the EI 201 to program new parameters and advertising schedules for the IMD 101.

[0048] RF circuitry 110 transmits one or more advertising notifications on one or more advertising channels. Each advertising channel is a point-to-multipoint, unidirectional channel that carries a repeating pattern of system information messages, such as network identification, permitted RF channels for establishing communication link 104, and / or similar content included in the advertising notification. The advertising notification can be repeatedly transmitted after a set duration or advertising interval based on an advertising schedule stored in memory 194 until a communication link 104 is established with EI 201.

[0049] IMD 101 may also include a physiological sensor 112, such as an accelerometer, which is often referred to as a "rate-responsive" sensor because it is typically used to record a patient's activity level based on the patient's exercise state. Optionally, physiological sensor 112 may also be used to detect changes in cardiac output, changes in cardiac physiological conditions, or changes in activity (e.g., detecting sleep and wake states) and the patient's motion position. Although shown as being included within IMD 101, it should be understood that physiological sensor 112 may also be external to IMD 101, still implanted in the patient or carried by the patient. A common type of rate-responsive sensor is an activity sensor that incorporates an accelerometer or piezoelectric crystal and is mounted within housing 102 of IMD 101. Other types of physiological sensors are also known, such as sensors that sense blood oxygen content, respiratory rate and / or minute ventilation, blood pH, ventricular gradients, etc. However, any sensor capable of sensing a physiological parameter corresponding to the patient's exercise state may be used, particularly sensors capable of detecting arousal from sleep or other exercise.

[0050] IMD 101 additionally includes a battery 113 that provides operating power for all of the circuitry shown. Optionally, IMD 101 may include an impedance measurement circuit 115 that is enabled by controller circuit 160 via control signal 214. Here, impedance detection is primarily used to assess ventricular end-diastolic volume (EDV), but is also used to track the respiratory cycle. Other uses of the impedance measurement circuit include, but are not limited to: lead impedance monitoring during acute and chronic stages for proper lead positioning or displacement; detecting an operable electrode and automatically switching to an operable pair if displacement occurs; measuring respiration or minute ventilation; measuring thoracic impedance to determine a shock threshold; detecting when the device has been implanted; measuring stroke volume; and detecting the opening of a heart valve, etc. Impedance measurement circuit 115 is advantageously coupled to switch 174 so that the impedance at any desired electrode can be obtained as quickly as possible.

[0051] BLE peripheral applications in fully awake and partially awake states

[0052] Figure 3AAn example set of initialization operations / boxes performed by a BLE peripheral application when entering a fully awake state is shown. The illustrated process represents a non-limiting example of a set of initialization actions or tasks for a BLE peripheral application operating while the communication circuitry of the RF circuitry 110 is in a fully awake state.

[0053] At 310, the wake-up timer expires and the BLE peripheral application is activated. For example, the IMD 101 may wake up from a predetermined sleep interval. This interval may occur between connection / advertisement events. These connection / advertisement events may be controlled by the timing control circuit 179, such as Figure 2 The timing control circuit 179 may include a sleep clock. When the wake-up timer expires at the end of the sleep interval, the timing control circuit 179 may process the current connection / advertisement event and establish a new sleep interval using the sleep clock.

[0054] At 315, the processor startup routine begins. For example, the boot module 210 can be utilized to control the processor's boot process. For example, after the timing control circuit 179 has determined the wake-up interval for the IMD 101, the boot module 210 can include a ROM or non-volatile flash memory with boot code for controlling the boot process. The ROM can load the boot process. The boot process can include power-on, operating system loading, and control transfer to the operating system. For example, after a power-on event initiated by the user, a condition, a timer, or other stimulus, a routine can be executed to ensure that the device drivers are functioning properly. Any problems encountered can halt the boot process. Each device in the boot list can load its own routine to ensure proper communication between the device and the boot module 210. After the routine successfully completes, the operating system 215 can be loaded.

