WO2023156212A1 - Ensemble collecteur - Google Patents

Ensemble collecteur Download PDF

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Publication number
WO2023156212A1
WO2023156212A1 PCT/EP2023/052573 EP2023052573W WO2023156212A1 WO 2023156212 A1 WO2023156212 A1 WO 2023156212A1 EP 2023052573 W EP2023052573 W EP 2023052573W WO 2023156212 A1 WO2023156212 A1 WO 2023156212A1
Authority
WO
WIPO (PCT)
Prior art keywords
nfc
signals
imd
header assembly
housing
Prior art date
Application number
PCT/EP2023/052573
Other languages
English (en)
Inventor
Jeffrey A. Von Arx
Alan Fryer
Gregory Jay Delmain
Original Assignee
Biotronik Se & Co. Kg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biotronik Se & Co. Kg filed Critical Biotronik Se & Co. Kg
Publication of WO2023156212A1 publication Critical patent/WO2023156212A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A61N1/37223—Circuits for electromagnetic coupling
    • A61N1/37229—Shape or location of the implanted or external antenna
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3752—Details of casing-lead connections
    • A61N1/3754—Feedthroughs

Definitions

  • the application refers to a header assembly for an implantable medical device (IMD) with a housing hermetically covering at least one internal electronic component electrically connected to a feedthrough component of the housing, wherein the header assembly comprises at least one of an electrode and at least one socket (for an electrode lead).
  • IMD implantable medical device
  • IMD Active or passive implantable medical devices
  • implantable spinal cord stimulation devices for example implantable spinal cord stimulation devices, implantable defibrillators, conventional pacemakers or implantable intracardiac pacemakers (also known as leadless pacemakers), and implantable loop recorders, are well known miniaturized medical devices which may be implanted into or at the patient's body.
  • Pacemakers apply electrical stimulation in the form of pulses to the heart in order to generate a physiologically appropriate heartrate and/or in the form of shocks for cardioversion or defibrillation in order to restore a more normal heart rhythm.
  • IMDs comprise providing other electrical or electromagnetic signals to the patient as well as measuring or surveilling of body activities, for example by an implantable loop recorder (ILR), such as a heart rate, heart rhythm, blood pressure, blood sugar, oxygen levels and/or alike.
  • ILR implantable loop recorder
  • the hermetically sealed housing of the IMD comprises electronic components, for example a processor for data processing and/or signal generating and an energy source (e.g. a battery or coil, for wireless charging).
  • the header assembly generally fixed to the distal end of the IMD provides the electric connection of the electronic components within the housing to at least one electrode or an electrode socket for an electrode lead using a feedthrough component.
  • the feedthrough component hermetically seals the housing of the IMD at its distal end.
  • RF radio frequency
  • BLE Bluetooth Low Energy
  • the far-field radio frequency (RF) communication is power intensive. In order to meet the extremely low power requirements of a long-life IMD, the far-field RF communications system must be turned off more than 99.9% of the time. This is because todays RF transceivers require tens of mA of current when turned on, and today’s long life IMDs can only support average current draws from the battery of at most a few tens of pA. Accordingly, far-field RF communication is usually provided timer based, for example communication to the IMD is planned on a daily routine resulting in certain communication periods.
  • the IMD wakes up its RF communication sub-system once (or several times) a day and checks to see if an authorized external device is available for initiating a communication session with. Only in these communication periods a communication with the IMD can be established. However, the timer based communication is not adequate for patient triggered events or on-demand communication with the implant.
  • low frequency inductive telemetry sub 300 kHz
  • HCP health care provider
  • US 2018/0243573 Al describes a system apparatus and a method for paring an implantable medical device (IMD) and an external device. Between the IMD and the external device a telemetry connection can be established using the first telemetry protocol.
  • a validation component is configured to restrict establishment of the telemetry connection with the
  • US 9,288,614 Bl describes a system and method for initiating a communication link between an implantable medical device and an external device.
  • the IMD detects activation field from a triggering device when the triggering device is positioned proximate to the IMD.
  • US 9,955,289 Bl describes a system and method for implantable medical devices including Near Field Communication (NFC).
  • NFC detector network includes a Bluetooth low energy (BLE) antenna and NFC antenna.
  • BLE Bluetooth low energy
  • the NFC path is configured to generate an activation signal for the BLE transceiver based on an NFC signal.
