DE102020132844B3 - Apparatus and method for muscle stimulation - Google Patents

Abstract

According to the invention is a device for muscle stimulation of the lower extremities, having three pairs of electrodes, each of which can be arranged on a first, a second and a third muscle group, wherein the pairs of electrodes are designed for the transcutaneous transmission of alternating electrical impulses, and wherein the three pairs of electrodes provide a successively cascading impulse excitation implement, as well as a control unit, which is connected to the pairs of electrodes, wherein the pairs of electrodes are designed to detect an electromyography signal and forward it to the control unit and wherein the detected electromyography signals can be evaluated by the control unit and excitation pulses can be generated by the control unit, wherein the time characteristics of the electromyography signals can be synchronized with the time characteristics of the excitation pulses by the control unit. According to the invention is also a method for muscle stimulation of the lower extremities, wherein a first, a second and a third muscle group of a lower extremity are stimulated with electrical impulses, wherein the impulse excitation takes place in a cascading manner, wherein the first, the second and the third muscle group is electromyographically Signals are detected and excitation pulses are generated therefrom, the time characteristics of the electromyography signals being synchronized with the time characteristics of the excitation pulses.

Description

The invention relates to a device and a method for muscle stimulation and has particular application to muscle stimulation of the lower extremities.

In addition to the pressure drop generated by the left ventricle, the muscle pumps represent the most important contribution to the venous return flow. These pumps connected in series only work when there is movement. In the rhythm of the skeletal muscles, a venous flow is generated from distal to proximal, especially in depth. The movements can be active, like walking, or passive, like mechanical mobilization.

In recent years, Grohmann, Krauss, Deußen and Herrmann have carried out further tests in which it was investigated whether the signal effects on the leg muscles can lead to an increase in blood circulation in the legs without causing pain for the test person. The use of Herrmann's special signaling protocols showed that a graduated and effective leg muscle activation with an accompanying increase in blood flow was possible without the subjects experiencing any unpleasant sensations at the signaling site. Measurements with the vein occlusion plethysmography on the lower leg showed the stability of the increase in blood flow over at least 10 minutes. These results prove that not only the arterial inflow can be increased in the short term, but that the venous outflow is also increased under these steady-state conditions. The documented increase in blood flow (factor 2-3) is accompanied by a sustained increase in muscle metabolism.

This was proven in preliminary studies, in which the oxygen consumption of the subjects was measured spirometrically while activating the leg muscles. A plethysmograph (Compactus/ Gutmann Medizinelektronik) was used to measure the arterial inflow into the lower extremities while the patient was at rest and under signal in a lying position. Through parallel recording, non-intervened (control) and intervened leg can be compared with each other.

The signal is generated by means of complex signal patterns tailored to the skeletal muscles. The influence of the signal intensity on the arterial inflow was examined with the same signal program. There was a signal-dependent increase in blood flow in the lower leg compared to rest. At maximum signal voltage (60 V), blood flow increased to more than 5 times the resting blood flow value. In addition to the signal intensity, the signal program is of essential importance for the contraction effect.

A new approach was the basis for the temporal structuring of the signal sequences to generate contraction profiles in the muscles of the lower extremities. The electrically conductive structures inside the muscle fibers are designed as thin tubes. PAERISCH compares the tubules to waveguides in which electromagnetic waves can propagate with periods in the order of 10-16 seconds. While nerve signals are propagated through coaxial cable-like structures, the propagation of signals in the form of electromagnetic waves occurs deep down to the muscle fibrils and sarcomeres through the tubular structures of the transverse tubules, terminal cisternae, and sarcoplasmic reticulum. Paerisch concludes from the structural design of the electrical conductor structures in the muscle fibrils and sarcomeres in the form of waveguides that electrical actuating impulses and period durations of electrical impulse trains must have dimensions of microseconds and nanoseconds and compares these values with the measured values of rotational movements of the myosin heads between the coupling segments of the myosin filaments.

These fundamental findings were obtained in the 1990s in a collaboration between Mr. Herrmann and Prof. Paerisch and further developed in various research projects. Now these findings are applied specifically to the muscles of the lower extremities to stimulate venous return. In particular, the cascading of muscle groups is a completely new approach to increasing venous return. So far only compression therapies are known for this.

For the task of a "muscle pump function" no number of muscle fibers must be put into a state of contraction via motor nerves, which form a closed motor unit with the nerve control channel. Rather, the task is to provoke strong, coordinated and timed contractions of three muscle groups in the form of peristalsis ("milking movement"). This can be achieved by transcutaneous transmission of alternating electric fields and charges using textile or other electrode assemblies.

