JP2903407B2 - Biostimulator for promoting bone growth - Google Patents

Description

Description: FIELD OF THE INVENTION The present invention relates to a biological stimulating device, and more particularly to a biological stimulating device for applying a low-frequency current to a living body to promote bone growth.

[Conventional technology]

It is known that bone tissue has bioelectric properties and changes its shape temporarily when stimulated by applying pressure, generating a DC potential which is a factor of bone growth.

The generation of this DC potential and the mechanism by which the DC potential promotes bone growth have not been well elucidated at present. However, since the growth or recovery part in bone tends to be negative, there has been an attempt to apply a negative voltage to the bone by an electrical method to promote the growth or treat the damaged part. Many have been done conventionally.

Such electrical methods can be broadly divided into two types, one of which is, for example, JA Spadaro (JASp
adaro), "Clinical Orthopaedics and Researc
h) ", No. 122, pp. 325-332 (1977), etc., a pair of electrodes made of a noble metal such as platinum or gold are embedded or inserted into a living body around bone. With
By applying a pulse voltage to the pair of electrodes, bone growth is promoted.

The other is, for example, EL Bassett (AL
Bassett et al), Science, 184
Vol., Pp. 575-580 (1974), a coil means is brought into contact with a suitable place outside the body surrounding a bone, and a pulse voltage is applied to the coil means to generate a pulse waveform in the bone. By applying the induced current, the bone growth is promoted.

Of these, the former method requires that the electrodes be buried or removed in the living body by surgery with bleeding before and after the operation, causing a great deal of physical pain to the patient,
Surgery itself has a serious disadvantage in that it can reduce vitality of the living body and, on the contrary, slow down bone growth. In addition, when treating a fracture by this method, for example, the patient must be energized for about 10 hours a day for one to two months. It is a great burden not only for the patient but also for the therapist and the nurse to attach the stimulator directly to the inconvenient body of the patient during this entire period. Further, there is a danger that the diseased part may be infected with a bacterium when the electrode is buried or removed, or heavy metals in the electrode may be oxidized, and heavy metal ions harmful to living organisms may be released into the body.

On the other hand, although the latter method has the advantage of not requiring a surgical procedure for implementation, it is difficult to generate an effective amount of induced current in a living body itself. On the contrary, there is a disadvantage that the treatment period is prolonged, and a large coil means and an oscillator are necessarily required, which is not common.

[Problems to be solved by the invention]

In view of such a situation, the present inventor has focused on the ratio of the positive voltage component to the negative voltage component of the stimulation voltage in the energization treatment, repeated tissue culture experiments, animal experiments, and clinical experiments, and implanted electrodes in the living body. A study was conducted on a biological stimulator capable of effectively promoting the growth of bone without the need for sacrifice.

[Means for solving the problem]

As a result, the ratio of the positive voltage component to the negative voltage component is about 0.1: 1
It has been found that stimulation voltages in the range of about 0.5: 1 to about 0.5: 1, preferably about 0.2: 1 to 0.3: 1, exert a significant bone growth promoting effect when energized to the body.

In addition, since such a stimulation voltage is extremely effective even with a small amount of current, the intended purpose is achieved by energizing the electrode in contact with the skin surrounding the bone without embedding the electrode in the living body. I found that I got it.

That is, the present invention provides a stimulus voltage generating means for generating a stimulus voltage having a ratio of a positive voltage component to a negative voltage component in a range of about 0.1: 1 to 0.5: 1, The gist of the present invention is a structure of a living body stimulating device for promoting the growth of bone, which is constituted by an electric conduction means.

[Function of the invention]

The stimulus voltage generating means in the present invention, for example, as shown in FIG. 2, the ratio of in the first wave and a positive voltage component e _p and the negative voltage component e _n stimulus voltage alternating positive and negative about 0.1 : 1 to 0.5:
1, preferably an electrical means for generating a stimulation voltage in the range of about 0.2: 1 to 0.3: 1, usually a pulsed stimulation voltage.

Especially, stimulation voltage is a stimulation voltage of the pulse waveform, the duration tau _n of the negative voltage component e _n in the first wave of the pulse of about 0.001 to 0.1 seconds, preferably from about 0.002 to 0.05
Seconds, also the duration tau _p is the duration of the positive voltage component e _p tau _n
It has been found that when a biphasic action potential waveform is about 1.1 to 2.0 times, desirably about 1.4 to 1.6 times of the above, an extremely high bone growth promoting effect can be achieved by supplying electricity to the living body.

