Patent Application
20240207622
The instant invention generally relates to a communication system for intra-body communication and a method for operating a communication system.
Within a communication system of the kind described herein a communication in between implantable medical devices shall be facilitated, such as cardiac stimulation devices (for example, a pacemaker device or a cardioverter defibrillator), sensor devices, recording devices or other medical devices to be implanted into a patient for providing a therapeutic or diagnostic function. A communication system of this kind may also be denoted as Body Area Network (BAN) system.
An implantable medical device of the kind concerned herein may, for example, be a pacemaker, an implantable cardioverter defibrillator, a sensor device such as a bio-sensor for measuring a blood pressure, or a recording device such as a loop recorder to be subcutaneously implanted in a patient.
An implantable pacemaker may, for example, be subcutaneously implanted in a patient and may comprise leads carrying electrodes and extending from a generator unit of the pacemaker device into the patient's heart, for example to provide a pacing action in the right ventricle of the heart. Alternatively, an implantable pacemaker device may be designed as a leadless pacemaker not comprising leads, but being directly implanted into the patient's heart, for example in the right ventricle in order to provide for a pacing action.
A cardioverter defibrillator may serve for monitoring and treating potentially life-threatening arrhythmias in a patient's heart, wherein a cardioverter defibrillator of this kind may, for example, be implanted subcutaneously and may comprise leads extending into the patient's heart in order to record signals and to inject stimulation energy into the patient's heart, for example to provide an electric shock (defibrillation).
Sensor devices, such as pressure sensors, flow sensors, temperature sensors or the like, may, for example, be implanted into a blood vessel, such as a vein, in order to provide for a monitoring of relevant parameters in the context of providing a therapy.
A loop recorder is, for example, subcutaneously implanted and serves to continuously record information, for example, about cardiac activity, such as an ECG. A loop recorder may continuously loop its memory and may store particular portions of signals, such that recorded signals may be communicated to an external device for analyzing the signals and for providing a diagnosis.
There is a desire that medical devices implanted in a patient may communicate with each other in order to allow the medical devices to interact. For example, signals sensed by a pacemaker device or an implanted sensor device may be transmitted to a loop recorder such that the loop recorder may record such signals. In addition, a pacemaker device may receive signals from a sensor device implanted remotely from the pacemaker device in order to take sensing signals of the sensor device into account for controlling a pacing action in the patient's heart.
For establishing a communication, approaches exist to create an intra-body network (IBN) linking implanted medical devices with each other such that signals may be exchanged in between the implanted medical devices.
For example, European Patent No. 2 327 609 B1 describes an acoustic communication link in between implanted medical devices for exchanging information in between the implanted medical devices. The acoustic communication link is established to permit wireless communication between the implanted medical devices, wherein transmission parameters may be adapted, such as a sensitivity and a carrier frequency, in order to improve an existing communication link.
Implantable medical devices may generally sense data which shall be communicated to another implantable medical device and in addition to an external device for further processing. Alternatively or in addition, implantable medical devices may receive configuration data from an external device in order to adapt operation of a particular implantable medical device. For this, a communication needs to be established with the external device.
In some approaches, a dedicated implantable medical device serves as a hub to provide a communication link to an external device with a dedicated communication concept differing from a signaling employed within the environment of the implantable medical devices. This comes with the drawback that the implantable medical device serving as the hub may exhibit an increased energy consumption, as communication with the external device may be power intensive. In addition, communication with the external device depends on the correct functioning of the implantable medical device serving as the hub, the hub having to implement different communication concepts in order to be able to establish a communication with the external device as well as with other implantable medical devices. Any failure of the dedicated implantable medical device serving as the hub may eliminate communication to the other implantable medical devices.