  • NFC is an international standard for near field communication specified in ISO/IEC 18092. It is commonly deployed in smart phones, key cards, and RFID. It operates at 13.56 MHz, typical range in air is ⁇ 10 cm, and data rates of up to 424 kbit/sec are supported.
  • the header assembly of an IMD comprises at least one of an electrode and at least one socket (for an electrode lead) with at least one contact area.
  • the header assembly further comprises an NFC coil and at least one wire (connected to the feedthrough component), wherein the at least one wire is configured to electrically connect the feedthrough component (of the IMD) with the electrode or the contact area of the socket, wherein a first connection of the NFC coil is electrically connected to the wire.
  • the feedthrough component may consist of only one feedthrough or may comprise two or more feedthroughs. It is also possible to use several feedthrough components for one housing or IMD, wherein each feedthrough component consists of only one feedthrough.
  • the header assembly further comprises a far field RF antenna, wherein the at least one wire is configured to electrically connect the feedthrough component with the far field RF antenna.
  • the header assembly further comprises a far field RF antenna, wherein the at least one wire electrically connecting the feedthrough component and the electrode or the contact area is also the far field RF antenna.
  • the wire and the far field RF antenna are one and the same part of the header assembly.
  • the IMD may be configured to be an active IMD, for example a pacemaker, transferring electric or electromagnetic therapy signals to specific body regions to stimulate these body regions or parts of these regions, for example the cardiac system, bladder, neuromuscular regions, or alike.
  • the IMD may be a passive IMD or may have functions of a passive IMD such as sensing and/or observing body parameters.
  • the IMD comprises a housing which hermetically covers at least one electronic component.
  • the electronic components comprise a battery, any kind of control means (processor), any kind of measuring means, communication means or alike.
  • the header assembly comprises header components that are electrically coupled to an electronic circuit and/or to a power source located inside the hermetically sealed housing via the feedthrough component.
  • the header assembly provides either a socket for attaching and detaching an electrode lead with at least one contact area, wherein the contact area is connected to an electrode, or forms a permanent connection to an electrode, preferably to an electrode at or near to its distal end.
  • the current implantable device utilizes a housing and a discrete feedthrough component to isolate the electronic circuit and the power source (battery) from body fluid intrusion.
  • the electrode, the electrode lead and or the wire may be configured to conduct or transmit electrical signals for therapy, measuring and/or surveilling body regions.
  • the electrode may be connected permanently to the header, while the electrode lead is formed like a plug at its proximal end to be mechanically attachable and detachable to the socket.
  • the electrode lead and the wire may be on and the same part of the header assembly.
  • the far-field radio frequency (RF) antenna allows a wireless communication between the IMD and an external device.
  • the IMD can be maintained easily.
  • the feedthrough component comprises at least one feedthrough, e.g. provided with or by a feedthrough pin, configured to electrically connect the at least one internal electric component of the IMD with the electrode, the socket for the electrode lead or if applicable, the far-field radio (RF) antenna.
  • An electrical connection between the at least one feedthrough with a header element e.g. the electrode, socket for the electric lead
  • the feedthrough component provides an electric isolation with regard to the housing and, if applicable, an electrical/electromagnetic shield.
  • the feedthrough component forms on one hand a wired electric connection of the inside electronic component of the housing to an electronic component of the header so that electric or electromagnetic signals may be conducted from the inside of the housing to the outside and in the opposite direction.
  • the feedthrough component electrically insulates the wire (connected to the feedthrough component) from the housing material. This arrangement allows the electronic component to be hermetically covered, while it communicates to external devices and/or transmits therapy signals and/or receives measuring signals.
  • a first connection of the NFC coil is electrically connected to the at least one wire.
  • Connecting the first connection of the NFC coil to the wire allows to transfer NFC signals to the interior of the housing using an existing feedthrough (of the feedthrough component, e.g. in form of a pin).
  • an existing feedthrough cuts costs, since it limits the size of the feedthrough component.
  • such an arrangement lowers the number of places through which fluids can penetrated through the hermetically covered housing increasing the safety of the IMD.
