JPH02177969A - Stimulating device - Google Patents

Abstract

PURPOSE:To know the reaction of a stimulated part to stimulation and to save labor for setting various levels by extracting the electromyographic waveform of the part, which is stimulated by a stimulation pulse, by the same electrode or the separate electrode arranged near the electrode each time the output of the stimulation pulse is stopped. CONSTITUTION:Stimulation data in a storing means 6 are serially supplied through a stimulation data output means 10 to a multiplexer 11 by an FES computer 5 and in the multiplexer 11, a switch S is successively changed over to an electrode 13a side, electrode 13b side-electrode 13n side. Then, the stimulation data are parallelly supplied to the electrodes 13a, 13b-13n. An electromyographic waveform (v) of the stimulated part reacting to a stimulation pulse (p) is sampled through the same electrode and an electromyographic waveform input means 16. Then, in the FES computer 5, the sampled electromyographic waveform (v) is outputted through a data bus 17 to a display device 18 or recorder 19 and displayed or recorded. Since the electromyographic waveform is monitored by the display device 18 or recorder 19, the muscular fatigue degree and muscular force recovery degree of a patient 12 can be judged with fixed quantity.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to a stimulator for stimulating the nerves and the like of a patient with motor paralysis to make the paralyzed part work.

The present invention detects the remaining functional movements of a paralyzed patient and supplies a digitized control signal to a functional electrical stimulation computer, and the control signal causes stimulation data to be stored in a storage means in the functional electrical stimulation computer. In a stimulator that outputs as a stimulation pulse and stimulates a plurality of electrodes implanted in the paralyzed patient to activate the paralytic function, each time the stimulation pulse output pauses, the area stimulated by the stimulation pulse is By extracting myoelectric waveforms through the same electrode or another electrode placed near the same electrode, it is possible to objectively and quantitatively know the response of the stimulation site to electrical stimulation, and This will save labor in detecting various levels of electrical stimulation (e.g. threshold level, maximum level, etc.) and generating stimulation data suitable for each individual patient, improve safety when using the stimulator, and improve muscle strength of paralyzed patients. This is intended to simplify data correction.

[Summary of the invention]

[Conventional technology] Conventionally, in order to recover the paralyzed limbs of motor paralyzed patients with severe limb paralysis, electromyograms, electroencephalograms, jaws, and shoulders have been used.

Mechanical displacement of the neck, etc. and voluntary biological signals such as voice are combined as operation command signal sources, and signals from detection means (sensors) attached to each of the above parts are used as functional electrical stimulation (Fu-nchion).
al electrical stimulation
:hereinafter referred to as FES) using a computer,
A stimulator that applies electrical stimulation programmed by the above-mentioned FES computer to electrodes implanted near nerves or parts, and causes muscle contractions to perform limb movements intended by the patient. It is disclosed in Japanese Patent Application Laid-Open No. 59160455. This type of FES computer-based stimulation device can activate the motor functions of not only the limbs, but also the respiratory muscles, condylar muscles, genitourinary organs, etc., and is particularly effective against muscle atrophy caused by motor paralysis caused by stroke, lung injury, etc. It has remarkable therapeutic effects on muscle shortening, muscle and joint contractures, bone atrophy, muscle spasticity, and circulation disorders. Various configurations of such stimulation devices have been proposed; for example, Japanese Patent Application Laid-Open No. 61-2
Publication No. 17174 describes a stimulation device (as shown in Fig. 10).
0) is shown. In Figure 10, (31a) ~ (31
n) is the residual voice, joint, and muscle displacement of patients with motor paralysis.

Respiration, biopotentials (electroencephalogram, electromyogram, bioaction potentials).

