DE102018126468A1 - Device and method for activating cell structures using electromagnetic energy - Google Patents

Abstract

A device is described, at least comprising: an energy source, an electronics unit, a recording unit, coupled to the electronics unit and designed to measure electromagnetic waves in the frequency range 10-10 Hz, the device being designed for implantation in the human or animal body The device is designed to detect that the electromagnetic waves have been emitted from genetically manipulated tissue.

Description

The invention describes a device and method for activating cell structures by means of electromagnetic energy.

Stimulators for stimulating human or animal tissue by electric current have been known for a long time. Electrical stimulation of nerve tissue activates the action potential, which is used in medical therapy and diagnostics. Examples of implantable stimulators include implantable pacemakers and defibrillators, spinal cord stimulators, vagus nerve stimulators, brain pacemakers.

Electrical stimulation devices are galvanically coupled to human or animal tissue and measure electrical potentials and / or stimulate the tissue by means of electrical current delivery to trigger action potentials. Disadvantages of electrical stimulation result, among other things, from the necessary galvanic connection to the tissue. Direct contacting of stimulation electrodes with the tissue and coupling of current can e.g. Necrosis, electrical after-potentials that limit the sensing functions, crosstalk (i.e. interference with parallel stimulation via different stimulation paths), unwanted external induction of therapy currents (e.g. caused by the high-frequency magnetic fields within a magnetic resonance tomograph), possible pain events, electroporation or unwanted stimulation in the vicinity Tissue (for example, in cardiac stimulators, the phrenic nerve can also be involuntarily stimulated). Further disadvantages result from the devices for electricity generation connected to the therapy current, which can be complex and voluminous (e.g. charging circuit in an implantable cardioverter defibrillator) and have limitations in the accessibility of the target tissue.

For several years, the genetic manipulation of tissue to generate excitability by means of electromagnetic waves has been the subject of scientific discussion and research. It has been possible to genetically modify target tissues so that action potentials can be evoked by means of electromagnetic waves.

• - Lung MS, Pilowsky P, Goldys EM., „Activation of the Mammalian cells by using light-sensitive ion channels.“ Methods Mol Biol. 2012;875:241-51; die Publikation beschreibt optogenetische Gewebemanipulation zum Zwecke der Auslösung von Aktionspotentialen mittels Licht im sichtbaren Spektrum;
• - Wang et al. „Optogenetic Control of Heart Rhythm by Selective Stimulation of Cardiomyocytes Derived from Pnmt+ Cells in Murine Heart“, Januar 2017 in Scientific Reports.

One of these methods is called optogenetic manipulation. This is described for example in

• - Lung MS, Pilowsky P, Goldys EM., "Activation of the Mammalian cells by using light-sensitive ion channels." Methods Mol Biol. 2012; 875: 241-51; the publication describes optogenetic tissue manipulation for the purpose of triggering action potentials using light in the visible spectrum;
• - Wang et al. "Optogenetic Control of Heart Rhythm by Selective Stimulation of Cardiomyocytes Derived from Pnmt + Cells in Murine Heart", January 2017 in Scientific Reports.

US 2009/0088680 A1 describes a catheter-based system for introducing a light guide into the heart, the heart tissue having previously been treated by means of optogenetic manipulation. In order to convey the light guide into the heart, a vascular access is placed on the patient, a catheter is pushed into the heart and the light guide is brought through the catheter into the heart. Light is guided into the heart via the light guide and endocardial stimulation of the manipulated tissue is carried out.

A disadvantage of the method described in US 2009/0088680 A1 is that it is carried out on an outpatient basis by a doctor and the light guide must be operated by an external device. Disadvantages also arise from venous vascular access and catheterization, such as infections and vascular occlusions.

The object of the invention is to detect action potentials in pretreated animal and / or human excitable cell structures in a permanently implantable device without the need for a galvanic impression of electrical current in said cell structures.

The object of the invention is to evoke, modulate, terminate and / or inhibit action potentials in pretreated animal and / or human excitable cell structures in a permanently implantable device without the need for a galvanic impression of electrical current.

The invention solves the task of detecting cellular action potentials without the need for a galvanic connection to the target tissue.

An object of the present invention is to provide a device and a system which does not have the disadvantages mentioned.

Another object of the present invention is to provide a device and a system for the stimulation of tissue by means of electromagnetic waves to trigger action potentials, the device allowing permanent stimulation without permanent vascular access, external devices or an outpatient session at the doctor is required.

The object is achieved by the features of the independent claims. Favorable configurations and advantages of the invention result from the further claims and the description.

• eine Energiequelle,
• eine Elektronikeinheit,
• einen Aktuator, der mit der Elektronik und/oder der Energiequelle gekoppelt ist, und wobei der Aktuator ausgelegt ist, elektromagnetische Wellen zur Stimulation von genetisch manipuliertem Gewebe auszusenden. Die Stimulationsvorrichtung ist zur mindestens temporären Implantation im menschlichen oder tierischen Körper ausgelegt. Die Elektronikeinheit umfasst eine Steuereinheit, die dazu ausgelegt ist, besagtes Gewebe mittels der elektromagnetischen Wellen des Aktuators zu stimulieren.

According to one aspect of the present invention, a stimulation device is proposed which at least comprises:

• an energy source,
• an electronic unit,
• an actuator that is coupled to the electronics and / or the energy source, and wherein the actuator is designed to emit electromagnetic waves for the stimulation of genetically manipulated tissue. The stimulation device is designed for at least temporary implantation in the human or animal body. The electronic unit comprises a control unit which is designed to stimulate said tissue by means of the electromagnetic waves of the actuator.

According to one embodiment of the invention, the actuator is designed to emit electromagnetic waves for the stimulation of optogenetically manipulated tissue.

The previously addressed problems are solved with an implantable device for stimulating genetically manipulated tissue. A permanent stimulation can be provided by an implant without catheterization of the patient or intervention by the doctor being necessary.

• - kardiale Bradykardie,
• - kardiale Tachykardie.
• - atriale Fibrillation,
• - ventrikuläre Fibrillation,
• - Herzinsuffizienz,
• - Parkinsonkrankheit,
• - Tremor,
• - Dystonie,
• - Depression,
• - Tourette-Syndrom,
• - chronische Schmerzen,
• - Epilepsie,
• - neuronale oder muskuläre Störungen.

The stimulation by the stimulation device according to the invention is preferably designed to treat at least one of the following diseases:

• - cardiac bradycardia,
• - cardiac tachycardia.
• atrial fibrillation,
• - ventricular fibrillation,
• - heart failure,
• - Parkinson's disease,
• - tremor,
• - dystonia,
• - depression,
• - Tourette syndrome,
• - chronic pain,
• - epilepsy,
• - neuronal or muscular disorders.

According to one embodiment of the stimulation device according to the invention, the actuator is designed to emit electromagnetic waves in the frequency spectrum from infrared light to X-rays. According to a preferred embodiment, the actuator is designed to emit electromagnetic waves in the frequency spectrum between 10 ¹³ and 10 ²⁰ Hz. The actuator is preferably designed to emit electromagnetic waves in the frequency spectrum between 10 ¹³ and 10 ¹⁶ Hz, which corresponds to a spectrum between including infrared radiation and ultraviolet radiation. According to one exemplary embodiment, the actuator is designed to emit electromagnetic waves in the frequency spectrum between 10 ¹⁴ and 10 ¹⁵ Hz, which corresponds approximately to the spectrum visible to the human eye. An advantage of this choice is the relatively simple implementation of such an actuator, as well as low energy consumption and the harmlessness of light for human or animal tissue. In the context of the present invention, the specifications of the frequency range limits are not to be interpreted as a hard limit, but rather the frequency range limit should lie approximately in the specified frequency with a certain tolerance. The tolerance should be based on the understanding of the expert. In particular, the tolerance should be based on which frequencies the person skilled in the electromagnetic spectrum assigns to a corresponding radiation type (for example spectrum of visible light, X-rays, infrared radiation).

In a preferred embodiment of the invention, the stimulation device comprises at least one housing, the housing comprising biocompatible material. The part of the stimulation device which is in direct contact with human or animal tissue in the implanted state preferably consists of biocompatible material, so that the stimulation device is not recognized by the organism as a foreign body and thus a biological defense reaction is prevented.

According to one embodiment of the present invention, the housing is hermetically sealed, so that no body fluids can penetrate into the interior of the housing in the implanted state.

According to a further aspect of the stimulation device according to the invention, the electronics unit is arranged inside the housing, wherein the energy source and / or the actuator are / is arranged inside the housing or outside the housing. The arrangement of components within a housing offers the advantage that the compactness of the device is increased and wiring paths are minimized. All components within the housing are also protected against external influences. The arrangement of the actuator outside the housing offers the advantage that greater flexibility in the placement of the actuator is thereby made possible. In this way, the actuator can be placed so that the area to be stimulated is irradiated with electromagnetic waves in a more targeted manner. If a rechargeable battery and a housing made of electrically conductive material are used, arranging the battery outside the housing offers the advantage that a charging process (for example inductively through an external coil) takes place more efficiently than with a battery arranged inside the housing, since eddy current losses result from the housing material can be reduced.

• - eine Aufnahmeeinheit ausgelegt zur Messung von Daten, die die Gewebeaktivität und/oder Erfolg einer Stimulation charakterisieren, und/oder
• - eine Auswerteeinheit zur Auswertung von Messdaten hinsichtlich des Erfordernisses einer Stimulation und/oder hinsichtlich des Erfolgs einer Stimulation.

Furthermore, according to one embodiment of the stimulation device according to the invention, the electronic unit has at least one of the following or a combination of the following units:

• a recording unit designed for measuring data that characterize the tissue activity and / or success of a stimulation, and / or
• an evaluation unit for evaluating measurement data with regard to the need for stimulation and / or with regard to the success of a stimulation.

• - die Intensität, d.h. die Amplitude der elektromagnetischen Wellen,
• - die Frequenz,
• - die Dauer eines Wellenzugs, und/oder
• - das Tastverhältnis der elektromagnetischen Wellen, d.h. Verhältnis zwischen Aussenden einer elektromagnetischen Welle und Pausieren über die Zeit, um somit eine Modulation der elektromagnetischen Welle bzw. dem elektromagnetischen Signal durchzuführen.