The "muscular organ system" plays a decisive role in terms of regulatory processes and therapeutic measures. As part of therapy measures, electrical stimulation of nerves and muscles is one of the means that is often used for rehabilitation purposes. The status of this therapy technology nik is published in the list of medical aids in product group 09 under electrical stimulation devices and can be seen in the Federal Gazette of March 28, 1995. A lack of treatment success combined with discomfort are identified by patients and the attending physicians as a limitation of this method after the appropriate aids have been prescribed. Although there are very extensive standards, guidelines and laws for the parameters and frequency spectra of these home therapy devices, the electrical parameters of the applied impulse sequences such as impulse frequency, impulse interval, impulse number, impulse duration and impulse shape are manufacturer-specific, very different in dimensioning and not optimally adapted to the motor function of the muscles and adapted to somatovisceral sensitivity. As a result, the stimulation methods, which are associated with disadvantages, are tolerated and promoted.

Venous diseases are a common clinical picture and also cause high social costs, so that it seems increasingly important to find effective forms of treatment that are also accepted by the patients. This speaks for a consistent further development of medical aids for these therapy options.

From the pamphlet DE 10 2018 103 134 A1 a system for stimulating blood circulation in legs and/or feet is known, comprising at least one shoe with a sole, a control and power supply unit and an inner piece of footwear that can be separated from the shoe and has at least one stimulation electrode that is designed to be connected to the control and power supply unit to be connected. It is proposed that the control and power supply unit is located in the sole of the shoe. A cascading stimulation of the muscle groups is not disclosed.

The pamphlet DE 10 2008 003158 A1 relates to a compression stocking or a compression cuff for application to a body extremity, with a compression body adapted to the body extremity. For effective thrombosis prophylaxis, it is provided according to the invention that a muscle stimulation device for muscle stimulation of the body extremities is assigned to the compression body. Although electrodes are arranged at the end of a muscle that is remote from and near to the body, the muscle is not acted upon in a cascading manner here either.

From the pamphlet DE 3 916 994 A1 a method and a device for improving the venous blood return in the leg vein system by electrostimulation of the leg muscles are known, with pairs of electrodes being distributed over the length of the leg, which are successively supplied with electrical excitation pulses at short intervals from the bottom pair of electrodes, causing the leg muscles to contract is brought. According to a preferred embodiment, the duration of the excitation pulses acting successively on the pairs of electrodes lasts until the uppermost pair of electrodes has also been excited. However, there is no specific excitation tailored to the patient by variable excitation impulses.

The pamphlet DE 20 2009 016 462 U1 discloses an item of footwear, wherein an electrostimulation device that fits into the item of footwear and belongs to it at least when it is in use, is arranged therein and has at least two electrodes connected or connectable to it, which can be attached to spaced-apart locations of the foot and/or leg to stimulate muscle contractions are. Here, too, a muscle or a muscle group is not stimulated in a cascading fashion from bottom to top.

In the pamphlet WO 2011 087 539 A1 describes a system, device and method for neuromuscular electrical stimulation (NMES) of the foot muscles. The device contains an electrical signal generator for generating a wave pattern with variable frequency, duration, intensity, ramp time and on-off cycle. The device also contains surface electrodes that can be positioned over the foot muscles or around the ankles and attached to the signal generator. The signal generator is programmed to stimulate the foot muscles and nerves. Electrode placement and programming are adjusted to reduce blood pooling in the sole veins of the calf and improve venous blood flow to prevent deep vein thrombosis (DVT), improve venous blood flow for the patient with postthrombotic syndrome to accelerate wound healing, reduce neuropathic foot and ankle pain, chronic musculoskeletal ankle and foot pain, acute postoperative foot and ankle pain, and prevent muscular atrophy of foot muscles. Although the electrical stimulation can be adjusted periodically or continuously, only areas of the foot are stimulated here.

Finally, in the pamphlet U.S. 6,282,448 B1 discloses an elongate rectangular cuff with electrodes combined with a motion detector to induce muscle contraction with an attached controller unit to provide a predetermined electrical signal to the electrodes. The predetermined electrical signal is essentially a square wave having a duration between 0.1 and 0.3 milliseconds, a frequency between 0.1 and 0.5 hertz, with 5 to 15 repetitions delivered at 5 to 15 minute intervals. The controller provides a controllable intensity between 0.20 and 4 milliamps and a voltage between 1 and 200 volts with an output resistance of essentially 50 kilohms. When the cuff or cuff is wrapped around the user's leg and positioned below the knee so that the electrodes touch the calf muscles, it provides muscle and nerve stimulation, resulting in contraction of the calf muscle. A motion detector monitors the contraction and provides feedback to the control unit to adjust the signal. Blood flow is therefore increased regardless of body position or movement, greatly reducing the possibility of developing deep vein thrombosis or pulmonary embolism, which can be fatal. In addition, ankle edema and discomfort in the legs that can occur with prolonged sitting are reduced. In addition, it prevents orthostatic hypotension. An applied signal is continuously adjusted so that there is a low risk of injury for the user.

