WO1988000845A1

WO1988000845A1 - Device (apparatus) for treating bone fractures, in particular for treating pseudoarthrosis

Info

Publication number: WO1988000845A1
Application number: PCT/DE1987/000343
Authority: WO
Inventors: Alaa El-Din Otaify
Original assignee: I.H.A.Z. Industrie- Und Handels-Ausstellungs-Zentr
Priority date: 1986-08-07
Filing date: 1987-08-05
Publication date: 1988-02-11
Also published as: EG17822A; EP0291512A1

Abstract

A device for treating incurable bone fractures, in particular pseudoarthrosis, by electrically stimulating bone cells with a direct current of about 20 microamperes has a housing (1) with an avometer (W) connected to the negative pole and which measures separately the current densities generated at each pole. An exchangeable battery supplies the circuit with electricity and is monitored during its use. An acoustic alarm system (C) and an optical control system (B) are integrated for constantly monitoring the working order of the apparatus. The circuit comprises four circuits (N) for generating direct currents applied to the fracturend end of the bone to be healed via cathode leads (2, 4). Another anode lead (3, 4) is laid on the skin of the patient thus closing the circuit between this anode (3) and the negative cathodes (2) in the area of the fracture. Bone fractures considered hitherto as incurable, in particular pseudoarthrosis, have been treated with great success with this apparatus.

Description

Apparatus (device) arthrosis for the treatment of bone fractures, in particular for the treatment of Pseud- _^.

On the basis of studies and research on the electrical properties of bones, it can be determined that the bones of living beings have two types of electrical potential. On the one hand there are dynamic electrical potentials (piezoelectric potentials) that are based on the morphological shape of a bone, as well as on the influence of mechanical loads (such as tensile and compressive stress) - positive charges are formed on the convex side (plane) the bone, which is under tensile stress and negative charges on the concave side (plane), which is under pressure, (compare; Fukasa, E. and Yasuda, * 1957 _» " 0n the piezo- 5 electric effect of bone ", JD phys. Soc. Jap 12, 1128). On the other hand, there are constant (constant) electrical potentials (bioelectric potentials) which are based on cellular and physiochemical mechanisms of action (compare: Friedenberg, ZB and Brighton, CT, o 1966, "Bioelectric potentials in bone", J. Bone & Joint surg ., vol. 48 a, 915) - one observes the formation of negative charges in the active and vital areas (for example in the area of the epiphysis and metaphysis of a bone) and positive charges in the 5 areas which are less active and are less thick (for example in the area of the diaphysis of a bone).

The constant electrical potentials (bioelectric potentials) are increased in the broken parts of a bone; they gradually decrease with progressive bone healing and fracture healing until after the

* (or JoSocAα.) final healing of the fracture return to normal values.

This increase in the permanent (bioelectrical) potentials helps the broken bones to heal quickly.

On the basis of the studies mentioned, a research group has studied the influence of low electrical currents on cell stimulation. The first scientist who then applied this methodology to animals was the o j apanic scientist Jasuda (see above

Quotation).

Based on these. Experiments he was able to determine that bone formation (0 steogenesis) is or is favored in the negative poles.

5 The present invention is based on the following principal

Starting point.

With the increasing use of modern means of transport, the complicated breaks have increased significantly. There are often broken bones that often exist for more than a year and have remained incurable for as long.

The reason for this is to be seen in the fact that the broken link has no possibility of movement and therefore measures the generation of dynamic (piezoelectric) voltages and the electrical charges which result from the movement sequence and the influence of tension and pressure on the

The basis of the mechanical stresses arise.

Since the traditional methods for the treatment of incurable bone fractures by inserting plates, _N ägeln and bone patches have failed, one has specifically concentrated on the other side of the mysterious bones. Our

Procure bones in such a way that they form positive and negative electrical charges, as well as dynamic (piezoelectric) and constant (bioelectric) voltages (potentials). Since the negative charges lead to cellular activities (interactions), fixing (determining) and generating (generating) these 10 charges on the incurable bone fracture can lead to cell stimulation, which then helps the fracture to heal.