  • the challenge with NFC is that its signals are too high a frequency (13.56 MHz) to effectively penetrate the titanium electronics housing of today’s IMDs. Less than 2% of the signal at these frequencies can penetrate a 400 pm thick titanium electronics housing. To address this, the coil for NFC communication is located in
  • the NFC coil may share at least one wire (connected to the feedthrough component) and/or one feedthrough of the feedthrough component with another signal (such as a therapeutic signal, a sensing signal, or far-field RF antenna signal).
  • NFC uses above- mentioned frequency for signal transfer over a distance of up to 10 cm within air.
  • establishing a wireless connection to an NFC unit is only possible within a close distance, increasing the connection security or safety.
  • NFC communication (receiving and/or transmitting signals) is a common feature throughout various kinds of handheld communication, such as smartphones tablets or alike, allowing to communicate with the IMD using of stock devices.
  • smartphones are able to communicate with the IMD, custom build hardware can be omitted, reducing costs.
  • the NFC connection may be used to wake up other communications means such as a RF communication system of the IMD. Since the NFC requires low energy, it is possible to allow NFC communication at all times, without limitation to any daily routines or alike. Nevertheless, it is also possible to communicate solely via NFC.
  • the far-field RF antenna is a Bluetooth Low Energy (BLE) antenna or a Medical Implant Communication System (MICS) antenna for BLE or MICS communication.
  • BLE and MICS communicate over longer distance than NFC, (several meters vs serval cm) and this longer distance results in much better usability and patient experience. This makes home monitoring possible without the patient having to bring an antenna close to the implant.
  • BLE is a communication standard specified in Bluetooth Core Specification by Bluetooth SIG.
  • the frequency of BLE is 2.400 - 2.483 GHz.
  • BLE allows communications with off the shelf smart phones.
  • BLE systems typically require tens of mA of current to power wake-up receivers, whereas the entire current budget for chronic active implantable medical devices today is in the tens of pA range.
  • NFC allows for extremely low power wakeup, so that it is advantageous to use an NFC signal for activation of BLE system.
  • the receiving circuitry necessary for NFC wake-up can be designed to require average current draw in the range of a few pA or less.
  • BLE may operate in the spectrum range of 2.400 to 2.4835 GHz of classic Bluetooth technology and has forty 2-MHz channels, which allows a data rate of up to 2 Mbit/sec over a distance of up to 100 m in air (although distances achievable from an implanted device are less due to tissue attenuation of the signals).
  • MICS may operate at frequencies in the 402 - 405 MHz frequency band using ten channels of 300 kHz each.
  • the wire (connected to the feedthrough component) is configured to transmit or conduct electrical signals such as therapy signals and/or measuring signals and/or BLE signals and/or MICS signals and NFC signals. Since the wire is configured to transmit various kinds of electrical signals different electronic components may be connected with this wire, e.g. via one feedthrough of the feedthrough component and at least one internal wire (located inside of the housing). This allows a cost effective production of an IMD.
  • the header assembly comprises a protective cover comprising nonconducting dielectric material comprising at least one material of the group comprising silicone, epoxy, polyurethane and polyetheretherketone (PEEK).
  • a polyurethane is tecothane.
  • Further materials of the group may be carbothane, tecoflex and/or pellothane.
  • the non-conduction dielectric material allows electrical separation of different electrical components, such as antennas, electrodes or sockets for electrode leads, form one another. Thus, properties of each electrical component can be adjusted carefully. Furthermore, such a material can be adjusted according to the individual functional requirement of different IMDs and local requirement of the treated organism.
  • the IMD comprises the header assembly as described above, a housing with a feedthrough component and at least one internal electronic component, wherein the housing is configured to hermetically cover the at least one internal electronic component.
  • the internal electronic component is (located inside of the housing and) electrically connected to the feedthrough component (of the housing).
  • the feedthrough component may be electrically connected to the at least one internal electronic component by an internal wire.
  • the electronic components comprise filtering and/or processing units as described below and/or a memory device in order to save data and/or a power supply, wherein the components are connected to each other and to the power supply.
  • the internal components may be connected to each other and/or to the feedthrough component via at least one internal wire.
  • An internal wire is located inside of the housing.
  • This arrangement allows unidirectional or bidirectional transmission of electric signals to the electronic component (e.g. through wires and/or the feedthrough component). This allows, for example, to transmit therapy signals, measuring signals, communication signals via MICS, BLE, NFC, alone or a combination of these signals, from the electronic component located inside the housing to the electronic component located outside of the housing (i.e. in the header assembly) and/or the other way around.