[0055] At 320, the RF circuitry is initialized. The RF circuitry 110 is controlled by the controller circuitry 160 and can support one or more wireless communication protocols, such as BLE, Bluetooth, MICS, etc., while communicating with the EI 201. The RF circuitry 110 can include a transmitter, a receiver, and / or a transceiver. The RF circuitry 110 transmits one or more advertising notifications on one or more advertising channels. Each advertising channel is a point-to-multipoint, unidirectional channel that carries a repeating pattern of system information messages, such as network identification, permitted RF channels for establishing the communication link 104, and / or similar content included in the advertising notifications. The advertising notifications can be repeatedly transmitted after a set duration, or advertising interval, based on an advertising schedule stored in the memory 194 until the communication link 104 is established with the EI 201.

[0056] At 325, memory 194 is initialized. For example, operating parameters may be loaded into certain memory locations and / or registers. Memory 194 may store programmable operating parameters used by controller circuit 160. Memory 194 also stores data sets, such as IEGM data, heart sound data, pressure data, SvO2 data, etc., at desired time periods. Memory 194 may also store instructions directing controller circuit 160 to analyze cardiac signals and heart sounds, identify characteristics of interest, and derive values ​​for predetermined statistical parameters. Furthermore, memory 194 may store one or more advertising schedules included in CPS instruction set 195.

[0057] At 330, external instrument initialization is performed. For example, an application on the external instrument (such as a programming or mobile device) is activated by the user for an interactive session, or by a pre-scheduled wake-up timer for background communication with the IMD for an IMD health check. Once the communication session is initiated by either method, the EI 201 sends a connection request. The connection request may include the unique ID of the external instrument. This unique ID may be loaded into a register of the RF circuit 110 during the initialization at 330.

[0058] At 335, operating system services are initialized. After successfully completing the BIOS, the operating system 215 can begin running applications. The operating system 215 can include various applications for collecting and analyzing biosignals.

[0059] At 340, the BLE protocol stack 220 is initialized. The protocol stack 220 may include a host and a controller including multiple layers for communication.

[0060] At 345, the BLE peripheral application sends one or more advertising notifications. The protocol stack 220 controls when the advertising notification(s) are sent. The link layer (LL) of the controller of the protocol stack 220 controls the radio frequency (RF) state of the device, which includes the advertising state. It should be noted that scan request and scan response activities occur during the advertising interval of both applications.

[0061] At 355, the BLE peripheral application determines whether a connection request has been received. If no connection request has been received, the process for both applications ends and the IMD goes back to sleep, as shown at 360. Alternatively, if a connection request has been received, the process proceeds to 350.

[0062] At 350, the BLE peripheral application analyzes the contents of the connection request, such as to determine whether the connection request was sent by an authorized EI 201. If the connection request was sent by an authorized EI 201, the IMD 101 and EI 201 exchange additional information to initiate a communication session. The EI 201 and IMD 101 are connected, and the EI 201 is allowed to access information gathered by the IMD 101, such as intracardiac electrograms, pressure data, acoustic data, SvO2 data, and status information related to the operation of the IMD 101. At this point in the process, the IMD 101 is fully awake.

[0063] Figure 3B An example of initialization operations / boxes for a BLE peripheral application in a partial wake state is shown. The BLE peripheral application runs in a partial wake state until full power is required and is shown from the perspective of firmware interacting with a Bluetooth low energy system-on-chip (SoC).

[0064] At 365, the wakeup timer expires and a partially awake (low power) BLE application is activated. For example, in any application, the IMD 101 may wake up from a predetermined sleep interval. This interval may occur between connection / advertisement events. These connection / advertisement events may be controlled by the timing control circuit 179, such as Figure 2 . The timing control circuit 179 may include a sleep clock. When the wake-up timer expires at the end of a sleep interval, the timing control circuit 179 may process the current connection / advertisement event and establish a new sleep interval using the sleep clock. At this point in the process, the IMD 101 is partially awake.

[0065] At 370, a processor startup routine is performed, similar to the routine described in connection with the operation at 310. At 375, the RF circuitry is initialized, similar to the routine described in connection with the operation at 315.

[0066] The low-power BLE application skips steps 325 through 340 as shown in the fully awake BLE peripheral application. The low-power BLE application does not initialize memory blocks, external instruments, OS services, or the BLE protocol stack in this part of the process. This change in process shortens the time the processor and hardware blocks must be active during each advertising opportunity, saving energy.