This is a detection means for detecting various biological signals obtained from other living organisms, and the detection signals from these detection means (31a) to (31n) are converted into detection signals by an analog-to-digital conversion circuit that constitutes a signal processing means (32). It is supplied to the FES computer (33) as a digitized control signal. F
The ES computer (33) stores stimulation data for each control signal in a storage means (34) within the computer, and checks the various control signals inputted by the signal processing means (32) and stores the stimulation data in the storage means (34). Select the stimulation data stored in 34). The stimulation data stored in this storage means (34) is created for each patient by a large-sized development computer 36). That is, the ROM in which stimulation data has been written by a ROM writer (37) is inserted into the storage means (34) of the FES computer (33). F mentioned above
A stimulation pulse train is created based on the stimulation data selected by the ES computer (33), and a plurality of electrodes (35) implanted in the living body are stimulated to activate the paralyzed part.

[Problems to be Solved by the Invention] In general, when using a stimulator, consideration must be given to the biological characteristics unique to individual paralyzed patients, such as variations in individual nerves and muscle groups, and the output characteristics of the stimulator used by a particular paralyzed patient. Since variations and the like must be taken into consideration, the stimulation device (0) in which standard stimulation patterns are stored in advance in the storage means (34) cannot be used as is. Therefore, before using the stimulation device (0), it is necessary to generate stimulation pattern data completely suited to each paralyzed patient. The standards for generating this stimulation pattern data are the threshold level and the maximum level.

Conventionally, when determining the above level, first a stimulation pulse is generated for one electrode, then the output of the stimulation pulse is increased, and the response of the stimulation region to the electrode is visually observed. The level at which the movement begins is set as the threshold hold level, and the level at which the movement of the stimulated region reaches saturation t FJ b is set as the maximum level. Thereafter, the above-mentioned levels are sequentially set for all electrodes in the same way, and stored in the ROM (37) or storage means (34) based on the threshold hold level and maximum level related to all electrodes. The stimulation pattern data is being corrected. With this conventional method, it is not possible to objectively and quantitatively know the response of the stimulation site, and there are variations in threshold level and maximum level settings depending on the observer or electrode, making it difficult to actually operate the stimulator. In this case, it is difficult to obtain the desired motion, and it is necessary to modify the stimulation pattern data many times, which requires considerable effort and time before the stimulation device can actually be used.

In addition, since the threshold level and maximum level are set while visually checking by the supervisor, even if the stimulation is unreasonable for the patient, especially when setting the maximum level, the degree of stimulation will be reduced. Unbeknownst to the supervisor, there is a risk that when the stimulator is actually used, the patient's muscles may become extremely fatigued.

On the other hand, in order to objectively know the response of the stimulation site, it is possible to attach a displacement sensor or pressure sensor, etc., and set the threshold hold level and maximum level based on the signal from the sensor. It is necessary to attach a large number of the above-mentioned sensors to the patient's body in addition to the stimulation electrodes, which poses the disadvantage of increasing the physiological burden on the patient.

Further, as the patient's muscle strength is gradually strengthened as the stimulator is used, it is necessary to modify the stimulation pattern data, that is, the output of the stimulation pulses, as the patient's muscle strength strengthens. Even in the case of this modification, as described above, the supervisor must sequentially set the threshold level and maximum level of all stimulation sites for all electrodes while visually checking, which is extremely troublesome.

The present invention has been made in view of the above points, and its purpose is to sample the myoelectric waveform of the stimulation site by using the pause time between one stimulation pulse and the next stimulation pulse.
By extracting (extracting), it is possible to objectively and quantitatively know the response of the stimulation site to the stimulation, and accordingly it is possible to save labor in setting various levels. The object of the present invention is to provide a stimulator that does not require physical stress and does not impose a physiological burden on a patient.

