DE202019100590U1 - Implantable brain-machine interface - Google Patents

Abstract

Implantable electronic unit (3) for electro-therapy of complaints in connection with the central nervous system, wherein the implantable electronic unit (3) comprises implantable electrodes (1, 2) and is adapted to be wireless with a communication unit (5) outside the body to communicate in which data is transmitted and received in a sequential manner via an ISM band communication link using radio frequencies in the ISM band of preferably 2.4 GHz - 2.5 GHz at up to 5 Mbit / s, preferably using 2 ms time windows The electronic unit (3) is adapted to be inductively supplied with energy via a head piece (4) outside the body using a 130 kHz alternating magnetic field, the intensity of which is regulated based on the requirement imposed by the implantable electronic unit (3) is reported using the ISM band communication link to ei Ensure safe implant operation with minimal power loss.

Description

This invention is in the field of medical devices, with a focus in the field of electronic brain implants to be used for electro-therapy for central nervous system complaints and in the field of implantable brain-machine interfaces. that allow electronic communication between the human brain and technical systems.

Electro-therapy of the human brain is dominated by deep brain stimulation (DBS), which continuously stimulates the brain using an electrical pattern defined by the clinician. Such a system does not take into account the condition of the target organ in order to discontinue therapy. It is called an open loop system.

Responsive neural stimulators monitor the state of the patient's brain using a few (typically 4) electrode contacts to identify a critical brain condition that indicates the early onset of an epileptic seizure. Once this onset is identified, the system initiates a therapeutic stimulation pattern of shape and intensity, which is predefined by a clinician. This therapy is referred to as brain-stimulation.

1. 1. Eine Open-Loop Stimulation bezieht nicht die Bedürfnisse des Patienten mit ein; z. B. wird das Gehirn während Zeiten stimuliert, wo keine therapeutische Notwendigkeit besteht oder - in einem weiteren Fall - es keine Stimulationsintensität empfängt, die hoch genug für einen optimalen therapeutischen Effekt ist.
2. 2. Derzeitige Systeme mit responsiven Gehirnstimulationen werden durch ein vordefiniertes elektrisches Stimulationsmuster ausgelöst, welches auf einem bestimmten Gehirnzustand basiert, welcher unter Verwendung eines kleinen Elektrodensatzes (typischerweise: 4) detektiert wird. Sie können nicht das Stimulationsmuster (z. B. die Stimulationsintensität) entsprechend dem Gehirnzustand modulieren.
3. 3. Gehirnstimulatoren aus dem Stand der Technik funktionieren entweder mit primären Zellen (nicht wieder aufladbare Batterien) oder mit sekundären Zellen (wieder aufladbare Batterien). Soweit die primären Zellen aufgebraucht sind oder die maximale Anzahl von Ladezyklen der sekundären Zellen erreicht ist, ist das implantierte System in der Funktion gestört und muss operativ ersetzt werden.

Problems related to the prior art

1. 1. Open loop stimulation does not address the patient's needs; e.g. B. the brain is stimulated during times when there is no therapeutic need or - in a further case - it does not receive stimulation intensity high enough for an optimal therapeutic effect.
2. 2. Current systems with responsive brain stimulations are triggered by a predefined electrical stimulation pattern, which is based on a specific brain state, which is detected using a small set of electrodes (typically: 4). You cannot modulate the stimulation pattern (e.g., the stimulation intensity) according to the state of the brain.
3. 3. Prior art brain stimulators work either with primary cells (non-rechargeable batteries) or with secondary cells (rechargeable batteries). As far as the primary cells have been used up or the maximum number of charging cycles of the secondary cells has been reached, the implanted system is malfunctioning and must be replaced surgically.

It is an object of the present invention to provide devices and systems which at least partially alleviate these problems.

This object is achieved by the devices and systems according to the independent claims. Further embodiments of the invention are defined in the respective dependent claims.