[0067] At 380, the BLE peripheral application sends one or more advertising notifications. At 385, the BLE peripheral application determines whether a connection request has been received. If no connection request has been received, the process ends and the IMD returns to sleep, as shown at 395. Alternatively, if a connection request has been received, the process proceeds to 390. At 390, the BLE peripheral application analyzes the connection request and, if appropriate, initiates a communication session. At this point in the process, the IMD 101 is fully awake.

[0068] Figure 4 An example of an application switching sequence between a low-power (partially awake) advertising application and a (fully awake) BLE peripheral firmware application is shown. While in a partially awake state, the IMD 101 sends advertising notifications 410 in advertising intervals 412 during different advertising periods. The EI 201 sends a scan request 415 to request a connection with the IMD 101. Once the scan request 415 is received by the IMD 101, a scan response 420 may be sent to the EI 201. If the scan response 420 indicates that the EI 201 is approved for connection 440 and subsequent communication 445 with the IMD 101, a switching operation 425 is initiated, and the partially awake advertising application 405 switches to the fully awake advertising application 430 upon receiving the connection request 435. The partially awake advertising application 405 then hands over the process to the fully awake advertising application 430. The scan request 415 may be processed by analyzing identification features of the EI 201.

[0069] When the fully awakened advertising application 430 takes control, the memory block 194 is initialized in the fully awakened advertising application ( Figure 3A 325). For example, program instructions and / or parameters may be loaded into RAM, registers, or other memory locations. Various indexes into memory are initialized. Additionally, external instruments are initialized (action / task 330). Furthermore, operating system services are initialized (action / task 335), and the BLE protocol stack 220 is initialized (action / task 340). Thereafter, the communication session is established.

[0070] Figure 5 is a state machine diagram illustrating states of the communication circuitry of IMD 101 configured according to embodiments herein. Initially, the communication circuitry begins in a sleep state 510. The communication circuitry remains in the sleep state until a wakeup timer expires. Once the wakeup timer expires, the communication circuitry transitions from the sleep state to a partially awake state 520, which may also be referred to as a low-power advertising state. During the partially awake state, the communication circuitry is configured to transmit advertising notifications on one or more channels according to a wireless communication protocol and scan one or more channels for connection requests from external devices.

[0071] If a connection request is received from an external device, the connection circuitry can be configured to transition to a fully awake state 530. The fully awake state can also be considered a full-power advertising state. During the fully awake state, the communication circuitry is configured to perform tasks and actions associated with the Communication Protocol Startup (CPS) instruction set, which includes a subset of advertising scan-related (ASR) instructions and a subset of non-ASR instructions. After completing the required processing responsibilities, the communication circuitry can return to the sleep state until the next wake-up timer expires.

[0072] However, if no connection request is received, the communication circuit may return to the sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPA instruction set.

[0073] Furthermore, when the communication circuit executes the CPA instruction set while in a fully awake state, the communication circuit utilizes a first amount of power. When executing the ASR instruction subset while in a partially awake state, the communication circuit utilizes a second amount of power that is less than the first amount of power. Compared to the limited set of tasks and actions of the ASR instruction subset, the full CPS instruction set includes more tasks and actions that require a longer period of time and more power to implement.

[0074] Additionally or alternatively, the communication circuitry may include hardware or firmware, in which case the ASR instruction subset may include at least two of: i) expiration of a wake-up timer, ii) processor startup, iii) initialization of a transmit circuit, iv) transmission of an advertising packet, v) scanning one or more channels for connection requests from external devices, or vi) validation or rejection of an incoming connection request. The ASR instruction subset may not include the non-ASR instruction subset.

[0075] Furthermore, the communication circuitry may include hardware or firmware, and the non-ASR instruction subset may include at least two of: i) initialization of a random access memory (RAM) segment / block, ii) initialization of an external instrument component, iii) initialization of an operating system service, or iv) initialization of a communication protocol stack.