For example, the control unit can be designed to vary one of the following properties or a combination of the following properties of the electromagnetic waves for the stimulation:

• - the intensity, ie the amplitude of the electromagnetic waves,
• - the frequency,
• - the duration of a wave train, and / or
• - The duty cycle of the electromagnetic waves, ie the ratio between the emission of an electromagnetic wave and pauses over time, in order to carry out a modulation of the electromagnetic wave or the electromagnetic signal.

According to one aspect of the present invention, the duration of a wave train is 0.1 ms-5s depending on the intended effect of the stimulation by the electromagnetic waves. A wave train is understood to be a continuous electromagnetic wave. For example, a wave train with a duration of 0.1 ms-2 ms can be selected for use in neurostimulation, for stimulating the heart as a pacemaker stimulus or for antitachycardia pacing (ATP) as a duration for a stimulus in a sequence of ATP stimuli. A duration of 0.1s-5s can e.g. can be chosen for the stimulation of the heart as a cardioversion or defibrillation stimulus.

Furthermore, according to an embodiment of the present invention, the frequency of the stimulation by means of electromagnetic waves in the frequency spectrum is between 10 ¹³ and 10 ²⁰ Hz. According to a preferred embodiment, a frequency in the range: 10 ¹³ -10 ¹⁶ or 10 ¹⁴ - 10 ¹⁵ Hz chosen.

According to a further aspect of the stimulation device according to the invention, the stimulation device has at least one electrode line or electrode probe. For example, the stimulation device can have an elongated, flexible electrode lead, as is used for conventional pacemakers or neurostimulators. According to one embodiment, the actuator can be arranged at the distal end of such an electrode line.

For example, according to one embodiment, the recording unit can be designed to receive electromagnetic waves and to convert them into electrically storable measurement data. Such a recording unit can comprise a light sensor, such as a photo detector. The recorded information of the electromagnetic waves is converted into measurement data and can then be analyzed using the evaluation unit. The evaluation unit can evaluate the measurement data, for example, with regard to various parameters that represent a physiological state of the patient and / or a state of the stimulation device itself. Exemplary parameters would be: success of a stimulation therapy, required state of a stimulation therapy, a health condition of the patient, a state parameter of the environment of the stimulation device, etc.

Furthermore, according to a preferred embodiment of the present invention, at least the energy source and the electronics unit are arranged within the housing. These units are sensitive to the sometimes aggressive body fluids to which they would be exposed when implanted. Therefore, according to one embodiment, the placement in a hermetically sealed housing is advantageous.

In a preferred embodiment, the electronics unit is at least partially by external device configurable. The configuration can take place wirelessly or, by coupling an external device to the electronic unit, wired. In this way, functions of the stimulation device according to the invention can be flexibly programmed and individually adapted to a patient.

According to a further aspect of the present invention, the stimulation device comprises at least one fixing unit, which is designed to fix at least a part of the stimulation device in tissue of a human or animal body. Examples of such a fixing unit are: screw elements, hook elements, anchor elements, tissue glue.

According to an exemplary embodiment of the present invention, the energy source comprises a battery which is designed as a primary cell or a secondary cell. The battery is preferably arranged inside the housing. In one embodiment, the battery is rechargeable, e.g. inductively via an external charger with a charging coil.

Furthermore, according to a preferred embodiment of the present invention, the stimulation device has a telemetry unit for wireless communication with at least one external device and / or data center. In this way, measurement data can be sent by the stimulation device and other data can be received, such as programming jobs, patient-specific data, etc.

According to one embodiment of the present invention, the actuator comprises at least one optical waveguide. The optical fiber is used to couple the electromagnetic waves to stimulate optogenetic tissue.

• - ein Beschleunigungssensor,
• - ein Temperatursensor,
• - ein akustischer Sensor,
• - ein Ultraschallsensor,
• - ein Sauerstoffsensor,
• - ein Drucksensor, und/oder
• - ein Magnetfeldsensor.

Furthermore, according to further embodiments of the present invention, the stimulation device can comprise one of the following sensors or a combination of the following sensors:

• - an acceleration sensor,
• - a temperature sensor,
• - an acoustic sensor,
• - an ultrasonic sensor,
• - an oxygen sensor,
• - a pressure sensor, and / or
• - a magnetic field sensor.

According to one embodiment of the present invention, additional sensors can be coupled to the evaluation unit. The evaluation unit can evaluate the sensor data, for example, with regard to various parameters that represent a physiological state of the patient and / or a state of the stimulation device itself. Exemplary parameters represent: success of a stimulation therapy, required state of a stimulation therapy, a state of health of the patient, a state parameter of the environment of the stimulation device, etc.

According to a further aspect of the present invention, the stimulation device is designed to deliver stimulation by the electromagnetic waves to heart tissue. The stimulation is carried out relative to a cardiac cycle. For example, a characteristic event can be measured in a signal representing the cardiac cycle (e.g. a bradycardia / tachycardia episode, an abnormality in the signal curve, etc.), whereupon a counter is started. If the counter determines that a time interval has elapsed, the stimulation is carried out. The stimulation is designed to cause at least one contraction of the heart.

According to one embodiment of the invention, the stimulation is delivered in the form of at least one stimulus,
if the evaluation unit detects a therapy requirement for bradycardia, the detection being based on the measured heart rate falling below at least one predetermined heart rate, and / or
if the evaluation unit detects a therapy requirement for ventricular fibrillation, the detection being based on the comparison of at least one defined ventricular rate and / or a defined stability of a ventricular rate by the measured ventricular rate.
In this embodiment, the stimulation device is designed for the therapy of bradycardia or ventricular fibrillation.

According to one aspect of the invention, the stimulation is delivered in the form of a plurality of stimuli when the evaluation unit detects a therapy requirement for a tachycardia, the detection being based on the at least one predetermined heart rate being exceeded by the measured heart rate, with a plurality of stimuli being delivered in a sequence , and or
if the evaluation unit detects a therapy requirement for a cardiac resynchronization, the detection being based on the evaluation of measurement data representing the cardiac activity, at least one first and one second stimulus being emitted and the at least first and second stimulus being designed to produce an im To achieve essentially synchronous contraction of the left and right half of the heart.

According to one aspect of the invention, the stimulation is delivered in the form of several stimuli when the evaluation unit detects a therapy requirement for tachycardia, the detection being based on the at least one fixed heart rate being exceeded by the measured heart rate, and the stimuli being delivered in one of the sequences and are designed to terminate the tachycardia. This is an atrial and / or ventricular tachycardia or atrial fibrillation. The detection of atrial fibrillation is based, for example, on the comparison of at least one specified atrial frequency and / or a specified stability of an atrial frequency with the measured atrial frequency. According to one exemplary embodiment, the stimuli of the sequence are designed to terminate the atrial fibrillation.

In the two aforementioned embodiments, the stimulation device is designed for the therapy of tachycardia or therapy of heart failure caused by the asynchrony between the contraction of the right and left heart half.

According to one aspect of the invention, the stimulation is delivered in the form of at least one stimulus when the evaluation unit detects a therapy requirement for ventricular fibrillation. The detection of the therapy requirement is based on the comparison of at least one fixed ventricular rate and / or a fixed stability of a ventricular rate based on the measured ventricular rate. The at least one stimulus delivered is designed to terminate ventricular fibrillation.

Furthermore, according to one aspect of the present invention, the stimulation device comprises one or more recording units in one or more heart chambers. For example, acquisition units can be arranged in the right atrium or right ventricle. The recording units are preferably arranged such that they can receive signals from the right atrium, right ventricle, left atrium, and / or left ventricle. The signals can be electromagnetic, electrical or acoustic in nature, for example.

According to a further exemplary embodiment of the present invention, the stimulus or the stimuli are delivered by the stimulation device relative to a cardiac cycle after a time interval has elapsed. The control unit has a timer unit or counter that can start or end the time interval. The start and end of the time interval is triggered by the recording unit, with a stimulation being triggered after the time interval has elapsed.

• Veranlassung der Stimulationsvorrichtung zur Aussendung elektromagnetischer Wellen, sodass eine Stimulation von genetisch manipuliertem Gewebe durch besagte elektromagnetische Wellen ausgelöst wird.

According to the invention, a method for controlling an implantable stimulation device is proposed, which comprises at least the steps:

• Causing the stimulation device to emit electromagnetic waves, so that stimulation of genetically manipulated tissue is triggered by said electromagnetic waves.

The aforementioned aspects and embodiments of the stimulation device according to the invention and the components included are also to be applied to the method for controlling the same and the components comprising the stimulation device according to the invention.

Furthermore, according to a further aspect, the stimulation device according to the invention comprises an implantable stimulator without an elongated electrode line. The electrode or probe lines often used in connection with electrical stimulation can represent an additional source of complications for infections or line breaks or short-circuits.

• - eine Energiequelle,
• - eine Elektronikeinheit, wobei die Elektronikeinheit eine Steuereinheit umfasst,
• - einen Aktuator, der mit der Elektronik und/oder der Energiequelle gekoppelt ist,
• - ein Gehäuse, wobei die Energiequelle, die Elektronikeinheit und der Aktuator im Gehäuse angeordnet sind,
• - eine Fixiereinheit, die mit dem Gehäuse gekoppelt ist, wobei die Fixiereinheit dazu ausgelegt ist, die Stimulationsvorrichtung an einem Herzen oder in einem Herzen zu fixieren. Der Aktuator ist dazu ausgelegt, elektromagnetische Wellen zur Stimulation von genetisch manipuliertem Gewebe auszusenden. Die Steuereinheit ist dazu ausgelegt, die Stimulation des Gewebes mittels der elektromagnetischen Wellen des Aktuators zu steuern.

According to one aspect of the invention, the stimulation device comprises at least:

• - an energy source,
• an electronics unit, the electronics unit comprising a control unit,
• an actuator which is coupled to the electronics and / or the energy source,
• a housing, the energy source, the electronics unit and the actuator being arranged in the housing,
• a fixing unit, which is coupled to the housing, the fixing unit being designed to fix the stimulation device to a heart or in a heart. The actuator is designed to emit electromagnetic waves to stimulate genetically manipulated tissue. The control unit is designed to control the stimulation of the tissue by means of the electromagnetic waves of the actuator.