Biphasic action potentials are usually observed in stimulated nerves. One wave consists of a pair of positive and negative voltage components as shown in FIG. 2, and both voltage components show a sharp spike. 5 is a pulse-like voltage waveform having the following. The low frequency treatment device described by the present inventor in, for example, Japanese Patent Application Laid-Open No. 1-56060 is suitable as the stimulation voltage generating means of the present invention.

By the way, in general, when you stimulate and excite nerves,
For a certain period of time (refractory period) there is no excitement for the next stimulus. Therefore, the frequency of the stimulation voltage that can be stimulated by energizing the living body depends on this refractory period, and in the case of normal energizing treatment, the frequency that can be stimulated by energizing the living body is about 40.
It is said that the upper limit is 0 to 1,000 Hz. Also,
Even with a stimulation voltage in such a frequency range, although a good response is shown for a short time from the start of energization, the response to the stimulation gradually decreases as the living body adapts, and the desired bone growth promoting effect is hardly achieved. Become. Such adaptation exerts a kind of anesthetic action, and although effective in reducing pain due to muscle stiffness, neuralgia, etc., bone tissue does not show growth under a constant stimulation. Based on these findings, we examined the effect of various frequencies of stimulation voltage with a ratio of positive voltage component to negative voltage component in the range of about 0.1: 1 to 0.5: 1 on the living body to stimulate bone growth. However, usually, about 1/400 to 10 seconds,
Desirably, a very significant promotion of bone growth is observed in the range of about 1/100 to 1 second, and the frequency of the stimulation voltage is changed periodically or randomly, more preferably, periodically within the above range. When this was done, a more pronounced bone growth promoting effect was observed. Also, it has been found that it is desirable to change the magnitude and / or the frequency of occurrence of the stimulation voltage periodically or randomly as well as the frequency.

In order to periodically change the frequency of the stimulus voltage, for example, as an oscillation circuit for oscillating the stimulus voltage, an oscillation circuit whose oscillation frequency changes according to the base bias voltage, such as a blocking oscillation circuit, is used. ,
If necessary, for example, by combining a time constant circuit, a filtering circuit, a modulation circuit, a clamp circuit, etc., with a suitable oscillation circuit such as a multivibrator, a voltage such as a rectangular wave, a sine wave, By generating a changing voltage and supplying this voltage as a base bias voltage or a power supply voltage of the oscillating circuit, a pulse train in which the pulse interval and / or the magnitude of the stimulus voltage increases or decreases stepwise or continuously in a constant cycle. Obtainable.

Also, for example, the appearance frequency of pulses as described in Masaharu Shinagawa et al., "Sasebo National College of Technology Research Report", Vol. 19, pp. 37-40 (1982), is changed for each section, When the sequence of the frequency and the sequence of the duration of the same frequency approximately follow the so-called "1 / f fluctuation rule", the decrease in the response of the living body to the stimulation voltage can be significantly reduced. In this case, for both the frequency series and the continuous series, for example, based on a series with 1 / f fluctuations collected from long-term frequency fluctuations of old and new classic songs, a certain frequency range and duration range are equally proportional to appropriate stages. And store them in the frequency sequence storage unit and the holding time storage unit, respectively, refer to the storage of the both, and control the signal from the clock oscillator to sequentially generate alternating pulses having positive and negative voltage components. I just need. Then, the alternating pulse is applied to the voltage-current converter via the interface and the output regulator, and the output of the high-voltage power supply is controlled so that the pulse current is supplied between the pair of electrodes.

In addition, for pulse voltages such as a biphasic action potential, a rectangular wave, a semilunar wave, a triangular wave, an exponential wave, a progressive wave, and a stab wave, the ratio of the positive voltage component to the negative voltage component in one wave and the ratio When the effect of promoting bone growth was examined, the ratio was about 0.1:
When the ratio is less than 1 or exceeds approximately 0.5: 1, it has been found that not only the desired effect of promoting bone growth is not achieved even when electricity is applied to the living body, but also undesirable side effects such as pain and dry skin are caused. .

In addition, the relationship between the ratio of the positive energy in a single repetitive panel wave to the negative energy and the effect of promoting bone growth and side effects was further investigated.
If the energy in the positive direction is equal to the energy in the negative direction,
Preferably, the ratio of the positive energy to the negative energy is set to be about 0.1: 1 to 1: 1, more preferably about 0.2: 1 to 0.6: 1. It was determined that there was virtually no side effect such as pain or inflammation due to energization, and the treatment could be performed extremely comfortably.

