WO1997038751A1 - Neurostimulateur transcutane - Google Patents

Neurostimulateur transcutane Download PDF

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Publication number
WO1997038751A1
WO1997038751A1 PCT/DE1997/000721 DE9700721W WO9738751A1 WO 1997038751 A1 WO1997038751 A1 WO 1997038751A1 DE 9700721 W DE9700721 W DE 9700721W WO 9738751 A1 WO9738751 A1 WO 9738751A1
Authority
WO
WIPO (PCT)
Prior art keywords
nerve stimulator
nerve
stimuli
stimulator according
electrodes
Prior art date
Application number
PCT/DE1997/000721
Other languages
German (de)
English (en)
Inventor
Brigitte Stroetmann
Siegfried Kallert
Alessandra D'intino
Waltraud Lager
Original Assignee
Siemens Aktiengesellschaft
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE1996121771 external-priority patent/DE19621771A1/de
Application filed by Siemens Aktiengesellschaft filed Critical Siemens Aktiengesellschaft
Publication of WO1997038751A1 publication Critical patent/WO1997038751A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters

Definitions

  • the invention relates to a transcutaneous nerve stimulator and its use for artificial ventilation or in combination with a conventional respirator to avoid the inactivity atrophy of the diaphragm that occurs during artificial ventilation.
  • the respiratory muscles create a negative pressure in relation to the ambient air pressure py by expanding the thoracic expansion in the thorax, so that inhalation takes place because of PL ⁇ PU.
  • passive exhalation occurs when the forces of the respiratory muscles, which expand the thorax and lungs, cease.
  • the pressure in the thorax is the same in both respiratory forms, but while in the physiological form of breathing for the inspiration phase, the pressure in the thorax drops, it increases in positive pressure ventilation.
  • This pressure and of course its changes are also transferred to the blood vessels according to the superposition principle. It mainly affects the veins and auricles. It comes with the physiological form of breathing, namely during inspiration through the increased pressure gradient between the thorax and Abdominal cavity to an increased venous inflow into the thorax and thus to the heart. As a result, the cardiac output is increased under otherwise completely identical conditions. This is referred to as the pumping effect of breathing on the circulation. In the case of positive pressure ventilation, an opposite pressure gradient is being built up for inhalation, so there is rather a counter-rotating, ie circulating pumping effect.
  • Respiratory rhythmic activation of the diaphragm by corresponding excitation of the phrenic nerve which triggers the contraction of the diaphragm, would bring the artificial respiratory mechanics closer to the physiological respiratory mechanics and thus enable the respiratory pump effect on the circulation. It is therefore a goal to manufacture devices that lead to ventilation by activating the diaphragm according to the normal, physiological breathing mechanism.
  • Inactivity atrophy of the diaphragm occurs to varying degrees in patients who are artificially ventilated for a long time using conventional positive pressure methods.
  • the muscle fibers of the diaphragm (skeletal muscles) become weaker and this leads to weakness in breathing and requires that the patient has to be weaned from the ventilator again after the artificial respiration.
  • Regular activation of the diaphragm during artificial ventilation via respiratory rhythmic stimulation of the phrenic nerve prevents this inactivity atrophy.
  • Electrostimulation of the phrenic nerve is already a clinically established method, but it is limited to implantable nerve stimulators.
  • Phrenoton As early as 1952, Siemens-Rutz-Werke developed an electrical stimulation device called Phrenoton (DE-PS 919 961) that was used for transcutaneous nerve stimulation.
  • the 4 ms pulse was obtained by chopping a low-frequency current of 5 kHz (or 7 kHz). This pulse was superimposed with rectangular pulses of frequency 10-60 / min generated by an RC element.
  • a stimulus is given to the nerves innervating it. This simultaneously triggers action potentials in the individual nerve fibers that add up to a total action potential. Depending on the strength of the stimulus, none, several or all nerve fibers are excited, which is shown in the occurrence or the amplitude and duration of the total action potential of the nerve. Each motor nerve fiber divides into several muscle fibers. The excitation of a nerve fiber also triggers action potential on all of the muscle fibers innervated by it. A muscle fiber twitch occurs at a single muscle fiber action potential.
  • tetanic muscle contraction A complex stimulus that causes a tetanic muscle contraction.
  • the object of the present invention is to provide a device for transcutaneous nerve stimulation which specifically triggers tetanic stimuli.
  • the invention relates to a transcutaneous nerve stimulator which comprises a pulse generator and stimulation electrodes, the pulse generator generating complex stimuli which are composed of individual stimuli, the current strength, subsequent frequency and duration of which can be variably adjusted, and the individual stimuli within a complex Each stimulus has the same shape and repetition frequency.
  • the invention furthermore relates to the use of such a nerve stimulator for contraction of the diaphragm via the stimulation of the phrenic nerve and the use of such a nerve stimulator for stimulation of the nerves on both sides. phrenici, the use of the nerve stimulator for artificial ventilation and finally the use of the stimulator in combination with a conventional ventilator to prevent diaphragmatic atrophy.