• eine Aufnahmeeinheit ausgelegt zur Messung von Daten, die die Gewebeaktivität und/oder Erfolg einer Stimulation charakterisieren, und/oder
• eine Auswerteeinheit zur Auswertung von Messdaten hinsichtlich des Erfordernisses einer Stimulation und/oder hinsichtlich des Erfolgs einer Stimulation.

Furthermore, according to one exemplary embodiment of the present invention, the electronic unit has at least one of the following or a combination of the following units:

• a recording unit designed for measuring data which characterize the tissue activity and / or success of a stimulation, and / or
• an evaluation unit for evaluating measurement data with regard to the requirement of stimulation and / or with regard to the success of a stimulation.

According to one embodiment of the present invention, the actuator is at least partially coated with a bio-compatible material. In particular if the actuator is arranged outside the housing and in direct contact with the surroundings, i.e. in the implanted state in contact with body fluids, the actuator requires such a biocompatible coating. According to one aspect of the stimulation device according to the invention, the actuator is designed to stimulate a local area on or in the heart by means of electromagnetic waves.

Preferably, according to an embodiment of the present invention, the stimulation device has at least a first and a second actuator, which are designed to stimulate different local areas on or in the heart by means of electromagnetic waves.
A second actuator can be connected to the electronics unit and / or control unit of the stimulation device and can be controlled by the same.

According to one embodiment, the fixation unit and / or at least parts of the housing is / are provided with anti-inflammatory medication, e.g. a steroid.

It would also be conceivable that the stimulation device according to the invention has a unit for electrical stimulation of the heart. The stimulation device could be controlled in such a way that it triggers stimulation of the tissue by means of electromagnetic waves or by means of galvanically coupled currents, or by a combination of the two. Electromagnetic waves would be emitted by the actuator, while galvanic currents would be injected through the cardiac electrical stimulation unit.

• - eine Energiequelle,
• - eine Elektronikeinheit, wobei die Elektronikeinheit eine Steuereinheit umfasst,
• - einen Aktuator, der mit der Elektronik und/oder der Energiequelle gekoppelt ist, und wobei der Aktuator ausgelegt ist, elektromagnetische Wellen zur Stimulation von genetisch manipuliertem Gewebe auszusenden,

eine Fixiereinheit,
wobei die Stimulationsvorrichtung zur mindestens temporären Implantation im menschlichen oder tierischen Körper ausgelegt ist, und die Steuereinheit dazu ausgelegt ist, die Stimulation besagten Gewebes mittels der elektromagnetischen Wellen des Aktuators zu steuern. Dazu weist die Stimulationsvorrichtung eine Kontrolleinheit auf, die Daten aufnimmt, die die Gewebeaktivität und/oder Erfolg einer Stimulation durch eine über den elektromagnetischen Aktuator durchgeführte Stimulation charakterisieren.According to one aspect of the present invention, the stimulation device comprises:

• - an energy source,
• an electronics unit, the electronics unit comprising a control unit,
• an actuator, which is coupled to the electronics and / or the energy source, and the actuator is designed to emit electromagnetic waves for the stimulation of genetically manipulated tissue,

a fuser,
wherein the stimulation device is designed for at least temporary implantation in the human or animal body, and the control unit is designed to control the stimulation of said tissue by means of the electromagnetic waves of the actuator. For this purpose, the stimulation device has a control unit which records data which characterize the tissue activity and / or success of a stimulation by means of a stimulation carried out via the electromagnetic actuator.

• - ein elektrisch abgeleitetes Fernfeldsignal,
• - Herztöne,
• - ein Drucksignal,
• - ein optisches Signal nach dem Prinzip der Pulsoxymetrie,
• - ein Ultraschallsignal,
• - ein Beschleunigungssignal, und/oder
• - ein thermisches Signal.

Furthermore, according to further exemplary embodiments of the present invention, the control unit records said data on the basis of at least one or a combination as the following signals:

• an electrically derived far field signal,
• - heart sounds,
• - a pressure signal,
• an optical signal based on the principle of pulse oximetry,
• - an ultrasound signal,
• - an acceleration signal, and / or
• - a thermal signal.

According to one exemplary embodiment, the stimulation device is designed to record and evaluate an ultrasound signal based on the Doppler technique, in order to be able to infer the flow velocities and directions of body fluids.

According to one embodiment of the stimulation device according to the invention, the control unit is not in electrical contact with the genetically manipulated tissue. The control unit is arranged in such a way that the signals to be evaluated, which characterize the tissue activity and / or the success of a stimulation by means of the actuator, can be recorded directly by the control unit using sensors. Alternatively, the sensors can be arranged separately from the control unit. Then the signals picked up by the sensors are forwarded to the control unit. The control unit can form part of the electronic unit.

• - eine Energiequelle,
• - eine Elektronikeinheit, wobei die Elektronikeinheit eine Steuereinheit umfasst,
• - einen Aktuator, der mit der Elektronik und/oder der Energiequelle gekoppelt ist, und wobei der Aktuator ausgelegt ist, elektromagnetische Wellen zur Stimulation von genetisch manipuliertem Gewebe auszusenden,
• - ein Gehäuse, in dem zumindest die Elektronikeinheit angeordnet ist,

wobei die Stimulationssystem zur mindestens temporären Implantation im menschlichen oder tierischen Körper ausgelegt ist, und die Steuereinheit dazu ausgelegt ist, die Stimulation besagten Gewebes mittels der elektromagnetischen Wellen des Aktuators zu steuern. Außerdem umfasst das Stimulationssystem ein Selektionsmittel, das dazu ausgelegt ist, den Bereich oder Areal des besagten Gewebes für die Stimulation zu wählen.According to an exemplary embodiment of the present invention, a stimulation system is described which at least comprises:

• - an energy source,
• an electronics unit, the electronics unit comprising a control unit,
• an actuator, which is coupled to the electronics and / or the energy source, and the actuator is designed to emit electromagnetic waves for the stimulation of genetically manipulated tissue,
• a housing in which at least the electronics unit is arranged,

wherein the stimulation system is designed for at least temporary implantation in the human or animal body, and the control unit is designed to control the stimulation of said tissue by means of the electromagnetic waves of the actuator. In addition, the stimulation system comprises a selection means which is designed to select the area or area of said tissue for the stimulation.

According to one aspect of the stimulation system according to the invention, the actuator is designed to emit the electromagnetic waves in at least one radiation direction, the selection means being designed to control the radiation direction.

According to one embodiment, the actuator emits electromagnetic waves at a solid angle of less than 4 * π.

Furthermore, according to one exemplary embodiment of the stimulation system according to the invention, the selection means has at least one masking means which is designed to mask an area of said tissue, so that the intensity of the stimulation for the area is reduced or equal to zero.

According to one embodiment, the masking means is designed to change a solid angle with which the electromagnetic waves are emitted by the actuator.

• - elektromagnetische Strahlung bestimmter Frequenzbereiche sperrt, oder
• - elektromagnetische Strahlung bestimmter Polarisationsrichtungen sperrt.

According to one embodiment, the masking means comprises at least one filter, the filter

• - blocks electromagnetic radiation of certain frequency ranges, or
• - blocks electromagnetic radiation of certain polarization directions.

According to one embodiment, the masking device is connected to the actuator or is fixed to the actuator. Alternatively, it can form a unit with the actuator.

According to one embodiment, the masking device is in contact with the area of said tissue. A concrete exemplary embodiment would be that the masking device is designed as a cover layer (e.g. paint opaque to electromagnetic radiation) or cover device that covers said tissue areas. Furthermore, according to an embodiment of the present invention, the masking device is formed by a part of the housing. This can be achieved, for example, by attaching the masking device to the housing (e.g. in the form of panels).

Furthermore, according to one exemplary embodiment, the actuator is arranged in such a way that, in the implanted state of the stimulation system, a surrounding object serves to mask at least one area of the said tissue, so that the intensity of the stimulation for the area is reduced or equal to zero. For this purpose, for example, the actuator can be arranged in a cavity in the vicinity of the implantation site, so that the tissue topology surrounding it serves as a natural mask for the emitted electromagnetic waves. If the stimulation system is implanted in the heart, the actuator can be implanted in the heart ear, which is located in the right atrium. This prevents electromagnetic waves from being radiated into the right ventricle, i.e. selective irradiation for the atrium is made possible. If, in a further example, the actuator is implanted below the moderator band, no electromagnetic waves can be radiated into the atrium, i.e. selective radiation into the right ventricle is made possible.

According to a further aspect of the stimulation system according to the invention, the area for the irradiation of said tissue can be changed by adapting the masking agent. For example, based on measurements of the stimulation success, it may be necessary to improve the treatment of the cell structures. The area for the radiation can optionally be expanded by additional treatment or reduced by using the masking agent.

According to one embodiment of the stimulation system according to the invention, the selection means has a support structure which is connected to the housing, the actuator being connected to the support structure. The support structure can be designed in such a way that the selection means and / or the actuator can be arranged and fixed at different points on the support structure. In this way one can change the spatial arrangement between the selection means and the actuator thus adapting the beam angle of the actuator more flexibly. According to one embodiment, the support structure is designed to restrict the radiation angle of the emitted electromagnetic waves by the actuator.

Furthermore, according to one aspect of the stimulation system according to the invention, the stimulation system has at least a first and a second actuator. The actuators are preferably arranged in such a way that interference is minimized when electromagnetic waves are emitted at the same time. In this way, two tissue areas can be irradiated independently of one another. According to one aspect of the invention, the electromagnetic waves emitted by the first and second actuators have different frequencies and / or different polarization.

• - Linsen,
• - Kollimatoren,
• - Vorrichtungen, die Materialien mit anisotropen Ausbreitungseigenschaften für die genutzte elektromagnetische Strahlung besitzen.

Furthermore, according to one exemplary embodiment of the stimulation system according to the invention, the stimulation system has a means for bundling electromagnetic radiation. A means of bundling includes, for example:

• - Lenses,
• - collimators,
• - Devices that have materials with anisotropic propagation properties for the electromagnetic radiation used.