  • the IMD comprises an NFC unit which is electrically connected to the feedthrough component, e.g. by an internal wire, wherein the NFC unit comprises NFC signal processing means and/or NFC signal generation means.
  • the NFC unit may receive NFC signals via the feedthrough component and possibly wires (including internal wires) and processes the signal in order to decide, for example, whether an activation signal is sent from an external device. If the NFC unit generates NFC signals it may be possible to communicate via the NFC coil to another external device (bi-directional). This communication may be used for cryptographic authentication and/or cryptographic key exchange.
  • the NFC coil and at least one electronic component e.g. a processor, a battery, a BLE unit, an NFC unit, a sensing and/or therapy unit, a high pass filter, a bandpass filter, a low pass filter, a high voltage clamp
  • the NFC coil and at least one electronic component are configured to provide cryptographic authentication and/or cryptographic key exchange.
  • the IMD comprises a filter for separating NFC signals from other signals, wherein the other signals are, for example, therapy signals, measuring signals, and/or radio frequency signals.
  • the radio frequency signals may be BLE signals or MICS signals or other radio frequency signals of frequency bands much higher in frequency than NFC (hundreds to thousands of MHz as opposed to ten-ish MHz).
  • the filter is connected to the feedthrough component (e.g. via an internal wire) transmitting these signals from the outside (i.e. the header assembly) to the interior of the housing.
  • Such filters allow to separate signals, such that an electrical component located within the housing receives dedicated signals.
  • the electrical component can be specified and dimensioned in accordance to its signals without risking exceeding the capability of the electrical component.
  • the filter comprises a band pass filter, a high pass filter and/or a low pass filter.
  • a band pass filter allows frequencies within a certain range to pass and rejects frequencies outside of that range such as 1 MHz to 100 MHz.
  • a high pass filter allows frequencies to pass, which are higher than a certain cutoff frequency such as 100 MHz and rejects frequencies below that cutoff frequency.
  • a low pass filter allows frequencies lower than a selected cutoff frequency such as 100 kHz to pass, while frequencies above that cutoff frequency are rejected. This arrangement allows to filter specific frequencies for an electronic component, such that each component receives matching frequencies.
  • a second connection of the NFC coil is connected to the housing.
  • the housing realizes the ground connection for the NFC coil.
  • the second connection of the NFC coil does not require any feedthrough, which again results in low costs.
  • the housing comprises at least one material of the group comprising titanium alloy and stainless steel. These kinds of materials can be in contact with organic solvent.
  • 20.002P-WO / 02.02.2023 material such as tissue without risking damaging the tissue or the material. Furthermore, the material can be adapted to induvial needs of the patient or organism.
  • TDMA Time Division Multiple Access
  • TDMA Time Division Multiple Access
  • some schedule like 1ms on one and then 1 ms on the other
  • time sampling may be extended to all (three) signals.
  • this invention describes an IMD with an NFC coil in the device header assembly.
  • the NFC coil shares at least one feedthrough component with other signals (i.e. sensed signals, BLE or MICS antenna signals, or stimulation electrode signal s/therapy signals).
  • the NFC coil is used to wake-up the far-field RF communication system, and in a second embodiment it is used as a secure sideband to exchange chronographic keys. This allows, for example
  • Fig. 1 depicts a first embodiment of an IMD in a side view with a partial section
  • Fig. 2 depicts a second embodiment of an IMD in a side view with a partial section
  • Fig 3 depicts a wiring diagram of an IMD.
  • FIG. 1 depicts a first embodiment of an IMD 1, namely an Implantable Loop Recorder (ILR), which is a heart monitoring device that records, for example, the heart rhythm over a longer time period, for example several years.
  • ILR Implantable Loop Recorder
  • the ILR has a housing 2 with a distal and a proximal end and a header assembly 3 located at the distal end, where the electronic components of the interior of the housing (can) 2 and the header assembly 3 are electrically connected via a feedthrough component 4.
  • the housing 2 is hermetically closed with regard to the environment and at its distal end the feedthrough 4 provides a hermetical closure to the housing 2 and at the same time at least one electrical connection between at least one header element (e.g.