  • the nerve stimulator is designed to be current stabilized, i.e. that when the skin resistance changes, for example by sweating or skin reactions, the nerve is in each case stimulated with approximately the same current strength.
  • the repetition frequency of the individual stimuli can vary between 100 ⁇ s and 2ms. However, if the applications require it, it can also be longer or shorter than the specified range.
  • the shape of the individual stimuli is also arbitrary, for example sinusoidal, trapezoidal or rectangular.
  • the amplitudes of the individual stimuli vary, for example between 0 and 50 mA.
  • the frequency of the individual stimuli is also variable and depends on the application of the nerve stimulator.
  • the form of the complex stimulus arises from the individual stimuli.
  • the duration of the complex stimulus, the repetition frequency of the complex stimulus and the amplitude (s) of the complex stimulus are also set via the pulse generator.
  • each complex stimulus per se consists of only a single pulse shape. According to the invention, pulse shapes are not superimposed.
  • the rise and fall time of each complex stimulus can be set such that, for example, a rise time of the complex stimulus of 2 s can be offset by a fall time of 1 s (see FIG. 1).
  • the shape of the complex stimulus can thus be both symmetrical and asymmetrical.
  • the complex stimuli do not have to be repetitive units that repeat themselves again and again.
  • biphasic pulses with charge compensation used.
  • a positive stimulus will alternate with a negative stimulus, or the individual individual stimuli may already have alternating positive and negative phases.
  • the stimulation electrodes for transcutaneous use are optimized after quick placement and simple handling. They are created from the outside and can be fixed to the body and also in a holder.
  • This holder can comprise one or more guide rails and fixing means for fixing the electrodes relative to one another and relative to the patient.
  • the holder is preferably fastened to the patient's neck or fixed relative to the neck by a bracket placed around the neck.
  • the guide rails are used for height, width and depth adjustment. This enables simple, quick and exact adjustment of the electrodes to the desired stimulus points on the patient's skin.
  • the electrodes can be attached to the skin itself with plaster or integrated into a plaster.
  • the stimulation electrode is integrated in a cushion, which is connected to an adjustable holder, in order to make an adjustment at the desired stimulus points and to enable an adjustment relative to the patient.
  • the stimulation electrodes consist of electrically conductive material and preferably have a porous surface for reducing the skin resistance.
  • an anesthetic or another medicament can also be applied, which releases the medicament into the skin layer to be stimulated according to the principle of iontophoresis (for example an anesthetic for local anesthetic).
  • the porous surface of the electrodes also allows devices to be created that allow automatic and uniform moistening of the electrodes.
  • the stimulation electrodes are made of an electrically conductive material such as stainless steel, platinum, titanium, titanium nitride, carbon, electrically conductive plastic, ceramics and others. These can be both rod-shaped and flat electrodes, and for better fixation these can be applied, for example, to a plaster, which in turn may also have included medication.
  • the invention is in no way intended to be limited to such types of electrodes, but rather can encompass all types of electrode systems.
  • the nerve to be stimulated is preferably stimulated symmetrically, i.e.
  • Both the right and left phrenic nerves are stimulated.
  • One advantage of bilateral or symmetrical stimulation compared to the one-sided stimulation is that both diaphragmatic aids are stimulated equally and on an equal footing. In the case of one-sided irritation, only the corresponding half of the diaphragm contracts. The other part contracts only slightly due to the mechanics.
  • the Nn. phrenici With the symmetrical contraction of the diaphragm, the Nn. phrenici with two counter electrodes each at their left and right motor points in the neck area and with one electrode at the exit point in the cervical area at C3 / C5.
  • the electrodes can be applied so that
  • the electrodes are placed on both sides in the neck area and the counter electrode at a suitable location, possibly in the neck.
  • the invention is described in more detail below on the basis of various exemplary embodiments and the associated five figures.
  • Figures 1 and 2 explain the device by way of example using various stimulus pulse patterns to trigger a tetanic diaphragm contraction
  • Figures 3 to 5 indicate different configurations for stimulation electrodes and their holders.
  • the period which here comprises 10s
  • the individual stimuli composing the complex stimulus have a repetition frequency of approx. 30 Hz.
  • the amplitude of the resulting complex stimuli is variable like that of the individual stimuli and is 30 to approx. 35 mA here.
  • the duration of the complex stimulus at the max. Ampere number and the time interval between two complex stimuli, which can also be expressed in such a way that the repetition frequency of the complex stimuli is variable.
  • the individual stimuli, shown on the top right in the picture have an amplitude of 0 to approx. 35 mA and a duration of approx. 100 ⁇ s to 2 ms, which are simple square-wave pulses in this example.
  • the entire current curve from 0 to 5000 ms is referred to as a complex stimulus.
  • FIG. 1 a The first complex stimulus from FIG. 1 is shown again in FIG. 1 a, a rectangle R being inserted at the leftmost edge. is drawing.