U.S. Publication No. 2006/0031378 A1 describes a system and method for providing digital data communications over a wireless intra-body network. A physical protocol layer is logically defined with an identifier uniquely assigned to a plurality of implantable devices in an intra-body network. Functions are specified within the physical protocol layer to permit data exchange over a wireless interface. A slave implantable device is activated in response to an activation signal transmitted through the wireless interface by a master implantable device. A wireless communication link is established between the slave implantable device and the master implantable device upon matching of the identifier assigned to the slave implantable device. Data is communicated intra-bodily over the communications link.
U.S. Publication No. 2007/0208389 A1 describes an apparatus and method for an implanted sound sensor wirelessly communicating with an implantable medical device, or with an external monitoring device.
The present disclosure is directed toward overcoming one or more of the above-mentioned problems, though not necessarily limited to embodiments that do.
It is an object of the instant invention to provide a communication system and a method for operating a communication system which allow for a reliable, yet power efficient communication in between implantable medical devices as well as with an external device.
It is a further object of the present invention to provide intra-body communication with minimized energy consumption and maximized system simplicity to best support the requirements for small and low energy implantable devices.
In one aspect, a communication system for establishing an intra-body communication comprises: a multiplicity of implantable medical devices, each of the multiplicity of implantable medical devices comprising communication circuitry for communicating with another of the multiplicity of the implantable medical devices using a first signaling technique; and at least one external device comprising first communication circuitry for communicating with the multiplicity of implantable medical devices using said first signaling technique and second communication circuitry for communicating with a remote system using a second signaling technique different than the first signaling technique.
Accordingly, within the communication system multiple implantable medical devices are configured to communicate with each other and with an external device using a first signaling technique. Hence, each of the implantable medical devices is enabled to communicate with other implantable medical devices and an external device, i.e., a device outside of the patient's body.
Because the external device may communicate with any of the implantable medical devices (when implanted in a patient), no dedicated implantable medical device serving as a hub for relaying communication is required. Rather, a common communication technique is used for an intra-body communication in between the implantable medical devices as well as for a communication of the implantable medical devices with the external device.
By utilizing the same signaling technique for the intra-body communication between implantable medical devices (in an implanted state) amongst each other as well as for communication between the implantable medical devices and one or multiple external devices, the implementation complexity for communication circuitry of intra-body devices can be minimized. In addition, the external device is able to address individual implantable medical devices without the need of a specific intra-body hub to perform, e.g., programming or interrogation tasks, and in addition to monitor a communication between the various medical devices to provide, e.g., network maintenance tasks.
In addition, by allowing the communication to any individual internal implantable medical device by an external device, battery depletion or failure of an implantable medical device would not prevent the communication to other implantable medical devices.
The first communication circuitry of the at least one external device in particular is configured to communicate with each of the multiplicity of implantable medical devices using the first signaling technique. Hence, any implantable medical device is enabled to directly communicate with one or multiple external devices, without the need for a relaying by means of another implantable medical device.
The first signaling technique and the second signaling technique allow for a wireless communication, such that the communication system wirelessly spans medical devices implanted in a patient as well as external devices utilizing a common wireless signaling technique.
In one embodiment, the first signaling technique is based on a first physical layer signaling using modulated oscillating electrical fields. For example, the Intrabody Communication (IBC) technology may be used for a communication, as described in the IEEE 802.15.6 WBAN protocol. Herein, external devices may in particular couple to the patient using a galvanic coupling or a capacitive coupling.
In another embodiment, the first signaling technique is based on a physical layer signaling using acoustic signals, in particular ultrasonic signals. For this, communication circuitry of the implantable medical devices as well as the at least one external device may be formed as an ultrasonic transducer which is packaged such that it is vibrationally coupled to the medium surrounding the implantable medical device respectively the external device. An external device may, for example, be placed on the patient's skin in order to couple to the patient, such that ultrasonic signals may be transmitted into the patient and may be received from the patient.
In yet another embodiment, the first signaling technique is based on a physical layer signaling using oscillating magnetic fields or electromagnetic wave signals. In this embodiment, the implantable medical devices as well as the at least one external device comprise communication circuitry using magnetic coils and using modulated oscillating magnetic fields for communication in between the implantable medical devices as well as with the external device.