The problem associated with an open loop and with a therapeutic stimulation triggered by the brain state is thus solved by providing information from a system which provides sufficient computing power to permit complex analysis. Based on this analysis, a stimulation pattern of adjustable amplitude, a pulse sequence scheme, can be initiated. The stimulation current is directed to the selected pair of stimulation electrons. The selection of this pair of electrodes can also be set at any given time.

1. a) einem Kopfstück, welches dem Implantat drahtlos Energie liefert durch induktive Kopplung. Dieses Kopfstück wird auf der Haut des Patienten positioniert, gegenüberliegend dem Implantat. Das Kopfstück wird über ein Kabel durch die Kommunikationseinheit mit Energie versorgt.
2. b) einer Kommunikationseinheit, welche drahtlos Informationen mit dem Implantat durch Funkübertragung austauscht. Die Einheit ist auch in der Lage, ein Auslösesignal zu empfangen. Das binäre Auslösesignal wird in den neuralen Datenstrom einspeist, die Kommunikationseinheit empfängt von dem Implantat, was eine Mittelwertbildung des Signals erlaubt, zum Beispiel in hervorgerufenen potentiellen Experimenten, eine Synchronisierung von mehreren Implantatsystemen (alle Systeme empfangen das gleiche Auslösesignal, welches danach in den neuralen Daten identifiziert werden kann), oder um permanent Ereignisse in der Zeit zu markieren, welche parallel zu der neuralen Datenaufzeichnung auftreten. Die Kommunikationseinheit ist mit einem Personal Computer (PC) durch eine Universal-Serial-Bus-(USB)-Schnittstelle verbunden, welche eine bidirektionale Kommunikation mit dem PC vorsieht und den USB Port des PCs verwendet, um die Kommunikationseinheit mit Energie zu versorgen.
3. c) einem Personal Computer, auf dem die Software zum Speichern der aufgezeichneten neuralen Daten läuft, zur Analyse der Daten und zur Entscheidungsfindung. Die Software empfängt auch Statusinformation von dem Implantat und kann Befehle an das Implantat senden, zum Beispiel elektrische Gehirnstimulationsmuster initiieren. Der Personal Computer kann zum Steuern von Hilfstechnologien, wie beispielsweise Buchstabierern (eine Kommunikationsschnittstelle, welche virtuelle Tastaturen auf dem Computerbildschirm verwendet), elektrischen Rollstühlen, Entertainment-Systemen, robotischen Gliedmaßen, etc. verwendet werden.

The system that analyzes the neural data and generates a therapeutic output is located outside the body. It is easily accessible to visualize the neural data and to set the analysis and decision making algorithms. The system consists of

1. a) a head piece, which wirelessly supplies the implant with energy by inductive coupling. This headpiece is positioned on the patient's skin, opposite the implant. The head piece is powered by the communication unit via a cable.
2. b) a communication unit which wirelessly exchanges information with the implant by radio transmission. The unit is also able to receive a trigger signal. The binary trigger signal is fed into the neural data stream, the communication unit receives from the implant, which allows the signal to be averaged, for example in evoked potential experiments, a synchronization of several implant systems (all systems receive the same trigger signal, which is then in the neural data can be identified), or to permanently mark events in time that occur in parallel with the neural data recording. The communication unit is with a personal computer (PC) through a universal serial bus (USB) interface connected, which provides bidirectional communication with the PC and uses the USB port of the PC to supply the communication unit with energy.
3. c) a personal computer running the software for storing the recorded neural data, analyzing the data and making decisions. The software also receives status information from the implant and can send commands to the implant, such as initiating electrical brain stimulation patterns. The personal computer can be used to control assistive technologies such as spelling (a communication interface that uses virtual keyboards on the computer screen), electric wheelchairs, entertainment systems, robotic limbs, etc.

To avoid the need for explanting once the battery of an implanted electronic device is depleted, the implanted electronic device has no battery or any other energy storage device. Instead, the implant receives its energy for operation inductively from the head piece, which is arranged outside the body.

• 1 ein Übersichtsschema ist, welches eine beispielhafte Realisierung auf Systemlevel gemäß der Erfindung darstellt;
• 2 eine Übersicht ist, welche Teile der Erfindung darstellt.

