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JP-7857309-B2 - Communication system and method for implantable medical devices

JP7857309B2JP 7857309 B2JP7857309 B2JP 7857309B2JP-7857309-B2

Inventors

  • タフ、ブライアン エム．
  • スウェエンソン、クルト
  • ベルグストロム、ディーン
  • マーリン、ジュリアン

Assignees

  • バイオトロニック エスエー アンド カンパニー カーゲー

Dates

Publication Date
20260512
Application Date
20220518
Priority Date
20210702

Claims (13)

  1. A communication system (10) for wireless message transfer between an implantable medical device (IMD, 40) and an external device (60), wherein the IMD (40) is configured to monitor the health status of a patient (30) and/or to deliver therapeutic signals to the patient, and the IMD (40) comprises a processor and a transceiver module configured to exchange messages bidirectionally with the external device (60), wherein the processor has at least a predefined Employing an active state and a predefined processing state, the processor of the IMD (40) is configured to create response messages (201, 202, 203, 204) to send from the transceiver module to the external device (60), and each response message (201, 202, 203, 204) includes a processor state field in a predefined location within the response message (201, 202, 203, 204). As long as the processor is currently in a predefined processing state, a predefined first value is assigned to the processor state field. If the processor is not currently in the processing state, a predefined second value different from the first value is assigned to the processor state field . A communication system (10) in which the external device (60) receives response messages (201, 202, 203, 204) from the IMD (40) that include the predefined first value assigned to the processor state field is configured to wait for all new request messages to be sent to the transceiver module of the IMD (40) until the latest response message (201, 202, 203, 204) includes the predefined second value assigned to the processor state field .
  2. The communication system according to claim 1, wherein the length of the processor state field is 1 to 4 bits.
  3. The communication system according to claim 1 or 2, wherein the response messages (201, 202, 203, 204) are proximity response messages, status report response messages, data payload/relay response messages, response messages carrying measurement data acquired through a trigger routine generated by the external device, or acknowledgment response messages.
  4. A communication system (10) for wireless message transfer between an implantable medical device (IMD, 40) and an external device (60), wherein the IMD (40) is configured to monitor the health status of a patient (30) and/or to deliver therapeutic signals to the patient, and the IMD (40) comprises a processor and a transceiver module configured to exchange messages bidirectionally with the external device (60), wherein the processor employs at least a predefined active state and a predefined processing state, and the external device (60) sends request messages (101, 102, 103) to the IMD (40) via the transceiver A communication system (10) configured to create the messages to be sent to an interceptor module, wherein each request message (101, 102, 103) includes a sequence field in a predefined location within the request message (101, 102, 103), the sequence field is toggled between at least a first value and a second value associated with the sequence field, and if the external device (60) receives a valid response from the IMD (40) to a first request message sent immediately before which the first value is included , the second request message (101, 102, 103) includes the toggled second value, or vice versa.
  5. The communication system according to claim 4 , wherein the length of the sequence field is 1 bit to 4 bits.
  6. The communication system according to claim 4 or 5, wherein the request messages (101, 102, 103) are proximity request messages, status request messages, data request messages, monitoring request messages, execution/measurement request messages, program write messages, program request messages, status request messages, execution request messages , or data request messages.
  7. The communication system according to claim 4 or 5, wherein when the IMD receives a request message (101, 102, 103) from the external device (60) that includes a value assigned to the sequence field equal to the value assigned to the sequence field of the request message (101, 102 , 103 ) that was received immediately before, the IMD (40) is configured to repeatedly send response messages to the external device (60).
  8. A communication method for data transfer between an implantable medical device (IMD, 40) and an external device (60), wherein the IMD (40) is configured to monitor the health status of a patient (30) and/or to deliver therapeutic signals to the patient, and the IMD (40) comprises a processor and a transceiver module configured to exchange messages bidirectionally with the external device (60), wherein the processor employs at least a predefined active state and a predefined processing state, and the processor of the IMD (40) is configured to create response messages (201, 202, 203, 204) and send the response messages (201, 202, 203, 204) from the transceiver module to the external device (60), and each response message (201, 202, 203, 204) includes a processor state field in a predefined location within the response message (201, 202, 203, 204). As long as the processor is currently in a predefined processing state, a predefined first value is assigned to the processor state field. If the processor is not currently in the processing state, a predefined second value different from the first value is assigned to the processor state field . A communication method in which the external device (60), which receives response messages (201, 202, 203, 204) from the IMD (40) that include the predefined first value assigned to the processor state field, waits for the latest response message (201, 202, 203, 204) to include the predefined second value assigned to the processor state field before sending all new request messages (101, 102, 103) to the transceiver module of the IMD (40) .
  9. A communication method for data transfer between an implantable medical device (IMD, 40) and an external device (60), wherein the IMD (40) is configured to monitor the health status of a patient (30) and/or to deliver therapeutic signals to the patient, and the IMD (40) comprises a processor and a transceiver module configured to exchange messages bidirectionally with the external device (60), wherein the processor employs at least a predefined active state and a predefined processing state, and the external device (60) sends request messages (101, 102, 103) to the transceiver module of the IMD (40). A communication method configured to create the messages to be sent, wherein each request message (101, 102, 103) includes a sequence field in a predefined location within the request message (101, 102, 103), the sequence field is toggled between at least a first value and a second value associated with the sequence field, and if the external device (60) receives from the IMD (40) a valid response to a first request message (101, 102, 103) sent immediately before, which includes the first value , then the second request message (101, 102, 103) includes the toggled second value, or vice versa.
  10. The communication method according to claim 8 or 9, wherein the response messages (201, 202, 203, 204) are proximity response messages, status report response messages, data payload/relay response messages, response messages carrying measurement data acquired through a trigger routine generated by the external device, or affirmative response messages, and the request messages (101, 102, 103) are proximity request messages, status request messages, data request messages, monitoring request messages, execution/measurement request messages, program write request messages, program request messages, status request messages, execution request messages, or data request messages.
  11. The communication method according to claim 8 or 9, wherein when the IMD (40) receives a request message (101, 102, 103) from the external device (60) that includes a value assigned to the sequence field equal to the value assigned to the sequence field of the request message ( 101 , 102, 103 ) received immediately before, the IMD (40) sends a repeat message to the external device (60).
  12. A computer program product that, when executed by a processor, includes instructions causing the processor to perform the steps of the method according to claim 8 or 9 .
  13. A computer-readable data carrier for storing the computer program product described in claim 12 .

