Synchronous display of real-time physiological signals obtained using implantable and external devices in wireless communication with each other

Abstract

An ED configured to wirelessly communicate with an IMD, a method used by the ED, a system including the ED and the IMD, and a method used by such a system are described. When a wireless connection is established between the ED and the IMD, the ED receives an IMD anchor point transmitted by the IMD, and the ED stores the IMD anchor point and the ED anchor point. Thereafter, a timestamp of the signal data and the stored anchor point are used to synchronize the display of different physiological signals, where at least one physiological signal is displayed based on signal data obtained from the IMD via the wireless connection, and where another physiological signal is obtained by the ED without using the wireless connection. Such embodiments enable synchronous common display of such physiological signals even in noisy environments where wireless connections are relatively poor.

Description

[0001] Priority Statement

[0002] This application claims priority to U.S. Non-Provisional Patent Application No. [fill in], filed September 24, 2025, entitled "SYNCHRONIZED DISPLAY OF REAL-TIME PHYSIOLOGIC SIGNALS OBTAINED USING IMPLANTABLE AND EXTERNAL DEVICES THAT WIRELESS COMMUNICATE WITH ONE ANOTHER," which claims priority to U.S. Provisional Patent Application No. 63 / 708,576, filed October 17, 2024, entitled "SYSTEMS AND METHODS THAT PROVIDE SYNCHRONIZED DISPLAY OF REALTIME PHYSIOLOGIC SIGNALS OBTAINED USING IMPLANTABLE AND EXTERNAL DEVICES THAT WIRELESS COMMUNICATE WITH ONE ANOTHER." Priority is claimed to each of the preceding applications, and each of the preceding applications is incorporated herein by reference as if it were set forth herein in its entirety. Technical Field

[0003] The embodiments of the technology described herein generally relate to systems, apparatus, and methods that include or are used with implantable medical devices (IMDs) and external devices (EDs), which are configured to communicate wirelessly with each other using wireless communication technologies such as, but not limited to, Bluetooth® Low Energy (BLE) technology. Background Technology

[0004] Implantable medical devices (IMDs) can utilize wireless telemetry (such as Bluetooth® Low Energy (BLE) telemetry) to communicate wirelessly with external devices (EDs), such as bedside monitors and / or programmers. Typically, such EDs are expected to provide a scrolling display of real-time or near-real-time physiological signal data acquired by both the ED and the IMD. For example, the ED can receive two types of real-time signal data for monitoring a patient's heart rhythm: one corresponding to surface electrocardiogram (ECG) signals acquired using skin electrodes, and the other corresponding to electrogram (EGM) signals sensed using implanted electrodes, but is not limited to these. ECG signals can be sensed from the patient's body using one or more directly or communicatively coupled skin electrodes, while EGM signals can be sensed using electrodes of the IMD or electrodes communicatively coupled to the IMD, and data indicating EGM signals can be wirelessly transmitted from the IMD to the ED using BLE or another type of wireless telemetry.

[0005] However, difficulties may arise when an ED attempts to display ECG and EGM signals simultaneously and in real-time or near real-time. Even when both types of real-time signals (i.e., real-time ECG and EGM signals) are generated simultaneously from the same heart, the sample data of the ECG and EGM signals follow different paths as the data travels from the patient to the ED. These different paths introduce different delays, causing the ECG and EGM sample data to arrive at the ED out of sync. If this is not corrected, the out-of-sync data is presented to the user at the ED's display (or a display communicatively coupled to the ED). More specifically, if the out-of-sync data is not corrected, the displayed ECG and the displayed EGM will be out of sync. If the ECG and EGM data are not presented in a coherent, synchronized manner, this can lead to misleading information being presented to a person (e.g., a clinician or other practicing physician) on the display.

[0006] When using BLE technology to wirelessly transmit EGM data (or other types of physiological signal data) from the IMD to the ED, the asynchrony between ECG and EGM data becomes more prevalent. The inherent characteristic of the BLE protocol is that it transmits data in short bursts rather than in a constant stream. While the BLE protocol seeks to utilize the maximum available BLE bandwidth, it is not optimized to provide real-time data (such as EGM data) in a way that provides a smooth, synchronized scrolling display of the real-time EGM trace. Furthermore, the IMD introduces a certain amount of processing latency to process EGM data and a communication latency to wirelessly transmit EGM data to the ED. These processing and communication latency introduce some constant and some indeterminate delays, which can cause the display of real-time EGM data to be delayed and interleaved relative to the corresponding ECG data.

[0007] Conventional methods for attempting to synchronize different types of physiological signal data (e.g., ECG and EGM data) sensed using different sensing electrodes and / or other types of sensors face design challenges that fail to compensate for various delays and do not convert short bursts of EGM data into a constant flow of EGM data at the desired rate. Conventional methods also do not result in the display of ECG and EGM data in a manner that enables clinicians to perform appropriate diagnoses.

[0008] To achieve sufficient EGM quality, the sampling rate of the sensed EGM signal can preferably be in the range of approximately 250 to 300 samples per second, with a minimum rate of 128 samples per second (i.e., where the minimum value of the sensed EGM signal is sampled once every 7.81 milliseconds). Sending EGM sample data from the IMD to the ED using BLE may involve software support that can act on interrupts to trigger data transfer from the EGM hardware buffer to the BLE transceiver via a serial-to-parallel interface (SPI). The BLE transceiver can then use the BLE protocol stack to send data via the BLE interface. Sending each sample of EGM data individually (e.g., at least every 7.81 milliseconds) can result in a corresponding data transfer interrupt every at least 7.81 milliseconds, which can lead to high current consumption due to software processing overhead.

[0009] To reduce power consumption, EGM data can alternatively be accumulated as batches of EGM packets over multiple sampling periods by the IMD hardware before triggering an interruption in EGM packet transmission. The ED can have a buffer large enough to store a sufficient batch of EGM packets for the interval algorithm before streaming EGM samples to the display, for example, as disclosed in U.S. Patent No. 10,686,878 entitled “METHODAND DEVICE FOR MANAGING DISPLAY OF MULTIPLE DATA STREAMS”. The mechanism described above in the '878 patent works well when air interference is relatively low. However, when air interference is high and causes many BLE packet retransmissions and / or BLE telemetry interruptions, the firmware application may need to discard incoming EGM data and / or restart the EGM hardware interface to recover from hardware errors such as hardware buffer overflows. In such scenarios, the relative position of newly arrived EGM packets with earlier received EGM packets is lost. This could cause the ED to terminate the EGM streaming and restart another synchronization process by buffering samples in a predefined time slot to stream synchronously with the surface ECG data. Therefore, it should be understood that the above mechanism does not guarantee synchronized streaming of surface ECG data and real-time EGM data in the presence of moderate or high atmospheric interference (which could lead to hardware errors), or when real-time EGM stops and then restarts.

[0010] Therefore, it is understood that new technologies are desired for achieving, for example, the simultaneous display of a surface ECG sensed using surface electrodes and an EGM sensed using implanted electrodes. More generally, new technologies are desired for achieving the simultaneous display of a first sensed physiological signal and a second sensed physiological signal, wherein signal sample data of one of the physiological signals is obtained by an IMD and signal sample data of the other physiological signal is obtained by an ED. Summary of the Invention

[0011] Some embodiments of this technology are directed to an ED configured to communicate wirelessly with an IMD, wherein the ED includes a memory, a transceiver enabling the ED to communicate wirelessly with the IMD, and at least one controller coupled to the transceiver and the memory.

[0012] According to some embodiments, during the process of establishing a wireless connection between the ED and the IMD, at least one controller is configured to: in response to receiving an announcement packet from the IMD, control the transceiver to send a connection request packet to the IMD, thereby enabling the establishment of a wireless connection between the ED and the IMD; in response to the IMD receiving a connection request packet from the ED, control the transceiver to receive an IMD anchor sent by the IMD from the IMD; store the IMD anchor in memory; and determine the ED anchor and also store the ED anchor in memory.

[0013] According to some embodiments, when a wireless connection is established between the ED and the IMD, at least one controller is configured to: control the transceiver to receive at least some of a plurality of data packets from the IMD, wherein each of the plurality of data packets received from the IMD includes a portion of physiological signal data and a corresponding timestamp included in the IMD; for each of the data packets received from the IMD, determine, from the perspective of the ED, the corresponding time when the data packet was sent by the IMD based on the ED anchor stored in memory, the IMD anchor stored in memory, and the corresponding timestamp included in the data packet received from the IMD; obtain another physiological signal data representing another physiological signal sensed using one or more skin electrodes or non-implantable sensors; and use the corresponding time determined for the data packets received from the IMD such that the corresponding segments of the physiological signal represented by the data packets are displayed together with the other physiological signal, such that they are synchronized with each other on the display of the ED or communicatively coupled to the display of the ED.