The stimulation voltage obtained in this manner may be applied to the living body by ordinary energizing means, and as the energizing means, an electrode conductor generally used for low-frequency treatment can be used.

That is, at the output terminal of the stimulus voltage generating means, if necessary, via an output transformer, a coupling capacitor, a crank circuit, an amplifier circuit, a low voltage circuit, a constant current circuit, a buffer circuit, an overcurrent prevention circuit, and the like. A pair of electrode conductors is connected, and the side of these conductors that functions as an inductive conductor at the time of energization is placed at a predetermined site in the living body, and the side that functions as an uninductor at the time of energization is placed in another appropriate position. The stimulus voltage may be applied between the two conductors in a state in which the stimulus voltage is in contact with the probe.

The biostimulator of the present invention exhibits a remarkable remarkable bone growth promoting effect even with a small amount of electricity, and it is not necessary to embed the electrodes in the living body around the bone unlike the conventionally known biostimulators. Depending on the shape, area, condition, etc. of the part to be
For example, a band, pad, roller, flat plate, rod, sphere, brush, or needle-shaped electrode conductor may be applied to the skin of a living body as necessary, such as a belt, band, string, suction cup, and suction. This is extremely convenient because it can be detachably formed by providing attachment means such as a dropper.

The method of energization depends on the purpose of energization, the condition of bones to promote growth, and individual differences in the living body. What is necessary is just to energize. For example, when energizing the living body during the growth period to promote the development of the limbs, it is about 0.1 to 5 hours daily, preferably about 10 minutes to 2 hours per part, for fracture, bone atrophy, and bone disease. In the case of treating a false joint trouble, the power may be supplied continuously or intermittently for about 1 to 15 hours, preferably about 8 to 12 hours every day.

Thus, by using the biostimulator of the present invention, in addition to fractures, bruises, sprains, senile bone atrophy, disuse bone atrophy, bone atrophy such as nervous bone atrophy, rickets ,
Ossification deficiency, arthritis, osteomyelitis, bone tuberculosis, bone syphilis, fibrous osteomyelitis, bone disease such as bone tumor, periodontal disease such as alveolar pyorrhea, bone damage due to false joint trouble, bone damage, pain, Significant effects are achieved in repairing and / or reducing inflammation.

Furthermore, the living body stimulator of the present invention can promote the development of the limbs by energizing the growing animal or human body. For example, in the case of athletes such as judo, karate, sumo wrestling, rugby, etc., there are cases where muscle development hinders the growth of bone tissue and height does not grow as desired. In such a case, a well-balanced development of the limbs can be promoted by regularly using the living body stimulator of the present invention for a living body during the growth period. In addition, when the biological stimulator of the present invention is used regularly for infants, it is possible to prevent bone growth failure.

In any of the above cases, the current supplied by the biological stimulator of the present invention may be, for example, a warm bath or a warm bath by a steam sauna or the like, for example, bone growth promoting factors, growth hormone, calcitonin, lymphokine preparations such as vitamins, hormones, etc. It has been found that the use of an agent and a chemotherapeutic agent achieves a remarkably high bone growth promoting effect.

By using the device of the present invention, it is possible to achieve a remarkable effect of promoting bone growth without embedding electrodes in a living body around the bone as in a conventionally known electrically-conductive biostimulator. Presumably promote bone growth very effectively.

Also, in the state of the art, a biological stimulator such as the present invention can be made extremely compact, and a conventional biological stimulator that induces an induced current in a living body to promote bone growth. The device itself does not become bulky as in the above.

 Hereinafter, the present invention will be described with reference to the illustrated embodiments.

〔Example〕

FIG. 1 is a circuit diagram showing an example of the stimulation voltage generating means used in the present invention.

Blocking oscillator circuit consisting of a transistor Tr ₁ and the transformer T in the figure is for generating a pulsed voltage biphasic action potential waveform as shown in Figure 2.
A pair of Shirubeko P, series connected diodes D ₁ and resistor R ₁ to E is to adjust the size of at positive voltage component e _p a stimulation voltage oscillation of the blocking oscillator circuit, a positive voltage component
e _p the ratio of the negative voltage component e _n is from about 0.1: 1 to 0.5: 1, preferably from about 0.2: 1 to 0.3: is for one of the ranges.