The invention is explained in more detail below by way of example using an exemplary embodiment shown in the drawings. In the figures, elements that are functionally identical or have the same effect are each numbered with the same reference numerals. The figure is a schematic representation of the invention and shows non-specific parameters of the invention. The figure only shows typical embodiments of the invention and is not intended to limit the invention to the embodiments shown.

• - eine Energiequelle,
• - einen Energiespeicher,
• - eine Elektronikeinheit,
• - wobei die Vorrichtung zur Implantation im menschlichen oder tierischen Körper ausgelegt ist,
• - und einen Aktuator, der mit dem Energiespeicher gekoppelt ist und dazu ausgelegt ist, durch Entladung des Energiespeichers elektromagnetische Wellen auszusenden.

According to an exemplary embodiment of the present invention, a device is proposed which comprises at least:

• - an energy source,
• - an energy store,
• - an electronic unit,
• the device being designed for implantation in the human or animal body,
• - And an actuator which is coupled to the energy store and is designed to emit electromagnetic waves by discharging the energy store.

Furthermore, according to one aspect of the present inventive device, the energy store has a capacitor and / or a coil.

• sie ist dazu ausgelegt, eine Ladung des Energiespeichers und Entladung des Energiespeichers an den Aktuator zu steuern,
  • - sie ist dazu ausgelegt, die Energiemenge für eine Ladung und Entladung zu steuern,
  • - sie ist mittels einer Programmiervorrichtung von extern konfigurierbar,
  • - sie weist eine Freigabeeinheit für die Entladung auf, und/oder
  • - die Entladung findet über mindestens zwei in Reihe geschaltete Impedanzen statt, wobei die Impedanzen mittels der Steuereinheit einstellbar sind.

According to one aspect of the present inventive device, the electronic unit comprises a control unit, the control unit having at least one of the following properties:

• it is designed to control charging of the energy store and discharge of the energy store to the actuator,
  • it is designed to control the amount of energy for a charge and discharge,
  • it can be configured externally by means of a programming device,
  • - It has a release unit for the discharge, and / or
  • - The discharge takes place via at least two impedances connected in series, the impedances being adjustable by means of the control unit.

For example, such impedances can be realized by electrical switch elements. Such switch elements thus enable the course of the discharge.

According to one embodiment of the device according to the invention, the discharge is controlled by the control unit in such a way that the actuator emits electromagnetic waves in the form of a continuous wave train in a period of 0.1 ms-5 s. For a neurostimulation application (e.g. spinal cord stimulation, vagus nerve stimulation), cardiac pacing or ATP stimulation, a period of 0.1ms-2ms can be selected, 0.1s-5s for cardioversion or defibrillation of the heart.

Furthermore, according to one aspect of the device according to the invention, the discharge takes place in more than one phase.

• - er umfasst mindestens eine Lichtquelle zur Aussendung der elektromagnetischen Wellen,
• - er umfasst mindestens einen Strombegrenzer (z.B. Widerstand oder Diode),
• - er wird durch den Energiespeicher mit 1V bis zu 1500 V betrieben (spezielle Lösungen wären z.B.: 1-10V für eine Parallelschaltung, 50-500 V für eine Reihenschaltung)
• - und/oder
• - er ist von einem Gehäuse der Vorrichtung getrennt angeordnet und verfügt über einen Steckverbinder, wobei der Steckverbinder kompatibel ist zu einem Steckerausgang eines implantierbaren Geräts zur elektrischen Herzstimulation.

According to one embodiment of the device according to the invention, the actuator has at least one of the following properties:

• it comprises at least one light source for emitting the electromagnetic waves,
• - it includes at least one current limiter (eg resistor or diode),
• - it is operated by the energy storage with 1V up to 1500 V (special solutions would be: 1-10V for a parallel connection, 50-500 V for a series connection)
• - and or
• - it is arranged separately from a housing of the device and has a plug connector, the plug connector being compatible with a plug output of an implantable device for electrical cardiac stimulation.

According to a further aspect of the invention, the light source comprises a series connection of LEDs (Light Emitting Diode), a parallel connection of LEDs, or a combination of series connection and parallel connection of LEDs.

According to one exemplary embodiment of the present invention, an implantable stimulation device for stimulating heart tissue or nerve tissue structures is proposed, said device having said device according to the invention. The device can have at least one stimulation electrode.

• - mittels des Aktuators durch elektromagnetische Wellen oder
• - mittels elektrischer Stimulation,
• - wobei die Stimulation durch elektromagnetische Wellen und durch elektrische Stimulation einzeln, nacheinander oder zeitgleich stattfindet,
• - wobei die Stimulation in einem Areal oder mehreren Arealen des Gewebes stattfindet.

According to one aspect of the stimulation device according to the invention, it is designed to induce stimulation of cardiac tissue, the stimulation

• - by means of the actuator by electromagnetic waves or
• - by means of electrical stimulation,
• the stimulation by electromagnetic waves and by electrical stimulation takes place individually, successively or simultaneously,
• - The stimulation taking place in one or more areas of the tissue.

• - einen Steckkontakt kompatibel für einen Aktuator, und/oder
• - einen Steckkontakt kompatibel für eine Elektrode für elektrische Stimulation, und/oder
• - Aktuator und eine Elektrode.

According to an embodiment of the present invention, the stimulation device further comprises:

• - A plug contact compatible for an actuator, and / or
• - A plug contact compatible for an electrode for electrical stimulation, and / or
• - actuator and an electrode.

According to one embodiment of the stimulation device, it emits electromagnetic waves for the stimulation of said manipulated tissue via the actuator, it has a success check and, in the case of an unsuccessful case, it emits additional electrical therapy. For example, it can also deliver both types of therapy at the same time or can be switched between the two. At which locations which form of therapy is used can be programmable and / or is determined and possibly converted on the basis of an analysis of the therapy successes of the past by the stimulation device itself. The stimulation device according to the invention preferably has dedicated connections for the electromagnetic actuator.

In a preferred embodiment, the stimulation device according to the invention has at least one connection which can be used both for an actuator according to the invention and for electrical stimulation according to the prior art. According to one embodiment, the actuator can be connected to the stimulation device via a plug which corresponds to a plug for a comparable component for electrical therapy (e.g. plug of an electrode line for cardiac stimulation). The actuator according to the invention is preferably operated by the same or at least similar voltages as those used for the electrical therapy according to the prior art (e.g. cardiac pacemaker therapy, neurostimulators).

According to an embodiment of the invention, a device that can be implanted in the human or animal body and that comprises at least one substance is proposed. The substance is designed to modify human or animal cell structures so that action potentials in the cell structures can be perceived and / or evoked by radiation from electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz. The device comprises an application means for delivering the substance to tissue.

• - eine Kanüle,
• - ein Mittel zum Sprühen, Aufpinseln, Träufeln und/oder Aufstempeln der Substanz.

Furthermore, according to one aspect of the present invention, the application means for delivering the substance to tissue comprises at least one of the following means:

• - a cannula,
• - A means of spraying, brushing, trickling and / or stamping the substance.

According to one embodiment of the present invention, the device has at least one feed line for the substance. It should also be considered if the device has at least one preservation device for the substance.

According to one embodiment, the device has a reservoir which is designed to store the substance. The device can have a housing, the reservoir being arranged inside the housing or outside the housing. The reservoir can have a biocompatible covering, and / or thermal insulation, and / or protection against hard radiation. In this way, the substance inside the reservoir can be effectively protected against external influences.

• - sie ist so positioniert, dass sie mit einem Werkzeug zum Befüllen mit der Substanz zugänglich ist,
• - sie ist mehrfach durchstechbar, und/oder
• - sie ist so ausgelegt, dass sie nach Entfernen des Werkzeugs zum Befüllen wieder schließt, sodass ein Austreten der befüllten Substanz im Wesentlichen verhindert wird.

According to one aspect of the device according to the invention, it has a port for filling the reservoir. The port can, for example, be attached to the supply line, the device housing or the reservoir. In one example, the port comprises a membrane. The membrane can have at least one of the following properties:

• - it is positioned so that it is accessible with a tool for filling with the substance,
• - it can be pierced several times, and / or
• - It is designed in such a way that it closes again after removal of the filling tool, so that leakage of the filled substance is essentially prevented.

According to one embodiment, the reservoir can form part of the feed line.

• - ein thermisches Element zur Kühlung und/oder Erhitzung,
• - einen Generator für Strahlung zur Sterilisation,
• - einen Speicher für eine Konservierungssubstanz, wobei die Konservierungssubstanz der Substanz zugebbar ist, und/oder
• - ein Kontrollmittel zur Ermittlung eines Konservierungsstatus der Substanz.

Furthermore, according to one aspect of the device according to the invention, the preservation device has at least one of the following means:

• a thermal element for cooling and / or heating,
• - a generator for radiation for sterilization,
• a memory for a preservative, the preservative being able to be added to the substance, and / or
• - a control agent for determining a preservation status of the substance.

• bei Ermittlung eines niedrigen Grads wird der Bedarf einer Abgabe der Substanz durch das Applikationsmittel festgestellt, und/oder
• die Ermittlung des Grads basiert auf Messdaten bezüglich einer Wahrnehmung und/oder Evozierung von Aktionspotentialen in Gewebe mittels elektromagnetischer Wellen im Frequenzbereich 10¹³-10²⁰ Hz.

According to one embodiment, the device according to the invention comprises or can be connected to a control means. The control means is designed to determine a degree of modification with respect to the perceptibility and / or evocability of action potentials in tissue by means of electromagnetic waves. The control device can have at least one of the following properties:

• if a low degree is determined, the need for the substance to be released by the application agent is determined, and / or
• the determination of the degree is based on measurement data relating to a perception and / or evocation of action potentials in tissue by means of electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz.

• ein Ventil zum Freisetzen der Substanz,
• eine Pumpe, und/oder
• eine Maskiervorrichtung, dazu ausgelegt, Gewebeareale zu maskieren, an die keine Substanz abgegeben werden soll.