[0014] According to some embodiments, the IMD anchor point and the ED anchor point correspond to when a wireless connection is established between the ED and the IMD. In other words, the IMD anchor point and the ED anchor point indicate the point in time when a wireless connection is established between the ED and the IMD.

[0015] According to some embodiments, at least one controller of the ED is configured to determine, from the ED's perspective, the corresponding time when the IMD sends a data packet for each data packet received by the ED, using the following equation: RT DATA =ANCHOR ED + TIME_STAMP IMD - ANCHOR IMD , of which RT DATA From the perspective of the ED (Edge Analyst), the response time of data packets sent by the IMD (Information Management Device) is determined by the ED, ANCHOR. ED It is the ED anchor point stored by ED, TIME_STAMP IMD It is the IMD timestamp included in the data packets received by ED, and ANCHOR IMD It is the IMD anchor point stored by ED.

[0016] According to some embodiments, the ED also includes one or more buffers, and the at least one controller of the ED is further configured to control one or more buffers to synchronize the other physiological signal with each other when the other physiological signal is co-displayed on the display of the ED or communicatively coupled to the display of the ED.

[0017] According to some embodiments, the physiological signal includes one of an EGM or a subcutaneous ECG, and another physiological signal that is displayed together with and synchronized with one of the EGM or the subcutaneous ECG includes an ECG sensed using one or more skin electrodes.

[0018] Some embodiments of this technology relate to a system that includes an ED according to one of the embodiments outlined above, and further includes an IMD, wherein the IMD includes a memory of the IMD, a transceiver of the IMD enabling the IMD to communicate wirelessly with the ED, and at least one controller of the IMD coupled to the transceiver of the IMD and the memory of the IMD.

[0019] According to certain embodiments, when a wireless connection is established between the transceiver of the ED and the transceiver of the IMD, at least one controller of the IMD is configured to: acquire physiological signal data representing physiological signals of a patient in which the IMD is implanted; and control the transceiver of the IMD to transmit a plurality of data packets to the ED, wherein each of the plurality of data packets transmitted by the IMD to the ED includes a portion of the physiological signal data and a corresponding timestamp specifying when the data packet was transmitted by the IMD from the perspective of the IMD.

[0020] According to some embodiments, during the process of establishing a wireless connection between the transceiver of the ED and the transceiver of the IMD, at least one controller of the IMD is configured to control the transceiver of the IMD to send an announcement packet, receive a connection request packet from the ED within a receive window after the IMD sends the announcement packet, and in response, send a connection response packet including the IMD anchor point to the ED.

[0021] According to some embodiments, the IMD includes a real-time clock (RTC), and the IMD anchor includes the value of the IMD's RTC when the IMD sends a connection response packet in response to receiving a connection request packet from the ED, and the corresponding timestamp of each data packet received by the ED from the IMD includes the corresponding value of the IMD's RTC when the data packet is sent by the IMD.

[0022] According to some embodiments, the ED includes an RTC, and the ED anchor point includes the value of the ED's RTC when the ED receives a connection response packet from the IMD.

[0023] According to some embodiments, physiological signal data obtained by the IMD is determined based on real-time physiological signals sensed by the IMD or by another implantable device communicatively coupled to the IMD. Another set of physiological signal data obtained by the ED is determined based on another real-time physiological signal sensed by the ED or by another external device communicatively coupled to the ED. In some such embodiments, corresponding segments of the physiological signals and the other physiological signal are displayed together in real-time or near real-time, such that they are synchronized with each other.

[0024] Some embodiments of this technology relate to a method for the synchronized display of signal segments, comprising: an ED sending a connection request packet to an IMD in response to receiving an announcement packet from an IMD, thereby enabling the establishment of a wireless connection between the ED and the IMD; the ED receiving an IMD anchor sent by the IMD in response to the IMD receiving the connection request packet during the establishment of the wireless connection between the ED and the IMD; and the ED storing the IMD anchor and the ED anchor. The method further comprises: when establishing a wireless connection between the ED and the IMD, the ED receiving a plurality of data packets, each of the plurality of data packets including a portion of physiological signal data of a patient obtained by the IMD and a corresponding IMD timestamp specifying when the data packet was sent by the IMD; and for each of the data packets received by the ED, the ED determining, from the ED's perspective, the corresponding time when the data packet was sent by the IMD, based on the ED anchor stored by the ED, the IMD anchor stored by the ED, and the IMD timestamp included in the data packet received by the ED. The method additionally includes: the ED acquiring another physiological signal data representing another physiological signal sensed using one or more skin electrodes or non-implantable sensors; and the ED using a corresponding time determined for the data packets received by the ED from the IMD to display the corresponding segments of the physiological signal represented by the data packets together with the other physiological signal, such that they are synchronized with each other.

[0025] According to certain embodiments, the ED determines the response time of a data packet sent by the IMD from the ED's perspective by the ED using the following equation for each data packet received by the ED: RT DATA =ANCHOR ED +TIME_STAMP IMD -ANCHOR IMD , of which RT DATA From the perspective of the ED (Edge Analyst), the response time of data packets sent by the IMD (Information Management Device) is determined by the ED, ANCHOR. ED It is the ED anchor point stored by ED, TIME_STAMP IMD It is the IMD timestamp included in the data packets received by ED, and ANCHOR IMD It is the IMD anchor point stored by ED.

[0026] According to some embodiments, the IMD and ED each include a corresponding RTC, the IMD anchor received by the ED includes the value of the IMD's RTC when the IMD sends a connection response packet in response to the IMD receiving a connection request packet from the ED, and the corresponding timestamp of each data packet in the data packets received by the ED from the IMD includes the value of the IMD's RTC when the data packet was sent by the IMD.

[0027] According to some embodiments, the ED anchor point includes the value of the ED's RTC when the ED receives a connection response packet from the IMD.

[0028] According to some embodiments, the ED also includes one or more buffers, and the method includes the ED controlling one or more buffers to synchronize another physiological signal and the physiological signal with each other when they are co-displayed.

[0029] According to some embodiments, during the process of establishing a wireless connection between the ED and the IMD, the method further includes: the IMD sending an announcement packet; and the IMD receiving a connection request packet from the ED within a receiving window after sending the announcement packet, and in response, the IMD sending a connection response packet including the IMD anchor point to the ED.

[0030] According to some embodiments, when a wireless connection is established between the ED and the IMD, the method further includes: the IMD acquiring physiological signal data of a patient in which the IMD is implanted; and the IMD sending a plurality of data packets to the ED, each of the plurality of data packets including a portion of the physiological signal data and a corresponding IMD timestamp specifying when the data packet was sent by the IMD.

[0031] This invention is not intended to be a complete description of embodiments of the present technology. Other features and advantages of embodiments of the present technology will become apparent from the following description, in conjunction with the accompanying drawings and claims, in which preferred embodiments have been set forth in detail. Attached Figure Description

[0032] Figure 1 A high-level block diagram of an example system including IMD and ED is illustrated, and embodiments of this technology can be used in this example system.

[0033] Figure 2 Examples Figure 1 The high-level block diagram of an example embodiment of IMD is described in the document.

[0034] Figure 3 Examples Figure 1 A high-level block diagram of an example embodiment of ED is described in the document.

[0035] Figure 4 A high-level flowchart illustrating a method for describing an embodiment of the present technology is shown, which is used with a system including an ED and an IMD, the ED and IMD being configured to communicate wirelessly with each other, for example, using BLE.

[0036] Figure 5 This is a high-level block diagram of a memory including various portions for storing various types of data, according to an embodiment of the present invention.

[0037] Figure 6AAn example is shown where the EGM and ECG are displayed out of sync.

[0038] Figure 6B It was shown that initially in Figure 6A The EGM and ECG shown in the figure, in an embodiment using this technology, demonstrate that the two signals are synchronized with each other. Detailed Implementation

[0039] Embodiments of the technology described herein relate to methods, systems, and devices that enable the simultaneous display, for example, of a surface ECG sensed using surface electrodes and an EGM sensed using implanted electrodes. More generally, embodiments of the technology described herein enable the simultaneous co-display of first and second sensed physiological signals, wherein signal sample data of one of the physiological signals is obtained by an IMD using an implanted electrode or implanted sensor, and signal sample data of the other physiological signal is obtained by an ED using a non-implanted electrode or non-implanted sensor. However, before providing additional details of such embodiments of the technology, reference is made below. Figure 1 , Figure 2 and Figure 3 Examples of systems and devices that can be used in embodiments of this technology are described.

