JP-7857316-B2 - Communication system and method for wireless data transmission between an implant and an external device

JP7857316B2JP 7857316 B2JP7857316 B2JP 7857316B2JP-7857316-B2

Inventors

エルスナー、ヨアヒム
ケッペル、ユルゲン
ビアーシュナイダー、エマヌエル
ガルツ、ヴォルフガング
カメンツ、ウーヴェ
ステューマー、ウーヴェ
シュテファン、エンリコ
グレツキ、グンナー

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: 20220608
Priority Date: 20210707

Claims (14)

A communication system (10) for wireless data transmission between an implantable medical device (IMD, 40) and an external device (60) comprising a communication unit (62) and a processor (61), wherein the system comprises the IMD (40) and the external device (60), the IMD (40) being configured to monitor the physical parameters of a patient (30) and/or to deliver therapeutic signals to the patient, the IMD comprising a transceiver module, the transceiver module being configured to exchange data with the communication unit of the external device in the uplink direction from the transceiver module to the communication unit and in the downlink direction from the communication unit to the transceiver module, the processor of the external device determining the signal strength ( CE ) of at least one data packet (P1) received by the communication unit and sent by the transceiver module of the embedded IMD at a predetermined initial data transfer rate, and the noise level (IE ) of the communication unit. A communication system (10) configured to determine the highest possible uplink data transfer rate (d UL) for uplink data transmission and the highest possible downlink data transfer rate (d DL ) for downlink data transmission, based on the signal strength of the at least one data packet received by the communication unit from the transceiver module and the current noise level of the communication unit.
The communication system according to claim 1, wherein the maximum possible uplink data transfer rate for data transmission in the uplink and downlink directions takes into account a bit error rate (BER ) between 10⁻¹ and 10⁻⁶ .
The communication system according to claim 1 or 2, wherein the maximum possible uplink data transfer rate for data transmission in the uplink and downlink directions takes into account a predetermined type of IMD transceiver module.
The communication system according to claim 1 or 2 , wherein the maximum possible uplink data transfer rate value for data transmission in the uplink and downlink directions takes into consideration a predetermined frequency band for data transmission.
The communication system according to claim 1 or 2, wherein the communication unit (62) of the external device (60) is further configured to transmit the determined maximum possible uplink data transfer rate value and the maximum possible downlink data transfer rate value to the transceiver module of the IMD (40), and the IMD is configured to set the uplink data transfer rate and the downlink data transfer rate that are then available for use by the transceiver module to the data transfer rate values received from the communication unit.
The communication system according to claim 1 or 2, wherein the external device (60) is configured to set the uplink data transfer rate and the downlink data transfer rate that can then be used by the communication unit (62) to the determined maximum possible downlink data transfer rate value and the determined maximum possible uplink data transfer rate value.
The communication system according to claim 1 or 2, wherein the processor (61) of the external device (60) is configured to determine the signal loss (L) in the uplink and downlink data transmissions, and/or the processor of the external device is configured to observe the noise level of the communication unit ( 62 ) over a predetermined time period, thereby identifying a subsection within that time period in which the noise level is typically higher than that of other subsections.
A communication method for wireless data transmission between an implantable medical device (IMD, 40) and an external device (60) comprising a communication unit (62) and a processor (61), wherein the IMD (40), after being implanted in the body of a patient (30), monitors the patient's physical parameters and/or delivers therapeutic signals to the patient, the IMD comprises a transceiver module, and the transceiver module exchanges data with the communication unit of the external device in the uplink direction from the transceiver module to the communication unit and in the downlink direction from the communication unit to the transceiver module. - The process involves the processor of the external device determining the signal strength (CE) of at least one data packet (P1) received by the communication unit and transmitted at a predetermined initial data transfer rate by the transceiver module of the embedded IMD , - The process involves the processor of the external device determining the noise level ( IE ) of the communication unit, A communication method comprising the steps of: the processor determining, based on the signal strength of the at least one data packet received by the communication unit from the transceiver module and the current noise level of the communication unit, the highest possible uplink data transfer rate value (d UL ) for uplink data transmission and the highest possible downlink data transfer rate value (d DL ) for downlink data transmission.
The communication method according to claim 8, wherein the maximum possible uplink data transfer rate value for data transmission in the uplink and downlink directions takes into account a bit error rate (BER ) between 10⁻¹ and 10⁻⁶ , and/or a predetermined type of IMD transceiver module, and/or a predetermined frequency band for data transmission.
The communication method according to claim 8 or 9, wherein the communication unit (62) of the external device (60) transmits the determined maximum possible uplink data transfer rate value and the maximum possible downlink data transfer rate value to the transceiver module of the IMD (40), and the IMD sets the uplink data transfer rate and the downlink data transfer rate that the transceiver module can then use to the transmitted data transfer rate value.
The communication method according to claim 8 or 9, wherein the external device (60) sets the uplink data transfer rate and the downlink data transfer rate that can then be used by the communication unit (62) to the determined maximum possible downlink data transfer rate value and the determined maximum possible uplink data transfer rate value.
The communication method according to claim 8 or 9, wherein the processor (61) of the external device (60) determines the signal loss (L) in the uplink and downlink data transmissions and/ or observes the noise level of the communication unit (62) over a predetermined period of time, thereby identifying a subsection within that period in which the noise level is typically higher than that of other subsections.
A computer program product that, when executed by the processor (61) of the external device (60), includes instructions causing the processor to perform the steps of the method according to claim 8 or 9 .
A computer-readable data carrier for storing the computer program product described in claim 13.