According to one example, the device according to the invention comprises at least one of the following means:

• a valve for releasing the substance,
• a pump, and / or
• a masking device designed to mask areas of tissue to which no substance is to be released.

• - eine Energiequelle,
• - eine Elektronikeinheit,
• - einen Aktuator, der mit der Elektronikeinheit und/oder der Energiequelle gekoppelt ist und dazu ausgelegt ist, elektromagnetische Wellen zur Stimulation von durch die Substanz behandeltes Gewebe auszusenden.

Furthermore, according to one embodiment, the device comprises at least:

• - an energy source,
• - an electronic unit,
• an actuator which is coupled to the electronic unit and / or the energy source and is designed to emit electromagnetic waves for stimulating tissue treated by the substance.

In one aspect, the delivery of the substance to the tissue by the application agent can be controlled over a period of time. For example, the application agent can control the delivery of the substance over a period of time, e.g. in which the delivery takes place at predetermined intervals at predetermined doses. Alternatively, the application agent can comprise a biodegradable agent that contains the substance over a longer period of time. Through contact with tissue, the biodegradable agent is released to the tissue together with the substance in a time-controlled manner. In one example, the substance itself is degradable over a long period of time.

• - eine Energiequelle,
• - eine Elektronikeinheit,
• - eine Aufnahmeeinheit, mit der Elektronikeinheit gekoppelt und dazu ausgelegt, elektromagnetische Wellen im Frequenzbereich 10¹³-10²⁰ Hz zu messen,
• - wobei die Vorrichtung zur Implantation im menschlichen oder tierischen Körper ausgelegt ist. Die Vorrichtung ist dazu ausgelegt, zu detektieren, dass die elektromagnetischen Wellen von genetisch manipuliertem Gewebe abgestrahlt wurden.

According to the invention, a device is proposed which comprises at least:

• - an energy source,
• - an electronic unit,
• a recording unit, coupled to the electronic unit and designed to measure electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz,
• - The device being designed for implantation in the human or animal body. The device is designed to detect that the electromagnetic waves have been emitted from genetically manipulated tissue.

According to one aspect of the device according to the invention, it has an actuator which is coupled to the electronics unit and / or the energy source and the actuator is designed to emit electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz.

According to one aspect of the device according to the invention, the electronic unit is designed to recognize that by the receiving unit measured electromagnetic waves were emitted by the actuator. For example, these can be waves emitted by the actuator and reflected on tissue. The reflected waves are detected by the recording unit and recognized accordingly by the electronics unit.

• - Reflexion,
• - Fluoreszenz,
• - Absorption,
• - Transmission, und/oder
• - Polarisation.

For example, according to one aspect of the device according to the invention, the electromagnetic wave measured by the recording unit is the modified electromagnetic wave emitted by the actuator. The change is based, for example, on at least one of the effects:

• - reflection,
• - fluorescence,
• - absorption,
• - Transmission, and / or
• - polarization.

• - Amplitude,
• - Frequenz oder Frequenzspektrum, und/oder
• - Polarisationsrichtung,
• - Phase,
• - wobei mindestens eines der folgenden Verfahren angewendet wird:
• - Modulationsverfahren
• - Pulsweitenmodulation (z.B. im Fall wenn die eingestrahlte elektromagnetische Welle durch die Gewebsstrukturen in Pulsen mit messbaren Pulsdauern umgesetzt wird, wobei aus den Pulsdauern Informationen über die Stimulation und/oder die Gewebseigenschaften gewonnen werden können),
• - Erkennung der Veränderung durch Anwendung von Filtern (z.B. zum Detektieren des Frequenzspektrums der gemessenen elektromagnetischen Wellen).

In one example, the electronics unit is designed to recognize at least one of the following parameters, a combination of these or a derived quantity from them in the electromagnetic wave measured by the recording unit:

• - amplitude,
• - frequency or frequency spectrum, and / or
• - direction of polarization,
• - phase,
• - using at least one of the following methods:
• - modulation method
• Pulse width modulation (for example in the case when the incident electromagnetic wave is converted by the tissue structures into pulses with measurable pulse durations, information about the stimulation and / or the tissue properties being able to be obtained from the pulse durations),
• - Detection of the change by using filters (eg for detecting the frequency spectrum of the measured electromagnetic waves).

According to a special exemplary embodiment, the electronic unit recognizes the frequency or a frequency spectrum or a frequency shift of the electromagnetic waves measured by the recording unit by detecting the change due to a filter effect.

According to one example, the electronics unit is designed to determine the spectral power density in the electromagnetic waves measured by the recording unit.

• - Verstärkung,
• - Demodulation,
• - Filterung,
• - AD-Wandlung,
• - Gleichrichtung,
• - Bestimmung der Signalleistung,
• - Schwellwertbestimmung,
• - Transformation in den Frequenzbereich (z.B. via Fourier-, Hartley- oder Wavelet-Transformation)
• - Bestimmung von Signalqualität (z.B. über Bestimmung des Signal-to-Noise-Ratio SNR), und/oder
• - Bestimmung signalmorphologischer Parameter (z.B. Signalamplitude, Signalzacken, Verhältnisse von Signalamplituden und/oder Signalzacken etc.).

Furthermore, according to one aspect of the device according to the invention, the electronic unit or recording unit converts the measured electromagnetic wave into an electronic signal and pre-processes it using at least one of the following methods:

• - reinforcement,
• - demodulation,
• - filtering,
• - AD conversion,
• - rectification,
• - determination of signal power,
• - threshold determination,
• - Transformation into the frequency domain (e.g. via Fourier, Hartley or wavelet transformation)
• - Determination of signal quality (eg by determining the signal-to-noise ratio SNR), and / or
• - Determination of signal morphological parameters (eg signal amplitude, signal spikes, relationships of signal amplitudes and / or signal spikes, etc.).

• - Segmentierung,
• - Ereigniserkennung,
• - Bestimmung von Periodizität,
• - Bestimmung der Phasenlage (z.B. wird die Phasenlage zwischen besagtem Signal und einem anderen aufgenommenen Signal oder einem Referenzsignal bestimmt),
• - Bestimmung von Stabilität (z.B. wird die Stabilität der Signalintensität oder die Stabilität eines in dem Signal detektierten Rhythmus erkannt), oder
• - Klassifikation von Rhythmen, und/oder
• - Klassifikation von signalmorphologischen Parametern.

According to one embodiment of the device according to the invention, the electronics unit or recording unit converts the measured electromagnetic wave into an electronic signal. Furthermore, the electronic unit performs an analysis of the signal based on at least one of the following methods:

• - segmentation,
• - event detection,
• - determination of periodicity,
• - determination of the phase position (for example the phase position between said signal and another recorded signal or a reference signal is determined),
• Determination of stability (for example the stability of the signal intensity or the stability of a rhythm detected in the signal is recognized), or
• - Classification of rhythms, and / or
• - Classification of signal morphological parameters.

• - Photodiode,
• - Phototransistor,
• - Charge-Coupled Device (CCD)- Element, und/oder
• - analoger oder digitaler Bildsensor.

According to an embodiment of the device according to the invention, the recording unit has at least one of the following sensors:

• - photodiode,
• - phototransistor,
• - Charge-Coupled Device (CCD) element, and / or
• - analog or digital image sensor.

Furthermore, according to one aspect of the present invention, the device comprises at least a first and a second actuator, the first and the second actuator emitting electromagnetic waves in different frequencies. The first actuator can be coupled to a housing of the device. Alternatively, the first actuator can be arranged at a distance from the housing. The first actuator can be connected to the receiving unit.

According to one embodiment, the device has an electrostimulation means. According to one aspect of the invention, the device is designed to emit electromagnetic waves to heart tissue or to nerve tissue in the spinal cord or muscle tissue.

According to exemplary embodiments, the at least first actuator comprises LEDs. In a special implementation, the actuator comprises a filter (e.g. polarization filter). The radiation characteristic (i.e. direction, intensity, frequency, duration of the radiation) is programmable by the control unit according to one embodiment. If the device is an implant, said programming can be carried out before and after the implantation.

According to one exemplary embodiment, the device comprises a fixing device. The fixing device is designed such that actuators and / or sensors are attached to it in such a way that the electromagnetic radiation penetrates the tissue.

The device according to the invention can be implanted using a controllable positioning aid (e.g. controllable catheter, steerable sheaths, over-the-wire OTW technology, etc.). The device can be positioned using imaging methods (e.g. x-ray imaging, computer tomography, magnetic resonance imaging, ultrasound, impedance tomography).