[0040] Example System

[0041] Reference Figure 1 System 100 is shown as including an implantable medical device (IMD) 101 and an external device (ED) 102, which are configured to communicate wirelessly with each other via a wireless link 103. Figure 1 In the diagram, the block shown to the left of the vertical dashed line is implanted in the patient's body, while the block shown to the right of the vertical dashed line is outside the patient's body (i.e., not implanted in the patient's body). System 100 is an example of a system that can utilize embodiments of the present technology. Figure 2 It shows Figure 1 The block diagram of an example embodiment of IMD 101 described herein, and Figure 3 Examples Figure 1 A block diagram of an example embodiment of ED 102 described herein.

[0042] IMD 101 may be an implantable pacemaker and / or implantable cardioverter defibrillator (ICD) comprising and / or coupled to one or more leads having one or more electrodes implanted in and / or near the patient's heart. Optionally, IMD 101 may be a leadless pacemaker (LP) implanted in or on a heart chamber, wherein the LP includes at least two electrodes for sensing the EGM. IMD 101 may also be an insertable cardiac monitor (ICM) including electrodes for sensing the EGM. Such IMD may additionally or alternatively include one or more sensors that enable the IMD to sense other types of physiological signals besides the EGM. See below for reference. Figure 3 In further detail, ED 102 may be, for example, a bedside or other type of external monitor or programmer, but is not limited thereto.

[0043] The IMD 101 can sense EGM using one or more implanted electrodes disposed on one or more leads disposed on and / or extending from the housing of the IMD 101. The sensed EGM can be associated with one or more pacing and / or sensing cardiac events. The IMD 101 can additionally or alternatively sense other types of physiological signals besides or in lieu of EGM. Examples of physiological signals that the IMD 101 can sense include, but are not limited to, EGM, subcutaneous ECG, pressure signals, cardiac impedance signals, respiratory signals, photoplethysmography (PPG) signals, impedance plethysmography (IPG) signals, temperature signals, flow signals, etc. For most of the following discussion, it will be assumed that the physiological signal sensed by the IMD 101 is an EGM signal. However, it should be understood that embodiments of this technology can also be used with other types of physiological signals, some examples of which have just been provided.

[0044] IMD 101 can process sensed physiological signals (e.g., sensed EGM signals) to generate physiological signal sample data (e.g., EGM sample data), and can transmit the physiological signal sample data (e.g., EGM sample data) to ED 102 via wireless link 103. According to some embodiments, the physiological signal sample data (e.g., EGM sample data) is transmitted via wireless link 103 according to a wireless protocol (such as Bluetooth® Low Energy (BLE) protocol), wherein IMD 101 transmits sample data in short bursts in an intermittent manner as defined by the BLE protocol. The BLE protocol defines burst-type data transmission, and therefore the sample data is transmitted at a non-uniform throughput. ED 102 receives the sample data stream with a corresponding throughput via wireless link 103. While wireless communication between IMD 101 and ED is generally described herein as being implemented using BLE, wireless communication can alternatively be implemented using other types of radio frequency (RF) communication besides BLE, such as utilizing classic Bluetooth®, ZigBee®, Wireless Universal Serial Bus (USB), and Medical Implantable Communication Services (MISC), but is not limited thereto. Other types of wireless communication besides RF communication, such as inductive or conductive communication, can also be used.

[0045] Note that the terms "ECG" and "ECG signal" are used interchangeably in this document. Similarly, it should be noted that the terms "EGM" and "EGM signal" are used interchangeably in this document. Furthermore, it should be noted that the terms "ECG data" and "ECG sample data" are used interchangeably in this document. Similarly, it should be noted that the terms "EGM data" and "EGM sample data" are used interchangeably in this document.

[0046] Example of an implantable medical device (IMD)

[0047] Figure 2 An example block diagram of IMD 101 is shown. IMD 101 has a housing 212 to hold electronic / computing components. The housing 212 (which is generally referred to as a “can,” “shell,” “encapsulation,” or “shell electrode”) can be programmably selected to act as an electrode for certain sensing modes. The housing 212 may include a connector (not shown) having at least one terminal and optional additional terminals, such as a head. In some embodiments, the terminal may be coupled to an electrode 213 disposed on or adjacent to the housing 212. Optionally, more than two terminals may be provided to support more than two sensing electrodes, such as for a bipolar sensing scheme using the housing 212 as a reference electrode. Additionally or alternatively, the terminal may be connected to one or more leads, each lead having one or more electrodes disposed thereon, wherein the electrodes are located at various locations around the heart. The type and location of each electrode can vary.

[0048] IMD 101 includes a programmable microcontroller 221 that controls various operations of IMD 101, such as cardiac monitoring and / or other types of physiological monitoring. The microcontroller 221, which may more generally be referred to as a controller, may include a microprocessor (or equivalent control circuitry), random access memory (RAM) and / or read-only memory (ROM), logic and timing circuitry, state machine circuitry, and input / output (I / O) circuitry. The microcontroller 221 may also perform certain operations described herein in conjunction with the collection of physiological signal sample data, such as, but not limited to, EGM sample data.

[0049] Optionally, a selector switch 217 is provided to allow selection of different electrode configurations under the control of microcontroller 221. The electrode configuration selector switch 217 may include multiple switches for connecting the desired electrode 213 to appropriate I / O circuitry, thereby facilitating electrode programmability. The selector switch 217 is controlled by a control signal from microcontroller 221. Optionally, the selector switch 217 may be omitted, and the I / O circuitry may be directly connected to the housing electrode and the other electrode 213.

[0050] Microcontroller 221 may include an optional arrhythmia detector 234 configured to analyze cardiac activity signals to identify potential arrhythmia episodes (e.g., tachycardia, bradycardia, cardiac arrest, atrial fibrillation (AF), etc.). Although not shown, microcontroller 221 may also include other dedicated circuitry and / or firmware / software components to assist in monitoring various conditions of the patient's heart and managing pacing therapy. The arrhythmia detector 234 of microcontroller 221 may include an onboard arrhythmia detection process that uses RR interval irregularities to detect arrhythmia episodes (such as AF episodes). The arrhythmia detector 234 may be implemented as firmware, software, and / or circuitry, including combinations thereof.

[0051] The IMD 101 is also equipped with a communication modem (modulator / demodulator) 240 for wireless communication. In one embodiment, the communication modem 240 uses high-frequency modulation, such as using Bluetooth® or Bluetooth® Low Energy (BLE) telemetry protocols. The signal is transmitted in the high-frequency range and will travel through body tissues in fluids without stimulating the heart or being felt by the patient. The communication modem 240 can be implemented in hardware as part of the microcontroller 221, or implemented as software / firmware instructions programmed into and executed by the microcontroller 221. Alternatively, the communication modem 240 can reside separately from the microcontroller 221 as a standalone component. The communication modem 240 facilitates data retrieval from a remote monitoring network. The communication modem 240 enables timely and accurate data transmission from the patient directly to the ED used by the physician.

[0052] IMD 101 includes sensing circuitry 224 coupled to (preferably selectively coupled to) one or more electrodes 213 that perform sensing operations via an optional switching switch 217 to detect cardiac activity data indicative of cardiac activity. Sensing circuitry 224 may include a dedicated sensing amplifier, a multiplexed amplifier, or a shared amplifier. It may also employ one or more low-power precision amplifiers with programmable gain and / or automatic gain control, bandpass filtering, and threshold detection circuitry to selectively sense features of interest. In one embodiment, switching switch 217 may be used to determine the sensing polarity of the cardiac signal by selectively closing an appropriate switching switch.

[0053] The output of sensing circuit 224 is connected to microcontroller 221, which in turn determines when to store EGM data (digitized by analog-to-digital (A / D) data acquisition system (DAS) 230) of a segment of the EGM in memory 250. For example, when a potential arrhythmia is detected, microcontroller 221 may only store the EGM data (from A / D data acquisition system 230) in memory 250. Sensing circuit 224 may receive control signals 226 from microcontroller 221 for timing control of gain, threshold, polarization charge removal circuitry (not shown), and any blocking circuitry (not shown) coupled to the input of sensing circuitry.

[0054] Optionally, the IMD 101 may include multiple sensing circuits similar to sensing circuit 224, wherein each sensing circuit is coupled to two or more electrodes and controlled by microcontroller 221 to sense cardiac electrical activity detected at the corresponding two or more electrodes. Sensing circuit 224 may operate in a unipolar sensing configuration or a bipolar sensing configuration. Optionally, sensing circuit 224 may be completely removed, and microcontroller 221 performs the operations described herein based on EGM from A / D data acquisition system 230 directly coupled to electrodes 213.

