JPS6141583B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION It is well known that by changing the electrochemical equilibrium in a living tissue, the mechanical state of the tissue can be changed. This type of action occurs constantly in intramuscular tissue. It is also known that changing the concentration of the salt solution surrounding the fibrous tissue causes collagen fibrous tissue, a connective tissue substance, to contract or stretch.

Piezoelectric motion of bones is an example of the reversibility of this principle. The dynamic equilibrium relationship between free calcium and phosphate ions in the blood and bound calcium and phosphate ions in the crystal lattice of hydroxyapatite is due to the deformation potential difference caused by mechanical stress and loading in the fibrous tissue of bone. controlled by

The change in state is caused by the disturbance of the mechanical and chemical equilibrium that exists between free and bound ions. Recovery to the original electrically neutral state is determined by the extent of free ion diffusion and the electrostatic distribution of electrons around the bound ions.

It has been proposed to promote healing of broken bones by alternating current generated by an induction coil mounted on a splint. This splint is
It supports the bone and has an electrode that extends into the gap, such as in a broken bone. It has been found that when using induction splints of this type therapeutically, their effectiveness cannot be fully explained by the electrotherapeutic action of the induced current. In view of the above ideas, it follows that each electrodynamic action (of which the changes in mechanical and chemical equilibrium mentioned above are of this kind) must be accompanied by a magnetic field. . However, it must then be possible to induce chemical and physical reactions within the organism's tissues under the influence of the magnetic field. Experiments conducted to distinguish between the biological effects of electric fields and those of magnetic fields have proven that this idea is correct. It has been found that when an electromagnetic field is applied for a certain period of time and in a limited location, new bone and tissue materials are formed. The generation of new blood vessels was observed under the influence of the magnetic field.

The subject of this invention is based on the above discovery.
An electrical device for promoting the formation of bone and tissue substances.

According to the invention, this problem is solved at frequencies below 150 Hz, preferably from 1 to 65 Hz, especially about 10 to 30 Hz.
This problem can be solved by using an alternator for generating low-frequency alternating current with a frequency of , and a coil connected to the output of this alternator. The shape of the coil is such that it is at least approximately, if not perfectly, adapted to the part of the body in which the generation of new biological tissue is to be promoted and the flow of the material structure to be formed.
Also, when used in conjunction with the device of the present invention, the coil can be fixed to or implanted in a body part, with a coil for concentrating the magnetic field generated by the coil on the body part where the substance is to be formed. It is desirable to have at least one solid element of ferromagnetic material.

The coil is synchronously controlled or waveform-modulated by an electrical signal corresponding to the patient's heartbeat or the normal heartbeat of a healthy person, or an electrical signal that simulates the normal heartbeat. It is necessary to generate a desired magnetic field through the low frequency alternating current.

Very significant curative effects were obtained using this device. For example, the time required for callus to harden after a fracture caused by a major accident could be reduced to half the time it would take under normal conditions. Also, wounds caused by prolonged bed rest were healed or their healing was accelerated.

Embodiments of the present invention will be described below with reference to the accompanying drawings.

The device shown schematically in FIG.
It is equipped with an alternator 10 that supplies low frequency alternating current to. The frequency of this alternating current is below 150 Hz, preferably between 1 and 50 or 65 Hz. In the experiment, a frequency band of 5 or 10 to 30Hz, e.g. 25Hz
It was good. The leading and trailing edges of a half-cycle of alternating current are relatively flat (e.g., rise and decay times are 1/4 to 1/8 of a cycle), so this alternating current
A small sine wave current or triangular wave current with distortion of, for example, 20% or less, preferably 10% or less may be used.

This current may be sinusoidal or triangular pulses of alternating polarity either alternately or with periods of zero current in between. In either case, it is clearly important that the leading and trailing edges of the pulse or half-cycle of the alternating current are relatively flat, that the rise and decay times are preferably 5 m s (for a 50 Hz sine wave) case) significantly larger than, at least 8 to 10
m·s·, preferably 80 m·s·.

A modulation device provided in the alternator 10 allows this alternating current to be superimposed with a high frequency alternating current component and/or a direct current component. The frequency of the high frequency component may be 3 times or 3 to 10 times the fundamental frequency. The alternating current can also be superimposed with a direct current component to make it asymmetrical with respect to its reference axis. Furthermore, the output current can contain subharmonic components of 10% or less.

Magnetic coil 14 is connected to output terminal 12 of alternator 10 . In the illustrated embodiment, the coil 14 is formed as a U-shaped plate-shaped coil by winding an insulated copper tape around a flexible flat magnetic core. Therefore, one turn of the coil consists of two parts bent at 180°, and each of these two parts is
It has oblong U-shaped portions that are relatively close to each other. Such a special shape of the coil makes it possible to generate a magnetic field B in a direction adapted to the structure of the bone and tissue material to be formed. When treating the leg 16 shown by the dotted line in FIG. 1, for example, a thigh with a broken femur, it is preferable to set the direction of the magnetic field B in the direction in which pressure or load is applied under normal conditions.