Description

This invention relates to a communication system for wireless data transmission 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 each communication method for wireless data transmission, each computer program product, and each computer-readable data carrier. Active and passive implantable medical devices (IMDs, implants), such as pacemakers (with leads), BioMonitors, implantable leadless pacers (ILPs), implantable leadless pressure sensors (ILPSs), implantable cardiodefibrillators (ICDs), or Shockboxes, encompass sensors that collect physiological signals to monitor a patient's health status and transmit them as data to external devices (e.g., smartphones, computers, remote servers) using communication units. Data collected from these various sensors may include, but are not limited to, ECG, impedance, activity, posture, heart sounds, pressure, respiratory data, and other data. Active IMDs, such as pacemakers, ILPs, ICDs, or shockboxes, can provide the patient with therapeutic signals, such as electrical stimulation within the ventricles or atria. Typically, such an IMD comprises a processor for data processing and a transceiver module configured to exchange messages bidirectionally with a communication unit of an external device, for example, when implanted in a patient's body. The communication unit of the external device, at least partially located outside the body, is configured to transmit data bidirectionally using the IMD's transceiver module. The communication unit generates messages and sends them to the IMD's transceiver module in the form of requests, for example, to receive data from the IMD regarding the patient's health status or IMD status, or to program it (to configure the IMD to apply appropriate therapy to the patient). U.S. Patent Application Publication No. 2003/0009204 (A1) describes a system and method for optimizing short-range and long-range telemetry communication between an implantable medical device and an external device such as an external programmer or remote monitor. According to the present invention, data is transmitted from the implantable device to the external device at either a faster or slower data transfer rate. U.S. Patent Application Publication No. 2018/0152972 (A1) describes a method and system for data transmission, in which a communication link is initiated between an external device and an IMD. During a first connection interval, data packets are carried between the external device and the IMD, and connection criteria, including at least one of the data throughput requirements, are monitored. Furthermore, to extend the lifespan of the IMD, the communication link is changed from the first connection interval to a second connection interval based on the connection criteria, the second connection interval may be longer than the first connection interval, and the change operation includes changing to the second connection interval when the data throughput requirements fall below a data threshold. According to the above document, communication parameters must be considered to avoid improper IMD battery depletion. This is especially true for telemetry communication between an IMD implanted in a patient's body and an external device. Such telemetry communication is often implemented as a short communication connection involving the exchange of several data packets, repeated at predefined, usually constant time intervals. Typically, low link margins are used for telemetry communication between an IMD and external devices. In such cases, high data transfer rates can cause communication loss, and potentially, high repetition rates lead to increased energy consumption. Because short-duration communication connections contain only a few data packets, the usual "negotiation" of the optimal data transfer rate between communication partners also increases energy consumption. The usual quality of service (QoS) methods for determining the overall performance of a data transmission service, including requirements for all aspects of the connection such as service response time, loss, signal-to-noise ratio, crosstalk, echo, interrupts, frequency response, loudness level, etc., are not effective for short-duration communications such as IMD-to-external device communication in the case of telemetry. U.S. Patent Application Publication No. 2003/0009204 (A1)U.S. Patent Application Publication No. 2018/0152972 (A1) This figure shows an embodiment of a communication system comprising an implantable leadless pacemaker (ILP) and a communication unit, with the ILP shown within a cross-section of the patient's heart.This graph shows the BER (in dB) of a typical receiver relative to the energy-to-noise power spectral density ratio E b / N 0 (in dB).Thi