[0055] IMD 101 also includes the aforementioned A / D data acquisition system 230, which is optionally coupled via a changeover switch 217 to one or more electrodes 213 to sample cardiac activity signals at both ends across any desired electrode. The A / D data acquisition system 230 is configured to acquire EGM signals (or fragments thereof), convert raw analog data into digital data, and store the digital data as EGM data for later processing and / or for real-time telemetry transmission to ED 102 (e.g., a programmer, local transceiver, or diagnostic system analyzer). The A / D data acquisition system 230 is preferably controlled by control signals 236 from microcontroller 221. The EGM can be used as cardiac activity data for analysis in response to potential arrhythmia episodes. Arrhythmia detection algorithms can be applied to the EGM from sensing circuitry 224 and / or the A / D data acquisition system 230.

[0056] IMD 101 may also include magnet detection circuitry (not shown) coupled to microcontroller 221 to detect when a magnet is placed over IMD 101. Clinicians can use the magnet to perform various test functions of housing 212 and / or signal microcontroller 221 that ED 102 is in place to receive or transmit data to microcontroller 221 via transceiver (TX / RX) 244. According to an embodiment, IMD 101 may initiate its announcement (e.g., BLE announcement) in response to IMD 101 detecting that a magnet has been placed over IMD 101.

[0057] IMD 101 may optionally include one or more physiological sensors 246. Signals generated by the physiological sensors 246 may be transmitted to microcontroller 221 for analysis in conjunction with cardiac activity data, markers, episodic event information, etc., and optionally stored in memory 250. Although shown as being included within housing 212, the physiological sensors(s)246 may be external to housing 212 but still implanted in or carried by the patient. Examples of physiological sensors may include sensors for sensing temperature, respiratory rate, blood pH, ventricular gradient, activity, position / posture, minute ventilation (MV), cardiac electrical activity, cardiac mechanical activity, etc. Examples of such physiological sensors 246 include accelerometers, pressure sensors, flow sensors, temperature sensors, etc. Sample data of physiological signals generated by the physiological sensors(s)246 may be transmitted from IMD 101 to ED 102 in real time, so that the signals(s) may be displayed by ED 102 on a display of ED 102 (or communicatively coupled to ED 102).

[0058] The microcontroller 221 is preferably coupled to the memory 250 via a suitable data / address bus. Programmable operating parameters used by the microcontroller 221 are stored in the memory 250 and used to customize the operation of the IMD 101 to suit the needs of a specific patient. Such operating parameters are defined, for example, detection rate thresholds, sensitivity, automatic features, arrhythmia detection criteria, activity sensing or other physiological sensors, and electrode polarity, etc.

[0059] In addition, memory 250 stores ECG and / or EGM data, as well as markers and other data associated with the detection of arrhythmia episodes. Operating parameters of IMD 101 can be non-invasively programmed into memory 250 via transceiver 244, which communicates telemetryally with ED 102 via communication link 103. Transceiver 244 is shown coupled to antenna 205, which enables IMD 101 to transmit and receive radio frequency (RF) signals (such as BLE signals) to and from ED 102. Transceiver 244 also enables physiological signal sample data (e.g., EGM sample data), classification data, and status information related to the operation of IMD 101 (such as that contained in microcontroller 221 or memory 250) to be transmitted to ED 102 via the established communication link 103. According to some embodiments, transceiver 244 is used to transmit real-time EGM sample data (and / or one or more other types of real-time physiological signal sample data) to ED 102, such that ED 102 can display EGM (and / or (one or more) other types of physiological signals) on a display of ED 102 (or on a display communicatively coupled to ED 102). According to some embodiments of the present technology described herein, ED 102 can simultaneously display ECG (and / or other types of additional physiological signals) sensed by ED 102, such that two or more signals (e.g., EGM and ECG) displayed together are synchronized with each other (also referred to as synchronization).

[0060] IMD 101 is also shown as including a real-time clock (RTC) 245, which may also be referred to as IMD_RTC 245. In embodiments, IMD_RTC 245 is a monotonically incrementing count. According to embodiments, IMD_RTC 245 reliably maintains and provides the current time through destructive system states such as suspend, sleep, and restart without requiring its time to be reset. The value of IMD_RTC 245 may be provided to microcontroller 221, and / or transceiver 244, and / or other components of IMD 101.

[0061] Battery 248 provides operating power to all components in IMD 101. Battery 248 is capable of long-term operation with low current consumption. Battery 248 also ideally has predictable discharge characteristics, allowing for the detection of selective replacement times. As an example, IMD 101 employs a lithium / silver vanadium oxide battery. Battery 248 can provide a variety of life cycles. In an alternative embodiment, battery 248 may be rechargeable.

[0062] Example External Device (ED)

[0063] Figure 3 Example components of an example ED 102 for communicating with and / or programming the IMD 101 are illustrated. As an example, ED 102 may represent a bedside monitor installed in a patient's home and used for wirelessly communicating with the IMD 101 while the patient is at home, in bed, or asleep. ED 102 may be a programmer used in the clinic to query the IMD 101, retrieve data, and program detection criteria and other features. ED 102 may be a handheld device (e.g., a smartphone, tablet, laptop, smartwatch, etc.) that can be coupled to remote monitoring services, medical networks, etc., via a network (e.g., the Internet). ED 102 can facilitate clinicians' access to patient data and allow physicians to view real-time EGM signals sensed by the IMD 101.

[0064] In some embodiments, ED 102 can be used to analyze EGM fragments acquired and stored by IMD 101. More generally, ED 102 can allow physicians or other authorized users to program the operation of IMD 101 and retrieve and display data received from IMD 101, such as EGM data and device diagnostic data. Furthermore, ED 102 can enable IMD 101 to perform functions necessary to accomplish certain algorithms of the embodiments described herein. ED 102 can also be capable of processing and analyzing data received from IMD 101. Additionally, ED 102 is capable of accepting various user inputs. According to some embodiments, ED 102 can be configured to provide a synchronized display, e.g., a synchronized co-display, of real-time signals sensed by IMD 101 (and / or by another implantable device communicatively coupled to IMD 101) and real-time signals sensed by ED 102 (and / or by another external device communicatively coupled to ED 102).

[0065] ED 102 can be controlled by controller 302, which may be a programmable microprocessor or microcontroller, or a special-purpose processing device such as an application-specific integrated circuit (ASIC). In an embodiment, controller 302 includes a central processing unit (CPU). Software instructions to be executed by controller 302 can be accessed from ROM 306 and RAM 330 via internal bus 304. Additional software can be accessed from hard disk drive 308, floppy disk drive 310, and CD ROM drive 312, or other suitable permanent mass storage devices. Depending on the specific implementation, the basic input / output system (BIOS) is retrieved from ROM 306 upon power-up. According to certain embodiments of the present technology, RAM 330 is used to store anchors and implement buffers for implementing specific embodiments, as referenced below. Figure 5 A more detailed explanation follows.

[0066] Once operational, controller 302 can display a programming options menu to the user via liquid crystal display (LCD) 314 or another suitable computer display device. For this purpose, controller 302 may, for example, display a menu of specific programming parameters to be programmed for IMD 101, or a menu of the types of diagnostic data to be retrieved and displayed. ED 102 may additionally or alternatively include and / or communicatively coupled to various other types of displays on which physiological signals can be displayed.

[0067] ED 102 may include or be communicatively coupled to ECG circuitry 334 capable of sensing one or more ECG signals. ECG circuitry 334 may be coupled via cable to a plurality of skin electrodes 335, which enable ECG circuitry 334 to sense one or more ECG signals. For a non-limiting example, ECG circuitry 334 may be coupled via cable (or wirelessly) to ten skin electrodes placed around a person's arm, leg, and chest to sense 12-channel or 14-channel ECG. These ten skin electrodes are referred to in the art as right arm (RA), left arm (LA), right leg (RL), left leg (LL), V1, V2, V3, V4, V5, and V6 electrodes. Electrodes V1, V2, V3, V4, V5, and V6 are placed around the chest. More specifically, electrode V1 is placed in the fourth intercostal space on the right sternum, electrode V2 is placed in the fourth intercostal space on the left sternum, electrode V3 is placed midway between the positions of electrodes V2 and V4, electrode V4 is placed in the fifth intercostal space at the midclavicular line, electrode V5 is placed anterior to the axillary line at the same level as electrode V4, electrode V6 is placed midway between the axillary lines at the same level as electrode V4, and electrode V6 is placed midway between the axillary lines at the same level as electrode V4. Limb electrodes RA, LA, RL, and LL are placed on the limbs. More specifically, electrode RA is placed anywhere between the right shoulder and right elbow, electrode RL is placed anywhere below the right torso and above the right ankle, electrode LA is placed anywhere between the left shoulder and left elbow, and electrode LL is placed anywhere below the left torso and above the left ankle. ECG circuit 334 can also be coupled to more or fewer than ten skin electrodes.