The object of the invention is to develop a device and a method for muscle stimulation which has a simple structural design and offers the possibility of individually adapting the excitation impulses to the respective stimulated muscle. In addition, a cascading of selected muscle pumps and an optimization of the signal parameters for each individual muscle pump should be achieved.

This object is achieved with the features of the first claim.

Advantageous configurations emerge from the dependent claims.

The object is achieved by a device for muscle stimulation of the lower extremities, having three pairs of electrodes, which can each be arranged on a first, a second and a third muscle group, the pairs of electrodes being designed for the transcutaneous transmission of alternating electrical impulses, and the three pairs of electrodes having a successively cascading pulse excitation, and a control unit, which is connected to the electrode pairs, the electrode pairs being designed to detect an electromyography signal and forward it to the control unit, and the detected electromyography signals can be evaluated by the control unit and excitation pulses can be generated by the control unit are, it being possible for the time characteristics of the electromyography signals to be synchronized with the time characteristics of the excitation pulses by the control unit.

The synchronization is achieved through millisecond-precise programming. Discrete time intervals are assigned to the determined time characteristic values from the OEMG measurements in such a way that the excitation consists of individual, delimited elements and is not a continuous continuum. The area of an OEMG curve determines the number of individual stimulation pulses within motor unit (muscle) cycle times.

When recording the electromyography signals, activity times are determined by the electrode pairs using OEMG measurements. This preferably follows in advance of the muscle stimulation for a predetermined period of time of, for example, 20 to 40 minutes, preferably about 30 minutes.

The three pairs of electrodes are preferably arranged on the muscle pumps of the lower extremities of a person, in particular each pair of electrodes is arranged on a different muscle pump. The muscle pumps are the foot muscle pump, the ankle pump, the calf muscle pump, the popliteal pump, the thigh muscle pump and the inguinal suction pump.

A successively cascading impulse excitation within the meaning of the application means that the three muscle groups, which are each provided with a pair of electrodes, are successively stimulated from distal to proximal. First, the most distal muscle group is stimulated, then, preferably while the first muscle group is being stimulated, the second, i.e. middle, muscle group is stimulated. The stimulation of the first, distal muscle group is then stopped and the third, proximal muscle group is stimulated, while at the same time the middle muscle group is still being stimulated. The excitation then begins again, again from distal to proximal. In this way, a repeated wave-like excitation of the three selected muscle pumps from distal to proximal is realized, which advantageously activates the muscle pumps and improves blood flow to the lower extremities. In addition, there is an improvement in lymphatic drainage.

The excitation pulses of the pairs of electrodes are generated by a control unit connected to the pairs of electrodes. For this purpose, the control unit evaluates the electromyography signals detected by the electrodes and transmitted to the control unit and synchronizes the time characteristics of the electromyography signals with the time characteristics of the excitation pulses. Natural time characteristic values are determined from the OEMG measurements and transferred to the control unit by programming. As a result, the natural time characteristics of the musculature correspond to the artificial time characteristics of the activated musculature.

In one embodiment, the control unit limits the amplitudes of the excitation pulses to a maximum of 500 V, the output current to a maximum of 100 mA and the pulse energy of each excitation pulse to a maximum of 300 mJ.

Advantageously, the pulse excitation takes place in pulse groups consisting of several rectangular pulses emitted by the electrodes.

In one embodiment, the impulse excitation takes place in impulse groups of 15 to 30, preferably 20 square-wave impulses with a pause of 0.15 ms to 0.3 ms between the individual impulse groups, the length of the pauses between each two impulse groups depending on the determined electromyography signals vary.

In this case, a pulse group is preferably emitted by the electrodes in each case immediately following the time regime of the determined activity times of a detected electromyography signal.

In particular, the pulse excitation takes place with a pulse duration of the rectangular pulses emitted by the electrodes of 2 μs to 7 μs, preferably 4 μs.

In each case, two of the square-wave pulses of a pulse group emitted by the electrodes are preferably at a distance of 4 μs to 16 μs from one another.