The invention can be better understood with reference to the drawing, in which

• 1 Figure 12 is an overview diagram illustrating an exemplary implementation at system level in accordance with the invention;
• 2nd is an overview of which parts of the invention.

Embodiments of the invention are described below.

One embodiment of the invention provides an implantable electronic device 3rd for electrotherapy of central nervous system related discomfort, the implantable electronic unit 3rd implantable electrodes 1 , 2nd includes, and is adapted to wirelessly communicate with an out-of-body communication unit 5 Via an ISM band communication link using radio frequencies in the ISM band of preferably 2.4 GHz - 2.5 GHz at up to 5 Mbit / s, preferably using 2 ms time windows, in which data is transmitted in a sequential manner and can be received to communicate with the implantable electronic device 3rd is adapted to be inductive via a headpiece located outside the body 4th to be powered using a 130 kHz alternating magnetic field, the intensity of which is regulated based on the need by the implantable electronic unit 3rd is reported using the ISM band communication link to ensure safe implant operation with minimal power dissipation.

The electronic unit 3rd can be implanted anywhere in the human body, preferably anywhere in the torso. The electrodes 1 , 2nd are implantable, for example in the brain.

The implantable electronic unit 3rd is further adapted to interface with the brain using brain surface electrode grids for recording and stimulating an electro-corticogram and / or using deep brain electrodes for electrical recording and stimulating the neural activity of deep brain structures. The implantable electronic unit 3rd is adapted to be connected to brain electrodes with a total of up to 32 electrode contacts. The implantable electronic unit 3rd is adapted to be able to record brain activity from up to 32 electrode contacts. The implantable electronic unit 3rd is adapted to be able to deliver electrical stimulation pulses to any (group) of 32 electrode contacts. The implantable electronic unit 3rd also includes an additional counter electrode contact 2nd , which can be used as a return electrode for the stimulation current. The implantable electronic unit 3rd is adapted to select any one of the electrode contacts to be used as the ground (return) electrode (s) for the stimulation current. The implantable electronic unit 3rd is adapted to select any one of the electrode contacts to be used as a reference electrode for neural recording. The implantable electronic unit 3rd is adapted to set and reset a function of each electrode contact upon request by a user, the function comprising one of recording, stimulation, mass, reference. The implantable electronic unit 3rd is adapted to measure the electrical impedance of each electrode contact. The implantable electronic unit 3rd is adapted to be surgically placed between the skull and skin, preferably in the area behind the ear of a human or animal. The implantable electronic unit 3rd is adapted to be powered wirelessly through the skin using an inductive energy transfer unit (head piece) outside the body. The alternating magnetic field is generated by an inductive receiving coil 9 added. The implant itself has no primary or secondary cell (battery) as an energy storage / source. The implantable electronic unit 3rd is adapted to communicate with the communication unit via a radio link. The electronics are opposite body fluids by using a ceramic housing 7 protected, which with silicone 10th is covered. The implantable electronic unit 3rd is protected in a hermetic ceramic housing with screen-printed electrical feedthroughs. The implantable electronic unit 3rd is adapted to a permanent magnet 8th the center of their energy-receiving coil 9 to wear, which allows easy alignment of the energy-transmitting headpiece outside the body. The implantable electronic unit 3rd is equipped with temperature sensors to detect dangerous situations of electrical overheating.