  • the header assembly 3 further comprises an NFC coil 5 having two NFC coil connections 6, 7, wherein a first connection 6 is connected to the feedthrough component 4 and a second connection 7 is connected to the housing 2 at a housing connection 8. At least one of the first connection 6 and the second connection 7 is realized by a wire.
  • the housing 2 forms the ground connection and is also electrically connected to the electronic components located within the housing 2.
  • the wire of the feedthrough component 4 is insulated from the housing 2.
  • the header assembly 3 comprises an electrode lead 9 and a far-field RF antenna 10. In this preferred embodiment the electrode lead 9 and the far-field RF antenna 10 are physically one and the same wire.
  • the electrode lead 9 is connected to a distal electrode 11 located at the distal end of the header assembly 3.
  • the electrode lead 9, the NFC coil 5, the RF antenna 10, the feedthrough component 4 and the respective connections are each covered by an insulating material.
  • the proximal end of the (essentially hollow rectangular cross section form of) housing 2 is formed by a proximal electrode 12.
  • the housing 2 acts as a second electrical conductor (or electrical connection) to the interior electronic components.
  • the housing 2 may consist of titanium alloy.
  • the isolating material of the header assembly 3 may consist of silicone rubber, tecothane, epoxy, polyurethane, polyetheretherketone (PEEK) or some combination of these materials. Further, the header assembly 3 may be molded directly onto the housing 2.
  • this embodiment uses a single shared feedthrough component 4 and its wire for the NFC coil, the sensing electrode 11, and for the RF antenna 10. Since these signals are distinct in frequency content (the RF antenna signal is either 2.4 GHz or 403 MHz, NFC is centered on 13.56 MHz, and the electrode sensing signal is ⁇ 1 kHz), it is feasible to separate these signals inside the titanium housing by filters.
  • Fig. 2 depicts a second embodiment of an IMD 1, namely a pacemaker, having a housing 2 and a header assembly 3.
  • the pacemaker comprises in its header assembly 3 two sockets 9a for electrode leads (not shown), each having two contact areas 9b for the electrodes of the electrode lead.
  • the components of the header assembly 3 and the interior of the housing 2 are electrically connected via a plurality of feedthroughs of the feedthrough component 4, wherein the plurality of feedthroughs form a feedthrough array 13.
  • Each feedthrough comprises a pin (not shown), which is insulated from the housing2.
  • the header 3 comprises an NFC coil 5 and a Bluetooth Low Energy (BLE) antenna 14.
  • the NFC coil 5 and the BLE antenna 14 are both connected to a not depicted wire of one single feedthrough component 4.
  • the first NFC coil connection 6 is connected to the wire of the feedthrough component 4, while the second NFC coil wire 7 is connected to the housing 2 at the NFC coil housing connection 8 wherein the housing 2 itself serves as the second feedthrough.
  • the housing 2 of the pacemaker is made from Titanium alloy, whereas the insulating material of the header assembly 3 consists of, for example, PEEK.
  • the number of required hermetic feedthroughs is minimized by the NFC coil 5 sharing a feedthrough component 4 with the far-field RF antenna 10 (i.e. BLE or MICS antenna).
  • the second NFC coil connection uses a second shared feedthrough. For example, it could share a feedthrough with one of the connections to a pacing ring electrode. Sharing a feedthrough with a pacing ring electrode connection is preferable to sharing with a pacing tip electrode connection because pacing tip electrodes are by design both in intimate contact with cardiac tissue and much smaller in area (to maximize the current density invoked at the electrode so that the heart can be captured with
  • the larger area of the pacing ring electrode (along with the high frequency of the NFC signal, and its less intimate contact with cardiac tissue) makes it very unlikely that the heart could be stimulated by the NFC signal that shares a feedthrough with it.
  • Fig. 3 depicts a wiring diagram of an example IMD 1.
  • the housing 2 hermetically covers electronic components.
  • the electronic components comprise a BLE unit 15, an NFC unit 16, a sensing and/or therapy unit 17, a high pass filter 18, a bandpass filter 19, a low pass filter 20 and a high voltage clamp 21.
  • the BLE unit 15 is connected to the high pass filter 18, the NFC unit 16 is connected to the bandpass filter 19 and the sensing and/or therapy unit 17 is connected to the low pass filter 20.
  • Each filter 18, 19, 20 is further connected to the high voltage clamp 20 which is connected to the wire 22 of the feedthrough component 4.