• 1 Schematische Darstellung eines Ausführungsbeispiels der erfindungsgemäßen Stimulationsvorrichtung im implantierten Zustand mit einem externen Gerät
• 2 Schematische Darstellung einer Methode zur Behandlung einer Bradykardie mittels optischer Stimulation für mindestens ein Ausführungsbeispiel der erfindungsgemäßen Stimulationsvorrichtung
• 3 Schematische Darstellung einer Methode zur Behandlung einer tachykarden Herzrhythmusstörung in Form einer ventrikulären oder atrialen Tachykardie für mindestens ein Ausführungsbeispiel der erfindungsgemäßen Stimulationsvorrichtung
• 4 Schematische Darstellung einer Methode zur Behandlung eines Vorhofflimmerns für mindestens ein Ausführungsbeispiel der erfindungsgemäßen Stimulationsvorrichtung
• 5 Schematische Darstellung einer Methode zur Behandlung eines Kammerflimmerns für mindestens ein Ausführungsbeispiel der erfindungsgemäßen Stimulationsvorrichtung
• 6 Schematische Darstellung einer Methode zur Anwendung der kardialen Resynchronisationstherapie mittels elektromagnetischer Wellen für mindestens ein Ausführungsbeispiel der erfindungsgemäßen Stimulationsvorrichtung
• 7 Schematische Darstellung einer Neurostimulationsmethode mittels elektromagnetischer Wellen für mindestens ein Ausführungsbeispiel der erfindungsgemäßen Stimulationsvorrichtung
• 8 Schematische Darstellung einer Ausführungsform eines erfindungsgemäßen implantierbaren Stimulators
• 9 Implantierbarer Stimulator gemäß 8 mit einer alternativen Fixiervorrichtung
• 10 Blockschaltbild des implantierbaren Stimulators gemäß einem Ausführungsbeispiel der Erfindung
• 8a Schematische Darstellung einer Ausführungsform der erfindungsgemäßen Stimulationsvorrichtung mit Therapieerfolgskontrolle
• 9a Blockschaltbild der erfindungsgemäßen Stimulationsvorrichtung gemäß eines Ausführungsbeispiels
• 10a zeigt beispielhaft zweidimensionale Charakteristiken elektromagnetischer Strahlers mit räumlich selektiver Wirkung.
• 8b Schematische Darstellung einer Ausführungsform der erfindungsgemäßen Stimulationsvorrichtung mit Defibrillationsfunktion
• 9b Implantierbarer Stimulator gemäß 8b mit einer alternativen Fixiervorrichtung
• 10b Blockschaltbild der erfindungsgemäßen Stimulationsvorrichtung gemäß eines Ausführungsbeispiels nach 8b
• 11 bis 14 zeigen Realisierungen des erfindungsgemäßen Stimulationssystems mit Selektionsmittel, das dazu ausgelegt ist, den Bereich des besagten Gewebes für die Stimulation zu wählen gemäß Ausführungsformen
• 15 Realisierung des erfindungsgemäßen Stimulationssystems mit Selektionsmittel, das dazu ausgelegt ist, den Bereich des besagten Gewebes für die Stimulation zu wählen, wobei das Stimulationssystem über Träger verfügt
• 16 Ablaufplan der Methode für das erfindungsgemäße Stimulationssystem gemäß Ausführungsbeispielen
• 17 Schematische Darstellung der lokalen Vorbehandlung zur Erzeugung empfindsamer Bereiche für elektromagnetische Strahlung
• 18 Schematische Darstellung der lokalen Vorbehandlung zur Erzeugung einer Maskierung ggf. empfindsamer Bereiche für elektromagnetische Strahlung.
• 19 Beispiel mit lokal vorbehandelten Bereichen für die Stimulation mittels elektromagnetischer Strahlung
• 20 Schematische Darstellung der selektiven Therapie durch Platzierung der Aktuatoren, so dass anatomische Beschaffenheiten des Gewebes zur Abschattung genutzt werden, gemäß Ausführungsbeispielen der vorliegenden Erfindung.
• 21 Blockschaltbild eines erfindungsgemäßen Stimulators gemäß einer Ausführungsform
• 22 Schematische Darstellung der Pulsentladung eines ICDs, die einen erfindungsgemäßen Stimulator mit Therapiemöglichkeit mittels elektromagnetischer Strahlung zur Abgabe einer gepulsten Therapie ansteuert.
• 23 Tabelle, aufzeigend beispielhafte Kombinationen von Stimulations- und Schockvektoren zwischen rechtem Ventrikel, Gehäuse der Stimulationsvorrichtung und rechtem Atrium.
• 24 Schematische Darstellung der erfindungsgemäßen Vorrichtung gemäß einer Ausführungsform, bei der die Vorrichtung über ein umfassend ein Applikationsmittel zur Abgabe einer Substanz an Gewebe.
• 25 Schematische Darstellung der erfindungsgemäßen implantierbaren Vorrichtung nach einem Ausführungsbeispiel, wobei die Vorrichtung mit einer Fixiereinrichtung am Gewebe fixiert ist
• 26 Schematische Darstellung der erfindungsgemäßen Vorrichtung gemäß einem Realisierungsbeispiel. Die Vorrichtung verfügt über Aktuatoren bzw Sensoren für elektromagnetische Strahlung, die in der Fixiereinheit eingebaut sind.
• 27 Schematische Darstellung der erfindungsgemäßen Vorrichtung gemäß einem weiteren Realisierungsbeispiel. Die Vorrichtung verfügt über Aktuatoren bzw Sensoren für elektromagnetische Strahlung, die in der Fixiereinheit eingebaut sind.
• 28 zeigt beispielhaft einen bevorzugten Signalverarbeitungsablauf der erfindungsgemäßen Methode
• 29 zeigt beispielhaft einen Signalverarbeitungsablauf der erfindungsgemäßen Methode

In the sense of the idea according to the invention, a method for controlling a device implantable in the human or animal body is proposed. The method has at least the following steps:
Arrange for a measurement of electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz, and
Initiation of a detection whether the electromagnetic waves were emitted from genetically manipulated tissue.

• 1 Schematic representation of an embodiment of the stimulation device according to the invention in the implanted state with an external device
• 2nd Schematic representation of a method for treating bradycardia by means of optical stimulation for at least one embodiment of the stimulation device according to the invention
• 3rd Schematic representation of a method for treating a tachycardia arrhythmia in the form of a ventricular or atrial tachycardia for at least one embodiment of the stimulation device according to the invention
• 4th Schematic representation of a method for treating atrial fibrillation for at least one embodiment of the stimulation device according to the invention
• 5 Schematic representation of a method for treating ventricular fibrillation for at least one embodiment of the stimulation device according to the invention
• 6 Schematic representation of a method for using cardiac resynchronization therapy by means of electromagnetic waves for at least one embodiment of the stimulation device according to the invention
• 7 Schematic representation of a neurostimulation method using electromagnetic waves for at least one embodiment of the stimulation device according to the invention
• 8th Schematic representation of an embodiment of an implantable stimulator according to the invention
• 9 Implantable stimulator according to 8th with an alternative fixation device
• 10th Block diagram of the implantable stimulator according to an embodiment of the invention
• 8a Schematic representation of an embodiment of the stimulation device according to the invention with therapy success control
• 9a Block diagram of the stimulation device according to the invention according to an embodiment
• 10a shows an example of two-dimensional characteristics of electromagnetic radiators with spatially selective effect.
• 8b Schematic representation of an embodiment of the stimulation device according to the invention with defibrillation function
• 9b Implantable stimulator according to 8b with an alternative fixation device
• 10b Block diagram of the stimulation device according to the invention according to an embodiment 8b
• 11 to 14 show implementations of the stimulation system according to the invention with selection means, which is designed to select the area of said tissue for the stimulation according to embodiments
• 15 Realization of the stimulation system according to the invention with a selection means, which is designed to select the area of said tissue for the stimulation, the stimulation system having carriers
• 16 Flow chart of the method for the stimulation system according to the invention in accordance with exemplary embodiments
• 17th Schematic representation of the local pretreatment to create sensitive areas for electromagnetic radiation
• 18th Schematic representation of the local pretreatment to generate a mask for sensitive areas for electromagnetic radiation.
• 19th Example with locally pretreated areas for stimulation using electromagnetic radiation
• 20th Schematic representation of the selective therapy by placing the actuators so that anatomical properties of the tissue are used for shading, according to exemplary embodiments of the present invention.
• 21 Block diagram of a stimulator according to the invention according to one embodiment
• 22 Schematic representation of the pulse discharge of an ICD, which controls a stimulator according to the invention with the possibility of therapy by means of electromagnetic radiation to deliver a pulsed therapy.
• 23 Table showing exemplary combinations of stimulation and shock vectors between the right ventricle, housing of the stimulation device and the right atrium.
• 24th Schematic representation of the device according to the invention according to one embodiment, in which the device comprises an application means for delivering a substance to tissue.
• 25th Schematic representation of the implantable device according to the invention according to one embodiment, the device being fixed to the tissue with a fixing device
• 26 Schematic representation of the device according to the invention according to an implementation example. The device has actuators or sensors for electromagnetic radiation which are installed in the fixing unit.
• 27 Schematic representation of the device according to the invention according to a further implementation example. The device has actuators or sensors for electromagnetic radiation which are installed in the fixing unit.
• 28 shows an example of a preferred signal processing sequence of the method according to the invention
• 29 shows an example of a signal processing sequence of the method according to the invention

In 1 An implantable stimulator according to the invention is shown. This gets into the patient's body tissue 10th implanted and encased in a hermetically sealed housing 11 . This is here with a fixation device 12th anchored in the body tissue. The implant housing 11 includes an energy source 13 , a control unit 14 and an actuator 15 , which is formed, an electromagnetic radiation 16 For example, in the area of visible light, to be able to deliver it to a body tissue previously pretreated, for example, using genetic, specially optogenetic manipulation, and, for example, to evoke an action potential, ie to trigger a stimulation by means of electromagnetic radiation 18th , for example a telemetry unit can be read out and / or programmed.

In the 2nd illustrates a method for treating bradycardia by stimulating genetically manipulated tissue, preferably optogenetically manipulated tissue. In the schematic EKG 100 is initially a regular heart action 110 presented in the form of an intrinsic QRS complex. This is initially registered in the proposed method 120 and then a time interval 130 started that corresponds to an expected heart rate. This expectation interval expires 140 without an intrinsic QRS complex being registered again, there is an optical stimulation 150 triggered, which triggers a stimulated QRS complex in the preferably optogenetically pretreated myocardial tissue.

In the 3rd is a method of treating a tachycardiac arrhythmia in the form of ventricular or atrial tachycardia. In the schematic EKG 200 is initially a regular contraction 210 shown a ventricle. To monitor the heart rhythm, each of these contractions is registered and a time measurement is started until the next registered contraction ( t1 ... t8 ). In the example shown, the heart rate in the form of a tachycardia is set too fast 230 which is initially registered and confirmed over a few cycles 240 . After confirmation 240 becomes a predetermined optical stimulation sequence 250 delivered to the preferably pretreated myocardium, which causes a series of stimulated excitations, which usually end the tachycardia and restore a regular rhythm 260 .

In the 4th is a method of treating atrial fibrillation illustrated. In the schematic EKG 300 is initially a QRS complex in sinus rhythm 310 shown. Then atrial fibrillation sets in 320 spontaneously. This is first registered and confirmed 330 . With the confirmation there is an optical stimulation 350 the atria of the pretreated heart, but synchronized and delayed to a QRS complex (cardioversion). This terminates the atrial fibrillation and restores a regular sinus rhythm 360.