[0068] Still refer to Figure 3 ED 102 is shown to include a telemetry subsystem 322. The telemetry subsystem 322 includes a transceiver 326 connected to an antenna 328 to enable ED 102 to communicate wirelessly with IMD 101 via a wireless communication protocol such as BLE. The telemetry subsystem 322 may optionally include its own microcontroller 324 for controlling communication between ED 102 and IMD 101. ED 102 may additionally include a main controller (e.g., a CPU) 302 for controlling other aspects of ED 102. ED 102 may also include only a single controller or more than two controllers. More generally, ED 102 may include one or more controllers 302, 324 for controlling the operation of ED 102.

[0069] ED 102 is also shown to include a real-time clock (RTC) 345, which may also be referred to as ED_RTC 345. In embodiments, ED_RTC 345 is a monotonically increasing count. According to embodiments, ED_RTC 345 reliably maintains and provides the current time through destructive system states such as suspend, sleep, and restart, without requiring its time to be reset. The value of ED_RTC 345 may be provided to controller 302, controller 324, telemetry subsystem 322, and / or other components of ED 102.

[0070] ED 102 may also include a network interface card (NIC) 360 to allow data to be sent to and from other computer systems via router 362 and wide area network (WAN) 364. Alternatively, ED 102 may include a modem for communication via the Public Switched Telephone Network (PSTN). Depending on the implementation, the modem may be directly connected to the internal bus 304, or it may be connected to the internal bus 304 via a parallel I / O port or circuit 340 or a serial I / O port or circuit 342. Data sent from other computer systems may include, for example, data about medications prescribed, administered, or sold to patients.

[0071] ED 102 can receive data from IMD 101, including parameters representing the current programming state of IMD 101. ED 102 can also receive EGM sample data (and / or sample data of one or more other types of physiological signals) from IMD 101. Any or all information displayed by ED 102 can also be printed using optional printer 336.

[0072] Includes an optional speaker 344 for providing an audible tone to the user, such as a warning beep in case a doctor provides incorrect input. One or more peripheral devices can also be connected to ED 102 via parallel I / O ports or circuitry 340 or serial I / O ports or circuitry 342. Although one of each is shown, multiple I / O ports or circuits may be provided.

[0073] Using the ED 102 configured as shown in the figure, physicians or other authorized users can retrieve, process, and display a wide range of information received from the IMD 101, and, if necessary, reprogram the IMD 101, including configuring operating parameters. This article is about... Figure 3 The description provided is intended only to provide an overview of the operation of the example ED 102 and is not intended to describe every feature of the device’s hardware and software in detail, nor is it intended to provide an exhaustive list of the functions performed by the device.

[0074] Example Method

[0075] Now will be used Figure 4 A high-level flowchart is provided to describe a method of using an embodiment of the present technology with a system (e.g., system 100) including an ED (e.g., ED 102) and an IMD (e.g., IMD 101), the ED and IMD being configured to communicate wirelessly with each other, for example, using BLE. As will be understood from the following discussion, such a method enables the ED to display (or more generally to display) multiple different physiological signals such that the different physiological signals being displayed are synchronized with each other, even if data of at least one of the physiological signals is obtained by the IMD and data of at least another of the physiological signals is obtained by the ED. In other words, the method enables the ED to compensate for data corresponding to different physiological signals that travel different communication paths and experience different signal processing delays, which, if not compensated, would result in the different signals being out of sync when displayed. For example, the method can be used to co-display EGM and ECG such that they are synchronized with each other, wherein EGM data (for displaying EGM) is obtained by the IMD and ECG data (for displaying ECG) is obtained by the ED.

[0076] exist Figure 4 In the diagram, the blocks or steps shown to the left of the vertical dashed line are executed by the IMD (e.g., IMD 101), and the blocks or steps shown to the right of the vertical dashed line are executed by the ED (e.g., ED 102). The steps executed by the IMD may be executed by and / or under the control of one or more controllers of the IMD (e.g., microcontroller 221). For example, briefly referencing... Figure 2 The steps performed by IMD 101 may be performed by microcontroller 221 and / or under the control of microcontroller 221. The steps performed by ED may be performed by one or more controllers of ED 102 (e.g., master controller 302 and / or telemetry controller 324) and / or under their control. For example, briefly returning to the reference... Figure 3 The steps performed by ED 102 can be performed by the main controller 302 and / or the telemetry controller 324 and / or under the control of the main controller 302 and / or the telemetry controller 324. Although Figure 2 IMD 101 is shown and described as having a single controller 221, but IMD 101 may include multiple controllers. Although Figure 3 ED 102 is shown and described as including controller 302 and controller 324, but ED 102 may include more than two controllers or a single controller.

[0077] Now refer to Figure 4Step 402 involves the IMD sending one or more notification packets according to a wireless communication protocol, such as a BLE protocol. In some embodiments, the IMD initiates sending notification packets in response to the IMD detecting that a magnet has been placed very close to the IMD. The IMD may alternatively or additionally initiate sending notification packets in response to one or more other types of triggering events, such as the IMD not communicating with the ED for at least a specified amount of time, or in response to the IMD detecting an alarm or other specific condition, but is not limited thereto. In some embodiments, the IMD may additionally or alternatively send notification packets according to one or more predetermined schedules. In embodiments, the IMD sends notification packets for each notification event on three BLE channels (e.g., channel 37 (2402 MHz), channel 38 (2426 MHz), and channel 39 (2480 MHz)). The notification packets may be sent at notification intervals that specify the time between notification events.

[0078] Still refer to Figure 4 Step 404 involves the ED scanning and receiving advertisement packets. In response to the ED receiving an advertisement packet from the IMD, at step 406 the ED sends a connection request to the IMD. The connection request sent by the ED may include connection parameters for establishing a wireless connection (such as a BLE connection), wherein the parameters may include, for example, a connection interval indicating the frequencies on which the IMD and ED will communicate, and a channel diagram identifying the channels on which they will communicate. The IMD can accept the connection request by tuning to the correct frequency at the correct time to send a connection response and establish a wireless connection, such as a BLE connection. This can be achieved through the transceiver in the IMD (e.g., ...). Figure 2 The transceiver 244 in the middle) and the transceiver of the ED (e.g., Figure 3 A wireless connection (such as a BLE connection) is established between transceivers 326 in the IMD to achieve the wireless connection between the IMD and ED as described in this article.

[0079] Step 408 involves the IMD receiving a connection request packet within a reception window after sending an announcement packet. According to an embodiment, in response to receiving the connection request packet, at step 410, the IMD sends a connection response packet including the IMD anchor point. According to an embodiment, the IMD anchor point is the IMD's real-time clock (RTC) when the IMD sends a connection response packet for establishing a wireless connection between the IMD and the ED (e.g., ...). Figure 2 The value of IMD_RTC 245). As will be understood from the following description, the ED will use the IMD anchor to display (or more generally, make display) physiological signals (for which data is obtained in step 416), such that the displayed physiological signals are synchronized with one or more other physiological signals for which the ED obtains data.

[0080] Step 412 involves the ED receiving the connection response packet including the IMD anchor point sent at step 410. At step 414, in response to receiving the connection response packet including the IMD anchor point, the ED stores the connection response packet in its memory (e.g., ...). Figure 3 The ED stores the IMD anchor point (received from the IMD at step 412) in RAM 330, and the ED also stores the ED anchor point in memory (e.g., RAM 330). Figure 3 In RAM 330). According to an embodiment, the ED anchor point is the real-time clock (RTC) of the ED when the ED receives a connection response packet from the IMD (e.g., RAM 330). Figure 3 The value of ED_RTC 345 in the reference. Briefly return the reference. Figure 3 The memory in which the ED stores the IMD anchor (received from the IMD at step 412) and the memory of the ED anchor can be part of RAM 330, but is not limited thereto.