  • FIG. 1b shows an enlargement of this rectangle 1 from FIG. La, in which the individual biphasic rectangular stimuli which result in the complex stimulus become visible.
  • FIGS. 1, 1a and 1b again shows a trapezoidal complex stimulus, the shape of the stimulus according to the invention not being fixed to a trapezoidal or rectangular shape, but being variable.
  • the individual stimulus repetition frequency is again approximately 30 Hz, the amplitude of the individual stimuli between 0 and 35 mA and the duration of the individual stimuli can vary between 100 ⁇ s and 2 ms.
  • a tetanic shredding contraction occurs when the Nn are stimulated.
  • phrenici in which case the time up to 2.8s can be referred to as the inhalation phase and the time from 2.8 to 5.0s can be referred to as the passive exhalation time.
  • FIGS. 2a and 2b show, analogously to FIGS. 1a and 1b, the marking of the rectangle R in the left complex stimulus of FIG. 2 (FIG. 2a) and the enlargement of this rectangle (FIG. 2b) so that the individual pulses become visible.
  • FIG. 3 shows the schematic representation of a pillow 4, the pillow being able to be ergonomically shaped, even without the details being discussed here.
  • the flat electrode 1 which is embedded in the pillow with a remaining increase of a few centimeters.
  • the metal bracket 2 on which the counter electrodes are attached.
  • the electrode 1 is guided and fixed in a rasterized guide and fixing rail 3.
  • nerve stimulation of the Nn. phrenicii it can be individually adapted to the neck or spine course of the respective patient.
  • the electrode 1 is connected to the pulse generator of a nerve stimulator via a contact 5.
  • the two counter electrodes are mounted on an insulated metal bracket 2, which stands vertically on an extra fixing rail 6.
  • an extra fixing rail 6 By means of a special grid at both ends of the metal bracket 2 (this can be clearly seen in FIG. 2), the latter can be lowered into the cushion 4 by the fixing rail 6 and its width setting can thus be changed. An individual adjustment to the neck circumference of the patient is easily possible.
  • the exact embodiment of the metal bracket 2 can be seen namely the grids at both ends and the straight course above.
  • the two electrodes 14 (counter electrodes) are each attached to the round metal bracket 2 with the aid of an annular hook 3, the hooks 3 being freely displaceable over the bracket.
  • the two rod-shaped electrodes 14 can be displaced and fixed along the bracket 2 as desired via the positioning aid 10, which can optionally be a screw. With this arrangement, the electrodes can be variably positioned on the stimulation points on the right and left in the neck area and then fixed with the screw 10 (positioning aid). After the stimulus point has been found, the rod electrodes 14 are pressed onto the motor point (stimulus point) of the nerve with the aid of the variable depth setting 7, which can change the length of the rod.
  • the pressure can be variably set using the depth setting 7.
  • the electrodes 14 are again connected to the pulse generator of the nerve stimulator via a cable 5.
  • the bracket 2 which is preferably an insulated metal bracket, the catches 9 can be seen, with the aid of which the depth adjustment of the bracket, ie how far the bracket is sunk into the cushion, can be adjusted.
  • FIG. 5 shows another variant of the electrode fixation, this arrangement consisting of two round, insulated metal brackets, namely the electrode bracket 2 and the counterelectrode bracket 2 '.
  • the electrode bracket 2 is placed tightly around the patient's neck in such a way that the electrode 12 lies well against the exit point of the nerve (s) in the neck.
  • the counter electrode bracket 2 ' which rests on the motor point (s) of the nerve (s), is placed loosely at the front around the patient's neck.
  • the two counter electrodes are in turn attached to the round counter electrode bracket 2 'with the aid of an annular fastening 3 and can be freely moved over the bracket.
  • Both brackets 2, 2 ' are attached to the pair of guide and fixing rails 17 with the aid of the fixing
  • I attached 8 rings The advantage of this arrangement is that the patient can sit down for example during the duration of the stimulation and thus have a little more freedom of movement.
  • the new stimulator both inhalation and exhalation are controlled and an even breathing process is achieved.
  • the invention is not limited to the irritation of the phrenic nerve, but rather can be used for all possible nerve irritations, in each case using the repetition frequency that is required for tetanic irritation of the muscle in question that is to be contracted.
  • a simple adaptation of the stimulation electrodes to the patient's body or its stimulation points is possible. Compared to implanted electrodes, the patient is less stressed and the electrodes are easier to apply.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Physiology (AREA)
  • Pulmonology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un neurostimulateur transcutané, ainsi que son utilisation pour la respiration artificielle ou, en combinaison avec un respirateur conventionnel, pour éviter une atrophie du diaphragme. Le neurostimulateur comprend des électrodes et un générateur d'impulsions et permet de générer des stimuli complexes, formés de stimuli individuels, les stimuli individuels d'un stimulus complexe ayant la même forme et la même fréquence de répétition.
PCT/DE1997/000721 1996-04-12 1997-04-09 Neurostimulateur transcutane WO1997038751A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE19614508 1996-04-12
DE19614508.2 1996-04-12
DE19621771.7 1996-05-30
DE1996121771 DE19621771A1 (de) 1996-05-30 1996-05-30 Vorrichtung zur Plazierung von transkutan wirkenden Geräten