[Means to solve the problem]

The stimulator of the present invention detects the remaining functional movements of the paralyzed patient (12) and supplies a digitized control signal to the FES computer (5), which controls the storage means (5) in the FES computer (5). The stimulation data stored in 6) is output as a stimulation pulse (p), and the stimulation data stored in
2) a plurality of electrodes (13a) and (13b) embedded in
)...In the stimulator (A) for stimulating the paralysis function by stimulating (13n), at each output pause time of the stimulation pulse (p), myoelectric waves of the part stimulated by the stimulation pulse or) The shape (■) is the same electrode (13a), (L3
b) ...(13n) or another electrode placed near the electrode.

[Effect]

According to the configuration of the present invention described above, it is possible to feed back the response of the stimulation site due to electrical stimulation to the FES computer (5) as a myoelectric waveform M, and therefore, the FES computer (5) can be fed back to the FES computer (5) based on this myoelectric waveform (v). In 5), it becomes possible to determine the threshold level, maximum level, etc. of the stimulation site, and it is possible to realize automation and labor-saving in level setting and stimulation data setting based on the level.

In addition, stimulation electrodes (13a), (13b)...
・Since it is possible to extract the myoelectric waveform (b) via (13n), there is no need to install a new sensor to detect the response of the stimulation site, which does not place a physiological burden on the patient. There is no.

In addition, the degree of muscle fatigue of the patient (12) can be determined by manually displaying the myoelectric waveform (V) on a subsequent display device (18) or the like.

The degree of muscle recovery can be judged objectively and quantitatively, and the stimulation electrodes (13a), (13b) = =
Since it is possible to instantly know about problems such as disconnection of the (13n), it is possible to quickly and appropriately correct the stimulation pattern data as the patient's muscles strengthen, and to use the stimulator safely. It becomes possible to do so.

〔Example〕

Hereinafter, the present invention will be explained in detail with reference to FIGS. 1 to 9.

As shown in FIG. 1, the stimulator (A) according to this embodiment detects the remaining functions of a patient with motor paralysis (12), such as voice, joints, muscle displacement, respiration, bioelectric potential, etc., that is, a voice detection means. (1a), joint and muscle displacement detecting means (1b), respiration detecting means (1c), biopotential detecting means (1n), etc. are extracted, and a plurality of amplifiers (2) and analog
The signal is supplied to a signal processing means (4) composed of a digital converter (A/D) (3), and one detection signal supplied to the A/D (3) is digitized as a control signal, and this control signal is is supplied to the FES computer (5). The storage means (6) of this FES computer (5), for example R
The AM stimulation data areas (6a) and (6b) store stimulation data for each channel (for example, channels 1-m), and the movement program data area (6c) also stores movement program data, etc. . Reading of such stimulation data can be obtained by specifying the address of the stimulation data using a control signal output from the A/D (3). For example, stimulation data of m channels is transmitted through a plurality of digital-to-analog converters (D/A) (stimulation data output means (9), an amplifier (8), and an isolator (9)).
Electrodes (13a), (13b) = (13) implanted in the body of a paralyzed patient (12) as a pulse train of analog signals from a multiplexer (11) via a multiplexer (10).
n). Electrodes (13a) (13b)...
(13n) is related to nerves and droplet groups, and is designed to stimulate paralyzed areas by stimulating these.

Furthermore, in this example, the above electrodes (1, 3a), (1
3b)...The response of the paralyzed area caused by stimulation by (13n) was measured using the same electrodes (13a) and (13b).
= (13n) as a myoelectric waveform (v), and the myoelectric waveform (■) is sent to an amplifier (14) and an analog-to-digital converter (A/D) via a multiplexer (11).
) (15), and the myoelectric waveform (■) is digitized and supplied to the FES computer (5).

This myoelectric waveform (■) is displayed or edited into print data by the FES computer (5) and transferred to the data bus (17).
via the subsequent display device (18) or recording device (19)
I am trying to output it to .