[0081] The IMD anchor and ED anchor correspond to when a wireless connection (e.g., a BLE connection) is established between the ED and the IMD. In other words, the IMD anchor and ED anchor indicate the point in time when a wireless connection is established between the ED and the IMD. Therefore, it can be understood that once the IMD anchor and ED anchor are stored by the ED, a wireless connection (e.g., a BLE connection) is established between the ED and the IMD. Once the wireless connection (e.g., a BLE connection) is established, the IMD and the ED can communicate with each other on / at the identified channel and time. BLE, for example, has specified data channels 0-36 that can be used for BLE communication sessions. See again. Figure 4 Shown above the horizontal dashed line Figure 4 The blocks or steps in the diagram occur before the establishment of a wireless connection (e.g., a BLE connection) between the ED and IMD, and the blocks or steps shown below the horizontal dashed line occur after and simultaneously with the establishment of a wireless connection (e.g., a BLE connection) between the ED and IMD.

[0082] Step 416 involves the IMD acquiring physiological signal data from the patient in which it is implanted. For example, the IMD can use its electrodes to sense the EGM and can use an analog-to-digital converter (ADC) or an A / D data acquisition system (e.g., Figure 2 The A / D data acquisition system 230 in the system samples the sensed EGM, in which case the physiological signal data can be referred to as EGM data. For another example, the IMD can use a pressure sensor (e.g., the pressure sensor of the IMD or communicatively coupled to the IMD) to sample the sensed EGM. Figure 2 The physiological sensor 246 in the image is used to sense the pressure signal, and the pressure signal can be sampled using an ADC. In this case, the physiological signal data can be referred to as pressure signal data. More generally, as used herein, the term physiological signal refers to the data obtained using two or more electrodes (e.g., ...). Figure 2 The physiological signals are analog or digital electrical signals sensed by electrodes 213 or sensors and optionally processed, for example, using one or more amplifiers and / or one or more filters, but are not limited thereto. Examples of physiological signals include, but are not limited to, EGM, subcutaneous ECG signals, pressure signals, cardiac impedance signals, respiratory signals, PPG signals, IPG signals, temperature signals, etc. The physiological signal data obtained by the IMD in step 416 may correspond to any of these types of physiological signals, but are not limited thereto.

[0083] Step 422 involves the IMD sending multiple packets to the ED, wherein each data packet sent by the IMD to the ED includes a portion of physiological signal data (obtained by the IMD) and a corresponding IMD timestamp specifying when the IMD sent the data packet. According to an embodiment, the IMD timestamp is the value of the IMD's RTC (also referred to as IMD_RTC) at the time the IMD sends the data packet to the ED. The portion of physiological signal data included in each data packet may correspond to a different segment of a specified duration of physiological signal (e.g., 500 milliseconds, but not limited thereto). For example, each EGM data packet may include EGM data corresponding to 500 milliseconds of an EGM signal sensed by the IMD (or by another implanted device communicatively coupled to the IMD).

[0084] Step 418 involves the ED acquiring additional physiological signal data from the patient in whom the IMD is implanted. For example, the ED may use skin electrodes to sense ECG, and may use ADCs (e.g., Figure 3 The ECG circuit 334 in the device samples the sensed ECG signal; in this case, another physiological signal data can be referred to as ECG data. For another example, the ED can use a PPG sensor placed on the patient's finger to sense the PPG signal, and an ADC can be used to sample the PPG signal; in this case, another physiological signal data can be referred to as PPG signal data (or more simply, PPG data). For yet another example, the ED can use a pressure cuff, etc., to sense the blood pressure signal, and an ADC can be used to sample the blood pressure signal; in this case, another physiological signal data can be referred to as blood pressure signal data (or more simply, blood pressure data). More typically, the ED can use two or more electrodes (e.g., ...). Figure 3 The electrode 335 in the ED or the sensor of the ED or a sensor communicatively coupled to the ED can acquire another physiological signal of it. The above examples of other physiological signals for which the ED can acquire data are not intended to be exhaustive. As is known in the art, these signals can be processed before and / or after sampling, including but not limited to amplification and / or filtering.

[0085] Step 420 involves the ED preferably storing a portion (e.g., a group) of another physiological data in a buffer memory, and an ED timestamp specifying when the portion (e.g., the group) of the other physiological data was stored for each of the portions (e.g., the group). According to an embodiment, the ED timestamp is the value of the ED's RTC (also referred to as ED_RTC) when the ED stores a portion (e.g., the group) of the other physiological data. Briefly returning to the reference... Figure 3 The buffer memory for storing another part of physiological data (e.g., grouping) and the ED timestamp can be implemented by a portion of RAM 330, but is not limited thereto.

[0086] The execution of steps 416 and 422 by the IMD overlaps with the execution of steps 418 and 420 by the ED in time. For example, the IMD may obtain EGM data (at step 416) and send the EGM data packet along with the IMD timestamp (at step 418), while the ED obtains ECG data (at step 418) and stores the ECG data along with the ED timestamp (at step 420).

[0087] Still refer to Figure 4 Step 424 involves the ED receiving at least some of the data packets sent by the IMD (at step 422). Preferably, the ED receives all the data packets sent by the IMD (at step 422). However, due to noise and / or other types of interference, one or more data packets sent by the IMD may be dropped or otherwise not received by the ED.

[0088] Step 426 involves the ED determining, from the ED's perspective, the time when the data packet was sent by the IMD for each data packet received by the ED (at step 422), based on the ED anchor point stored in memory by the ED, the IMD anchor point stored in memory by the ED, and the IMD timestamp included in the data packets received by the ED.

[0089] According to an embodiment, at step 426, the ED determines the corresponding time when the IMD sends the data packet from the ED's perspective for each data packet received by the ED using the following equation:

[0090] RT DATA =ANCHOR ED + TIME_STAMP IMD - ANCHOR IMD ,

[0091] in

[0092] RT DATAFrom the perspective of ED, the corresponding time when the data packet is sent by IMD is determined by ED in step 426.

[0093] ANCHOR ED It is the ED anchor point stored in memory by ED.

[0094] TIME_STAMP IMD This includes the IMD timestamp in the data packets received by ED, and

[0095] ANCHOR IMD It is the IMD anchor point stored in memory by ED.

[0096] Still refer to Figure 4 Step 428 involves the ED using the corresponding time (e.g., RT) determined for the data packets received by the ED from the IMD. DATA The process involves the ED inducing the display of a corresponding segment of a physiological signal represented by data groups, so that the two co-displayed signals are synchronized with each other. More specifically, according to an embodiment, the ED controls one or more buffers of the ED to synchronize the other physiological signal and the co-displayed physiological signal with each other. For example, one type of physiological signal data (e.g., EGM data) may be stored in a first set of buffers (which includes at least one buffer), while another type of physiological signal data (e.g., ECG data) may be stored in a second set of buffers (which includes at least one other buffer), and the controller of the ED (e.g., Figure 3 The controller 302 in the buffer can control how data is transferred from the buffer (e.g., Figure 3 The buffer in RAM 330 outputs and is used to display corresponding physiological signals (e.g., EGM and ECG), synchronizing multiple physiological signals with each other. Continuing the example, the co-displayed EGM and ECG are synchronized with each other, where the characteristics of two different signals corresponding to the same cardiac event (e.g., R wave, P wave, T wave, etc.) are aligned with each other in time. Simply return to the reference. Figure 3 The first set of buffers can be implemented using the first portion of RAM 330, while the second set of buffers can be implemented using the second portion of RAM 330. Let's briefly return to the reference... Figure 3 Physiological signals that are synchronized with each other can be displayed together on an LCD display 314, a touch screen 314, or on a printout produced by a printer 336, but are not limited thereto. Other variations are also possible and are within the scope of the embodiments described herein.

[0097] According to an embodiment, the physiological signal data obtained by the IMD at step 416 is determined based on real-time physiological signals sensed by the IMD or by another implantable device communicatively coupled to the IMD. Furthermore, the physiological signal data obtained by the IMD includes real-time physiological signal data. In an embodiment, the multiple data packets sent from the IMD to the ED include real-time data packets. As used herein, a real-time data packet is a data packet (corresponding to a segment of physiological signal) generated and sent from the IMD to the ED within 1 second of a segment of sensed signal. According to an embodiment, the physiological signal displayed at step 428 is a real-time or near-real-time physiological signal. As used herein, a real-time physiological signal is a physiological signal displayed within 1 second of sensing (i.e., the time offset between the actually sensed signal and the displayed signal is less than 1 second), preferably within 750 milliseconds (ms) of sensing, more preferably within 500 ms of sensing, and most preferably within 250 ms of sensing. As used in this article, near real-time physiological signals are physiological signals that are displayed within 1 to 5 seconds of being sensed; that is, the time offset between the actual sensed signal and the displayed signal is in the range of 1 to 5 seconds.