The object on which the present invention is based is to provide a device or a device of the generic type, with which, on the basis of the above knowledge, the healing of broken bones in humans is made possible in the first place under certain circumstances.

In principle, this object is achieved by proposing a device of the type mentioned which has the following features in the form of a simple and compact (hand) device:

With the device, the dose of the negative electrical charges, which is necessary for the treatment of incurable fractures, is defined, fixed and kept constant; the appropriate shape for the electrical sign is selected at the same time. (The biological activities of the cells are investigated using isotopes, as is their resonance for the external electrical charges).

The device maintains the appropriate dose of the electrical charges without reduction, in spite of the change in temperature in the human body. per due to the bone formation on the negative poles. (This is achieved by means of a self-regulating *, the transistor circuit which maintains the desired current strength during the three-month treatment period).

The device guarantees the uninterrupted (constant) supply of the appropriate dose of electrical charges during the treatment period. This is done by means of an acoustic and an optical alarm system in order to warn the patient acoustically if the current at one pole (at any negative pole) fails due to an interruption in a direct current circuit, and to signal the patient to display a light cell belonging to the optical alarm system 5, which is the fault location.

With the device, the generated (generated) current strength is measured at all four negative poles. Each of the four poles can be switched on separately by an external o avometer. (In order to facilitate the use of this device by the orthopedic surgeon, who is not very familiar with the use of the avometer, the device is equipped with an internal micro-avometer to separate the generated current 5 for each negative pole and directly by four

To be able to measure the changeover switch, and to measure the differences in the battery voltage when using a fifth changeover switch).

It has been shown that a direct current of 20 micro-amperes is the most suitable current for the treatment of the fractures to be healed. (To treat so-called congenital bone fractures, an alternating current with a period of 1 second is used instead of a direct current of 2o AiA.) However, it has also been shown that the incurable bone fractures, in which artificial joints are inserted, do not react to the treatment with the electrical stimulation of the bone cells, which has been found by investigations with isotopes.

The percentage healing ratio of bone fractures that remained unhealed for more than a year, in the treatment of which traditional methods such as plates, nails and bone patches were used, is 93 _» 3o percent in 3o examined and with that

G es treated cases. (Only two cases did not respond to the treatment because, as stated above, there was an artificial joint; the result was proven by means of isotopes.)

1 The invention is explained below with reference to the drawing. This shows in

1 shows a complete device for the treatment of incurable bone fractures by using electrical stimulation of the bone cells by means of low-° (light) direct current;

FIG. 2 shows the electrical circuit arrangements or circuits used in the device according to FIG. 1;

3 shows an application example for a device according to FIG. 1 .

25 Fig. 1 shows the complete structure of the electrical rule

Device for stimulating bone cells. It consists of a rectangular housing box 1 with the device dimensions - length x width x height approximately 10 x 6 x 2.5 cm (centimeters). In the upper part of the housing, the device contains a micro avometer (measuring device for current and

Voltage), which is approximately the same distance from both sides of the housing. and which is connected to the negative poles (cathode) 2 in order to generate the current strengths generated at each negative pole (at each cathode) 2 to be measured separately and directly by means of a switch 1o, 11, 12, 13 of the switching unit N provided for each circuit - compare FIG. 2. Another switch 0 of the viewing unit N is used to measure the voltage difference (voltage deviation) of the battery during the use (operation) of the device. The micro-avometer has a display which is subdivided for the ranges 1 to 100 micro-amperes and 1 to 10 volts; the ikro-Avometer is marked with the reference symbol w.

The device contains a display H which tests (monitors) the battery during operation. In addition, the device comprises an acoustic alarm system (loudspeaker) C and four optical (lighting) control systems. The acoustic alarm system warns the patient when one of the four direct current circuits which generate the direct current is interrupted. One of the light-emitting diodes 15, 16, 17, 18 (compare diodes D_, according to FIG. 2) of a light-emitting diode line B indicates the point of failure or the interrupted direct current circuit.