  • the wire 22 is electrically connected to the NFC coil 5 via the first NFC coil connection 6, to the BLE/MICS antenna 14 and to the first electrode 11.
  • the NFC coil 5 is further connected to the housing 2 at connection 8 via the second NFC coil connection 7.
  • the NFC coil 5, BLE/MICS antenna 14, the electrode 11 and the feedthrough component 4 are disposed in the header assembly (3 in Figs 1, 2).
  • the mentioned electronic components may be separate units or may, at least partially, be integrated into one unit, for example the processor of the IMD 1, thereby forming a part of the processor.
  • the NFC unit 16 comprises NFC signal processing means and/or NFC signal generation means, the BLE unit 15 BLE signal processing means and/or BLE signal generation means.
  • the sensing and/or therapy unit 17 comprises sensing and/or therapy signal processing means and/or means for generating therapy signals and/or means for generating sensing requests for the respective electrode.
  • NFC, BLE (and alternatively MICS) units 16, 15 may operate in the electromagnetic spectrum as indicated above. All or some of the lines in Fig. 3 connecting the electronic components 15, 16, 17, 18, 19, 29, 21 to each other or to the feedthrough component 4 may be realized by internal wires.
  • the NFC unit 16 allows a communication with an external device (not shown), using frequencies which are different from the far-field RF communication.
  • far-field RF communication may be woken up by using NFC communication.
  • NFC communication requires little power, it is advantageous to activate RF communication using the NFC. Due to its relatively or extremely short signals transmitting range, NFC can act as a secure side channel allowing exchange of security keys and other highly sensitive information, to improve safe communication between the IMD 1 and an external device. Depending on the amount of data to be exchanged with the IMD 1, it is possible to communicate solely via the NFC without activating the far field RF communication.
  • band pass filter 19 and low pass filter 20 allows signals to be transferred to the matching unit, respective the BLE unit 15, the NFC unit 16 and the sensing and/or therapy unit 17.
  • the high pass filter 18, e.g. with a pole or zero of -100 MHz (chosen to be between the NFC carrier frequency of 13.56 MHz and the 2.4 GHz BLE carrier frequency) blocks the NFC signal and low frequency biological signals, allowing only the BLE (or MICS) signal to pass.
  • the bandpass filter 19 allowing through only frequencies of -1 MHz to 100 MHz blocks low frequency physiological signals such as cardiac signals and simultaneous high frequency RF signals such as BLE, leaving only the NFC signal to pass.
  • the low pass filter 20 (such as with a pole of 100 kHz), allows low frequency physiological signals to pass while blocking the NFC and BLE signals.
  • the high voltage clamp 21 protects the filters 18, 19, 20 and subsequent circuitry from high voltage at the feedthrough that may occur due to electrostatic discharge, or from an externally applied defibrillator.
  • the filters 18, 19, 20 are capable of filtering signals for example therapy signals, measuring signals, NFC signals, and far field RF communication signals such as BLE and/or MICS signals.
  • Each of the units 15, 16, 17 is further connected to a power supply located within the housing 2.
  • a second NFC coil wire 7 is connected to the housing 2 via an NFC coil housing connection 8.
  • This arrangement may be adapted to the far field RF communication, respective BLE or MICS communication.
  • the second NFC coil 5 may be connected to and share (a wire and/or) a feedthrough of the feedthrough component 4 with the far field RF antenna 14.
  • NFC coil 5 in the IMD 1 only for receiving NFC signals has the advantage that it eliminates or at least reduces any concern that the active drive signal of the NFC coil 5 may stimulate tissue or polarize at any electrode that it shares the feedthrough component 4 with.
  • NFC received signals are significantly lower in amplitude than the transmit signals (especially when the receive coil is small in size, as would be the case for a small implantable device) so a receive only configuration is less likely to stimulate tissue, or polarize the electrode.
  • This receive only embodiment is ideal for systems that use the NFC coil 5 only for BLE or MICS sub-system wake-up, because for that application only IMD inbound communication by NFC is required.
  • NFC coil 5 may be used as a secure side band for exchanging cryptographic keys.
  • the IMD’s NFC coil must transmit as well as receive.
  • such systems can opt to share the NFC feedthrough with non-electrode feedthroughs such as the BLE or MICS antenna feedthrough.