[0098] Figure 5 An example memory 502, exemplified by or at least accessible by ED 102, includes a memory portion 512 storing IMD anchor points and a memory portion 514 storing ED anchor points. Memory 502 is also shown including a first set of buffers 522 for storing one type of physiological signal data (e.g., EGM data) received from the IMD using a wireless connection (e.g., BLE connection) and a second set of buffers 524 for storing another type of physiological signal data (e.g., ECG data) sensed by ED 102 or by another non-implantable device communicatively coupled to ED 102. Memory 502 can be... Figure 3 The RAM 330 in the ED 102 is used for implementation, but is not limited to this. The controller of the ED 102 (e.g., Figure 3 The main controller 302 and / or telemetry controller 324 (but not limited thereto) can be used to control the storage of anchor points in memory sections 512 and 514, respectively. Such controllers(one or more) can also be used to control how and when signal data is output from the set of buffers 522, 524, and to jointly display physiological signals (for which signal data is stored in the set of buffers 522, 524), so that the signals are synchronized with each other.

[0099] Figure 6AExamples of EGM 601 and ECG 602 displayed under the control of an ED (e.g., ED 102) are shown, wherein EGM 601 is displayed based on EGM data obtained by an IMD (e.g., IMD 101) using an implanted electrode and transmitted to the ED using a wireless communication protocol (such as BLE), and wherein ECG 602 is displayed based on ECG data obtained by the ED using a non-implanted skin electrode. Figure 6A The peak amplitudes of the maximum amplitudes in EGM 601 and ECG 602 correspond to intrinsic ventricular depolarization. Alternatively, this can be interpreted as... Figure 6A The peak values ​​of the maximum amplitude in EGM 601 and ECG 602 correspond to the R wave. (As shown in...) Figure 6A Understandably, the R wave in EGM 601 is shown to be significantly temporally offset from the R wave in ECG 602. Figure 6A The significant time offset between EGM 601 and ECG 602 shown may be due to the ED not properly compensating for the different paths that the ECG and EGM data may have traveled before being provided for display by the ED. Figure 6A The significant time offset between EGM 601 and ECG 602 shown may also be due to the ED not properly compensating for EGM data transmitted in noisy environments where the wireless connection (e.g., BLE connection) between the IMD and ED is relatively poor. Figure 6A The significant time offset between EGM 601 and ECG 602 shown may also be due to the ED not properly compensating for the EGM data transmitted by the IMD using a wireless communication protocol (e.g., BLE) that transmits data in short bursts instead of a constant flow.

[0100] Figure 6B Similar to Figure 6A ,because Figure 6B It shows Figure 6A The same EGM 601 and the same ECG 602 are shown. However, in Figure 6B In this context, ED has used embodiments of this technology to appropriately compensate for the different paths that ECG and EGM data may travel before being provided for display by the ED, and to compensate for EGM data transmitted in noisy environments and EGM data transmitted in short bursts rather than constant streams. (See from...) Figure 6B Understandably, the R wave in EGM 601 is shown to be time-aligned with the R wave in ECG 602.

[0101] For most of the discussion above, the ED is described as inducing the display of two physiological signals synchronized with each other, wherein one physiological signal is displayed based on data acquired from the IMD using implanted electrodes or sensors and transmitted to the IMD, for example, using BLE, and wherein the other physiological signal is displayed based on data acquired by the ED using non-implanted electrodes or sensors. Examples of such displayed physiological signals include Figure 6B EGM 601 and ECG 602 are shown. However, it should be understood that the ED can also use embodiments of the present technology to display other types of physiological signals based on physiological signal data obtained from the IMD (using one or more implanted electrodes and / or one or more implanted sensors) and / or based on physiological signal data obtained by the ED (using one or more non-implanted electrodes and / or non-implanted sensors), such that all displayed physiological signals are displayed synchronously with each other.

[0102] In the above description, the first and second physiological signals described as being sensed and displayed together to synchronize with each other are generally described as an EGM (or sub-ECG) sensed by the IMD and an ECG sensed by the ED (or by an external electrode communicatively coupled to the ED). However, it should be understood that embodiments of the technology described herein are not limited to use with these specific types of physiological signals. Examples of other types of first and second physiological signals that can be sensed and correspond to the first or second physiological signal being displayed include, but are not limited to, pressure signals, cardiac impedance signals, respiratory signals, photoplethysmography (PPG) signals, impedance plethysmography (IPG) signals, temperature signals, flow signals, and a few others. For example, the first physiological signal may be an EGM and / or IPG signal sensed by the IMD, and the second physiological signal may be a PPG signal paced on a finger, earlobe, or forehead using a PPG sensor, but is not limited thereto. In another example, the first physiological signal could be an arterial pressure signal sensed by the IMD (or an implantable sensor communicatively coupled to the IMD), and the second physiological signal could be a respiratory signal sensed by an external ventilator sensor of the ED or communicatively coupled to the ED. These are just a few examples and are not intended to be exhaustive.

[0103] While the embodiments of this technology described above are generally described as being used in cases where wireless communication between the IMD and ED is implemented using BLE, the invention can also be used with other types of radio frequency (RF) communication besides BLE, such as with Bluetooth® Classic, ZigBee®, Wireless Universal Serial Bus (USB), and Medical Implantable Communication Services (MISC), but is not limited thereto. In addition to RF communication, embodiments of this technology can also be used with other types of wireless communication, such as inductive or conducted communication. However, in cases where wireless communication between the IMD and ED is performed using inductive or conducted communication, the problems overcome by the embodiments of this technology may not exist, and in such cases, it may not be necessary to utilize the embodiments of this technology. However, it should be understood that embodiments of this technology can be used whenever it is desired to improve the synchronization of displayed signals, wherein one signal is obtained by the IMD and another signal is obtained by the ED, and wherein the IMD and ED communicate with each other wirelessly.

[0104] It should be understood that the subject matter described herein is not limited in its application to the construction details and component arrangements set forth in the description or shown in the accompanying drawings. The subject matter described herein can have other embodiments and can be practiced or performed in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “including,” “comprising,” or “having,” and variations thereof, herein is intended to cover the items listed thereafter and their equivalents, as well as additional items. Furthermore, it should be noted that, unless otherwise stated, the term “based on” as used herein should be interpreted as meaning at least partially based on, meaning that one or more additional factors, such as those involved in making a decision, may exist. For example, if a decision is based on the results of a comparison, then in addition to being based on the results of the comparison, the decision may also be based on one or more other factors.

[0105] The embodiments have been described above using functional building blocks that exemplify the execution of specified functions and their relationships. For ease of description, the boundaries of these functional building blocks are generally defined herein. Alternative boundaries may be defined, provided that the specified functions and their relationships are performed appropriately. Therefore, any such alternative boundaries are within the scope of the claimed invention. For example, some steps shown in various flowcharts may be combined or separated. It is also possible to perform only a subset of the steps shown in various flowcharts. As another example, the boundaries of some block diagrams may be changed.

[0106] It should be understood that the above description is intended to be illustrative and not restrictive. For example, the above embodiments (and / or aspects thereof) can be used in combination with each other. Furthermore, many modifications can be made to adapt particular situations or materials to the teachings of the embodiments without departing from the scope of the invention. While the dimensions and types of materials and coatings described herein are intended to define parameters of embodiments of the technology, they are by no means restrictive but rather exemplary embodiments. Many other embodiments will be apparent to those skilled in the art after reading the above description. Therefore, the scope of embodiments of the technology should be determined by reference to the appended claims and the full scope of their equivalents. In the appended claims, the terms “including” and “in which” are used as concise English equivalents to the corresponding terms “comprising” and “wherein”. Furthermore, in the appended claims, the terms “first,” “second,” and “third,” etc., are used merely as labels and are not intended to impose numerical requirements on their objects. Furthermore, the limitations of the following claims are not written in a component plus function format and are not intended to be interpreted based on 35 USC § 112(f), unless and until such a claim limitation expressly uses the phrase “component for…” followed by a functional statement without further structure.