The pulse excitation is advantageously carried out with a pulse frequency of the square-wave pulses emitted by the electrodes of 4 Hz to 8 Hz.

In one embodiment, the control unit is designed to generate one to five, preferably two, prestressing pulses between each two pulse groups in order to generate a prestressing of the excited muscle group. This advantageously overcomes the mechanical inertia of the muscle and better achieves the state of contractive tension.

In particular, the bias pulses have an energy density of 10 mJ to 300 mJ. The bias pulses are preferably delivered in the form of pulse doublets with a spacing of 4 μs between the individual pulses.

A bias pulse has a maximum spacing of 10 µs from the subsequent pulse group.

The object is also achieved by a method for muscle stimulation of the lower extremities, in which a first, a second and a third muscle group of a lower extremity are stimulated with electrical impulses, the impulse excitation being carried out in a cascading manner, characterized in that the first, the second and the third muscle group, electromyography signals are detected and excitation pulses are generated therefrom, the time characteristics of the electromyography signals being synchronized with the time characteristics of the excitation pulses.

In the method according to the invention, too, the three pairs of electrodes are preferably arranged on the muscle pumps of the lower extremities of a person, in particular each pair of electrodes is arranged on a different muscle pump. The muscle pumps are the foot muscle pump, the ankle pump, the calf muscle pump, the popliteal pump, the thigh muscle pump and the inguinal suction pump.

The excitation pulses of the pairs of electrodes are preferably generated by a control unit connected to the pairs of electrodes. For this purpose, the control unit evaluates the electromyography signals detected by the electrodes and transmitted to the control unit and synchronizes the time characteristics of the electromyography signals with the time characteristics of the excitation pulses. Natural time characteristic values are determined from the OEMG measurements and transferred to the control unit by programming. As a result, the natural time characteristics of the musculature correspond to the artificial time characteristics of the activated musculature.

The synchronization is achieved through millisecond-precise programming. Discrete time intervals are assigned to the determined time characteristic values from the OEMG measurements in such a way that the excitation consists of individual, delimited elements and is not a continuous continuum. The area of an OEMG curve Determines the number of individual stimulation pulses within the cycle times of motor units (muscles).

In one embodiment, the control unit limits the amplitudes of the excitation pulses to a maximum of 500 V, the output current to a maximum of 100 mA and the pulse energy of each excitation pulse to a maximum of 300 mJ.

Advantageously, the impulse excitation takes place in impulse groups consisting of several square-wave impulses.

In particular, the impulse excitation takes place in impulse groups of 15 to 30, preferably 20 square-wave impulses with a pause of 0.15 ms to 0.3 ms between the individual impulse groups, the length of the pauses between each two impulse groups varying depending on the determined electromyography signals.

In this case, a pulse group is preferably emitted by the electrodes in each case immediately following the time regime of the determined activity times of a detected electromyography signal.

The pulse excitation advantageously takes place with a pulse duration of the rectangular pulses of 2 μs to 7 μs, preferably 4 μs.

In each case, two of the square-wave pulses of a pulse group are preferably at a distance of 4 μs to 16 μs from one another.

The pulse excitation is advantageously carried out with a pulse frequency of the square-wave pulses of 4 Hz to 8 Hz.

In one embodiment, one to five, preferably two, prestressing pulses are generated between each two pulse groups in order to generate a prestressing of the excited muscle group. This advantageously overcomes the mechanical inertia of the muscle and better achieves the state of contractive tension.

In particular, the bias pulses have an energy density of 10 mJ to 300 mJ and a pulse duration of 2 μs to 7 μs, preferably 4 μs. The bias pulses are preferably delivered in the form of pulse doublets with a spacing of 4 μs between the individual pulses.

A bias pulse has a maximum spacing of 10 µs from the subsequent pulse group.

The innovation consists in the application of an intelligent signal structure working according to a time regime, which controls up to 6 muscle pumps via a bandage with a function. The effective signal effects, e.g. B. on the intensity of the venous return and other systemic effects are greater in comparison with the known procedures and methods of electromedicine. This desired cascaded muscle pump control with a peristaltic function is new, easy to use and very easy to handle.

The invention is explained in more detail below using an exemplary embodiment and an associated drawing.

• 1 die schematische Darstellung einer unteren Extremität mit einer daran angebrachten erfindungsgemäßen Vorrichtung zur Durchführung eines erfindungsgemäßen Verfahrens.

It shows:

• 1 the schematic representation of a lower extremity with a device according to the invention attached thereto for carrying out a method according to the invention.