  • such systems can share NFC and electrode feedthroughs and rely on the fact that the carrier frequency of NFC is much higher than what tissue responds to, and hence is exceedingly unlikely to cause cardiac, nerve or muscle stimulation.
  • Added security from tissue stimulation can be achieved by having the low energy side of the NFC coil 5 (the AC grounded side) share the feedthrough, with the higher energy side (the excited side) being a separate dedicated feedthrough.
  • IMD insulin receptor

Abstract

L'invention concerne un ensemble collecteur (3) pour un dispositif médical implantable (IMD, 1) avec un boîtier (2) recouvrant hermétiquement au moins un composant électronique interne connecté électriquement à un composant de traversée (4) du boîtier (2), l'ensemble collecteur (3) comprenant au moins l'une d'une électrode (11) et d'au moins une prise (9a) avec au moins une zone de contact (9b), l'ensemble collecteur (3) comprenant en outre une bobine de communication en champ proche (NFC) (5) et au moins un fil (9, 22) connecté au composant de traversée (4), le ou les fils (9, 22) étant configurés pour connecter électriquement le composant de traversée (4) à l'électrode (11) ou à la zone de contact (9b) de la prise (9a), une première connexion de la bobine NFC (5) étant électriquement connectée au fil (22). L'invention concerne en outre un IMD doté d'un tel ensemble collecteur.
PCT/EP2023/052573 2022-02-15 2023-02-02 Ensemble collecteur WO2023156212A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202263310289P 2022-02-15 2022-02-15
US63/310,289 2022-02-15
EP22161226.0 2022-03-10
EP22161226 2022-03-10

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WO2023156212A1 true WO2023156212A1 (fr) 2023-08-24

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117771545A (zh) * 2024-02-26 2024-03-29 苏州新云医疗设备有限公司 植入式电刺激器及电刺激系统

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120071951A1 (en) * 2010-03-23 2012-03-22 John Swanson Connector design for implantable pulse generator for neurostimulation, implantable stimulation lead, and methods of fabrication
US9288614B1 (en) 2015-03-03 2016-03-15 Pacesetter, Inc. Systems and methods for initiating a communication link between an implantable medical device and an external device
US20170281957A1 (en) * 2016-03-29 2017-10-05 Boston Scientific Neuromodulation Corporation Far-Field Short-Range Radio-Frequency Antenna on the Side of an Implantable Medical Device Case
US9955289B1 (en) 2016-09-14 2018-04-24 Pacesetter, Inc. Systems and methods for implantable medical devices including near field communications
US20180243573A1 (en) 2017-02-27 2018-08-30 Medtronic, Inc. Facilitating trusted pairing of an implantable device and an external device
US20200129773A1 (en) * 2018-10-31 2020-04-30 Medtronic, Inc. Facilitating acceleration of advertising rates for medical devices
US20200324126A1 (en) * 2019-04-15 2020-10-15 Advanced Neuromodulation Systems, Inc. Wireless power transfer circuit for a rechargeable implantable pulse generator

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120071951A1 (en) * 2010-03-23 2012-03-22 John Swanson Connector design for implantable pulse generator for neurostimulation, implantable stimulation lead, and methods of fabrication
US9288614B1 (en) 2015-03-03 2016-03-15 Pacesetter, Inc. Systems and methods for initiating a communication link between an implantable medical device and an external device
US20170281957A1 (en) * 2016-03-29 2017-10-05 Boston Scientific Neuromodulation Corporation Far-Field Short-Range Radio-Frequency Antenna on the Side of an Implantable Medical Device Case
US9955289B1 (en) 2016-09-14 2018-04-24 Pacesetter, Inc. Systems and methods for implantable medical devices including near field communications
US20180243573A1 (en) 2017-02-27 2018-08-30 Medtronic, Inc. Facilitating trusted pairing of an implantable device and an external device
US20200129773A1 (en) * 2018-10-31 2020-04-30 Medtronic, Inc. Facilitating acceleration of advertising rates for medical devices
US20200324126A1 (en) * 2019-04-15 2020-10-15 Advanced Neuromodulation Systems, Inc. Wireless power transfer circuit for a rechargeable implantable pulse generator

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117771545A (zh) * 2024-02-26 2024-03-29 苏州新云医疗设备有限公司 植入式电刺激器及电刺激系统

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