[0076] Conclusion

[0077] It should be clearly understood that the various arrangements and processes broadly described and illustrated with respect to the accompanying drawings, and / or one or more individual components or elements of such arrangements and / or one or more process operations associated with such processes, can be employed independently of or in conjunction with one or more other components, elements, and / or process operations described and illustrated herein. Therefore, while various arrangements and processes are broadly contemplated, described, and illustrated herein, it should be understood that they are provided merely in an illustrative and non-limiting manner and may also be considered merely as examples of possible operating environments in which one or more arrangements or processes may be run or operated.

[0078] As will be appreciated by those skilled in the art, various aspects may be embodied as systems, methods, or computer (device) program products. Accordingly, various aspects may take the form of entirely hardware embodiments or embodiments comprising hardware and software, which may all be generally referred to herein as "circuits," "modules," or "systems." Furthermore, various aspects may take the form of a computer (device) program product embodied in one or more computer (device) readable storage media having computer (device) readable program code embodied thereon.

[0079] Any combination of one or more non-signal computer (device) readable media may be utilized. The non-signal medium may be a storage medium. The storage medium may be, for example, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, device, or apparatus, or any suitable combination of the foregoing. More specific examples of storage media include the following: a portable computer floppy disk, a hard disk, a random access memory (RAM), a dynamic random access memory (DRAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.

[0080] The program code of execution operation can be written with any combination of one or more programming languages.Program code can be executed completely on single device, partly on single device, executed as an independent software data packet, partly on single device and partly on another device, or executed completely on another device.In some cases, it is possible to connect equipment by any type of network (including local area network (local area network, LAN) or wide area network (wide area network, WAN)), or can be connected by other equipment (for example, by using the Internet of Internet Service Provider) or by hard-wire connection (such as being connected by USB).For example, a server with a first processor, a network interface and a storage device for storing code can store a program code for execution operation, and by its network interface, the code is provided to the second device with the second processor via the network, so that the code is executed on the second device.

[0081] Various aspects are described herein with reference to the accompanying drawings, which illustrate example methods, devices, and program products according to various example embodiments. Program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device or information processing device to produce a machine, so that the instructions executed by the processor of the device implement the specified function / action. Program instructions can also be stored in a device-readable medium that can instruct the device to operate in a specific manner so that the instructions stored in the device-readable medium produce a manufactured article including instructions for implementing the specified function / action. Program instructions can also be loaded onto a device to cause a series of operating steps to be performed on the device to produce a process implemented by the device, so that the instructions executed on the device provide a process for implementing the specified function / action.

[0082] The units / modules / applications herein may include any processor-based or microprocessor-based system, including systems using microcontrollers, reduced instruction set computers (RISCs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), logic circuits, and any other circuits or processors capable of performing the functions described herein. Additionally or alternatively, the modules / controllers herein may represent circuit modules that can be implemented as hardware associated with instructions for performing the operations described herein (e.g., software stored on a tangible and non-transitory computer-readable storage medium such as a computer hard drive, ROM, RAM, etc.). The above examples are merely exemplary and are not intended to limit the definition and / or meaning of the term "controller" in any way. The units / modules / applications herein may execute instruction sets stored in one or more storage elements to process data. The storage elements may also store data or other information as desired or required. The storage elements may be in the form of an information source or a physical memory element within the modules / controllers herein. The instruction set may include various commands that instruct the modules / applications herein to perform specific operations, such as the methods and processes of the various embodiments of the subject matter described herein. The instruction set may be in the form of a software program. The software may be in various forms such as system software or application software. Furthermore, the software may be in the form of a collection of independent programs or modules, program modules within a larger program, or portions of program modules. The software may also include modular programming in the form of object-oriented programming. The processing of input data by the processing machine may be in response to user commands, or in response to the results of previous processing, or in response to a request made by another processing machine.

[0083] It should be understood that the subject matter described herein is not limited in its application to the structural details and component arrangements set forth in the description herein or shown in the drawings herein. The subject matter described herein can have other embodiments and can be practiced or implemented in various ways. In addition, it should be understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "including," "comprising," or "having" and variations thereof herein is intended to encompass the items listed thereafter and their equivalents as well as additional items.