Publications (1)

Publication Number Publication Date
WO1997038751A1 true WO1997038751A1 (fr) 1997-10-23

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PCT/DE1997/000721 WO1997038751A1 (fr) 1996-04-12 1997-04-09 Neurostimulateur transcutane

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WO (1) WO1997038751A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0993841A1 (fr) * 1998-10-14 2000-04-19 Siemens-Elema AB Système d'assistance respiratoire
EP1393773A1 (fr) * 2002-08-28 2004-03-03 Siemens-Elema AB Dispositif de la stimulation des nerfs
EP1940504A1 (fr) * 2005-05-13 2008-07-09 Neurosignal Technologies, Inc Procédé et système permettant de réguler la respiration au moyen de signaux neuroélectriques codés et simulés
US9233553B2 (en) 2000-09-11 2016-01-12 Videojet Technologies (Nottingham) Limited Tape drive and printing apparatus
US10792495B2 (en) 2016-12-01 2020-10-06 Thimble Bioelectronics, Inc. Neuromodulation device and method for use
WO2022175317A1 (fr) * 2021-02-17 2022-08-25 Stimit Ag Procédés de stimulation pour une respiration spontanée commandée électromagnétiquement ou électriquement
WO2022268927A1 (fr) * 2021-06-23 2022-12-29 Stimit Ag Procédés de stimulation pour une respiration spontanée commandée électromagnétiquement ou électriquement
WO2023232927A1 (fr) * 2022-06-01 2023-12-07 Stimit Ag Appareil favorisant la respiration