The multiplexer (11) has two types of changeover switches (S,
), (S, ), and one switch (Sl) is FES
The stimulation data from the computer (5) is transferred to the electrode (13a).
, (13b) ”...When supplying to (13n) (stimulation data output side) (a) and the electrode (13a),
(13b) ... = When supplying the myoelectric waveform CV of the stimulation site extracted in (13n) to the FES computer (5) side (myoelectric waveform input side), it is switched to (b), and, The other switch (S2) has two functions, one is when the switch (S,) is on the stimulation data output side (a), it outputs serially sent stimulation data to all electrodes (13a) at predetermined intervals. )(13b)...(13
The second one is for parallel output to n).
When the switch (S,) is at the myoelectric waveform input end (b),
All electrodes (13a), (13b) = = (13n
) is used to serially supply the myoelectric waveforms taken out at predetermined intervals to the FES computer (5> side).

On the other hand, a stimulation pattern generation computer (20) that generates stimulation pattern data for each paralyzed patient (12);
Storage means (21) included in the computer such as RAM
and a generation device (B) consisting of an external storage device (22), etc.
is normally separated from the stimulation device (A), but as will be described later, a data bus is used between the FES computer (5) and the stimulation pattern generation computer (2o) when generating and modifying stimulation pattern data. (23) and other transmission lines.

This transmission path is not limited to the data bus (23) but also a telemeter.

It may also be performed via infrared rays, electromagnetic coupling means, etc.

Next, the procedure for generating stimulation pattern data, which is performed prior to using the stimulation device (A), will be explained based on the twenty-first flowchart.

First, the start (STo), that is, the stimulation device (A) and the generation device (B) are initialized by turning on the power to the stimulation device (A) and the generation device (B), and then the next step (ST, )
Now, a standard stimulation pattern written on a floppy disk or the like is loaded into the external storage device (22) in the generation device (B). This standard stimulation pattern involves envelope detection of an electromyogram waveform that detects joint muscle displacement, etc. of a healthy person (normal person who is not paralyzed), obtains a pulse train by sampling this enprobe waveform, and then generates a pulse train of each pulse of this pulse train. Stimulation pattern data with voltage amplitude or pulse width as digital values is recorded. This stimulation pattern data is, for example,
Data corresponding to all movements of grasping kelp with hands is recorded. In the next step (STZ), the multiplexer (11) and multiple electrodes ( 13a) - (13n)
In addition, a data bus (
Please contact us at 23). And the next step (s'r+)
Now, control the generator (B) and activate the stimulator (A).
) via the FES computer (5) of paralyzed patients (12
) and vary the output of the stimulation pulse to find the threshold level and maximum level of the individual drop groups. This is the timer (24)
The FES and stimulation pattern generation computers (5) and (20) are automatically found according to the programs in the FES and stimulation pattern generation computers (5) and (20). To explain this operation in detail based on the flowchart in FIG. 3 and the timing chart in FIG.
ST, ), the switch (
The states of Sz) and (S2) are as shown in FIG. After switching to side (a), a certain stimulation pulse CP) is output from the FES computer (5) to one electrode, for example electrode (13a). This stimulation pulse (p) is set at a predetermined frequency, for example, 2 by a timer (24).
It is designed to output in synchronization with 0Hz. (At this time, the pulse synchronization (T) of the stimulation pulse (p) is 50 m5 as shown in FIG. 4).