[0084] It should be understood that the above description is intended to be illustrative, not restrictive. For example, the embodiments described above (and / or aspects thereof) can be used in combination with each other. In addition, many modifications can be made to adapt specific situations or materials to the teachings herein without departing from the scope thereof. Although the dimensions, types of materials, and coatings described herein are intended to define various parameters, they are by no means restrictive, but rather illustrative in nature. After reviewing the above description, many other embodiments will be apparent to those skilled in the art. Therefore, the scope of the present embodiment should be determined with reference to the appended claims and the full scope of equivalents to which such claims are entitled. In the appended claims, the terms "including" and "wherein" are used as the plain Chinese equivalents of the respective terms "comprising" and "wherein." In addition, in the claims, the terms "first," "second," and "third," etc. are used merely as labels, and are not intended to impose numerical requirements on their objects or an execution order on their actions.

Claims

1. An implantable medical device (IMD), comprising: a sensing circuit configured to collect a biological signal; a memory configured to store program instructions; a processor configured to implement the program instructions to perform at least one of: analyzing the biosignal, managing storage of the biosignal, or delivering therapy; a communication circuit configured to communicate wirelessly with at least one other implantable or external device, the communication circuit configured to transition between a sleep state, a partially awake state, and a fully awake state; When in the fully awake state, the communication circuit is configured to perform tasks and actions associated with a communication protocol startup CPS instruction set, the CPS instruction set including an advertisement scan related ASR instruction subset and a non-ASR instruction subset; When in the partially awake state, the communication circuit is configured to execute according to the ASR instruction subset: sending an advertisement notification on one or more channels according to a wireless communication protocol; scanning the one or more channels to obtain a connection request from an external device; as well as When no connection request is received, the system returns to the sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPS instruction set.

2. The IMD of claim 1, wherein: The communication circuit is configured to: transition from the sleep state to the partially awake state in conjunction with expiration of a timer; transition from the partially awake state to the fully awake state upon receipt of a valid connection request; and transitioning from the partially awake state to the sleep state when the valid connection request is not received.

3. The IMD of claim 1 , wherein: The communication circuit utilizes a first amount of power when executing the CPS instruction set in the fully awake state, and wherein the communication circuit utilizes a second amount of power less than the first amount of power when executing the ASR instruction subset in the partially awake state.

4. The IMD of claim 1 , wherein: The CPS instruction set includes additional tasks and actions that require a longer period of time and utilize more power to implement than the period of time and power associated with implementing the tasks and actions of the ASR instruction subset.

5. The IMD of claim 1 , wherein: The communication circuitry includes at least one of hardware or firmware, and wherein the ASR instruction subset includes at least two of: i) expiration of a wake-up timer, ii) processor startup, iii) initialization of a transmit circuit, iv) transmission of an advertising packet, v) scanning one or more channels for a connection request from an external device, or vi) validation or rejection of an incoming connection request, wherein the ASR instruction subset does not include a non-ASR instruction subset.

6. The IMD of claim 1 , wherein: The communication circuitry includes at least one of hardware or firmware, and wherein the non-ASR instruction subset includes at least two of: i) initialization of a random access memory (RAM) segment / block, ii) initialization of an external instrument component, iii) initialization of an operating system service, or iv) initialization of a communication protocol stack, wherein the non-ASR instruction subset does not include an ASR instruction subset.

7. The IMD of claim 1 , wherein: While in the partially awake state, the communication circuitry does not perform at least two of: i) initialization of random access memory (RAM) segments / blocks, ii) initialization of external instrument components, iii) initialization of operating system services, or iv) initialization of a communication protocol stack.

8. The IMD of claim 1 , wherein: The IMD represents at least one of: a neurostimulator device, an implantable leadless monitoring device, an implantable leadless therapy device, a body-generated analyte testing device, a pacemaker, a cardioverter, a cardiac rhythm management device, or a defibrillator.