In the 5 a method of treating ventricular fibrillation is illustrated. In the schematic EKG 400 is initially a QRS complex in sinus rhythm 410 shown. Subsequently, ventricular fibrillation sets in 420 which is first registered and then confirmed 430 . With the confirmation there is a large-area optical stimulation 440 triggered in the area of the preferably optogenetically pretreated ventricles, which terminates ventricular fibrillation and a sinus rhythm 450 restores.

In the 6 is a cardiac resynchronization method illustrated for the stimulation of genetically manipulated tissue, preferably optogenetically manipulated tissue. The intracardiac ECG leads from both ventricles of the heart are shown schematically 500 : Left ventricle (LV; 510 ) and right ventricle (RV, 520 ). The ECG leads initially show a time delay 530 left ventricular heart actions versus right ventricular heart actions. This offset is the expression of a so-called left bundle branch block, which requires therapy in the form of resynchronization of both ventricles in the event of advanced structural damage to the heart muscle. This resynchronization takes place here by means of simultaneous or quasi-simultaneous optical stimulation 540 , 550 both ventricles of the heart, so that at the same time a mechanical contraction 560 both ventricles are made permanently.

In the 7 is exemplified a neurostimulation of genetically manipulated tissue, preferably optogenetically manipulated tissue. In the example shown, there is an EEG section on the left 610 an epileptic seizure. An optical stimulation sequence is used to treat it 620 delivered to one or more regions of the brain, preferably optogenetically pretreated, in order to terminate the epileptic seizure 630 . This representation is intended to illustrate the method of optical neurostimulation representative of all other applications, such as spinal cord stimulation, further applications of deep brain stimulation or cortical stimulation, isolated nerve stimulation, muscle stimulation etc.

In the 8th A possible embodiment of an implantable stimulator according to the invention is shown. This consists of a battery 81 and implant electronics 82 which are the components of the block diagram 10th includes, both housed in a hermetic housing. At the bottom of the case is a light source 83 attached, which is also hermetically sealed, but in such a way that the frequency spectrum of this light source penetrates the hermetic seal and the target tissue - here myocardium - 85 can excite. The implant is fixed with a helix 84 in the myocardium 85 .

In the 9 the implantable stimulator is off 8th consisting of a battery 81 and implant electronics 82 shown, but with an alternative fixing device 94 , 94` in the form of laterally attached barbs made of eg Nitinol. At the bottom of the case is a light source 93 attached, which is hermetically sealed, such that the frequency spectrum of this light source penetrates the hermetic seal and the target tissue - here myocardium - 95 can excite.

In the 10th is the block diagram of the implantable stimulator 100 shown. This includes an energy source 101 , a sensor interface 102 to perceive a feature representing a heart action, connected to a perception unit 103 , which in turn perceives heart actions to the connected control unit 104 signals. This control unit 104 is with a therapy generator 105 connected, which upon receipt of a trigger signal from the control unit 104 an LED connected to the therapy generator 106 stimulates and thus emits a light signal stimulating the myocardial tissue. The therapy generator 105 can do that Light signal vary in intensity, duration, signal form and color.

In the 8a A possible embodiment of an implantable stimulator according to the invention with therapy success monitoring is shown. This consists of a battery 8a1 and implant electronics 8a2 which are the components of the block diagram 9a includes, both housed in a hermetic housing. At the bottom of the case is a light source 8a3 attached, which is also hermetically sealed, but in such a way that the frequency spectrum of this light source penetrates the hermetic seal and the target tissue - here myocardium - 8a5 can excite. The implant is fixed with a helix 8a4 in the myocardium 8a5 . In this exemplary embodiment, the implant electronics comprise 8a2 additionally a 3D acceleration sensor 8a6 , which is used to monitor the success of the therapy in such a way that after each optical stimulation it is evaluated whether an acceleration of the implant fixed to the myocardium is determined. In this case, the stimulation is considered effective because a contraction of the heart tissue leads to acceleration. If there is no acceleration, the stimulation is considered ineffective and is repeated, for example, with a higher amplitude, or alternatively an ineffective stimulation is signaled to a remote monitoring system.

In the 9a is the block diagram of the implantable stimulator 9a0 shown. This includes an energy source 9a1 , a sensor interface 9a2 to perceive a feature representing a heart action, connected to a perception unit 9a3 , which in turn perceives heart actions to the connected control unit 9a4 signals. This control unit 9a4 is with a therapy generator 9a5 connected, which upon receipt of a trigger signal from the control unit 9a4 an LED connected to the therapy generator 9a6 stimulates and thus emits a light signal stimulating the myocardial tissue. The therapy generator 9a5 the light signal can vary in intensity, duration, signal form and color.
The unit of perception 9a3 is also with a 3D acceleration sensor 9a7 connected, which is used for therapy success monitoring in such a way that after each optical stimulation it is evaluated whether an acceleration of the implant fixed to the myocardium is determined. In this case, the stimulation is considered effective because a contraction of the heart tissue leads to acceleration. If there is no acceleration, the stimulation is considered ineffective and is repeated, for example, with higher intensity, duration, alternative signal form or other color.

10a shows an example of two-dimensional characteristics of electromagnetic radiators with spatially selective effect.

In the 8b One possible embodiment of an implantable defibrillator according to the invention is shown. This consists of a high-performance LED 8b1 and an encapsulated implant electronics with energy source 8b2 which are the components of the block diagram 3rd includes, both housed in a hermetic housing. At the bottom of the case is another local light source 8b3 attached, which is attached and dimensioned such that it only local depolarization in the pretreated myocardium 8b5 can trigger. The implant is fixed with a helix 8b4 in the myocardium 8b5 . The high-performance LED 8b1 is dimensioned in such a way that it can “shine through” almost the entire heart for the purpose of defibrillation, so that simultaneous depolarization of all excitable myocardial cells is possible at the moment of defibrillation.

In the 9b the implantable stimulator is off 8b shown, but with an alternative fixing device 9b4 , 9b4` in the form of laterally attached barbs made of Nitinol. At the bottom of the case is a light source 9b3 attached, which is hermetically sealed, such that the frequency spectrum of this light source penetrates the hermetic seal and the target tissue - here myocardium - 9b5 can excite.

In the 10b is the block diagram of the implantable stimulator 10b0 according to 8b shown. This includes an energy source 10b1 , a sensor interface 10b2 to perceive a feature representing a heart action, connected to a perception unit 10b3 , which in turn perceives heart actions to the connected control unit 10b4 signals. This control unit 10b4 is with a therapy generator 10b5 connected, which upon receipt of a trigger signal from the control unit 10b4 an LED connected to the therapy generator 10b6 stimulates and thus emits a light signal stimulating the myocardial tissue. The therapy generator 10b5 the light signal can vary in intensity, duration, signal form and color.

In the 11 a typical implementation is shown. The implant 110 is with a fixing device 113 attached to organ tissue and has an electromagnetic radiator 111 the one with the mask 112 is masked to only within the knitting cone 114 and 1141 electromagnetic energy on the tissue to be treated 115 to let in.

In the 12th the realization is revealed in which the mask 122 represents a second unit and independent of the implant with a fixation device 1221 attached to prevent electromagnetic energy from entering the covered tissue regions. The implant 120 is with a fixing device 123 attached to organ tissue and has an electromagnetic radiator 121 the one with the mask 122 is masked .. The therapy only works in the non-masked regions 126 and 1261 on the tissue to be treated 125 .

13 shows a realization with locally pretreated tissue. The effective range 136 the radiation reaches the entire tissue 135 , but only works in the regions 137 and 1371 .. the implant 130 is with a fixing device 133 attached to organ tissue and has an electromagnetic radiator 131 . The therapy only works in the pretreated regions 137 and 1371 on the tissue to be treated 135 .

14 discloses a solution with locally frequency-specific (or polarization-specific) reacting or pretreated tissue. Depending on the frequency (band) or polarization of the radiator, only one shows 148 or the other 1481 Region impact. The effective range 146 the radiation reaches the entire tissue 145 , but only works in the regions 148 and 1481 . The implant 140 is with a fixing device 143 attached to organ tissue and has an electromagnetic radiator 141 .

15 shows a solution with radiators located distal to the implant housing 151 and 1511 either directly (not shown) or by means of a carrier 154 with fixation 156 are attached to the tissue to be treated. The wearer also takes on the role of a mask and shadows the rest of the organ. The emitters are from the implant 150 over a line 1515 provided. Alternatively, the implant itself can take on the role of a carrier. The spotlights are then attached directly to the housing. The implant 150 is with a fixing device 153 attached to organ tissue.

In the 16 the flowchart of the method for the stimulation system according to the invention is shown according to exemplary embodiments. After start 160 pretreatment is carried out 161 followed by implantation and attachment of the stimulator 162 . After that, the test 163 the effectiveness of the therapy. If this is not successful in the process 164 touched up. Otherwise the method is finished 165 .

17th shows the tissue 175 with the pre-treated areas 177 and 1771 . The stimulator 170 with electromagnetic actuator 171 comes with the fixation 173 attached to the fabric.

18th shows the tissue 185 with the areas masked by pretreatment 182 . So it's just the areas 186 and 1861 for that from the actuator 181 emitted radiation stimulable. The implant 180 is with a fixing device 183 attached to organ tissue and has an electromagnetic radiator 181 .

19th shows an example with locally pretreated areas 198 and 1981 which, however, are sensitive to different frequencies of electromagnetic radiation. The selective effect of the therapy is due to the fact that the actuator 191 electromagnetic radiation once on one frequency 199 and another time on a different frequency 1991 delivers. The effective range 196 the radiation reaches the entire tissue 195 , but only works in the regions 198 and 1981 . The implant 190 is with a fixing device 193 attached to organ tissue and has an electromagnetic radiator 191 .

20th shows an example of a selective therapy by placing the actuators so that anatomical properties of the tissue are used for shading. 20th shows how selective therapy is achieved by placing the actuators 201 and 2011 (with the stimulator 200 connected by lines 2015 and 2016 ) anatomical shapes 202 of the fabric 205 can be used for shading. The implant 200 is with a fixing device 203 attached to organ tissue.