In another embodiment, the first signaling technique is based on a physical layer using RF technology with a carrier frequency suitable for penetrating body tissue.
Within the communication, a common physical layer signaling as well as a common communication protocol is used for communication in between the implantable medical devices and the at least one external device. The physical layer herein denotes a logical layer defining a physical signaling in between the different devices using a common technology according to a common communication protocol. Each implantable medical device as well as the at least one external device herein may be identified within communication messages by means of a unique identifier, such that messages transmitted through the patient's body are received by all devices and processed by the devices according to identifier information included in the messages.
In one embodiment, the at least one external device is configured to externally contact a patient. For example, the at least one external device may be configured to be worn on a patient's body. For example, the at least one external device may have the shape of a wrist watch and hence may be worn on a patient's wrist, wherein a contact face of the at least one external device is configured to be brought into contact with the patient's skin for coupling to the patient, for example for introducing electrical signals or acoustical signals (in particular ultrasonic signals) into the patient or receiving such signals from the patient.
The at least one external device in addition implements a second signaling technique, which, for example, is based on a second physical layer signaling using RF signals. The second signaling technique may, for example, employ a standardized communication technology, such as a Bluetooth technique, in particular Bluetooth Low Energy (BLE), a Zigbee technique, a Near Field Communication (NFC) technique, or a Wi-Fi technique.
The second signal technique implements a second (logical) physical layer for establishing a communication of the at least one external device with a remote system, such as a remote server accessible via a public communications network, such as the Internet. By means of the second signaling technique the at least one external device may, e.g., connect to a communication device serving as a relay device, such as a local computer, a mobile device such as a smart phone or another local device in proximity to the patient, wherein by means of the second signaling technique in particular a communication within a local environment may be established. By means of the communication device data may be relayed to and from the remote system, for example using a common communication protocol scheme by means of the public communications network.
In one embodiment, the second signaling technique is based on a second physical layer using acoustic signals. For example, the second communication circuitry of the at least one external device may comprise an acoustic transducer which is configured to produce acoustic signals in an audible acoustic frequency range, for example in between 50 Hz to 8 KHz, which may be transmitted using a Public Switched Telephone Network (PSTN). For example, for relaying data to a remote system, a user may call a phone number using a telephone, the phone number being associated with a central server link station. The user may then place the at least one external device in proximity to the telephone's microphone such that a data transmission may take place by transferring the acoustic signals produced by the at least one external device via the telephone to the remote system, without requiring an Internet connection or other specialized hardware.
In one embodiment, at least one of the implantable medical devices is a cardiac stimulation device, such as a pacemaker device or a cardioverter defibrillator.
In one embodiment, at least one of the implantable medical devices is a leadless cardiac stimulation device, that is a cardiac stimulation device not comprising leads carrying electrodes. A leadless cardiac stimulation device of this kind may in particular be implanted directly into the patient's heart, for example the right ventricle or the right atrium.
Generally, one or multiple implantable medical devices of the communication system may be implanted subcutaneously into a patient or directly into the patient's heart. For example, in one embodiment, one implantable medical device is implanted into the right ventricle and another implantable medical device is implanted into the right atrium of the patient's heart, a communication being established in between the intra-cardiac implantable medical devices within the communication system.
In one embodiment, at least one of the implantable medical devices is a subcutaneous cardiac loop recorder or a bio-sensor for measuring the blood pressure.
Generally, within the communication system different implantable medical devices, e.g., in the shape of stimulation devices, sensing devices, recording devices or marking devices may communicate with one another and with at least one external device making use of a common (first) signaling technique, involving a common physical layer as well as a common communication protocol.
In one embodiment, within the communication system an intra-cardiac pacemaker is implanted in the right ventricle and an intra-cardiac pacemaker is implanted in the right atrium.