Claims

1. An external device (ED) configured to wirelessly communicate with an implantable medical device (IMD), the ED comprising: Memory; A transceiver that enables the ED to communicate wirelessly with the IMD; as well as At least one controller, the at least one controller being coupled to the transceiver and the memory; During the process of establishing a wireless connection between the ED and the IMD, the at least one controller is configured to: In response to receiving an announcement packet from the IMD, the transceiver is controlled to send a connection request packet to the IMD, thereby enabling the wireless connection to be established between the ED and the IMD; In response to the IMD receiving the connection request packet from the ED, the transceiver is controlled to receive the IMD anchor sent by the IMD from the IMD; The IMD anchor points are stored in memory; and The ED anchor point is determined and the ED anchor point is stored in the memory; and Wherein, when the wireless connection is established between the ED and the IMD, the at least one controller is configured to: The transceiver is controlled to receive at least some of a plurality of data packets from the IMD, wherein each of the plurality of data packets received from the IMD includes a portion of physiological signal data and a corresponding timestamp included in the IMD; For each data packet received from the IMD, the corresponding time when the data packet was sent by the IMD is determined from the perspective of the ED, based on the ED anchor stored in the memory, the IMD anchor stored in the memory, and the corresponding timestamp included in the data packet received from the IMD. Obtain additional physiological signal data representing another physiological signal sensed using one or more skin electrodes or non-implantable sensors; and Using the corresponding time determined for the data packets received from the IMD, corresponding segments of the physiological signals represented by the data packets are displayed together with the other physiological signal, such that they are synchronized with each other on the display of the ED or communicatively coupled to the display of the ED.

2. The ED according to claim 1, wherein, The IMD anchor point and the ED anchor point correspond to when a wireless connection is established between the ED and the IMD.

3. The ED according to claim 1, wherein, The at least one controller is configured to determine, from the perspective of the ED, the corresponding time when the data packet is sent by the IMD for each data packet received by the ED, using the following equation: RT DATA =ANCHOR ED + TIME_STAMP IMD - ANCHOR IMD , in RT DATA is the respective time at which the data packet was sent by the IMD from the perspective of the ED, the respective time determined by the ED, ANCHOR ED is the ED anchor stored by the ED, TIME_STAMP IMD is an IMD time stamp included in the data packet received by the ED, and ANCHOR IMD The IMD anchor point is stored by the ED.

4. The ED according to claim 1, further comprising: One or more buffers; and The at least one controller is further configured to control the one or more buffers to synchronize the other physiological signal and the physiological signal with each other when the other physiological signal and the physiological signal are co-displayed on the display of the ED or communicatively coupled to the display of the ED.

5. The ED according to claim 1, wherein: The physiological signals include either electrogram (EGM) or subcutaneous electrocardiogram (ECG); and The other physiological signal that is displayed together and synchronized with one of the EGM or the subcutaneous ECG includes an electrocardiogram (ECG) sensed using the one or more skin electrodes.

6. A system comprising the ED according to any one of claims 1 to 5, and further comprising the IMD, wherein, The IMD includes: The memory of the IMD; The transceiver of the IMD enables the IMD to communicate wirelessly with the ED; and At least one controller of the IMD is coupled to the transceiver and memory of the IMD; Wherein, when the wireless connection is established between the transceiver of the ED and the transceiver of the IMD, the at least one controller of the IMD is configured to: Obtain physiological signal data representing the physiological signals of a patient in whom the IMD is implanted; and The transceiver of the IMD controls the transmission of the plurality of data packets to the ED, wherein each of the plurality of data packets transmitted by the IMD to the ED includes a portion of the physiological signal data and a corresponding timestamp specifying when the data packet was transmitted by the IMD from the perspective of the IMD.

7. The system according to claim 6, wherein, During the process of establishing the wireless connection between the transceiver of the ED and the transceiver of the IMD, the at least one controller of the IMD is configured to control the transceiver of the IMD to send an announcement packet, receive the connection request packet from the ED within a receive window after the IMD sends the announcement packet, and in response, send a connection response packet including the IMD anchor point to the ED.

8. The system according to claim 6, wherein: IMD includes a real-time clock (RTC); The IMD anchor point includes the value of the RTC of the IMD when the IMD sends a connection response packet in response to the IMD receiving the connection request packet from the ED; as well as The corresponding timestamp of each data packet received by the ED from the IMD includes the corresponding value of the IMD's RTC when the data packet was sent by the IMD.

9. The system according to claim 8, wherein: The ED includes a real-time clock (RTC); and The ED anchor point includes the value of the RTC of the ED when the ED receives the connection response packet from the IMD.

10. The system according to claim 6, wherein: The physiological signal data obtained by the IMD is determined based on real-time physiological signals sensed by the IMD or by another implantable device communicatively coupled to the IMD; The other physiological signal data obtained by the ED is determined based on another real-time physiological signal sensed by the ED or by another external device communicatively coupled to the ED; and The physiological signal and corresponding segments of the other physiological signal are displayed together in real time or near real time, so that they are synchronized with each other.

11. A method for synchronous display of signal segments, the method comprising: In response to receiving a notification packet from an implantable medical device (IMD), the external device (ED) sends a connection request packet to the IMD, thereby enabling the establishment of a wireless connection between the ED and the IMD; During the process of establishing the wireless connection between the ED and the IMD, the ED receives an IMD anchor sent by the IMD in response to the IMD receiving the connection request packet; The ED stores the IMD anchor point and the ED anchor point; When the wireless connection is established between the ED and the IMD, the ED receives multiple data packets, each of which includes a portion of the patient's physiological signal data obtained by the IMD and a corresponding IMD timestamp specifying when the data packet was sent by the IMD; For each data packet received by the ED, the ED determines, from the perspective of the ED, the corresponding time when the data packet was sent by the IMD, based on the ED anchor point stored by the ED, the IMD anchor point stored by the ED, and the IMD timestamp included in the data packet received by the ED. The ED acquires additional physiological signal data representing another physiological signal sensed using one or more skin electrodes or non-implantable sensors; and The ED uses the corresponding time determined for the data packets received by the ED from the IMD to display corresponding segments of the physiological signals represented by the data packets together with the other physiological signal, so that they are synchronized with each other.

12. The method according to claim 11, wherein, The ED determines the corresponding time when the data packet is sent by the IMD from the ED's perspective by performing the following equation for each of the data packets received by the ED: RT DATA =ANCHOR ED + TIME_STAMP IMD - ANCHOR IMD , in RT DATA From the perspective of the ED, the data packet is sent by the IMD at a corresponding time, which is determined by the ED. ANCHOR ED The ED anchor point is stored by the ED. TIME_STAMP IMD The IMD timestamp is included in the data packet received by the ED, and ANCHOR IMD The IMD anchor point is stored by the ED.

13. The method according to claim 11, wherein: The IMD and the ED each include a corresponding real-time clock (RTC). The IMD anchor point received by the ED includes the RTC value of the IMD when the IMD sends a connection response packet in response to the IMD receiving the connection request packet from the ED; as well as The corresponding timestamp of each data packet received by the ED from the IMD includes the value of the IMD's RTC when the data packet was sent by the IMD.

14. The method of claim 13, wherein: The ED anchor point includes the value of the RTC of the ED when the ED receives the connection response packet from the IMD.

15. The method according to claim 11, wherein, The ED also includes one or more buffers, and the method includes the ED controlling the one or more buffers to synchronize the other physiological signal and the physiological signal with each other when they are displayed together.

16. The method according to any one of claims 11 to 15, wherein: The physiological signal includes either an electrogram (EGM) or a subcutaneous electrocardiogram (ECG); as well as The other physiological signal that is displayed together and synchronized with one of the EGM or the subcutaneous ECG includes an electrocardiogram (ECG) sensed using the one or more skin electrodes.

17. The method according to any one of claims 11 to 15, wherein: The physiological signal data obtained by the IMD is determined based on real-time physiological signals sensed by the IMD or by another implantable device communicatively coupled to the IMD; The other physiological signal data obtained by the ED is determined based on another real-time physiological signal sensed by the ED or by another external device communicatively coupled to the ED; and The physiological signal and corresponding segments of the other physiological signal are displayed together in real time or near real time, so that they are synchronized with each other.

18. The method according to any one of claims 11 to 15, wherein, During the process of establishing the wireless connection between the ED and the IMD, the method further includes: The IMD sends notification packets; and The IMD receives the connection request packet from the ED within the receive window after sending the notification packet, and in response, the IMD sends the connection response packet, which includes the IMD anchor, to the ED.

19. The method according to any one of claims 11 to 15, wherein, When establishing the wireless connection between the ED and the IMD, the method further includes: The IMD acquires physiological signal data of the patient in whom the IMD is implanted; and The IMD sends the plurality of data packets to the ED, each of the plurality of data packets including a portion of the physiological signal data and a corresponding IMD timestamp specifying when the data packet was sent by the IMD.

20. The method of claim 19, wherein: The physiological signals include either an electrophysiological recording (EGM) or a subcutaneous electrocardiogram (ECG); and The other physiological signal that is displayed together and synchronized with one of the EGM or the subcutaneous ECG includes an electrocardiogram (ECG) sensed using the one or more skin electrodes.

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