In the 21 the block diagram of the stimulator described in the claims with an optical therapy output is shown. The stimulator 210 includes an energy source 211 , at least one energy storage 214 , a device for loading 213 of the energy storage 214 , a device for releasing energy 215 . An actuator is also shown 216 , wherein the actuator has a light source 218 , as well as a current limiter 217 (e.g. resistor or diode). The stimulator 210 has a control unit 212 . Stimulator 210 includes a perceptual unit 2125 . Actuator 216 can be realized as a unit that can be separated from the rest of the device according to the invention and via an interface 219 to make contact.

In the 22 The pulse discharge of an ICD is shown, which controls an optical therapy actuator implemented according to the invention for delivering a pulsed therapy.

In an embodiment according to the invention, known electrical devices can be Stimulation devices (eg cardiac pacemaker, neuro-stimulator) can be supplemented with an actuator for emitting electromagnetic radiation in order to carry out stimulation by means of electromagnetic waves. Apart from the actuator, the stimulation device requires little or no modification.

23 shows a table of exemplary combinations of stimulation and shock vectors between the right ventricle RV, the housing of the stimulation device CAN and the right atrium RA. If one looks at the second and third lines of the table as an example, this represents a combination of two vectors: a first vector from housing CAN to the right ventricle RV for stimulation by an actuator according to the invention, and a second shock vector between housing CAN and right atrium RA. In a commercially available ICD, these electrical poles can be realized by a right-ventricular shock coil, the ICD housing and a supraventricular shock coil. A vector leads from a first pole marked by the cross to a second. The stimulation can be carried out by electromagnetic radiation via an actuator according to the invention, or by known electrical stimulation, or by a combination of the two.

24th schematically shows an embodiment of the device according to the invention comprising an application agent for delivering a substance to tissue. The device 241 is in the twill 240 implanted. It has a reservoir 242 for the therapeutic substance and supply lines 2435 , 2425 and 2445 . The reservoir is through a port 243 filled. The pump pumps controlled by the control unit 247 the substance for the device-tissue interface or application agent 245 that have an optional mask 2455 the organ 246 treated with this substance. A control unit 249 perceives the reservoir level and reports it via the telemetry unit 2495 outward. To test the effectiveness of 247 controlled the therapy unit 248 a test signal 2485 from. The reaction is determined via a perception unit (not shown here) and reported to the control unit.

25th shows the implantable device according to the invention 250 the one with fixing device 251 on the fabric 254 is fixed and via a sensor 252 for the perception of electromagnetic radiation 256 has the primary radiation from the observable (optionally pretreated) excitable cell structures 255 runs out when these develop action potentials.
In an alternative implementation / application scenario, the implantable device has 250 via an additional actuator 253 for the generation of electromagnetic radiation 257 . This is due to the excitable cell structures to be observed (optionally pretreated) 255 modulates and returns as secondary radiation depending on their action potentials 256 to the sensor 252 back.

In the 26 discloses an implementation with actuators and sensors for electromagnetic radiation built into the fixing unit. The fuser 261 here consists of a shaft 2611 with foldable, lockable arms 2612 which, for example, the sensors 262 wear. The actuators 263 are opposite, for example on the housing 260 fixed. When implanted, the arms are aligned towards the shaft through the organ wall 268 stung and then folded down and locked in the position so that they fit the actuators on the other side of the wall

• - 280 Start der Implantation
• - 281 Vorbehandlung des Zielgewebes
• - 282 Feststellung des geeigneten Implantationsortes
• - 283 Positionierung der Vorrichtung, solange bis der geeignete Implantationsort erreicht ist
• - 2835 Nachstellen der Position
• - 284 Fixierung
• - 285 Parametereinstellung und Start der Wahrnehmungsmethode (inkl. Aufbereitung und Analyse)
• - 286 Testung
• - 2865 Nachstellen der Parameter
• - 287 Ende der Implantation.

In the 27 is a further implementation with actuators built into the fusing unit 273 and sensors 272 for electromagnetic radiation. Here is the fuser 271 of the actuators 273 and sensors 272 as Zwacke 270 executed. A supply line 271 leads to the device (not shown).
28 shows an example of a preferred implantation procedure of the method according to the invention. The steps shown are:

• - 280 start of implantation
• - 281 Pretreatment of the target tissue
• - 282 Determination of the suitable implantation location
• - 283 Position the device until the appropriate implantation location is reached
• - 2835 Readjust the position
• - 284 fixation
• - 285 parameter setting and start of the perception method (incl. Preparation and analysis)
• - 286 testing
• - 2865 Readjustment of the parameters
• - 287 end of implantation.

• - 290 Start der Wahrnehmung (Messung)
• - 291 Verstärkung,
• - 2911 Demodulation,
• - 2912 analoge Filterung,
• - 292 AD-Wandlung,
• - 2921 digitale Filterung,
• - 2922 Bestimmung der Signalleistung,
• - 2923 Schwellwertbestimmung,
• - 293 Segmentierung,
• - 2931 Ereigniserkennung,
• - 2932 Bestimmung von Periodizität,
• - 294 Klassifikation von Rhythmen
• - 295 Ende der Wahrnehmung (Messung)

29 shows an example of a preferred signal processing sequence of the method according to the invention. The steps shown are:

• - 290 start of perception (measurement)
• - 291 reinforcement,
• - 2911 demodulation,
• - 2912 analog filtering,
• - 292 AD conversion,
• - 2921 digital filtering,
• - 2922 determination of the signal power,
• - 2923 threshold determination,
• - 293 segmentation,
• - 2931 event detection,
• - 2932 determination of periodicity,
• - 294 Classification of rhythms
• - 295 end of perception (measurement)

The invention completely or partially eliminates the disadvantageous effects of galvanically coupled electrical therapy currents for the therapy of heart tissue, neuronal tissue or muscle tissue.
This selective therapy approach opens up new possibilities for multifocal therapy without having to implant a separate probe for each stimulation location. The multifocal therapy, which is possible over a large area, can stimulate excitation patterns that map the natural spatio-temporal conditions much better than before.
The energy requirements of such implants can be significantly reduced. Completely new designs of such implants are also possible.

In the context of the invention, the following terms are used as a synonym for the implantable device according to the invention for sensing electromagnetic waves emitted by genetically manipulated tissue and / or for stimulating genetically manipulated tissue by means of electromagnetic waves: stimulator, stimulation device, stimulation device, device / Device for stimulation, stimulation system (device is at least part of such a described stimulation system).

• - wird unter „Wellenzug“ eine durchgehende elektromagnetische Welle verstanden;
• - werden die Begriffe „Elektromagnetische Strahlung“, „Elektromagnetische Welle“ als Synonym verwendet
• - ATP hat die Bedeutung „Anti tachycardia pacing“, IPG hat die Bedeutung „Implantable Pulse Generator“, ICD hat die Bedeutung „Implantable Cardioverter-Defibrillator“

In the context of the invention:

• - “wave train” means a continuous electromagnetic wave;
• - The terms "electromagnetic radiation" and "electromagnetic wave" are used synonymously
• - ATP has the meaning "Anti tachycardia pacing", IPG has the meaning "Implantable Pulse Generator", ICD has the meaning "Implantable Cardioverter Defibrillator"

Claims (15)

Device, at least comprising: - an energy source, - an electronics unit, - a recording unit, coupled to the electronics unit and designed to measure electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz, the device being designed for implantation in the human or animal body , characterized in that the device is designed to detect that the electromagnetic waves have been emitted from genetically manipulated tissue. Device after Claim 1 , wherein the device has an actuator which is coupled to the electronic unit and / or the energy source and the actuator is designed to emit electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz. Device after Claim 2 , The electronics unit being designed to recognize that electromagnetic waves measured by the recording unit have been emitted by the actuator. Device after Claim 3 , the electromagnetic wave measured by the recording unit being the modified electromagnetic wave emitted by the actuator, the change being based on at least one of the effects: reflection, fluorescence, absorption, transmission, and / or - polarization. Device according to at least one of the Claims 3 or 4th , wherein the electronics unit is designed to recognize at least one of the following parameters, a combination of these or a derived quantity from them in the electromagnetic wave measured by the recording unit: amplitude, frequency or frequency spectrum, and / or direction of polarization, Phase, wherein at least one of the following methods is used: - modulation method - pulse width modulation, - detection of the change by using filters. Device according to at least one of the preceding claims, wherein the electronics unit or recording unit converts the measured electromagnetic wave into an electronic signal and preprocessed using at least one of the following methods: amplification, demodulation, filtering, AD conversion, rectification, determination the signal power, - threshold value determination, - Transformation into the frequency range - determination of signal quality, and / or - determination of signal morphological parameters. Device according to at least one of the preceding claims, wherein the electronic unit or recording unit converts the measured electromagnetic wave into an electronic signal and analyzes it using at least one of the following methods: - segmentation, - event detection, - determination of periodicity, - determination of the phase position, - determination of stability, - Classification of rhythms, and / or - Classification of signal morphological parameters. Device according to at least one of the preceding claims, wherein the receiving unit has at least one of the following sensors: - photodiode, - phototransistor, - CCD element, and / or - analog or digital image sensor. Device according to at least one of the preceding claims, wherein the device comprises at least a first and a second actuator which emit electromagnetic waves in different frequencies. Device according to at least one of the previous Claims 2 to 9 , wherein the at least first actuator is coupled to a housing of the device or is arranged remote from the housing, and the actuator is connected to the receiving unit. Device according to at least one of the preceding claims, wherein the device comprises a fixing device which is designed to fix the device in human or animal tissue and which is designed to conduct the electromagnetic wave through the tissue. Device according to at least one of the preceding claims, wherein the device has an electrostimulation means. Device according to at least one of the preceding claims, wherein the device is designed for emitting electromagnetic waves to heart tissue or to nerve tissue in the spinal cord or muscle tissue. Device according to at least one of the Claims 2 to 13 , wherein the actuator is designed to emit electromagnetic waves for the stimulation of genetically manipulated tissue, the stimulation being in the frequency range 10 ¹³ to 10 ²⁰ Hz. Method for controlling a device that can be implanted in the human or animal body, at least comprising the steps: - initiating a measurement of electromagnetic waves in the frequency range 10 ¹³ -10 ²⁰ Hz, and - initiating a detection of whether the electromagnetic waves have been emitted from genetically manipulated tissue.

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