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0009920A1 (fr) * 1978-09-26 1980-04-16 Stimtech, Inc. Stimulateur électronique de tissus avec des signaux de sortie commandés
WO1983001742A1 (fr) * 1981-11-23 1983-05-26 Van Rij, Gerhard, Leendert Appareil et procede permettant de generer des signaux de stimulation des nerfs ou des muscles
EP0293068A1 (fr) * 1987-05-27 1988-11-30 Teijin Limited Appareil d'électrothérapie
US4827935A (en) * 1986-04-24 1989-05-09 Purdue Research Foundation Demand electroventilator
US4830008A (en) * 1987-04-24 1989-05-16 Meer Jeffrey A Method and system for treatment of sleep apnea
WO1991005583A1 (fr) * 1989-10-16 1991-05-02 Brunswick Biomedical Technologies, Inc. Procede et appareil de regulation de la respiration, employant des electrodes interne et externes
WO1994015527A1 (fr) * 1993-01-11 1994-07-21 Jens Axelgaard Systeme medical a electrodes
EP0702978A2 (fr) * 1994-09-21 1996-03-27 Medtronic, Inc. Dispositif de traitement des apnées obstructives du sommeil

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0009920A1 (fr) * 1978-09-26 1980-04-16 Stimtech, Inc. Stimulateur électronique de tissus avec des signaux de sortie commandés
WO1983001742A1 (fr) * 1981-11-23 1983-05-26 Van Rij, Gerhard, Leendert Appareil et procede permettant de generer des signaux de stimulation des nerfs ou des muscles
US4827935A (en) * 1986-04-24 1989-05-09 Purdue Research Foundation Demand electroventilator
US4830008A (en) * 1987-04-24 1989-05-16 Meer Jeffrey A Method and system for treatment of sleep apnea
EP0293068A1 (fr) * 1987-05-27 1988-11-30 Teijin Limited Appareil d'électrothérapie
WO1991005583A1 (fr) * 1989-10-16 1991-05-02 Brunswick Biomedical Technologies, Inc. Procede et appareil de regulation de la respiration, employant des electrodes interne et externes
WO1994015527A1 (fr) * 1993-01-11 1994-07-21 Jens Axelgaard Systeme medical a electrodes
EP0702978A2 (fr) * 1994-09-21 1996-03-27 Medtronic, Inc. Dispositif de traitement des apnées obstructives du sommeil

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0993841A1 (fr) * 1998-10-14 2000-04-19 Siemens-Elema AB Système d'assistance respiratoire
US6360740B1 (en) 1998-10-14 2002-03-26 Siemens Elema Ab Method and apparatus for assisted breathing
US9233553B2 (en) 2000-09-11 2016-01-12 Videojet Technologies (Nottingham) Limited Tape drive and printing apparatus
EP1393773A1 (fr) * 2002-08-28 2004-03-03 Siemens-Elema AB Dispositif de la stimulation des nerfs
US7283875B2 (en) 2002-08-28 2007-10-16 Maquet Critical Care Ab Nerve stimulation device
EP1940504A1 (fr) * 2005-05-13 2008-07-09 Neurosignal Technologies, Inc Procédé et système permettant de réguler la respiration au moyen de signaux neuroélectriques codés et simulés
EP1940504A4 (fr) * 2005-05-13 2009-02-18 Neurosignal Technologies Inc Procede et systeme permettant de reguler la respiration au moyen de signaux neuroelectriques codes et simules
US10792495B2 (en) 2016-12-01 2020-10-06 Thimble Bioelectronics, Inc. Neuromodulation device and method for use
US11801383B2 (en) 2016-12-01 2023-10-31 Hinge Health, Inc. Neuromodulation device and method for use
WO2022175317A1 (fr) * 2021-02-17 2022-08-25 Stimit Ag Procédés de stimulation pour une respiration spontanée commandée électromagnétiquement ou électriquement
WO2022268927A1 (fr) * 2021-06-23 2022-12-29 Stimit Ag Procédés de stimulation pour une respiration spontanée commandée électromagnétiquement ou électriquement
WO2023232927A1 (fr) * 2022-06-01 2023-12-07 Stimit Ag Appareil favorisant la respiration

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