When one stimulation pulse (1) is output to the electrode (13a), proceed to the next step (ST: +b) and switch the switch (Sl) in the multiplexer (11) to the myoelectric waveform input side (b). This time, the myoelectric waveform (■) of the stimulation site by the stimulation pulse (p) is extracted by the same electrode (13a), and the analog myoelectric waveform (■) is extracted in the subsequent A/D (15). the predetermined sampling period (1)
After being digitized based on the data, it is supplied to the FES computer (5) via the data bus (17).
The stimulation data is supplied from the S computer (5) to the stimulation data generation computer (20) via the data bus (23). This sampling period (1) is determined by a timer (24) such that the frequency becomes a necessary myoelectric waveform band.
00 to several thousand Hz, that is, several hundred μs to several ms. In addition, the switching timing width (I]) of the switch (St) is set to be slightly longer than the pulse width (h) of the stimulation pulse, and the timing period (S) is set to <50 m5, which is the same as the stimulation pulse. . After that, proceed to the next step (ST3c), and calculate the sampled myoelectric waveform (v) in the stimulation data generation computer (20) to determine whether it is at a predetermined level, in this case, a threshold level. . The determination M'J compares, for example, the maximum value of the sampled myoelectric waveform with a predetermined level, and if (max value>predetermined level), it is determined that the threshold level is reached and the process proceeds to step (sTid). On the other hand, if it is the maximum value (predetermined level), it means that the stimulation pulse output is still insufficient, so step (
Proceed to ST, ) to increase the stimulation pulse output by a predetermined amount, return to step (STY, ) again to output the stimulation pulse, sample the myoelectric waveform in step (ST3b), and proceed to the next step (ST3-). to determine whether it is at the threshold level again. This routine continues until the myoelectric waveform (■) reaches the threshold level.

On the other hand, when proceeding to step (ST:+4), the current stimulation pulse output value is stored in the threshold level storage table (21d) in the storage means (21). When storing,
The current electrode NO is stored as an index at a predetermined address in the threshold level storage table (21d). After that, the next step (ST: +r)
Increase the stimulation pulse output by a predetermined amount with , and proceed to the next step (S
The pulse is output at T:+9). In this case as well, the multiplexer (11
) is switched to the stimulation data output side (a). In the next step (STff,,), the multiplexer (11
After switching the switch (Sl) in ) to the myoelectric waveform input terminal (b), sample the myoelectric waveform (■) at the stimulation site. Then, in the next step (s'r, =), it is determined whether the sampled myoelectric waveform (■) is at the maximum level. The judgment criterion is, for example, whether the maximum values of the myoelectric waveforms are approximately the same at regular intervals. That is, the stage at which the amplitude of the myoelectric waveform (■) is saturated is determined to be the maximum level. If judged as the max level,
Proceed to step (STffJ), and if it is determined that it is not at the maximum level, return to step (ST□,) again and increase the stimulation pulse output (step (S
TY, )) and sampling of myoelectric waveforms (step (S
T3. , )) in the same way and repeat step (ST: +
;) to determine whether it is at the max level. This routine is performed until the myoelectric waveform (■) reaches the maximum level, similarly to the setting of the threshold level.

On the other hand, when proceeding to step (s'r3i), the current stimulation pulse output value is stored in the maximum level storage table (21e) in the storage means (21). The storage method is, for example, the threshold level storage table (21d) mentioned above.
). And then the next step (
sT, +b), the threshold level and maximum level are set for all electrodes (13a).

(13b) . . . It is determined whether or not it has been performed for (13n). All electrodes (13a), (13b)・
...If the settings have not been completed for (13n),
Proceeding to step (ST3n), the electrode NO is updated and the stimulation pulse output is initialized, and the step (ST3n) is performed again.
Returning to T:+a), the threshold level and maximum level are set for the corresponding electrode in the same manner as described above.

On the other hand, all electrodes (13a), (13b)...(
13n), proceed to the next step (S T s-), stop the operation of the timer (24) and stop the stimulation pulse output, and then proceed to the flowchart in Fig. 2. Proceed to step (sT,) shown in FIG. In this step (ST), the standard stimulation pattern level stored in the storage means (21) is modified to a pattern suitable for the individual patient in accordance with the found threshold level and maximum level for each stimulation site. For example, the threshold level storage table (
21d) and the max level storage table (21e), respectively, read the stimulation pulse output values corresponding to the electrodes and the above levels, and based on the output values, read out the stimulation pulse output values from the stimulation data area (21e).
a), (21b) and operation program data area (
Correct the data in 21C).