In 1 a lower extremity is shown schematically with a device according to the invention attached thereto for carrying out a method according to the invention.

A first pair of electrodes 1 is arranged on a first muscle group 5 , a second pair of electrodes 2 on a second muscle group 6 and a third pair of electrodes 3 on a third muscle group 7 . In the 1 only one electrode of each pair of electrodes can be seen. As a possible (only exemplary) embodiment, the first muscle pump is the ankle pump 5', the second muscle pump is the calf muscle pump 6' and the third muscle pump is the thigh muscle pump 7'. Alternatively, individual pairs of electrodes can also be arranged on other muscle pumps, such as the inguinal suction pump 8 , the popliteal pump 9 or the foot muscle pump 10 . It is only relevant that the first pair of electrodes 1 is arranged on the most distally arranged muscle pump of the three selected muscle pumps, the second pair of electrodes 2 is arranged on the middle one of the three selected muscle pumps and the third pair of electrodes 3 is arranged on the muscle pump arranged furthest proximally of the three selected muscle pumps .

The three pairs of electrodes 1, 2, 3 are designed to detect an electromyography signal of the respective muscle group. The three pairs of electrodes 1, 2, 3 are connected to a control unit 4, to which they transmit the respectively detected electromyography signal. The control unit 4 evaluates the transmitted electromyography signals and generates excitation pulses for each pair of electrodes 1, 2, 3, which are transmitted through the electrodes pairs 1, 2, 3 are transferred transcutaneously to the respective muscle group.

The first pair of electrodes 1 emits pulses in time. This is followed by the second pair of electrodes 2 , offset in time, when the first pair of electrodes 1 still emits pulses. Finally, the pulse emission of the first pair of electrodes 1 is interrupted and the third pair of electrodes 3 begins to emit pulses, while the second pair of electrodes 2 is still emitting pulses. Finally, the pulse emission of the second pair of electrodes 2 is interrupted and the first pair of electrodes 1 begins to emit pulses again. In this way, a repeated cascading excitation of the three selected muscle pumps from distal to proximal is realized. Advantageously, this activates the muscle pumps and improves blood flow.

Reference List

1

First pair of electrodes

2

Second pair of electrodes

3

Third pair of electrodes

4

control unit

5

first muscle group

5'

ankle pump

6

second muscle group

6'

calf muscle pump

7

third muscle group

7'

thigh muscle pump

8th

inguinal suction pump

9

popliteal pump

10

foot muscle pump

Claims (6)

Device for muscle stimulation of the lower extremities, having three pairs of electrodes (1, 2, 3) which can each be arranged on a first (5), a second (6) and a third (7) muscle group, the pairs of electrodes (1, 2, 3) designed for the transcutaneous transmission of alternating electrical impulses, and with the three pairs of electrodes (1, 2, 3) realizing successively cascading impulse excitation, and a control unit (4) which is connected to the pairs of electrodes (1, 2, 3), - wherein the pairs of electrodes (1, 2, 3) are designed to capture an electromyography signal and forward it to the control unit (4), and wherein the captured electromyography signals can be evaluated by the control unit (4) and excitation pulses by the control unit (4) can be generated - the time characteristic values of the electromyography signals being able to be synchronized with the time characteristic values of the excitation pulses by the control unit (4), - an impulse excitation takes place in impulse groups of several rectangular impulses, - the control unit (4) is designed to generate one to five, preferably two, preload pulses between two groups of pulses to generate a preload of the excited muscle group and the preload pulses have an energy density of 10 mJ to 300 mJ and a pulse duration of 2 µs to 7 µs, preferably of 4 μs. device after claim 1 , characterized in that the control unit (4) limits the amplitudes of the excitation pulses to a maximum of 500 V, the output current to a maximum of 100 mA and the pulse energy of each excitation pulse to a maximum of 300 mJ. device after claim 1 , characterized in that the impulse excitation takes place in impulse groups of 15 to 30, preferably 20, rectangular impulses with a pause of 0.15 ms to 0.3 ms between the individual impulse groups, the lengths of the pauses between each two impulse groups depending on the determined Electromyography signals vary. device after claim 1 or 3 , characterized in that the pulse excitation takes place with a pulse duration of the rectangular pulses of 2 µs to 7 µs, preferably 4 µs. Device according to one of Claims 1 until 4 , characterized in that in each case two square-wave pulses of a pulse group have a distance of 4 µs to 16 µs from one another. Device according to one of Claims 1 until 5 , characterized in that the pulse excitation takes place with a pulse frequency of the rectangular pulses of 4 Hz to 8 Hz.

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