Consisting of transistor Tr ₂ and transistor Tr _3, etc.
The output terminal of the multivibrator oscillates a square wave as shown in Fig. 3 lower frequency than the stimulation voltage is connected to an input terminal of an emitter follower having a time constant made such transistors Tr _4, also, the emitter and since the output terminal of the follower is connected to the base of the in transistor Tr ₁ in the blocking oscillator circuit, the transistors Tr 3 and a positive voltage region and the zero-voltage region as shown in FIG time interval tau ₁ to ₁ , the square wave appearing at a tau ₂ is supplied as a base bias voltage. In general, the oscillation frequency of the blocking oscillation circuit depends on the base bias voltage, and the oscillation frequency increases as the base bias voltage increases. Therefore, when a rectangular wave as shown in FIG. , E, pulse trains of biphasic action potential waveforms having different pulse intervals as shown in FIG. 4 are supplied alternately at time intervals τ ₁ and τ ₂ .

FIG. 5, FIG. 6 and FIG. 7 show a pair of conductors used in combination with the stimulation voltage generating means shown in FIG.

FIG. 5 and FIG. 6 show a pad conductor (1), which normally functions as a conductor when energized. The pad guide (1) has a belt member (2) for operating by putting a hand on the upper part thereof, and a cover member (3) made of a non-conductive material such as plastic curved on the opposite side to the belt member (2). ), An electrode (4) formed of a conductive material such as stainless steel attached to the surface of the cover member (3) opposite to the belt member (2) in a plate shape, and a cover covering the electrode (4). A sponge member (5) made of a water-containing material, such as a water-containing cloth or a sponge, which is detachably attached to the member (3). Sponge member (5)
When the pad conductor (1) is immersed in a bathtub or the like, a conductive liquid such as water or an electrolyte solution can freely enter the electrode (4) when the pad conductor (1) is used by immersing the pad conductor (1) in a bathtub or the like. May be provided. (6) is a lead for connecting the conductor to the stimulation voltage generating means, and is electrically connected to the electrode (4).

FIG. 7 shows a gripping guide (7), which normally functions as an unrelated guide when energized.

In the figure, (4) is an electrode formed of a conductive material such as stainless steel in the shape of a hollow cylinder, and a sponge member (5) formed in a bag shape except a part of the tip to which the lead (6) is attached. Is fitted inside.

The method of using the living body stimulating device of this embodiment will be described with reference to FIG. 8. First, a pad conductor (1) and a gripping conductor (7) are provided with a stimulating voltage generating means inside a device body (8).
Then, the sponge member (5) of the pad conductor (1) and the gripping conductor (7) is impregnated with a conductive liquid such as water or an electrolyte solution. After that, while holding and supporting the guide (7) with one hand, the other hand is inserted into the belt member (2) of the pad guide (1) and abuts on an appropriate part of the body. And energize. Power switch SW and variable resistor during energization
Turn the knob (9) that is linked to the VR to set the pad conductor (1)
The stimulus voltage applied to the device may be appropriately adjusted.

Next, the effectiveness of the biological stimulator of the present invention will be described based on clinical experiments performed using the biological stimulator of the above embodiment.

Forearm, rib, lower medulla, collarbone, hand, humerus, femur,
After performing normal reduction and fixation for 121 patients who had a complete or incomplete fracture in the foot, patella, sternum, scapula, spine, pelvis, massage, warm bath, performing post-treatment such as automatic exercise, Figure 1 and tau _n by biostimulation device of the present invention shown in the fifth to seventh figure of about 0.0035 to 0.0041 seconds, e _p / e _n is from about 0.35 to 0.42 seconds, pulse interval in the range of about 3 to 8 Hz A pulsed stimulation voltage having a biphasic action potential waveform that changes in two steps was applied, and the energization treatment was performed in parallel.

The power is supplied by a physiotherapist, nurse or patient under the guidance of a physician or a physician. The patient is energized daily for about 1 to 8 hours while paying attention to the condition of the affected part, and the cure rate (= cured patients / total patients) Number).

As a result, when the electrification treatment was performed using the biostimulator of the present invention, 109 patients (90.0%) were cured after one plastic surgery, and 10 patients (8.3%) were cured twice, out of a total of 121 patients. Healed after 2 surgeries and 2 (1.7%) healed after 3 surgeries, with a total cure rate of 100% achieved with an average of 1.1 surgeries. Further, during treatment, the fractured portion was observed under fluoroscopy by X-ray fluoroscopy. As a result, remarkable callus formation was observed in a very short time from the fracture, and the union after healing was extremely good. There were no cases of amputation.