9. A method implemented by one or more processors of a medical device, wherein the one or more processors are configured with specific executable instructions to perform the method, comprising: Collect biological signals; implementing program instructions to perform at least one of: analyzing the biosignal, managing storage of the biosignal, or delivering therapy; wirelessly communicate with at least one other implantable or external device; When in a fully awake state, executing tasks and actions associated with a communication protocol startup CPS instruction set, the CPS instruction set including an advertisement scanning related ASR instruction subset and a non-ASR instruction subset; When in the partially awake state, the following ASR instruction subset is executed: sending an advertisement notification on one or more channels according to a wireless communication protocol; scanning the one or more channels to obtain a connection request from an external device; as well as When no connection request is received, the system returns to the sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPS instruction set.

10. The method of claim 9, further comprising: transitioning from the sleep state to the partially awake state in conjunction with expiration of a timer; transitioning from the partially awake state to the fully awake state upon receiving a valid connection request; and transitioning from the partially awake state to the sleep state when the valid connection request is not received.

11. The method of claim 9, further comprising: utilizing a first amount of power when executing the CPS instruction set in the fully awake state; and utilizing a second amount of power less than the first amount of power when executing the subset of ASR instructions in the partial wake state.

12. The method of claim 9, wherein: The CPS instruction set includes additional tasks and actions that require a longer period of time and utilize more power to implement than the period of time and power associated with implementing the tasks and actions of the ASR instruction subset.

13. The method of claim 9, wherein: The ASR instruction subset further includes at least two of: i) expiration of a wake-up timer, ii) processor startup, iii) initialization of a transmit circuit, iv) transmission of an advertising packet, v) scanning one or more channels for a connection request from an external device, or vi) validation or rejection of an incoming connection request, wherein the ASR instruction subset does not include a non-ASR instruction subset.

14. The method of claim 9, wherein: The non-ASR instruction subset further includes at least two of: i) initialization of a random access memory (RAM) segment / block, ii) initialization of an external instrument component, iii) initialization of an operating system service, or iv) initialization of a communication protocol stack, wherein the non-ASR instruction subset does not include the ASR instruction subset.

15. The method of claim 9, wherein: While in the partially awake state, the method does not perform at least two of: i) initialization of random access memory (RAM) segments / blocks, ii) initialization of external instrument components, iii) initialization of operating system services, or iv) initialization of a communication protocol stack.

16. A computer program product comprising a non-transitory computer-readable storage medium comprising computer-executable code for: Collect biological signals; performing at least one of: analyzing the biosignal, managing storage of the biosignal, or delivering therapy; wirelessly communicate with at least one other implantable or external device; When in a fully awake state, executing tasks and actions associated with a communication protocol startup CPS instruction set, the CPS instruction set including an advertisement scanning related ASR instruction subset and a non-ASR instruction subset; When in the partially awake state, the following ASR instruction subset is executed: sending an advertisement notification on one or more channels according to a wireless communication protocol; scanning the one or more channels for connection requests from external devices; and When no connection request is received, the system returns to the sleep state without performing actions or tasks associated with the non-ASR instruction subset of the CPS instruction set.

17. The computer program product of claim 16 , further comprising computer executable code for: transitioning from the sleep state to the partially awake state in conjunction with expiration of a timer; transitioning from the partially awake state to the fully awake state upon receiving a valid connection request; and transitioning from the partially awake state to the sleep state upon not receiving the valid connection request.

18. The computer program product of claim 16, further comprising computer executable code for utilizing a first amount of power when executing the CPS instruction set in the fully awake state, and utilizing a second amount of power less than the first amount of power when executing the ASR instruction subset in the partially awake state.

19. The computer program product of claim 16, wherein: The CPS instruction set includes additional tasks and actions that require a longer period of time and utilize more power to implement than the period of time and power associated with implementing the tasks and actions of the ASR instruction subset.

20. The computer program product of claim 16, wherein: The ASR instruction subset further includes at least two of: i) expiration of a wake-up timer, ii) processor startup, iii) initialization of a transmit circuit, iv) transmission of an advertising packet, v) scanning one or more channels for a connection request from an external device, or vi) validation or rejection of an incoming connection request, wherein the ASR instruction subset does not include a non-ASR instruction subset.

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