Another embodiment of the invention provides a headpiece 4th outside the body for electro-therapy of central nervous system complaints, for use with an implantable electronic unit 3rd , in particular according to one of the preceding claims, wherein the head piece 4th is adapted outside the body to carry an energy-transmitting inductive coil. The headpiece 4th outside the body also includes a permanent magnet in the center of the inductive coil so that it is well aligned with the magnet of the implant. The magnet strength can be adjusted to allow for a secure adjustment while avoiding discomfort caused by excessive attraction between the implant magnet and the head piece magnet. The headpiece 4th outside the body includes a temperature sensor to detect a dangerous situation for the patient (coil overheating with the effect of irritation of the patient's skin as a single accident). The headpiece 4th outside of the body is light and can be connected to a communication unit via a cable of some 10 cm in length. Furthermore, a communication unit for the electrotherapy of complaints in connection with the central nervous system is provided for use with an implantable electronic unit 3rd and a head piece, in particular according to one of the preceding claims, which is adapted to supply the head piece with energy which drives the transmitting coil and / or reads and evaluates the temperature from the head piece temperature sensor and / or with the implant via a modulated radio frequency communicates and / or has a trigger input that allows external events to be correlated with the data stream coming from the implant and / or to be connected to the personal computer via a USB cable.

Furthermore, a personal computer for use with an implantable electronic unit 3rd , in particular provided according to one of the preceding claims, which is adapted to
to supply the communication unit with energy via USB,
to communicate with the communication unit via USB, and to execute an application programming interface which provides a software interface which allows the control of the implant and the recording of neural signals, in particular via the communication unit.

An implant system is also provided, comprising
an implantable electronic unit 3rd with implantable electrodes 1 , 2nd ,
a headpiece 4th outside the body,
a communication unit 5 outside the body,
and a personal computer 6 outside the body for which the implantable electronic unit 3rd is adapted to wirelessly communicate with the communication unit via an ISM band communication link using radio frequencies in the ISM band of preferably 2.4 GHz - 2.5 GHz at up to 5 Mbit / s, preferably using 2 ms time slots in which data can be transmitted and received in a sequential manner to communicate while the implant is adapted to be inductive via the headpiece 4th to be powered using a 130 kHz alternating magnetic field, the intensity of which is regulated based on the requirement imposed by the implantable electronic device 3rd is reported using the ISM band communication link to ensure safe implant operation with minimal performance loss.

Reference symbol list

1:

implantable electrodes (grid, strips, DBS)

2:

Counter electrode (stimulation return path, optional)

3:

implantable electronic unit

4:

Head piece

5:

Communication unit

6:

Personal computer

7:

ceramic capsule

8th:

inductive coil

9:

Permanent magnet

10:

Silicone cover

11:

Electrode cables that carry wires that electrically connect the electrode contacts to the bushings of the hermetic housing.

Claims (25)