In one embodiment, within the communication system an intra-cardiac pacemaker is implanted in the right ventricle and a loop recorder is implanted subcutaneously.
In one embodiment, within the communication system an intra-cardiac pacemaker is implanted in the right ventricle and a sensor (e.g., a bio sensor) measuring the blood pressure is implanted in a blood vessel of the patient and/or integrated into the intra-cardiac pacemaker.
The communication system may be based on energy saving optimizations using modulated oscillating electric fields to communicate between implanted devices within a body. Such communication concepts utilize high frequency electric pulses to either being phase-shift keying (PSK) or on-off keying (OOK) modulated to convey bit information. In either case the carrier frequency may be generated by a 50% duty cycle square pulse shaped signal. In case of a PSK modulation, the carrier frequency signal is continuous, and phase shifts of the carrier frequency are indicative for the change in the bit value transmitted. In case of an OOK modulation, the presence of the carrier frequency for a predetermined time represents the code for the bit value 1 and the absence of the carrier frequency, again for a predetermined time frame, represents the code for bit value 0. This basic principle of the OOK modulation makes it a good candidate for a simple communication concept with good energy saving potential.
There may be two energy saving parameter available for an OOK modulated oscillating electric field with a 50% duty cycle square pulse signal shape of the carrier frequency:
Tests indicate that the demodulation of OOK modulated oscillating electric fields may be performed for significantly reduced pulse width times together with a strong reduced duty cycle. Reducing the duty cycle for the active part of the pulse interval effectively produces a wideband signal. The narrower the pulse the wider the frequency spectrum will be. Applying both energy saving methods for the generation of the communication signal can yield a magnitude of energy savings in comparison to the existing state of the art technology. This can be observed by comparing the active signal time (AST) as used in existing technologies (e.g., ZAND communication) with test results utilizing energy optimized signal parameters. Since AST represents the time an active voltage is applied to the transmitting electrodes, reducing AST will directly reduce the energy needed to generate the transmission signal.
AST in OOK may apply by design only to bit transmissions of the value 1 where the predetermined bit time can be expressed in the numbers of carrier frequency intervals needed for that time. Finally, with the duty cycle of the square pulse shape further limiting the active signal time, AST can be expressed as
For the communication with OOK modulation the number of intervals may be about 60 and the duty cycle used may be 0.5 (50%). For example, successful communication may be achieved with parameter N set to 10 and the duty cycle value set to 0.1 (10%), yield an energy reduction factor of 30 in comparison to the settings above.
The described embodiments above and any combination of them allow for implanted devices to perform communication with minimal energy consumption by utilizing non-complex technology.
In another aspect, a method for operating a communication system for intra-body communication comprises: establishing a communication in between a multiplicity of implantable medical devices, each comprising communication circuitry for communicating with another of the multiplicity of implantable medical devices using a first signaling technique; establishing a communication in between at least one external device and the multiplicity of implantable medical devices, the at least one external device comprising first communication circuitry for communicating with the multiplicity of implantable medical devices using said first signaling technique; and establishing a communication between the at least one external device and a remote system, the at least one external device comprising second communication circuitry for communicating with the remote system using a second signaling technique different than the first signaling technique.
The advantages and advantageous embodiments described above for the communication system equally apply also to the method, such that it shall be referred to the above in this respect.
Additional features, aspects, objects, advantages, and possible applications of the present disclosure will become apparent from a study of the exemplary embodiments and examples described below, in combination with the Figures and the appended claims.
The various features and advantages of the present invention may be more readily understood with reference to the following detailed description and the embodiments shown in the drawings. Herein,
Subsequently, embodiments of the present invention shall be described in detail with reference to the drawings. In the drawings, like reference numerals designate like structural elements.
It is to be noted that the embodiments are not limiting for the present invention, but merely represent illustrative examples.