However, it is preferable to adjust not only the spatial orientation of the magnetic field but also its temporal variation to the state of the tissue. Besides the well-known spatial structure of bones and tissues, temporal changes are also important. The most important temporal variation of internal mechanical influences on the material of a tissue follows the beating of the heart. This is because the rising rhythm and shape of blood pressure waves in a tissue substantially governs the metabolism, including the biochemical and biophysical reactions of the tissue. For this purpose, the systolic blood pressure wave in the area of application of the device regulates and/or controls the rhythm of the alternator 10 and thus of the electromagnetic field generated. This is primarily done with a blood pressure monitor 18 placed near the treatment area, ie between the body area to be treated and the heart.

Trigger pulses generated by the sphygmomanometer 18 in response to the systolic blood pressure wave are activated by the alternator 10 to generate each cycle of oscillations in the output current, or to synchronize the continuous oscillation output current. It can be used inside. Furthermore, the current supply period can also be set using this pulse.

The pulses generated by the sphygmomanometer may also generate an oscillating current at the output of some alternating current generators 10. This output current is generated by a special function generator, for example a magnetic tape device, and its oscillatory waveform is suitable for systolic blood pressure waves, especially in young people with elastic blood vessels. It corresponds to this. The output current curve of the generator can also be controlled by the signal from this blood pressure monitor.

FIG. 2 shows another example of a magnetic field coil that can be used in this device. The coil in FIG. 2 consists of a plurality of plate-shaped coils 14a, the winding of which is shown by the line 20 of the topmost coil. Plate coil 1
4a has a laminated core made of ferromagnetic material, and has a hinge coupling member on the side of the bent portion of the winding. The magnetic field coil 14', consisting of plate coils connected in parallel or in series with each other, can be attached to a part of the body as desired and a magnetic field in the direction indicated by arrow B can be induced in that part of the body. Further, when treating the spinal column with this magnetic field coil, the plate-like coils can be connected to each other at the side edges 15.

The coil 14'' of FIG. 3 is identical in principle to the coil of FIG. 2, except that the flexibly coupled coil 14b has a circular cross-section. However, it can be shaped into an oval or other shape that easily fits the treatment area.

The cylindrical coil shown in FIG. 4, ie, the solenoid coil 14, can also be used as this magnetic field coil.

The winding distribution of the field coil can be asymmetrical if desired to concentrate the magnetic field. For example, a desired magnetic field distribution can be obtained by increasing the winding density of the coils 14', 14'' and 14 toward the inside, or by connecting smaller coils.

Since the inner diameter of the solenoid coil 14 shown in FIG. 4 is large, for example, when used to treat a broken femur, it can be fixed to the entire leg to be treated.
The bones 24 are fastened with Kuntscher nails 26 in a known manner. A bar-shaped magnetic field concentrator 28 made of a ferromagnetic material with high initial magnetic permeability and low residual magnetism, ie, a ferromagnetic material, is inserted into the nail 26. This magnetic field concentrator 28 is
0, it is fixed at the desired position. This concentrator causes the magnetic field to be concentrated at the fracture 32.
The core is lined with an inert polytetrafluoroethylene tube. Several separate magnetic cores may be used, similar to that shown in FIG. Between these magnetic cores, a relatively strong stray magnetic field is generated that reaches into and flows through the fracture gap.
Facilitate the formation of new organizations.

In FIG. 5, a so-called compression screw 3 having an axial hole is shown.
4 is shown. This shaft hole accommodates a ferromagnetic material 36 for magnetic field concentration, which is preferably a soft magnetic material.

FIG. 6 shows an implantable splint or support plate commonly used for the fixation of fractured bones, adapted to be joined by screws. However, in the splint in Figure 6,
A member 40 made of ferromagnetic material is implanted, and this member 40 functions to concentrate the magnetic field generated by the coil on the fracture site.

According to the present invention, since bone and tissue-forming materials can be regenerated in a relatively short period of time, the splint 38, like other supporting members such as nails, can be fairly light. For example, splint 38 may be made of plastic material and used only for fixation of a fracture. This is because the bone quickly recovers to a state where it can support the load placed on it.

Preferably, the support structure is made of organic material, for example cut from animal bone. This protein-free material can be absorbed by the body if necessary, thereby making prognostic treatment much easier. Not only for this purpose,
It is useful to construct fracture support members such as nails, plates, pins or screws from aggregate or synthetic absorbable materials containing calcium or orthophosphates. The ferromagnetic member can also be mounted on a support.

FIG. 7 is another example of a device for magnetic field concentration. The device includes a tube 42 made of an inert material, such as polyethylene, and a small rod-shaped member 44 made of a soft magnetic material with high magnetic permeability in the tube 42.
is embedded. After inserting the rod-shaped member 44,
The size of tube 42 is reduced slightly and members 44 are secured apart from each other. The tube with member 44 is then implanted into the newly forming tissue.