In the next step (ST5), the modified data stored in the stimulation data areas (21a), (21b) and operation program data area (21c) of the storage means (21) is transferred to the FES computer (21) via the data bus (23).
Stimulus data area (6a) of storage means (6) of 5),
(6b) and the operation program area (6c). In this case, although the operation program data is also transferred, only the stimulation pattern data may be transferred. In the next step (ST6), the data bus (23) between the generator (B) and the stimulator (A) is disconnected. Next step (ST
In 7), since the stimulation pattern data has been modified or set in the memory contents in the storage means (6), stimulation pulses are supplied to a specific paralyzed patient (12), and, for example, the stimulation device controls the grasping motion of the hand, etc. Perform it alone to reach the end (ST,).

In the above embodiment, the case where all the stimulation pattern data was set and transferred was explained, but it is also possible to transfer only the modified part of the stimulation pattern data, or a part of the operation program data can be transferred to the generation device (B). ), and only the modified part is sent to the FES computer (5) via the data bus (23).
) of the storage means (6) of the operation program data area (6c
).

Next, a method of correcting the stimulus data generated as described above will be explained.

The need to correct this generated data is due to the fact that, for example, when the stimulator (A) is used for a long period of time, the patient's (12) muscle strength gradually recovers, so that the threshold level and the maximum level at the time of generation are This is because it will show a different level than the original.

Now, this modification method is basically the same as the generation procedure described above, and the only difference is that step (ST, ) is not required, so the details thereof will be omitted.

Note that the above generation method and modification method are assisted by a caregiver up to step (ST2), and from step (ST:l) onwards, the patient (
12) You may do it yourself. In this case, in the detection means, for example, the voice detection means (1a), the patient (12
) utters “generate” or “modify”, and when the FES computer (5) senses the uttered data, the timer (2)
4) and the stimulus data generation computer (20) are operated to automatically perform the procedures after step (STff). In addition, a stimulation device (A) and a generation device (B
), in step (ST5), when the data transfer is completed, a lamp or alarm indicating the completion is outputted, and the caregiver can connect the stimulation device (A) and the generator based on the lamp or alarm. The device (B) may also be separated.

Next, various functions of the stimulation device (A) during use will be explained.

While the stimulator (A) is in use, the FES computer (5) serially outputs the stimulation data in the storage means (6) to the multiplexer via the stimulation data output means (10), as shown in the timing chart of FIG. (11), and in this multiplexer (11), the switch (S2) is sequentially connected to the electrode (13a) side and the electrode (13b) side.
Side: By switching to the electrode (13n) side, the stimulation data is transferred in parallel to the electrodes (13a) and (13b).
...(13n). Now, as shown in Figure 1, the multiplexer (11)
The inner switch (S2) is on the electrode (13a) side, the switch (S2) is on the electrode (13a) side,
When Sl) is on the myoelectric waveform input side (b), for example, when supplying stimulation pulses (p) to the electrode (13a), after switching the switch (S,) to the stimulation data output side (a),
The stimulation pulse Φ) is sent from the FES computer (5) to the electrode (
13a), and then the switch (Sl) is switched to the myoelectric waveform input side), and the myoelectric waveform (■) of the stimulation site that has responded to the stimulation pulse (ρ) is transferred to the same electrode (13a) and the myoelectric waveform At the same time, the FES computer (5) outputs the sampled myoelectric waveform (■) to the display device (18) or recording device (19) via the data bus (17). do. For example, on the display device ff (18), the sampled myoelectric waveform (■) is displayed together with the corresponding electrode number. After a predetermined time (ffi), the switch (Sl) in the multiplexer (11) is switched to the stimulation data output side (a), and the switch (S2) is then switched to the electrode (13b) side, and then the FES computer (5 ) to the electrode (13
A stimulation pulse p) is output for b). After the output, switch the switch (Sl) to the myoelectric waveform input side (b), sample the myoelectric waveform (■) from the electric field ff1H3b), and display it on the display device (18) or recording device (19) in the same manner as described above.
) to display or record the myoelectric waveform (■). Repeat these operations until the electrode (13n) is reached.
When the process is completed, the electrode (13a) returns to output a pulse.
Sampling the myoelectric waveform and displaying or recording the myoelectric waveform.