Referring to
There generally exists a desire for a data communication in between different medical devices 1, 2, 3 implanted in a patient P. Approaches exist to establish a communication of this kind in a wireless fashion by establishing an intra-body network linking the medical devices 1, 2, 3 together, such that data may be exchanged in between the medical device 1, 2, 3. A loop recorder may hence, for example, record sensor data of a sensor device, or data of a pacemaker or a cardioverter defibrillator, and may also provide data, for example, to a pacemaker or a cardioverter defibrillator to control a therapeutic action.
In order to allow for a data communication, a communication link between medical devices 1, 2, 3 needs to be established. Signals herein are exchanged in a modulated fashion making use of a particular transmission technology, such as an acoustic, electric or magnetic (inductive) signal transmission, and a particular modulation scheme, such as a PCM, FSK, PSK, QPSK, FM, or AM modulation or the like.
Referring now to
A first medical device 1, for example in the shape of a leadless pacemaker, may herein comprise a housing 10, a control circuitry 11, an electrode arrangement 12 for emitting stimulation signals or receiving sense signals, a communication circuitry 13 and an energy storage 14, for example in the shape of a battery.
A second medical device 2, for example in the shape of an implantable sensor device, such as a pressure sensor, or in the shape of a loop recorder, comprises a housing 20, a control circuitry 21, a communication circuitry 23, and an energy storage 24, for example in the shape of a battery.
The communication circuitry 13, 23, in each case, comprises a transmission unit 130, 230, and a reception unit 131, 231. The communication circuitry 13, 23, is designed for the specific transmission technology, that is for transmitting and receiving acoustic, electric or magnetic signals. Also, the communication circuitry 13, 23 is designed to modulate respectively demodulate signals for transmission and reception, to optimize transmission parameters, to amplify received signals and to process signals in order to forward processed signals to the control circuitry 11, 21 for an analysis and control of the operation of the medical device 1, 2.
Generally, within a communication system as schematically shown in
Referring now to
In addition, the medical devices 1, 2, 3 implanted in the patient P may communicate with one or multiple external devices 4, 5 in order to transfer data, for example measurement data, from the medical device 1, 2, 3 towards the external device 4, 5, or to receive configuration data from the external device 4, 5 to adapt operation of the implanted medical device 1, 2, 3. Communication herein takes place via communication links L15, L25, L35, L34 connecting the external devices 4, 5 and the implanted medical devices 1, 2, 3 with each other, wherein in addition the external devices 4, 5 may also communicate with each other via a communication link L45.
In order to facilitate communication in between the intra-body medical devices 1, 2, 3 and the external devices 4, 5, it herein is proposed to use a common communication technology for both the internal, intra-body devices 1, 2, 3 and the external devices 4, 5, such that the medical devices 1, 2, 3 may communicate with each other as well as with the external devices 4, 5 using the same communication technology.
The common communication technology in particular involves a common physical layer signaling and a common communication protocol.
For example, the implantable medical devices 1, 2, 3 and the external devices 4, 5 may use a signaling technique based on a physical layer signaling using modulated oscillating electric fields. For example, a signaling according to the standardized Intra-Body Communication (IBC) may be employed, using a galvanic coupling or a capacitive coupling of the external devices 4, 5 to the patient P.
In another embodiment, the implantable medical devices 1, 2, 3 and the external devices 4, 5 may use a signaling technique based on a physical layer signaling using acoustic signals, in particular ultrasonic signals. In this case, the implantable medical devices 1, 2, 3 and the external devices 4, 5 employ an acoustic transducer in order to couple to surrounding medium. In particular, the implantable medical devices 1, 2, 3 may employ a transducer contacting tissue. The external devices 4, 5 may be placed on the patient's skin, as it, for example, is the case for the external device 4 having the shape of a wrist watch in the embodiment of
In yet another embodiment, the implantable medical devices 1, 2, 3 and the external devices 4, 5 may use a signaling technique based on a physical layer signaling using modulated oscillating magnetic fields. In this case the medical devices 1, 2, 3 and the external devices 4, 5 comprise a transducer in the shape of a magnetic coil to induce oscillating magnetic fields.