Implantable electronic unit (3) for electro-therapy of complaints in connection with the central nervous system, wherein the implantable electronic unit (3) comprises implantable electrodes (1, 2) and is adapted to be wireless with a communication unit (5) outside the body to communicate in which data is transmitted and received in a sequential manner via an ISM band communication link using radio frequencies in the ISM band of preferably 2.4 GHz - 2.5 GHz at up to 5 Mbit / s, preferably using 2 ms time windows The electronic unit (3) is adapted to be inductively supplied with energy via a head piece (4) outside the body using a 130 kHz alternating magnetic field, the intensity of which is regulated based on the requirement imposed by the implantable electronic unit (3) is reported using the ISM band communication link to ei Ensure safe implant operation with minimal power loss. Implantable electronic unit (3) according to Claim 1 , which is further adapted to connect the brain using many surface electrode grids for recording and stimulating an electro-corticogram, and / or using deep brain electrodes for electrically recording and stimulating neural activity in deep brain structures. Implantable electronic unit (3) according to Claim 1 or 2nd , which is adapted to be connected to electrodes with up to a total of 32 electrode contacts via wires (11) Implantable electronic unit (3) according to any one of the preceding claims, which is adapted to be able to electrically record brain activity of up to 32 electrode contacts. An implantable electronic unit (3) according to any one of the preceding claims, which is adapted to deliver electrical stimulation pulses to any (group) of the 32 electrode contacts. Implantable electronic unit (3) according to any one of the preceding claims, further comprising an additional counter electrode contact (2), which can be used as a return electrode for the stimulation current. Implantable electronic unit (3) according to any one of the preceding claims, which is adapted to select any one of the electrode contacts to be used as the ground (return) electrode (s) for the stimulation current. Implantable electronic unit (3) according to any one of the preceding claims, which is adapted to select any one of the electrode contacts to be used as a reference electrode for neural recording. Implantable electronic unit (3) according to any one of the preceding claims, adapted to set and reset a function of each electrode contact upon user request, the function comprising one of records, stimulation, mass, reference. Implantable electronic unit (3) according to any one of the preceding claims, which is adapted to measure the electrical impedance of each electrode contact. Implantable electronic unit (3) according to any one of the preceding claims, which is adapted to be surgically placed between the skull and skin, preferably in the area behind the ear of a human or animal. An implantable electronic unit (3) according to any one of the preceding claims, which is adapted to be powered wirelessly through the skin using an inductive energy transfer unit (head) outside the body. The alternating magnetic field is picked up by an inductive receiving coil (9). The implant itself has no primary or secondary cell (battery) as an energy storage / source. Implantable electronic unit (3) according to any one of the preceding claims, which is adapted to communicate with the communication unit via a radio frequency connection. Implantable electronic unit (3) according to any one of the preceding claims, wherein the electronics are protected against body fluids by using a ceramic housing (7) which is coated with silicone (10). Implantable electronic unit (3) according to any one of the preceding claims, which is protected in a hermetic ceramic housing with screen-printed electrical feedthroughs. Implantable electronic unit (3) according to any one of the preceding claims, which is adapted to carry a permanent magnet (8) in the center of its energy-receiving coil (9), thereby allowing easy alignment of the energy-transmitting headpiece outside the body. Implantable electronic unit (3) according to any one of the preceding claims, which is equipped with temperature sensors to detect dangerous situations of electrical overheating. Headpiece (4) outside the body for electro-therapy of complaints related to the central nervous system, for use with an implantable electronic unit (3), in particular according to any one of the preceding claims, wherein the headpiece (4) is adapted to transmit energy wear inductive coil. Headpiece (4) outside the body according to the preceding claim, comprising a permanent magnet in the center of the inductive coil so that it is well aligned with the magnet of the implant. Headpiece (4) outside the body according to the preceding claim, wherein the magnet can be adjusted in magnetic strength to allow a safe adjustment, while avoiding discomfort caused by excessive attraction between the implant magnet and the head magnet. Headpiece (4) outside the body according to the preceding claim, comprising a temperature sensor for detecting a dangerous situation for the patient (coil overheating with an effect of irritation of the patient's skin as a single accident). Headpiece (4) outside the body according to the preceding claim, which is light and can be connected to a communication unit via a cable of some 10 cm in length. Communication unit for electro-therapy of complaints related to the central nervous system, for use with an implantable electronic unit (3) and a headpiece, in particular according to any one of the preceding claims, which is adapted to supplying energy to the head piece which drives the transmitting coil, and / or read out and evaluate the temperature from the head piece temperature sensor, and / or communicate with the implant via a modulated radio frequency, and / or have a trigger input which allows external events to be correlated with the data stream coming from the implant and / or to be connected to the personal computer via a USB cable. Personal computer for use with an implantable electronic unit (3), in particular according to any one of the preceding claims, which is adapted to to supply the communication unit with energy via USB, to communicate with the communication unit via USB, and to carry out an application programming interface which provides a software interface which permits the control of the implant and the recording of neural signals, in particular via the communication unit. Implant system, comprehensive an implantable electronic unit (3) with implantable electrodes (1, 2), - a head piece (4) outside the body, - a communication unit (5) outside the body, - And a personal computer (6) outside the body, for which the implantable electronic unit is adapted to wirelessly communicate with the communication unit via an ISM band communication link using radio frequencies in the ISM band of preferably 2.4 GHz - 2.5 GHz to communicate up to 5 Mbit / s, preferably using 2 ms time slots, in which data can be transmitted and received in a sequential manner while the implant is adapted to be inductively powered using the header (4) a 130 kHz alternating magnetic field, the intensity of which is regulated based on the requirement which is regulated by the implantable electronic unit (3) using the ISM band communication link in order to ensure safe implant operation with minimal power loss.

Images