Description

This invention relates to a communication system for data transfer between an implantable medical device (IMD) and an external device, wherein the IMD is configured to monitor the patient's health status and/or to deliver therapeutic signals to the patient. The external device is located at least partially outside the body. This invention further relates to a corresponding method for data transfer, a corresponding computer program, and a corresponding computer-readable data carrier. The computer program product may be, for example, a software routine related to hardware support means within the IMD and/or the external device. Active and passive implantable medical devices (IMDs), such as pacemakers (with leads), implantable cardiac monitors (ICM), implantable leadless pacers (ILP), implantable leadless pressure sensors (ILPS), implantable cardiac defibrillators (ICD), or subcutaneous implantable cardiac defibrillators. A Defibrillator (i.e., S-ICD) includes sensors that collect physiological signals to monitor a patient's health status and transmit them as data to a physician's device or a remote server using an external device. Data collected from these various or any such sensors may include, but are not limited to, ECG, impedance, activity, posture, heart sounds, pressure, respiration, and other data. An active IMD (e.g., pacemaker, ILP, ICD, or S-ICD) may provide a therapeutic output, such as electrical stimulation within the cardiac chambers (e.g., atria or ventricles), to the patient. Typically, such an IMD consists of a processor for data processing and a transceiver module configured to exchange messages bidirectionally with an external device, for example, if implanted in a patient's body. An external device, which may use its own transceiver, is also configured to exchange messages bidirectionally with the IMD's transceiver module. The external device may be a separate device connected to a computer (sometimes called a programmer) or a module integrated within a remote device such as a computer. The external device creates messages in the form of requests and sends them to the IMD's transceiver, for example, to receive data from the IMD regarding the patient's health status or the IMD's status, or to program it (for the purpose of configuring the IMD to apply appropriate treatment to the patient). Processing data, applying algorithms to data, and having the IMD manage communication with external devices presents difficulties and drawbacks due to the low power requirements and limited computing resources within the IMD. Most of the management of such routines cannot be performed within the IMD without risking adverse effects on device lifespan. To extend the lifespan of the IMD (by achieving the best access to meaningful clinical benefits), there is a need to accommodate more power/energy within the IMD. Unfortunately, if such power/energy cannot be incorporated into the IMD through high-power/energy-density battery chemistry, the use of a larger battery may be required to extend lifespan. Given the small size of modern IMDs, larger batteries risk increasing the physical size of the IMD, which is clinically undesirable, as is the potential for reduced lifespan (especially in the case of leadless pacemaker IMDs, which are devices that reside within cardiac volume). Therefore, the communication infrastructure and message processing required within the IMD system must be optimized for low-energy operation. Such optimized communication and messaging also avoids overloading the communication infrastructure (e.g., information routing to buses), 1.) A system command initiation source, such as an external device, is notified by a downstream handler such as an IMD about the processing of its generated (instate) request. 2.) In a manner that avoids any possible problematic handling of the IMD, such as when it receives repeated requests from an external device (i.e., when the external device is unaware that it has requested the IMD and therefore "retries"), 3.) In a manner that provides means for managing navigation through data memory within the IMD without incurring undesirable overhead, The command/response dynamics need to be properly configured. Communication protocols/architectures are known to include some functionality for polling the status of data processing units within a system. Such support often embodies "ping" requests from one or more in-system command initiation sources that can report on the progress of a previously issued request in the service status of a downstream handler (e.g., the task completion bar often seen in the installation process of Windows® applications). Such situations can take various forms with varying degrees of complexity, but often correspond to a specific command or series of commands asking the downstream handler, "Are you finished?" However, such communication procedures can cause excessive congestion on the data message link between the IMD and external devices, ma