In yet another embodiment, the implantable medical devices 1, 2, 3 and the external devices 4, 5 may use a signaling technique based on a physical layer signaling using modulated electromagnetic waves. In this case the medical devices 1, 2, 3 and the external devices 4, 5 comprise a transducer in the shape of a suitable antenna.
One or multiple of the external devices 4, 5 may be placed on the patient's skin and for this may, for example, be worn by the patient P, as it is the case for the external device 4 in the shape of the wrist watch in the embodiment of
Communication in between the implantable medical devices 1, 2, 3 amongst each other, in between the implantable medical devices 1, 2, 3 and the external device 4, 5, and in between the external devices 4, 5 amongst each other using the common signaling technique is based on a transmission of modulated signals, wherein the signals may encode identifier information identifying and addressing devices 1-5. Each device 1-5 herein may be identified by a unique identifier, such that messages can be exchanged in between the devices 1-5.
The communication links as illustrated in
In the embodiment of
Referring now to
In addition, the external device 4, 5 comprises a second communication circuitry 42 for establishing a communication with the remote system 6 using a physical layer signaling PHY2 different from the physical layer signaling PHY1. By means of the communication circuitry 42 data may be exchanged with the remote system 6.
The physical layer signaling PHY2 may, for example, utilize a standard close-proximity communication scheme such as Bluetooth, Zigbee, Near Field Communication (NFC), or Wi-Fi. In order to establish a communication to the remote system 6, herein a connection using the physical layer signaling PHY2 may be established to a local communication device 7, such as a mobile device or a local computer, which relays the data and communicates with a remote server 6 via a public communication network. The remote systems 6 can be the remote server 6 and vice versa.
A control unit 40 serves to control operation of the external device 4, 5 and processes data. For example, the control unit 40 may be configured to translate data between the different communication circuitry 41, 42, for transmission in between the remote server 6 and the implantable medical devices 1, 2, 3.
Referring now to
The implantable medical devices 1, 2, 3 within the communication system may, for example, be cardiac stimulation devices, such as a leadless pacemaker devices or cardioverter defibrillators, sensing devices such as biosensors, for example, for sensing a blood pressure, or recording devices such as a loop recorder.
Generally, the implantable medical devices 1, 2, 3 may be implanted fully or in part directly into the patient's heart, for example the right ventricle or the right atrium. In another embodiment, the implantable medical devices 1, 2, 3 may be implanted fully or in part subcutaneously within the patient.
As a communication between the external devices 4, 5 and the implantable medical devices 1, 2, 3, in the above embodiment, may be established possibly only by bringing the external devices 4, 5 into close proximity with the patient P, beneficially in contact with the patient's skin, inherently an increased security is achieved, in that communication with the implantable medical devices 1, 2, 3 cannot easily be corrupted or interrupted.
It will be apparent to those skilled in the art that numerous modifications and variations of the described examples and embodiments are possible in light of the above teachings of the disclosure. The disclosed examples and embodiments are presented for purposes of illustration only. Other alternate embodiments may include some or all of the features disclosed herein. Therefore, it is the intent to cover all such modifications and alternate embodiments as may come within the true scope of this invention, which is to be given the full breadth thereof. Additionally, the disclosure of a range of values is a disclosure of every numerical value within that range, including the end points.
| Number | Date | Country | Kind |
|---|---|---|---|
| 21183021.1 | Jul 2021 | EP | regional |
This application is the United States National Phase under 35 U.S.C. § 371 of PCT International Patent Application No. PCT/EP2022/062411, filed on May 9, 2022, which claims the benefit of European Patent Application No. 21183021.1, filed on Jul. 1, 2021, and U.S. Provisional Patent Application No. 63/193,285, filed on May 26, 2021, the disclosures of which are hereby incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2022/062411 | 5/9/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63193285 | May 2021 | US |