On the other hand, in the absence of electrification treatment, 26 (26.8%) healed after one plastic surgery and 31 (32.0%) healed after two surgery, out of a total of 97 patients. , 18 (1
(8.5%) healed after three surgeries, leaving the remaining 22
Approximately 41%, including humans (22.7%), underwent 3 to 8 surgeries, 73.2% were cured, and 7.1% were expected to be cured. Also,
About 9% of cases required amputation.

Even from a simple comparison of the above results, it is presumed that a remarkable cure can be achieved by the current-carrying treatment using the biological stimulator of the present invention.

In addition to fracture patients, bruises, sprains, senile bone atrophy,
Disuse bone atrophy, bone atrophy such as nervous bone atrophy, rickets,
It was also found to be remarkably effective in reducing inflammation and pain caused by bone diseases such as ossification deficiency, arthritis, osteomyelitis, bone tuberculosis, bone syphilis, fibrous osteomyelitis, bone tumor, and pseudoarthritis.

〔The invention's effect〕

As described above, the biological stimulator of the present invention uses a stimulation voltage in which the ratio of the positive voltage component to the negative voltage component is in the range of about 0.1: 1 to 0.5: 1. It can promote bone growth.

Further, since the stimulation voltage energizes the living body to promote bone growth extremely effectively, it is not necessary to embed the electrode in the living body around the bone unlike the conventional living body stimulating device. Therefore, according to the living body stimulating device of the present invention, it is sufficient that the current applying means is brought into contact with the skin only when electricity is supplied, and the trouble of attaching the stimulating device over the entire period of treatment as in the conventional living body stimulating device is eliminated. Not only is it unnecessary to use expensive electrodes made of noble metals such as platinum and gold.

In addition, since the stimulation voltage used in the present invention hardly causes side effects such as pain, burns, and dry skin even when the living body is energized, it can be performed very comfortably even when energizing for a relatively long time.

Therefore, the device of the present invention promotes the growth of limbs in a living body during growth, prevents bone damage based on bone dysgenesis, and furthermore, fractures, bruises, sprains, senile bone atrophy, disuse bone atrophy,
Bone damage, inflammation and / or pain based on bone diseases such as bone atrophy such as neurogenic bone atrophy, rickets, ossification deficiency, arthritis, osteomyelitis, bone tuberculosis, bone syphilis, fibrous ostitis, bone tumors, etc. It can be used very advantageously for repairing or reducing.

The present invention has such a remarkable effect, and is a great invention for contributing to the art.

[Brief description of the drawings]

FIG. 1 shows a circuit diagram of an embodiment of the present invention. FIG. 2 is a waveform diagram of a biphasic action potential wave generated by a blocking oscillation circuit, FIG. 3 is a waveform diagram of a base bias voltage oscillated by a multivibrator, and FIG. 4 is a waveform of a stimulation voltage generated between conductors. FIG. 5 to 7 show a conductor used in the present invention, FIG. 5 shows a plan view of the pad conductor, FIG. 6 shows a side view of the pad conductor, and FIG. 7 shows a part of the gripping conductor. Figure 3 shows a cutaway side view. FIG. 8 is a perspective view showing a use state of the biological stimulator of the present invention. To explain the signs and symbols in the figure, R is a resistor,
C is a capacitor, Tr is a transistor, T is a transformer, D
Is a diode, VR is a variable resistor, SW is a switch, B is a battery, (1) is a pad conductor, (2) is a belt member, (3)
Is a cover member, (4) is an electrode, (5) is a sponge member,
(6) is a lead, (7) is a grip conductor, (8) is an apparatus main body in which stimulation voltage generating means is provided, and (9) is a knob.

Claims (3)

(57) [Claims] 1. A stimulation voltage comprising a pulse train having a ratio of a positive voltage component to a negative voltage component in one pulse in a range of about 0.1: 1 to 0.5: 1, wherein a duration of the negative voltage component is about 0.001.
And a stimulation voltage generating means for generating a stimulation voltage having a duration of the positive voltage component in a range of about 1.1 to 2.0 times the duration of the negative voltage component, and applying the stimulation voltage to a living body. A biological stimulator for promoting bone growth, comprising a power supply means for supplying power. 2. The biological stimulator for promoting bone growth according to claim 1, wherein the pulse interval of the stimulation voltage changes periodically. 3. A stimulus voltage generating means comprising: a first oscillating circuit for generating a stimulus voltage; and an oscillating circuit for generating a pulse voltage having a frequency lower than the stimulus voltage. The biological stimulator for promoting bone growth according to claim 2, further comprising a second oscillation circuit connected to an input end of the first oscillation circuit.