In this way, by monitoring the myoelectric waveform with the display device (18) or the recording device (19), it is possible to quantitatively determine the degree of muscle fatigue and muscle recovery of the patient (12), as described later. , electrode (13a).

(13b)...(13n) troubles such as disconnection can be easily detected.

That is, in order to judge the degree of muscle fatigue, as shown in the flowchart of FIG. ) and the next step (STI
:I) monitors a predetermined pulse output as a reference,
If the output of the myoelectric waveform (v) with respect to the pulse output is decreasing, it is determined that fatigue is occurring, and the process proceeds to the next step (ST, . . . ). In step (ST, ,), for example, the display device (18
), while the myoelectric waveform corresponding to the electrode number is displayed together with the corresponding electrode number, change the color of the electrode number or display the word "fatigue" near the electrode No. to inform the patient or caregiver. Let them know. In this case, temporarily suspend the use of the stimulator (A) or use the FES computer (
5), and then stop the pulse output in 1. Avoid giving unnecessary stimulation to small children.

On the other hand, if the output of the myoelectric waveform (■) does not decrease,
Judging that the patient is not yet fatigued, continue using the stimulator (A). This judgment applies to all electrodes (13a), (13b
)...This is performed for (13n).

Next, regarding the judgment of the degree of muscle recovery, as shown in the flowchart of Fig. 7, after outputting a stimulation pulse in step (S'r'z-), the next step (STt
Sample the myoelectric waveform (■) at , and proceed to the next step (
In ST23), a certain predetermined pulse output is monitored as a reference, and for example, the maximum value of the myoelectric waveform when the pulse output occurs is stored in the trend data file (6) in the storage means (6).
6d). For example, a trend data file (6d
) is stored in the corresponding address. This trend data file (6d) includes all electrodes (13a), (13b),
...(13n), each has a capacity that can store one month's worth of data.

When the display device (18) requests the trend graph and target electrode number, one month's worth of trend data is read from the corresponding address of the trend data file (6d) using the electrode number as an index, and the trend graph editing program Edit it on the display device (1
8), a trend graph as shown in FIG. 8, for example, is displayed.

The myoelectric integral value on the group axis indicates the progression of the maximum value of the myoelectric waveform with respect to a predetermined pulse output, and as muscle strength recovers, the progression curve takes an upward slope to the right.

Also, time is plotted on the horizontal axis. Note that this progress curve also functions as a guide for when to correct data. That is, as the elapsed curve gradually rises, the current threshold level and maximum level may be different from the levels at the time of generation. Therefore, a value for the amount of change in the maximum value that is considered to need to be corrected is determined in advance, and when the amount of change in the maximum value of the progress curve reaches that value, a message saying "correction required" is displayed on the screen. You can.

Next, regarding the hardware check for electrode breakage, etc., as shown in the flowchart of FIG.
After outputting a stimulation pulse at Tffl), the myoelectric waveform (■) is sampled at the next step (ST, □), and the myoelectric waveform (■) is normal at the next step (STi:+). Determine whether the data was sampled. The criterion for this judgment is, for example, if a certain electrode is disconnected, the stimulation site corresponding to that electrode will not respond, or even if it does, the myoelectric waveform (■) will not be input, so the myoelectric waveform (■) related to that stimulation site will not be input. The shape (■) does not represent a myoelectric waveform that responded to the stimulation pulse at a normal position. in this case,
It is determined that there is an abnormality and the process proceeds to the next step (ST34). In this step (STj4), the color of the electrode No. is changed to red, for example, while the myoelectric waveform (■) corresponding to the electrode No. is displayed on the display device (18) together with the electrode No. , to notify the person or the attendant of the disconnection failure by blinking it. Also,
Preferably, a warning is output together with the above display. This judgment applies to all electrodes (13a), (13b)
... is performed for (13n).