Five connecting lines (wires) 4 are connected to the device. One of these connecting lines 4 is the positive pole (is connected to the positive pole), which is connected to a thin rectangular anode plate 3 et ^ 5 w with the dimensions 4 x 2.5 cm. This sheet 3 is placed and fixed on the patient's skin when the device is used. The other connecting lines 4- are the negative poles (are connected to the negative poles); these lines are connected to a Kirschner needle (Kirschner wire) 2 with a thickness of approximately 1.2 mm (millimeters). This Kir¬schner needle is covered with an insulating jacket made of polytetrafluoroethylene (trade name TEFLON), up to a distance of about 1 cm from the tip; this tip is inserted (inserted) at the bone fracture (in the area of the bone fracture).

The device is operated by a (alkaline) battery with approximately 9 volt operating voltage, which has its special place in the device and which has a special one

Cover on the back of the device (the housing) is replaceable.

FIG. 2 shows the electrical circuits which explain (disclose) the complete circuit structure of the device according to FIG. 1. This circuit consists of four

Transistor circuits A, four transistor circuits B, one circuit C and one circuit D.

The circuit A forms the direct current source and consists of a variable resistor M- (with 5 approximately 100 kohm) and a transistor ₁ (for example of the type BF 244; this is an NPN silicon transistor for example from the company Texas Instruments or Valvo), which are connected to an (alkaline battery S with a battery voltage of about 9 volts. This circuit o A generates a direct current of about 20 microamps, regardless of a change in resistance in the human body (of the patient) due to the formation of bones in the region of the negative poles This is achieved by the self-regulating properties with regard to keeping the desired (required) current constant with the transistor T ₁ (of the BF 244 type).

Circuit B forms the optical control system. It consists of a transistor _ (for example of the type BC 1o8; this is an NP transistor for low-frequency pre and driver stages, for example from the Siemens company) as a changeover switch (switching transistor), Current passage (current flow) in circuit B allows (opens) when the corresponding (coupled) circuit A of the direct current source is interrupted. The circuit B also consists of two resistors M ₂ 5 and M- ₂ (both about 47o Ohm), and a transistor T (for example of the type BC 1o9; this is an NPN transistor for low-frequency pre- and driver stages, for example from Siemens). This group (this circuit part) is connected to a light-emitting diode D ₁ (light cell) o which lights up in the event of an interruption in the assigned circuit A and indicates this (to the faulty circuit).

Circuit C forms the acoustic alarm system. It warns acoustically in the event of an interruption of any of the four circuits A and consists of a transistor T 1 (for example of the type B ¹ C 10 7; this is an NP transistor for low-frequency preliminary and driver stages for Example from Siemens), two serially connected diodes D 2 ₀ and O _ and an automatic o L autton (acoustic generator) G, which is an acoustic

Emits signal.

The circuit D serves as a test circuit for checking the transistor operation (the transistor functions) and consists of two resistors M, (with about 47o Ohm) 5 and H r (with about 6o kOhm), a basis (one base) for the transistor mounting K and a light emitting diode

Since all of the above-mentioned transistors are fastened to bases (on bases), it is easy to take these transistors out (“to be removed”) and to place them on the transistor base (the mounting base) K of test circuit D. The light-emitting diode D, luminous then if the checked transistor is OK _ _$ _

(fully functional). This test circuit D is used for simple maintenance and testing of the entire device according to FIG. 1, without having to resort to a specialist.

5 The circuit arrangement shown in Fig. 2 also shows the arrangement of the micro-Avo eters W, as well as the display H for the B tterie voltage and the group of four switches 1o, 11, 12, 13 of the switching unit, which indicates the current intensity generated Measure each negative pole o separately, and the changeover switch 0, which measures the difference in the battery voltage during use (during operation).

With regard to the connection of the circuits mentioned to one another and the connection to the battery, 5 is explicitly referred to the drawing in FIG. 2.

3 shows the use of the device according to the invention for the treatment of broken bones, in particular of so-called pseudarthroses, with regard to the surgical handling.