The position of the magnetic cores 44 in the tube 42 of FIG. 7 can also be fixed by spacers 43, such as members made of polytetrafluoroethylene material, arranged between the magnetic cores.

The “bone marrow nail” 26′ shown in FIG.
Like the nail 26 of FIG. 4, it includes a magnetic core 28' for concentrating the magnetic field at the fracture site. Furthermore, the magnetic core has at least one winding in which an alternating voltage is induced by a low-frequency magnetic field. Both ends of the winding are connected to natural platinum iridium electrodes 48 of filament type or laminated type.
These electrodes are either placed on the insulation part 50 of the surface of the nail or are insulated and embedded in the surface of the nail. The alternating current flowing between the electrodes 48 through the fractured portion is
As described for splints, promote healing and callus formation.

A ferromagnetic material with relatively low residual magnetism can also be used instead of a soft magnetic material. The value of this residual magnetism should be chosen to produce a certain degree of polarity, on which the alternating current magnetism induced by the coil is superimposed. A similar effect can be obtained by superimposing a DC component on the AC current applied to the magnetic field coil.

Of course, other coils or magnetic core devices may be used to concentrate the low frequency alternating magnetic field in areas where the formation of biological tissue needs to be promoted. According to the coil having the above-described configuration, the direction of the magnetic lines of force is parallel to the direction of the fibrous tissue or blood vessel to be formed.

At least the surfaces of the components that are likely to come into contact with body substances should be made of physiologically compatible materials.

FIG. 9 shows cases in which the device of the present invention was used (indicated by solid line A) and the conventional method without using it (indicated by broken line B) in the treatment of fracture patients at a certain hospital.
FIG. 2 is a diagram showing the cure rate of The horizontal axis shows the number of times plastic surgery was performed, and the vertical axis shows the cure rate (number of cured patients/total number of patients).

As is clear from this figure, when using the device of this invention, 92 patients (87.6
%) were cured after one plastic surgery, and 11 (10.4%) were cured after one plastic surgery.
%) were cured after two surgeries, and the same two patients (1.9%) were cured after three surgeries, resulting in an overall cure rate of 99.1% with an average of 1.1 surgeries. There was no amputation of the affected area.

On the other hand, when using the conventional method, out of a total of 252 patients, 74 (29.4%) were cured after one plastic surgery, 77 (30.6%) were cured after two surgeries, and 52 (29.4%) were cured after two surgeries. 20.6%) of these 52 patients after 3 surgeries.
Approximately 44% (49 patients (19.5%)) were cured after undergoing 3 to 8 surgeries, and overall, 87.5% (79.2% were cured, 8.3% expected to be cured) after undergoing an average of 2.5 operations. ) was cured. Approximately 10% of cases required amputation of the affected area.

Even by a simple comparison of the above results, it can be estimated that there is a good healing effect when the device of the present invention is used.

[Brief explanation of the drawing]

FIG. 1 is a schematic diagram showing the configuration of one embodiment of the device of the present invention, FIGS. 2 and 3 are perspective views of various types of magnetic coils used in the device of the present invention, and FIG.
Figure 5 is a longitudinal cross-sectional view of a broken femur with a medullary nail, i.e., a bone marrow nail, including a device for applying a magnetic field used in conjunction with the coil in the device of the invention;
The figure is a schematic diagram showing a state in which a pressure screw having a magnetic field concentration device is attached to a bone to be treated when using the device of the present invention, and FIG. 6 is a diagram showing a splint in which a magnetic core for magnetic field concentration is embedded. FIG. 7 shows an implantable device for magnetic field concentration; FIG. 8 shows a "cancer nail" with a magnetic core for magnetic field concentration and induced currents in the bone; FIG. FIG. 9 is a diagram showing the effect of using the device of the present invention in treating a patient with a fracture. 10... Generator, 12... Output terminal, 14...
Magnetic coil, 16... Part of body, 26... Kiyuncha nail containing magnetic field concentrator 28, 32... Fractured part.

Claims (1)

[Claims] 1. A coil for generating a low-frequency alternating current magnetic field, a device having a control input terminal and supplying a low-frequency alternating current of 150 Hz or less to the coil, and a device coupled to the control input terminal of the device to supply a control signal to the device. The control device converts the heartbeat of a patient obtained by a blood pressure monitor into an electrical signal, or a train of electrical pulses obtained by converting the heartbeat of a healthy person into an electrical signal. A device that outputs an electrical pulse train obtained by conversion or an electrical pulse train simulating the above-mentioned normal heartbeat as a control signal,
The control signal modulates the waveform of the low-frequency alternating current or the waveform of the low-frequency alternating current is controlled to be synchronized with this signal, and the low-frequency alternating current magnetic field is applied to living tissue for the purpose of treating bone fractures or promoting blood vessel generation. Device.