As described above, according to this example, the myoelectric waveform related to the stimulation site is sampled from the same electrode using the pause time of the stimulation pulse output, so the threshold hold level and the maximum level are determined by the stimulation data generation computer ( 20), it becomes possible to judge objectively and quantitatively, and as a result, it is possible to automatically set the above-mentioned level and generate stimulation data suitable for each individual patient. You can save labor.

Further, periodic data correction as the patient's muscle strength is strengthened by using the stimulator (A) can be automatically performed in the same way as in the above generation case, and it is also possible to save labor for data correction.

In addition, when using the stimulator (A), the myoelectric waveform (■) is
The subsequent display device (18) via the S computer (5)
Alternatively, by monitoring with the recording device (19), it is possible to quantitatively judge the patient's degree of muscle fatigue, degree of muscle recovery, etc., and it is also possible to easily discover troubles such as disconnection of electrodes.

Further, in the above embodiment, the stimulation electrodes (13a), (1
3b) Since the myoelectric waveform (■) is extracted from (13n), there is no need to install a new sensor to monitor the reaction of the stimulation site due to electrical stimulation, and this reduces the physiological burden on the patient. I don't have to worry about it.

In the above embodiment, the myoelectric waveform is transferred to the stimulation electrode (13a).
, (13b) ... (13n), but it may be taken out via another electrode placed near these electrodes.

〔Effect of the invention〕

Since the present invention is structured like a silver type, it is possible to objectively and quantitatively know the response of the stimulation site to electrical stimulation, and it is possible to detect various levels of electrical stimulation at the stimulation site and to adjust it to each patient. It is possible to save labor in generating suitable stimulation data, improve safety when using the stimulator, and simplify data correction as the patient's muscle strength increases.

[Brief explanation of the drawing]

Fig. 1 is a block diagram showing the configuration of the stimulation device according to this embodiment, Fig. 2 is an example flowchart showing the stimulation data generation procedure, Fig. 3 is an example flowchart showing the level setting procedure, and Fig. 4 is the data generation procedure. Fig. 5 shows the timing chart of stimulation pulse output and myoelectric waveform sampling when using the stimulator, Fig. 6 shows the procedure for monitoring the degree of muscle fatigue. An example of a flowchart, FIG. 7 is an example of a flowchart showing a procedure for monitoring the degree of muscle recovery, FIG. 8 is an example of a trend graph, FIG. 9 is an example of a flowchart showing a procedure for monitoring electrode disconnection, etc., and FIG. FIG. 2 is a block diagram showing a conventional example. (A) is a stimulation device, (B) is a generation device, (4) is a signal processing means, (5) is an FES computer, (6) is a storage means, (10) is a stimulation data output means, and (11) is a multiplexer. , (12) is a paralyzed patient, (13) is an electrode, (1
6) is myoelectric waveform input means, (17) is a data bus, (1
8) is a display device, (19) is a recording device, (20) is a stimulation pattern generation computer, (21) is a storage means, (
22) is an external storage device, (23) is a data bus, (24)
) is a timer.

Claims (1)

[Claims] A control signal obtained by detecting the remaining functional movements of a paralyzed patient and digitized is supplied to a functional electrical stimulation computer, and the control signal causes stimulation stored in a storage means in the functional electrical stimulation computer. Outputs data as stimulation pulses,
In the stimulator for stimulating a plurality of electrodes implanted in a paralyzed patient to activate a paralytic function, each time the stimulation pulse output pauses, the myoelectric waveform of the region stimulated by the stimulation pulse is detected using the same electrode or A stimulation device characterized in that extraction is performed via another electrode placed near the electrode.