3 shows a fracture of a bone to which the four cathodes 2 of the device are attached or implanted. These cathodes 2 are each implanted in pairs on the end faces of the 5 break point, specifically obliquely to these end faces; the cathodes 2 are inserted so far through cannulas guided through the patient's flesh adjacent to the fracture that the tips of the cathodes 2 protrude in the free area between the bones to be connected; these tips are the areas left free when the cathodes are encased. - 1o -

The clamping connection boxes 5 are fixed between the cathodes 2 and the connecting lines 4 on the surface of the broken limb or bone, that is to say on the skin. The connecting lines 4 themselves then lead to the device, which the patient can conveniently insert into the pocket due to the minimal dimensions; Of course, the device can also be fixed with a strap.

Claims

Patents to sayings

1. Device (device) for the treatment of incurable bone fractures by using electrical stimulation of the bone cells by means of (light) direct current 5 of (approximately) 20 micro-amperes, characterized in that the device consists of a housing which is in the upper part the front panel has an avometer (ammeter / voltmeter) (W) on. the negative poles (cathodes 2) is connected in order to measure the current strengths generated at each pole separately and directly by means of a switch (switching unit N) for each circuit (see FIG. 2) that an (alkaline) battery An operating voltage of about 9 volts is provided, which has its special place in the device and which can be exchanged via a special cover on the back of the device, such that a changeover switch (0) for measuring voltage difference Reference (voltage deviations) of the battery in use (during operation) is provided that a display (H) is provided which tests (monitors) the battery during operation, that an acoustic alarm system (C) and four optical 5 control systems are provided are, wherein the acoustic alarm system (C) warns the patient in the event of an interruption of one of the four DC circuits (A), and wherein the optical control system (B) over light t- or diodes indicates the fault location and the interrupted circuit that five outer connecting lines (4) are provided, one of which is the positive pole, the one on thin rectangular (anode) leaflets (3) of about 4 x 2.5 cm, which is to be placed on the patient's skin and whose four further connecting lines are the negative poles 5, which are attached to a Kirschner needle (2 ) about

1, 2 mm thick are connected with a

I provided a polytetrafluoroethylene insulation jacket

CLOSE, which extends up to _/ about a distance of one cm from the tip, which is inserted into the fracture area of the o bone.

2. Device (device) according to claim 1, characterized in that the electrical circuits used in the device from four circuits (A) for direct current generation, four circuits (B) for generating an optical control signal, a circuit (C) for generating an acoustic alarm signal and a circuit (D) for testing the transistor functions, o where the circuit (A) for generating the direct current consists of a variable resistor of approximately 100 kOHM and a transistor (T ₁ ) ^ . which are connected to a (alkaline) battery (S) of about 9 volts and generate a direct current of about 5 20o micro-amperes, which is kept constant regardless of a change in resistance in the human body due to the formation of bones in the negative poles by the self-regulating property of the transistors ( ₁ ) with a view to maintaining the desired current strength, the circuit (B) for forming the optical control system each consisting of a transistor (T) as a changeover switch which controls the current flow in the circuit ( B) allowed (opens) if the corresponding one (Associated) circuit (A) for generating the direct current is interrupted, consisting of two resistors (M i Mr) of approximately 47 ohms each, and a further transistor (T,) which are coupled to a light emitting diode (DJ) which lights up in the event of the interruption of the coupled circuit (A) for generating the direct current and indicates this, the circuit (C) forming the acoustic alarm system consisting of a fourth transistor (_.) and two Diodes (D ₂ , D- _∑ ) and an acoustic generator (G) and, in the event of an interruption of one of the four circuits (A) for generating the direct current, automatically emits an acoustic alarm signal, the circuit (D ) to check the transistor function in order to facilitate device maintenance without the help of a specialist, consists of two resistors (. with about 47o Ohm, Mswith about 6o o kOh) and a base (a base) for transistor attachment (K), U.N d whereby all transistors are easily detachable attached to bases (bases) and can be placed (plugged) for testing on the base (base) for transistor attachment (K) of the test circuit (D), whereby a light-emitting diode (D in the test circuit ( D) lights up when the transistor being tested is in order, and a micro-avometer (w) is provided for measuring the current and the battery voltage.